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1 DRAFT_EO12866_IUR Mods_FRM_2010-12-30.doc

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3 Revised to address Interagency Comments received under EO 12866 Review.

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5 BILLING CODE 6560–-50–-P

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9 ENVIRONMENTAL PROTECTION AGENCY

10 40 CFR Parts 704, 710, and 711

11 [EPA–-HQ–-OPPT–-2009–-0187; FRL– 8833–5-XXXX-X]

12 RIN 2070–-AJ43

13 TSCA Inventory Update Reporting Modifications

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15 AGENCY: Environmental Protection Agency (EPA).

16 ACTION: Final rule.

17 SUMMARY: EPA is amending the Toxic Substances Control Act (TSCA) section 8(a) 

18 Inventory Update Reporting (IUR) rule. The IUR enables EPA to collect and publish 

19 information on the manufacturing, processing, and use of commercial chemical 

20 substances and mixtures (referred to hereafter as chemical substances) on the TSCA 

21 Chemical Substance Inventory (TSCA Inventory). This includes current information on 

22 chemical substance production volumes, manufacturing sites, and how the 

23 chemicalschemical substances are used. This information helps the Agency determine 

24 whether people or the environment are potentially exposed to reported 

25 chemicals.chemical substances. EPA publishes submitted IUR data that is not 

26 Confidential Business Information (CBI). EPA is amending the IUR rule to require 

27 submission of information that will better address Agency and public information needs, 

28 improve the usability and reliability of the reported data, and ensure that data are 
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29 available in a timely manner. EPA is requiring electronic reporting of IUR information 

30 and modifying IUR reporting requirements, including certain circumstances that trigger 

31 reporting, the specific data to be reported, the reporting standard for processing and use 

32 information, and CBI reporting procedures. 

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

34 Federal Register].

35

36 ADDRESSES: EPA has established a docket for this action under docket identification 

37 (ID) number EPA–-HQ–-OPPT–2009-2009-0187.. All documents in the docket are 

38 listed in the docket index available at http://www.regulations.gov. Although listed in the 

39 index, some information is not publicly available, e.g., Confidential Business Information 

40 (CBI) or other information whose disclosure is restricted by statute. Certain other 

41 material, such as copyrighted material, is not placed on the Internet and will be publicly 

42 available only in hard copy form. Publicly available docket materials are available in the 

43 electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the

44 OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 

45 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 

46 Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through 

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

48 Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–

49 0280. Docket visitors are required to show photographic identification, pass through a 

50 metal detector, and sign the EPA visitor log. All visitor bags are processed through an X51 ray machine and subject to search. Visitors will be provided an EPA/DC badge that must 

52 be visible at all times in the building and returned upon departure.
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54 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

55 Chenise Farquharson, Chemical Control Division (7405M), Office of Pollution

56 Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 

57 NW., Washington, DC 20460–-0001; telephone number: 202-564-7768; e-mail address: 

58 farquharson.chenise@epa.gov.Farquharson.chenise@epa.gov.

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

60 Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–-1404; e-mail address: 

61 TSCA-Hotline@epa.gov.

62

63 SUPPLEMENTARY INFORMATION:

64

65 I. Does this Action Apply to Me?

66

67 You may be potentially affected by this action if you manufacture (including 

68 manufacture as a byproduct) or import, for commercial purposes, chemical substances 

69 listed on the TSCA Inventory (under TSCA section 3, ―import‖ is included in the 

70 definition of manufacture). Potentially affected entities may include, but are not limited 

71 to:

72 • Chemical substance manufacturers and importers (NAICS codes 325 and 

73 324110; e.g., chemical substance manufacturing and processing and petroleum 

74 refineries).

75 • Chemical substance users and processors who, in addition to manufacturers 

76 described abovein this section, may manufacture a byproduct chemical substance 
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77 (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal 

78 manufacturing, and semiconductor and other electronic component manufacturing).

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

80 readers regarding entities likely to be affected by this action. Other types of entities not 

81 listed in this unit could also be affected. The North American Industrial Classification 

82 System (NAICS) codes have been provided to assist you and others in determining 

83 whether this action might apply to certain entities. If you have any questions regarding 

84 the applicability of this action to a particular entity, consult the technical person listed 

85 under FOR FURTHER INFORMATION CONTACT.

86 II. Background

87

88 A. What Action is the Agency Taking?

89 In this action, EPA is promulgating several amendments to the IUR rule, taking 

90 into consideration comments received on the proposal.proposed rule. The amendments 

91 were proposed on August 13, 2010 (75 FR 49656)(FRL-8833-5) (Ref. 1). The 

92 amendments contained in this final rule, as well as the TSCA Inventory update provisions 

93 of 40 CFR part 710 subpart C unchanged by these amendments, appear in a new part, 40 

94 CFR part 711. The following is a brief listing of the primary amendments to the IUR. 

95 These amendments are described in more detail in Unit II.EIII.

96 1. EPA is amending 40 CFR 710.59, which appears in the new part 711 as 

97 §711.35, to require electronic reporting of the IUR data, using an Agency-provided, web98 based reporting softwaretool (e-IURweb) to submit IUR reports through the Internet to 

99 EPA‘s Central Data Exchange (CDX). After the final rule‘s effective date [see DATES], 

100 paper submissions will no longer be accepted.
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101 2. EPA is adding a new definition section, which appears in the new part 711 as 

102 §711.3; revising the definition for manufacture and site; and making other needed 

103 definitional modifications and additions.

104 3. EPA is amending 40 CFR 710.53, which appears in the new part 711 as 

105 §711.20, to change the reporting frequency from every 5 years to every 4 years.

106 4. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as 

107 §711.8(a), to modify the method used to determine whether a manufacturer (including 

108 importer) is subject to IUR reporting. The method wouldwill be effective after the 

109 20112012 IUR submission period. Subsequent to 20112012, reporting is required if the 

110 production volume of a chemical substance met or exceeded the 25,000 pound (lb.))

111 threshold in any calendar year since the last principal reporting year (e.g., 20102011).

112 5. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as 

113 §711.15(cb), to eliminatereplace the 300,000 lb. reporting threshold for processing and 

114 use information, thereby requiring all submitters of non-excluded chemical substances to 

115 report by phasing in a lower threshold. For the 2012 submission period, the threshold for 

116 reporting processing and use information in all parts ofis 100,000 lb. In subsequent

117 submission periods, the IUR reporting form (Form U).threshold will be 25,000 lb. 

118 6. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as 

119 §711.8(ab), to eliminatereplace the 25,000 lb. threshold for certainspecific chemical 

120 substances that are the subject of particular TSCA rules and/or orders, thereby requiring 

121 manufacturers (including importers) of such. The new reporting threshold for these

122 chemical substances to report underis 2,500 lb, which is effective for the IUR rule, 
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123 regardless of the production volume2016 submission period and subsequent submission 

124 periods. 

125 7. EPA is amending 40 CFR 710.46, which appears in the new part 711 as §711.6, 

126 to make chemical substances for which an enforceable consent agreement (ECA) to 

127 conduct testing has been made under 40 CFR part 790 ineligible for exemptions, to 

128 provide a full exemption from IUR requirements for water, and to remove polymers, 

129 which are already fully exempt from the partially exempt list of chemical substances at 

130 40 CFR 710.46(b)(2)(iv), which appears in the new part 711 as §711.6(b)(2)(iv). 

131 8. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as 

132 §711.15(cb), to modify the reporting requirements for certain manufacturing data 

133 elements. Specifically, manufacturers (including importers) are required to report:

134 ia. The name and address belonging to the parent company. 

135 iib. The current Chemical Abstracts (CA) Index Name, as used to list the 

136 chemical substance on the TSCA Inventory, as part of the chemical identity. 

137 iiic. For the 2012 submission period only, the production volume for calendar 

138 year 2010. 

139 d. The production volume for each of the years since the last principal reporting 

140 year. This requirement will be effective after the 2012 reporting cycle (i.e., for the 2016 

141 submission period and subsequent submission periods).

142 ive. The volume of a manufactured (including imported) chemical substance used 

143 at the reporting site. 

144 vf. Whether an imported chemical substance is physically present at the reporting 

145 site.
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146 vig. The volume directly exported and not domestically processed or used.

147 viih. When a manufactured chemical substance, such as a byproduct, is being 

148 recycled, remanufactured, reprocessed, or reused.

149 9. EPA is replacing the ―readily obtainable‖ reporting standard used for the 

150 reporting of processing and use information required by 40 CFR 710.52(c)(4), which 

151 appears in the new part 711 as §711.15(b)(4), with the ―known to or reasonably 

152 ascertainable by‖ reporting standard. 

153 10. EPA is amending 40 CFR 710.58, which appears in the new part 711 as 

154 §711.30, to require upfront substantiation when processing and use information required 

155 by 40 CFR 710.52(c)(4), which appears in the new part 711 as §711.15(b)(4), is claimed 

156 as CBI.

157 11. EPA will disallow confidentiality claims for processing and use data elements 

158 identified as not ―known to or reasonably ascertainable by‖ (40 CFR 710.52(c)(4)), which 

159 appears in the new part 711 as §711.15(b)(4).

160 12. EPA is revising the list of industrial function categories for the reporting of 

161 processing and use information. EPA is also amending 40 CFR 710.52(c)(4)(i)(C), which 

162 appears in the new part 711 as §711.15(b)(4)(i)(B), to replace the 5-digit NAICS codes 

163 with 48 Industrial Sectors (IS).

164 13. EPA is amending 40 CFR 710.52(c)(4)(ii), which appears in the new part 711 

165 as §711.15(b)(4)(ii), to revise the list of consumer and commercial product categories for 

166 the reporting of consumer and commercial use information. EPA is also requiring the 

167 separate reporting for consumer or commercial categories and the reporting of the 
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168 number of commercial workers reasonably likely to be exposed to the subject chemical 

169 substance. 

170 14. EPA is eliminating the gaps in the ranges used to report concentration in 40 

171 CFR 710.52(c)(3) and (c)(4), which appear in the new part 711 as §§711.15(b)(3) and 

172 (b)(4).

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

174 EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and 

175 keep current an inventory of chemical substances manufactured or processed in the 

176 United States. This inventory is known as the TSCA Chemical Substance Inventory 

177 (TSCA Inventory). The Agency maintains the Master Inventory File as the authoritative 

178 list of all the chemical substances reported to EPA for inclusion on the TSCA Inventory. 

179 In 1977, EPA promulgated a rule published in the Federal Register issue of December 

180 23, 1977 (Ref. 12) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory 

181 of chemical substances in commerce at that time. In 1986, EPA promulgated the initial 

182 IUR rule under TSCA section 8(a) at 40 CFR part 710 published in the Federal Register

183 issue of June 12, 1986 (Ref. 23) to facilitate the periodic updating of information on 

184 chemical substances listed on the TSCA Inventory and to support activities associated 

185 with the implementation of TSCA. In 2003, EPA promulgated extensive amendments to 

186 the IUR rule, published in the Federal Register issue of January 7, 2003 (2003 IUR 

187 Amendments) (Ref. 34) to collect exposure-related information associated with the 

188 manufacturing, processing, and use of eligible chemical substances and to make certain 

189 other changes.
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190 Section 8(a)(1) of TSCA authorizes the EPA Administrator to promulgate rules 

191 under which manufacturers and processors of chemical substances must maintain such 

192 records and submit such information as the EPA Administrator may reasonably require. 

193 Section 8(a) of TSCA generally excludes small manufacturers and processors of chemical 

194 substances from the reporting requirements established in TSCA section 8(a). However, 

195 EPA is authorized by TSCA section 8(a)(3)(A)(ii) to require TSCA section 8(a) reporting 

196 from small manufacturers and processors with respect to any chemical substance that is 

197 the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that 

198 is the subject of an order in effect under TSCA section 5(e), or that is the subject of relief 

199 granted pursuant to a civil action under TSCA section 5 or 7. The standard for 

200 determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR 

201 part 710, which appears in the new part, 40 CFR part 711, is found at 40 CFR 704.3. 

202 Processors are not currently subject to the rules at 40 CFR part 710, which appears in the 

203 new part 40 CFR part 711.

204 This document promulgates the IUR as 40 CFR part 711, which includes 

205 provisions copied from the existing IUR regulations in 40 CFR part 710 subpart C that 

206 are not substantively changed as a part of this rulemaking, and the new IUR provisions in 

207 this final rule. Failure to comply fully with any provision of this final rule will be a 

208 violation of TSCA section 15 and will subject the violator to the penalties of TSCA 

209 sections 16 and 17.

210

211 C. What Was the TSCA Inventory Update Reporting (IUR) Rule Prior to These 

212 Modifications? 
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213 The IUR rule, as modified by the 2003 Amendments, required U.S. manufacturers 

214 (including importers) of chemical substances listed on the TSCA Inventory to report the 

215 identity of chemical substances manufactured (including imported) during the reporting 

216 year in quantities of 25,000 lb. or greater at any single site they own or control to EPA 

217 every five years. IUR data were collected five times prior to the 2003 Amendments: 

218 1986, 1990, 1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. 

219 EPA uses the TSCA Inventory and data reported under the IUR rule to support many 

220 TSCA-related activities and to support a number of EPA and other Federal health, safety, 

221 and environmental protection activities. The Agency also makes the data available to the 

222 public, to the extent possible given CBI claims. 

223 Persons manufacturing (including importing) chemical substances were required 

224 to report information such as company name, site location and other identifying 

225 information, production volume of the reportable chemical substance, and exposure226 related information associated with the manufacture of each reportable chemical 

227 substance. This exposure-related information included the physical form and maximum 

228 concentration of the chemical substance and the number of potentially exposed workers. 

229 Several groups of chemical substances were and will continue to be generally excluded 

230 from IUR reporting requirements: e.g., polymers, microorganisms, naturally occurring 

231 chemical substances, and certain natural gas substances.

232 Manufacturers (including importers) of chemicalschemical substances in larger 

233 volumes (i.e., 300,000 lb. or greater manufactured (including imported) during the 

234 reporting year at any single site) were required also to report certain processing and use 

235 information for the 2006 submission. This information includes process or use category; 
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236 NAICS code; industrial function category; percent production volume associated with 

237 each process or use category; number of use sites; number of potentially exposed 

238 workers; and consumer/commercial information such as use category, use in or on 

239 products intended for use by children, and maximum concentration.

240 The 2006 submission was the first instance where manufacturers (including 

241 importers) of inorganic chemical substances were required to report under the IUR rule. 

242 For the 2006 submission only, inorganic chemical substances were partially exempted 

243 from the IUR rule, and manufacturers of such chemicalschemical substances were 

244 required to report the manufacturing information and not the processing and use 

245 information, regardless of production volume. Under the previous rule, for future 

246 collections (i.e., for 2011 or 2016 IUR collections, etc.), the partial exemption for 

247 inorganic chemicalschemical substances would have no longer been applicable and 

248 submitters would have reported in the same manner as was required for organic 

249 chemicalschemical substances, including processing and use information. In addition, 

250 starting with the 2006 collection and for future collections, specifically listed petroleum 

251 process streams and other specifically listed chemical substances were partially exempt, 

252 and manufacturers of such chemical substances were not required to report processing 

253 and use information. These partial exemptions will continue in subsequent submission 

254 periods under the IUR as revised todayin this final rule (including 2011the 2012 IUR

255 collection), for as long as the chemical substances remain on these partial exemption lists 

256 §§711.6(b)(1) and (b)(2).
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257 Non-confidential data, including both searchable and separately downloadable 

258 databases, and the 2006 IUR data summary report are available to the public on the IUR 

259 website (http://www.epa.gov/iur).

260 D. Why is the Agency Amending the IUR Rule?

261 EPA has modified the IUR rule to meet four primary goals:

262 1. To tailor the information collected to better meet the Agency‘s overall 

263 information needs.

264 2. To increase its ability to effectively provide public access to the information.

265 3. To obtain new and updated information relating to potential exposures to a 

266 subset of chemical substances listed on the TSCA Inventory.

267 4. To improve the usefulness of the information reported.

268 EPA believes that expanding the range of chemical substances for which more in-depth 

269 processing and use information is to be reported and adjusting the specific reported 

270 information, the method and frequency of collecting the information, and CBI 

271 requirements will accomplish these goals.

272 These goals are supported by a policy outlined in TSCA section 2, which is that 

273 ―adequate data should be developed with respect to the effect of chemical substances and 

274 mixtures on health and the environment and that the development of such data should be 

275 the responsibility of those who manufacture and those who process such chemical 

276 substances and mixtures‖ (TSCA section 2(b)(1)). Modifications to the IUR 

277 requirements by the 2003 Amendments provided many improvements to the data 

278 collected through that rule, and EPA‘s efforts to use the 2006 IUR data identified areas 

279 where further improvements are needed. The modifications described in this final rule 
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280 change some of the reporting requirements in an effort by EPA to ensure the required 

281 information is properly reported and that the information in the Agency‘s database 

282 reflects the information provided in the IUR reports; increase the usability of the 

283 collected information; increase the availability of information for the public; and focus 

284 reporting on information that is most needed by the Agency.

285 In addition, these changes will enable EPA and other Federal agencies to improve 

286 their risk screening capabilities, enabling them to better assess and manage risk, and 

287 improve public awareness of basic information about a large number of chemical 

288 substances.

289 EPA provided reporting software for the 2006 IUR submission period and 

290 encouraged electronic reporting through the Internet, using the Agency‘s CDX. EPA‘s 

291 experience with populating the IUR database and with using the 2006 IUR data provided 

292 insight into how well both the reporting software and submission methods worked. For 

293 instance, because of validations built into the reporting software, electronic submissions 

294 were able to be quickly assimilated into the IUR database. Other forms of submission 

295 required the documents to be scanned in or hand entered, and resulted in many introduced 

296 errors during the data entry process. Additionally, for the 2006 IUR, certain types of 

297 submissions (e.g., joint submissions) could not be reported electronically. Other 

298 problems, such as incorrect chemical identities, delayed the incorporationinclusion of the 

299 data into the database, resulting in the Agency‘s inability to begin using the 2006 IUR 

300 data and providing public access in a timely manner. The modifications in today‘sthis

301 final rule associated with reporting methods and changes to the reporting software will 
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302 better ensure the information reported to the Agency is accurate and in compliance with 

303 the IUR requirements. 

304 During the development of the 2003 Amendments, the Agency considered the 

305 data accuracy and reliability needed for screening level exposure analyses and took 

306 several steps to ensure the IUR data met those needs. Screening level data need not be 

307 precise, but should be accurate and reliable enough for the Agency to develop screening 

308 level assessments. The 2003 amendments to the IUR rule supplysupplied exposure309 related information the Agency did not previously possess, recognizing that industry has 

310 a greater knowledge than EPA about its own operations and the uses of chemical 

311 substances it manufactures and sells.

312 EPA‘s extensive use of the 2006 IUR data in the Agency‘s Existing Chemicals 

313 Program is consistent with how EPA envisioned the data would be used when the 2003 

314 Amendments were promulgated. In 2007, the Agency began to develop and post 

315 screening-level hazard, exposure, and risk characterizations for high production volume 

316 (HPV) chemicalschemical substances, which are those chemicalschemical substances

317 produced nationally at aggregated volumes of one million lb. or more per year. In 

318 developing these characterizations, EPA identified areas where the IUR data collection 

319 can be improved and enhanced. Improvements would allow EPA to better identify and 

320 take follow-up action on chemical substances that may pose potential risks to human 

321 health or the environment. 

322 During its review of the IUR data, EPA identified numerous examples of CBI 

323 claims where the same or similar information to that claimed as CBI was already 

324 available to the public. In several cases, information on production volume and uses for a 
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325 chemical substance or group of chemical substances was claimed CBI on Form U, while 

326 the same or similar information was submitted voluntarily by the company without such a 

327 claim under the HPV Challenge Program. In those cases, EPA had previously made the 

328 information publicly available through the High Production Volume Information System 

329 (HPVIS) or on EPA‘s Existing Chemicals website. More detailed CBI substantiation 

330 requirements will encourage the correct designation of non-confidential reported 

331 information, thereby facilitating reporting of this information to the public. 

332 EPA Administrator Lisa P. Jackson has made it a priority to strengthen the 

333 Agency‘s chemical management program, including the development of new regulatory 

334 risk management actions, the development of Chemical Action Plans targeting the 

335 Agency‘s risk management efforts, requiring the reporting of information needed to 

336 understand chemical substance risks, and increasing public access to information about 

337 chemical substances (Ref. 45). The IUR provides exposure-related data needed to 

338 understand chemical substance risks. The modifications to the IUR rule will enhance the 

339 capabilities of the Agency to ensure risk management actions are taken on chemical 

340 substances which may pose the greatest concern. More in-depth reporting of the 

341 processing and use data, more careful consideration of the need for confidentiality claims, 

342 and adjustments to the specific data elements are important aspects of this action. By 

343 enhancing the data supplied to the Agency, EPA expects to more effectively and 

344 expeditiously identify and address potential risks posed by chemical substances and 

345 provide improved access and information to the public. 

346 An important and anticipated result of this action is that EPA will receive more 

347 publicly available, non-CBI information, therefore increasing the transparency and public 
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348 accessibility of the chemical substance use, and exposure information and ensuring 

349 consistency with the President‘s policy goals for government reliance on and public 

350 availability of scientific information.

351 E. When is Reporting Required? 

352 EPA promulgated a final rule, published in the Federal Register issue of May 11, 

353 2011, (76 FR 27271) (FRL-8874-2) (Ref. 6) to suspend the 2011 IUR submission period. 

354 EPA suspended the submission period to allow additional time to finalize the proposed 

355 modifications, and to provide sufficient time for companies to comply with the amended 

356 IUR reporting requirements. This action supersedes the suspension of the 2011 IUR 

357 submission period by establishing a new sequence of submission periods, beginning with 

358 an IUR submission period in 2012. For the 2012 IUR, all information reported to EPA in 

359 response to 40 CFR part 711 must be submitted between February 1, 2012 and June 30, 

360 2012. Beginning in 2016 and for each subsequent submission period, the submission 

361 period will begin June 1 and end September 30 (40 CFR 711.20).

362 III. What Are the Revised Requirements of the IUR?

363 EPA is making a number of revisions to the IUR, as described in this unit. The 

364 regulatory text of this document describes the full specific IUR reporting requirements 

365 and includes both the modified and the unmodified portions of the regulatory text (see 40 

366 CFR part 711). EPA has also developed guidance documents with specific reporting 

367 instructions, questions and answers, and case studies, and intends to conduct a webinar to 

368 help potential IUR submitters become familiar with the revised reporting form (Form U) 

369 and amended reporting requirements. Guidance documents and information on the 

370 webinar are available on the IUR website, (http://www.epa.gov/iur.).
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371 A. What technical modifications have been made to the regulatory text? The 

372 Agency is making several technical modification related to moving the regulatory text to 

373 its own section in the CFR. The chemical substances that are covered by the IUR rule are 

374 on the Master Inventory File, which includes chemical substances from the original 

375 TSCA Inventory compilation and those added subsequently through the notice 

376 requirements of TSCA section 5. Because the IUR rule applies to a list of chemical 

377 substances included on the original TSCA Inventory plus additional chemical substances 

378 added subsequently, and because the Agency from time to time has modified the IUR 

379 rule, the Agency believes the regulatory text associated with the IUR rule should be in its 

380 own section in the CFR, distinct from both the original TSCA Inventory rules and from 

381 the TSCA section 5 requirements. 

382 1. Move the IUR regulatory text from 40 CFR part 710, subpart C, to 40 CFR 

383 part 711 and eliminate subpart divisions. Subpart C of 40 CFR part 710, 40 CFR 710.43 

384 to 710.59, contains the IUR regulatory text. EPA is moving all of the subpart C text 

385 from 40 CFR part 710 to a new 40 CFR part 711 and adding a new scope and compliance 

386 section (40 CFR 711.1). 

387 Table 1.—Relocation of 40 CFR 710, Subpart C ProvisionsRegulatory Text

Old CFR Citation New CFR Citation

40 CFR 710.43 40 CFR 711.3

40 CFR 710.45 40 CFR 711.5

40 CFR 710.46 40 CFR 711.6

40 CFR 710.48 40 CFR 711.8

40 CFR 710.49 40 CFR 711.9

40 CFR 710.50 40 CFR 711.10

40 CFR 710.52 40 CFR 711.15

40 CFR 710.53 40 CFR 711.20

40 CFR 710.55 40 CFR 711.22

40 CFR 710.57 40 CFR 711.25

40 CFR 710.58 40 CFR 711.30

40 CFR 710.59 40 CFR 711.35
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388

389 Because all of the text of subpart C was moved to 40 CFR part 711, 40 CFR part 

390 710 no longer has a subpart C. Neither 40 CFR part 710 nor 40 CFR part 711 have any 

391 subparts.

392 2. Consolidate definitions. As part of moving the regulatory text from 40 CFR 

393 part 710, subpart C, to 40 CFR part 711, EPA is consolidating definitions copied from 40 

394 CFR 710.3 and 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropriate 

395 definition is already in place in TSCA section 3 or at 40 CFR 704.3, and an additional 

396 definition of the term in 40 CFR 711.3 was therefore unnecessarily duplicative. The 

397 definitions in TSCA section 3 and at 40 CFR 704.3 are incorporated intoincluded in 40 

398 CFR 711.3, except insofar as 40 CFR 711.3 provides a modified definition of a term also 

399 defined at 40 CFR 704.3.

400 The term mixture is defined in both 40 CFR 710.3 and TSCA section 3. For 

401 purposes of the IUR rule, EPA is incorporatingincluding the definition of mixture from 

402 TSCA section 3. with the definitions at 40 CFR 711.3. The TSCA mixture definition 

403 differs from the definition in 40 CFR 710.3 and 40 CFR 720.3, the regulations used to 

404 determine the chemical substances listed on the TSCA Inventory, in that it does not 

405 specifically address hydrates. A hydrate is a mixture of water and an anhydrous chemical 

406 substance. Because they are mixtures, hydrates are not listed as such on the TSCA 

407 Inventory. For this reason, EPA believes it is superfluous to include a specific discussion 

408 of hydrates in the IUR definition of mixture. Please see the instruction 

409 manualInstructions for the 2012 Inventory Update Reporting (Instructions document) for 

410 additional discussion (Ref. 57).
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411 Unit II.E.3 contains further discussions about changes to specific definitions, in 

412 relation to the modifications included in this final rule. A summary of all IUR-related 

413 definitions is available in the docket (Ref. 68).

414 3. Delete Remove “non-isolated intermediate” definition from 40 CFR 710.3. 

415 EPA added a definition to 40 CFR 710.43 for the term ―non-isolated intermediate‖ as part 

416 of the 2003 Amendments. Subsequently, as part of the IUR Revisions Rule published in 

417 the Federal Register issue of December 19, 2005 (Ref. 79), EPA erroneously moved the 

418 definition to 40 CFR 710.3 from 40 CFR 710.43. EPA is deletingremoving the definition 

419 from 40 CFR 710.3 as this definition was not associated with the original TSCA 

420 Inventory, and therefore does not belong in 40 CFR 710.3. A definition of this term, 

421 codified elsewhere at 40 CFR 704.3, is incorporated intoincluded with the IUR 

422 definitions at 40 CFR 711.3.

423 4. DeleteRemove 40 CFR part 710, subpart B text. EPA is deletingremoving the 

424 regulatory text contained in 40 CFR part 710, 40 CFR 710.23 to 710.39 (subpart B). This 

425 text refers to IUR submission periods of 2002 and earlier and is obsolete. As noted in 40 

426 CFR 710.1, the Agency expressed its intent to remove subpart B once the 2002 update 

427 was complete.

428 5. DeleteRemove superfluous text associated with reporting production volumes. 

429 EPA is deletingremoving the phrase ―provided that the reported figures are within ±10% 

430 of the actual volume‖ from the production volume reporting requirements found in 40 

431 CFR 710.52(c)(3)(iv), which appears in the new 40 CFR part 711 as 40 CFR 

432 711.15(b)(3)(iv). The revised wording would be ―This amount must be reported to two 

433 significant figures of accuracy.‖ The deleted phrase that was removed is superfluous 
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434 because any number reported accurately to two significant figures is within 10% of the 

435 correct value.

436 6. Correct text associated with reporting number of sites and number of workers.

437 EPA is replacing the phrase ―less than‖ with the phrase ―fewer than‖ in the ranges used to 

438 report the number of workers found in the table in 40 CFR 710.52(c)(3)(v), which 

439 appears in the new 40 CFR part 711 as 40 CFR 711.15(b)(3)(vii) and the number of sites 

440 found in the table in 40 CFR 710.52(c)(4)(i)(E), which appears in the new 40 CFR part 

441 711 as 40 CFR 711.15(b)(4)(i)(E). This change makes the phrases describing the ranges 

442 grammatically correct.

443 B. What are the changes to the method of submission? EPA is requiring the 

444 mandatory use of Agency-provided, web-based reporting softwaretool (e-IURweb) and 

445 CDX to submit the completed Form U to the Agency. After the final rule‘s effective 

446 date, EPA will no longer accept paper submissions or electronic media (i.e., as a file on a 

447 CD-ROM) for any IUR submission. 

448 In order to submit electronically to EPA via CDX, individuals acting on behalf of 

449 the submitter must first register with CDX. CDX registration is a requirement for all 

450 electronic submissions using CDX; this requirement predates today‘sthis final rule. EPA 

451 has modified the 2006 electronic signature agreement (ESA) form to identify more 

452 clearly the individual(s) required to sign the agreementESA (Ref. 810). Each IUR 

453 submission must have an authorized official associated with the submission, who is the 

454 person signing the certification statement and submitting the IUR report via CDX. The 

455 authorized official must complete both an ESA and the CDX registration process. 

456 Companies can access the reporting softwaretool upon completion of their CDX 
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457 registration. The instruction manual and other guidance materials are available on EPA‘s 

458 website at www.epa.gov/iur.http://www.epa.gov/iur.

459 C. What definitions have been modified or added to clarify the reporting 

460 requirements? As part of developing the definition section for 40 CFR part 711, EPA is 

461 modifying six definitions associated with the IUR rule and adding four new definitions. 

462 In 40 CFR 704.3 and 40 CFR 710.3, EPA is also modifying the definition of importer by 

463 removing the citation to 19 CFR 1.11. 

464 1. Manufacture and manufacturer. To improve the information submitted 

465 through the IUR rule, EPA is modifying the definition of manufacture by 

466 incorporatingincluding elements from the 40 CFR 720.3 definition for manufacturer. The 

467 Agency is also adding a simple definition for the term manufacturer to 40 CFR 711.3. In 

468 addition to the change to the definition of manufacture, EPA is adding a paragraph (c) to 

469 the regulation at 40 CFR 711.22 to clarify the reporting relationship between the 

470 contracting company and the toll manufacturer. The contracting company and the toll 

471 manufacturer should confer with each other to avoid duplicate reporting, and both the 

472 contracting company and the toll manufacturer are liable if no report is made. EPA 

473 agreed with comments that the "primarily responsible" language that was proposed was 

474 confusing and needed to be revised. As a result, EPA modified paragraph (c) to clarify 

475 that the contracting company and the toll manufacturer should determine among 

476 themselves who should submit the required report for the site. EPA also added ―per site‖ 

477 in two places in paragraph (c) to specify that there is supposed to be one report per 

478 chemical substance, per site. See Unit III.3.bC.2. for further discussion of the site for 

479 contract manufacturing situations.
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480 This final rule defines the term manufacture under the IUR to mean ―to 

481 manufacture, produce, or import, for commercial purposes. Manufacture includes the 

482 extraction, for commercial purposes, of a component chemical substance from a 

483 previously existing chemical substance or a complex combination of substances. When a 

484 chemical substance, manufactured other than by import, is:

485 (1) Produced exclusively for another person who contracts for such production, 

486 and 

487 (2) that other person specifies the identity of the chemical substance and controls 

488 the total amount produced and the basic technology for the plant process, then that 

489 chemical substance is comanufacturedco-manufactured by the producing manufacturer 

490 and the person contracting for such production.‖

491 This final rule defines the term manufacturer under the IUR to mean ―a person 

492 who manufactures a chemical substance.‖

493 2. Site. EPA is amending the definition of site to clarify that the importer‘s site 

494 must be a U.S. address; accommodate manufacturing under contract; and accommodate 

495 portable manufacturing units. See Unit III10III.J. for a further discussion of this final rule 

496 as it relates to importers. 

497 This final rule defines the term site under the IUR to mean ―a contiguous property 

498 unit. Property divided only by a public right-of-way shall be considered one site. More 

499 than one plant may be located on a single site.

500 (1) For chemical substances manufactured under contract, i.e., by a toll 

501 manufacturer, the site is the location where the chemical substance is physically 

502 manufactured.
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503 (2) The site for an importer who imports a chemical substance described in 40 

504 CFR 711.5 is the U.S. site of the operating unit within the person's organization that is 

505 directly responsible for importing the chemical substance. The import site, in some cases, 

506 may be the organization's headquarters in the United States. If there is no such operating 

507 unit or headquarters in the United States, the site address for the importer is the U.S. 

508 address of an agent acting on behalf of the importer who is authorized to accept service of 

509 process for the importer.

510 (3) For portable manufacturing units sent out to different locations from a single 

511 distribution center, the distribution center shall be considered the site.‖

512 3. Electronic-reporting related definitions. EPA is adding two new terms, Central 

513 Data Exchange (CDX) and e-IURweb. The Agency is adding these terms to provide 

514 clarity to the requirement for electronic reporting of IUR data. The term CDX means 

515 ―EPA‘s centralized electronic document receiving system, or its successors.‖ The term e516 IURweb means the ―electronic, web-based IUR softwaretool provided by EPA for the 

517 completion and submission of the IUR data.‖

518 4. Processing and use-related definitions. EPA is amending the definitions of the 

519 terms commercial use and consumer use in order to make them more consistent with the 

520 definitions developed collaboratively by the United States and Canada. See Unit II.E.6.h. 

521 for further information. While the definitions for these two terms differ in their precise 

522 wording from the Canadian version (to preserve the use of terminology defined in IUR 

523 and related regulations), EPA does not expect the basic application of these two terms to 

524 differ from the basic application of the Canadian definitions (Ref. 911). The term 

525 commercial use means ―the use of a chemical substance or a mixture containing a 
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526 chemical substance (including as part of an article) in a commercial enterprise providing 

527 saleable goods or services.‖ Examples included in the 40 CFR 710.43 definition have 

528 been eliminated. The slightly modified definition of consumer use is ―the use of a 

529 chemical substance or a mixture containing a chemical substance (including as part of an 

530 article) when sold to or made available to consumers for their use.‖ The restrictions 

531 associated with where a consumer would use the product have been removed.

532 EPA is adding a definition for the term industrial function. For the 2006 IUR, 

533 EPA defined industrial use and did not define industrial function. The inclusion of both 

534 definitions provides clarity for the industrial processing and use reporting requirements 

535 and makes the Agency‘s requirements consistent with those collaboratively developed 

536 with Canada (Ref. 911). Additional discussion of those requirements is in Unit III.E.6.g. 

537 With this final rule, industrial function means ―the intended physical or chemical 

538 characteristic for which a chemical substance or mixture is consumed as a reactant; 

539 incorporated into a formulation, mixture, reaction product, or article; repackaged; or 

540 used.‖

541 5. Principal reporting year and submission period. As described in Unit II.A., 

542 EPA is changing the reporting cycle from every 5 years to every 4 years and requiring the 

543 reporting of production volumes for each calendar year since the last principal reporting 

544 year. EPA is modifying the terms reporting year and submission period to reflect these 

545 changes.

546 The term reporting year is modified to add the term ―principal‖ and to replace the 

547 word ―information‖ with ―manufacturing, processing and use data.‖ These changes are 

548 to indicate that the principal reporting year is the year in which most of the reported data 
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549 are based. Under the final rule, the principal reporting year is the latest complete 

550 calendar year preceding the submission period. Additionally, EPA is removing the 

551 reference to ―the calendar year at 5–year intervals thereafter‖ and removing the reference 

552 to ―calendar year 2005.‖ With these changes, the term principal reporting year is defined 

553 as ―the latest complete calendar year preceding the submission period.‖

554 The term submission period is modified by deletingremoving the phrase 

555 ―generated during the reporting year.‖ With this change, the definition of submission 

556 period reflects that data for years in addition to the principal reporting year would be 

557 reported. With this change, the definition of submission period means ―the period in 

558 which manufacturing, processing, and use data are submitted to EPA.‖

559 D. Has the reporting frequency been changed? As proposed, EPA has changed 

560 the reporting frequency to every 4 years. The Agency has determined that reporting every 

561 5 years is too infrequent and believes that returning reporting to every 4 years will 

562 provide data sufficiently current to meet Agency and public needs. After the 2011 

563 reporting cycle2012 submission period, the next reportingsubmission period under the 

564 IUR rule will occur in 20152016. The submission period will continue to occur in the 

565 year following the principal reporting year. 

566 E. How have the reporting thresholds changed? Reporting thresholds are used to 

567 determine when IUR reporting is required for a subject chemical substance at a 

568 manufacturing (including importing) site. EPA has made three changes related to the 

569 reporting thresholds:

570 Determination of whether you meet the 25,000 lb. threshold.
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571 EliminationReplacement of the 300,000 lb. threshold for reporting 

572 information in Part III of Form U.

573 EliminationReduction of the 25,000 lb. threshold for certain chemical 

574 substances.

575 1. Method for determining whether a person is subject to IUR reporting 

576 requirements. For the 20112012 submission period, manufacturers (including importers) 

577 are required to report under the IUR rule if they manufacture (including import) a 

578 chemical substance listed on the TSCA Inventory during the principal reporting year (i.e., 

579 20102011 for the 20112012 submission period); the chemical substance is not otherwise 

580 exempt; and the associated production volume (domestically manufactured plus imported 

581 volumes) at a site met or exceeded 25,000 lb. during the principal reporting year (i.e.., 

582 20102011 for the 20112012 submission period).

583 For submission periods subsequent to the 20112012 submission period, the 

584 determination of the need to report is based on whether, for any calendar year since the 

585 last principal reporting year, a chemical substance was manufactured (including 

586 imported) at a site in production volumes of 25,000 lb. or greater. For example, for the 

587 20152016 submission period, it would be necessary to examine the annual production 

588 volumes for the calendar years 20112012 to 20142015 for the site. If the production 

589 volume for a reportable chemical substance were 25,000 lb. or greater for any calendar 

590 year during that four year period, then it would be necessary to report the chemical 

591 substance, unless it were otherwise exempt. For instance, a subject chemical substance 

592 with production volumes of 5,000 lb. in 20142015 and 35,000 lb. in 2012 would be 

593 reported for the 20152016 IUR. Regardless of the 20142015 production volume, in this 
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594 example scenario the 20152016 IUR submission would contain detailed information 

595 based on the production volume during the 20142015 calendar year and production 

596 volume information only for the years 20112012 through 20132014. See Unit III.D.1 of 

597 the proposed rule preamble(Ref. 1) for further discussion. 

598 EPA is finalizing this change because of the mounting evidence that many 

599 chemical substances, even larger production volume chemical substances, often 

600 experience wide fluctuations in production volume from year to year. (See Unit III.D.1 

601 inof the proposed rule.) (Ref. 1).) This can result in the production volume of a chemical 

602 substance exceeding the threshold for several years, then falling below the threshold 

603 during the IUR principal reporting year. EPA believes that using production volume 

604 reporting for all years since the last principal reporting year to determine reporting 

605 obligations will yield a much more accurate picture of the chemical substances currently 

606 in commerce, ensuring proper review under EPA‘s risk screening, assessment, and 

607 management activities and providing better information to the public. This issue is 

608 addressingaddressed further in Unit V.C. of this preamble as well as in the 

609 response―Summary of EPA‘s Responses to public commentsPublic Comments Submitted 

610 in Response to Proposed TSCA Inventory Update Reporting Modifications Rule‖

611 (Responses to Comments document) (Ref. 1312). 

612 2. EliminationReplacement of the 300,000 lb. threshold for processing and use 

613 information. EPA is eliminatingreplacing the 300,000 lb. threshold for processing and use 

614 information, thereby requiring by phasing in a lower reporting threshold. For the 2012 

615 IUR, all submitters of non-excluded chemical substances are required to report 

616 processing and use information in all partsif they manufactured (including imported) 
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617 100,000 lb or more of Form U. a chemical substance in 2011. Subsequent to the 2012 

618 submission period, the reporting threshold will be 25,000 lb (or 2,500 lb for chemical 

619 substances subject to 711.8(b)). EPA is eliminating thisreplacing the 300,000 lb 

620 reporting threshold in order to collect information necessary to complete screening-level 

621 exposure characterizations for IUR reportable chemical substances. EPA is phasing in 

622 the lower threshold in order to give chemical manufacturers time to comply with the 

623 modified reporting requirements. 

624 In order to select a threshold for processing and use reporting, EPA considered the 

625 burden of reporting as well as the Agency‘s needs for processing and use information on 

626 the maximum number of chemical substances. As discussed elsewhere in this preamble 

627 and other supporting documents, EPA identified that the processing and use data received 

628 from the 2006 IUR was not sufficient in part because it did not include information on 

629 many HPV and most moderate production volume (MPV) chemical substances that EPA 

630 was trying to assess. Therefore, in its proposal, EPA proposed lowering the processing 

631 and use reporting threshold from 300,000 lb to 25,000 lb in order to enable the Agency to 

632 collect exposure-related information needed to screen and prioritize the HPV and MPV 

633 chemical substances. EPA received comments suggesting that the Agency adopt a 

634 phased-in approach for reducing the threshold, similar to the approach used for

635 introducing the requirement for reporting information for inorganic chemical substances. 

636 Manufacturers reporting for inorganic chemical substances were provided a one-time 

637 partial exemption for those substances for the 2006 IUR, thereby phasing in reporting. 

638 Other commenters suggested that because reporting of processing and use information for 

639 inorganic chemicals was not required for the 2006 IUR, the industry sector is still 
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640 inexperienced with reporting such information and therefore should be given an 

641 opportunity to report under the existing thresholds. Another commenter suggested that 

642 EPA lower the processing and use threshold to 100,000 lb, which is consistent with one 

643 of the triggers for the small business exemption. 

644 EPA agrees with a phased-in approach because it provides submitters with an 

645 opportunity to become familiar with the reporting requirements, while at the same time

646 providing much needed and more complete processing and use information on chemical 

647 substances of interest to the Agency. Future reporting of the processing and use 

648 information by all submitters will provide EPA and others with needed additional 

649 information for those chemical substances with production volumes of 25,000 lb or more 

650 at a site. In the future, EPA may find it necessary to collect information on chemical 

651 substances at reporting thresholds below the thresholds introduced in this action.

652 Using the 2006 IUR data, EPA looked at the effect of setting the processing and 

653 use reporting threshold at various levels. Based on this information, lowering the 

654 threshold to 25,000 lb would not have brought in a significant number of new reporters 

655 for the 2012 submission period, because about 89% of companies and 86% of sites 

656 reported at least one chemical substance with a production volume of 300,000 lb or more 

657 in 2006 (Ref. 13). Therefore, most companies would be expected to be generally aware of 

658 the processing and use reporting requirements because the company would have reported 

659 such information on at least one chemical substance. 

660 On a chemical-by-chemical basis, EPA‘s examination of the 2006 IUR data 

661 revealed that approximately 66% of the individual reports were above the 300,000 lb

662 threshold, and that these reports covered approximately 60% of the chemical substances 
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663 reported for the 2006 IUR. Lowering the threshold to 25,000 lb would result in 

664 processing and use information on 40% more chemicals and would have greatly informed

665 EPA‘s existing chemicals program. As discussed earlier, EPA recognized the need to 

666 allow companies time to become familiar with reporting the processing and use 

667 information, and therefore considered alternate reporting thresholds for the 2012 IUR. 

668 Lowering the threshold to 100,000 lb results in processing and use information on 

669 approximately 23% more chemical substances than the 300,000 lb threshold, while 

670 increasing the number of reports by only approximately 18%. EPA believes that the 

671 100,000 lb threshold, as an interim threshold, provides an appropriate balance between 

672 increasing the number of chemicals with processing and use information and increasing 

673 the reporting burden on industry. See the Economic Analysis (Ref. 14) for further 

674 discussion.

675 The exposure information is an essential part of developing risk evaluations and, 

676 based on its experience in using this information, the Agency believes that collecting this 

677 exposure information is critical to its mission of characterizing exposure, identifying 

678 potential risks, and noting uncertainties for these lower production volume chemical 

679 substances. In addition, this changethe lower thresholds will provide the public with 

680 information on a greater number of chemical substances. This issue is addressed further 

681 in Unit V.C.2 of this preamble as well as in the Responses to Comments document (Ref. 

682 12). 

683 3. EliminationReduction of the 25,000 lb. threshold for certainspecific regulated 

684 chemical substances. For the 2012 IUR, EPA is eliminatingmaintaining the 25,000 lb.

685 reporting threshold for certain chemical substances that are the subject of particular 
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686 TSCA rules and/or orders. For future IUR collections, EPA is reducing the threshold 

687 (including the threshold for the collection of processing and requiringuse information) to 

688 2,500 lb for those chemical substances (40 CFR 711.8(b)). 

689 EPA proposed to eliminate the threshold, which would have required

690 manufacturers (including importers) of such chemical substances to report under the IUR 

691 rule, regardless of the production volume. EPA is eliminating the 25,000 lb. threshold for 

692 those chemical substances that are: A number of commenters supported the proposal to 

693 eliminate the reporting threshold while others felt the requirement would be overly 

694 burdensome, especially for imported chemical substances or mixtures. In its proposal, 

695 EPA specifically asked for comment on whether a de minimis production volume 

696 threshold should be set for these chemical substances and how best to set such a de 

697 minimis threshold. Some commenters opposed setting a de minimis threshold and others 

698 suggested a variety of methods for establishing one.

699 For many of the reasons identified by commenters (e.g., the expense and burden 

700 of collecting the information, and difficulty in knowing whether low-concentration 

701 chemical substances are present in formulated mixtures), EPA has decided to set a de 

702 minimis threshold and to delay its implementation. Beginning with the 2016 submission 

703 period, the reporting threshold will be reduced to 2,500 lb for those chemical substances 

704 that are:

705 • The subject of a rule proposed or promulgated under TSCA section 5(a)(2), 

706 5(b)(4), or 6,

707 • The subject of an order issued under TSCA section 5(e) or 5(f), or
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708 • The subject of relief that has been granted under a civil action under TSCA 

709 section 5 or 7. (40 CFR 711.8(b))

710 For the 2016 submission period and submission periods thereafter, a manufacturer 

711 (including importer) of such chemical substances is required to report manufacturing 

712 information on the chemical substances if they are manufactured (including imported) in 

713 volumes of 2,500 lb or more during any of the years since the last principal reporting year

714 (e.g., 2011). Information on the processing and use of the chemical substances must be 

715 reported if they were manufactured (including imported) in volumes of 2,500 lb or more

716 during any of the years since the last principal reporting year. In addition to the 

717 manufacturing, processing and use information for the principal reporting year (e.g., 

718 2015), the production volumes for each year since the last principal reporting year must 

719 also be reported. For the 2016 submission period, for example, a manufacturer (including 

720 importer) must consider the manufactured or imported volume during the years 2012

721 through 2015 to determine the need to report; must report the production volumes for 

722 each year from 2012 to 2015; and must report the full manufacturing, processing, and use 

723 information for 2015. 

724 Chemical substances that are the subject of these particular TSCA actions are of 

725 demonstrated high interest to the Agency. EPA is promulgating this change to help 

726 reduce the reporting burden for submitters and to ensure the availability of current 

727 information when the Agency has expressed a concern in the form of regulatory action on 

728 those chemical substances, regardless of the production volume.. EPA will use the IUR 

729 data associated with these specific regulated chemical substances to monitor chemical 

730 substance production and compliance with the rules. In the future, EPA may find it 
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731 necessary to collect information on chemical substances at a reporting threshold below 

732 the 2,500 lb threshold introduced in this action. Although the 2,500 lb threshold is higher 

733 than the proposed threshold of zero, the enhanced information that will be gathered 

734 during the 2016 submission period will enable the Agency and others to more efficiently 

735 identify those chemical substances warranting further, more in-depth review, as well as 

736 chemical substances of lesser concern. See Unit V.C.3. of this preamble for further 

737 discussion.

738 Under this final rule, for the 2011 submission period, a manufacturer (including 

739 importer) of such chemical substances is required to report information on the 

740 manufacturing, processing, and use of the chemical substances if that person 

741 manufactured (including imported) any quantity of these chemical substances during the 

742 principal reporting year (i.e., 2010) and must report the production volumes for each year 

743 from 2006 to 2010 and the full manufacturing, processing, and use information for 2010. 

744 For subsequent IUR reporting cycles, a manufacturer (including importer) of such 

745 chemical substances is required to report information on the manufacturing, processing, 

746 and use of the chemical substances if that person manufactured (including imported) any 

747 quantity of these chemical substances during any of the years since the last principal 

748 reporting year, including quantities under 25,000 lb. For 2015 reporting, the 

749 manufacturer must consider the manufacture or import during the years 2011 through 

750 2014; must report the production volumes for each year from 2011 to 2014; and must 

751 report the full manufacturing, processing, and use information for 2014. 

752 In the IUR proposalAs under the 2006 IUR, if a manufacturer qualifies for the 

753 small manufacturer exemption at 40 CFR 711.9, it is exempt from IUR reporting. 

754 Nothing in this final rule affects the scope of this exemption at 40 CFR 711.9. However, 

755 because the reduction in the reporting threshold to 2,500 lb is generally applicable to all 

756 manufacturers of the subject chemical substances, for the 2016 submission period and 

757 subsequent submission periods, it may affect small manufacturers to the extent they are 

758 non-exempt under 40 CFR 711.9. As under the 2006 IUR, small manufacturers are 

759 generally exempt from IUR reporting but are specifically subject to reporting with respect 

760 to any chemical substance that is the subject of a rule proposed or promulgated under 
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761 TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 

762 5(e), or is the subject of relief that has been granted under a civil action under TSCA 

763 section 5 or 7 (40 CFR 711.9). With the exception of rules proposed or promulgated 

764 under TSCA section 4, the same TSCA actions that make small manufacturers ineligible 

765 for an IUR exemption under 40 CFR 711.9 (with respect to the particular chemical 

766 substance that is the subject of the action) will also make those small manufacturers 

767 subject to the 2,500 lb reporting threshold in the 2016 submission period and subsequent 

768 submission periods (40 CFR 711.8(b)). The proposal or promulgation of a rule under 

769 TSCA section 4 affects the small manufacturer exemption but it does not affect the 

770 applicable reporting threshold under IUR.

771 In the proposed rule, EPA specifically sought comment on whether circumstances 

772 triggering an exception to the 25,000 lb. reporting threshold for a chemical substance 

773 should include the proposal of certain rules for the chemical substance, under TSCA 

774 section 5(a)(2), 5(b)(4), or 6. EPA explained that such an approach would more closely 

775 parallel the exception language in the introductory paragraph to 40 CFR 711.6 and in 40 

776 CFR 711.9. (See Unit III.D.3 of the preamble of the proposal, at 75 FR 49664).proposed 

777 rule (Ref. 1)). Including these types of proposed rules in the list of triggering 

778 circumstances is also more consistent with reporting obligations under other parts of 

779 TSCA, such as 12(b). Among other situations, reporting under TSCA 12(b) is required 

780 when any rule under section 5 or 6 is proposed or promulgated. In response to the 

781 comments received, EPA has determined that chemical substances subject to a rule 

782 proposed under TSCA section 5(a)(2), 5(b)(4), or 6 will be excepted from the 25,000 lb.
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783 reporting threshold, and thus will be reportable at any production volume.2,500 lb

784 beginning with the 2016 IUR. See Unit V.C.23. of this preamble for further discussion. 

785 F. What are the changes to the chemical substances covered by IUR? 

786 1. Water. EPA is fully exempting all (both naturally occurring and manufactured) 

787 water (CASRN 7732–18–5) (40 CFR 711.6(a)(4)) from reporting under the IUR rule.

788 2. Fully exempt polymers removed from partially exempt list. Polymers are a class 

789 of chemical substances for which IUR reporting is not required (40 CFR 711.6(a)(1)). 

790 However, three polymers were previously listed in the partially exempt list of chemical 

791 substances at 40 CFR 710.46(b)(2)(iv): Starch (CASRN 9005–25–8), Dextrin (CASRN 

792 9004–53–9), and Maltodextrin (CASRN 9050–36–6). EPA has removed from the 

793 partially exempt list of chemical substances at 40 CFR 711.6(b)(2)(iv) these three 

794 chemical substances which, as polymers, are fully exempt from reporting.

795 3. Chemical substances that are the subject of an Enforceable Consent Agreement 

796 (ECA) are ineligible for exemptions. EPA may enter into an ECA, pursuant to procedures 

797 at 40 CFR part 790, with a manufacturer of a chemical substance to obtain testing where 

798 a consensus exists among EPA, affected manufacturers and/or processors, and interested 

799 members of the public concerning the need for and scope of testing. Chemical 

800 substances that are the subject of an ECA are now included in the list of chemical 

801 substances that are ineligible for an IUR exemption, in the introductory paragraph of 40 

802 CFR 711.6, along with the other chemical substances that are likewise not eligible for an 

803 IUR exemption. The paragraph states that a chemical substance ―is not exempted from 

804 any of the reporting requirements of this part if that substance is the subject of a rule 

805 proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the 
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806 subject of a consent agreement developed under the procedures of 40 CFR part 790, or is 

807 the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of 

808 relief that has been granted under a civil action under section 5 or 7 of the Act.‖

809 G. What changes have been made to reportable data elements? 1. Parent 

810 company and site identity. Manufacturers (including importers) are required to report the 

811 company name and Dun & Bradstreet D-U-N-S® (D&B) number to identify the 

812 company associated with the plant site, and also to report the site name, address, and 

813 D&B number. If the company associated with the plant site does not have a D&B 

814 number, the manufacturer (including importer) must obtain one for the company. 

815 Likewise, if the plant site does not have a D&B number, the manufacturer (including 

816 importer) must obtain one for the site. EPA received a variety of questions concerning 

817 the correct company name to report during the 2006 IUR submission period. EPA is now 

818 clarifying what is meant by company name, by requiring at 40 CFR 711.15(b)(2)(ii) that 

819 the company name provided be the parent company name. U.S. parent company name

820 and defining "U.S. parent company," at 40 CFR 711.3, to mean "the highest level 

821 company, located in the United States, that directly owns at least 50 percent of the voting 

822 stock of the manufacturer." As noted in the proposed rule (Ref. 1), EPA believes this 

823 change will reduce confusion by making this reporting requirementthat using an approach 

824 that is consistent with the TRI reporting requirements would be most clear both for 

825 reporters and users of the data. The IUR definition of "U.S. parent company name" is 

826 consistent with the use of the term of "parent company" in Section 5 of the 2009 Toxic 

827 Chemical Release Inventory (TRI) requirements for parent company name. For further 

828 clarification regarding the correct parent company name and the distinction between 
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829 domestic (U.S.) and foreign parent company, in particular for the small business 

830 determination, please refer to the ―Reporting Forms and Instructions for 2011 Inventory 

831 Update Reporting‖ (Ref. 515). The 2006 IUR submissions from different reporting sites 

832 contained varying D&B numbers for parent companies that appeared to be the same 

833 company. In order to better identify when reporting sites are under the same parent 

834 company, EPA is requiring the address as well as the D&B number of the parent 

835 company.

836 2. Technical contact. Manufacturers (including importers) are required to provide 

837 a technical contact for their IUR submission. The technical contact does not have to be a 

838 person located at the manufacturing (including importing) site, but must be a person who 

839 can answer questions EPA may have about the reported chemical substance. In the 

840 proposed rule, EPA had stated that the technical contact should be a person located at the 

841 manufacturing (including importing) site. EPA has decided, however, to not impose 

842 limitations on where the technical contact can be located. Therefore, companies may use 

843 their discretion in selecting a technical contact or multiple technical contacts, as provided 

844 by the new e-IURweb softwaretool. Submitters should consider, in selecting the technical 

845 contact, that EPA may have follow-up questions about an IUR submission, one or more 

846 years after the submission date. 

847 3. Manufacturers (including importers) are required to submit the correct 

848 chemical identity for each subject chemical substance. 

849 a. Chemical name. EPA is requiring the reporting of the Chemical Abstracts (CA) 

850 Index Name currently used to list the chemical substance on the TSCA Inventory as the 

851 chemical name reported for IUR. The reporting softwaretool will be directly linked to 
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852 the nonconfidential portion of the TSCA Inventory through the Agency‘s Substance 

853 Registry Services (SRS) database, which lists all chemical substances on the TSCA 

854 Inventory. This link will enable submitters to select the correct CA Index Name for their 

855 reportable chemical substance(s) from SRS. EPA believes that using SRS to select the 

856 chemical name as currently listed on the TSCA Inventory will greatly reduce the number 

857 of incorrectly identified chemical substances and allow the data to be released more 

858 quickly to the public. See the discussion in unit 3.a. regarding identifying confidential 

859 chemical substances. Manufacturers (including importers) are allowed to supply, as part 

860 of a joint submission, an alternate chemical name, and in the case of importers, a trade 

861 name, in those instances where a supplier will not disclose to the submitter the specific 

862 chemical name of the imported TSCA Inventory chemical substance or a reactant used to 

863 manufacture the TSCA Inventory chemical substance. In these cases, the manufacturer 

864 (including importer) and the supplier may report the information required in this part in a 

865 joint submission. In order to clarify this requirement, EPA is amending 40 CFR part 

866 711.15(b)(3)(i), to state that the importer must ask the supplier of the confidential 

867 chemical substance to directly provide EPA with the correct chemical identity, in a joint 

868 submission with the manufacturer. Similarly, in the event a manufacturer submitting a 

869 Form U cannot provide the whole chemical identity because the reportable chemical 

870 substance is manufactured using a reactant having an unknown specific chemical identity 

871 claimed as confidential by its supplier, the manufacturer must ask that the supplier 

872 directly provide to EPA the correct chemical identity of the confidential reactant in a joint 

873 submission. Nothing in 40 CFR Part 711.15(b)(3)(i) relieves a manufacturer (including 

874 an importer) of its obligation to report information that it actually knows or can 
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875 reasonably ascertain. See Unit III.10 for additional information regarding joint 

876 submissions. Detailed instructions regarding joint submissions are included in the 

877 instructions manualInstructions document included in the docket (Ref. 57). 

878 b. Chemical identifying number. As part of the chemical identity, submitters 

879 provide a chemical identifying number associated with the correct CA Index Name, as 

880 described in Unit II.E.7.c.i. EPA is requiring that submitters report only the CASRN as a 

881 chemical identifying number, except in the case of confidential chemical substances. In 

882 the case of confidential chemical substances, EPA is requiring that submitters report only 

883 the TSCA Accession Number as a chemical identifying number. EPA is removing the 

884 Pre-manufacture Notification (PMN) number as an allowed chemical identifying number 

885 because each TSCA Inventory chemical substance has either (or both) a CASRN or a 

886 TSCA Accession Number, which are likely to be already known to the submitter. 

887 Submitters who, in the past, have reported using the PMN number of a confidential 

888 substance can identify the TSCA Accession Number from SRS by searching on the PMN 

889 number. Those submitters who are not able to identify the TSCA Accession Number by 

890 searching SRS may contact EPA in writing, if necessary, to learn the TSCA Accession 

891 Number assigned when the Notice of Commencement (NOC) was submitted to the 

892 Agency. Specific information is included in the Instructions for Reporting 

893 manualdocument.

894 c. Chemical identity for chemical substances listed on the confidential portion of 

895 the TSCA Inventory. In cases where a chemical substance is listed on the confidential 

896 portion of the TSCA Inventory, submitters are to report the chemical‘schemical

897 substance‘s Accession Number and generic name, which are listed on the non-
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898 confidential portion of the TSCA Inventory and are included in SRS. In order to continue 

899 to protect the confidentiality of the underlying specific chemical identification 

900 information (i.e., the CASRN and specific chemical name), the submitter must claim the 

901 chemical identity as CBI and complete the upfront substantiation. Doing so will maintain 

902 a confidentiality claim for the underlying CASRN and specific chemical name on the 

903 confidential portion of the TSCA Inventory (the Accession Number and generic chemical 

904 name remain non-confidential). Failure to identify the chemical identity as CBI and 

905 complete the upfront substantiation will waive any CBI claim to the chemical identity 

906 and will result in the transfer of the chemical substance from the confidential portion of 

907 the TSCA Inventory to the non-confidential, publicly releasable, portion of the TSCA 

908 Inventory.

909

910 4. Production volume. Manufacturers (including importers) are required to report 

911 production volume information for each chemical substance for which they submit an 

912 IUR report. EPA has made a number of changes to the reporting of production volume 

913 and associated information. 

914 a. Report production volume for each of the years since the last principal 

915 reporting year. In addition to the production volume for the principal reporting year, EPA 

916 is requiring the reporting of production volume for 2010 for the 2012 submission period 

917 and for each of the years since the last principal reporting year beginning with the 2016 

918 submission period. More specifically, for the 2012 submission period, manufacturers 

919 (including importers) will be required to report the total annual volume (domestically 

920 manufactured and imported volumes in pounds) of each reportable chemical substance at 

921 each site during calendar year 2010. For submission periods subsequent to the 2012 
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922 submission period, manufacturers (including importers) will be required to report the 

923 total annual volume (domestically manufactured and imported volumes in pounds) of 

924 each reportable chemical substance at each site for each complete calendar year since the 

925 last IUR principal reporting year. ThusFor example, for the 2011submission2016

926 submission period, manufacturers (including importers) of a chemical at or above the 

927 25,000 lb. threshold during the principal reporting year reportable chemical substance 

928 will report the production volume of that chemical substance for each of the following 

929 calendar years: 2010, 2009, 2008, 2007, and 2006. Collecting the production volume for 

930 multiple years will provide greater detail than the current once-every-reporting cycle 

931 snapshot.2015, 2014, 2013, and 2012. 

932 EPA had proposed that this requirement begin in full starting with the 

933 current submission period, which would have required submitters to report production 

934 volumes for 2006 through 2010 for the 2012 submission period. Several commenters

935 supported the proposed change while others stated that the requirement would be overly 

936 burdensome, especially for the submission period immediately following promulgation of 

937 the rule. Some commenters recommended that EPA delay the implementation of the 

938 requirement until the next reporting cycle to allow companies sufficient time to prepare 

939 for the additional data collection effort. In response to the comments received. EPA 

940 believes its decision to defer this requirement until the next reporting cycle is warranted 

941 in light of other simultaneous changes to the IUR rule which increase reporting burden. 

942 The Agency also believes the delay will give companies adequate time to establish 

943 systems to collect and compile the required information.
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944 For the principal reporting year, e.g., 20102011, the domestic manufacture and the 

945 import production volume will continue to be reported separately on the same report. 

946 EPA review and analysis of the 2006 IUR data has revealed that some submitters are 

947 erroneously submitting multiple reports for the same chemical substance, at times 

948 reporting the information associated with domestic manufacturing and importing in 

949 different reports. Submitters should complete only one report for each chemical 

950 substance.

951 b. Volume of chemical substance used on-site. EPA is requiring that submitters 

952 report the volume of a manufactured (including imported) chemical substance used at the 

953 reporting site. The requirement to report the volume used on-site is replacing the 

954 requirement to indicate that the chemical substance is site-limited. Under this final rule, 

955 either domestically manufactured or imported chemical substances can be reported as 

956 used at the reporting site.

957 c. Indicate whether imported chemical substances are physically at reporting site.

958 EPA is adding a requirement to indicate whether an imported chemical substance is 

959 physically at the reporting site. Often, the site reporting an imported chemical substance 

960 never physically receives the chemical substance, but instead ships it directly to another 

961 location such as a warehouse, a processing or use site, or a customer‘s site. 

962 d. Report volume exported. EPA is adding a requirement to report the production 

963 volume directly exported and not domestically processed or used. This will allow EPA to 

964 better identify the proportion of the production volume accounted for by the processing 

965 and use reporting, given that such downstream reporting is not required for directly 

966 exported chemical substances.
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967 5. Identify whether a chemical substance is to be recycled, remanufactured, 

968 reprocessed, or reused. In the proposed rule, EPA sought comment on adding a checkbox 

969 indicating whether a manufactured chemical substance was recycled, remanufactured, 

970 reprocessed, reused, or reworked. In response to the comments received, EPA has 

971 determined that the term ―reworked‖ may be interpreted and applied too broadly to 

972 provide the type of information that EPA needs to collect and has removed ―reworked‖ 

973 from the list of recycling synonyms, but has chosen to otherwise finalize this reporting 

974 requirement as proposed. Consequently, EPA is adding a requirement to indicate 

975 whether a manufactured chemical substance, such as a byproduct, is to be recycled, 

976 remanufactured, reprocessed, or reused. Submitters should indicate whether their 

977 manufactured chemical substance, which otherwise would be disposed of as a waste, is 

978 being removed from the waste stream and has a commercial purpose (i.e., it is being 

979 recycled, remanufactured, reprocessed, or reused). Indicating that a manufactured 

980 chemical substance, such as a byproduct, is to be recycled, remanufactured, reprocessed, 

981 or reused does not affect the reporting requirements associated with any chemical 

982 substance manufactured from the byproduct. See Unit II.F.2. for detailed information on 

983 byproduct reporting.

984 6. Concentration ranges. EPA is eliminating gaps in the ranges used to report 

985 concentration in 40 CFR 711.15(b)(3) and (4)). The ranges are now:

986 • Less than 1% by weight.

987 • At least 1% but less than 30% by weight.

988 • At least 30% but less than 60% by weight.

989 • At least 60% but less than 90% by weight.
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990 • At least 90% by weight.

991 7. Industrial processing and use information reporting. EPA is revising the list of 

992 industrial function categories and replacing the NAICS codes with industrial sector 

993 categories, as described in sections i. and ii.

994 a. Industrial function categories. EPA is revising the list of industrial function 

995 categories by combining categories that lead to common exposure scenarios and adding 

996 categories where the Agency believes the existing categories do not adequately describe 

997 potential uses. EPA worked with Environment Canada and Health Canada to develop the 

998 set of categories, which will be used by both the United States and Canada for inventory 

999 reporting (Ref. 911).

1000 EPA is adding eight new industrial function categories and deletingremoving six 

1001 existing categories from the previous list; the total number of industrial function 

1002 categories has increased to 35. Also, EPA is renaming several of the industrial function 

1003 categories to provide a more informative description of the function of chemical 

1004 substances that should be reported in that category. Lastly, EPA is requiring that if a 

1005 submitter selects the category ―Other,‖ the submitter must provide its own description of 

1006 the industrial function of the chemical substance. EPA is using the industrial function 

1007 categories listed in Table 1 of this unit:

1008 Table 1.—Codes for Reporting Industrial Function Categories

Code Category

U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents

U008 Dyes
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U009 Fillers

U010 Finishing agents

U011 Flame retardants

U012 Fuels and fuel additives

U013 Functional fluids (closed systems)

U014 Functional fluids (open systems)

U015 Intermediates

U016 Ion exchange agents

U017 Lubricants and lubricant additives

U018 Odor agents

U019 Oxidizing/reducing agents

U020 Photosensitive chemicals

U021 Pigments

U022 Plasticizers

U023 Plating agents and surface treating agents

U024 Process regulators

U025 Processing aids, specific to petroleum production

U026 Processing aids, not otherwise listed 

U027 Propellants and blowing agents

U028 Solids separation agents

U029 Solvents (for cleaning or degreasing)

U030 Solvents (which become part of product formulation or mixture)

U031 Surface active agents

U032 Viscosity adjustors

U033 Laboratory chemicals

U034 Paint additives and coating additives not described by other 

categories

U999 Other (specify)

1009

1010 b. Industrial sectors. EPA is replacing the 5–digit NAICS codes with 48 IS codes 

1011 (Ref. 1016). The sectors were adapted from the European Union‘s (EU‘s) ―Guidance on 

1012 Information Requirements and Chemical Safety Assessment.‖ The IS codes divide the 

1013 entire range of NAICS codes into sectors so that there is a sector corresponding to any 

1014 NAICS code (see the Instructions for Reportingdocument, Ref. 7). The use of the sectors 

1015 will reduce the number of unique combinations, thereby increasing the usability of the 

1016 data, and also reducing the IUR reporting burden.

1017 EPA is using the 48 sectors listed in Table 2 of this unit:
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1018 Table 2.—Industrial Sectors

Code Sector Description

IS1 Agriculture, Forestry, Fishing and Hunting

IS2 Oil and Gas Drilling, Extraction, and support activities

IS3 Mining (except Oil and Gas) and support activities

IS4 Utilities

IS5 Construction

IS6 Food, beverage, and tobacco product manufacturing

IS7 Textiles, apparel, and leather manufacturing

IS8 Wood Product Manufacturing

IS9 Paper Manufacturing

IS10 Printing and Related Support Activities

IS11 Petroleum Refineries

IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing

IS13 Petroleum Lubricating Oil and Grease Manufacturing

IS14 All other Petroleum and Coal Products Manufacturing

IS15 Petrochemical Manufacturing

IS16 Industrial Gas Manufacturing

IS17 Synthetic Dye and Pigment Manufacturing

IS18 Carbon Black Manufacturing

IS19 All Other Basic Inorganic Chemical Manufacturing

IS20 Cyclic Crude and Intermediate Manufacturing

IS21 All Other Basic Organic Chemical Manufacturing

IS22 Plastics Material and Resin Manufacturing

IS23 Synthetic Rubber Manufacturing

IS24 Organic Fiber Manufacturing

IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

IS26 Pharmaceutical and Medicine Manufacturing

IS27 Paint and Coating Manufacturing

IS28 Adhesive Manufacturing

IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing

IS30 Printing Ink Manufacturing

IS31 Explosives Manufacturing

IS32 Custom Compounding of Purchased Resins

IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing

IS34 All Other Chemical Product and Preparation Manufacturing

IS35 Plastics Product Manufacturing

IS36 Rubber Product Manufacturing

IS37 Non-metallic Mineral Product Manufacturing (includes clay, glass, cement, 

concrete, lime, gypsum, and other non-metallic mineral product 

manufacturing)

IS38 Primary Metal Manufacturing

IS39 Fabricated Metal Product Manufacturing

IS40 Machinery Manufacturing

IS41 Computer and Electronic Product Manufacturing
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IS42 Electrical Equipment, Appliance, and Component Manufacturing

IS43 Transportation Equipment Manufacturing

IS44 Furniture and Related Product Manufacturing

IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade 

IS47 Services

IS48 Other (requires additional information)

1019

1020 When the category reported for the IS code is ―Other,‖ the submitter is required to 

1021 provide a written description of the use of the chemical substance, which may include the 

1022 NAICS code.

1023 8. Consumer and commercial use reporting. EPA is making four changes to the 

1024 consumer and commercial information required to be reported: 

1025 • Revising and expanding the list of consumer and commercial product categories.

1026 • Requiring the provision of a description when the product category ―Other‖ is 

1027 reported.

1028 • Identifying whether the use is a consumer or a commercial use, or both.

1029 • Reporting the number of commercial workers reasonably likely to be exposed 

1030 while using the reported chemical substance.

1031 Reporting associated with children‘s use, the maximum concentration, and the percent 

1032 production volume remains unchanged.

1033 a. Consumer and commercial product categories. EPA is revising the list of 

1034 consumer and commercial product categories by combining categories that lead to 

1035 common exposure scenarios and adding categories that were not adequately described in 

1036 the initial set of categories. EPA worked with Environment Canada and Health Canada 

1037 to develop the categories. Harmonized categories will facilitate consistent reporting of 
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1038 chemical substance use information by industry in the United States and Canada (Ref. 

1039 911).

1040 The list includes 33 product categories, including ―Other.‖ Examples of new 

1041 categories which have been added include explosive materials, building/construction 

1042 products not covered elsewhere, and air care products. The glass and ceramic products 

1043 category had relatively few IUR submissions in 2006 and overlaps with the new 

1044 categories, and so has been eliminated. Also, several of the consumer and commercial 

1045 product categories have been renamed to better describe the products that should be 

1046 reported in those categories. In addition to revising the overall product categories, 

1047 narrower definitions and expanded lists of examples of products in which the chemical 

1048 substance would be used will be added to each category descriptor. The examples were 

1049 selected to include items that could have fit into other categories in order to address the 

1050 overlap inherent in any product category list. The product categories were then placed 

1051 into several broader groupings, e.g., ―Chemicals with Agriculture and Outdoor Uses‖ 

1052 based on the similarities of products. EPA believes that the user will find the current 

1053 groupings easier to use than the alphabetical listing used for the 2006 IUR. EPA is also 

1054 requiring that if a submitter chooses the product category ―Other,‖ the submitter must 

1055 include a text description for the consumer and commercial product containing the 

1056 chemical substance. 

1057 EPA is using the consumer and commercial product categories listed in Table 3 of 

1058 this unit:

1059 Table 3.—Codes for Reporting Consumer and Commercial Product Categories

Code Category

 Chemical Substances in Furnishing, Cleaning, Treatment Care Products

C101 Floor Coverings 
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C102 Foam Seating and Bedding Products 

C103 Furniture and Furnishings not covered elsewhere 

C104 Fabric, Textile, and Leather Products not covered elsewhere 

C105 Cleaning and Furnishing Care Products 

C106 Laundry and Dishwashing Products 

C107 Water Treatment Products 

C108 Personal Care Products 

C109 Air Care Products

C110 Apparel and Footwear Care Products

Chemical Substances in Construction, Paint, Electrical, and Metal Products

C201 Adhesives and Sealants 

C202 Paints and Coatings

C203 Building/Construction Materials - Wood and Engineered Wood Products 

C204 Building/Construction Materials not covered elsewhere 

C205 Electrical and Electronic Products 

C206 Metal Products not covered elsewhere 

C207 Batteries 

 Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products

C301 Food Packaging

C302 Paper Products 

C303 Plastic and Rubber Products not covered elsewhere

C304 Toys, Playground, and Sporting Equipment

C305 Arts, Crafts, and Hobby Materials 

C306 Ink, Toner, and Colorant Products 

C307 Photographic Supplies, Film, and Photochemicals 

 Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products

C401 Automotive Care Products 

C402 Lubricants and Greases 

C403 Anti-Freeze and De-icing Products 

C404 Fuels and Related Products

C405 Explosive Materials 

C406 Agricultural Products (non-pesticidal) 

C407 Lawn and Garden Care Products 

 Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)

1060

1061 b. Designation of consumer or commercial use. EPA is requiring submitters to 

1062 designate, via a checkbox, whether the indicated product category is a consumer or a 

1063 commercial use, or both. 
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1064 c. Number of commercial workers reasonably likely to be exposed. EPA is 

1065 requiring that submitters report the total number of commercial workers, including those 

1066 at sites not under the submitter‘s control, that are reasonably likely to be exposed while 

1067 using the reportable chemical substance, with respect to each commercial use. The 

1068 approximate number of workers should be reported using the same definitions and ranges 

1069 used for manufacturing and industrial processing and use workers required by 40 CFR 

1070 711.15(b)(3)(vii) and (4)(i)(F), respectively. The ranges are:

1071 • Fewer than 10 workers.

1072 • At least 10 but fewer than 25 workers.

1073 • At least 25 but fewer than 50 workers.

1074 • At least 50 but fewer than 100 workers.

1075 • At least 100 but fewer than 500 workers.

1076 • At least 500 but fewer than 1,000 workers.

1077 • At least 1,000 but fewer than 10,000 workers.

1078 • At least 10,000 workers.

1079 H. What changes have been made to the standard for the reporting of processing 

1080 and use information? In order to collect more complete information regarding industrial 

1081 processing and use, and commercial and consumer use of chemicalschemical substances, 

1082 EPA is, in 40 CFR 711.15(b)(4), replacing the ―readily obtainable‖ reporting standard 

1083 used for reporting under 40 CFR 710.52(c)(4) with the ―known to or reasonably 

1084 ascertainable by‖ reporting standard set forth under TSCA section 8(a)(2). This is the 

1085 same standard that applied to the reporting of information described in the regulations at 

1086 40 CFR 710.52(c)(1), (c)(2), and (c)(3) for the 2006 IUR submission, and this standard 
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1087 continues to apply to the reporting of such information under 40 CFR 711.15(b)(1), 

1088 (b)(2), and (b)(3). This standard covers all information in a person‘s possession or 

1089 control, plus all information that a reasonable person similarly situated might be expected 

1090 to possess, control, or know. 

1091 Under the standard, a submitter would therefore prepare its report about the 

1092 processing and use of a chemical substance it manufactures (including imports), without 

1093 confining its inquiry solely to what is known to managerial and supervisory employees, 

1094 but would also be expected to review information which the manufacturer (including 

1095 importer) may have in their possession or control, plus all information that a reasonable 

1096 person similarly situated might be expected to possess, control, or know. The inquiry 

1097 would be as extensive as a reasonable person, similarly situated, might be expected to 

1098 perform. The standard does not necessarily require that the manufacturer conduct an 

1099 exhaustive survey of all employees.

1100 ‖Known to or reasonably ascertainable‖ information includes, but is not limited 

1101 to, information that may be possessed by employees or other agents of the company 

1102 reporting under the IUR rule, including persons involved in the research, development, 

1103 manufacturing or marketing of a chemical substance and includes knowledge gained 

1104 through discussions, symposia, and technical publications. Examples of types of 

1105 information that are considered to be in a person‘s possession or control, or that a 

1106 reasonable person similarly situated might be expected to posses, control, or know, 

1107 include files maintained by the submitter, such as marketing studies, sales reports, or 

1108 customer surveys; information contained in standard references, such as MSDSs, that 
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1109 contain use information or concentrations of chemicals in mixtures; and information from 

1110 the Chemical Abstracts Service (CAS) and from Dun & Bradstreet D-U-N-S®.

1111 The following hypothetical examples illustrate the anticipated application of the 

1112 ―known to or reasonably ascertainable standard,‖ in the specific context of the collection 

1113 of processing and use data under the IUR. Because the standard applies on a case-by1114 case basis, however, these examples cannot substitute for a complete analysis of a 

1115 submitter‘s particular circumstances:

1116 Company XYZ discovers that it has no knowledge of how a particular reportable 

1117 chemical substance (Substance #1) is processed or used by its customers. Company 

1118 XYZ usually maintains marketing data documenting customers‘ use of its chemicals, in 

1119 line with the reasonable business practices typical of comparable manufacturers, but it 

1120 irrevocably lost these data for Substance #1 due to an inadvertent computer malfunction. 

1121 Company XYZ has many customers, but it expects that it could substantially reconstruct 

1122 this missing information by briefly contacting its largest customer and asking that 

1123 customer what Substance #1 is generally used for. Company XYZ contacts this 

1124 customer, reports on the basis of the processing and use data that the customer was 

1125 willing to provide. Company XYZ has likely fulfilled its duties under the reporting 

1126 standard. Company XYZ would not have fulfilled its duties under the reporting standard 

1127 if it had not endeavored to supplement the information it already knew.

1128 Company XYZ has never maintained information on how a particular reportable 

1129 chemical substance (Substance #2) is processed or used by its customers. However, it is 

1130 typical for comparable manufacturers to collect such information as part of their 

1131 reasonable business practices. Company XYZ has many customers but it expects that it 
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1132 could substantially fill this data gap by reviewing the public web site of its largest 

1133 customer. Company XYZ reviews this web site, and reports on the basis of the 

1134 information contained in the web site. Company XYZ has likely fulfilled its duties under 

1135 the reporting standard. Company XYZ would not have fulfilled its duties under the 

1136 reporting standard if it had not endeavored to supplement the information it already 

1137 knew.

1138 Company ABC maintains seasonal marketing data on changes in use patterns for 

1139 a particular chemical substance (Substance #3). Comparable manufacturers typically 

1140 only maintain such data on an annual basis, in line with reasonable business practices. 

1141 Company ABC irrevocably loses its summer marketing data for Substance #3, due to an 

1142 inadvertent computer malfunction. Company ABC expects that it could substantially 

1143 reconstruct the missing summer marketing data by contacting its largest customer and 

1144 asking the customer what it used or processed Substance #3 for in the past summer. 

1145 Nevertheless, instead of attempting to reconstruct the summer data in this manner, 

1146 Company ABC reports on the basis of the processing and use data that it already knows 

1147 (regarding the winter, spring, and fall of the year). Company ABC has likely fulfilled its 

1148 duties under the reporting standard. Company ABC would not have fulfilled its duties 

1149 under the reporting standard if it designated the information as ―not known or reasonably 

1150 ascertainable‖ simply because one of the seasonal marketing reports was missing.

1151 Company ABC has never maintained information on how a particular reportable 

1152 chemical substance (Substance #4) is processed or used by its customers. However, it is 

1153 typical for comparable manufacturers to collect such information as part of their 

1154 reasonable business practices. Company ABC has one major customer and ten minor 
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1155 customers. Company ABC asks its major customer to supply information about how 

1156 Substance #4 is processed and used, but that customer is unwilling to supply this 

1157 information. Company ABC reasonably expects that the only remaining way to 

1158 substantially fill this data gap would be to send a survey to its ten minor customers. 

1159 Company ABC reports that the information is ―not known or reasonably ascertainable‖ to 

1160 it. Company ABC has likely fulfilled its duties under the reporting standard.

1161 EPA would like furthermore to clarify that submitters are not required to conduct 

1162 customer surveys under this standard, buta new or additional customer survey (i.e., to 

1163 pose a comprehensive set of identical questions to multiple customers) under this 

1164 standard. If particular information cannot be derived or reasonably estimated from the 

1165 information available to the company without conducting further customer surveys, it is 

1166 not ―known to or reasonably ascertainable‖ to the submitter for purposes of the IUR. 

1167 However, to the extent that customer surveys are already in the submitter‘s possession or 

1168 control, and to the extent that reasonable efforts to analyze or synthesizederive 

1169 information from already-available customer surveys may inform processing and use 

1170 information that is reported, the information is generally ―known to or reasonably 

1171 ascertainable.‖ See Unit V.E.1. of this preamble and the Responses to Comments 

1172 document (Ref. 12) for further discussion. EPA‘s reporting softwaretool permits 

1173 submitters to enter or select ―NKRA‖ on Form U to address circumstances where the 

1174 information is not known to or reasonably ascertainable by the submitter. 

1175 I. What changes have been made to requirements for making CBI claims? EPA is 

1176 making several changes to the requirements for claiming information as confidential. 

1177 Submitters may claim certain information reported under the IUR as CBI in accordance 
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1178 with 40 CFR part 2 and IUR rules at 40 CFR 711.30. Claims of confidentiality may be 

1179 made for chemical identity, site identity, and processing and use information, and 

1180 submitters must substantiate these claims at the time information is submitted to EPA. 

1181 EPA‘s procedures for handling information claimed as confidential are set forth at 40 

1182 CFR part 2, subpart B. EPA strongly encourages submitters to review confidentiality 

1183 claims carefully to ensure that the information in question falls within the parameters of 

1184 TSCA section 14. EPA cautions submitters that they may be subject to criminal penalties 

1185 under 18 U.S.C. § 1001 if they knowingly and willfully make a false statement in 

1186 connection with the assertion of a CBI claim. CBI claims should be limited to only those 

1187 data elements the release of which would likely cause substantial harm to the business‘ 

1188 competitive position. Interested persons are reminded that with regard to chemical 

1189 substance use information, EPA is interested in aggregated, general uses, not detailed 

1190 uses associated with specific customers.

1191 To claim information as confidential, a submitter must indicate its claim by both 

1192 checking the appropriate box and signing the certification statement on the reporting 

1193 form, and may also be required (depending on the data element) to provide substantiation 

1194 of the claim at the time it is made. A submitter must indicate its claims at the time the 

1195 information is submitted. If a submitter fails to follow these procedures, EPA may 

1196 release the information to the public without further notice to the submitter. By signing 

1197 the certification statement the submitter attests to the secrecy and value of the 

1198 information for which confidentiality claims have been asserted.

1199 1. Chemical identity CBI claims. There is no substantive change to submitters' 

1200 ability to make confidentiality claims for chemical identity in the IUR. As in the past, a 
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1201 submitter may assert a claim of confidentiality for the identity of the reported chemical 

1202 substance only when the chemical substance is listed on the confidential portion of the 

1203 TSCA Inventory. Submitters who assert a confidentiality claim for chemical identity 

1204 must also provide substantiation for the claim at time of filing. See 40 CFR 711.30(b).

1205

1206 However, in response to commentcomments, this final rule incorporatesincludes

1207 some changes to the process that must be used to in makingmake this type of CBI claim. 

1208 The proposed rule, at 40 CFR 711.15(ab)(3)(i), provided that ―[a] submitter under this 

1209 part may use an EPA-designated TSCA Accession Number for a confidential chemical 

1210 substance in lieu of a CASRN when a CASRN is not known to or reasonably 

1211 ascertainable by the submitter.‖ In the proposed rule, EPA also noted that up to 5% of 

1212 the reports submitted under the 2006 IUR contained chemical identity problems. EPA 

1213 therefore proposed to require that submitters report using the CA Index Name currently 

1214 used to list the chemical substance on the TSCA inventory. EPA further indicated that it 

1215 would incorporateinclude CASRNs and CA Index Names into the e-IURweb 

1216 softwaretool, to the extent possible without jeopardizing confidentiality claims. EPA 

1217 believes that selecting chemical identity from a pre-populated list, rather than keying in 

1218 the chemical identity information, will significantly improve the accuracy and 

1219 consistency of submitted reports.

1220

1221 EPA received several comments from industry groups requesting that the e1222 IURweb software incorporatetool include security safeguards to adequately protect CBI. 

1223 In light of the security concerns expressed in public comments, EPA has decided not to 

1224 incorporateinclude CASRNs and CA Index Names for chemicalschemical substances on 
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1225 the confidential portion of the TSCA Inventory into the portions of the e-IURweb 

1226 softwaretool that will be publicly accessible. However, EPA still believes it is important 

1227 to require that all chemical identities be selected from a pre-populated list, to avoid 

1228 repeating the chemical identity problems experienced with the 2006 IUR. Therefore, 40 

1229 CFR 711.15(a)(3)(i) has been revised in this final rule to require that submitters who wish 

1230 to report chemical substances listed on the confidential portion of the TSCA Inventory 

1231 use the chemical‘schemical substance‘s TSCA Accession Number and generic name. 

1232 Requiring the use of accession numbers and generic names will allow EPA to adequately 

1233 protect confidential CASRNs and CA Index Names (by omitting them from the pre1234 populated selection list) while still obtaining the improvements in reporting accuracy it 

1235 sought in the proposed rule.

1236

1237 In SRS, a submitter can readily find a cross-reference list that displays the 

1238 Accession Number, generic chemical name, and the PMN case number (or for an initial 

1239 TSCA Inventory chemical substance, the TSCA Inventory reporting form number) for 

1240 any confidential chemical substance listed on the TSCA Inventory. Submitters who wish 

1241 to retain the CBI claim for the chemical substance identified by the Accession number 

1242 must assert and substantiate the claim at time of filing. Submitters who do not wish to 

1243 retain the CBI claim for the chemical substance identity, and who wish the chemical 

1244 substance to be listed on the public portion of the TSCA Inventory, should not assert a 

1245 CBI claim or provide substantiation. Submitters who fail to follow the required 

1246 procedures for asserting CBI claims for chemical identity will waive the claims, and EPA 

1247 may release the information without further notice to the submitter. See the regulatory 

1248 text at 40 CFR 711.30(e). 
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1249 

1250 2. Upfront substantiation for processing and use information CBI claims. Under 

1251 the IUR, a submitter may assert a claim of confidentiality for data associated with the 

1252 processing and use of its chemical substance if the submitter has reason to believe that 

1253 release of the information would reveal trade secrets, or confidential commercial or 

1254 financial information, as provided by TSCA section 14 and 40 CFR part 2. Under this 

1255 final rule, EPA is requiring upfront substantiation for CBI claims for processing and use 

1256 information.

1257 In order to submit a claim of confidentiality for processing and use information 

1258 data elements, the submitter is required (in addition to signing the certification statement) 

1259 to both check the appropriate box on the reporting form and substantiate the claim in 

1260 writing, within the reporting softwaretool, by answering certain questions provided in 40 

1261 CFR 711.30(d). EPA revised the substantiation question at 40 CFR 711.30(d)(1)(ii), 

1262 respecting competitive harm, to include harmful effect ―to your customer‘s competitive 

1263 position.‖ Where a submitter fails to submit substantiation of the processing and use CBI 

1264 claim in accordance with the applicable rules (i.e., the submitter does not provide an 

1265 answer to all the required questions associated with the claim on the Form U it submits 

1266 via e-IURweb), EPA will consider the information not subject to a confidentiality claim 

1267 and may make the information available to the public without further notice to the 

1268 submitter.

1269 3. Prohibition of confidentiality claims for data elements identified as “not known 

1270 or reasonably ascertainable.” EPA is prohibiting claims of confidentiality pertaining to 

1271 the designation that information is ―not known or reasonably ascertainable.‖ As described 

1272 in Unit II.A., for the 20112012 and future IUR collections, submitters will be required to 
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1273 report processing and use information to the extent that it is known to or reasonably 

1274 ascertainable by them. 

1275 For the 2006 IUR collection, EPA observed that, on occasion, processing and use 

1276 information was claimed as confidential when a submitter determined that the 

1277 information was not readily obtainable. Section 14 of TSCA limits the disclosure of 

1278 information entitled to confidential treatment under Exemption 4 of the Freedom of 

1279 Information Act (FOIA). EPA has considered the NKRA designation and its relationship 

1280 to a potential CBI or trade secret claim. Given that a NKRA assertion is an assertion that 

1281 no information is available, the Agency does not believe that the designation conveys 

1282 trade secret or confidential commercial or financial information. 

1283 J. What changes specifically affect importers?

1284 1. Importer site address. Submitters report IUR data on chemical substances that 

1285 they manufacture domestically and that they import into the United States. Previously, 

1286 the regulations defining the site for importer reporting were found in both the definition 

1287 for site in 40 CFR 710.3 and in paragraph 40 CFR 710.48(b). EPA is eliminating 

1288 unnecessary duplication in the IUR regulation by moving the additional information 

1289 regarding the importer site from 40 CFR 710.48(b) into a revised definition for site at 40 

1290 CFR 711.3, as described in Unit II.F.3.b., and eliminating 40 CFR 710.48(b).

1291 In addition, EPA has observed that submitters occasionally use a foreign address 

1292 as the site address for the importer. EPA now is requiring that submitters report a U.S. 

1293 site address, by modifying the definition for site to state specifically that the site must be 

1294 a U.S. site. The U.S. address of an agent acting on behalf of the importer, and authorized 

1295 to accept service of process for the importer, may be reported as the importer‘s site 
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1296 address if the operating unit that is directly responsible for importing the chemical 

1297 substance and that controls the import transaction has no U.S. address. The Agency 

1298 expects that all importers will have a U.S. site, as defined in the 40 CFR 711.3 definition 

1299 for site, because, under Customs regulations at 19 CFR 141.18, a non-resident 

1300 corporation is not permitted to enter merchandise for consumption unless it has a resident 

1301 agent in the State where the port of entry is located, who is authorized to accept service of 

1302 process against the corporation.

1303 2. Joint submissions. For purposes of IUR, submitters are allowed to report the 

1304 IUR information jointly with the foreign supplier of a reportable chemical substance 

1305 whose chemical identity is unknown to the importer. Previously, joint submissions could 

1306 not be made electronically. EPA is now requiring that submitters use CDX and e-IURweb 

1307 for preparation and submission of joint submissions. See 40 CFR 711.15(b)(3)(i)(C). 

1308 Therefore, the authorized officials of the jointly submitting companies will need to 

1309 register with CDX in order to submit a joint report to EPA.

1310 Importers may not know the specific chemical identity of a chemical substance 

1311 because the foreign supplier chooses to keep it confidential. In such a situation, the 

1312 importer must use e-IURweb to ask the foreign supplier to submit the chemical identity 

1313 information directly to EPA through a joint report. To submit a joint report, the importer 

1314 completes the majority of the required information, and supplies a trade name or other 

1315 designation to identify the chemical substance, and provides contact information for the 

1316 foreign supplier. The importer then uses e-IURweb to contact the foreign supplier and 

1317 request that the foreign supplier report the specific chemical identity information directly 

1318 to EPA. The importer must submit a copy of such request to EPA, along with the rest of 
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1319 its IUR submission for the chemical substance. As a general matter, EPA expects that 

1320 importers will supply the information described at 40 CFR 711.15(b)(3)(i)(A), rather than 

1321 an ―NKRA‖ designation, when importers do not know the confidential chemical identity 

1322 of a chemical substance they import. EPA believes that an NKRA designation would 

1323 generally only be appropriate in the unlikely event that an importer did not know, and 

1324 could not reasonably ascertain, the information needed to link its submission with a 

1325 secondary report from the supplier.

1326 In an acceptable joint submission, the secondary submitter supplies the chemical 

1327 identity, as well as its technical contact and company information, and provides the 

1328 primary submitter‘s site information. EPA will not accept joint submissions that are not 

1329 submitted electronically using e-IURweb and CDX. All information will be saved by the 

1330 reporting softwaretool and both submissions will be matched based upon company and 

1331 chemical substance information. Once the forms are linked, EPA will process the joint 

1332 submission as one report for the reported chemical substance. See the guidance manual, 

1333 available on EPA‘s website at www.epa.gov/iur,http://www.epa.gov/iur, for detailed 

1334 instructions on submitting a joint report.

1335 IV. What clarifications have been made to reporting requirements?

1336 1. Clarification of the Relationship Between Company Name and Site Identity CBI 

1337 Claims. Under the IUR, submitters are able to separately claim as CBI the company 

1338 name and site identity associated with a chemical substance for which they are reporting 

1339 under the IUR. The submitter is required to provide an upfront substantiation for CBI 

1340 claims for the site identity. EPA believes there is some confusion as to what is 
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1341 considered confidential when such claims are made, and is taking this opportunity to 

1342 provide clarification.

1343 The CBI claim protects the link between the company and/or site identity and the 

1344 particular chemical substance. If the company or site identity associated with a particular 

1345 chemical substance is not claimed as CBI, EPA may make that information available to 

1346 the public without further notice to the submitter. EPA will not impute the existence of a 

1347 CBI claim for company identity or for site identity from a CBI claim associated with a 

1348 different chemical substance.

1349 Company and site identity CBI claims are separate claims, and in some cases one 

1350 type of claim may be justified while the other is not. Therefore, a submitter is permitted 

1351 to assert its CBI claim for the company identity, the site identity, or both the company 

1352 and site identity. Such claims must be made for each chemical substance for which such 

1353 claims are being made. Because the circumstances for each chemical substance can vary, 

1354 the IUR rule does not allow for blanket claims covering all chemicalschemical substances

1355 in a site‘s IUR report. 

1356 Likewise, the submitter must provide separately the required upfront 

1357 substantiation for the site identity CBI claims associated with each chemical substance. 

1358 For instance, if the submitter is reporting for five chemical substances and wishes to 

1359 claim its site information confidential for three of the five chemical substances, it must 

1360 assert the claim and provide separate upfront substantiation three times, once for each of 

1361 the three chemical substances. 

1362 EPA has also observed that submitters sometimes claim only their company 

1363 identity, and not their site identity, as confidential. If the site identity for a particular 
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1364 chemical substance is not claimed as CBI, or is claimed but not substantiated pursuant to 

1365 40 CFR 711.30(c), EPA may make that information available to the public without 

1366 further notice to the submitter. EPA will not impute the existence of a CBI claim for site 

1367 identity from a CBI claim for company identity, even if the company name appears 

1368 within the site identity information. To help ensure that submitters consider this issue, 

1369 the e-IURweb reporting softwaretool provides a warning whenever the company identity 

1370 is claimed as CBI for a particular chemical substance and the site identity is not also 

1371 claimed as CBI for that chemical substance.

1372 2. Explanation of Byproduct Reporting. During the 2006 submission period, EPA 

1373 received questions about the requirements for reporting byproducts. The questions 

1374 included whether byproduct manufacturers (including importers) were required to report 

1375 the byproducts under the IUR rule. Based on those and subsequent inquiries, and from 

1376 the public comments from the proposed rule, it is apparent that scope of the IUR 

1377 obligation to report byproducts is not well understood by industry. The scope of 

1378 byproduct reporting has become a particularly pertinent issue because (by the terms of 

1379 the 2003 Amendments to the IUR) inorganic chemicalschemical substances are now no 

1380 longer exempt from reporting under IUR, including (beginning with the 20112012 IUR) 

1381 the information collection requirements for processing and use information. Inorganic 

1382 chemicalschemical substances are often recycled, thereby triggeringwhich may trigger

1383 the need to report a byproduct substance that is recycled. In an effort to further clarify 

1384 reporting obligations, EPA is providing additional information on byproduct reporting, 

1385 including circumstances under which reporting is not required, in the instruction manual 

1386 and in othertwo guidance materialsdocuments included in the docket for this final rule 
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1387 (Refs. 5, 11, and 12 7 and16) and on EPA‘s website at www.epa.gov/iur.

1388 http://www.epa.gov/iur. For purposes of IUR, a byproduct is a chemical substance 

1389 produced without a separate commercial intent during the manufacture, processing, use 

1390 or disposal of another chemical substance or mixture (40 CFR 704.3). Thus, for example, 

1391 when a chemical substance or mixture is used for the purpose of manufacturing an article, 

1392 and that manufacture results in the production of a different chemical substance, that 

1393 different chemical substance is a byproduct for purposes of the IUR. Chemical 

1394 substances that are byproducts of the manufacture, processing, use, or disposal of another 

1395 chemical substance or mixture, like any other manufactured chemical substances, are 

1396 subject to IUR reporting if they are listed inon the TSCA Inventory, are not otherwise 

1397 excluded from reporting, and their manufacturer is not specifically exempted from IUR 

1398 reporting requirements.

1399 The 40 CFR 704.3 definition of manufacture for commercial purposes states that 

1400 ―[m]anufacture for commercial purposes also applies to substances that are produced 

1401 coincidentally during the manufacture, processing, use, or disposal of another substance 

1402 or mixture, including both byproducts that are separated from that other substance or 

1403 mixture and impurities that remain in that substance or mixture. Such byproducts and 

1404 impurities may, or may not, in themselves have commercial value. They are nonetheless 

1405 produced for the purpose of obtaining a commercial advantage since they are part of the 

1406 manufacture of a chemical product for a commercial purpose.‖ Thus, byproducts of the 

1407 manufacture, processing, use, or disposal of another chemical substance or mixture for a 

1408 commercial purpose are themselves both ―manufactured‖ and ―manufactured for 

1409 commercial purposes.‖ Also, considering the overall context of this definition, EPA 
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1410 interprets ―chemical product‖ broadly to include any product of the manufacturing, 

1411 processing, use, or disposal of another chemical substance or mixture, other than a 

1412 byproduct.

1413

1414 Byproducts that are manufactured (including imported) in volumes of 25,000 lb.

1415 or more at a single site are potentially subject to IUR requirements. However, 40 CFR 

1416 711.10(c) excludes from reporting those chemical substances meeting the requirements of 

1417 40 CFR 720.30(g) or (h). Manufacturers (including importers) of byproducts are not 

1418 required to report the manufacture (including import) of a byproduct if the byproduct is 

1419 not used for commercial purposes. See 40 CFR 720.30(h)(2). Thus, even where a 

1420 byproduct is manufactured (including imported) for a commercial purpose, if the 

1421 byproduct is not subsequently put to use for another commercial purpose, the byproduct 

1422 is excluded from IUR reporting. Furthermore, if the byproduct‘s ―only commercial 

1423 purpose is for use by public or private organizations that: (1) burn it as a fuel, (2) dispose 

1424 of it as a waste, including in a landfill or for enriching soil, or (3) extract component 

1425 chemical substances from it for commercial purposes,‖ 40 CFR 720.30(g), that byproduct 

1426 is also excluded from IUR reporting. This exclusion applies only to the byproduct; it 

1427 does not apply to the component chemical substances extracted from the byproduct. The 

1428 Instructions document includes a decision tree to assist a byproduct manufacturer 

1429 (including importer) in its determination of the need to report its byproduct chemicals. 

1430 (Ref 7)

1431 Some manufacturers (including importers) of byproducts have expressed a belief 

1432 that a chemical substance that is regulated by another EPA program, such as under the 

1433 Resource Conservation and Recovery Act (RCRA), or that is exempt from certain 
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1434 requirements by the other program based on certain treatments or disposals, should not be 

1435 required to be reported for IUR purposes. However, under this rule, when such chemical 

1436 substances have a commercial purpose not exempted by 40 CFR 720.30(g), the 

1437 manufacturer (including importer) of such a chemical substance may have IUR reporting 

1438 obligations, and is not relieved of those obligations based on exemptions under other 

1439 laws.

1440 Although the need to report for byproduct chemical substances is not a new 

1441 requirement, EPA recognizes that there were many comments and concerns raised about 

1442 byproduct chemical substances, as stated earlier in this section, and that there may be 

1443 byproduct manufacturers that remain unsure of their reporting obligations under the IUR. 

1444 In particular, the Agency recognizes that this may be an issue for those byproduct 

1445 manufacturers who recycle byproducts by sending them off-site to a recycler. The 

1446 Agency is committed to helping byproduct manufacturers report according to the IUR 

1447 requirements and views the 2012 reporting cycle as an opportunity for the Agency and 

1448 byproduct manufacturers to work together. Among other things, the Agency will use this 

1449 opportunity to determine whether additional guidance tailored to these manufacturers is 

1450 needed. In addition, EPA intends to provide training specific to byproduct reporting and 

1451 to make available Agency personnel to answer questions on an individual basis.

1452 EPA also intends to continue to work with industry and the interested public. 

1453 EPA encourages recycling. The Agency intends to examine the collected information 

1454 related to byproducts, recognizing the importance of recycling, to identify whether there 

1455 are segments of byproduct manufacturing for which EPA can determine that there is no 

1456 need for the IUR information for the 2016 or other future reporting cycles.
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1457 V. Public Comments

1458 EPA carefully considered the comments it received on the proposed IUR 

1459 modifications. Major comments are discussed below. Additional comment summaries 

1460 and more detailed responses, including responses to most of the additional issues that 

1461 EPA requested comment on, are contained in the  ̳ ̳Summary of EPA‘s Responses to 

1462 Public Comments Submitted in Response to Proposed TSCA Inventory Update Reporting 

1463 Modifications‘‘ (document  ̳(Ref. 1312).

1464

1465 A. General Comments

1466

1467 1. Justification for Proposed Modifications. Several commenters supported many 

1468 of EPA‘s proposed reporting changes, stating that the changes will facilitate EPA‘s 

1469 ability to track chemicalschemical substances used and made in the United States, which 

1470 would strengthen EPA‘s ability to identify chemicalschemical substances for further 

1471 assessment. They also noted that the IUR data not only supports activities under EPA 

1472 authorities, but is also used by other Federal agencies, the states, and other interested 

1473 stakeholders to identify potential chemicalschemical substances of concern. Other 

1474 commenters expressed the view that EPA has not provided adequate justification 

1475 supporting the Agency‘s need for the IUR data and has not sufficiently tailored the 

1476 requested information to meet EPA‘s goals. One commenter did not agree that the 

1477 modifications will increase the ―usability of collected information‖ or ―focus reporting‖ 

1478 on what is ―most needed‖ by EPA. Another commenter mentioned that the Agency does 

1479 not explain how the existing IUR fails to meet these goals or why an IUR expansion is 

1480 needed to carry out its Congressionally-mandated TSCA duties. Additionally, 
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1481 commenters suggested that EPA should clearly indicate how the IUR data will be utilized 

1482 in programs that systematically review hazard and exposure of existing chemicals. 

1483

1484 EPA has an obligation under TSCA to protect human health and the environment 

1485 from unreasonable risks associated with chemicalschemical substances under its 

1486 jurisdiction. EPA is amending the IUR rule to improve and enhance data reporting 

1487 requirements under IUR reporting beyond that required during the 2006 reporting 

1488 cycle.submission period. There were problems associated with many 2006 IUR data 

1489 submissions that severely limited EPA‘s ability to screen chemicalschemical substances

1490 for exposure and risks and to make data available to the public. These problems included 

1491 the fact that many submissions were incomplete or improperly completed, contained 

1492 invalid chemical identities, and/or inappropriately or incorrectly claimed certain data 

1493 elements as CBI. EPA anticipates that today‘s amendmentsthis final rule will (1) ensure 

1494 the required information is properly reported and that the information in the Agency‘s 

1495 database reflects the information provided in the IUR reports; (2) increase the usability of 

1496 the collected information; (3) increase the availability of information for the public; and 

1497 (4) focus reporting on information that is most needed by the Agency. Additionally, EPA 

1498 believes that the modifications to the rule will supply manufacturing, and processing and 

1499 use information the Agency did not previously possess and should be accurate and 

1500 reliable enough to develop screening level assessments. 

1501

1502 Data collected under the IUR will be used in a wide variety of programs 

1503 fundamental to fulfilling the Agency‘s TSCA statutory mandate. EPA believes that the 

1504 IUR data is the most basic data set that will give EPA and the public an understanding of 
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1505 the volume of chemicalschemical substances produced or imported into the United States, 

1506 how the chemicalschemical substances are or may be used, and the types of exposures 

1507 (occupational, consumer, environmental, etc.) potentially associated with the 

1508 chemicals.chemical substances. Many chemicals are exempted from reporting under the 

1509 IUR rule, which further tailors IUR requirements to EPA‘s information needs. Data 

1510 about production volume, exposures, and/or environmental releases are required to make 

1511 some of the findings necessary to require testing under section 4, and helps EPA to 

1512 prioritize chemicals for further data gathering or risk management action. chemical

1513 substances for further data gathering or risk management action. For example, data 

1514 supplied by the IUR have supported a series of test rules in the HPV Challenge Program, 

1515 which were implemented to generate health and environmental effects data on HPV 

1516 chemical substances for risk assessment purposes. The IUR supported these test rules by 

1517 providing production volume and exposure information needed to make the findings for 

1518 these test rules. Without the IUR information, EPA might not have been able to make 

1519 these findings. The Agency anticipates that the data collected under the 2012 IUR will 

1520 better support the development of test rules. 

1521 The Agency‘s Existing Chemicals program will use the IUR data to assess 

1522 whether the Agency needs additional data about the hazards or exposures to a particular 

1523 chemical substance under sections 4 or 8 of TSCA, and may use IUR data to inform risk 

1524 management actions such as those identified in TSCA Sections 5 and 6. EPA‘s extensive 

1525 use of the 2006 IUR data in the Agency‘s Existing Chemicals Program is consistent with 

1526 how EPA envisioned the data would be used when the 2003 Amendments were 

1527 promulgated. For example, in 2007, the Agency began to develop and post screening-
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1528 level hazard, exposure, and risk characterizations for HPV chemicals, which are those 

1529 chemicals produced nationally at aggregated volumes of one million lb. or more per year. 

1530 In developing these characterizations, EPA identified areas whereused the 2006 IUR data 

1531 could be improved and enhanced. The amendments in today‘s final rule will allow EPA 

1532 to better identify and take follow-up actiontogether with other available information in 

1533 developing Action Plans on chemical substances that may pose potential risks to human 

1534 health orbeginning in 2009, and noted the limitations inherent in those data. Any future 

1535 program is expected to be similar in analytical approach regarding the environment.use of 

1536 screening-level hazard and screening-level exposure data to develop risk prioritizations. 

1537 EPA‘s future Existing Chemicals program will build on the experience of this past 

1538 program, and the modified IUR data collected during the 2012 and future submission 

1539 periods will enable the Agency to further enhance its program. , More detailed 

1540 discussions are in the Responses to Comments document (Ref. 1312).

1541

1542 2. Transitioning to 20112012. Commenters stated the new requirements are 

1543 overly burdensome and unrealistic considering the time constraints. Another commenter 

1544 stated there would be insufficient time for collecting and verifying data, conducting 

1545 quality checks, or completingCommenters supported delaying the necessary paperwork 

1546 for the report. Many commenters suggested that EPA should extend the IUR submission 

1547 deadlineperiod in a variety of ways, including: (1) extending by several months and 

1548 makedelaying the implementation of changes that are finalized effective in until the next 

1549 submission period, (2) delaying the submission period until 9 to 12 months following the 

1550 promulgation of the final rule, or (3) moving the submission period to 2012 and changing 

1551 the principal reporting periodyear to 2011.
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1552

1553 EPA disagrees that transitioning intoIn light of these comments, to provide 

1554 sufficient time for companies to comply with the new 2011 amended reporting 

1555 requirements is overly burdensome, and unrealistic.to finalize the proposed 

1556 modifications, EPA promulgated a rule (Ref. 6) to suspend the 2011 IUR submission 

1557 period. In this action, EPA supersedes the suspension of the submission period by 

1558 establishing a new sequence of submission period, beginning with one from February 1, 

1559 2012, through June 30, 2012. EPA believes that the four monthtiming of the 2012

1560 submission period provides companies sufficient time to collect and submit the required 

1561 data, and that steps taken by the Agency providedhave and will provide the opportunity 

1562 for companies to gain an understanding of the submission process and to prepare their 

1563 internal electronic systems as needed. For example, EPA was asked by several 

1564 companies and trade organizations to provide an overview of the reporting softwaretool.

1565 Acknowledging that companies were concerned about the time needed to develop their 

1566 internal databases to collect the required information, on November 30, 2010, the Agency 

1567 held an informational workshop and webinar to help companies develop a better 

1568 understanding of the CDX registration process and the e-IURweb electronic reporting 

1569 tool. A recording of the workshop and a summary of the questions and answers is 

1570 available on the IUR website (www.epa.gov/iur).(http://www.epa.gov/iur). EPA used 

1571 stakeholders‘ comments from the workshop and additional comments obtained during the 

1572 tool‘s beta-test to help ensure the tool would address the needs of the submitters. The In 

1573 addition, the Agency plans to provide an opportunity, prior to finalization of the e1574 IURweb, for stakeholders to test a pre-release version of the tool. EPA plans to conduct a 

1575 training webinar shortly after the publication of this final rule to provide detailed 
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1576 instructions on the reporting requirements and on using the reporting software, e1577 IURweb, to complete and submit Form U. Finally, to the extent that the timing of the 

1578 next submission period actually presents a substantial obstacle to the submission of any 

1579 particular data element, notwithstanding EPA‘s efforts to familiarize submitters with the 

1580 draft and final reporting softwaretool, and EPA‘s post-promulgation efforts to familiarize 

1581 submitters with the reporting requirements, the IUR reporting standard of ―known to or 

1582 reasonably ascertainable‖ addresses such circumstances without the need for a delay in 

1583 implementation (see Unit V.E.1.). 

1584

1585 One commenter suggested that EPA continue under the old IUR rule for this 

1586 submission period. The Agency does not agree that it should revert to the existing 2006 

1587 IUR rule because the enhancements addressed in the proposal will significantly increase 

1588 the amount of exposure information available to the public and Agency. The new and 

1589 updated information collected under this final rule will increase the Agency‘s ability to 

1590 understand exposure concerns.continue under the IUR rule in effect for the 2006 

1591 submission period; however, the Agency recognizes that additional time may be 

1592 necessary for many submitters to become familiar with the updated IUR reporting 

1593 requirements and develop processes for collecting the information. Therefore, the Agency 

1594 will be phasing in certain requirements so that the scope of exposure-related information 

1595 to be collected will be increased for the 2012 IUR data collection and then further 

1596 increased for the 2016 data collection and subsequent reporting years. As mentioned by 

1597 one commenter, the ―IUR rule is one of the very few means by which the federal 

1598 government can obtain and provide public access to robust information on the identity, 

1599 production, processing and use of‖ chemical substances (Ref. 17). In order to fulfill the 
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1600 Administrator‘s goal of enhancing EPA‘s TSCA chemical management program, EPA 

1601 needs to begin collecting some of the new and updated information in the 2012 

1602 submission period. As described on EPA‘s website 

1603 (http://www.epa.gov/opptintr/existingchemicals/pubs/enhanchems.html), EPA‘s 

1604 comprehensive approach to enhancing the Agency‘s current chemicals management 

1605 program includes obtaining information needed to understand chemical substance risks 

1606 and increasing transparency and public access to information about chemical substances. 

1607 The proposed changes to the IUR are specifically identified as a key component for these 

1608 aspects of the enhanced program, including required electronic reporting and the 

1609 expanded manufacturing, processing and use information. For example, the expansion of 

1610 reporting processing and use information for all chemical substances addresses the 

1611 identified lack or insufficiency of such information for most chemical substances –

1612 including HPV chemical substances. EPA‘s efforts to understand and prioritize chemical

1613 substances based on risk, using the 2006 IUR data, were instrumental in identifying the

1614 needed changes to the IUR requirements. These included: 

1615 EPA‘s Risk-Based Prioritization Process (RBP) was developed to take the 

1616 hazard data assembled for HPV chemical substances under EPA‘s HPV 

1617 Challenge Program to conduct screening-level hazard assessments and use the 

1618 2006 IUR data to develop screening-level exposure assessments, with the goal 

1619 of using the two types of assessments to develop screening-level risk 

1620 prioritizations for the HPV chemical substances with fairly complete SIDS 

1621 data sets. EPA quickly discovered that while the hazard data allowed EPA to 

1622 make a screening-level conclusion about hazard, the 2006 IUR data rarely 
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1623 provided sufficient information for EPA to reach a screening-level conclusion 

1624 about exposure. 

1625 EPA discovered with the 2006 IUR that a larger than expected portion of HPV 

1626 chemical substance manufacturers produced below the 300,000 lb threshold at 

1627 individual sites, resulting in many submitters not being required to provide 

1628 processing and use information for those volumes. In some cases, all of the 

1629 reporters fell below the threshold. 

1630 For Moderate Production Volume chemical substances, with national 

1631 production volumes between 25,000 and one million pounds, even fewer 

1632 individual sites reported production volumes over the 300,000 lb threshold. 

1633 Although EPA desired to include these chemical substances in its risk-based 

1634 prioritization process, the screening-level exposure information was not 

1635 available.

1636 For those chemical substances for which EPA had some processing and use 

1637 data, the Agency had difficulty evaluating exposure for commercial workers 

1638 and consumers because the 2006 IUR data did not differentiate between these 

1639 populations. The separation of these populations for future IUR collections, 

1640 and including other information such as that related to children‘s use of the 

1641 chemical substances, will help EPA better identify potential risks to more 

1642 targeted populations. 

1643 These examples illustrate several obstacles EPA encountered in understanding

1644 chemical substance risks, which stemmed from the scope of the 2006 IUR data 

1645 collection. They also illustrate how the revised IUR data collection will increase the 
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1646 Agency‘s ability to understand exposure concerns so that EPA will be better able to 

1647 identify steps needed to manage risks associated with chemical substances. Not only will 

1648 the revised IUR data collection provide information that would have been helpful for 

1649 past programs, it is directly applicable to the Agency‘s current and future programs. 

1650 EPA will be able to use the 2012 IUR data to identify additional chemical substances for 

1651 its Chemical Action Plan program, will also be able to identify if any of the current 

1652 action plans may need to be revised, and will be able to develop other aspects of the 

1653 enhanced existing chemical substance management program that are associated with 

1654 understanding chemical substance risk.

1655 In addition, requiring the use of electronic reporting will help ensure that data are 

1656 available in a timely manner and it will reduce data entry errors, thereby increasing the 

1657 usability and reliability of the data for EPA and other federal agencies as well as. It will 

1658 also help to fulfill the Administrator‘s commitment to increase public access to 

1659 information on chemicalschemical substances.

1660

1661 3. EPA’s use of IUR data. The Agency received comments related to how IUR 

1662 data can best be used to assist in assessing, prioritizing, and taking action on 

1663 chemicalschemical substances that pose unreasonable risks. Commenters stated that the 

1664 current IUR was sufficient for EPA to use as a screening tool for the prioritization of 

1665 chemicalschemical substances in commerce, and that EPA should use the Agency‘s wide 

1666 variety of regulatory tools and authorities to collect more detailed information. 

1667 Commenters also expressed interest in providing input on using the IUR and the 

1668 Agency‘s prioritization process. 

1669
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1670 EPA disagrees that the current IUR is sufficient for its purposes. Between August 

1671 2007 and mid-2009, EPA developed screening-level hazard, exposure, and risk 

1672 characterizations for some chemicalschemical substances produced or imported in 

1673 quantities of 25,000 poundslb or greater a year. Based on those characterizations, EPA 

1674 developed either a risk-based prioritization (RBP) or a hazard-based prioritization (HBP) 

1675 for individual chemicalschemical substances or a group of chemicalschemical substances

1676 that were similar in some way, e.g., structure, properties, toxicity. Those prioritizations 

1677 did not constitute definitive determinations regarding hazard, risk, or the sufficiency of 

1678 available information for any regulatory purpose, but were rather initial evaluations of 

1679 data and understanding currently available to EPA. EPA‘s experience using the IUR 

1680 information to develop the prioritizations was that the 2006 IUR data were not sufficient 

1681 to provide the needed exposure-related information. When EPA was developing RBPs 

1682 for its HPV chemicalschemical substances, it needed both hazard and exposure 

1683 screening-level information. Lacking sufficient exposure information, EPA found it 

1684 necessary in many cases to make assumptions about exposure and the resulting 

1685 prioritization decision was primarily hazard-based, as opposed to risk-based, as 

1686 evidenced by statements in many of the RBP as well as HBP documents that EPA 

1687 developed (available at 

1688 http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML) that 

1689 further information on exposure was needed to confirm the prioritization. Thus the 

1690 exposure information provided in the 2006 IUR reporting did not provide EPA with 

1691 sufficient information to prioritize chemicalschemical substances for which it generally 

1692 possessed a base set of hazard data. Therefore, for some of the RBPs the next steps 
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1693 indicated that additional exposure information would be necessary to validate the 

1694 prioritizations before determining whether any further action was needed. In developing 

1695 these characterizations, EPA identified areas where the IUR data collection should be 

1696 improved and enhanced. These improvements, which are reflected in the modifications 

1697 to the reporting requirements in the current rule, will allow EPA to better prioritize 

1698 chemicalschemical substances for further assessment as well as make appropriate risk 

1699 management decisions for follow-up action on chemical substances that may pose 

1700 potential risks to human health or the environment.

1701

1702 EPA is considering using other regulatory tools and authorities to collect more in1703 depth information, but believes the IUR is the correct mechanism for the data collection 

1704 finalized in this notice. EPA also is considering ways to obtain public input on its use of 

1705 the IUR data and its chemical substance prioritization process, as suggested by the 

1706 commenters.

1707

1708 4. Canada’s prioritization approach. Some commenters recommended that EPA 

1709 adopt Canada‘s prioritization approach. EPA assumes that the commenters were 

1710 referring to the Domestic Substances List Categorization that Canada completed in 2006. 

1711 The DSL Categorization was a statutorily mandated risk-based prioritization which 

1712 required review of both hazard and exposure information for 23,000 chemicalschemical

1713 substances in a very short period of time. Health Canada was required to identify 

1714 chemicalschemical substances presenting human health hazards as well as the greatest 

1715 potential for exposure to Canadians. Even though categorization was a legally mandated 

1716 process with a deadline for consideration of all chemicalschemical substances on the 

1717 DSL, Health Canada felt that production volume alone was not a sufficient surrogate for 

1718 exposure and developed a complex process for the exposure portion that required 

1719 extensive literature review, input of. In order to move beyond production volume, Health 

1720 Canada sought additional information from industry, and used, including some of the 

1721 types of data that EPA is requestingrequiring for the 20112012 IUR reporting period 

1722 (Ref. 14). 

1723
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1724 18). Based on its review of hazard and IUR data collected on HPV and medium 

1725 production volume (MPV) chemicals chemical substances, EPA also believes that using 

1726 large production volume as the sole surrogate for exposure is not sufficient to identify 

1727 chemicalschemical substances of highest concern. Some of the risk-based prioritizations 

1728 of HPV chemicalschemical substances resulted in low priority decisions for the HPV 

1729 chemicalschemical substances that were low hazard, used in closed systems and 

1730 consumed as intermediates. On the other hand, some of the MPV chemicalschemical

1731 substances were identified as potentially high or medium priority, because they had high 

1732 or medium hazard and would present high or medium risk concerns if they had 

1733 widespread exposure or dispersive uses. The only way for the Agency to move from 

1734 prioritizations based primarily on hazard to truly risk-based prioritization is for it to 

1735 receive regularly updated information on exposure and use for chemical substances being 

1736 made and used in the United States. The chemical substance manufacturing industry has 

1737 indicated in several ways, including in comments on the proposed rule, that it supports 

1738 risk-based as opposed to hazard-based prioritization. A commenter also noted that 

1739 industry strongly supports risk-based decisions and for that reason needs to provide 

1740 robust production, processing and use data. 

1741

1742 B. Comments on Electronic Reporting

1743

1744 EPA received various comments on the proposed requirement to use the reporting 

1745 softwaretool, e-IURweb, to submit all IUR submissions. In general, comments were 

1746 submitted on the reporting software,tool phasing-in electronic reporting registering with 
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1747 CDX, and electronic signatures. See Section B. in the Responses to Comments document 

1748 (Ref. 1312) for further discussion on electronic reporting.

1749

1750 1. Comments on the reporting softwaretool and phasing-in electronic reporting. 

1751 In general, commenters supported electronic reporting. Some commenters suggested that 

1752 the Agency develop a phased-in process for electronic reporting, in order to provide more 

1753 time for companies to become familiar with the new format and to develop their own data 

1754 systems. Some commenters wanted to be able to upload data via an XML file into the 

1755 web-based tool. The requirement to use electronic submissions over the internet was a 

1756 concern for some commenters. 

1757

1758 EPA, based on its experience collecting and managing the 2006 IUR reports, has 

1759 concluded that mandatory electronic reporting is a critical next step for collection of the 

1760 20112012 data. Optional electronic reporting for the 2006 IUR provided the Agency with 

1761 experience relating to both industry and Agency needs, and the Agency has applied this 

1762 experience in the course of developing of the 20112012 electronic reporting tool (e1763 IURweb). For example, the use of a web-based solutiontool for the 20112012 IUR will 

1764 eliminate many of the software compatibility and firewall setting issues that were 

1765 encountered during the 2006 submission period. In addition, the 2011 e-IURweb utilizes 

1766 other Agency systems, such as SRS, enabling the submitter to readily select the chemical 

1767 identity in the correct format, thereby eliminating problems relating to the previous need 

1768 to type or write in the chemical name. With these enhancements, EPA believes the use of 

1769 e-IURweb will substantially reduce error rates and burden; consequently, EPA does not 

1770 believe it is necessary to have another optional electronic reporting period.

1771

1772 In addition, the Agency‘s CDX service is increasingly being used by a variety of 

1773 programs, as the Agency moves toward comprehensive electronic reporting. EPA is 

1774 continually looking for ways to improve CDX, to better address submitter and Agency 
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1775 needs. For example, the EPA has developed an eTSCA registration for CDX which, 

1776 when fully implemented, will eliminate the need to register separately for eIURto use the

1777 e-IURweb and ePMN. For the 2011 eIUR, systems. ePMN registrations using the 

1778 current eTSCA arewill be acceptable eIURe-IURweb registrations. 

1779

1780 The Agency believes that commenters‘ concerns regarding mandatory use of the 

1781 new electronic reporting tool reflect a lack of understanding of the tool‘s capabilities and 

1782 enhancements. The reporting tool provides the ability to submit data in an XML format 

1783 and includes enhancements to CDX that are designed to allow for multi-user capabilities 

1784 and otherwise facilitate electronic reporting. EPA has provided training opportunities and 

1785 guidance materials to facilitate electronic reporting, as well as product testing 

1786 opportunities, to alleviate particular commenters‘ concerns. 

1787

1788 For example, the Agency held an informational workshop and webinar inon

1789 November 30, 2010. The workshop was designed to help companies develop a better 

1790 understanding of the CDX registration process and the e-IURweb electronic reporting 

1791 tool. In early January, 2011, EPA providedThe workshop, which was recorded live as a 

1792 webinar, was posted to the IUR website at http://www.epa.gov/iur along with 

1793 accompanying slides, a question and answer document, and a draft XML schema, 

1794 allowing companies to ensure their internal systems will be able to directly upload data to 

1795 the e-IURweb. In addition, EPA invitedplans to invite several companies to test e1796 IURweb. EPA invited each company to identify areas where it believedneeding 

1797 improvements. The comments and concerns of industry representatives will be taken into 

1798 consideration as EPA further develops the reporting tool could be improved. A recording 

1799 of the workshop, summary questions and answers, the final schema, and additional 

1800 webinar training that provides detailed instructions of using the reporting tool are 

1801 available on the IUR website, www.epa.gov/IUR. In 2011, EPA. EPA also intends to 

1802 hold further training and outreach sessions at which industry representatives may express 
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1803 remaining questions and concerns regarding the operation of the e-IURweb softwaretool,

1804 which EPA will address. Additionally, EPA has published a revised Instructions

1805 document (Ref. 7) explaining the reporting requirements and how to complete Form U 

1806 using the reporting tool.

1807

1808 Electronic reporting was first offered as an option for the 2006 IUR. As 

1809 explained in the preamble to the proposed rule and the Responses to Comments 

1810 document, there were many problems, errors, and delays associated with paper 

1811 submissions of the 2006 IUR data, which make the continued use of paper reporting 

1812 highly inefficient and therefore undesirable. In light of the substantial disadvantages 

1813 associated with allowing paper submissions, and the reporting tool improvements and 

1814 training opportunities outlined in this unit (and explained in greater detail in the proposed 

1815 rule and the Responses to Comments document) EPA does not believe it is reasonable to 

1816 phase in electronic reporting over another reporting period and is confident that 

1817 submitters will be able to successfully use the e-IURweb tool to electronically report 

1818 under the IUR rule in 20112012.

1819

1820 2. Comments on registering with CDX and providing electronic signatures. 

1821 Commenters thought the modified Electronic Signature Authority Form, in particular the 

1822 need for multiple notarized signatures, was burdensome and unnecessary. Commenters 

1823 stated that there should be more than one individual with an electronic signature and that 

1824 multiple persons may need to be able to input and submit IUR data for a company‘s U.S. 

1825 sites. The commenters noted that the actual preparer/drafter would rarely be the 
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1826 signatory. Another respondent noted that companies should be allowed, but not required, 

1827 to have the same authorized official for the PMN and IUR submission. 

1828

1829 EPA understands and is cognizant of the concerns presented by industry regarding 

1830 the revised Electronic Signature form. An electronic signature agreement is required for 

1831 CDX registration and is necessary to submit electronic data to EPA. Regarding the prior 

1832 need for multiple notarized signatures, EPA has determined that requiring a notarized 

1833 signature as part of the electronic signature agreement is no longer necessary. EPA is also 

1834 exploring an approach to eliminate the need for an individual to register multiple times 

1835 with CDX to submit to various TSCA programs. As with PMN electronic submissions, 

1836 multiple people from the same site or company are able to register with CDX and 

1837 participate in completing the site‘s Form U. Although one individual will be designated 

1838 as an authorized official who will sign and submit the completed Form U, the e-IURweb 

1839 tool allows for more than one individual to edit a submission. Ultimately, EPA‘s goal is 

1840 to provide one electronic signature agreement across all TSCA programs and is exploring 

1841 the reuse of e-electronic signatures issued under the e-PMNNew Chemicals program, as 

1842 well as other EPA programs. Regarding notarized signatures, EPA has determined that 

1843 requiring a notarized signature as part of the electronic signature agreement is no longer 

1844 necessary. 

1845

1846 C. Comments on Reporting Thresholds

1847

1848 1. Method for determining whether you must report. EPA proposed to modify the 

1849 method used to determine whether a person is subject to IUR reporting. The new method 

1850 requires persons to report under the IUR if they manufactured (including imported) 

1851 25,000 lb. or more of a chemical substance at any single site in any calendar year since 

1852 the last principal reporting year, (note. This method becomes effective after the 2012 IUR 
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1853 submission period. (Note: there is noalso a lowered production volume threshold for 

1854 certain chemicals, seechemical substances, effective after the 2012 IUR submission 

1855 period. See 40 CFR 711.8(b)). This method becomes effective after the 2011 IUR 

1856 submission period. 

1857

1858 ).)Several commenters believed the change is appropriate and should be 

1859 implemented for the 2015 reporting cycle.submission period following the upcoming 

1860 submission period (i.e., in the submission period following the proposed 2011 submission 

1861 period). They noted that the new requirement is essential to effectively capture the 

1862 substantial year-to–year fluctuation in production/import volumes that was missed in past 

1863 IUR reporting cycles, thereby skewing the picture of how many and which 

1864 chemicalschemical substances are actually in commerce at a given time and what levels 

1865 of production or import. One commenter went further to say that the modification would 

1866 eliminate gaps and uncertainties in the information collected under the current IUR that 

1867 result from infrequent collections and reporting of data. Another said that this will keep 

1868 manufacturers from disguising their actual output by producing certain specialty 

1869 chemicalschemical substances only in years that are not currently subject to IUR 

1870 reporting. Two commenters supported the change but opposed the proposal to delay 

1871 implementation until after the 2015 reporting cycleproposed 2011 submission period,

1872 because it would further delay the ability to obtain accurate annual production 

1873 information.

1874

1875 In contrast, others had mixed opinions or did not think the change was needed. 

1876 Some commenters felt that unless the value of collecting and analyzing 

1877 retroactivehistorical data could be clearly demonstrated such that the resource for the 

1878 Agency and regulatory community can be justified, EPA should retain the mechanism 

1879 whereby the need to report is based on consideration of a single reporting year and 

1880 current threshold. Some commenters stated that EPA had not shown special utility for the 

1881 information generated. Another commenter believes that there is no significant 
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1882 incremental benefit to require reporting from companies that produce or import less than 

1883 25,000 lb. of a reportable chemical substance for four out of five years. 

1884

1885 The Agency realizes that the new multi-year consideration of production volume 

1886 will increase reporting burden on industry, but believes that there is sufficient evidence 

1887 that wide fluctuations in production volumes from year to year indicate the past IUR 

1888 reporting was not accurately characterizing the chemical production. As EPA noted in the 

1889 proposed rule preamble, production volumes of chemical substances vacillating above 

1890 and below reporting thresholds in different IUR reporting periods resulted in a change of 

1891 approximately 30% in the composition of the chemicalschemical substances being 

1892 reported from one IUR reporting period to the next. For example, EPA prepared a 

1893 prioritization document for the Butenedioic Acid Dialkyl Esters Cluster, which consists 

1894 of 10 butenedioic acid dialkyl esters, seven of which were MPVs and three HPVs in 2006 

1895 (Ref. 1519). Three of the chemicalschemical substances have had fluctuating production 

1896 volumes above and below one million pounds. In 1990 and 1994 when the HPV 

1897 Challenge program was being developed, the CASRNs 68921-51-7, 141-05-9, and 624-

1898 48-6 had production volumes below one million pounds and so were not included in the 

1899 HPV Challenge for completion of SIDS datasets. In 1998 and 2006, CASRN 68921-51-

1900 7‘s production volumes have been above one million pounds, making it an HPV in those 

1901 years. In 2002, CASRNs 141-05-9 and 624-48-6 had production volumes above one 

1902 million pounds. In part because of their fluctuating production volumes, neither SIDS 

1903 datasets nor consistent exposure and use information were available for these 

1904 chemicalschemical substances and so they were included in a cluster for an HBP as 

1905 opposed to an RBP. One commenter also submitted an analysis of the degree of 

1906 fluctuation of chemicalschemical substances and production volumes in the 2002 and 
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1907 2006 IUR reporting years. This analysis found that about 32% of the organic 

1908 chemicalschemical substances reported in 2002, including 400 HPVs, were not reported 

1909 for 2006 and that about 26% of the chemicalschemical substances reported in 2006, 

1910 including more than 200 organic HPVs, were not reported in 2002.

1911

1912 In addition, in comments submitted to the Agency in response to other programs, 

1913 industry representatives expressed concern that short reporting determination periods 

1914 would drastically misrepresent the chemical substances that currently are in commerce. 

1915 They stated they manufactured or imported some chemical substances only occasionally, 

1916 and that these chemical substances would not be captured if the reporting covered too 

1917 short a period. The proposed rule preamble provides a more detailed discussion of these 

1918 comments (see 75 FR 49664Ref. 1). 

1919

1920 EPA believes that most sites will be able to gather production volume information 

1921 without a substantial effort. In many instances, production volumes for recent past years 

1922 are tracked under standard business practices. For example, EPA believes it is standard 

1923 business practice for a company to furnish records of recent operations in the case of a 

1924 proposed sale or merger, and that companies therefore typically retain such records so as 

1925 to be prepared for such eventualities. EPA also notes that in the case that prior years‘ 

1926 production volume information is not known to or reasonably ascertainable by the 

1927 submitter (EPA expects that such cases would be extremely rare), those data would not 

1928 be subject to reporting under the IUR and therefore would not trigger an obligation to 

1929 report Furthermore, persons who have submitted a PMN to the Agency‘s New 

1930 Chemicals program are required to maintain records of production volume for the first 3 
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1931 years of production or import, including but not limited to the names, addresses of any 

1932 person to whom the chemical substance is distributed ( info includes any distributed) . 

1933 They must be maintained for 5 years from the date of commencement of manufacture or 

1934 import (See 720.78). EPA expects that many companies would also track production 

1935 volumes for planning, marketing, and sales projection purposes. Several TSCA

1936 regulations, such as 5(a)(2) SNURs and 5(e) orders also require that production volume 

1937 records be kept for five years for certain chemicalschemical substances, and several 

1938 commenters indicated that they archived these records. 

1939

1940 2. Elimination of the 300,000 lb. threshold. The Agency received a substantial 

1941 number of comments on the proposed elimination of the 300,000 lb. threshold for 

1942 reporting processing and use information. Comments submitted on various topics are 

1943 described in this unit. 

1944

1945 a. Increased numbers of covered chemical substances. Commenters asserted that 

1946 the influx of inorganic chemicalschemical substances, coupled with the threshold change 

1947 for processing and use information, will result in a substantial increase in the amount of 

1948 data being submitted to the Agency. Commenters felt that EPA staff will need significant 

1949 time to compile, review, and analyze the data submitted. One commenter suggested the 

1950 Agency use a phased-in approach to adequately collect and process the increased 

1951 information. 

1952

1953 In response to these comments and comments received during interagency review, 

1954 EPA decided to phase in the eventual elimination of the 300,000 lb threshold as a 

1955 separate reporting threshold. For the 2012 submission period, all submitters of non1956 excluded chemical substances are required to report processing and use information if 

1957 they manufactured (including imported) 100,000 lb or more of a chemical substance in 
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1958 2011. For subsequent submission periods, the reporting threshold for processing and use 

1959 information will be the same as for other types of information: 25, 000 lb (or 2,500 lb. for 

1960 chemicals subject to 40 CFR 711.8(b)). Thus, there will be no separate threshold for the 

1961 reporting of production and use information after 2012—the applicable reporting 

1962 threshold will be the same as for other types of information. EPA believes this is a 

1963 reasonable approach because it provides new submitters with an opportunity to become 

1964 familiar with the reporting requirements, and provides much needed processing and use 

1965 information on additional chemical substances. Future full reporting of exposure-related 

1966 information will provide EPA and others with needed additional information for those 

1967 chemical substances with production volumes of 25,000 lb or more at a site. While it is 

1968 true that the amount of data in the IUR reports is expected to increase substantially in the 

1969 20112012 and subsequent reporting yearssubmission periods, EPA is better prepared now 

1970 than it was for the 2006 IUR to compile, review, and analyze the anticipated increase of 

1971 data. With the new e-IURweb electronic tool, large amounts of data will be able to be 

1972 submitted with less difficulty on the part of the submitter, and will be more readily 

1973 organized, analyzed, and made available to the public by the Agency. In addition, the use 

1974 of SRS for identifying chemical substances and validation process built into the e1975 IURweb tool will eliminate most or all of the problems EPA had with missing 

1976 information (which necessitated phone calls and emails to submitters), and manual entry 

1977 of data, which was time-consuming and resulted in many mistakes. Given the 

1978 requirement for mandatory electronic submissions and the corresponding improvements 

1979 to the e-IURweb tool, the Agency is confident that the increase in data submissions will 
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1980 be easily managed for this reportingthe 2012 submission period and the next, and both 

1981 EPA and the public will quickly have a useable set of exposure-related IUR data. 

1982

1983 b. Reporting Burden. Numerous commenters were concerned about the increased 

1984 reporting burden, particularly for smaller companies, and the complexity of IUR Form U 

1985 Part III. One commenter stated that EPA should assess the benefits of the additional 

1986 reporting requirements to establish a cost justification of the proposal. Other commenters 

1987 were concerned that the lowered threshold would increase the number of imported 

1988 mixtures and that it would be difficult to calculate and aggregate across products for 

1989 lower volume chemicalschemical substances. 

1990

1991 EPA analyzed the potential impacts of this requirement to all submitters, 

1992 including potential burden to small businesses, in the Economic Analysis (Ref. 1914).

1993 EPA recognizes that reducing the reporting threshold for processing and use information 

1994 increases the reporting burden; however, phasing in the lower threshold reduces the 

1995 burden for this reporting cycle, but and the cost to industry will decrease in all future 

1996 reporting cycles. 

1997

1998 EPA disagrees with comments suggesting that the requirement may have a 

1999 disproportionate effect on smaller companies (commenters suggested that smaller 

2000 companies are more likely to manufacture below the 300,000 lb. threshold that is 

2001 eventually being eliminated.) The quantity of a chemical substance that is manufactured 

2002 (including imported) at a site is not necessarily dependent on the number of employees, 

2003 which is the criteria by which a company is considered to be small. For example, a highly 

2004 automated facility could produce large volumes of a chemical substance with a relatively 

2005 small number of employees. Additionally, as noted in the Economic Analysis, the 

2006 Agency determined that because the small businesses affected by today‘sthis final rule 

2007 actually have average sales of more than $11 million, and because any potentially 
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2008 affected companies with sales of $1.020.81 million or less (the level at which the cost-to2009 sales ratio of the final rule would exceed 1%) would generally be exempt from reporting 

2010 obligations under the IUR, small entities will not be significantly affected by today‘sthis

2011 final amendments to the IUR rule.

2012

2013 EPA recognizes that, with the reduction and eventual elimination of the 300,000 

2014 lb. threshold, importers may face an increase in burden to identify more component 

2015 chemicalschemical substances contained within more imported mixtures. However, ,EPA 

2016 disagreesbelieves that due to the deferral of the threshold reduction until the 2012 

2017 submission period (which involves reporting on the processing and use of imports 

2018 occurring in 2011) and the deferral of the threshold elimination until the 2016 submission 

2019 period (which includes reporting on the processing and use of imports occurring in 2015), 

2020 importers are unpreparedwill have had sufficient time to conduct a reasonablean inquiry 

2021 as to the specific chemicalschemical substances they import in mixtures. Furthermore, 

2022 the inquiry need only be as extensive as a reasonable person, similarly situated, might be 

2023 expected to perform. 

2024 EPA has several reasons to expect that importers have a reasonable awareness of 

2025 the component chemical substances contained within imported mixtures. Importers have 

2026 long been responsible for certifying that their imported chemical substances, including 

2027 those chemical substances present as part of mixtures, are in compliance with TSCA (See 

2028 19 CFR 12.119). Furthermore, importers have long been required to provide chemical -

2029 specific information as to the constituents of imported mixtures under the IUR (see the 

2030 definition of ―importer‖ at 40 CFR 704.3 and the note at 40 CFR 710.4(c)(2)) and under 

2031 the PMN program (40 CFR 720.30(b). Furthermore, importers are often required to 
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2032 report chemical -specific information regarding imported mixtures under other EPA2033 administered statutes, such as the Emergency Planning and Community Right-To-Know 

2034 Act (EPCRA) and the Resource Conservation and Recovery Act (RCRA).RCRA. While 

2035 reporting under the IUR differs in many significant respects from reporting under the 

2036 EPCRA and RCRA programs, in all cases the importer is required to know the 

2037 identifyidentity of the chemical substances they import. EPA notes that one commenter 

2038 described, in detail, its practice of accounting for component chemical substances in 

2039 imported mixtures. The commenter stated that ―[w]ith the advent of the [Registration, 

2040 Evaluation, Authorisation and Restriction of Chemicals] REACH we recently 

2041 implemented an application that is capable of tracking volumes of individual substances 

2042 in mixtures and summing them up over a period of time. The system automatically looks 

2043 at the current formulation of any product that is crossing a border and adds the volume of 

2044 each component to the cumulative total for that substance‖ (Ref. 18). EPA expects that 

2045 the burden associated with reporting these chemicals will decline in reporting periods 

2046 subsequent to 2011, as additional recordkeeping procedures are put into practice.20).

2047 Finally, EPA notes that a chemical substance that is imported solely in small quantities 

2048 for research and development, as an impurity, as part of an article, or in certain other 

2049 forms, see 40 CFR 720.30(g) and (h), is not subject to the IUR reporting requirements. 

2050 See 40 CFR 711.10. 

2051

2052 c. Justification for data. Several commenters strongly supported EPA‘s proposed 

2053 change, stating that the information is essential for the completion of prioritizations for 

2054 IUR reportable chemical substances; is critical for evaluating the potential for release of 

2055 and exposure to chemicalschemical substances in commerce; and that the information 

2056 requested is basic, screening-level data that should be required for all reported 

2057 chemicals.chemical substances. Additional commenters generally supported the 

2058 changeschange, but wanted the changeit to take effect after the 2011 reporting cycle. 
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2059 Other commenters had concerns about the value of the information that is reported in Part 

2060 III. One commenter stated that EPA has not made public documentation of the past use of 

2061 this information to address screening and prioritization of chemicals.chemical substances.

2062 Another commenter believes that EPA should provide more specificity on its needs and 

2063 explain why other, more tailored, options do not provide the necessary data. 

2064

2065 EPA‘s information needs have changed since the last major amendment of the 

2066 IUR rule in 2003. Production volume changes from year to year, so chemicalschemical

2067 substances can easily fluctuate above and below a relatively high reporting threshold, 

2068 such as the previous 300,000 lb. threshold for reporting processing and use, making it 

2069 difficult for EPA to collect regular exposure information on many chemicals.chemical

2070 substances. Requiring the reporting of processing and use information on an expanded 

2071 list of chemicalschemical substances will assist the Agency and others in screening 

2072 potential exposures and risks resulting from industrial chemical substance operations and 

2073 commercial and consumer uses of chemical substances. The information will also help to 

2074 provide an accurate and readily available source of, as noted in Unit V.A.1, basic 

2075 exposure-related information for a subset of chemicalschemical substances listed on the 

2076 TSCA Inventory. Furthermore, collection of this data is consistent with the 

2077 Administrator‘s strong commitment to provide the public with more information on a 

2078 greater number of chemicals.chemical substances.

2079

2080 As mentioned in the preamble of the proposed rule and as explained in Units 

2081 V.A.3 and V.A.4 herein, the data reported in 2006 did not provide an adequate amount of 

2082 exposure-related information, especially for HPV chemicals.As EPA discusses below and 

2083 elsewhere, the 2006 IUR information did not provide sufficient useable exposure-related 

2084 data for EPA‘s screening level assessments. If EPA delayed reducing the processing and 

2085 use reporting threshold until the 2016 submission period, EPA would have to wait several 
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2086 more years before more useful exposure-related information is received for chemical

2087 substances for which EPA has already determined are currently in need of such 

2088 information. With the phased-in approach, EPA will be able to collect much needed 

2089 processing and use information on additional chemical substances during the 2012

2090 submission period. Requiring full reporting for all chemical substances in subsequent 

2091 reporting cycles (i.e., eliminating the separate, higher, threshold for production and use 

2092 information) provides EPA with the exposure-related information needed to continue 

2093 efforts begun with the 2012 data. For example, the data reported in 2006 did not provide 

2094 an adequate amount of exposure-related information, especially for HPV chemical

2095 substances. When attempting to use the 2006 IUR data for its screening level exposure 

2096 assessments, EPA found that numerous chemicalschemical substances previously 

2097 identified as HPVs were reported in amounts classifying them as MPV 

2098 chemicalschemical substances, below the 300,000 lb. cut off, and thus processing and use 

2099 information was not provided for chemicalschemical substances for which EPA had a 

2100 relatively complete hazard data set from the HPV Challenge. For example, an RBP was 

2101 prepared for the Chlorobenzenes Category, which consisted of four chlorobenzenes 

2102 sponsored under the HPV Challenge (Ref. 1821). Only one of the four substances, 1,3-

2103 dichloro benzene (CASRN 541-73-1), was considered high priority; however, because it 

2104 was an MPV chemical substance in 2006, no exposure and use data was available from 

2105 the IUR reporting, so the high priority determination was based on high human health 

2106 hazard and assumptions made about exposure. 

2107

2108 The 2006 IUR data did not provide sufficient information on moderate production 

2109 volume (MPV) chemicals chemical substances for use by the Agency‘s Existing 

2110 Chemicals Program. Screening chemical substance risks generally requires a combination 
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2111 of both hazard and exposure information. Because most MPV chemicalschemical

2112 substances were produced below the 300,000 lb. reporting threshold, EPA did not have 

2113 exposure information available from the 2006 IUR and therefore, developed hazard based 

2114 prioritizations which were supported by a screening level hazard characterization and 

2115 consideration of very limited exposure and use data. The lack of information on exposure 

2116 and use was especially problematic in those instances where the screening level hazard 

2117 characterization identified either a medium or high hazard. Basic hazard data is easier 

2118 to find in existing databases; however, specific exposure data is needed to make a priority 

2119 determination risk-based. EPA believes that the lowerlowering of the reporting threshold 

2120 will provide more exposure-related information on a greater number of MPV chemicals.

2121

2122 chemical substances.EPA disagrees with the comment that it has not made public 

2123 documentation of the past use of processing and use information to address screening and 

2124 prioritization of chemicals.chemical substances. As discussed above in Unit V.A.3, EPA 

2125 used 2006 IUR data starting in 2007 in its development of RBPs and HBPs which it has 

2126 made available on its website. More recently, the Existing Chemicals Program used the 

2127 IUR database when developing the Chemical Action Plans. For some Action Plan 

2128 chemicalschemical substances, the 2006 IUR data were not sufficiently complete to be 

2129 useful. An example is the Action Plan for Dyes Derived from Benzidine and Its 

2130 Congeners, where the chemical substances of concern are known or reasonably 

2131 anticipated human carcinogens; however, those listed were produced in amounts below 

2132 the 300,000 lb. threshold and so little exposure data was reported. Based on IUR data 

2133 from prior reporting periods, some of the other dyes had been reported in the 10,000 to 

2134 25,000 lb. range, but there was no 2006 IUR data available to determine whether these 

2135 chemicalschemical substances were still being used in amounts beyond the small 

2136 amounts used as analytical reagents. The Action Plans are available on EPA‘s web site at 

2137 http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html.

2138

2139 By lowering the reporting threshold for processing and use information to 25,000 

2140 lb in 2016, EPA is increasing consistency for the IUR with reporting requirements of the 

2141 TRI program. Under the TRI program, chemicalschemical substances that are not 

2142 chemicalschemical substances of special concern listed at 40 CFR section 372.28 (e.g., 

2143 mercury, lead) are required to be reported if they are manufactured or processed in 

2144 volumes of 25,000 lb. or more annually or otherwise used in volumes of 10,000 lb. or 

2145 more annually. Though the chemicalschemical substances on the TRI toxic chemical

2146 substance list may be different from those reported under the IUR, an analysis showed 

2147 that over 80 percent of the sites that reported under the 2006 IUR also reported under TRI 
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2148 in 2006. Given that there is some overlap in the companies that report and the 

2149 information collected on activities and uses of chemicalschemical substances under both 

2150 programs, EPA believes that many companies are already accustomed to reporting on 

2151 lower volume chemicalschemical substances. 

2152

2153 d. Lack of data for chemical substances. Several commenters noted that the 2010 

2154 reporting year will be over by the time the rule is finalized, and companies would not 

2155 have had the opportunity to establish systems for collecting the information for 

2156 chemicalschemical substances in the 25,000 to 300,000 lb. range. Other commenters 

2157 asserted that EPA was seeking data that are limited or unavailable because manufacturers 

2158 do not know how their chemicals are used by their customers downstream from the 

2159 manufacturingcustomers use their chemical substances. Another commenter asserted that 

2160 the lowered threshold will not enhance the quality or integrity of the resulting IUR data 

2161 due to uncertainties in making estimates. 

2162

2163 EPA recognizes that submitters may not always have detailed information about 

2164 how the chemical substance(s) they manufacture (including import) are used. As a result, 

2165 submitters will be required only to report this information to the extent that it is known or 

2166 can be reasonably ascertained. Based on its experience with the New Chemicals Program, 

2167 discussions with industry about voluntary risk management programs, and industry‘s 

2168 various self-regulation initiatives, the Agency believes that most submitters have at least 

2169 some basic information about downstream uses, such as the information that is required 

2170 by the IUR rule. 

2171

2172 EPA acknowledges that the final rule will be published shortly before the start of 

2173 the submission period. EPA does not anticipate that the quality of the data collected in 

2174 20112012 will significantly decrease due to the timing of the amendment to the reporting 

2175 threshold. ManyAs mentioned earlier, EPA published a final rule (Ref. 6) to suspend the 

2176 2011 submission period to provide sufficient time for companies to comply with the 

2177 updated IUR reporting requirements. This final rule is published in advance of the 2012 

2178 submission period, which is February 1, 2012 to June 30, 2012. For these reasons, 

2179 companies should have the opportunity to establish systems for collecting the information

2180 on their reportable chemical substances. Furthermore, many of the reporting elements are 
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2181 the same as in past IUR reporting periods, and EPA notes that the rule affords sufficient 

2182 flexibility to account for those circumstances in which information is truly unknown and 

2183 not reasonably ascertainable. The Agency believes that the data will be of sufficient 

2184 reliability for use by the Agency and others for purposes such as screening-level risk 

2185 assessments and prioritization.

2186

2187 3. Eliminate 25,000 lb. threshold for selectedspecific regulated chemical

2188 substances. EPA proposed to eliminate the 25,000 lb. reporting threshold for certain

2189 chemical substances subject to particular TSCA rules and/or orders and to require 

2190 manufacturers (including importers) of such chemical substances to report under the IUR, 

2191 regardless of the production volume. Comments submitted on various topics are 

2192 described in this unit.

2193

2194 a. Burden. One commenter stated that companies not expecting this significant 

2195 change will be unprepared to gather required information. Several commenters expressed 

2196 the view that the requirement will increase the burden upon industry without any real 

2197 benefit to the environment and will create a situation where manufacturers (including 

2198 importers) are responsible for knowing all byproducts of their process, no matter how 

2199 small. Others felt that enacting this requirement without a de minimis concentration 

2200 threshold would add an unnecessary additional layer of complexity to IUR analysis and 

2201 would result in each reporting entity responsible for a far greater number of Form U 

2202 submittals. 

2203

2204 The Agency believes it is unlikely that recordkeeping practices were not already 

2205 in place for companies to track the volumes of the chemicals they are manufacturing. 

2206 EPA analyzed the potential impacts of this requirement to submitters and recognizes that 
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2207 eliminating the 25,000 lb threshold for these substances increases the reporting burden 

2208 (see the Economic Analysis). However, the burden of reporting will be ameliorated by 

2209 the use of electronic reporting. 

2210

2211 The Agency believes it is likely that recordkeeping practices were already in place 

2212 for a company to track the volumes of the chemical substances it is manufacturing

2213 (including importing). In response to commenters, EPA decided to take two steps to limit 

2214 the burden increase associated with IUR reporting for the specific regulated chemical 

2215 substances. As a result, EPA is reducing the reporting threshold for these chemical 

2216 substances to 2,500 lb, instead of entirely eliminating the reporting threshold. In 

2217 addition, EPA is phasing in this change to the IUR: it will not affect IUR submissions 

2218 until the 2016 submission period (i.e., it applies to the submission in 2016, of records of 

2219 production occurring between 2012 and 2015). EPA believes this should help to reduce 

2220 the reporting burden for submitters because it provides sufficient time for companies to 

2221 put in place recordkeeping procedures to collect and report the required data for 

2222 situations where the recordkeeping procedures do not already exist. The burden of 

2223 reporting will also be greatly diminished by the use of the reporting tool. The Economic 

2224 Analysis contains EPA‘s analysis of the burden associated with this reporting (Ref. 14).

2225 EPA disagrees that the increased burden will not yield any real benefit and agrees 

2226 with the commenters who supported eliminating the 25,000 pound threshold for certain 

2227 TSCA-subject chemicals so that more useful information would be receivedbenefits. 

2228 Chemical substances that are the subject of particular TSCA rules and/or orders are of 

2229 demonstrated high interest to the Agency. Receipt of up-to-date exposure and use 

2230 information on these chemicals, regardless of production volumechemical substances, 

2231 produced at 2,500 lb or more, will help EPA as it develops risk management strategies 
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2232 for those chemicalschemical substances subject to proposed rules. Additionally, EPA 

2233 will use the 2016 IUR data as it monitors chemical substance production and compliance 

2234 with the rules. The new requirement will also contribute to the Administrator‘s 

2235 commitment to increase the availability of chemical information to the public. EPA 

2236 expects instances when the required information is not known or reasonably ascertainable 

2237 will decline substantially in reporting cycles subsequent to 2011, as additional 

2238 recordkeeping procedures are put into practice.substance information to the public.

2239

2240 b. Imports and Mixtures. Commenters thought this requirement will be difficult to 

2241 meet in practice, particularly for imported chemicalschemical substances or mixtures. 

2242 One commenter felt the requirement would create a needle-in-a-haystack situation in 

2243 which a company would need to examine all chemicalschemical substances and/or 

2244 mixtures imported, regardless of the concentration of the chemical substance or volume 

2245 of the import. Other commenters believed that importers would have great difficulty 

2246 knowing that low-concentration ingredients are present in formulated mixtures, especially 

2247 when they are not subject to inclusion on a label or Material Safety Data Sheets (MSDS).

2248

2249 EPA recognizes that eliminating the 25,000 lb. reporting threshold may, in some 

2250 instances, make it more difficult for importers to determine the production information 

2251 for component chemical substances in imported products. However, the IUR incorporates

2252 Consequently, the reporting threshold will be 2,500 lb, instead of zero, and will be phased 

2253 in to begin with the 2016 IUR. The IUR also includes a number of exemptions that 

2254 address the ―needle-in-a-haystack‖ concern expressed by the commenter. IUR reporting 

2255 is not required for a chemical substance that is imported solely in small quantities for 

2256 research and development, as an impurity, as part of an article, or in certain other forms. 

2257 See 40 CFR 711.10, 40 CFR 720.30(g) and (h). Furthermore, for the reasons discussed in 

2258 Unit II.D.5., companies should be accustomed to reporting chemical -specific information 

2259 to EPA because the Agency has always sought information on individual chemical 
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2260 substances in mixtures under the IUR and PMN programs. Similar to the requirement to

2261 report processing and use information for lower volume chemicals (see Unit E.5.b), EPA 

2262 believes that instances where this information is not known or reasonably ascertainable 

2263 will decline substantially for reporting periods subsequent to 2011 as additional 

2264 recordkeeping procedures are established.TSCA regulations. For example, TSCA section 

2265 13 requires chemical importers to certify that the chemical substance or mixture it is

2266 importing is not being imported in violation of TSCA; an importer must, therefore, have 

2267 knowledge of the regulatory status of the chemical substances it is importing. If an 

2268 importer does not know, or can‘t reasonably ascertain that a particular chemical

2269 substance is present in a mixture, it is not required to report the chemical substance. If an 

2270 MSDS makes no mention of the presence of an ingredient, and the importer does not 

2271 otherwise know that the ingredient is present, EPA would generally agree that the 

2272 importer does not know, and cannot reasonably ascertain that it is importing that 

2273 ingredient. Therefore, no IUR report for that ingredient would be required. In addition, 

2274 manufacturers (including importers) are not required to report impurities. 

2275

2276 If an importer does not know and cannot reasonably ascertain that a particular 

2277 chemical substance is present in an imported mixture, it is not required to report the 

2278 chemical substance under the IUR. Importers of mixtures with constituents of 

2279 proprietary or otherwise unknown chemical identity should ask the supplier for the 

2280 chemical identity to help determine whether an IUR report must be completed. If an 

2281 importer knows that it is importing a particular chemical substance above the relevant 

2282 threshold, but does not know the chemical identity because the supplier is unwilling to 

2283 share the chemical identity with the importer, it is sufficient for the importer to follow the 
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2284 procedures in 40 CFR 711.15(b)(3)(i)(A), requesting that the foreign supplier provide the 

2285 chemical identity directly to EPA in a joint submission.

2286 The IUR reporting related to mixtures and UVCB substances (chemical 

2287 substances that are of Unknown or Variable composition, Complex reaction products, or 

2288 Biological materials) requires careful consideration by submitters. Whenever a submitter 

2289 has manufactured or imported a combination of several chemical substances, the 

2290 submitter must first determine whether for TSCA purposes it is a mixture or a single 

2291 UVCB chemical substance. A mixture is any combination of chemical substances that 

2292 meets the statutory definition of ―mixture‖ at TSCA section 3(8). Mixtures are not 

2293 reported to IUR – rather the mixture's component chemical substances, the chemical

2294 substances that make it up, are potentially subject to reporting, as described below. A 

2295 UVCB substance is an indefinite combination of chemicals, that does not meet the 

2296 statutory definition of ―mixture‖ at TSCA section 3(8), whose number and individual 

2297 identities and/or composition are not precisely or completely known. A UVCB 

2298 combination of chemical substances is subject to reporting under IUR and is considered a 

2299 single chemical substance. Generally, the determination of whether a combination of 

2300 chemical substances is a mixture or a UVCB substance is made by the time that chemical 

2301 substance has been commercialized and, as such, would be clear early in the IUR process. 

2302 The following discussion is presented with this generality in mind.

2303 If you imported a mixture, you will need to report the individual chemical 

2304 components of the mixture to the extent that your total volume for the individual 

2305 chemical substance triggers reporting (i.e., generally to the extent that such 

2306 volume reaches the 25,000 lb threshold). 
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2307 If you domestically manufactured a mixture, you will need to determine whether 

2308 any chemical substances were formed from a chemical reaction that occurred as 

2309 part of manufacturing the mixture. If a chemical reaction has occurred, a chemical 

2310 substance formed from the chemical reaction may be subject to reporting, based 

2311 on its production volume or the applicability of other exemptions. If a chemical 

2312 reaction has not occurred, you have not manufactured any reportable chemical 

2313 substances in the production of the mixture. In such a case, the production of the 

2314 mixture has not triggered any IUR reporting requirement. 

2315 Domestic manufacturers and importers should also consider whether the 

2316 combination of chemicals they have domestically manufactured or imported 

2317 (respectively) should be chemically identified for TSCA purposes as a single 

2318 UVCB chemical substance instead of a mixture. 

2319 EPA has developed two Inventory nomenclature guidance documents related to 

2320 the mixture-UVCB determination titled: (1) Toxic Substances Control Act Inventory 

2321 Representation For Chemical Substances Of Unknown Or Variable Composition, 

2322 Complex Reaction Products And Biological Materials: UVCB Substances available on2323 line at: http://www.epa.gov/oppt/newchems/pubs/uvcb.txt; (2) Toxic Substances Control 

2324 Act Inventory Representation For Combinations Of Two Or More Substances: Complex 

2325 Reaction Products available on-line at: 

2326 http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt.

2327 c. List of subject chemical substances. Commenters suggested that EPA provide 

2328 an up-to-date list of the chemical substances impacted at the beginning of the information 

2329 collection year to ensure more accurate and complete reporting. EPA provides just such a 
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2330 list. It is titled ―Chemical Substances that are the Subject of Certain TSCA Orders, 

2331 Proposed or Final TSCA Rules, or Relief Granted under Civil Actions.‖‖ It can be found 

2332 in Appendix CB of the Instructions for Reporting Guidance Document.document (Ref. 

2333 7). The pertinent chemicals are listed both by CASRNs (for non-confidential chemical 

2334 substances) or by Accession Numbers (for confidential substances) that are the subject of 

2335 a rule. This document, which will be updated for the 2011 IUR reporting, is available in 

2336 the docket for this final rule and on EPA‘s IUR website at www.epa.gov/iur. This list is 

2337 intended to be a helpful information resource, but it is not legally determinative of the 

2338 status of any particular chemical substance.

2339

2340 d. Reporting for chemicals chemical substances subject to a proposed rule. Some 

2341 commenters supported EPA‘s suggestion to eliminate the 25,000 lb. threshold for certain 

2342 chemical substances that are the subject of a rule proposed under TSCA section 5(a)(2), 

2343 5(b)(4), or 6. Another commenter believed it was inappropriate to impose expanded 

2344 reporting requirements on substances subject to proposed rules which might not be 

2345 finalized.

2346

2347 The Agency generally agrees with the commenters who stated that if 

2348 chemicalschemical substances that would typically be exempted from reporting are 

2349 subject of a rule proposed under TSCA Section 5(a)(2), 5(b)(4) or 6, the reporting 

2350 threshold should be eliminated and the chemicalschemical substances should be reported 

2351 despite the lower volumes produced. However, as discussed elsewhere in Unit IV.C.3, 

2352 EPA has decided to reduce the reporting threshold for these chemical substances to 2,500 

2353 lb, instead of entirely eliminating the reporting threshold. In addition, EPA is phasing in 

2354 this change to the IUR: it will not affect IUR submissions until the 2016 submission 

2355 period.
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2356 The Agency disagrees with the commenter who argued that the elimination 

2357 ofchange to the 25,000 lb reporting threshold at (at 40 CFR 711.8(b), promulgated under 

2358 TSCA § 8(a)) should not be triggered by the mere issuance of a proposed rule for a 

2359 chemical. The latter commenter suggested that it would be inappropriate to collect more 

2360 detailed information on such a chemical substance until the proposed rule had been fully 

2361 vetted and analyzed, noting that finalization can often take a number of years. However, 

2362 EPA believes that the issuance of one of the proposed rules described above represents an 

2363 appropriate circumstance to trigger enhanced information collection under the IUR. 

2364 EPA issues a proposed rule under TSCA sections 5, or 6 only after making proposed 

2365 findings that a chemical substance or some specified use of a chemical substance presents 

2366 some level of concern. Precisely because the regulatory status of the chemical substance

2367 would be under analysis and because there might be an opportunity for a fuller IUR 

2368 dataset to help inform that analysis and the development of risk management actions, 

2369 EPA believes it is appropriate for the eliminationreduction of the 25,000 lb reporting 

2370 threshold to be triggered at rule proposal. Furthermore, those chemicalschemical

2371 substances that are the subject of a rule proposed under sections 5(a)(2), 5(b)(4), or 6 are 

2372 of demonstrated high interest to the Agency. In an effort to better understand the extent 

2373 of manufacture, use, and potential exposure to such chemicalschemical substances, EPA 

2374 believes it is appropriate to eliminatereduce the 25,000 lb. threshold forand require

2375 reporting on their manufacturethese chemical substances during the 2016 reporting cycle 

2376 if they are manufactured (including imported) in volumes of 2,500 lb or more.

2377

2378 e. De minimis threshold volume. EPA asked for comment on whether a de 

2379 minimis production volume threshold should be set for these chemical substances. 
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2380 SomeSeveral commenters opposed setting a newsupported the concept of a de minimis

2381 threshold. Other, although one of the commenters suggested a variety of methods for 

2382 establishing a de minimis threshold. Specifically, one commenter recommendedindicated

2383 that EPA set a it would be difficult to choose an appropriate level to decrease the 

2384 reporting burden due to the difficulty associated with definitively identifying a 

2385 production volume level below which there are not chemicals of interest. A few of these 

2386 commenters supported setting a de minimis threshold of 2,500 lb.,, as this is 10% of the 

2387 25,000 lb reporting threshold and is similar to the de minimis under the European Union‘s 

2388 REACH regulation‘s registration threshold of 2,200 lbregulations. One commenter 

2389 thought a de minimis volume should be set on a chemical-by-chemical basis for 

2390 chemicals for which EPA needs specific information. Another commenter Some 

2391 commenters opposed setting a de minimis threshold, either because they felt that there 

2392 should be no threshold level for persistent, bioaccumulative, or toxic chemicals (PBTs). 

2393 Other commenters thought the reporting threshold volumeor they felt that the threshold

2394 should be keptremain at 25,000 lb. One commenter specifically opposed a de minimis

2395 threshold for any persistent, bioaccumulative and toxic (PBT) chemical substances.

2396

2397 The Agency agrees with the commenters who opposed setting a de 

2398 minimis level. While a 2,500 lb. de minimis threshold level would harmonize more 

2399 closely with the European REACH regulations‘ reporting threshold, the two programs are 

2400 not completely analogous, e.g., REACH does not require periodic reporting. EPA 

2401 alsoEPA agrees with some commenters who noted that a 2,500 lb threshold would 

2402 provide sufficient data for the Agency to monitor production and compliance with certain

2403 proposed or promulgated rules and/or actions. Therefore, the Agency has decided to 
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2404 lower the reporting threshold to 2,500 lb, instead of zero, beginning with the 2016 IUR. 

2405 EPA believes that, at this time, the 2,500 lb threshold is a reasonable de minimis

2406 threshold that is low enough to help decrease the burden on submitters, yet will provide 

2407 much needed data on chemical substances of known concern to the Agency. The reduced 

2408 threshold is essential to ensuring that information is available on chemical substances that 

2409 could pose health or environmental concerns at levels of production or import below the 

2410 25,000 lb threshold. In the future, EPA may find it necessary to collect information on 

2411 these chemical substances at a reporting threshold below the 2,500 lb threshold 

2412 introduced in this action.

2413 EPA also believes that the regulated community should be sufficiently familiar 

2414 with the 2,500 lb threshold as it is similar to the threshold that is used under the EU‘s

2415 REACH regulations to submit registration dossiers. Under REACH, a person who 

2416 manufactures or imports a chemical substance in quantities of 1 tonne (metric tonne (mt) 

2417 or if converted to pounds, about 2,205 lb) or more per year within the European 

2418 Economic Area (EEA) must register the chemical substance (Ref. 22). 

2419 EPA believes that setting a de minimis threshold on a chemical-by-chemical basis 

2420 or special thresholds for PBTs or carcinogens would require more time and resources 

2421 than are presently available. Chemicals regulated or proposed for regulation under the 

2422 rules listed in 40 CFR 711.8(b) are of demonstrated high interest to the Agency, and may 

2423 present unreasonable risks at even relatively low concentrations. At this time, EPA does 

2424 not have an informed basis to set a uniform de minimis concentration (such as the 1% or 

2425 0.1% concentrations suggested by the commenter) for these chemicals. However, if an 

2426 importer does not know, or can‘t reasonably ascertain that a particular chemical is present 
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2427 in a mixture, they are not required to report it The Agency recognizes that because of this 

2428 de minimis threshold, there may be some chemical substances for which the Agency will 

2429 have an interest in the IUR data (e.g., for evaluating potential exposures), but for which 

2430 IUR data are not reported because production volume is below 2,500 lb per site. 

2431 However, EPA believes the 2,500 lb threshold will be sufficient for most circumstances. 

2432 To address any future need for additional exposure-related information respecting 

2433 chemical substances with per-site production volume below 2,500 lb, EPA may propose 

2434 to amend the IUR further in the future, or may evaluate whether other action under TSCA 

2435 would be appropriate. 

2436

2437 D. Comments on Specific Data Elements

2438

2439 1. Parent company and site identity.1. Parent company and site identity. Two 

2440 comments were received in support of using the company name, address, and D&B 

2441 number for reporting purposes, and clarifying the meaning of "company name." 

2442 Respecting the clarification, one commenter suggested that the word ―ultimate‖ be 

2443 removed from the phrase ―ultimate domestic parent company‖ and that instead 

2444 companies should be allowed to name their domestic company, as is understood within 

2445 their particular corporate organization. The commenter also noted that the intended 

2446 clarification was not reflected in the actual regulatory text at proposed 40 CFR 

2447 711.15(b)(2)(i), which only referred to "parent company name."

2448 During the 2006 submission period, submitters indicated that further clarification 

2449 was needed to identify the correct company name for reporting purposes. Based on these 

2450 previous comments, EPA has determined that the parent company‘s name, address, and 
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2451 Dun and Bradstreet NumberD&B number is necessary to provide clarity as to which 

2452 company name to use for reporting under the IUR. This EPA agrees that further 

2453 specification of "company name" is appropriate, and that the appropriate name for 

2454 reporting requirement, at 40 CFR 711.15(b)(2)(ii),should be clearly identified in the rule, 

2455 but disagrees that "domestic parent company name" is sufficiently specific. As noted in 

2456 the proposed rule (Ref. 1), EPA believes that using an approach that is consistent with the 

2457 TRI reporting requirements would be most clear both for reporters and users of the data. 

2458 EPA is therefore amending 40 CFR 711.15(b)(2)(i) to refer to "U.S. parent company 

2459 name" and defining "U.S. parent company," at 40 CFR 711.3, to mean "the highest level 

2460 company, located in the United States, that directly owns at least 50 percent of the voting 

2461 stock of the manufacturer." The IUR definition of "U.S. parent company name" is 

2462 consistent with the use of the term of "parent company" in Section 5 of the 2009 Toxic 

2463 Chemical Release Inventory (TRI) requirements for parent company name and it will 

2464 help to better identify reporting sites that are under the same parent company.Reporting

2465 Forms and Instructions (Ref. 15). EPA provides further clarification regarding the 

2466 correct domestic (U.S.) parent company name in the ―Instructions for 2011 Inventory 

2467 Update Reportingdocument (Ref. 57). 

2468

2469 2. Technical contact. EPA requested comment on requiring that the technical 

2470 contact be a person knowledgeable about the reported chemical substance and be located 

2471 at the manufacturing (including importing) site. Several commenters stated that 

2472 companies should be able to use their discretion in identifying the most appropriate 

2473 contact or contacts. They believe that the technical contact need not be physically located 

2474 at the reporting site, and that information may be more reasonably generated by a 
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2475 corporate contact rather than a technical contact at the production site. Some commenters 

2476 said that the technical contact should be an employee of the submitting company.

2477

2478 EPA agrees with commenters who stated that companies should use their 

2479 discretion in selecting a technical contact or multiple technical contacts, as permitted by 

2480 the new e-IURweb softwaretool. However, EPA believes that a technical contact must be 

2481 someone who can answer detailed follow-up questions that EPA may have regarding the 

2482 submission. EPA has found that technical contacts not at the reporting site generally are 

2483 less knowledgeable about the submission or chemical substance and therefore may not be 

2484 able to discuss follow-up questions. Also, it has been EPA's general experience that 

2485 short-term contractors have not been suitable technical contacts, because they may no 

2486 longer be under contract with the submitting company when EPA contacts them a year or 

2487 more after the submission is made.

2488

2489 3. Correct chemical name. 

2490

2491 a. Comments on imported chemicalschemical substances and joint submissions. 

2492 EPA received several comments regarding its proposal to require that importers ensure 

2493 that their supplier completes the joint reporting of the CA Index Name currently used to 

2494 list the chemical substance on the TSCA Inventory. The comments indicated that it would 

2495 be difficult for an importer to require that another party complete a joint submission 

2496 because foreign suppliers are not subject to the same Federal regulations as U.S. 

2497 companies, compliance with U.S. regulations is not their top priority, and in some cases 

2498 they are slow to comply. 

2499
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2500 EPA agrees with the commenters that its proposed joint submission procedures 

2501 for importers, which required the importer to ensure that a foreign supplier prepared a 

2502 secondary submission on its behalf, presented implementation difficulties. This is 

2503 because, as the commenters suggested, the foreign supplier may not be subject to any 

2504 direct legal obligation to provide the information to EPA. The Agency also notes that 

2505 this issue extends to the regulations at 40 CFR 711.15(b)(3)(i)(B), as there may be 

2506 circumstances in which the manufacture of a chemical substance is reportable under the 

2507 IUR, yet the supplier of a reactant used in manufacturing that chemical substance would 

2508 not have an independent legal obligation to report the chemical identity of the reactant 

2509 under the IUR. 

2510

2511 Therefore, the Agency has modified the regulatory requirements at 40 CFR 

2512 711.15(b)(3)(i) to reflect the primary submitter‘s underlying obligation to provide what it 

2513 knows or can reasonably ascertain respecting the identity of a chemical substance subject 

2514 to reporting. The joint submission requirement is no longer to ensure that suppliers 

2515 provide secondary submissions to EPA, but to properly ask that they do so. Consistent 

2516 with 40 CFR 711.15(b)(3)(i), a request for a secondary submission to EPA must be 

2517 prepared using e-IURweb, include instructions for electronically submitting the 

2518 information to EPA, and explain how to provide a clear reference to the primary 

2519 submission. Documentation of the request to the supplier must be submitted to EPA 

2520 along with the rest of the primary submission. 

2521

2522 Finally, EPA has also modified the regulatory requirements to more clearly 

2523 reflect, see proposal at 75 FR 49666,proposed rule (Ref. 1), that they only apply in cases 
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2524 where a supplier will not reveal the pertinent chemical identity information to the 

2525 submitter. In the event that a manufacturer (including importer) actually knows the 

2526 chemical identity of a chemical substance subject to IUR reporting, the manufacturer 

2527 must provide that information irrespective of a supplier‘s confidentiality claims. EPA 

2528 has modified the substantiation question at 40 CFR 711.30(b)(1)(i) to include information 

2529 about harm to the submitter‘s competitive position ―or to your supplier‘s competitive 

2530 position.‖ 

2531

2532 b. Comments on reporting (International Union of Pure and Applied Chemistry) 

2533 IUPAC names as an alternate. A commenter recommended allowing IUPAC names as a 

2534 substitute for CA Index Names for discrete chemicalschemical substances, because the 

2535 IUPAC nomenclature provides the exact chemical structure and because the commenter 

2536 was concerned that submitters would be required to go through a particular fee-based 

2537 service to obtain CA Index Names for chemicals. chemical substances.

2538

2539 The Agency disagrees that IUPAC names should be allowed as a substitute for 

2540 CA Index Names in reporting discrete chemicalschemical substances for the IUR. 

2541 Chemicals Chemical substances are listed on the TSCA Inventory using CA Index 

2542 Names, and only chemicalschemical substances listed on the TSCA Inventory are to be 

2543 reported for IUR. The requirement for using CA Index names is directly related to 

2544 positively identifying the listed TSCA Inventory chemical substance. Using a different 

2545 nomenclature for the purposes of reporting for IUR could create confusion, both for 

2546 Industryindustry and for EPA. 

2547
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2548 Additionally, there will generally be no need for submitters to use a fee-based 

2549 service to obtain the CA Index Name and corresponding CASRN for IUR reporting 

2550 purposes. As part of the electronic reporting process for the IUR, submitters will be able 

2551 to easily connect electronically from the IUR reporting softwaretool directly to the 

2552 Agency's SRS database in order to obtain CA Index Names and corresponding CASRNs 

2553 for all of their non-confidential chemical substances on the TSCA Inventory. These data 

2554 can then be electronically copied back to the IUR reporting tool. 

2555

2556 4. Chemical Identifying Number. Some commenters were opposed to removing 

2557 the PMN number as an allowed identifying number, suggesting that the Agency might be 

2558 inundated with requests for Accession Numbers, and that for historical products, this may 

2559 pose an extra burden for both industry and EPA. It was suggested that the Agency 

2560 provide a cross-reference list of PMN numbers to Accession Numbers so that the 

2561 information can be easily obtained without additional burden on industry and the Agency.

2562

2563 The Agency has added PMN numbers to the SRS listing to provide a cross2564 reference list, as suggested by the commenters. The e-IURweb reporting tool allows the 

2565 user to search SRS using the PMN number in order to populate the IUR report with the 

2566 pertinent chemical identification information for confidential chemical substances listed 

2567 on the TSCA Inventory. 

2568

2569 There are certain circumstances where a submitter occasionally may not be sure 

2570 of the particular PMN case number and Accession Number the Agency has assigned to 

2571 one of its confidential substances, such that the submitter would not be able to definitely 

2572 determine this solely from searching in the SRS. This could happen, for example, if the
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2573 chemical substance were originally reported as part of a consolidated PMN and the 

2574 submitter did not learn from EPA which particular case number in the consolidated PMN 

2575 number sequence corresponds to which of the several reported confidential substances. 

2576 This could also happen if a certain PMN represented a mixture of two or more 

2577 confidential substances, such that multiple Accession Numbers were assigned to the 

2578 different substances reported in that single PMN, and the submitter didn't already request 

2579 the particular Accession Numbers from EPA for the individual chemical substances 

2580 comprising that multi-component type of PMN. In such circumstances, a submitter 

2581 should contact EPA in writing, well before initiating IUR reporting, to obtain the required 

2582 Accession Numbers from the Agency. The Agency will respond to such inquiries in as 

2583 timely a manner as possible. It is the responsibility of the submitter to contact the EPA 

2584 for such information in sufficient time to allow for the Agency to respond. 

2585

2586 5. Production volume

2587

2588 a. Report production volume for each year. EPA requested comment on the 

2589 requirement to report production volume for each of the five years since the last IUR 

2590 principal reporting year. Comments submitted on various topics are described in this unit.

2591

2592 i. Insufficient time to collect data. Most commenters stated that companies were 

2593 prepared to compile and report the required information for the 2010 reporting year; 

2594 some companies indicated, however, that they had not established systems to collect and 

2595 compile information for 2006-2009. Several commenters recommended that EPA delay 

2596 the implementation of the reporting requirement until the next reporting cycle to allow 

2597 companies sufficient time to prepare for the additional data collection effort. One 
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2598 commenter was concerned that the short period of time given by EPA to collect the 

2599 information will result in significantly decreased data quality and reliability. Another 

2600 commenter said that most companies archive data after 18-24 months. Some found it 

2601 confusing that the threshold to determine the need to report in the 2015 cycleone 

2602 submission period would change to include production data from previous years, but that 

2603 the reporting of production data from previous years would take effect in the 2011 

2604 cycle.an earlier submission period. 

2605

2606 EPA acknowledges that there will be submitters for whom certain information for 

2607 2006 to 2009 will not be known or reasonably ascertainable. However, EPA believes it is 

2608 unlikely that normal business practices would not include tracking the volumes of the 

2609 chemicals a company was manufacturing, at least for a few years. In many instances, 

2610 production volumes for recent past months and years are tracked under standard business 

2611 practices. For example, several TSCA regulations, such as 5(a)(2) SNURs and 5(e) 

2612 orders, require that production volume records be kept for five years for certain 

2613 chemicals, and several commenters indicated that they archived these records. EPA does 

2614 not anticipate that the quality of the data reported will decrease because of the new 

2615 reporting requirement, particularly for the data elements that are not new. EPA believes 

2616 that the data will be of sufficient reliability for use by the Agency and others for purposes 

2617 such as screening-level risk assessments and prioritization. To the extent that required 

2618 information is indeed not known or reasonably ascertainable, EPA expects such 

2619 circumstances to be less frequent in reporting periods subsequent to 2011, as additional 

2620 recordkeeping procedures are put into practice.

2621

2622 EPA acknowledges the possibility that certain information respecting past 

2623 production volume, for the years between 2006 and 2009, might not be known or 

2624 reasonably ascertainable to a submitter in 2012. While submitters are free to designate as 

2625 ―not known or reasonably ascertainable‖ any information that has indeed passed out of 

2626 the scope of reporting due to the passage of time, EPA has determined it is nevertheless

2627 appropriate to reduce the extent to which submitters will need to resort to such 

2628 designations, and to focus on more recent production. EPA believes that phasing in the 
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2629 reporting of past production volumes as follows will both improve the quality of the 

2630 information collected and reduce the burden of collecting it. 

2631 Based on the comments received, EPA is requiring that for the 2012 submission 

2632 period, manufacturers (including importers) are required to report the total annual volume 

2633 (domestically manufactured and imported volumes in pounds) of each reportable 

2634 chemical substance at each site during the calendar years 2010 and 2011. For submission 

2635 periods subsequent to the 2012 submission period, the total annual volume (domestically 

2636 manufactured and imported volumes in pounds) of each reportable chemical substance at 

2637 each site for each complete calendar year since the last principal reporting year are 

2638 required to be reported. EPA believes its decision to require the reporting of 2010 

2639 production volumes in a 2012 submission period is consistent with the comments noting 

2640 that companies were prepared to report 2010 data and that the Agency‘s decision to phase 

2641 in reporting for each complete calendar year since the last principal reporting year is 

2642 warranted in light of other simultaneous changes to the IUR rule which increased 

2643 reporting burden. The Agency also believes the delay to report the production volume for 

2644 each year since the last principal reporting year will give companies adequate time to 

2645 establish systems to collect and compile the required information. 

2646 ii. Reporting burden. Several commenters stated that the requirement is overly 

2647 burdensome, especially for chemical substance importers and manufacturers who 

2648 (according to the commenters) will need to analyze all products to track the volumes of 

2649 all component chemicals. Another commenter acknowledges that, while the burden of 

2650 reporting the data for each principal reporting year was minor, the information would be 

2651 of little value to the Agency. On the other hand, one commenter stated that this 
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2652 requirement could increase the burden by at least three fold. Another commenter said 

2653 that in some cases, businesses have no need to capture past production volumes. One 

2654 commenter asserted that many companies will consider the production volume in every 

2655 year to be CBI and will take the necessary steps to request CBI coverage of this 

2656 information. The commenter acknowledged that the information will still be available to 

2657 EPA for consideration, but was concerned that the burden on EPA of keeping the 

2658 information confidential will increase substantially due to the potential number of CBI 

2659 claims. 

2660

2661 EPA‘s burden estimates represent the average burden across all sites for providing 

2662 production volumes. As such, commenters should be aware that their particular 

2663 circumstance may not be average and, therefore, the estimate may not accurately reflect 

2664 their own, individual, circumstance. circumstances. However, because the estimate 

2665 represents an average across all sites, EPA is confident that the estimate does reflect the 

2666 average burden and, when taken as a whole encompassesacross all sites and encompass

2667 the range of burdens faced by submitters.

2668

2669 In addition, some comments identified a misunderstanding of the reporting 

2670 requirements. For example, one commenter stated that many electronics manufacturers 

2671 have never considered themselves with respect to be engaged in chemical manufacturing 

2672 when they recycle their spent chemicals, and therefore have not been collecting and 

2673 tracking the production volume of each component chemical substance comprising their 

2674 byproducts. As described elsewhere in this Unit, accounting for the manufacture of a 

2675 byproduct does not necessarily entail accounting for each individual component chemical 
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2676 substance in the byproduct. Therefore, EPA believesSee the commenter is 

2677 overestimating the burden associated with developing production volume information. In 

2678 any event, it is not a new requirement that byproduct manufacturers are subjectmore 

2679 detailed discussion of issues related to the IUR—that is an established feature of the IUR 

2680 that predates the amendments being finalizedbyproducts in this rule.Unit F.3 of the 

2681 Responses to Comments document (Ref. 12). The Agency does expect that the reporting 

2682 burden will decrease in reporting cycles beyond 20112016, as submitters put additional 

2683 recordkeeping procedures into practice. 

2684 As with any data element, CBI claims should only be made when warranted. 

2685 While more CBI claims may increase EPA‘s burden slightly, the Economic Analysis 

2686 estimates the amendments will save EPA approximately $18068,000 in the first 

2687 reporting year and $175,000 in subsequent reporting cycles through efficiencies from 

2688 electronic reporting. CBI claims on production volumes are unlikely to create any 

2689 significant burden beyond what is estimated in the Economic Analysis. Inappropriate CBI 

2690 claims willdo, however, prevent valuable information about chemical substance

2691 manufacture (including import) from becoming publicly available. 

2692

2693 iii. Retroactive reporting. Several commenters expressed concerns asserting that 

2694 EPA retroactively is requiring historical data and that the requirement for past production 

2695 information was beyond the scope of EPA‘s TSCA authority for IUR reporting. Another 

2696 commenter said it was not feasible to accurately produce this historical data for the many 

2697 byproducts that companies produce and send for recycling, primarily because 

2698 manufacturers did not know they needed to have such data gathering mechanisms in 

2699 place. 
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2700

2701 EPA disagrees with commenters‘ suggestion that requiring reporting information 

2702 on past production constitutes an imposition of retroactive reporting requirements. While 

2703 the rule establishes new requirements to report production volumes from several previous 

2704 years prior to the finalization of the rule, it does not alter the reporting requirements for 

2705 the 2006 reporting cycle, or any other prior reporting cycles. Neither does the final rule

2706 This is because the final rule does not establish a new legal requirement to have taken 

2707 some particular recordkeeping action in the past. Instead, it holds submitters to a 

2708 prospective standard of reasonableness. EPA acknowledges that for the 2011 reporting 

2709 period, some companies may neither know nor be able to reasonably ascertain all of the 

2710 newly requested information. However, EPA does not expect such circumstances to be 

2711 prevalent in 2011, and it would expects such circumstances will further decline in 

2712 reporting periods subsequent to 2011, as additional recordkeeping procedures are put into 

2713 practice. To the extent that a particular piece of information about the past is indeed not 

2714 known or reasonably ascertainable at the time that a person is obligated to make a 

2715 submission (either because of the timing of a change in the reporting requirements or for 

2716 some other reason), the submitter may simply indicate that the information is ―not known 

2717 or reasonably ascertainable.‖

2718

2719 iv. Alternate approaches. iv. Alternate approaches.Several commenters 

2720 recommended that EPA delay the implementation of the reporting requirement until the 

2721 next reporting cycle to allow companies sufficient time to prepare for the additional data 

2722 collection effort. A few commenters suggested that burden would be reduced if 

2723 companies reported in ranges or provided best estimates. Other commenters suggested 
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2724 that reporting be limited to a subset of industries or chemicalschemical substances, based 

2725 on criteria to focus on data collection and evaluation activities that are more valuable to 

2726 the Agency. Examples of criteria include substances with a history of fluctuations in 

2727 chemical substance manufacture and import practices or substances that are considered 

2728 hazardous. With the advent of REACH, one commenter said they recently implemented 

2729 an application that is capable of tracking volumes of individual substances in mixtures 

2730 and summing them up over a period of time. 

2731

2732 EPA disagrees that a delay is needed to allow submitters time to gather the 

2733 information. As discussed in Unit V.B, production volumes can vary significantly over a 

2734 five year reporting cycle and it is not uncommon for chemicals to rise above or fall below 

2735 the reporting threshold each reporting cycle. As some commenters pointed out, the 

2736 requirement is essential to effectively capture the substantial year-to-year fluctuations 

2737 that occur in manufactured volumes that were found to be missing in past IUR reporting 

2738 cycles (Ref EDF comments). EPA does not believe it practicable to provide a definitive 

2739 list of chemicals with a ―known history of fluctuations.‖EPA The Agency does not have 

2740 such a list, and believes that because year to year fluctuation could be caused by such a 

2741 wide variety of circumstances, including circumstances such as economic changes and 

2742 manufacturing practices, that developing and maintaining such a list is not only not 

2743 practicable, but confining that list to substances with a ―history‖ of fluctuations would not 

2744 capture the industry variability that EPA is seeking. 

2745

2746 EPA also disagrees that reporting production volume in ranges or estimates would 

2747 provide data of comparable value. Though EPA requires some of the IUR information to 
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2748 be reported in specified ranges, EPA sees little value in allowing submitters to report the 

2749 production volumes in ranges or . Similarly, EPA sees little value in allowing submitters 

2750 to provide estimates, or requiring the that do not reflect all information for only 

2751 chemicals that are hazardous.known or reasonably ascertainable. EPA believes that a 

2752 higher level of confidence in data accuracy will be achieved by requiring specific 

2753 numeric data. that reflect all information known or reasonably ascertainable to the 

2754 submitter. It is important to note that EPA is interested in use and other exposure and use2755 related data on all chemicalschemical substances that are not exempted from IUR 

2756 reporting, and manufacturing exposure-related data on partially exempted chemical

2757 substances. Especially since there is a multi-year gap between IUR submission periods, 

2758 the mere fact that a chemical substance is not known to be hazardous at this time does not 

2759 mean that EPA is not interested in exposures and uses of that chemical substance. Under 

2760 a contrary policy, EPA would potentially need to wait several years before obtaining the 

2761 basic exposure information necessary to determine whether a hazardous chemical 

2762 substance may present an unreasonable risk (since the collection of screening-level 

2763 exposure information would not be triggered until hazard data had been assessed). In 

2764 summary, after considering the suggestions, EPA believes its decision to collect multi2765 year production volume understarting with the 20112016 IUR submission period is still 

2766 sound.

2767

2768 EPA disagrees with the suggestion that reporting be limited to a subset of 

2769 industries or chemical substances. The IUR data are used extensively in the Agency‘s 

2770 screening and prioritization process. As such, identifying a list of chemicals or industries

2771 prior to screening would not provide EPA with the data needed for its programs and 
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2772 defeats the purpose of collecting the data. EPA does not believe it practicable to provide 

2773 a definitive list of chemical substances with a ―known history of fluctuations.‖ The 

2774 Agency does not have such a list, and believes that because year to year fluctuation could 

2775 be caused by such a wide variety of circumstances, including circumstances such as 

2776 economic changes and manufacturing practices, that developing and maintaining such a 

2777 list is not only not practicable, but confining that list to substances with a ―history‖ of 

2778 fluctuations would not capture the industry variability that EPA is seeking. 

2779 b. Volume of chemical substances used on site. One commenter stated that this 

2780 data element was essential to improving accuracy and utility of the reported production 

2781 volume and two commenters stated they thought there was no value in this data element 

2782 and that the Agency should retain the site-limited check box because, the commenters 

2783 stated, it was more informative for screening-level risk assessment. Five commenters 

2784 expressed confusion about the requirements of reporting this data element. Specific 

2785 concerns included a concern about duplicative reporting for this data element and the 

2786 industrial processing and use information for chemicalschemical substances used on-site; 

2787 whether this applied to chemicals used in synthesis or also to chemicals that were 

2788 repackaged; and the need to identify the amount of a chemical substance present on site 

2789 during a specific time period. 

2790

2791 EPA agrees with the commenter who felt that reporting volumes of chemical 

2792 substance used at a site will increase the accuracy and utility of the IUR reporting 

2793 information. Reporting the volume used on-site provides valuable information related to 

2794 potential exposures associated with the on-site volumes, providing the Agency with better 

2795 information for exposure assessments. The usefulness of this IUR data element has been 
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2796 demonstrated by EPA‘s use of similar data in the New Chemicals Program. PMNs for 

2797 new chemical substances submitted to EPA under TSCA section 5 require many of the 

2798 same exposure-related data elements that will be reported under the IUR. Exposure2799 related data in PMNs include estimates of production volume, categories of use, percent 

2800 production volume in the categories of use, maximum numbers of workers exposed, and 

2801 concentrations and physical forms of the chemical substance. EPA uses these exposure2802 related data to generate screening-level risk assessments for regulatory decision making 

2803 under TSCA section 5. The reporting obligation and the phrase ―site use‖ applies to all 

2804 nonexempt substances produced for commercial purposes that are on the TSCA 

2805 Inventory.

2806 Some of the commenters have misunderstood this data element, which provides 

2807 more detailed and clearer information than did the previous site-limited check box. 

2808 Previously, submitters checked a box to indicate that a reported chemical substance was 

2809 site limited – in other words, that it was both manufactured and used on the site. Some 

2810 submitters misreported, identifying an imported chemical substance as site-limited (a 

2811 situation that is not possible because the imported chemical substance, by definition, is 

2812 brought onto the site from outside of the U.S., and therefore is not physically 

2813 manufactured and used at the reporting site) or reporting the same substance twice, once 

2814 for the volume that is site limited and once for the volume that is sent off site. Because of 

2815 this confusion, EPA replaced the site-limited check box with reporting the volume of the 

2816 chemical substance production volume reported on the form that is used on the site. For 

2817 example, if 50,000 lb. of a substance was manufactured and used on the same site, the 

2818 submitter would report 50,000 lb. for domestically manufactured and 50,000 lb. for the 
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2819 volume used on-site. If 70,000 lb. of a substance was manufactured, 25,000 lb. was used 

2820 on-site and 45,000 lb. was shipped to a different site, the submitter would report 70,000 

2821 lb. for domestically manufactured and 25,000 lb. for the volume used on-site. If a site 

2822 imported 30,000 lb. and used it at the import site, the submitter would report 30,000 lb.

2823 for imported production volume and 30,000 lb. for the volume used on-site. If a site 

2824 imported 100,000 lb. and shipped it to an alternate site, the submitter would report 

2825 100,000 lb. for imported production volume and 0 lb. for the volume used on-site. As 

2826 these examples illustrate, the submitter is not identifying the amount of a chemical 

2827 substance on-site during a particular time period, but rather that amount of a chemical

2828 substance that is manufactured (including imported) and used at the same site.

2829

2830 Commenters also asked for clarification regarding the activities considered to be 

2831 ―used at the reporting site.‖ For a domestically manufactured substance, if the volume 

2832 would have been considered to be site-limited, then the chemical substance is used on 

2833 site. If the chemical substance is domestically manufactured, temporarily stored, and 

2834 then packaged for shipment off of the site, that volume would not be considered ―used at 

2835 the reporting site.‖ For an imported substance, any use at the importing site (e.g. 

2836 consumed in a reaction or crosslinked or cured in an article) would be considered ―used 

2837 at the reporting site.‖

2838

2839 EPA does not believe reporting the portion of the production volume that is both 

2840 manufactured and used on site will result in duplicative reporting. Even with the 

2841 previous site-limited check box, submitters provided information about the use of a 

2842 chemical substance in both the manufacturing and industrial processing and use sections 
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2843 of the IUR Form U. The information reported under the manufacturing section identifies 

2844 that this substance is processed or used at that particular site and reports the number of 

2845 workers associated with the manufacture of that substance. In the same report, the 

2846 information reported under the industrial processing and use section provides more 

2847 details about how the chemical substance is processed or use and, in the event that a 

2848 substance has a use identified by the same combination of use, function, and NAICS code 

2849 by another site, the production volumes, sites, and workers would be combined with the 

2850 information describing the other sites‘ processing or uses.

2851

2852 c. Report volume exported. The majority of the comments against reporting the 

2853 volume directly exported stated that capturing the volumes for each chemical substance 

2854 in each exported product was difficult and burdensome. These comments indicated a 

2855 misunderstanding of the reporting requirement, and EPA believes that a better 

2856 understanding will eliminate those concerns. For the chemical substance that was 

2857 manufactured and is being reported, the submitter is to report the volume of that chemical 

2858 substance that is directly exported. If the chemical substance is processed in any way 

2859 (e.g., combined with other substances to form a mixture), the chemical substance is not 

2860 directly exported. Also, if a chemical is sent to a distributor who then exports it, the 

2861 chemical is not directly exported. In both of these examples, the manufacturer would 

2862 instead report either the processing to form a mixture or the transfer to a distributor under 

2863 the processing and use portion of the IUR reporting form. ―Directly Exported‖ and 

2864 ―Domestically Processed or Used‖ are mutually exclusive designations; only one 

2865 designation applies to any particular portion of the production volume.

2866
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2867 6. Identify whether a chemical substance is to be recycled, remanufactured, 

2868 reprocessed, reused or reworked. EPA received several comments on the proposal to add 

2869 a checkbox indicating whether a manufactured chemical substance was or is expected to 

2870 be recycled, including remanufactured, reprocessed, reused, or reworked. Some 

2871 commenters were supportive of adding this reporting element, but several of the 

2872 commenters were concerned that the term ―recycle‖ has been difficult to define in other 

2873 programs, indicated confusion about EPA‘s purpose in including the checkbox, and 

2874 expressed doubt that this data element would yield useful information. 

2875

2876 EPA intends that this checkbox would be used by manufacturers to indicate 

2877 whether a chemical substance they manufactured, such as a byproduct, which might 

2878 otherwise be disposed of as waste, was or is expected to be recycled. EPA also included 

2879 the terms remanufactured, reprocessed, reused, or reworked, intending to capture a broad 

2880 array of similar, and perhaps synonymous, activities by which a substance (that would 

2881 otherwise be disposed of as waste) may be put to use. EPA is interested in the exposures 

2882 from these activities, and believes that having more information about which 

2883 chemicalschemical substances are being recycled will help the Agency to refine future 

2884 IUR reporting requirements (i.e., if EPA knows enough about exposures to a chemical

2885 substance from an on-site recycling use, EPA could consider an exemption in the future). 

2886

2887 EPA also believes that this information would help the Agency to identify where 

2888 this activity is already occurring, and could be used to recognize companies, industries, 

2889 and sectors that are using ―green‖ practices. This information would also help to identify 

2890 sectors where recycling is not occurring, providing useful data to measure the 
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2891 effectiveness of various EPA programs, such as the Resource Conservation Challenge 

2892 (RCC) Program, and informing other Agency efforts to encourage practices that reduce 

2893 waste. EPA disagrees that a precise definition of ―recycle‖ is needed to make this data 

2894 element useful for the purposes that EPA has identified. Submitters should simply 

2895 indicate, to the extent that they know or can reasonably ascertain, whether the reported 

2896 volume of the chemical substance that they manufactured, which would otherwise be 

2897 disposed of as waste, was or is expected to be recycled, remanufactured, reprocessed, or 

2898 reused, as those terms are understood by the submitter. 

2899

2900 One commenter indicated that many chemicalschemical substances are 

2901 ―reworked‖ in many industrial processes, at least at some point, so this box would be 

2902 checked so often that it would provide little meaningful data. EPA agrees that the term 

2903 may be interpreted and applied too broadly to provide the type of information that EPA is 

2904 trying to collect, so has removed ―reworked‖ from the list of recycling synonyms. Two 

2905 commenters expressed concern that revealing whether a substance they manufactured 

2906 was recycled would reveal confidential business information. In such a situation, the 

2907 submitter will be able to claim the information as confidential. Another commenter 

2908 suggested that EPA collect information about recycling under a separate rule. EPA 

2909 disagrees that this would be an efficient way to collect the desired information. A 

2910 separate rulemaking for one ―yes or no‖ data element would be extremely inefficient and 

2911 needlessly time-consuming for both the Agency and industry, particularly when the IUR 

2912 rule already provides a suitable vehicle to collect chemical substance manufacturing, 

2913 processing, and use information.

2914
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2915 7. Industrial processing and use information

2916

2917 a. Industrial function categories. The Agency received several comments 

2918 regarding revising the list of industrial function categories for processing and use 

2919 information. Some commenters were in favor of the changes and supported EPA‘s efforts 

2920 to work collaboratively with Canada to align the categories. Other commenters said that 

2921 this would require additional effort by the regulated community to assign the new codes, 

2922 and a clear explanation of the changes with the reporting instructions, e.g., a ―read 

2923 across‖ of old and new codes, including additional definitions to ensure that activities are 

2924 consistently coded across companies. Commenters stated that providing a description for 

2925 ―other‖ will be challenging, may not provide useful information (e.g., due to lack of 

2926 information from the downstream customers), and would require additional burden to 

2927 report. One commenter felt that the list of industrial function category codes is too 

2928 limited for inorganic chemicalschemical substances, and suggested that the Agency add 

2929 an IFC code for ―Solid Manufacturing Materials.‖ The comment stated that such a code 

2930 would alleviate the need to address many industrial uses in the "other" category, thereby 

2931 reducing reporting burden.

2932

2933 EPA agrees with the commenters that a table indicating the relationship between 

2934 the 2006 IFC codes and the new 20112012 IFC codes would be useful, along with clear 

2935 definitions for each code. Such information is contained in the 20112012 IUR 

2936 Instructions for Reporting.document (Ref 7). 

2937

2938 EPA also recognizes that the requirement to report a description when the 

2939 submitter selects the IFC code ―Other‖ may be more burdensome than for the other IFC
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2940 codes, but expects any increase to be minor. The descriptive information is essential to 

2941 enable users of the data to estimate potential exposures associated with the overall 

2942 processing or use of the chemical substance, of which the function is an important 

2943 component. The Agency‘s experience with the 2006 IUR data was that the category of 

2944 ―other,‖ with no further description, was insufficient for the data to be of much use. 

2945

2946 EPA disagrees with the suggestion to include a ―Solid Manufacturing Materials‖ 

2947 IFC code and believes such a code will not accurately describe the industrial function of 

2948 the chemical substance. In addition, EPA believes the proposed list of IFC codes covers 

2949 the majority of the industrial functions. This belief is based on the past experience of 

2950 both the U.S. 2006 IUR and Canadian reporting. However, EPA does recognize that it 

2951 did not collect such information for inorganic chemicalschemical substances in the past, 

2952 and therefore will use the written description for ―Other‖ to help evaluate and improve 

2953 the inclusiveness of future IFC codes, including those applicable to inorganic 

2954 chemicalschemical substances.

2955

2956 b. Industrial sectors. EPA proposed to replace the five digit NAICS code with a 

2957 new code, Industrial Sector (IS), to describe the industrial setting. Some commenters 

2958 were in favor of this change, noting that using code harmonized with Canadian codes 

2959 would be helpful to both industry and data users. Other commenters stated that many 

2960 companies have already begun the process of data collection based on the former system, 

2961 which has precedent. The commenters believe NAICS codes are the classification 

2962 system with which industry and regulators are most familiar, and in some cases, the IS 

2963 codes are less descriptive than the NAICS codes. Commenters also asserted that the 
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2964 Agency should recognize that these changes will result in increased reporting burden and 

2965 time.

2966

2967 EPA disagrees with the commenters that the use of IS codes in place of the 

2968 NAICS codes will present increased burden on industry. The IS codes simply group 

2969 together similar NAICS codes while still providing the sufficient differentiation needed 

2970 to differentiate overall industrial processing and use scenarios. The IS codes span the 

2971 entire range of NAICS codes and can be translated from known NAICS codes. Both the 

2972 e-IURweb reporting tool and the 20112012 IUR Instructions for Reportingdocument

2973 (Ref. 7) contain cross-walk tables for submitters to use to determine the proper IS code, 

2974 based on the NAICS code information they may already have collected. 

2975

2976 Information on the Agency‘s development of the IS codes is described in the 

2977 technical support document ―Inventory Update Reporting (IUR) Technical Support 

2978 Document-- Replacement of 5-digit NAICS Codes with Industrial Sector (IS) Codes‖ 

2979 (EPA-HQ-OPPT-2009-0187-0005Ref. 16). In developing the IS codes, EPA considered 

2980 the level of detail required for developing use and exposure scenarios, the number of 

2981 2006 IUR submissions using the code, the code definition, and the level of difficulty 

2982 required in reporting more detailed codes. Submissions to the 2006 IUR reported over 

2983 340 unique five-digit NAICS codes. In the 2006 IUR, the three-code combination of 

2984 processing and use (P/U) code, NAICS code, and IFC codes resulted in a large number of 

2985 possible exposure scenarios that could be reported. Although not all of the NAICS codes 

2986 are applicable to chemical substance manufacturing and processing, the 2006 IUR 

2987 database has over 2,300 unique combinations of P/U, NAICS, and IFC. Many of the 
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2988 NAICS codes reported are from similar industries that would have similar exposure 

2989 scenarios. 

2990

2991 EPA agrees that the new IS codes are less descriptive than NAICS codes, but 

2992 believes the reduction in specificity will not adversely affect, and will actually improve, 

2993 the Agency‘s ability to use the processing and use data for screening-level purposes. The 

2994 large number of unique combinations increases the difficulty and time required to sort 

2995 and classify chemicalschemical substances since EPA would either need to develop 

2996 exposure scenarios for each unique combination or determine which three-code 

2997 combinations have similar exposure scenarios and can be grouped together. By replacing 

2998 the NAICS codes with the IS code, the number of potential three-code combinations is 

2999 reduced from in excess of 100,000 possible combinations to 7,920 combinations. Based 

3000 on information collected from the last reporting cycle the number of combinations 

3001 actually reported would be significantly less. Additionally, the IS codes will more closely 

3002 align to the EU Sector of Use codes which will allow EPA to compare U.S. data with that 

3003 collected by the European Union.

3004

3005 8. Consumer and commercial use

3006

3007 a. Consumer and commercial product categories. Many commenters supported 

3008 revising the list of consumer and commercial product categories for consumer and 

3009 commercial use information. Those commenters stated that harmonizing codes with 

3010 Canada, revising the product categories, and requiring descriptive information when the 

3011 ―other‖ category is reported are essential to improving the consumer and commercial 

3012 data. The commenters stated also that these changes will provide a better understanding 
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3013 of how chemicalschemical substances are used in downstream products and will help 

3014 facilitate consistent reporting of chemical substance use information in the United States 

3015 and Canada. Other commenters wanted more explanation as to why the categories are 

3016 being revised and requested that the Agency provide more descriptive information for 

3017 each product category, including a table identifying how the new categories relate to the 

3018 previous categories. Some commenters stated that providing a description for the 

3019 category ―other‖ will be challenging and may not provide useful information. One 

3020 commenter stated that the Agency should not further complicated downstream reporting, 

3021 noting that was already challenging to choose the top ten categories for substances with a 

3022 large number of uses. 

3023

3024 EPA appreciates the support for the harmonized consumer and commercial 

3025 product categories, and agrees that the changes finalized in this rule will improve the IUR 

3026 data. As described in Unit III.G.8.a., information from data collected during the 2006 

3027 IUR and from Canada was used to develop a more useable listing of product categories. 

3028 EPA eliminated categories for which few chemicalschemical substances were reported, 

3029 added categories identified as needed, and eliminated overlap in categories. In addition, 

3030 some categories were renamed to better match their definitions, other categories 

3031 descriptors were improved, and categories were grouped to allow for easier identification. 

3032 EPA believes these changes will make reporting easier for the submitter, and does not 

3033 agree that these changes result in more complicated reporting. The Agency is providing 

3034 more detailed descriptive information in the 20112012 IUR Instructions for 

3035 Reportingdocument (Ref. 7) and other guidance materials. 
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3036 EPA recognizes that the requirement to report a description when the submitter 

3037 selects the product code ―Other‖ may be more burdensome than for the other product 

3038 codes, but expects any increase to be minor. The descriptive information is essential to 

3039 enable users of the data to estimate potential exposures associated with the consumer or 

3040 commercial use of the chemical substance. The Agency‘s experience with the 2006 IUR 

3041 data was that the category of ―other,‖ with no further description, was insufficient for the 

3042 data to be of much use.

3043

3044 b. Designation of consumer or commercial use. Commenters had mixed 

3045 viewpoints regarding the need to designate whether the indicated product category is 

3046 consumer use, commercial use, or both. One commenter strongly in support of making 

3047 this designation stated that such distinctions are critical to EPA‘s ability to assess 

3048 exposure at even the most basic level. Others didn‘t oppose the added designation, but 

3049 did ask for further clarification between consumer and commercial uses. Commenters 

3050 opposing the added designation stated that they were too removed from the consumer and 

3051 commercial uses to have a clear understanding of the uses at that level of distinction, 

3052 especially for commodity chemicalschemical substances with a large number of uses. 

3053 One commenter said suppliers to formulated products were less likely to know the 

3054 distinction because of the confidentiality of the downstream user formulations. 

3055

3056 The intent of the consumer and commercial use data element is to clearly identify 

3057 the exposed populations. These two populations (i.e., consumers and commercial 

3058 workers) are very different from each other, and the ability to distinguish uses between 

3059 the two enables better exposure-based screening of chemicals.chemical substances. EPA 
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3060 recognizes that submitters may not always have detailed information about how the 

3061 chemical substance(s) they make are used and to what extent they are used. However, 

3062 EPA believes a manufacturer generally has a certain awareness of the downstream uses 

3063 of chemicalschemical substances it manufactures and sells, even if it does not control its 

3064 customers‘ sites, and can report this information, based on what is known to or 

3065 reasonably ascertainable by the submitter. 

3066

3067 c. Number of commercial workers. Commenters strongly opposed EPA‘s 

3068 proposal to require that submitters report the number of commercial workers reasonably 

3069 likely to be exposed while using a product containing a reportable substance. Most 

3070 commenters indicated that they do not have sufficient information about the work 

3071 practices of eventual commercial users to estimate this number, that such information is 

3072 not typically shared upstream, and that any such data EPA received would be, at best, an 

3073 educated guess. It was suggested that the Agency rely on worker statistics from the 

3074 Bureau of Labor as it conducts risk assessments, or gather additional data under a 

3075 separate TSCA Section 8(a) rule.

3076

3077 EPA is requiring this information to better assess the size of the commercial 

3078 population in screening risk assessments. In the past, the Agency has used the Bureau of 

3079 Labor Statistics for general workers statistics to conduct chemical-specific risk 

3080 assessments; however, these worker statistics, which are industry-specific, overestimate 

3081 the exposures associated with a chemical substance because a chemical substance is 

3082 likely to be used by only a portion of the industry. Identifying chemical-specific worker 

3083 populations for downstream activities will fill this gap for the Agency. The knowledge of 
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3084 a chemical‘schemical substance‘s uses in industry and the respective commercial 

3085 population potentially affected by their uses provides the Agency a more complete 

3086 picture of the potential risks associated with a chemical substance.

3087

3088 EPA recognizes that submitters may not always have detailed information about 

3089 how the chemical substance(s) they manufacture are used and to what extent they are 

3090 used in commercial enterprises. However, EPA believes that a manufacturer generally 

3091 has a certain awareness of downstream uses of chemicalschemical substances it 

3092 manufactures and sells, even if it does not control its customers‘ sites. Based on its 

3093 experience with the PMN program, many stakeholder meetings, discussions about 

3094 voluntary risk management programs, and industry‘s various self-regulation initiatives, 

3095 the Agency believes that most submitters can report on downstream uses, including the 

3096 information that would be reported under IUR, based on what is known to or reasonably 

3097 ascertainable by the submitter. To reduce the burden in reporting, the IUR provides that 

3098 the number of commercial workers need only be reported in ranges, and the ranges are 

3099 the same as for manufacturing and industrial workers. Reporting in ranges will lessen the 

3100 reporting burden when the precise number of workers for multiple end uses is not known. 

3101 Although this may result in some uncertainty in the data reported, the chemical substance 

3102 manufacturer or importer has fulfilled his obligation by providing information to the 

3103 extent it is known or reasonably ascertainable. EPA believes that the data will be 

3104 sufficiently reliable for the Agency and others to use for screening-level risk assessments 

3105 and prioritization. 

3106

3107 E. Definitions and Clarification Requests
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3108

3109 1. Changing the reporting standard for processing and use information to 

3110 “known to or reasonably ascertainable.” A number of commenters requested further 

3111 clarification (beyond that offered in Section 4.0 of the Reporting Instructions) document 

3112 (Ref. 7)) of the scope of pre-reporting inquiry that would be required under the ―known to 

3113 or reasonably ascertainable by‖ reporting standard. Specifically, the commenters 

3114 requested further clarification of how this reporting standard would apply in the case of 

3115 information reported under 40 CFR 711.15(b)(4) (―specific information related to 

3116 processing and use‖). The commenters also expressed some confusion about how this 

3117 standard would differ from the ―not readily obtainable‖ standard,‖, previously applicable 

3118 to such reporting, and whether the change of standard indicates that ―extensive file 

3119 searches and customer surveys‖ would now be expected of submitters. Other commenters 

3120 from the chemical industry expressed their understanding that the change in reporting 

3121 standard only altered the level of diligence with which submitters must search for 

3122 information within their own organization. They requested confirmation that, as under 

3123 the ―not readily obtainable‖ standard, submitters would not be required to conduct 

3124 customer surveys in order to assemble data for purposes of inventory update 

3125 reportingIUR. 

3126

3127 The term ―known to or reasonably ascertainable by‖ is defined at 40 CFR 704.3. 

3128 It means ―all information in a person‘s possession or control, plus all information that a 

3129 reasonable person similarly situated might be expected to possess, control, or know.‖ By 

3130 contrast, ―readily obtainable‖ information does not even cover all the information in a 

3131 submitter‘s possession or control. As defined for the 2006 IUR, it was limited to what 
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3132 was known by certain ―management and supervisory employees of the submitter.‖ See 

3133 68 FR 879 (2003). 

3134 Under the ―known to‖ portion of the ―known to or reasonably ascertainable by‖ 

3135 standard, a submitter mustwould therefore ascertain what it knows about the processing 

3136 and use of a chemical substance it manufactures, (including imports), without confining 

3137 its inquiry solely to what is known to managerial and supervisory employees., but would 

3138 also be expected to review other information which the manufacturer (including 

3139 importer) may have in its possession. In response to comments regarding the level of 

3140 diligence with which submitters must search for information within their organization, 

3141 this standard requires that submitters conduct a reasonable inquiry within the full scope 

3142 of their organization (not just the information known to managerial or supervisory 

3143 employees). The inquiry mustwould be as extensive as a reasonable person, similarly 

3144 situated, might be expected to perform within the organization. Information derived from 

3145 customer surveys or other customer contacts, like any other information, would be 

3146 ―known to or reasonably ascertainable by‖ to‖ the submitter if it is available after a 

3147 reasonably extensivereasonable inquiry. within the organization. The standard does not 

3148 necessarily require that the manufacturer conduct an exhaustive survey of all employees. 

3149

3150 EPA agrees that further clarification would be useful regarding what is 

3151 ―reasonably ascertainable‖ to submitters about processing and use information because 

3152 this component of the reporting standard potentially may require submitters to obtain 

3153 information previously unknown to them, for the purposes of reporting. This would 

3154 occurcircumstance could arise if a submitter knows less than that what is reasonably 
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3155 ascertainable to it. EPA is therefore offering the following further guidance regarding the 

3156 interpretation of this term.

3157

3158 For many of the reasons identified by industry commenters (e.g., the expense and 

3159 burden of surveying customers, and uncertainty as to the extent to which customers will 

3160 respond to such surveys), EPA agrees that if particular information cannot be 

3161 developedderived or reasonably estimated without conducting further customer surveys,

3162 (i.e., without sending a comprehensive set of identical questions to multiple customers), it 

3163 is generallywould not be ―reasonably ascertainable‖ to the submitter. Thus there is not a 

3164 need to conduct new customer surveys for purposes of the IUR. However, to the extent 

3165 that customer surveys are already in the submitter‘s possession or control, and to the 

3166 extent that reasonable efforts to locate or analyze those surveys may result in additional 

3167 processing and use information (or reasonable estimates of such information), the 

3168 information is generally ―reasonably ascertainable.‖ Also, as illustrated by the examples 

3169 in Unit III.H., inquiry under the ―reasonably ascertainable‖ standard may entail inquiries 

3170 outside the organization to fill gaps in the submitter‘s knowledge. Further examples of 

3171 actions that would meet the ―known to or reasonably ascertainable by‖ reporting standard 

3172 are provided in Unit III.H.

3173

3174 A number of commenters requested that EPA specify the precise degree of effort 

3175 required of manufacturers if they must survey their customers to generate data for the 

3176 IUR; e.g., how far down the chain of commerce must such inquiries go? How persistent 

3177 must the manufacturer be in seeking such information? As described earlier, EPA does 

3178 not anticipate that the IUR will generally require any degree of effort to survey 

3179 customers. However, where surveys have already been performed, and the results are 

3180 already in the submitters‘ possession or control, EPA expects that submissions will be 

3181 informed by the submitters‘ reasonable efforts to identify and interpret the results.

3182
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3183 A number of commenters objected to the ―known to or reasonably ascertainable 

3184 by‖ standard on the grounds that it was subjective or too vague to be appropriately 

3185 applied to the collection of processing and use information outside of the submitter‘s 

3186 direct control. Other commenters objected to the standard‘s reference to what a 

3187 reasonable person similarly situated ―might‖ be expected to possess, control, or know. 

3188 They suggested that the standard be amended to what a reasonable person ―should‖ be 

3189 expected to know. 

3190

3191 EPA does not agree that the ―known to or reasonably ascertainable‖ standard is 

3192 subjective or excessively vague. The standard is set forth in EPA‘s statutory authority to 

3193 collect information under Section 8(a) of TSCA, and EPA‘s definition is consistent with 

3194 Congressional intent to establish an objective standard: ―The conferees intend that the 

3195  ̳reasonably ascertainable‘ standard be an objective rather than a subjective one. Thus, 

3196 the manufacturer or processor must provide information of which a reasonable person 

3197 similarly situated might be expected to have knowledge.‖‖ (Ref. 23, H.R. Rep. 94-1679 

3198 at 80 (1976). ). Thus, whether a particular level of diligence meets this standard does not 

3199 depend on the submitter‘s subjective view of what seems a reasonable person ―should‖ be 

3200 expected to know. It turns on an objective question: the level of diligence that a 

3201 reasonable person, similarly situated, might expect to undertake. EPA believes it is 

3202 appropriate to define the standard consistently for all persons reporting under Section 8(a) 

3203 of TSCA, and that the existing definition appropriately reflects Congressional intent. 

3204 Finally, EPA does not think the standard of objective reasonableness will be unfamiliar to 

3205 submitters. It is incorporatedincluded into a wide variety of legal standards under state 

3206 and federal law, and in the 2006 IUR it applied to all aspects of the information collection 

3207 other than processing and use information. 

3208

3209 2. Clarifications to byproduct reporting. a. Concern that new byproduct 

3210 reporting requirements are being added. In general, some commenters asserted that 

3211 EPA‘s explanation of the IUR byproduct-related reporting requirements reflect new 

3212 requirements, inconsistent with current byproduct exemptions. 

3213

3214 EPA is clarifying, not enlarging, the reporting requirements for byproducts, which 

3215 have been in place for decades. Byproducts are defined The definitions of ―Byproduct‖ 
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3216 and ―Manufacture for commercial purposes‖ (referencing byproducts) at 40 CFR 704.3, 

3217 under an existing definition that has been in place since 1988. have been in place since 

3218 1983 (Ref. 24), and have been applicable to the IUR since the IUR‘s inception in 1986 

3219 (Ref. 3, 51 FR at 21447 (incorporating definitions from 40 CFR 704.3)). The reporting

3220 exemptions for byproducts at 40 CFR 720.30(g) and (h)) (cross referenced at 40 CFR 

3221 711.10) have also been in place since 1983. , (Ref. 25), and have also been applicable to 

3222 the IUR since the IUR‘s inception (Ref. 3, 51 FR at 21447). While this final rule is

3223 modifying the applicable definition of ―manufacture,‖ the pertinent languageportion of 

3224 the revised definition (providing that manufacture includes ―the extraction, for 

3225 commercial purposes, of a component chemical substance from a previously existing 

3226 chemical substance or complex combination of chemical substances‖) is consolidated 

3227 from materially identical in all material respects to language found in the previously 

3228 applicable definition of ―manufacture‖ and ―manufacturer‖ at 40 CFR 704.3 That 

3229 language. This specification of the scope of ―manufacture‖ has been in force, and 

3230 applicable to the for IUR, purposes since 1988. See 51 FR at 21447 (1986 incorporation 

3231 of definitions from 40 CFR 704.3 into the IUR) (Ref. 3) and 53 FR at 51716 (1988 

3232 revision to 40 CFR 704.3) (Ref. 26).

3233

3234 In 1983, EPA promulgated a rule that made clear (for subsequent IUR and PMN 

3235 purposes) that the reporting exemption for the manufacture of byproducts is only 

3236 potentially applicable to the manufacture of the byproduct and would in no case apply to 

3237 the manufacture of component substances extracted from the byproduct. 40 CFR 

3238 720.30(g)(3). Furthermore, it has been the Agency‘s position since at least 1991 that, in 

3239 order for byproduct manufacture to qualify for the 720.30(g)(3) exemption, ―the 

3240 component to be extracted must be already existing as a distinct chemical substance in 

3241 the waste stream.‖‖ (Ref.2027). When the chemical substance present in the byproduct 

3242 and the chemical substance extracted from the byproduct are distinct chemical 

3243 substances, neither the manufacture of the byproduct nor the manufacture of the extracted

3244 chemical substance qualify for the 720.30(g)(3) exemption.
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3245

3246 See also the discussion in Unit IV.2.The guidance docketed with today‘s 

3247 noticethis final rule, which explains existing byproducts reporting requirements under the 

3248 IUR, is consistent with past guidance issued in connection with the IUR and TSCA new 

3249 chemicals program.New Chemicals Program. For example: In a 2002 response to public 

3250 comments on a previous proposed amendment to the TSCA Inventory Update Rule (see 

3251 2003 final rule published at 68 FR 848, Ref. 18Ref. 4), EPA explained that ―distillation, 

3252 extraction, refining, and similar activities may result in the manufacture of a chemical 

3253 substance.‖ In a 2006 letter to the Aluminum Association, EPA described a circumstance 

3254 in which the extraction of aluminum from aluminum dross byproduct constituted the 

3255 reportable manufacture of aluminum, while cautioning that if the aluminum is 

3256 ―chemically changed during the extraction process,‖ then not only the extracted 

3257 aluminum but also the dross byproduct would be reportable under the IUR (Ref. 2128). 

3258 In 2008, EPA provided similar guidance by letter to IPC, another trade group (Ref. 2229).

3259

3260 Due to the 2003 expansion of the IUR reporting requirements to inorganic 

3261 chemicalschemical substances, many companies have recently become aware of their 

3262 status as chemical substance manufacturers when they recycle their waste materials. 

3263 Instead of disposing of those waste materials, the manufacturers return them to commerce 

3264 by recycling the materials – either themselves or through a third party. Recycling may be 

3265 beneficial for many reasons: it conserves resources, may reduce the expense of 

3266 purchasing new raw or starting materials, may reduce the reliance of the United States on 

3267 foreign suppliers of raw materials, reduces the need for landfill or other disposal sites, 

3268 and returns a waste to commerce. However, many recycling activities fit the TSCA and 
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3269 IUR rule definition of manufacture, and are likely to be considered ―manufacture for a 

3270 commercial purpose.‖ EPA has finalized the draft IUR guidance documents that were 

3271 published with the proposed rule. These documents include examples of many common 

3272 manufacturing scenarios to assist individuals in determining whether their company is 

3273 manufacturing a chemical substance that needs to be reported under the IUR (Refs. 117

3274 and 1230). 

3275

3276 b. Concerns about the IUR byproduct reporting requirements, in relation to 

3277 RCRA and the Toxics Release Inventory. Some commenters asserted that byproducts 

3278 should be regulated, if at all, under RCRA and/or reported under TRI, and should not 

3279 subject to IUR reporting requirements. One commenter suggested that EPA revisit the 

3280 entire issue of the management of recycled materials to determine the appropriate roles 

3281 for the TSCA and RCRA programs. Some commenters also asserted that reporting under 

3282 IUR presents a disincentive for recycling.

3283

3284 In broad terms, the purpose of TSCA sections 8 (governing the IUR) and 5 

3285 (governing PMN reporting) is to understand the universe of chemicalschemical

3286 substances in commerce in the United States. (Section 5 also provides EPA with the 

3287 ability to control for risks of new chemicalschemical substances before they are placed 

3288 into commerce.) The IUR requires reporting of manufacture, processing, and use 

3289 information for chemicalschemical substances in commerce, and exemptions exist for 

3290 those substances or manufacturing activities for which EPA has a low current interest. 

3291 With limited exception, such as those included in 40 CFR 720.30, all chemical substances 

3292 in commerce in the United States are to be listed on the TSCA Inventory; companies can 
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3293 trigger the addition of a chemical substance to the TSCA Inventory by filing a PMN and 

3294 meeting certain other requirements. 

3295

3296 RCRA is focused on waste – it is concerned with the generation, transportation, 

3297 treatment, storage, and disposal of hazardous wastes and the management of non3298 hazardous solid wastes. RCRA is also focused on waste minimization, phasing out land 

3299 disposal of hazardous waste, corrective action for releases, and recycling. EPA notes that 

3300 while RCRA or other statutes may exempt a certain chemical substance from reporting 

3301 requirements based on certain treatments or disposals, RCRA exemptions doin most 

3302 cases are not applyrelevant to TSCA reporting obligations, and, given the different 

3303 purposes of RCRA reporting and the TSCA IUR rule, are not necessarily relevant to IUR 

3304 reporting. It is important to note that finding a commercial use for a substance previously 

3305 treated as a waste under RCRA can relieve the manufacturer of that substance from some 

3306 RCRA requirements, but may then subject that manufacturer to TSCA reporting 

3307 requirements. EPA is aware that, inAlso note that 40 CFR 720.30(g) provides IUR 

3308 exemptions for certain uses of byproducts. In certain circumstances, reporting under both 

3309 RCRA and TSCA may be required. It is As noted earlier, the Agency‘s intention to 

3310 identify and address such circumstances, retainingpurposes for reporting under the 

3311 ruleRCRA and the TSCA IUR are different, and therefore the required data sets are 

3312 different. While the data sets are not duplicative, EPA recognizes that best fits Agency 

3313 needs. However, there may be limited circumstances where particular elements of the 

3314 data sets overlap. EPA strives to reduce such overlap, while ensuring that it is important 

3315 to note that the administratively feasible to collect and collate the data that are needed for 

3316 TSCA purposes. The TSCA program is workingcontinuing its work with the RCRA 
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3317 program --to maintain coordination between the two programs. It is important to note 

3318 that the application of RCRA regulations varies state-by-state, and recent changes to 

3319 RCRA regulations have not been adopted by all states. Therefore the overlap between 

3320 RCRA reporting and IUR reporting may vary depending upon the state in which a 

3321 submitter‘s site is located. 

3322

3323 A similar situation exists for some sites that meet the requirements to report under 

3324 both TRI and IUR. The TRI program goal is to provide communities with information 

3325 about toxic chemical substance releases and waste management, and the TRI reporting 

3326 requirements are designed to address that goal. Because the IUR program goals differ, 

3327 the specific information collected under each program is not the same. Where a person 

3328 must report for both for the same site, EPA and the public will have a broader picture of 

3329 the exposure scenarios at that site, including environmental releases from that site; while 

3330 the two information collections may be complementary, neither is an adequate substitute 

3331 for the other. A more in-depth discussion is provided in the Responses to Comments 

3332 document (Ref. 1312). 

3333

3334 EPA believes that commenters‘ concern that reporting under IUR would be a 

3335 disincentive to recycle reflects certain misunderstandings of the IUR requirements. The 

3336 Agency expects that revised byproduct guidance materials, as well as EPA‘s responses to 

3337 the comments concerning, for instance, byproduct chemical identification requirements, 

3338 will help to alleviate the majority of those concerns. EPA believes that many factors play 

3339 into whether a company chooses to recycle, including the value of the recovered 

3340 materials, the expense of disposal, desire to maintain or build a ―green‖ reputation, 
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3341 technical limitations or flexibility, state and local requirements or incentives, and the 

3342 incentives offered or requirements imposed by other federal laws (such as RCRA). EPA 

3343 strongly believes that the benefits of recycling usually outweigh the burden associated 

3344 with IUR reporting for these materials, and, just as with any other chemical substance 

3345 whose manufacture must be reported under the IUR, production volume, worker 

3346 exposure and other IUR data collected on byproduct chemicalschemical substances

3347 supports the Agency‘s mandate to protect human health and the environment. 

3348

3349 c. Concerns about how to identify the byproduct chemical substance and with 

3350 reporting both the byproduct and a substance extracted from the byproduct.

3351 Commenters stated that it is very difficult to identify the chemicalschemical substances in 

3352 a byproduct mixture, and that the mixture can vary over time, depending upon the 

3353 specific manufacturing situation. Commenters also argued that there would be duplicative 

3354 reporting by the byproduct manufacturer and the recycler/processor who extracted a 

3355 component chemical substance from the byproduct mixture.

3356

3357 The comments reflect a misperception that characterizing the identity of complex 

3358 chemical substances, as are found in or comprise many byproducts, necessarily involves a 

3359 detailed analysis of the ―individual components of the chemical substance.‖ In reality, a 

3360 byproduct may be listed inon the TSCA Inventory as a single chemical substance that 

3361 represents, for TSCA purposes, what may be a complex composition of 

3362 chemicals.chemical substances. In this way, the chemical identity of a byproduct may 

3363 represent a chemical substance process stream. Complex chemical substances are listed 

3364 (or can be listed) on the TSCA Inventory as chemical substances of Unknown or Variable 
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3365 composition, Complex reaction products and Biological materials (―UVCB‖ chemical 

3366 substances). As described by the commenters, the byproduct ―mixture‖ is often complex 

3367 and varies over time, making the identification of the individual components a very 

3368 difficult task. This description itself indicates that the proper identification of such a 

3369 reaction product is as a UVCB chemical substance. As stated in EPA‘s on-line guidance, 

3370 ―Each combination of substances resulting from a reaction is considered by the Agency 

3371 to be either (1) a mixture, composed of two or more well-defined chemical substances to 

3372 be named and listed separately, or (2) a reaction product, to be listed as a single chemical 

3373 substance, using one name that collectively describes the products, or, failing that, the 

3374 reactants used to make the products. ― (see.‖ (See

3375 http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt ) Situations may exist where the 

3376 byproduct substance is actually a mixture, but as further described in the aforementioned 

3377 guidance, ―A combination of products resulting from a chemical reaction is considered a 

3378 mixture provided that all of the component product substances are unambiguously 

3379 identified and are represented as forming each time the reaction is run.‖ 

3380

3381 UVCB chemical substances in some cases include ana TSCA Inventory definition 

3382 to further describe the chemical substance. Here is one example from EPA‘s on-line 

3383 guidance (see http://www.epa.gov/oppt/newchems/pubs/uvcb.txt):

3384

3385 Dust, iron-ore, sinter 

3386 CASRN 69012-53-9 

3387 Definition: Dust generated during the making, breaking and handling of sinter 

3388 which is recovered through the use of pollution abatement equipment. 
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3389

3390 A byproduct manufacturer, therefore, would potentially report the UVCB name 

3391 for the byproduct composition, while the subsequent recycler of the byproduct would

3392 potentially report the specific chemical identity of the chemical substance they 

3393 chemically manufacture from the byproduct. EPA does not agree that such reporting is 

3394 duplicative, because reporting will fall into one of following two scenarios. If the 

3395 chemical substance manufactured from the UVCB byproduct is already present as a 

3396 constituent of the UVCB byproduct, then the byproduct manufacturer need not report the 

3397 byproduct that is sent for such processing/recycling. If the chemical substance 

3398 manufactured from the UVCB byproduct is distinct from any chemical substance present 

3399 in the UVCB byproduct as a constituent, then the separate reporting by the byproduct 

3400 manufacturer and the processor/recycler reflects a change in chemical composition. 

3401 Either way, there is no duplication of reporting between the manufacturer of the UVCB 

3402 byproduct and the processor/recycler. As a general matter, if there is to be appropriate 

3403 stewardship of potential chemicalschemical substance risks, EPA believes that chemical 

3404 substance manufacturers, processors, and users should know and understand the identities 

3405 of chemicalschemical substances they handle.

3406

3407 Some commenters stated that many byproduct mixtures in the metals industry are 

3408 processed to recover the metal values and indicated that the metal value should be 

3409 considered a component chemical substance (i.e., that if Nickel (II) hydroxide (Ni(OH)2) 

3410 is present in a byproduct mixture, then the elemental substance Nickel (Ni) should be 

3411 considered the component chemical substance). EPA disagrees with this statement. (See 

3412 Ref. 2027 for a precedent from a 1991 prenotice communication.) Under TSCA, 
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3413 Ni(OH)2 and elemental Ni are two different chemical substances, with separate listings 

3414 on the TSCA Inventory. If the byproduct contains Ni(OH)2 but not elemental Ni, only 

3415 Ni(OH)2 is considered a component chemical substance of the byproduct. The 

3416 manufacture of elemental Ni from either the Ni(OH)2 –bearing byproduct (or Ni(OH)2

3417 itself) results in a potential need to report under IUR. That is, if the extracted component 

3418 substance is an oxide and used as an intermediate to form an elemental metal, then both 

3419 the oxide and elemental metal are subject to reporting by their manufacturer(s). Note that 

3420 information pertaining to manufacture of a chemical substance need only be reported to 

3421 the extent that the information is known to or reasonably ascertainable by the submitter. 

3422

3423 A second example of a metal-containing byproduct is:

3424

3425 Electrolytes, copper-manufg., spent 

3426 CASRN 69012-54-0

3427 Definition: Spent copper sulfate electrolyte consisting of copper sulfate and 

3428 sulfuric acid resulting from the electrolytic refining of copper. 

3429

3430 This spent material is a UVCB chemical substance that is likely to be recycled. If 

3431 the only commercial purpose for this spent material is to extract the component chemical 

3432 substance copper sulfate, then the manufacture of the spent material is exempted from 

3433 reporting (but the manufacture of the copper sulfate [via extraction from the byproduct] is 

3434 subject to reporting). On the other hand, if the spent material is used directly to 

3435 manufacture elemental copper, then both the spent material and the elemental copper are 

3436 subject to reporting under the IUR by their respective manufacturers, because elemental 

3437 copper is not a component chemical substance in the spent material byproduct.
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3438

3439 d. Concerns regarding determining when a byproduct is manufactured.

3440 Commenters stated that clarification is needed regarding purification and extraction and 

3441 when a chemical substance is considered manufactured versus purified. Commenters 

3442 asserted that where there is no change in chemical identity, only a change in purity, a 

3443 chemical substance should not be considered manufactured, regardless of the method of 

3444 purification. 

3445

3446 Much of the commenters‘ confusion regarding the differences between 

3447 purification and extraction appears to concern whether extraction or purification involves 

3448 a change in chemical identity; the potential for a change in chemical identity is closely 

3449 linked with the proper identification of the manufactured substance, as described in the 

3450 previous comment response. Where there is no change in chemical identity but rather 

3451 just a change in purity (an impure chemical substance correctly identified for TSCA 

3452 purposes as ―substance A,‖ for example, undergoing purification to a more pure form of 

3453 ―substance A‖), the Agency agrees with the commenter that, for purposes of IUR, the 

3454 chemical substance is not being manufactured. The chemical substance that appears on 

3455 the TSCA Inventory may actually represent a category consisting of the same chemical 

3456 substance in various degrees of purity. For example, if a company manufactures a 

3457 specific, discrete chemical substance at 90% purity and it is correctly identified as that 

3458 discrete substance (not having a UVCB name), then increasing the purity of the chemical 

3459 substance (such that it retains its chemical identity) is considered purification and, for 

3460 purposes of IUR, such purification is not considered manufacture. 

3461
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3462 Note, however, that the extraction of component chemical substances from certain 

3463 complex byproduct mixtures or process streams (i.e., UVCB chemical substances), is not 

3464 considered purification, because the complex byproduct mixture and the extracted 

3465 substance do not have the same chemical identity. For example, a manufacturing process 

3466 involving the use of solvent A results in the manufacture of a spent solvent. As a 

3467 variable, complex mixture of solvent A, finished product, unreacted reactants, individual 

3468 byproduct substances, and other impurities, the spent solvent is considered to be a UVCB 

3469 chemical substance. It is not unusual for the manufacturemanufacturer to extract solvent 

3470 A from this UVCB chemical substance. In such a case, the extracted solvent A is 

3471 considered to be manufactured, and therefore is reportable for purposes of IUR. When 

3472 the spent solvent is a byproduct whose only commercial purpose is the extraction of a 

3473 component chemical substance, solvent A, the byproduct exemption at 40 CFR 720(g)(3) 

3474 can be applied and the spent solvent byproduct does not need to be reported. The 

3475 extracted solvent A is nevertheless reportable for purposes of IUR.

3476

3477 3. Definitions of Manufacture and manufacturer. EPA received several 

3478 comments on the definition of ―manufacture,‖ asserting that the definition of manufacture 

3479 included in the proposed rule was inconsistent with past definitions, over-broad, and 

3480 confusing. 

3481

3482 EPA disagrees, except with respect to minor typographical errors noted below. 

3483 EPA consolidated existing definitions into a single ―manufacture‖ definition to reduce 

3484 confusion. EPA also added a very short clarifying definition that ―a manufacturer is a 

3485 person who manufactures a chemical substance,‖ to direct the reader to the relevant 
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3486 language in the definition of ―manufacture,‖ and to avoid confusion with an existing 

3487 definition of ―manufacturer‖ in 704.3. The definition of ―manufacture‖ is consistent with 

3488 established regulatory and statutory definitions, and is sufficiently flexible to 

3489 accommodate the actual allocation of knowledge between toll manufacturers and 

3490 contracting companies. EPA has separately addressed the comments received relating to 

3491 the extraction of component chemical substances. (See the discussion on reporting 

3492 byproducts and recycling elsewhere in this Unit.) 

3493

3494 The first part of the definition of manufacture in today‘sthis final rule is as 

3495 follows: ―Manufacture means to manufacture, produce, or import, for commercial 

3496 purposes. Manufacture includes the extraction, for commercial purposes, of a component 

3497 chemical substance from a previously existing chemical substance or complex 

3498 combination of substances.‖ It is similar to the definitions of ―manufacture‖ and 

3499 ―manufacturer‖ used for past IUR reporting. (Ref.31). For example, the definition of 

3500 manufacturer in effect for the 2006 IUR reporting period is in 40 CFR 704.3: 

3501 ―Manufacturer means a person who imports, produces, or manufactures a chemical 

3502 substance. A person who extracts a component chemical substance from a previously 

3503 existing chemical substance or a complex combination of substances is a manufacturer of 

3504 that component chemical substance.‖ The two similar definitions of ―manufacture‖ in 

3505 effect for the 2006 IUR reporting period were found in 40 CFR 710.3 (―to manufacture, 

3506 produce, or import for commercial purposes,‖ and 40 CFR 704.3 (―to manufacture for 

3507 commercial purposes‖). The Part 711 definition of ―manufacture‖ is also consistent with 

3508 the established definition of ―manufacturer‖ used for purposes of PMN reporting, at 40 

3509 CFR 720.3. Existing Part 704.3, which was not modified in today‘sthis final rule, also 
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3510 includes a definition of manufacture: ―Manufacture means to manufacture for 

3511 commercial purposes,‖ and a definition of ―manufacture for commercial purposes‖ that 

3512 makes clear that byproducts produced during manufacturer are also ―manufactured for a 

3513 commercial purpose.‖ 

3514

3515 The definition of ―manufacture‖ in today‘sthis final rule is also similar to and 

3516 consistent with TSCA‘s definition of ―manufacture‖ at Section 3: ―‘manufacture‘ means 

3517 to import in the customs territory of the United States, produce, or manufacture,‖ and 

3518 Section 8: (―For purposes of this section, the term ―manufacture‖ . . . mean[s] 

3519 manufacture . . . for commercial purposes.‖) Finally, EPA disagrees with one 

3520 commenter‘s suggestion that a new definition of ―produce‖ is necessary to clarify that 

3521 production involves a chemical substance that is ―chemically different‖ from the 

3522 chemical substance in the starting materials. ―Chemically different‖ is itself an undefined 

3523 term, so it would not bring additional clarity to a new definition of ―produce.‖ 

3524 Furthermore, the difference between one chemical substance and another (and hence, the 

3525 question of whether a chemical substance is being produced) already has a basis in the 

3526 statutory definition of ―chemical substance‖ at TSCA 3(2), and in the differences 

3527 between the entries of the TSCA Inventory. 

3528

3529 The second part of the definition, as noted in the preamble to the proposed rule, 

3530 adds an explanation, derived from the definition of ―manufacturer‖ in Part 720, of the 

3531 conditions under which a contract manufacturer would be considered to ―manufacture,‖ 

3532 and therefore be responsible for IUR reporting. Persons contracting with a toll 

3533 manufacturer and toll manufacturers are now considered to be co-joint manufacturers of 
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3534 what is produced at the toll manufacturer‘s site. Consistent with 40 CFR 711.22(c), such 

3535 parties should coordinate amongst themselves to submit a single report, rather than 

3536 duplicative individual reports, respecting what they have co-manufactured. The joint 

3537 submission mechanism, under 40 CFR 711.15(b)(3)(i), is not available to co-joint 

3538 manufacturers. The joint submission mechanism addresses distinct circumstances: those 

3539 in which one party is the manufacturer/importer, and a second party (not a manufacturer 

3540 of the chemical substance in question) possesses confidential information needed to 

3541 determine the chemical identity of what the first party has manufactured/imported. In the 

3542 final rule, EPA uses the term ―co-manufactured‖ rather than the proposed term ―jointly 

3543 manufactured.‖ This change of terminology is intended to avoid confusion between the 

3544 reporting provisions at 40 CFR 711.22(c) and those at 40 CFR 711.15(b)(3)(i).

3545

3546 EPA notes that one change to the definition of ―manufacture‖ was made to correct 

3547 a typographical error in the definition as proposed and to address a comment that the 

3548 definition used confusing syntax. The word ―and‖ should have been included between 

3549 the paragraphs numbered (1) and (2), and the text should have been formatted 

3550 differently,The words ―and‖ and ―then‖ were added to make clear that the conditions in 

3551 paragraph (1), and the conditions in paragraph (2) (up to the comma), must both be 

3552 satisfied before a chemical substance will be considered ―co-manufactured‖ by the 

3553 producing manufacturer (i.e., the toll manufacturer) and the person contracting for such 

3554 production (i.e., the contracting company).

3555

3556 Several commenters suggested that the toll manufacturer should be primarily or

3557 solely responsible for IUR reporting, or expressed concern that the rule would compel 
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3558 contracting companies to submit information on behalf of toll manufacturers. Another 

3559 commenter supported the assignment of responsibility as proposed. Some commenters 

3560 also suggested that EPA should ―acknowledge the complexity of contractual mechanisms 

3561 and not offer a blanket,  ̳one size fits all‘ requirement for reporting responsibilities.‖ 

3562

3563 EPA agrees that a diversity of contractual arrangements may exist, and notes that 

3564 there was nothing in the proposed IUR rule to prevent toll and contracting manufacturers 

3565 from sharing information and agreeing between themselves that one or the other will 

3566 undertake all or a portion of the work associated with IUR reporting for a given chemical

3567 substance, though comments indicated that there was some confusion caused by EPA‘s 

3568 assignment of ―primary‖ responsibility for reporting to the contracting manufacturer (see 

3569 40 CFR 711.22(c)). EPA expects that in most instances, a person that contracts with a 

3570 toll manufacturer will generally know more about the particular chemical substances, and 

3571 will usually be a better position to report on industrial processing and use of a chemical 

3572 substance, and on commercial and consumer uses of products containing the chemical 

3573 substance. Similarly, EPA expects that the toll manufacturer will generally be in a better 

3574 position to report on the number of workers and other information about their plant. In 

3575 light of the contracting company‘s control over the ―total amount produced and the basic 

3576 technology for the plant process,‖ and based on EPA‘s expectations of the relative 

3577 knowledge of the contracting company, EPA initially indicated, in proposed section 

3578 711.22(c), that the contracting company would be ―primarily responsible‖ for IUR 

3579 reporting. However, given the confusion introduced by indicating that one party or the 

3580 other is ―primarily‖ responsible for reporting, and not wishing to interfere in contractual 

3581 agreements to the contrary, EPA has decided not to allocate ―primary‖ responsibility to 
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3582 either party in the final rule. Conforming changes have been made to section 711.22(c) 

3583 in this final rule. However, the enforceability of the rule requires EPA to specify the 

3584 persons who are legally responsible for reporting. In fairness, EPA has chosen to make 

3585 both parties responsible for reporting on the chemical substances they have co3586 manufactured, as specified in the proposed rule. 

3587

3588 4. Definition of Site. Several commenters asserted that the proposed revision to 

3589 the definition of ―site‖ would force different companies that are at the same site to report 

3590 together. EPA disagrees with this assertion. In the proposalproposed rule, EPA added 

3591 explanations to accommodate manufacturing under contract and for portable 

3592 manufacturing units, and clarified that an importer‘s site must be a US address. The 

3593 definition of site used in the past, at 40 CFR 710.3, was not otherwise significantly 

3594 changed. The old definition states that ―Site means a contiguous property unit. Property 

3595 divided only by a public right-of-way will be considered one site. There may be more 

3596 than one manufacturing plant on a single site. ...‖ This portion of the definition was 

3597 retained, with slight wording change (―More than one plant may be located on a single 

3598 site.‖), in the proposed rule. 

3599

3600 The statement ―More than one plant may be located on a single site‖ is meant to 

3601 guide companies that have multiple plants at one site to sum production volumes and 

3602 other IUR-reportable data across all of their plants at one site and produce one report for 

3603 each reportable substance at each site (not at each plant). The definition does not require 

3604 different companies located at the same site to report together.

3605
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3606 5. Processing and use-related definitions. EPA received comments in favor of the 

3607 amended definitions for commercial and consumer use. However, a commenter indicated 

3608 that the definitions of "industrial," "commercial," "function," and "use," were unclear and 

3609 referred to problems in reporting both product- and substance-level information. EPA 

3610 appreciates the support for the amending the terms commercial and consumer use to 

3611 harmonize the definitions developed by the U.S. and Canada. 

3612

3613 EPA feels the terms industrial and commercial are adequately defined. To clarify, 

3614 EPA defines industrial function as ―the intended physical or chemical characteristic for 

3615 which a chemical substance or mixture is consumed as a reactant; incorporated into a 

3616 formulation, mixture, reaction product, or article; repackaged; or used.‖ This definition

3617 can be found in the document ―IUR Modifications Rule: Development of Definitions for 

3618 40 CFR 711.3‖, which is located in EPA IUR docket (EPA-HQ-OPPT-2009-0187-0032) 

3619 and will be part of the proposed regulation changes.‖ (Ref. 8). EPA also notes that the 

3620 terms ―use‖, ―industrial use,‖ ―consumer use,‖ and ―commercial use‖ have already been 

3621 in use for IUR and were previously defined in 40 CFR Part 710.43 (relocated in 

3622 today‘sthis final rule to 711.3).

3623

3624 F. Confidential Business Information

3625

3626 1. Release of information not validly claimed as CBI. The Agency received 

3627 comments about the proposed change to make information claimed as CBI available to 

3628 the public without further notice to the submitter, in the circumstance that the required 

3629 substantiation is not submitted with the claim. Opponents of the change are concerned 

3630 that a reporting error could result in public release of legitimate CBI. They suggested 
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3631 notifying the submitter if further substantiation is needed prior to releasing data to the 

3632 public. The commenters are in favor of a warning system that would allow submitters 

3633 time to provide additional substantiation on CBI claims before the Agency determines the 

3634 data is non-CBI and releases it as public information.

3635

3636 There are three situations during which the Agency will release IUR information 

3637 claimed as CBI without further notice to the submitter. First is the circumstance that a 

3638 CBI claim is made for the identity of a chemical substance already listed on the non3639 confidential portion of the Master Inventory File. Any such CBI claims were invalid 

3640 under the previous IUR regulations (applicable to the 2006 and earlier submission 

3641 periods). 

3642

3643 The second is the circumstance that a submission lacks the certification required 

3644 under 40 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a certification stating that the 

3645 submitted information has been completed in compliance with the requirements of this 

3646 part and that the confidentiality claims made on the Form U are true and correct. The 

3647 certification must be signed and dated by the authorized official for the submitter 

3648 company, and provide that person‘s name, official title, and e-mail address. Consistent 

3649 with this regulatory provision, the e-IUR softwareIURweb tool is designed to entirely 

3650 block the submission of a Form U lacking an appropriate certification. 

3651

3652 The third is the circumstance that a particular CBI claim is not accompanied by 

3653 upfront substantiation required under 40 CFR 711.30(b),(), (c), or (d) (e.g., upfront 

3654 substantiation of processing and use information). The e-IURweb reporting tool is 

3655 designed to protect against a company not providing an upfront substantiation. When a 
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3656 CBI claim is made and substantiation is required, the reporting tool will open the 

3657 substantiation question page. Should the submitter choose not to complete the 

3658 substantiation at that time, or to only partially complete it, the validation portion of the 

3659 tool will again alert the submitter to the need for substantiation. The tool also includes 

3660 warnings that information with unsubstantiated CBI claims will be released without 

3661 further notice to the submitter. EPA believes these reminders provide sufficient notice to 

3662 the submitter of the need to substantiate these claims. 

3663

3664 2 . Upfront substantiation for processing and use information. The Agency 

3665 received comments both for and against the proposed upfront substantiation requirement 

3666 when processing and use information is claimed as confidential. Commenters opposing 

3667 the proposed change explained that processing and use information is often considered 

3668 confidential by customers to protect their competitive positions in the market. 

3669 Commenters voiced concern that the proposed change will impact their ability to remain 

3670 competitive or will reduce innovation. These commenters were concerned that the 

3671 manufacturers of the chemical substances would not correctly identify CBI associated 

3672 with downstream uses, and that confidentiality agreements between the chemical 

3673 substance manufacturer and the downstream users would not provide sufficient 

3674 substantiation for the processing and use information. The Agency believes that the 

3675 processing and use information in the publicly-released IUR reports is sufficiently 

3676 agglomerated to address these concerns. However, the Agency also recognizes that there 

3677 are circumstances when the release of information about a particular use could harm the 

3678 competitive position of the submitter‘s customer. Therefore, EPA has modified the 

3679 substantiation question at proposed 40 CFR 711.30(d)(1)(ii) to include information about 
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3680 harm to the submitter‘s competitive position ―or to your customer‘s competitive 

3681 position.‖ EPA also notes that under its confidentiality regulations, the Agency normally 

3682 solicits input from all affected businesses when making a final confidentiality 

3683 determination respecting information claimed as CBI.

3684

3685 Some commenters stated that providing written explanations for multiple 

3686 scenarios would be burdensome. Another commenter argued, however, that requiring 

3687 such explanations will help to limit CBI claims to information that in fact warrants 

3688 protection as a legitimate trade secret. The commenter asserted that the frequency with 

3689 which site information was claimed as CBI dropped from 28% to 7% after EPA added an 

3690 upfront substantiation requirement for that data element, and suggested that the drop 

3691 represented an elimination of ―excessive‖ trade secrecy claims.

3692

3693 The Agency recognizes that there is a burden associated with providing written 

3694 explanations. However, based on the significant number of CBI claims for processing 

3695 and use information in the last information collection, EPA believes that allowing 

3696 submitters to assert CBI claims merely by checking a box encourages submitters to assert 

3697 such claims without sufficiently considering whether there is a basis for the claim. While 

3698 EPA believes that such claims are appropriate under certain circumstances, the Agency 

3699 wants to ensure that all such claims are carefully considered and only information that is 

3700 truly confidential, the release of which would substantially injure the competitive position 

3701 of the submitter, is claimed as CBI. A substantiation requirement for such claims helps 

3702 ensure that this consideration takes place.

3703
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3704 3. Prohibition of confidentiality claims for data elements designated as “not 

3705 known or reasonably ascertainable.” Commenters agreed with prohibiting CBI claims 

3706 for processing and use information when designated as ―not known or reasonably 

3707 ascertainable." The primary reason cited by supporters was that the proposed change will 

3708 reduce the potential for unwarranted CBI claims.

3709

3710 G. Administrative Comments

3711

3712 1. Changes to reporting frequency. The Agency received comments regarding the 

3713 proposed change to increase the IUR reporting frequency from every 5 years to every 4 

3714 years. Some commenters suggested a change to the reporting frequency would still 

3715 present a burden to industry and that EPA has not provided adequate justification to 

3716 warrant or support any increase in the reporting frequency. Other commenters expressed 

3717 support for the return to the reporting frequency of every 4 years but some felt that to 

3718 increase the frequency further would be problematic. Additional commenters suggesting 

3719 even more frequent reporting cycles and these comments are addressed in more detail in 

3720 the  ̳ ̳Summary of EPA‘s Responses to Public Comments Submitted in Response to 

3721 Proposed TSCA Inventory Update Reporting Modifications‘‘document (Ref. 1312).

3722

3723 In the 2003 IUR Amendments, EPA changed its reporting requirement from every 

3724 4 years to every 5 years to lessen the burden associated with complying with the 

3725 amendments. However, EPA has decided to return to the reporting frequency of every 4 

3726 years, in order to better meet Agency needs. EPA has determined that reporting every 5 

3727 years is too infrequent, and does not provide enough data to sufficiently cover the 

3728 Agency's and public's needs. As discussed in Unit III.D.1 of the proposed rule, many 
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3729 chemical substances, even larger volume chemical substances, often experience wide 

3730 fluctuations in manufacturing volume from year to year. This can result in the production 

3731 volume of a chemical substance exceeding the threshold for several years, then falling 

3732 below the threshold during the IUR principal reporting year. A review of the previous 

3733 reporting under the IUR indicates an approximately 30% change in the 

3734 chemicalschemical substances that are reported from one reporting period to the next. 

3735 Therefore, the 1–year snapshot of production volume does not provide an accurate 

3736 picture of the chemical substances in commerce, and may provide an erroneous view of 

3737 the exposure scenarios associated with a particular chemical substance. In addition, EPA 

3738 has been criticized for using outdated information, which will be remedied with more 

3739 frequent reporting. As such, EPA has determined that the value gained through obtaining 

3740 more current and useful data is essential to fulfilling the Agency‘s statutory obligations 

3741 under TSCA, and outweighs the incremental burden to submitters. 

3742

3743 2. DeleteRemove superfluous text regarding production volume. The Agency 

3744 received comments on the proposal to deleteremove superfluous text associated with 

3745 reporting production volumes, in particular the +/- 10 percent standard of precision. All 

3746 commenters opposed changing the current language. Several commenters indicated that 

3747 reporting accurately to two significant figures is not equivalent to reporting to a precision 

3748 of +/- 10%. One commenter indicated that, if reporting to two significant figures, at 

3749 higher production volumes there would be a narrower allowable range of variation.

3750

3751 EPA is replacing ―provided that the reported figures are within +/-10% of the 

3752 actual volume‖ currently found in 40 CFR 710.52(c)(3)(iv) with ―This amount must be 
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3753 reported to two significant figures of accuracy.‖ The deleted phrase that was removed is 

3754 superfluous because any number reported accurately to two significant figures is within 

3755 10% of the correct value. EPA recognizes some commenters‘ concern that this will result 

3756 in a sliding precision scale between 1% and 10% that is solely based on the reported 

3757 digits. However, EPA believes that reporting to two significant figures will maintain a 

3758 balance between data needs for exposure screening and the industry burden associated 

3759 with data collection. In the 2006 IUR data collection, nearly all manufacturers reported 

3760 production volumes in greater precision (i.e., more significant figures) than is required 

3761 for 20112012 reporting. Based on years of experience assessing chemical substance risks 

3762 through programs such as the New Chemicals Program, the Agency believes requiring 

3763 reporting to two or more significant figures is appropriate to facilitate the Agency‘s initial 

3764 exposure screens of chemicalschemical substances, and to prioritize and make basic risk 

3765 management decisions about those chemicalschemical substances of greatest concern. 

3766 Those decisions then can prompt more detailed assessments as necessary. 

3767

3768 H. Economic Impact Estimates

3769

3770 1. General burden comments. The Agency received a number of comments 

3771 expressing concerns about the Economic Analysis (Ref. 1914); the majority of which 

3772 suggest that the Agency has significantly underestimated the effort required to collect, 

3773 organize, verify and report IUR data. Commenters disagreed with EPA‘s burden 

3774 estimates for several proposed modifications to the rule, including the retroactive 

3775 reporting of production volumes, reporting on imported mixtures, mandatory electronic 

3776 submission, the lowering of the threshold for downstream processing and use 
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3777 information, the change in the standard of reporting from ―readily obtainable‖ to ―known 

3778 to or reasonably ascertainable by‖,,‖ and the change in the reporting cycle from every 

3779 five to every four years. Several commenters asserted that the reporting burden will 

3780 increase to between two and six times the burden for reporting in 2006. However, few 

3781 commenters provided specific reasons for why they believe that the Agency‘s estimates 

3782 were low, and no commenters provided any analytical basis for revising EPA‘s estimates 

3783 or substantiated their alternative estimates. The Agency has used the best available data 

3784 to estimate the burden associated with the modifications to the IUR rule, and disagrees 

3785 with the commenters. The burden estimates presented in the economic analysis are 

3786 reasonable estimates for the average IUR submitter. 

3787

3788 a. Identification of affected entities. In general, commenters stated that the 

3789 Economic Analysis does not identify all affected entities, and EPA has inaccurately 

3790 assumed that the proposed rule will affect only chemical substance manufacturers. 

3791 Another commenter noted that a wide range of industries manufacture byproducts, so to 

3792 accurately estimate the burden of the proposed rule, EPA must identify all affected 

3793 industries and facilities. The commenter further stated that byproducts sent for recycling 

3794 are new chemicalschemical substances reportable under the IUR rule and the Economic 

3795 Analysis fails to identify these manufacturers.

3796

3797 The Economic Analysis assumes that all companies manufacturing or(including

3798 importing chemicals) chemical substances annually in amounts of 25,000 lb. or greater 

3799 that are listed on the TSCA Inventory will report under this rule. Chemical substance

3800 users and processors who may manufacture a byproduct chemical substance for a 

3801 commercial purpose, e.g., utilities, paper manufacturers, primary metal manufacturers, 
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3802 and semiconductor and other electronic component manufacturers (NAICS codes 22, 

3803 322, 331, and 3344), are considered to be chemical substance manufacturers for the 

3804 purposes of the IUR rule. Sites that manufactured a byproduct in a volume above the 

3805 25,000 lb. threshold during the 2006 reporting cyclesubmission period were required to 

3806 report under IUR, and therefore are included in the 2006 baseline estimates. 

3807

3808 b. Total industry compliance determination burden. Commenters made a number 

3809 of specific points regarding the compliance determination burden. According to one 

3810 commenter, provisions requiring reporting of more data for many chemicalschemical

3811 substances, replacing NAICS codes with European IS codes, and requiring upfront 

3812 substantiation for CBI claims for Part III information will contribute to the increased 

3813 effort required to report. 

3814

3815 EPA disagrees that the Economic Analysis underestimates the reporting costs and 

3816 burdens of today‘s IURthis final rule amendments as asserted by the commenters. EPA 

3817 does agree that many of the amended rule requirements, including provisions requiring 

3818 reporting of more data for many chemicalschemical substances, replacing NAICS codes 

3819 with Industrial Sector codes, and requiring upfront substantiation for CBI claims for Part 

3820 III information, will cause an increase in burden and cost. While EPA does state 

3821 throughout the EA that the burdens and costs may be overestimated, the analysis also 

3822 says that they may be underestimated. The statements regarding limitations of the study 

3823 serve to make the analysis more transparent. EPA does not have the ability to take into 

3824 account the effects of individual company circumstances concerning downsizing, growth, 
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3825 mergers and acquisitions, on estimates of reporting burden and cost, as mentioned by one 

3826 commenter. 

3827

3828 Several commenters assertasserted that EPA has underestimated the burden 

3829 associated with IUR compliance determination by estimating the burden on a per-report 

3830 basis. According to the comments, this methodology does not capture the burden 

3831 associated with tracking, screening, and keeping records for chemicalschemical

3832 substances that ultimately are not required to be reported to IUR because they are 

3833 manufactured or imported in quantities below the reporting threshold. 

3834

3835 Compliance determination occurs on a per-site basis and is based on a 

3836 manufacturer (including importer) determining that it manufactures at least one chemical 

3837 substance at or above the threshold, thus necessitating that the site complete and submit a 

3838 Form U. The Economic Analysis assumes all sites that report to the IUR incur the same 

3839 average cost for compliance determination regardless of the number of 

3840 chemicalschemical substances reported. EPA expects that it is standard company practice 

3841 to track and maintain records of production volumes for all chemicalschemical

3842 substances manufactured at a given site. Therefore, EPA expects that the burden 

3843 associated with compliance determination should not be substantial. The commenters 

3844 appear to have misinterpreted EPA‘s compliance determination burden to include the 

3845 burden of actually reporting for the chemicalschemical substances subject to the IUR, but 

3846 this is not the case. See Section 4.2.2 of Ref. 1914 for further clarification. 

3847

3848 Finally, EPA notes that the IUR does not require submitters to retain 

3849 documentation showing that particular chemicalschemical substances did not need to be 
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163

3850 included in a given year‘s report. In addition, once a submitter has made a compliance 

3851 determination that it has reporting obligations under the IUR, it can rely on production 

3852 volume information already reasonably available, in the ordinary course of business, to 

3853 determine that particular chemicalschemical substances do not need to be reported under 

3854 the IUR. For this reason, EPA believes it is unreasonable to attribute to the rule the costs 

3855 of tracking, screening, and keeping records of the various production volumes of 

3856 chemicalschemical substances that ultimately are not required to be reported to IUR 

3857 because they are below the reporting threshold.

3858

3859 c. Underlying assumptions and data: baseline costs. Commenters 

3860 questionquestioned the baseline number of reports EPA used in calculating baseline 

3861 costs. One commenter questionsquestioned whether EPA‘s estimate included inorganic

3862 substances. Another commenter questionsquestioned whether EPA has adjusted the 

3863 baseline estimates to account for new manufacturing facilities that never previously 

3864 reported under the IUR rule, the elimination the 300,000 lb. threshold for processing and 

3865 use data, and the change in the method of determining the eligibility to report. 

3866

3867 The 2006 IUR submission data provide the best estimate for the number of reports 

3868 that would be submitted under the baseline scenario. The baseline scenario in the 

3869 Economic Analysis assumes no changes have been made to the 2006 reporting 

3870 requirements. This cost is used as a basis on which to calculate the incremental cost of 

3871 the rule. Therefore, in the baseline, the number of reports should not be adjusted to 

3872 account for any proposed modifications. The Economic Analysis does estimate the 

3873 additional number of Part III reports that will be submitted as a result of today‘sthis final 
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3874 rule amendments, including the elimination of the 300,000 lb. threshold (see Section 

3875 4.4.4 of Ref. 1914), as well as the additional number of reports submitted as a result of 

3876 the change in the method of determining the eligibility to report (see Section 4.4.3 of Ref. 

3877 1914). In addition, the Economic Analysis accounts for rule familiarization costs for any 

3878 new companies submitting data (see Section 4.2.2 of Ref. 1914). The 2006 data do 

3879 include reports for inorganic chemicalschemical substances, because while inorganic 

3880 chemical substance manufacturers were exempt from submitting downstream processing 

3881 and use information in the 2006 reporting cyclesubmission period, they were required to 

3882 submit Parts I and II of Form U, and therefore are included in the baseline number of 

3883 reports. 

3884

3885 GI. Request for Comment on Additional Issues.

3886 EPA requested comment on several additional topics in Unit V of the preamble to 

3887 the proposal, at p. 49676. (Ref. 1). The comment summaries and responses to these issues 

3888 are contained in the ―Summary of EPA‘s Responses to Public Comments Submitted in 

3889 Response to Proposed TSCA Inventory Update Reporting Modifications Rule‖ (Ref 

3890 13document (Ref. 12). 

3891

3892 IV. References

3893 As indicated under ADDRESSES, a docket has been established for this 

3894 rulemaking under docket ID number EPA–HQ–OPPT–2009–0187. The following is a 

3895 listing of the documents that are specifically referenced in this document. The docket 

3896 includes these documents and other information considered by EPA in developing this 

3897 final rule, including documents that are referenced within the documents that are included 
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3898 in the docket, even if the referenced document is not physically located in the docket. 

3899 For assistance in locating these other documents, please consult the technical person 

3900 listed under FOR FURTHER INFORMATION CONTACT.

3901 1. EPA. TSCA Inventory Update Reporting Modifications; Proposed rule. 

3902 Federal Register (75 FR 49656, August 13, 2010) (FRL–8833–5).

3903 2. EPA. Inventory Reporting Regulations; Final rule. Federal Register (42 FR 

3904 64572, December 23, 1977) (FRL–817–1).

3905 23. EPA. Partial Updating of TSCA Inventory Data Base; Production and Site 

3906 Reports; Final rule. Federal Register (51 FR 21438, June 12, 1986) (FRL–2973–3).

3907 34. EPA. TSCA Inventory Update Rule Amendments; Final rule. Federal 

3908 Register (68 FR 848, January 7, 2003) (FRL–6767–4).

3909 45. EPA. OPPT. Enhancing EPA's Chemical Management Program. Available 

3910 on-line at: http//://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html.

3911 5. 6. EPA. TSCA Inventory Reporting Modifications; Submission Period 

3912 Suspension; Final rule. Federal Register (76 FR 27271, May 11, 2011) (FRL–8874–2).

3913 7. EPA. Instructions for 20112012 Inventory Update Reporting, July 2010. May 

3914 2011.

3915 68. EPA. OPPT. IUR Modifications Rule: Development of Definitions for 

3916 Proposed 40 CFR 711.3. July 8, 2010.

3917 79. EPA. TSCA Inventory Update Reporting Revisions; Final rule. Federal 

3918 Register (70 FR 75059, December 19, 2005) (FRL–7743–9).

3919 810. EPA. OPPT. Electronic Signature Agreement. August 2009.
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3920 911. EPA/Environment Canada/Health Canada, Overview of Harmonized U.S.-

3921 Canada Industrial Function and Consumer and Commercial Product Codes for Chemical 

3922 Inventory Reporting. June 2009, Revised November 2009.

3923 1012. EPA. OPPT. Summary of EPA‘s Responses to Public Comments Submitted 

3924 in Response to Proposed TSCA Inventory Update Reporting Modifications Rule. Federal 

3925 Register (75 FR 49656, August 13, 2010) (FRL-8833-5).) .May 2011.

3926 1113. EPA. OPPT. 2006 IUR Database Statistics for the IUR Modifications Rule. 

3927 December 17, 2008. 

3928 14. EPA. OPPT. Economics, Exposure and Technology Division (EETD). 

3929 Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule. 

3930 June, 2011.

3931 15. EPA. Toxic Chemical Release Inventory Reporting Forms and Instructions. 

3932 October 2009. Available online at: http://www.epa.gov/tri/report/rfi/ry2009rfi121709.pdf.

3933 16. EPA. OPPT. EETD. Inventory Update Reporting (IUR) Technical Support 

3934 Document — Replacement of 5–digit NAICS Codes with Industrial Sector (IS) Codes. 

3935 October 2009.

3936 12. EPA. OPPT. Fact Sheet: Recycling and the TSCA Inventory of Chemical 

3937 Substances Premanufacture Notification and Inventory Update Reporting Requirements. 

3938 July 2010.

3939 13. EPA. OPPT. Q&A Document: Recycling and the TSCA Inventory of 

3940 Chemical Substances Premanufacture Notification and Inventory Update Reporting 

3941 Requirements. July 2010.

3942 1417. Environmental Defense Fund, Letter to Docket ID Number EPA-HQ3943 OPPT-2009-0187 (on behalf of 32 organizations), from Richard Denison, PhD, October 

3944 12, 2010.
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3945 18. Proposal for Priority Setting for Existing Substances on the Domestic 

3946 Substances List under the Canadian Environmental Protection Act, 1999. Greatest 

3947 Potential for Human Exposure, Canada, 2003.

3948 1519. EPA. OPPT. Screening-Level Hazard Characterization and Prioritization 

3949 Document. March 2009. Available on-line at: 

3950 http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP

3951 _March%202009.pdf.Available on-line at: 

3952 http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP

3953 _March%202009.pdf.

3954 16. EPA. OPPT. Economics, Exposure and Technology Division (EETD). 

3955 Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications 

3956 Rule. July 20, 2010.

3957 17.20. NOVA Chemicals, Letter to Docket ID No. EPA-HQ-OPPT-2009-0187, 

3958 from Linda Santry. October 7, 2010.

3959 1821. EPA. OPPT. Initial Risk-Based Prioritization of High Production Volume 

3960 (HPV) Chemicals. April 2009. Available on-line at : 

3961 http://www.epa.gov/chemrtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.p

3962 df.

3963 19. Environmental Defense Fund, Letter to Docket # EPA-HQ-OPPT-2009-0187 

3964 (on behalf of 32 organizations), from Richard Denison, PhD, October 12, 2010.

3965 2022. European Commission. REACH. January 2011. Available online at: 

3966 http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm.

3967 23.H.R. Rep. 94-1679, 94th Cong., 2d Sess. (1976), reprinted in Environmental 

3968 and Natural Resources Policy Division of the Library of Congress, 94th Cong. 2d Sess., 
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3969 A Legislative History of the Toxic Substances Control Act, (Com. Print 1976) (―Leg. 

3970 Hist.‖) at 667-721.

3971 24. EPA. Recordkeeping and Reporting Requirements. Final rule/ 

3972 Redesignation. Federal Register (48 FR 23420, May 25, 1983) (FRL-2370-70).

3973 25. EPA. Premanufacture Notification. Premanufacture Notice Requirements 

3974 and Review Procedures. Final Rule and notice form. Federal Register (48 FR 21722, 

3975 May 13, 1983) (FRL 2998-5).

3976 26. EPA. Comprehensive Assessment Information Rule. Final Rule. Federal 

3977 Register (53 FR 51698, December 12, 1988) (FRL-3368-1). 

3978 27. Prenotice Communication Letter from Mary E. Cushmac, EPA, July 29, 1991. 

3979 2128. Letter from Susan Sharkey, EPA, to Robert P. Strieter, The Aluminum 

3980 Association, October 24, 2006. 

3981 22. 29. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC, August 27, 

3982 2008. 

3983 30. EPA. OPPT. Q&A Document: Recycling and the TSCA Chemical Substance 

3984 Inventory- Premanufacture Notification and Inventory Update Reporting Requirements. 

3985 May 2011.

3986 31. EPA Table of Comparison of 2012 v 2006 IUR Definitions, February 9, 2011

3987 32. EPA. Agency Information Collection Activities; Final Collection; Partial 

3988 Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Reports; 

3989 EPA ICR No. 1884.04, OMB Control No. 2070–0162; Notice. Federal Register (73 FR 

3990 51805, September 5, 2008) (FRL–8370–3).

3991 V. Statutory and Executive Order Reviews
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3992

3993 A. Executive Order 12866

3994 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 

3995 51735, October 4, 1993), this action has been designated a ―significant regulatory action‖ 

3996 by the Office of Management and Budget (OMB). Accordingly, EPA submitted this 

3997 action to OMB for review under Executive Order 12866 and any changes made in 

3998 response to OMB recommendations have been documented in the docket for this action.

3999 In addition, EPA has prepared an economic analysis of the potential impacts 

4000 associated with this action. A copy of this economic analysis, entitled, Economic 

4001 Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (Ref. 1914),

4002 is available in the docket and is briefly summarized in this unit. The Agency, in 

4003 promulgating this rule, is required under TSCA to consider the potential costs and 

4004 benefits associated with IUR. The analysis was therefore used by the decision-makers to 

4005 help in the selection of the final rule requirements presented in this document. 

4006

4007 The amendments in this rule affect the number of reports submitted during a 

4008 submission period, the burden to prepare a report, and the reporting frequency. EPA 

4009 estimates that the combined impact of all the amendments will increase the total burden 

4010 and cost to industry associated with IUR reporting.

4011 In its Economic Analysis, EPA estimated industry cost and burden on a per-report 

4012 and a per-site basis and at the industry level. Industry cost and burden are incurred by 

4013 performing activities to comply with the amendments, including compliance 

4014 determination, rule familiarization, preparation and submission of reports, and 

4015 recordkeeping.
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4016 On a per-report basis, EPA estimated incremental increases of 4.280.47 hours and 

4017 $350118 for a site to complete a partial report for one chemical substance and 17.3813.57

4018 hours and $1,408176 to complete a full report for one chemical substance, in the first 

4019 reporting cycle after the effective date of the rule amendments. A partial report includes 

4020 Parts I and II of Form U. A full report includes Parts I, II, and III of Form U. For future 

4021 reporting cycles, EPA estimated incremental increases of 3.282.26 hours and $275212 for 

4022 a site to complete a partial report for one chemical substance and 12.9811.96 hours and

4023 $1,075012 to complete a full report for one chemical substance.

4024 As a result of the amendments, EPA estimates that the average site will submit 

4025 approximately 0.90 and 2.01 fewer partial reports and 2.98 additionalin the first reporting 

4026 cycle and future reporting cycles, respectively. An increase in full reports in a 

4027 submissionper site of 0.89 in the first reporting period. and 2.88 in future reporting 

4028 periods is expected. For the average site, this will increase the burden by 341121 hours 

4029 during the first reporting cycle and 264249 hours for all subsequent reporting cycles. 

4030 EPA estimates that the average site will incur a net cost increase of $22,4939,000 during 

4031 the first reporting cycle and $17,51716,551 during all future reporting cycles.

4032 At the industry level for all sites submitting a Form U, EPA estimates a net total 

4033 burden increase of 1.390.50 million hours in the first reporting cycle, and 1.2114 million 

4034 hours for all subsequent reporting cycles. EPA estimates a net cost increase of 

4035 $91.8736.76 million in the first reporting cycle of the rule, and $79.2975.12 million in all 

4036 subsequent reporting cycles. When the reporting cycle costs are averaged over the four–

4037 year reporting cycle, the average annualized increase in industry cost attributable to the 
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4038 amendments is approximately $21.61 million over a 25–year period (at a 3% discount 

4039 rate).

4040 EPA estimates that the Agency will experience a reduction in both burden and 

4041 cost to administer the IUR rule as a result of the amendments. Specifically, EPA expects 

4042 to experience a net burden reduction of 1,721940 hours in the first reporting cycle and 

4043 all1,678 in subsequent reporting cycles. The Agency estimates it will experience a net 

4044 savings of $179,600approximately $68,000 during eachthe first reporting cycle and 

4045 $175,000 in subsequent reporting cycles. This information will be reflected in the ICR 

4046 that is submitted every three years to OMB under the Paperwork Reduction Act (PRA), 

4047 44 U.S.C. 3501 et seq. 

4048 EPA believes that this final rule represents an appropriate balance between the 

4049 burden placed on industry to provide information and the Agency‘s need for that 

4050 information to fill its statutory obligations and fulfill its mission under TSCA and, as part 

4051 of that mission, to provide information needed by other agencies (OSHA, NIOSH, CPSC, 

4052 etc.). 

4053

4054 B. Paperwork Reduction Act

4055 The information collection requirements in 40 CFR part 710 related to the 

4056 submission of Form Us are already approved by OMB under PRA. That ICR has been 

4057 assigned EPA ICR No. 1884 and OMB control no. 2070–0162. Because this final rule 

4058 involves new or revised information collection activities that require additional OMB 

4059 approval, EPA has prepared an addendum to the currently approved ICR (Ref. 2032). An 

4060 agency may not conduct or sponsor, and a person is not required to respond to an 

4061 information collection request subject to PRA, unless it displays a currently valid OMB 
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4062 control number. The OMB control numbers for EPA‘s regulations are listed in 40 CFR 

4063 part 9 and included on any related collection instrument (e.g., on the form or survey).

4064 Under PRA, the term ―burden‖ is interpreted as the total time, effort, or financial 

4065 resources expended by people to generate, maintain, retain, disclose, or provide 

4066 information to or for a Federal agency. This includes the time needed by regulated 

4067 entities to review instructions and to develop, acquire, install, and use technology and 

4068 systems to collect, validate, verify, and disclose information. Time taken to adjust 

4069 existing ways to comply with any previously applicable instructions and requirements 

4070 and to train personnel to respond to the information collection task is also included. In 

4071 this analysis, total industry burden hours represent the sum of time spent on reporting and 

4072 on other administrative activities. Industry respondents will spend time on the following 

4073 activities associated with the IUR rule: Compliance determination, rule familiarization, 

4074 preparation and submission of reports, and recordkeeping.

4075 As presented in the Economic Analysis (Ref. 1914) and the addendum ICR, (30),

4076 EPA estimates that the final rule would generate a total incremental industry burden of 

4077 1.390.50 million hours in the first reporting cycle. The burden for a site to complete a 

4078 full IUR report for one chemical substance in the first reporting cycle is estimated to be 

4079 140.38136.57 hours, which includesis an incremental burden increase of 17.3813.57

4080 hours over the current estimated burden. The burden for a site to complete a partial IUR 

4081 report for one chemical substance in the first reporting cycle is estimated to be 

4082 57.3653.55 hours, which includesis an incremental burden increase of 5.280.47 hours 

4083 over the current estimated burden. For future reporting cycles, EPA estimates that the 

4084 final rule would create a total incremental industry burden of 1.2114 million hours. The 
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4085 burden to complete a full report is estimated to be 95.0394.01 hours, which is an 

4086 incremental increase of 12.9811.94 hours over the current estimated future burden. The 

4087 burden for a partial report is estimated to be 29.4028.38 hours, which is an incremental 

4088 increase of 3.282.24 hours over the current estimate. 

4089 C. Regulatory Flexibility Act

4090 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 

4091 et seq.), the Agency hereby certifies that this action will not have a significant adverse 

4092 economic impact on a substantial number of small entities. The Agency‘s basis is briefly 

4093 summarized here and is detailed in the Economic Analysis (Ref. 1914).

4094 Under RFA, small entities include small businesses, small organizations, and 

4095 small governmental jurisdictions. For purposes of assessing the impacts of this rule on 

4096 small entities, small entity is defined as:

4097 1. A small business, as defined by the SBA's regulations at 13 CFR 121.201. The 

4098 SBA definitions typically are based upon either a sales or an employment level, 

4099 depending on the nature of the industry. Companies engaged in chemical substance

4100 manufacturing (NAICS Code 325) or petroleum refining (NAICS Code 324110) are the 

4101 most likely to report under the IUR rule. These employee size standards range from 500 

4102 employees to 1,500 employees for NAICS Codes 325 and 324110.

4103 2. A small governmental jurisdiction that is a government of a city, county, town, 

4104 school district, or special district with a population of less than 50,000.

4105 3. A small organization that is any not-for-profit enterprise which is 

4106 independently owned and operated and is not dominant in its field. 
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4107 Since the regulated community does not include small governmental jurisdictions or 

4108 small not-for-profit organizations, the analysis focuses on small businesses.

4109 The existing IUR rule, at 40 CFR 710.5949, generally exempts from reporting 

4110 small businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 

4111 million and less than 100,000 lb. production of any given chemical substance at a site; or 

4112 annual sales of less than $4 million. This exemption is maintained in today‘sthis final 

4113 amendmentsrule. A small business would be required to report under the final rule, 

4114 however, if it produces any chemical substance that is the subject of a regulation 

4115 proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an 

4116 order under TSCA section 5(e), or that is the subject of relief that has been granted 

4117 pursuant to a civil action under TSCA section 5 or 7. (40 CFR 711.9 and TSCA section 

4118 8(a)(3)(A)(ii)). A small business may also report voluntarily.

4119 EPA analyzed potential small business impacts from this final rule using both the 

4120 SBA employee size standards and the TSCA sales-based definition of small business. 

4121 EPA estimates that 466 small firms potentially would be affected by this final rule using 

4122 the employment-based definition, and 280 small firms potentially would be affected 

4123 using the sales-based definition. Based on costs annualized over a four–year period and 

4124 average sales data for the parent companies, EPA estimated that the cost-to-sales ratio of 

4125 the final rule would be less than 0.1% for an average small company subject to the rule. 

4126 For a company to have a cost-to-sales ratio larger than 1%, company sales would have to 

4127 be less than $1.020.81 million. Because the small businesses affected by the final rule 

4128 have average sales of more than $412.7 million under the employment-based definition, 
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4129 and $11.8116 million under the sales-based definition, small entities will not be affected 

4130 by the amendments to the IUR rule at a cost-to-sales ratio of greater than 1% (Ref. 1914).

4131 D. Unfunded Mandates Reform Act

4132 This action does not contain any Federal mandates for State, local, or tribal 

4133 governments or the private sector under the provisions of Title II of the Unfunded 

4134 Mandates Reform Act (UMRA), 2 U.S.C. 1531–1538. EPA has determined that this 

4135 regulatory action will not result in annual expenditures of $100 million or more for State, 

4136 local, and tribal governments, in the aggregate, or for the private sector. The costs 

4137 associated with this action are briefly described in Unit V.A., and is contained in the 

4138 Economic Analysis (Ref. 1914).

4139 Based on EPA's past experience, State, local, and tribal governments have not 

4140 been affected by this reporting requirement, and EPA does not have any reason to believe 

4141 that any State, local, or tribal government will be affected by this final rule. As such, EPA 

4142 has determined that this final rule does not impose any enforceable duty, contain any 

4143 unfunded mandate, or otherwise have any effect on small governments. Accordingly, 

4144 this final rule is not subject to the requirements of sections 202, 203, or 205 of UMRA.

4145 E. Executive Order 13132

4146 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 

4147 10, 1999), EPA has determined that this final rule does not have federalism implications 

4148 because it will not have substantial direct effects on the States, on the relationship 

4149 between the national government and the States, or on the distribution of power and 

4150 responsibilities among the various levels of government, as specified in the Executive 

4151 Order. This final rule simply amends the IUR rule in several ways to provide information 
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4152 to better address Agency and public information needs, improve the usability and 

4153 reliability of the reported data, and ensure that data are available in a timely manner. 

4154 Because EPA has no information to indicate that any State or local government 

4155 manufactures or processes the chemical substances covered by this action, the final rule 

4156 does not apply directly to States and localities and will not affect State and local 

4157 governments. Thus, Executive Order 13132 does not apply to the final rule.

4158 F. Executive Order 13175

4159 As required by Executive Order 13175, entitled Consultation and Coordination 

4160 with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined 

4161 that this final rule does not have tribal implications because it will not have any effect on 

4162 tribal governments, on the relationship between the Federal Government and the Indian 

4163 tribes, or on the distribution of power and responsibilities between the Federal 

4164 Government and Indian tribes, as specified in the Order. Thus, Executive Order 13175 

4165 does not apply to this final rule.

4166 G. Executive Order 13045

4167 EPA interprets Executive Order 13045, entitled Protection of Children from 

4168 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 

4169 only to those regulatory actions that concern health or safety risks, such that the analysis 

4170 required under section 5–501 of Executive Order 13045 has the potential to influence the 

4171 regulation. This action is not subject to Executive Order 13045 because it does not 

4172 establish an environmental standard intended to mitigate health or safety risks. 

4173 Nevertheless, the information obtained by the reporting required by this final rule will be 

4174 used to inform the Agency‘s decision making process regarding chemical substances to 
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4175 which children may be disproportionately exposed. This information will also assist the 

4176 Agency and others in determining whether the chemical substances in this final rule 

4177 present potential risks, allowing the Agency and others to take appropriate action to 

4178 investigate and mitigate those risks.

4179 H. Executive Order 13211

4180 This action is not a ―significant energy action‖ as defined in Executive Order 

4181 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 

4182 Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have a 

4183 significant adverse effect on the supply, distribution, or use of energy as described in the 

4184 Executive Order.

4185 I. National Technology Transfer and Advancement Act

4186 Since this action does not involve any technical standards, section 12(d) of the 

4187 National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 

4188 104–113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

4189 J. Executive Order 12898

4190 The final rule does not have an adverse impact on the environmental and health 

4191 conditions in low-income and minority communities that require special consideration by 

4192 the Agency under Executive Order 12898, entitled Federal Actions to Address 

4193 Environmental Justice in Minority Populations and Low-Income Populations (59 FR 

4194 7629, February 16, 1994). The Agency believes that the information collected under this 

4195 final rule will assist EPA and others in determining the potential hazards and risks 

4196 associated with the chemical substances covered by the rule. Because the IUR rule is an 

4197 information collection requirement, the information that will become available through 
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4198 the rule will enable the Agency to target educational, regulatory, or enforcement activities 

4199 towards industries or chemical substances that pose the greatest risks and/or to target 

4200 programs for geographic areas that are at the highest risk. Thus, the information to be 

4201 gathered under the rule will help EPA make decisions that will benefit potentially at-risk 

4202 communities, some of which may be disadvantaged.

4203 The final rule is directed at manufacturers (including importers) of chemical 

4204 substances. All consumers of these chemical products and all workers who come into 

4205 contact with these chemical substances could benefit if data regarding the chemical 

4206 substances‘ health and environmental effects were developed. Therefore, it does not 

4207 appear that the costs and the benefits of the final rule will be disproportionately 

4208 distributed across different geographic regions or among different categories of 

4209 individuals.

4210 IVV1. Congressional Review Act

4211

4212 The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that 

4213 before a rule may take effect, the agency promulgating the rule must submit a rule report 

4214 to each House of the Congress and the Comptroller General of the United States. EPA 

4215 will submit a report containing this rule and other required information to the U.S. 

4216 Senate, the U.S. House of Representatives, and the Comptroller General of the United 

4217 States prior to publication of the rule in the Federal Register. This rule is not a ―major 

4218 rule‖ as defined by 5 U.S.C. 804(2).

4219

4220 List of Subjects in 40 CFR Parts 704, 710, and 711
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4221 Environmental protection, Chemicals, Confidential Business Information (CBI), 

4222 Hazardous materials, Imports, Reporting and recordkeeping requirements.

4223 Dated: ______________________________________

4224 ________________________________________________

4225 ____________________________________

4226 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

4227

4228 Therefore, 40 CFR chapter I is amended as follows:

4229 PART 704—[AMENDED]

4230 1. The authority citation for part 704 continues to read as follows:

4231 Authority: 15 U.S.C. 2607(a).

4232 § 704.3 [Amended]

4233 2. In § 704.3, remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph 

4234 (1)(ii) of the definition importer.

4235 PART 710—COMPILATION OF THE TSCA CHEMICAL INVENTORY

4236 3. The authority citation for part 710 continues to read as follows:

4237 Authority: 15 U.S.C. 2607(a).

4238 4. Revise the heading for part 710 to read as set forth above.

4239 5. Remove the heading ―Subpart A—General Provisions.‖

4240 6. Revise paragraph (b) of § 710.1 to read as follows:

4241 § 710.1 Scope and compliance.

4242 * * * * *
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4243 (b) This part applies to the activities associated with the compilation of the TSCA 

4244 Chemical Substance Inventory (TSCA Inventory) and the update of information on a 

4245 subset of the chemical substances included on the TSCA Inventory.

4246 * * * * *

4247 7. Section 710.3 is amended as follows:

4248 i. Remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (2) of the definition 

4249 importer.

4250 ii. Remove the definition non-isolated intermediate.

4251 iii. Revise the introductory text of the section to read as follows:

4252 § 710.3 Definitions.

4253 For purposes of this part: 

4254 * * * * *

4255 Subpart B §§ 710.23–710.39 [Removed]

4256 8. Remove subpart B, consisting of §§ 710.23–710.39.

4257 Subpart C §§ 710.43–710.59 [Removed]

4258 9. Remove subpart C, consisting of §§ 710.43–710.59.

4259 10. Add new part 711 to subchapter R to read as follows:

4260 PART 711—TSCA INVENTORY UPDATE REPORTING REQUIREMENTS

4261 Sec.

4262

4263 711.1 Scope and compliance.

4264 711.3 Definitions.

4265 711.5 Chemical substances for which information must be reported.

4266 711.6 Chemical substances for which information is not required.
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4267 711.8 Persons who must report.

4268 711.9 Persons not subject to this part.

4269 711.10 Activities for which reporting is not required.

4270 711.15 Reporting information to EPA.

4271 711.20 When to report.

4272 711.22 Duplicative reporting.

4273 711.25 Recordkeeping requirements.

4274 711.30 Confidentiality claims.

4275 711.35 Electronic filing.

4276

4277 Authority: 15 U.S.C. 2607(a).

4278

4279 § 711.1 Scope and compliance.

4280 (a) This part specifies reporting and recordkeeping procedures under section 8(a) 

4281 of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain 

4282 manufacturers (including importers) of chemical substances. Section 8(a) of TSCA 

4283 authorizes the EPA Administrator to require reporting of information necessary for 

4284 administration of TSCA, including issuing regulations for the purpose of compiling and 

4285 keeping current the TSCA Chemical Substance Inventory (TSCA Inventory) 

4286 manufactured or processed in the United States as required by TSCA section 8(b). In 

4287 accordance with TSCA section 8(b), EPA amends the TSCA Inventory to include new 

4288 chemical substances manufactured (including imported) in the United States and reported 

4289 under TSCA section 5(a)(1). EPA also revises the categories of chemical substances and 

4290 makes other amendments as appropriate.
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4291 (b) This part applies to the activities associated with the periodic update of 

4292 information on a subset of the chemical substances included on the TSCA Inventory.

4293 (c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to 

4294 submit information required under this part. In addition, TSCA section 15(3) makes it 

4295 unlawful for any person to fail to keep, and permit access to, records required by this 

4296 part. Section 16 of TSCA provides that any person who violates a provision of TSCA 

4297 section 15 is liable to the United States for a civil penalty and may be criminally 

4298 prosecuted. Pursuant to TSCA section 17, the Federal Government may seek judicial 

4299 relief to compel submission of TSCA section 8(a) information and to otherwise restrain 

4300 any violation of TSCA section 15. (EPA does not intend to concentrate its enforcement 

4301 efforts on insignificant clerical errors in reporting.)

4302 (d) Each person who reports under this part must maintain records that document 

4303 information reported under this part and, in accordance with TSCA, permit access to, and 

4304 the copying of, such records by EPA officials.

4305 § 711.3 Definitions.

4306 The definitions in this section and the definitions in TSCA section 3 apply to this 

4307 part. In addition, the definitions in 40 CFR 704.3 also apply to this part, except the 

4308 definitions manufacture and manufacturer in 40 CFR 704.3.

4309 CDX or Central Data Exchange means EPA's centralized electronic document 

4310 receiving system, or its successors.

4311 Commercial use means the use of a chemical substance or a mixture containing a 

4312 chemical substance (including as part of an article) in a commercial enterprise providing 

4313 saleable goods or services.
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4314 Consumer use means the use of a chemical substance or a mixture containing a 

4315 chemical substance (including as part of an article) when sold to or made available to 

4316 consumers for their use.

4317 e-IURweb means the electronic, web-based IUR softwaretool provided by EPA 

4318 for the completion and submission of the IUR data.

4319 Industrial function means the intended physical or chemical characteristic for 

4320 which a chemical substance or mixture is consumed as a reactant; incorporated into a 

4321 formulation, mixture, reaction product, or article; repackaged; or used.

4322 Industrial use means use at a site at which one or more chemical substances or 

4323 mixtures are manufactured (including imported) or processed.

4324 Intended for use by children means the chemical substance or mixture is used in 

4325 or on a product that is specifically intended for use by children age 14 or younger. A 

4326 chemical substance or mixture is intended for use by children when the submitter answers 

4327 ―yes‖ to at least one of the following questions for the product into which the submitter's 

4328 chemical substance or mixture is incorporated:

4329 (1) Is the product commonly recognized (i.e., by a reasonable person) as being 

4330 intended for children age 14 or younger?

4331 (2) Does the manufacturer of the product state through product labeling or other 

4332 written materials that the product is intended for or will be used by children age 14 or 

4333 younger?

4334 (3) Is the advertising, promotion, or marketing of the product aimed at children 

4335 age 14 or younger?
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4336 Manufacture means to manufacture, produce, or import, for commercial purposes. 

4337 Manufacture includes the extraction, for commercial purposes, of a component chemical 

4338 substance from a previously existing chemical substance or complex combination of 

4339 chemical substances. When a chemical substance, manufactured other than by import, 

4340 is:

4341 (1) Produced exclusively for another person who contracts for such production, 

4342 and

4343 (2) that other person specifies the identity of the chemical substance and controls 

4344 the total amount produced and the basic technology for the plant process, then that 

4345 chemical substance is co-manufactured by the producing manufacturer and the person 

4346 contracting for such production.

4347 Manufacturer means a person who manufactures a chemical substance.

4348 Master Inventory File means EPA's comprehensive list of chemical substances 

4349 which constitutes the TSCA Inventory compiled under TSCA section 8(b). It includes 

4350 chemical substances reported under 40 CFR part 710 and substances reported under 40 

4351 CFR part 720 for which a Notice of Commencement of Manufacture or Import has been 

4352 received under 40 CFR 720.120.

4353 Principal reporting year means the latest complete calendar year preceding the 

4354 submission period.

4355 Reasonably likely to be exposed means an exposure to a chemical substance 

4356 which, under foreseeable conditions of manufacture (including import), processing, 

4357 distribution in commerce, or use of the chemical substance, is more likely to occur than 

4358 not to occur. Such exposures would normally include, but would not be limited to, 
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4359 activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, 

4360 maintenance operations, materials handling and transfers, and analytical operations. 

4361 Covered exposures include exposures through any route of entry (inhalation, ingestion, 

4362 skin contact, absorption, etc.), but excludes accidental or theoretical exposures.

4363 Repackaging means the physical transfer of a chemical substance or mixture, as 

4364 is, from one container to another container or containers in preparation for distribution of 

4365 the chemical substance or mixture in commerce.

4366 Reportable chemical substance means a chemical substance described in § 711.5.

4367 Site means a contiguous property unit. Property divided only by a public right-of4368 way shall be considered one site. More than one manufacturing plant may be located on a 

4369 single site.

4370 (1) For chemical substances manufactured under contract, i.e., by a toll 

4371 manufacturer, the site is the location where the chemical substance is physically 

4372 manufactured.

4373 (2) The site for an importer who imports a chemical substance described in §

4374 711.5 is the U.S. site of the operating unit within the person's organization that is directly 

4375 responsible for importing the chemical substance. The import site, in some cases, may be 

4376 the organization's headquarters in the United States. If there is no such operating unit or 

4377 headquarters in the United States, the site address for the importer is the U.S. address of 

4378 an agent acting on behalf of the importer who is authorized to accept service of process 

4379 for the importer.

4380 (3) For portable manufacturing units sent to different locations from a single 

4381 distribution center, the distribution center shall be considered the site.
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4382 Site-limited means a chemical substance is manufactured and processed only 

4383 within a site and is not distributed for commercial purposes as a chemical substance or as 

4384 part of a mixture or article outside the site. Imported chemical substances are never site4385 limited. Although a site-limited chemical substance is not distributed for commercial 

4386 purposes outside the site at which it is manufactured and processed, the chemical 

4387 substance is considered to have been manufactured and processed for commercial 

4388 purposes.

4389 Submission period means the period in which the manufacturing, processing, and 

4390 use data are submitted to EPA.

4391 Use means any utilization of a chemical substance or mixture that is not otherwise 

4392 covered by the terms manufacture or process. Relabeling or redistributing a container 

4393 holding a chemical substance or mixture where no repackaging of the chemical substance 

4394 or mixture occurs does not constitute use or processing of the chemical substance or 

4395 mixture.

4396 U.S. parent company means the highest level company, located in the United 

4397 States, that directly owns at least 50 percent of the voting stock of the manufacturer.

4398 § 711.5 Chemical substances for which information must be reported.

4399 Any chemical substance that is in the Master Inventory File at the beginning of a 

4400 submission period described in § 711.20, unless the chemical substance is specifically 

4401 excluded by § 711.6.

4402 § 711.6 Chemical substances for which information is not required.

4403 The following groups or categories of chemical substances are exempted from 

4404 some or all of the reporting requirements of this part, with the following exception: A 
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4405 chemical substance described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is 

4406 not exempted from any of the reporting requirements of this part if that chemical 

4407 substance is the subject of a rule proposed or promulgated under TSCA section 4, 5(a)(2), 

4408 5(b)(4), or 6, or is the subject of aan enforceable consent agreement (ECA) developed 

4409 under the procedures of 40 CFR part 790, or is the subject of an order issued under TSCA 

4410 section 5(e) or 5(f), or is the subject of relief that has been granted under a civil action 

4411 under TSCA section 5 or 7.

4412 (a) Full exemptions. The following categories of chemical substances are 

4413 exempted from the reporting requirements of this part.

4414 (1) Polymers—(i) Any chemical substance described with the word fragments 

4415 ―*polym,‖ ―*alkyd,‖ or ―*oxylated‖ in the Chemical Abstracts (CA) Index Name in the 

4416 Master Inventory File, where the asterisk (*) in the listed word fragments indicates that 

4417 any sets of characters may precede, or follow, the character string defined.

4418 (ii) Any chemical substance that is identified in the Master Inventory File as 

4419 siloxane and silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, 

4420 hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), rubber, or lignin.

4421 (iii) This exclusion does not apply to a polymeric substance that has been 

4422 hydrolyzed, depolymerized, or otherwise chemically modified, except in cases where the 

4423 intended product of this reaction is totally polymeric in structure.

4424 (2) Microorganisms. Any combination of chemical substances that is a living 

4425 organism, and that meets the definition of ―microorganism‖ at 40 CFR 725.3. Any 

4426 chemical substance produced from a living microorganism is reportable under this part

4427 unless otherwise excluded.
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4428 (3) Naturally occurring chemical substances. Any naturally occurring chemical 

4429 substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is 

4430 determined in each case by the specific activities of the person who manufactures the 

4431 chemical substance in question. Some chemical substances can be manufactured both as 

4432 described in 40 CFR 710.4(b) and by means other than those described in 40 CFR 

4433 710.4(b). If a person described in § 711.8 manufactures a chemical substance by means 

4434 other than those described in 40 CFR 710.4(b), the person must report regardless of 

4435 whether the chemical substance also could have been produced as described in 40 CFR 

4436 710.4(b). Any chemical substance that is produced from such a naturally occurring 

4437 chemical substance described in 40 CFR 710.4(b) is reportable unless otherwise 

4438 excluded.

4439 (4) Certain forms of natural gas and water. Chemical substances with the 

4440 following CASRN: CASRN 64741–48–6, natural gas (petroleum), raw liq. mix; CASRN 

4441 68919–39–1, natural gas condensates; CASRN 8006–61–9, gasoline, natural; CASRN 

4442 68425–31–0, gasoline (natural gas), natural; CASRN 8006–14–2, natural gas; CASRN 

4443 68410–63–9, natural gas, dried; and CASRN 7732–18–5, water.

4444 (b) Partial exemptions. The following groups of chemical substances are partially 

4445 exempted from the reporting requirements of this part (i.e., the information described in §

4446 711.15(b)(4) need not be reported for these chemical substances). Such chemical 

4447 substances are not excluded from the other reporting requirements under this part.

4448 (1) Petroleum process streams. EPA has designated the chemical substances 

4449 listed in Table 1 of this paragraph by CASRN, as partially exempt from reporting under 

4450 the IUR.
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

189

4451 Table 1.—CAS Registry NumbersCASRNs of Partially Exempt Chemical 

4452 Substances Termed ―Petroleum Process Streams‖ for Purposes of Inventory Update 

4453 Reporting

CASRN Product

8002–05–9 Petroleum

8002–74–2 Paraffin waxes and hydrocarbon waxes

8006–20–0 Fuel gases, low and medium B.T.U.

8008–20–6 Kerosine (petroleum)

8009–03–8 Petrolatum

8012–95–1 Paraffin oils

8030–30–6 Naphtha

8032–32–4 Ligroine

8042–47–5 White mineral oil (petroleum)

8052–41–3 Stoddard solvent

8052–42–4 Asphalt

61789–60–4 Pitch

63231–60–7 Paraffin waxes and hydrocarbon waxes, microcryst.

64741–41–9 Naphtha (petroleum), heavy straight-run

64741–42–0 Naphtha (petroleum), full-range straight-run

64741–43–1 Gas oils (petroleum), straight-run

64741–44–2 Distillates (petroleum), straight-run middle

64741–45–3 Residues (petroleum), atm. towerTower

64741–46–4 Naphtha (petroleum), light straight-run

64741–47–5 Natural gas condensates (petroleum)

64741–49–7 Condensates (petroleum), vacuum tower

64741–50–0 Distillates (petroleum), light paraffinic

64741–51–1 Distillates (petroleum), heavy paraffinic

64741–52–2 Distillates (petroleum), light naphthenic

64741–53–3 Distillates (petroleum), heavy naphthenic

64741–54–4 Naphtha (petroleum), heavy catalytic cracked

64741–55–5 Naphtha (petroleum), light catalytic cracked

64741–56–6 Residues (petroleum), vacuum

64741–57–7 Gas oils (petroleum), heavy vacuum

64741–58–8 Gas oils (petroleum), light vacuum

64741–59–9 Distillates (petroleum), light catalytic cracked

64741–60–2 Distillates (petroleum), intermediate catalytic cracked

64741–61–3 Distillates (petroleum), heavy catalytic cracked

64741–62–4 Clarified oils (petroleum), catalytic cracked

64741–63–5 Naphtha (petroleum), light catalytic reformed

64741–64–6 Naphtha (petroleum), full-range alkylate

64741–65–7 Naphtha (petroleum), heavy alkylate

64741–66–8 Naphtha (petroleum), light alkylate

64741–67–9 Residues (petroleum), catalytic reformer fractionator

64741–68–0 Naphtha (petroleum), heavy catalytic reformed

64741–69–1 Naphtha (petroleum), light hydrocracked
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

190

64741–70–4 Naphtha (petroleum), isomerization

64741–73–7 Distillates (petroleum), alkylate

64741–74–8 Naphtha (petroleum), light thermal cracked

64741–75–9 Residues (petroleum), hydrocracked

64741–76–0 Distillates (petroleum), heavy hydrocracked

64741–77–1 Distillates (petroleum), light hydrocracked

64741–78–2 Naphtha (petroleum), heavy hydrocracked

64741–79–3 Coke (petroleum)

64741–80–6 Residues (petroleum), thermal cracked

64741–81–7 Distillates (petroleum), heavy thermal cracked

64741–82–8 Distillates (petroleum), light thermal cracked

64741–83–9 Naphtha (petroleum), heavy thermal cracked

64741–84–0 Naphtha (petroleum), solvent-refined light

64741–85–1 Raffinates (petroleum), sorption process

64741–86–2 Distillates (petroleum), sweetened middle

64741–87–3 Naphtha (petroleum), sweetened

64741–88–4 Distillates (petroleum), solvent-refined heavy paraffinic

64741–89–5 Distillates (petroleum), solvent-refined light paraffinic

64741–90–8 Gas oils (petroleum), solvent-refined

64741–91–9 Distillates (petroleum), solvent-refined middle

64741–92–0 Naphtha (petroleum), solvent-refined heavy

64741–95–3 Residual oils (petroleum), solvent deasphalted

64741–96–4 Distillates (petroleum), solvent-refined heavy naphthenic

64741–97–5 Distillates (petroleum), solvent-refined light naphthenic

64741–98–6 Extracts (petroleum), heavy naphtha solvent

64741–99–7 Extracts (petroleum), light naphtha solvent

64742–01–4 Residual oils (petroleum), solvent-refined

64742–03–6 Extracts (petroleum), light naphthenic distillate solvent

64742–04–7 Extracts (petroleum), heavy paraffinic distillate solvent

64742–05–8 Extracts (petroleum), light paraffinic distillate solvent

64742–06–9 Extracts (petroleum), middle distillate solvent

64742–07–0 Raffinates (petroleum), residual oil decarbonization

64742–08–1 Raffinates (petroleum), heavy naphthenic distillate decarbonization

64742–09–2 Raffinates (petroleum), heavy paraffinic distillate decarbonization

64742–10–5 Extracts (petroleum), residual oil solvent

64742–11–6 Extracts (petroleum), heavy naphthenic distillate solvent

64742–12–7 Gas oils (petroleum), acid-treated

64742–13–8 Distillates (petroleum), acid-treated middle

64742–14–9 Distillates (petroleum), acid-treated light

64742–15–0 Naphtha (petroleum), acid-treated

64742–16–1 Petroleum resins

64742–18–3 Distillates (petroleum), acid-treated heavy naphthenic

64742–19–4 Distillates (petroleum), acid-treated light naphthenic

64742–20–7 Distillates (petroleum), acid-treated heavy paraffinic

64742–21–8 Distillates (petroleum), acid-treated light paraffinic
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

191

64742–22–9 Naphtha (petroleum), chemically neutralized heavy

64742–23–0 Naphtha (petroleum), chemically neutralized light

64742–24–1 Sludges (petroleum), acid

64742–25–2 Lubricating oils (petroleum), acid-treated spent

64742–26–3 Hydrocarbon waxes (petroleum), acid-treated

64742–27–4 Distillates (petroleum), chemically neutralized heavy paraffinic

64742–28–5 Distillates (petroleum), chemically neutralized light paraffinic

64742–29–6 Gas oils (petroleum), chemically neutralized

64742–30–9 Distillates (petroleum), chemically neutralized middle

64742–31–0 Distillates (petroleum), chemically neutralized light

64742–32–1 Lubricating oils (petroleum), chemically neutralized spent

64742–33–2 Hydrocarbon waxes (petroleum), chemically neutralized

64742–34–3 Distillates (petroleum), chemically neutralized heavy naphthenic

64742–35–4 Distillates (petroleum), chemically neutralized light naphthenic

64742–36–5 Distillates (petroleum), clay-treated heavy paraffinic

64742–37–6 Distillates (petroleum), clay-treated light paraffinic

64742–38–7 Distillates (petroleum), clay-treated middle

64742–39–8 Neutralizing agents (petroleum), spent sodium carbonate

64742–40–1 Neutralizing agents (petroleum), spent sodium hydroxide

64742–41–2 Residual oils (petroleum), clay-treated

64742–42–3 Hydrocarbon waxes (petroleum), clay-treated microcryst.

64742–43–4 Paraffin waxes (petroleum), clay-treated

64742–44–5 Distillates (petroleum), clay-treated heavy naphthenic

64742–45–6 Distillates (petroleum), clay-treated light naphthenic

64742–46–7 Distillates (petroleum), hydrotreated middle

64742–47–8 Distillates (petroleum), hydrotreated light

64742–48–9 Naphtha (petroleum), hydrotreated heavy

64742–49–0 Naphtha (petroleum), hydrotreated light

64742–50–3 Lubricating oils (petroleum), clay-treated spent

64742–51–4 Paraffin waxes (petroleum), hydrotreated

64742–52–5 Distillates (petroleum), hydrotreated heavy naphthenic

64742–53–6 Distillates (petroleum), hydrotreated light naphthenic

64742–54–7 Distillates (petroleum), hydrotreated heavy paraffinic

64742–55–8 Distillates (petroleum), hydrotreated light paraffinic

64742–56–9 Distillates (petroleum), solvent-dewaxed light paraffinic

64742–57–0 Residual oils (petroleum), hydrotreated

64742–58–1 Lubricating oils (petroleum), hydrotreated spent

64742–59–2 Gas oils (petroleum), hydrotreated vacuum

64742–60–5 Hydrocarbon waxes (petroleum), hydrotreated microcryst.

64742–61–6 Slack wax (petroleum)

64742–62–7 Residual oils (petroleum), solvent-dewaxed

64742–63–8 Distillates (petroleum), solvent-dewaxed heavy naphthenic

64742–64–9 Distillates (petroleum), solvent-dewaxed light naphthenic

64742–65–0 Distillates (petroleum), solvent-dewaxed heavy paraffinic

64742–67–2 Foots oil (petroleum)
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

192

64742–68–3 Naphthenic oils (petroleum), catalytic dewaxed heavy

64742–69–4 Naphthenic oils (petroleum), catalytic dewaxed light

64742–70–7 Paraffin oils (petroleum), catalytic dewaxed heavy

64742–71–8 Paraffin oils (petroleum), catalytic dewaxed light

64742–72–9 Distillates (petroleum), catalytic dewaxed middle

64742–73–0 Naphtha (petroleum), hydrodesulfurized light

64742–75–2 Naphthenic oils (petroleum), complex dewaxed heavy

64742–76–3 Naphthenic oils (petroleum), complex dewaxed light

64742–78–5 Residues (petroleum), hydrodesulfurized atmospheric tower

64742–79–6 Gas oils (petroleum), hydrodesulfurized

64742–80–9 Distillates (petroleum), hydrodesulfurized middle

64742–81–0 Kerosine (petroleum), hydrodesulfurized

64742–82–1 Naphtha (petroleum), hydrodesulfurized heavy

64742–83–2 Naphtha (petroleum), light steam-cracked

64742–85–4 Residues (petroleum), hydrodesulfurized vacuum

64742–86–5 Gas oils (petroleum), hydrodesulfurized heavy vacuum

64742–87–6 Gas oils (petroleum), hydrodesulfurized light vacuum

64742–88–7 Solvent naphtha (petroleum), medium aliph.

64742–89–8 Solvent naphtha (petroleum), light aliph.

64742–90–1 Residues (petroleum), steam-cracked

64742–91–2 Distillates (petroleum), steam-cracked

64742–92–3 Petroleum resins, oxidized

64742–93–4 Asphalt, oxidized

64742–94–5 Solvent naphtha (petroleum), heavy arom.

64742–95–6 Solvent naphtha (petroleum), light arom.

64742–96–7 Solvent naphtha (petroleum), heavy aliph.

64742–97–8 Distillates (petroleum), oxidized heavy

64742–98–9 Distillates (petroleum), oxidized light

64742–99–0 Residual oils (petroleum), oxidized

64743–00–6 Hydrocarbon waxes (petroleum), oxidized

64743–01–7 Petrolatum (petroleum), oxidized

64743–02–8 Alkenes, C>10 .alpha.-

64743–03–9 Phenols (petroleum)

64743–04–0 Coke (petroleum), recovery

64743–05–1 Coke (petroleum), calcined

64743–06–2 Extracts (petroleum), gas oil solvent

64743–07–3 Sludges (petroleum), chemically neutralized

64754–89–8 Naphthenic acids (petroleum), crude

64771–71–7 Paraffins (petroleum), normal C>10

64771–72–8 Paraffins (petroleum), normal C5-20

67254–74–4 Naphthenic oils

67674–12–8 Residual oils (petroleum), oxidized, compounds with triethanolamine

67674–13–9 Petrolatum (petroleum), oxidized, partially deacidified

67674–15–1 Petrolatum (petroleum), oxidized, Me ester

67674–16–2 Hydrocarbon waxes (petroleum), oxidized, partially deacidified
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

193

67674–17–3 Distillates (petroleum), oxidized light, compounds with triethanolamine

67674–18–4 Distillates (petroleum), oxidized light, Bu esters

67891–79–6 Distillates (petroleum), heavy arom.

67891–80–9 Distillates (petroleum), light arom.

67891–81–0 Distillates (petroleum), oxidized light, potassium salts

67891–82–1 Hydrocarbon waxes (petroleum), oxidized, compounds with 

ethanolamine

67891–83–2 Hydrocarbon waxes (petroleum), oxidized, compounds with 

isopropanolamine

67891–85–4 Hydrocarbon waxes (petroleum), oxidized, compounds with 

triisopropanolamine

67891–86–5 Hydrocarbon waxes (petroleum), oxidized, compds. with 

diisopropanolamine

68131–05–5 Hydrocarbon oils, process blends

68131–49–7 Aromatic hydrocarbons, C6-10, acid-treated, neutralized

68131–75–9 Gases (petroleum), C3-4

68153–22–0 Paraffin waxes and Hydrocarbon waxes, oxidized

68187–57–5 Pitch, coal tar-petroleum

68187–58–6 Pitch, petroleum, arom.

68187–60–0 Hydrocarbons, C4, ethane-propane-cracked

68307–98–2 Tail gas (petroleum), catalytic cracked distillate and catalytic cracked 

naphtha fractionation absorber

68307–99–3 Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer

68308–00–9 Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, 

hydrogen sulfide-free

68308–01–0 Tail gas (petroleum), cracked distillate hydrotreater stripper

68308–02–1 Tail gas (petroleum), distn., hydrogen sulfide-free

68308–03–2 Tail gas (petroleum), gas oil catalytic cracking absorber

68308–04–3 Tail gas (petroleum), gas recovery plant

68308–05–4 Tail gas (petroleum), gas recovery plant deethanizer

68308–06–5 Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized 

naphtha fractionator, acid-free

68308–07–6 Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, 

hydrogen sulfide-free

68308–08–7 Tail gas (petroleum), isomerized naphtha fractionation stabilizer

68308–09–8 Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen 

sulfide-free

68308–10–1 Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen 

sulfide-free

68308–11–2 Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer

68308–12–3 Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen 

sulfide-free

68308–27–0 Fuel gases, refinery

68333–22–2 Residues (petroleum), atmospheric

68333–23–3 Naphtha (petroleum), heavy coker
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

194

68333–24–4 Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine

68333–25–5 Distillates (petroleum), hydrodesulfurized light catalytic cracked

68333–26–6 Clarified oils (petroleum), hydrodesulfurized catalytic cracked

68333–27–7 Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked

68333–28–8 Distillates (petroleum), hydrodesulfurized heavy catalytic cracked

68333–29–9 Residues (petroleum), light naphtha solvent extracts

68333–30–2 Distillates (petroleum), oxidized heavy thermal cracked

68333–81–3 Alkanes, C4-12

68333–88–0 Aromatic hydrocarbons, C9-17

68334–30–5 Fuels, diesel

68409–99–4 Gases (petroleum), catalytic cracked overheads

68410–00–4 Distillates (petroleum), crude oil

68410–05–9 Distillates (petroleum), straight-run light

68410–12–8 Distillates (petroleum), steam-cracked, C5-10 fraction, high-temp. 

stripping products with light steam-cracked petroleum naphtha C5 

fraction polymers

68410–71–9 Raffinates (petroleum), catalytic reformer ethylene glycol-water 

countercurrent exts.

68410–96–8 Distillates (petroleum), hydrotreated middle, intermediate boiling

68410–97–9 Distillates (petroleum), light distillate hydrotreating process, low-boiling

68410–98–0 Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer 

overheads

68411–00–7 Alkenes, C>8

68425–29–6 Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasolineblending

68425–33–2 Petrolatum (petroleum), oxidized, barium salt

68425–34–3 Petrolatum (petroleum), oxidized, calcium salt

68425–35–4 Raffinates (petroleum), reformer, Lurgi unit-sepd.

68425–39–8 Alkenes, C>10 .alpha.-, oxidized

68441–09–8 Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. 

polyethylene, oxidized

68459–78–9 Alkenes, C18-24 .alpha.-, dimers

68475–57–0 Alkanes, C1-2

68475–58–1 Alkanes, C2-3

68475–59–2 Alkanes, C3-4

68475–60–5 Alkanes, C4-5

68475–61–6 Alkenes, C5, naphtha-raffinate pyrolyzate-derived

68475–70–7 Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived

68475–79–6 Distillates (petroleum), catalytic reformed depentanizer

68475–80–9 Distillates (petroleum), light steam-cracked naphtha

68476–26–6 Fuel gases

68476–27–7 Fuel gases, amine system residues

68476–28–8 Fuel gases, C6-8 catalytic reformer

68476–29–9 Fuel gases, crude oil distillates

68476–30–2 Fuel oil, no. 2
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

195

68476–31–3 Fuel oil, no. 4

68476–32–4 Fuel oil, residues-straight-run gas oils, high-sulfur

68476–33–5 Fuel oil, residual

68476–34–6 Fuels, diesel, no. 2

68476–39–1 Hydrocarbons, aliph.-arom.-C4-5-olefinic

68476–40–4 Hydrocarbons, C3-4

68476–42–6 Hydrocarbons, C4-5

68476–43–7 Hydrocarbons, C4-6, C5-rich

68476–44–8 Hydrocarbons, C>3

68476–45–9 Hydrocarbons, C5-10 arom. conc., ethylene-manuf.-by-product

68476–46–0 Hydrocarbons, C3-11, catalytic cracker distillates

68476–47–1 Hydrocarbons, C2-6, C6-8 catalytic reformer

68476–49–3 Hydrocarbons, C2-4, C3-rich

68476–50–6 Hydrocarbons, C≥5, C5-6-rich

68476–52–8 Hydrocarbons, C4, ethylene-manuf.-by-product

68476–53–9 Hydrocarbons, C≥20, petroleum wastes

68476–54–0 Hydrocarbons, C3-5, polymn. unit feed

68476–55–1 Hydrocarbons, C5-rich

68476–56–2 Hydrocarbons, cyclic C5 and C6

68476–77–7 Lubricating oils, refined used

68476–81–3 Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts

68476–84–6 Petroleum products, gases, inorg.

68476–85–7 Petroleum gases, liquefied

68476–86–8 Petroleum gases, liquefied, sweetened

68477–25–8 Waste gases, vent gas, C1-6

68477–26–9 Wastes, petroleum

68477–29–2 Distillates (petroleum), catalytic reformer fractionator residue, highboiling

68477–30–5 Distillates (petroleum), catalytic reformer fractionator residue, 

intermediate-boiling

68477–31–6 Distillates (petroleum), catalytic reformer fractionator residue, lowboiling

68477–33–8 Gases (petroleum), C3-4, isobutane-rich

68477–34–9 Distillates (petroleum), C3-5, 2-methyl-2-butene-rich

68477–35–0 Distillates (petroleum), C3-6, piperylene-rich

68477–36–1 Distillates (petroleum), cracked steam-cracked, C5-18 fraction

68477–38–3 Distillates (petroleum), cracked steam-cracked petroleum distillates

68477–39–4 Distillates (petroleum), cracked stripped steam-cracked petroleum 

distillates, C8-10 fraction

68477–40–7 Distillates (petroleum), cracked stripped steam-cracked petroleum 

distillates, C10-12 fraction

68477–41–8 Gases (petroleum), extractive, C3-5, butadiene-butene-rich

68477–42–9 Gases (petroleum), extractive, C3-5, butene-isobutylene-rich

68477–44–1 Distillates (petroleum), heavy naphthenic, mixed with steam-cracked 

petroleum distillates C5-12 fraction
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

196

68477–47–4 Distillates (petroleum), mixed heavy olefin vacuum, heart-cut

68477–48–5 Distillates (petroleum), mixed heavy olefin vacuum, low-boiling

68477–53–2 Distillates (petroleum), steam-cracked, C5-12 fraction

68477–54–3 Distillates (petroleum), steam-cracked, C8-12 fraction

68477–55–4 Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light 

steam-cracked petroleum naphtha C5 fraction

68477–58–7 Distillates (petroleum), steam-cracked petroleum distillates, C5-18 

fraction

68477–59–8 Distillates (petroleum), steam-cracked petroleum distillates 

cyclopentadiene conc.

68477–60–1 Extracts (petroleum), cold-acid

68477–61–2 Extracts (petroleum), cold-acid, C4-6

68477–62–3 Extracts (petroleum), cold-acid, C3-5, butene-rich

68477–63–4 Extracts (petroleum), reformer recycle

68477–64–5 Gases (petroleum), acetylene manuf. off

68477–65–6 Gases (petroleum), amine system feed

68477–66–7 Gases (petroleum), benzene unit hydrodesulfurizer off

68477–67–8 Gases (petroleum), benzene unit recycle, hydrogen-rich

68477–68–9 Gases (petroleum), blend oil, hydrogen-nitrogen-rich

68477–69–0 Gases (petroleum), butane splitter overheads

68477–70–3 Gases (petroleum), C2-3

68477–71–4 Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-

rich acid-free

68477–72–5 Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3-5-

rich

68477–73–6 Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-

rich acid-free

68477–74–7 Gases (petroleum), catalytic cracker

68477–75–8 Gases (petroleum), catalytic cracker, C1-5-rich

68477–76–9 Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2-4-

rich

68477–77–0 Gases (petroleum), catalytic reformed naphtha stripper overheads

68477–79–2 Gases (petroleum), catalytic reformer, C1-4-rich

68477–80–5 Gases (petroleum), C6-8 catalytic reformer recycle

68477–81–6 Gases (petroleum), C6-8 catalytic reformer

68477–82–7 Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich

68477–83–8 Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed

68477–84–9 Gases (petroleum), C2-return stream

68477–85–0 Gases (petroleum), C4-rich

68477–86–1 Gases (petroleum), deethanizer overheads

68477–87–2 Gases (petroleum), deisobutanizer tower overheads

68477–88–3 Gases (petroleum), deethanizer overheads, C3-rich

68477–89–4 Distillates (petroleum), depentanizer overheads

68477–90–7 Gases (petroleum), depropanizer dry, propene-rich

68477–91–8 Gases (petroleum), depropanizer overheads
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

197

68477–92–9 Gases (petroleum), dry sour, gas-concn.-unit-off

68477–93–0 Gases (petroleum), gas concn. reabsorber distn.

68477–94–1 Gases (petroleum), gas recovery plant depropanizer overheads

68477–95–2 Gases (petroleum), Girbatol unit feed

68477–96–3 Gases (petroleum), hydrogen absorber off

68477–97–4 Gases (petroleum), hydrogen-rich

68477–98–5 Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen rich

68477–99–6 Gases (petroleum), isomerized naphtha fractionater, C4-rich, hydrogen 

sulfide- free

68478–00–2 Gases (petroleum), recycle, hydrogen-rich

68478–01–3 Gases (petroleum), reformer make-up, hydrogen-rich

68478–02–4 Gases (petroleum), reforming hydrotreater

68478–03–5 Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich

68478–04–6 Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich

68478–05–7 Gases (petroleum), thermal cracking distn.

68478–08–0 Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc.

68478–10–4 Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-

cycloalkadiene conc.

68478–12–6 Residues (petroleum), butane splitter bottoms

68478–13–7 Residues (petroleum), catalytic reformer fractionator residue distn.

68478–15–9 Residues (petroleum), C6-8 catalytic reformer

68478–16–0 Residual oils (petroleum), deisobutanizer tower

68478–17–1 Residues (petroleum), heavy coker gas oil and vacuum gas oil

68478–18–2 Residues (petroleum), heavy olefin vacuum

68478–19–3 Residual oils (petroleum), propene purifn. splitter

68478–20–6 Residues (petroleum), steam-cracked petroleum distillates 

cyclopentadiene conc., C4-cyclopentadiene-free

68478–22–8 Tail gas (petroleum), catalytic cracked naphtha stabilization absorber

68478–24–0 Tail gas (petroleum), catalytic cracker, catalytic reformer and 

hydrodesulfurizer combined fractionater

68478–25–1 Tail gas (petroleum), catalytic cracker refractionation absorber

68478–26–2 Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer

68478–27–3 Tail gas (petroleum), catalytic reformed naphtha separator

68478–28–4 Tail gas (petroleum), catalytic reformed naphtha stabilizer

68478–29–5 Tail gas (petroleum), cracked distillate hydrotreater separator

68478–30–8 Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator

68478–31–9 Tail gas (petroleum), isomerized naphtha fractionates, hydrogen sulfidefree

68478–32–0 Tail gas (petroleum), saturate gas plant mixed stream, C4-rich

68478–33–1 Tail gas (petroleum), saturate gas recovery plant, C1-2-rich

68478–34–2 Tail gas (petroleum), vacuum residues thermal cracker

68512–61–8 Residues (petroleum), heavy coker and light vacuum

68512–62–9 Residues (petroleum), light vacuum

68512–78–7 Solvent naphtha (petroleum), light arom., hydrotreated

68512–91–4 Hydrocarbons, C3-4-rich, petroleum distillates
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

198

68513–02–0 Naphtha (petroleum), full-range coker

68513–03–1 Naphtha (petroleum), light catalytic reformed, arom.-free

68513–11–1 Fuel gases, hydrotreater fractionation, scrubbed

68513–12–2 Fuel gases, saturate gas unit fractionater-absorber overheads

68513–13–3 Fuel gases, thermal cracked catalytic cracking residue

68513–14–4 Gases (petroleum), catalytic reformed straight-run naphtha stabilizer 

overheads

68513–15–5 Gases (petroleum), full-range straight-run naphtha dehexanizer off

68513–16–6 Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich

68513–17–7 Gases (petroleum), light straight-run naphtha stabilizer off

68513–18–8 Gases (petroleum), reformer effluent high-pressure flash drum off

68513–19–9 Gases (petroleum), reformer effluent low-pressure flash drum off

68513–62–2 Disulfides, C5-12-alkyl

68513–63–3 Distillates (petroleum), catalytic reformed straight-run naphtha overheads

68513–65–5 Butane, branched and linear

68513–66–6 Residues (petroleum), alkylation splitter, C4-rich

68513–67–7 Residues (petroleum), cyclooctadiene bottoms

68513–68–8 Residues (petroleum), deethanizer tower

68513–69–9 Residues (petroleum), steam-cracked light

68513–74–6 Waste gases, ethylene oxide absorber-reactor

68514–15–8 Gasoline, vapor-recovery

68514–29–4 Hydrocarbons, amylene feed debutanizer overheads non-extractable 

raffinates

68514–31–8 Hydrocarbons, C1-4

68514–32–9 Hydrocarbons, C10 and C12, olefin-rich

68514–33–0 Hydrocarbons, C12 and C14, olefin-rich

68514–34–1 Hydrocarbons, C9-14, ethylene-manuf.-by-product

68514–35–2 Hydrocarbons, C14-30, olefin-rich

68514–36–3 Hydrocarbons, C1-4, sweetened

68514–37–4 Hydrocarbons, C4-5-unsatd.

68514–38–5 Hydrocarbons, C4-10-unsatd.

68514–39–6 Naphtha (petroleum), light steam-cracked, isoprene-rich

68514–79–4 Petroleum products, hydrofiner-powerformer reformates

68515–25–3 Benzene, C1-9-alkyl derivs.

68515–26–4 Benzene, di-C12-14-alkyl derivs.

68515–27–5 Benzene, di-C10-14-alkyl derivs., fractionation overheads, heavy ends

68515–28–6 Benzene, di-C10-14-alkyl derivs., fractionation overheads, light ends

68515–29–7 Benzene, di-C10-14-alkyl derivs., fractionation overheads, middle cut

68515–30–0 Benzene, mono-C20-48-alkyl derivs.

68515–32–2 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms

68515–33–3 Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, heavy ends

68515–34–4 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, heavy ends

68515–35–5 Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, light ends

68515–36–6 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, light ends

68516–20–1 Naphtha (petroleum), steam-cracked middle arom.
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

199

68526–52–3 Alkenes, C6

68526–53–4 Alkenes, C6-8, C7-rich

68526–54–5 Alkenes, C7-9, C8-rich

68526–55–6 Alkenes, C8-10, C9-rich

68526–56–7 Alkenes, C9-11, C10-rich

68526–57–8 Alkenes, C10-12, C11-rich

68526–58–9 Alkenes, C11-13, C12-rich

68526–77–2 Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum

68526–99–8 Alkenes, C6-9 .alpha.-

68527–00–4 Alkenes, C8-9 .alpha.-

68527–11–7 Alkenes, C5

68527–13–9 Gases (petroleum), acid, ethanolamine scrubber

68527–14–0 Gases (petroleum), methane-rich off

68527–15–1 Gases (petroleum), oil refinery gas distn. off

68527–16–2 Hydrocarbons, C1-3

68527–18–4 Gas oils (petroleum), steam-cracked

68527–19–5 Hydrocarbons, C1-4, debutanizer fraction

68527–21–9 Naphtha (petroleum), clay-treated full-range straight-run

68527–22–0 Naphtha (petroleum), clay-treated light straight-run

68527–23–1 Naphtha (petroleum), light steam-cracked arom.

68527–26–4 Naphtha (petroleum), light steam-cracked, debenzenized

68527–27–5 Naphtha (petroleum), full-range alkylate, butane-contg.

68553–00–4 Fuel oil, no. 6

68553–14–0 Hydrocarbons, C8-11

68602–79–9 Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads

68602–81–3 Distillates, hydrocarbon resin prodn. higher boiling

68602–82–4 Gases (petroleum), benzene unit hydrotreater depentenizer overheads

68602–83–5 Gases (petroleum), C1-5, wet

68602–84–6 Gases (petroleum), secondary absorber off, fluidized catalytic cracker 

overheads fractionater

68602–96–0 Distillates (petroleum), oxidized light, strong acid components, compds. 

with diethanolamine

68602–97–1 Distillates (petroleum), oxidized light, strong acid components, sodium 

salts

68602–98–2 Distillates (petroleum), oxidized light, strong acid components

68602–99–3 Distillates (petroleum), oxidized light, strong acid-free

68603–00–9 Distillates (petroleum), thermal cracked naphtha and gas oil

68603–01–0 Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimercontg.

68603–02–1 Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized

68603–03–2 Distillates (petroleum), thermal cracked naphtha and gas oil, extractive

68603–08–7 Naphtha (petroleum), arom.-contg.

68603–09–8 Hydrocarbon waxes (petroleum), oxidized, calcium salts

68603–10–1 Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts

68603–11–2 Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

200

68603–12–3 Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts

68603–13–4 Petrolatum (petroleum), oxidized, ester with sorbitol

68603–14–5 Residual oils (petroleum), oxidized, calcium salts

68603–31–6 Alkenes, C10, tert-amylene concentrator by-product

68603–32–7 Alkenes, C15-20 .alpha.-, isomerized

68606–09–7 Fuel gases, expander off

68606–10–0 Gasoline, pyrolysis, debutanizer bottoms

68606–11–1 Gasoline, straight-run, topping-plant

68606–24–6 Hydrocarbons, C4, butene concentrator by-product

68606–25–7 Hydrocarbons, C2-4

68606–26–8 Hydrocarbons, C3

68606–27–9 Gases (petroleum), alkylation feed

68606–28–0 Hydrocarbons, C5 and C10-aliph. and C6-8-arom.

68606–31–5 Hydrocarbons, C3-5, butadiene purifn. by-product

68606–34–8 Gases (petroleum), depropanizer bottoms fractionation off

68606–36–0 Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product

68607–11–4 Petroleum products, refinery gases

68607–30–7 Residues (petroleum), topping plant, low-sulfur

68608–56–0 Waste gases, from carbon black manuf.

68647–60–9 Hydrocarbons, C>4

68647–61–0 Hydrocarbons, C4-5, tert-amylene concentrator by-product

68647–62–1 Hydrocarbons, C4-5, butene concentrator by-product, sour

68650–36–2 Aromatic hydrocarbons, C8, o -xylene-lean

68650–37–3 Paraffin waxes (petroleum), oxidized, sodium salts

68782–97–8 Distillates (petroleum), hydrofined lubricating-oil

68782–98–9 Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg.

68782–99–0 Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-

contg.

68783–00–6 Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc.

68783–01–7 Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc.

68783–02–8 Extracts (petroleum), intermediate clarified oil solvent, condensed-ringarom.-contg.

68783–04–0 Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent

68783–05–1 Gases (petroleum), ammonia-hydrogen sulfide, water-satd.

68783–06–2 Gases (petroleum), hydrocracking low-pressure separator

68783–07–3 Gases (petroleum), refinery blend

68783–08–4 Gas oils (petroleum), heavy atmospheric

68783–09–5 Naphtha (petroleum), catalytic cracked light distd.

68783–12–0 Naphtha (petroleum), unsweetened

68783–13–1 Residues (petroleum), coker scrubber, condensed-ring-arom.-contg.

68783–15–3 Alkenes, C6-7 .alpha.-

68783–61–9 Fuel gases, refinery, sweetened

68783–62–0 Fuel gases, refinery, unsweetened

68783–64–2 Gases (petroleum), catalytic cracking

68783–65–3 Gases (petroleum), C2-4, sweetened
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

201

68783–66–4 Naphtha (petroleum), light, sweetened

68814–47–1 Waste gases, refinery vent

68814–67–5 Gases (petroleum), refinery

68814–87–9 Distillates (petroleum), full-range straight-run middle

68814–89–1 Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted

68814–90–4 Gases (petroleum), platformer products separator off

68814–91–5 Alkenes, C5-9 .alpha.-

68855–57–2 Alkenes, C6-12 .alpha.-

68855–58–3 Alkenes, C10-16 .alpha.-

68855–59–4 Alkenes, C14-18 .alpha.-

68855–60–7 Alkenes, C14-20 .alpha.-

68911–58–0 Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off

68911–59–1 Gases (petroleum), hydrotreated sour kerosine flash drum

68915–96–8 Distillates (petroleum), heavy straight-run

68915–97–9 Gas oils (petroleum), straight-run, high-boiling

68918–69–4 Petrolatum (petroleum), oxidized, zinc salt

68918–73–0 Residues (petroleum), clay-treating filter wash

68918–93–4 Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts

68918–98–9 Fuel gases, refinery, hydrogen sulfide-free

68918–99–0 Gases (petroleum), crude oil fractionation off

68919–00–6 Gases (petroleum), dehexanizer off

68919–01–7 Gases (petroleum), distillate unifiner desulfurization stripper off

68919–02–8 Gases (petroleum), fluidized catalytic cracker fractionation off

68919–03–9 Gases (petroleum), fluidized catalytic cracker scrubbing secondary 

absorber off

68919–04–0 Gases (petroleum), heavy distillate hydrotreater desulfurization stripper 

off

68919–05–1 Gases (petroleum), light straight run gasoline fractionation stabilizer off

68919–06–2 Gases (petroleum), naphtha unifiner desulfurization stripper off

68919–07–3 Gases (petroleum), platformer stabilizer off, light ends fractionation

68919–08–4 Gases (petroleum), preflash tower off, crude distn.

68919–09–5 Gases (petroleum), straight-run naphtha catalytic reforming off

68919–10–8 Gases (petroleum), straight-run stabilizer off

68919–11–9 Gases (petroleum), tar stripper off

68919–12–0 Gases (petroleum), unifiner stripper off

68919–15–3 Hydrocarbons, C6-12, benzene-recovery

68919–16–4 Hydrocarbons, catalytic alkylation, by-products, C3-6

68919–17–5 Hydrocarbons, C12-20, catalytic alkylation by-products

68919–19–7 Gases (petroleum), fluidized catalytic cracker splitter residues

68919–20–0 Gases (petroleum), fluidized catalytic cracker splitter overheads

68919–37–9 Naphtha (petroleum), full-range reformed

68920–06–9 Hydrocarbons, C7-9

68920–07–0 Hydrocarbons, C`10-linear

68920–64–9 Disulfides, di-C1-2-alkyl

68921–07–3 Distillates (petroleum), hydrotreated light catalytic cracked
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

202

68921–08–4 Distillates (petroleum), light straight-run gasoline fractionation stabilizer 

overheads

68921–09–5 Distillates (petroleum), naphtha unifiner stripper

68921–67–5 Hydrocarbons, ethylene-manuf.-by-product distn. residues

68952–76–1 Gases (petroleum), catalytic cracked naphtha debutanizer

68952–77–2 Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer

68952–78–3 Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation 

stabilizer, hydrogen sulfide-free

68952–79–4 Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator

68952–80–7 Tail gas (petroleum), straight-run naphtha hydrodesulfurizer

68952–81–8 Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha 

absorber

68952–82–9 Tail gas (petroleum), thermal cracked hydrocarbon fractionation 

stabilizer, petroleum coking

68953–80–0 Benzene, mixed with toluene, dealkylation product

68955–27–1 Distillates (petroleum), petroleum residues vacuum

68955–28–2 Gases (petroleum), light steam-cracked, butadiene conc.

68955–31–7 Gases (petroleum), butadiene process, inorg.

68955–32–8 Natural gas, substitute, steam-reformed desulfurized naphtha

68955–33–9 Gases (petroleum), sponge absorber off, fluidized catalytic cracker and 

gas oil desulfurizer overhead fractionation

68955–34–0 Gases (petroleum), straight-run naphtha catalytic reformer stabilizer 

overhead

68955–35–1 Naphtha (petroleum), catalytic reformed

68955–36–2 Residues (petroleum), steam-cracked, resinous

68955–76–0 Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich

68955–96–4 Disulfides, dialkyl and di-Ph, naphtha sweetening

68956–47–8 Fuel oil, isoprene reject absorption

68956–48–9 Fuel oil, residual, wastewater skimmings

68956–52–5 Hydrocarbons, C4-8

68956–54–7 Hydrocarbons, C4-unsatd.

68956–55–8 Hydrocarbons, C5-unsatd.

68956–70–7 Petroleum products, C5-12, reclaimed, wastewater treatment

68988–79–4 Benzene, C10-12-alkyl derivs., distn. residues

68988–99–8 Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. 

scrubber residues

68989–88–8 Gases (petroleum), crude distn. and catalytic cracking

68990–35–2 Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich

68991–49–1 Alkanes, C10-13, arom.-free desulfurized

68991–50–4 Alkanes, C14-17, arom.-free desulfurized

68991–51–5 Alkanes, C10-13, desulfurized

68991–52–6 Alkenes, C10-16

69013–21–4 Fuel oil, pyrolysis

69029–75–0 Oils, reclaimed

69430–33–7 Hydrocarbons, C6-30
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

203

70024–88–3 Ethene, thermal cracking products

70528–71–1 Distillates (petroleum), heavy distillate solvent ext. heart-cut

70528–72–2 Distillates (petroleum), heavy distillate solvent ext. vacuum overheads

70528–73–3 Residues (petroleum), heavy distillate solvent ext. vacuum

70592–76–6 Distillates (petroleum), intermediate vacuum

70592–77–7 Distillates (petroleum), light vacuum

70592–78–8 Distillates (petroleum), vacuum

70592–79–9 Residues (petroleum), atm. tower, light

70693–00–4 Hydrocarbon waxes (petroleum), oxidized, sodium salts

70693–06–0 Aromatic hydrocarbons, C9-11

70913–85–8 Residues (petroleum), solvent-extd. vacuum distilled atm. residuum

70913–86–9 Alkanes, C18-70

70955–08–7 Alkanes, C4-6

70955–09–8 Alkenes, C13-14 .alpha.-

70955–10–1 Alkenes, C15-18 .alpha.-

70955–17–8 Aromatic hydrocarbons, C12-20

71243–66–8 Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, 

potassium salts

71302–82–4 Hydrocarbons, C5-8, Houdry butadiene manuf. by-product

71329–37–8 Residues (petroleum), catalytic cracking depropanizer, C4-rich

71808–30–5 Tail gas (petroleum), thermal cracking absorber

72230–71–8 Distillates (petroleum), cracked steam-cracked, C5-17 fraction

72623–83–7 Lubricating oils (petroleum), C>25, hydrotreated bright stock-based

72623–84–8 Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, 

contg. solvent deasphalted residual oil

72623–85–9 Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, 

high-viscosity

72623–86–0 Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based

72623–87–1 Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based

73138–65–5 Hydrocarbon waxes (petroleum), oxidized, magnesium salts

92045–43–7 Lubricating oils (petroleum), hydrocracked non-arom. solvent 

deparaffined

92045–58–4 Naphtha (petroleum), isomerization, C6-fraction

92062–09–4 Slack wax (petroleum), hydrotreated

93762–80–2 Alkenes, C15-18

98859–55–3 Distillates (petroleum), oxidized heavy, compds. with diethanolamine

98859–56–4 Distillates (petroleum), oxidized heavy, sodium salts

101316–73–8 Lubricating oils (petroleum), used, non-catalytically refined

164907–78–2 Extracts (petroleum), asphaltene-low vacuum residue solvent

164907–79–3 Residues (petroleum), vacuum, asphaltene-low

178603–63–9 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C10-25

178603–64–0 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C15-30, branched and cyclic

178603–65–1 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

204

hydrogenated, C20-40, branched and cyclic

178603–66–2 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C25-55, branched and cyclic

212210–93–0 Solvent naphtha (petroleum), heavy arom., distn. residues

221120–39–4 Distillates (petroleum), cracked steam-cracked, C5-12 fraction

445411–73–4 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C10-25, branched and cyclic

4454

4455 (2) Specific exempted chemical substances—(i) Exemption. EPA has determined 

4456 that, at this time, the information in § 711.15(b)(4) associated with the chemical 

4457 substances listed in paragraph (b)(2)(iv) of this section is of low current interest.

4458 (ii) Considerations. In making its determination of whether this partial exemption 

4459 should apply to a particular chemical substance, EPA will consider the totality of 

4460 information available for the chemical substance in question, including but not limited to, 

4461 one or more of the following considerations:

4462 (A) Whether the chemical substance qualifies or has qualified in past IUR 

4463 collections for the reporting of the information described in § 711.15(b)(4) (i.e., at least 

4464 one site manufactures 300,000 pounds (lb.) or more of the chemical substance).).

4465 (B) The chemical substance's chemical and physical properties or potential for 

4466 persistence, bioaccumulation, health effects, or environmental effects (considered 

4467 independently or together).

4468 (C) The information needs of EPA, other Federal agencies, tribes, States, and 

4469 local governments, as well as members of the public.

4470 (D) The availability of other complementary risk screening information.

4471 (E) The availability of comparable processing and use information.

4472 (F) Whether the potential risks of the chemical substance are adequately managed.
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

205

4473 (iii) Amendments. EPA may amend the chemical substance list in paragraph 

4474 (b)(2)(iv) of this section on its own initiative or in response to a request from the public 

4475 based on EPA's determination of whether the information in § 711.15(b)(4) is of low 

4476 interest.

4477 (A) Any person may request that EPA amend the chemical substance list in Table 

4478 2 in paragraph (b)(2)(iv) of this section. Your request must be in writing and must be 

4479 submitted to the following address: OPPT IUR Submission Coordinator (Mail Code 

4480 7407M), Attention: Inventory Update Reporting, Office of Pollution Prevention and 

4481 Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 

4482 DC 20460–0001. Requests must identify the chemical substance in question, as well as 

4483 its CASRN or other chemical identification number as identified in § 711.15(b)(3)(i), and 

4484 must contain a written rationale for the request that provides sufficient specific 

4485 information, addressing the considerations listed in § 711.6(b)(2)(ii), including cites and 

4486 relevant documents, to demonstrate to EPA that the collection of the information in §

4487 711.15(b)(4) for the chemical substance in question either is or is not of low current 

4488 interest. If a request related to a particular chemical substance is resubmitted, any 

4489 subsequent request must clearly identify new information contained in the request. EPA 

4490 may request other information that it believes necessary to evaluate the request. EPA will 

4491 issue a written response to each request within 120 days of receipt of the request, and will 

4492 maintain copies of these responses in a docket that will be established for each reporting 

4493 cycle.

4494 (B) As needed, the Agency will initiate rulemaking to make revisions to Table 2 

4495 in paragraph (b)(2)(iv) of this section.
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

206

4496 (C) To assist EPA in reaching a decision regarding a particular request prior to a 

4497 given principal reporting year, requests must be submitted to EPA no later than 12 

4498 months prior to the start of the next principal reporting year.

4499 (iv) List of chemical substances. EPA has designated the chemical substances 

4500 listed in Table 2 of this paragraph by CASRN, as partially exempt from reporting under 

4501 the IUR.

4502 Table 2.—CASRN of Partially Exempt Chemical Substances 

CASRN Chemical

50–70–4 D-Glucitol

50–81–7 L-Ascorbic acid

50–99–7 D-Glucose

56–81–5 1,2,3-Propanetriol

56–87–1 L-Lysine

57–50–1 .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl

58–95–7 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-

4,8,12- trimethyltridecyl]-, acetate, (2R)-

59–02–9 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-

4,8,12- trimethyltridecyl]-, (2R)-

59–51–8 Methionine

69–65–8 D-Mannitol

87–79–6 L-Sorbose

87–99–0 Xylitol

96–10–6 Aluminum, chlorodiethyl97–93–8 Aluminum, triethyl100–99–2 Aluminum, tris(2-methylpropyl)-

123–94–4 Octadecanoic acid, 2,3-dihydroxypropyl ester

124–38–9 Carbon dioxide

137–08–6 .beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-dimethyl-1-oxobutyl]-, 

calcium alt (2:1)

142–47–2 L-Glutamic acid, monosodium salt

150–30–1 Phenylalanine

563–43–9 Aluminum, dichloroethyl1070–00–4 Aluminum, trioctyl1116–70–7 Aluminum, tributyl1116–73–0 Aluminum, trihexyl1191–15–7 Aluminum, hydrobis(2-methylpropyl)-

1317–65–3 Limestone

1333–74–0 Hydrogen

1592–23–0 Octadecanoic acid, calcium salt
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review 

***

207

7440–37–1 Argon

7440–44–0 Carbon

7727–37–9 Nitrogen

7782–42–5 Graphite

7782–44–7 Oxygen

8001–21–6 Sunflower oil

8001–22–7 Soybean oil

8001–23–8 Safflower oil

8001–26–1 Linseed oil

8001–29–4 Cottonseed oil

8001–30–7 Corn oil

8001–31–8 Coconut oil

8001–78–3 Castor oil, hydrogenated

8001–79–4 Castor oil

8002–03–7 Peanut oil

8002–13–9 Rape oil

8002–43–5 Lecithins

8002–75–3 Palm oil

8006–54–0 Lanolin

8016–28–2 Lard, oil

8016–70–4 Soybean oil, hydrogenated

8021–99–6 Charcoal, bone

8029–43–4 Syrups, hydrolyzed starch

11103–57–4 Vitamin A

12075–68–2 Aluminum, di-.mu.-chlorochlorotriethyldi12542–85–7 Aluminum, trichlorotrimethyldi16291–96–6 Charcoal

26836–47–5 D-Glucitol, monooctadecanoate

61789–44–4 Fatty acids, castor-oil

61789–97–7 Tallow

61789–99–9 Lard

64147–40–6 Castor oil, dehydrated

64755–01–7 Fatty acids, tallow, calcium salts

65996–63–6 Starch, acid-hydrolyzed

65996–64–7 Starch, enzyme-hydrolyzed

67701–01–3 Fatty acids, C12-18

68002–85–7 Fatty acids, C14-22 and C16-22-unsatd.

68131–37–3 Syrups, hydrolyzed starch, dehydrated

68188–81–8 Grease, poultry

68308–36–1 Soybean meal

68308–54–3 Glycerides, tallow mono-, di- and tri-, hydrogenated

68334–00–9 Cottonseed oil, hydrogenated

68334–28–1 Fats and glyceridic oils, vegetable, hydrogenated

68409–76–7 Bone meal, steamed

68424–45–3 Fatty acids, linseed-oil
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68424–61–3 Glycerides, C16-18 and C18-unsatd. mono- and di68425–17–2 Syrups, hydrolyzed starch, hydrogenated

68439–86–1 Bone, ash

68442–69–3 Benzene, mono-C10-14-alkyl derivs.

68476–78–8 Molasses

68514–27–2 Grease, catch basin

68514–74–9 Palm oil, hydrogenated

68525–87–1 Corn oil, hydrogenated

68648–87–3 Benzene, C10-16-alkyl derivs.

68918–42–3 Soaps, stocks, soya

68952–94–3 Soaps, stocks, vegetable-oil

68956–68–3 Fats and glyceridic oils, vegetable

68989–98–0 Fats and glyceridic oils, vegetable, residues

73138–67–7 Lard, hydrogenated

120962–03–0 Canola oil

129813–58–7 Benzene, mono-C10-13-alkyl derivs.

129813–59–8 Benzene, mono-C12-14-alkyl derivs.

129813–60–1 Benzene, mono-C14-16-alkyl derivs.

4503

4504 § 711.8 Persons who must report.

4505 Except as provided in § 711.9 and § 711.10, the following persons are subject to 

4506 the requirements of this part. Persons must determine whether they must report under this 

4507 section for each chemical substance that they manufacture (including import) at an 

4508 individual site.

4509 (a) Persons subject to recurring reporting—(1) For the 20112012 submission 

4510 period, any person who manufactured (including imported) for commercial purposes 

4511 25,000 lb. (11,340 kilogram (kg)) or more of a chemical substance described in § 711.5 at 

4512 any single site owned or controlled by that person during the principal reporting year 

4513 (i.e., calendar year 20102011) is subject to reporting.

4514 (2) For the submission periods subsequent to the 20112012 submission period, 

4515 any person who manufactured (including imported) for commercial purposes 25,000 lb.

4516 (11,340 kg) or more of a chemical substance described in § 711.5 at any single site 
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4517 owned or controlled by that person during any calendar year since the last principal 

4518 reporting year (e.g., for the 20152016 submission period, consider calendar years 2011, 

4519 2012, 2013, and 2014, and 2015, given that 20102011 was the last principal reporting 

4520 year).

4521 (b) Exceptions. Any For the 2016 submission period and subsequent submission 

4522 periods, any person who manufactured (including imported) for commercial purposes any 

4523 chemical substance that is the subject of a rule proposed or promulgated under TSCA 

4524 section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 

4525 5(e), or is the subject of relief that has been granted under a civil action under TSCA 

4526 section 5 or 7 is subject to reporting foras described in § 711.8(a), except that chemical 

4527 substance, regardless of thethe applicable production volume. threshold is 2,500 lb (1,134 

4528 kg).

4529 § 711.9 Persons not subject to this part.

4530 A person described in § 711.8 is not subject to the requirements of this part if that 

4531 person qualifies as a small manufacturer as that term is defined in 40 CFR 704.3. 

4532 Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject 

4533 to this part with respect to any chemical substance that is the subject of a rule proposed or 

4534 promulgated under TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect 

4535 under TSCA section 5(e), or is the subject of relief that has been granted under a civil 

4536 action under TSCA section 5 or 7.

4537 § 711.10 Activities for which reporting is not required.
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4538 A person described in § 711.8 is not subject to the requirements of this part with 

4539 respect to any chemical substance described in § 711.5 that the person solely 

4540 manufactured or imported under the following circumstances:

4541 (a) The person manufactured or imported the chemical substance described in §

4542 711.5 solely in small quantities for research and development.

4543 (b) The person imported the chemical substance described in § 711.5 as part of an 

4544 article.

4545 (c) The person manufactured the chemical substance described in § 711.5 in a 

4546 manner described in 40 CFR 720.30(g) or (h).

4547 § 711.15 Reporting information to EPA.

4548 For the 2011For the 2012 submission period, any person who must report under 

4549 this part, as described in § 711.8, must submit the information described in this section 

4550 for each chemical substance described in § 711.5 that the person manufactured (including 

4551 imported) for commercial purposes in an amount of 25,000 lb (11,340 kg) or more at any 

4552 one site during the principal reporting year (i.e., calendar year 2011). For the submission 

4553 periods subsequent to the 2012 submission period, any person who must report under this 

4554 part, as described in § 711.8, must submit the information described in this section for 

4555 each chemical substance described in § 711.5 that the person manufactured (including 

4556 imported) for commercial purposes in an amount of 25,000 lb. (11,340 kg) or more (or 

4557 lower volume for chemical substances subject to the rules, orders, or actions described in 

4558 § 711.8(b)) at any one site during the principal reporting year (i.e., calendar year 2010). 

4559 For the submission periods subsequent to the 2011 submission period, any person who 

4560 must report under this part, as described in § 711.8(b), must submit the information 
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4561 described in this section for each chemical substance described in § 711.5 that the person 

4562 manufactured (including imported) for commercial purposes in an amount of 

4563 25,0002,500 lb. (11,340 [1,134 kg)] or more (or lower volume for chemical substances 

4564 subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any 

4565 calendar year since the last principal reporting year (e.g., for the 20152016 submission 

4566 period, consider calendar years 2011, 2012, 2013, and 2014, since 2010and 2015, 

4567 because 2011 was the last principal reporting year). The principal reporting year for each 

4568 submission period is the previous calendar year (e.g., the principal reporting year for the 

4569 20152016 submission period is calendar year 20142015). For all submission periods, a 

4570 separate report must be submitted for each chemical substance at each site for which the 

4571 submitter is required to report. A submitter of information under this part must report 

4572 information as described in this section to the extent that such information is known to or 

4573 reasonably ascertainable by that person.

4574 (a) Reporting information to EPA. Any person who reports information to EPA 

4575 must do so using the e-IURweb reporting softwaretool provided by EPA at the address 

4576 set forth in § 711.35. The submission must include all information described in paragraph 

4577 (b) of this section. Persons must submit a separate Form U for each site for which the 

4578 person is required to report. The e-IURweb reporting softwaretool is described in the 

4579 instructions available from EPA at the website set forth in § 711.35.

4580 (b) Information to be reported. Manufacturers For the 2012 submission period, 

4581 manufacturers (including importers) of a reportable chemical substance in an amount of 

4582 25,000 lb. (11,340 kg) or more at a site during any calendar year since the last principal 

4583 reporting year (i.e., 2011) must report the information described in this section. As 
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4584 described in § 711.6paragraphs (b)(1)), (b)(2), and (b)(2), manufacturers 3) of certain 

4585 chemical substances are not required tothis section. For the 2012 submission period, 

4586 manufacturers (including importers) of a reportable chemical substance in an amount of 

4587 100,000 lb (45,359 kg) or more at a site during the principal reporting year (i.e., 2011)

4588 must additionally report the information described in paragraph (b)(4) of this section. For 

4589 submission periods subsequent to the 2012 submission period, the information described 

4590 in paragraphs (b)(1), (b)(2), (b)(3), and (b)(4) of this section must be reported for each 

4591 chemical substance manufactured (including imported) in an amount of 25,000 lb (11,340 

4592 kg) or more (or in an amount of 2,500 lb [1,134 kg] or more for chemical substances 

4593 subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any 

4594 calendar year since the last principal reporting year. The requirement to report 

4595 information described in (b)(4) of this section is subject to exemption as described in §

4596 711.6

4597 (1) A certification statement signed and dated by an authorized official of the 

4598 submitter company. Persons reporting must submit this information using e-IURweb as 

4599 described in § 711.35. The authorized official must certify that the submitted information 

4600 has been completed in compliance with the requirements of this part and that the 

4601 confidentiality claims made on the Form U are true and correct. The certification must be 

4602 signed and dated by the authorized official for the submitter company, and provide that 

4603 person‘s name, official title, and e-mail address.

4604 (2) Company and plant site information. The following currently correct company 

4605 and plant site information must be reported for each site at which at least 25,000 lb. 

4606 (11,340 kg) of a reportable chemical substance is manufactured (including imported) 
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4607 during any calendar year sinceabove the last principal reporting yearapplicable 

4608 production volume threshold, as described in this section (see § 711.3 for the ―site‖ for 

4609 importers):

4610 (i) The U.S. parent company name, address, and Dun and Bradstreet Number.D4611 U-N-S® (D&B) number. A submitter under this part must obtain a Dun and Bradstreet 

4612 NumberD&B number for the parent company if none exists.

4613 (ii) The name of a person who will serve as technical contact for the submitter 

4614 company, and who will be able to answer questions about the information submitted by 

4615 the company to EPA, the contact person's full mailing address, telephone number, and e4616 mail address.

4617 (iii) The name and full street address of each site. A submitter under this part must 

4618 include the appropriate Dun and Bradstreet NumberD&B number for each plant site 

4619 reported, and the county or parish (or other jurisdictional indicator) in which the plant site 

4620 is located. A submitter under this part must obtain a Dun and Bradstreet NumberDB 

4621 number for the site reported if none exists.

4622 (3) Specific information for chemical substances manufactured in amounts of 

4623 25,000 lb. or moreChemical-specific information. The following chemical-specific 

4624 information must be reported for each reportable chemical substance manufactured 

4625 (including imported) at each site in amounts of 25,000 lb. (11,340 kg) or more during any

4626 calendar year sinceabove the last principal reporting yearapplicable production volume 

4627 threshold, as described in paragraph (b) of this section:

4628 (i) The specific, currently correct Chemical Abstracts (CA) Index name as used to 

4629 list the chemical substance on the TSCA Inventory and the correct corresponding 
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4630 Chemical Abstracts Service (CAS) Registry Number (CASRN) for each reportable 

4631 chemical substance at each site. A submitter under this part may use an EPA-designated 

4632 TSCA Accession Number for a chemical substance in lieu of a CASRN when a CASRN 

4633 is not known to or reasonably ascertainable by the submitter. Submitters who wish to 

4634 report chemical substances listed on the confidential portion of the TSCA Inventory will 

4635 need to report the chemical substance using a TSCA Accession Number. 

4636 In addition to reporting the number itself, submitters must specify the type of 

4637 number they are reporting by selecting from among the codes in Table 3 of this 

4638 paragraph.

4639 Table 3.—Codes to Specify Type of Chemical Identifying Number

Code Number Type

A Accession Number

C Chemical Abstracts Service Registry Number (CASRN)

4640

4641

4642 (A) If an importer submitting a report cannot provide the information specified in 

4643 § 711.15(b)(3)(i) of this section because it is unknown to the importer and claimed as 

4644 confidential by the supplier of the chemical substance or mixture, the importer must use 

4645 e-IURweb to ask the supplier to provide the correct chemical identity information directly 

4646 to EPA in a joint submission. Such request must include instructions for submitting 

4647 chemical identity information electronically, using e-IURweb and CDX (see § 711.35), 

4648 and for clearly referencing the importer's submission. Contact information for the 

4649 supplier, a trade name or other designation for the chemical substance or mixture, and a 

4650 copy of the request to the supplier must be included with the importer‘s submission 

4651 respecting the chemical substance.
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4652 (B) If a manufacturer submitting a report cannot provide the information specified 

4653 in § 711.15(b)(3)(i) of this section because the reportable chemical substance is 

4654 manufactured using a reactant having a specific chemical identity that is unknown to the 

4655 manufacturer and claimed as confidential by its supplier, the manufacturer must use e4656 IURweb to ask the supplier of the confidential reactant to provide the correct chemical 

4657 identity of the confidential reactant directly to EPA in a joint submission. Such request 

4658 must include instructions for submitting chemical identity information electronically 

4659 using e-IURweb and CDX (see § 711.35), and for clearly referencing the manufacturer's 

4660 submission. Contact information for the supplier, a trade name or other designation for 

4661 the chemical substance, and a copy of the request to the supplier must be included with 

4662 the importer‘s submission respecting the chemical substance.

4663 (C) EPA will only accept joint submissions that are submitted electronically using 

4664 e-IURweb and CDX (see § 711.35) and that clearly reference the primary submission to 

4665 which they refer.

4666 (ii) For the principal reporting year only, a statement indicating, for each 

4667 reportable chemical substance at each site, whether the chemical substance is 

4668 manufactured in the United States, imported into the United States, or both manufactured 

4669 in the United States and imported into the United States.

4670 (iii) For the principal reporting year, the total annual volume (in pounds) of each 

4671 reportable chemical substance domestically manufactured andor imported at each site. 

4672 The total annual domestically manufactured volume (not including imported volume) and 

4673 the total annual imported volume must be separately reported. This amountThese

4674 amounts must be reported to two significant figures of accuracy. For each complete 
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4675 calendar year since the last principal reporting year In addition, for the 2012 submission 

4676 period only, the total annual volume (domestically manufactured andplus imported 

4677 volumes in pounds) of each reportable chemical substance at each site during calendar 

4678 year 2010. In addition, for submission periods subsequent to the 2012 submission period, 

4679 the total annual volume (domestically manufactured plus imported volumes in pounds) of 

4680 each reportable chemical substance at each site for each complete calendar year since the 

4681 last principal reporting year.

4682 (iv) For the principal reporting year only, the volume used on site and the volume 

4683 directly exported of each reportable chemical substance domestically manufactured andor

4684 imported at each site. This amount These amounts must be reported to two significant 

4685 figures of accuracy.

4686 (v) For the principal reporting year only, a designation indicating, for each 

4687 imported reportable chemical substance at each site, whether the imported chemical 

4688 substance is physically present at the reporting site.

4689 (vi) For the principal reporting year only, a designation indicating, for each 

4690 reportable chemical substance at each site, whether the chemical substance is being 

4691 recycled, remanufactured, reprocessed, reused, or otherwise used for a commercial 

4692 purpose instead of being disposed of as a waste or included in a waste stream.

4693 (vii) For the principal reporting year only, the total number of workers reasonably 

4694 likely to be exposed to each reportable chemical substance at each site. For each 

4695 reportable chemical substance at each site, the submitter must select from among the 

4696 ranges of workers listed in Table 4 of this paragraph and report the corresponding code 

4697 (i.e., W1 through W8):
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4698 Table 4.—Codes for Reporting Number of Workers Reasonably Likely To Be 

4699 Exposed

Code Range

W1 Fewer than 10 workers

W2 At least 10 but fewer than 25 workers

W3 At least 25 but fewer than 50 workers

W4 At least 50 but fewer than 100 workers

W5 At least 100 but fewer than 500 workers

W6 At least 500 but fewer than 1,000 workers

W7 At least 1,000 but fewer than 10,000 workers

W8 At least 10,000 workers

4700

4701 (viii) For the principal reporting year only, the maximum concentration, measured 

4702 by percentage of weight, of each reportable chemical substance at the time it is sent off4703 site from each site. If the chemical substance is site-limited, you must report the 

4704 maximum concentration, measured by percentage of weight of the reportable chemical 

4705 substance at the time it is reacted on-site to produce a different chemical substance. This 

4706 information must be reported regardless of the physical form(s) in which the chemical 

4707 substance is sent off-site/reacted on-site. For each chemical substance at each site, select 

4708 the maximum concentration of the chemical substance from among the ranges listed in 

4709 Table 5 of this paragraph and report the corresponding code (i.e., M1 through M5):

4710 Table 5.—Codes for Reporting Maximum Concentration of Chemical Substance

Code Concentration Range (% weight)

M1 Less than 1% by weight

M2 At least 1 but less than 30% by weight

M3 At least 30 but less than 60% by weight

M4 At least 60 but less than 90% by weight

M5 At least 90% by weight

4711

4712 (ix) For the principal reporting year only, the physical form(s) of the reportable 

4713 chemical substance as it is sent off-site from each site. If the chemical substance is site4714 limited, you must report the physical form(s) of the reportable chemical substance at the 

4715 time it is reacted on-site to produce a different chemical substance. For each chemical 
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4716 substance at each site, the submitter must report as many physical forms as applicable 

4717 from among the physical forms listed in this unit:

4718 (A) Dry powder.

4719 (B) Pellets or large crystals.

4720 (C) Water- or solvent-wet solid.

4721 (D) Other solid.

4722 (E) Gas or vapor.

4723 (F) Liquid.

4724 (x) For the principal reporting year only, submitters must report the percentage, 

4725 rounded off to the closest 10%, of total production volume of the reportable chemical 

4726 substance, reported in response to paragraph (b)(3)(iii) of this section, that is associated

4727 with each physical form reported under paragraph (b)(3)(ix) of this section. 

4728 (4) SpecificChemical-specific information related to processing and use. The 

4729 following chemical-specific information must be reported for each reportable chemical 

4730 substance manufactured (including imported) above the applicable production volume 

4731 threshold, as described in this section. Persons subject to paragraph (b)(34) of this section 

4732 must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this section 

4733 for each reportable chemical substance at sites under their control and at sites that receive 

4734 a reportable chemical substance from the submitter directly or indirectly (including 

4735 through a broker/distributor, from a customer of the submitter, etc.). Information reported 

4736 in response to this paragraph must be reported for the principal reporting year only and 

4737 only to the extent that it is known to or reasonably ascertainable by the submitter. 

4738 Information required to be reported under this paragraph is limited to domestic (i.e., 
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4739 within the customs territory of the United States) processing and use activities. If 

4740 information responsive to a given data requirement under this paragraph, including 

4741 information in the form of an estimate, is not known or reasonably ascertainable, the 

4742 submitter is not required to respond to the requirement.

4743 (i) Industrial processing and use information—(A) A designation indicating the 

4744 type of industrial processing or use operation(s) at each site that receives a reportable 

4745 chemical substance from the submitter site directly or indirectly (whether the recipient 

4746 site(s) are controlled by the submitter site or not). For each chemical substance, report the 

4747 letters which correspond to the appropriate processing or use operation(s) listed in Table

4748 6 of this paragraph. A particular designation may need to be reported more than once, to 

4749 the extent that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of 

4750 this section) that applies to a given designation under this paragraph.

4751 Table 6.—Codes for Reporting Type of Industrial Processing or Use Operation

Designation Operation

PC Processing as a reactant

PF Processing—incorporation into formulation, mixture or reaction 

product

PA Processing—incorporation into article

PK Processing—repackaging

U Use—non-incorporative activities

4752

4753 (B) A code indicating the sector(s) that best describe the industrial activities 

4754 associated with each industrial processing or use operation reported under paragraph 

4755 (b)(4)(i)(A) of this section. For each chemical substance, report the code that corresponds 

4756 to the appropriate sector(s) listed in Table 7 of this paragraph. A particular sector code 

4757 may need to be reported more than once, to the extent that a submitter reports more than 

4758 one industrial function code (under paragraph (b)(4)(i)(C) of this section) that applies to a 

4759 given sector code under this paragraph.
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4760 Table 7.—Codes for Reporting Industrial Sectors

Code Sector Description

IS1 Agriculture, Forestry, Fishing and Hunting

IS2 Oil and Gas Drilling, Extraction, and support activities

IS3 Mining (except Oil and Gas) and support activities

IS4 Utilities

IS5 Construction

IS6 Food, beverage, and tobacco product manufacturing

IS7 Textiles, apparel, and leather manufacturing

IS8 Wood Product Manufacturing

IS9 Paper Manufacturing

IS10 Printing and Related Support Activities

IS11 Petroleum Refineries

IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing

IS13 Petroleum Lubricating Oil and Grease Manufacturing

IS14 All other Petroleum and Coal Products Manufacturing

IS15 Petrochemical Manufacturing

IS16 Industrial Gas Manufacturing

IS17 Synthetic Dye and Pigment Manufacturing

IS18 Carbon Black Manufacturing

IS19 All Other Basic Inorganic Chemical Manufacturing

IS20 Cyclic Crude and Intermediate Manufacturing

IS21 All Other Basic Organic Chemical Manufacturing

IS22 Plastics Material and Resin Manufacturing

IS23 Synthetic Rubber Manufacturing

IS24 Organic Fiber Manufacturing

IS25 Pesticide, Fertilizer, and Other Agricultural Chemical 

Manufacturing

IS26 Pharmaceutical and Medicine Manufacturing

IS27 Paint and Coating Manufacturing

IS28 Adhesive Manufacturing

IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing

IS30 Printing Ink Manufacturing

IS31 Explosives Manufacturing

IS32 Custom Compounding of Purchased Resins

IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing

IS34 All Other Chemical Product and Preparation Manufacturing

IS35 Plastics Product Manufacturing

IS36 Rubber Product Manufacturing

IS37 Non-metallic Mineral Product Manufacturing (includes clay, glass, 

cement, concrete, lime, gypsum, and other non-metallic mineral 

product manufacturing)

IS38 Primary Metal Manufacturing

IS39 Fabricated Metal Product Manufacturing

IS40 Machinery Manufacturing
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IS41 Computer and Electronic Product Manufacturing

IS42 Electrical Equipment, Appliance, and Component Manufacturing

IS43 Transportation Equipment Manufacturing

IS44 Furniture and Related Product Manufacturing

IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade 

IS47 Services

IS48 Other (requires additional information)

4761

4762 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s) 

4763 from Table 8 of this paragraph must be selected to designate the industrial function 

4764 category(ies) that best represents the specific manner in which the chemical substance is 

4765 used. A particular industrial function category may need to be reported more than once, 

4766 to the extent that a submitter reports more than one industrial processing or use 

4767 operation/sector combination (under paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this 

4768 section) that applies to a given industrial function category under this paragraph. If more 

4769 than 10 unique combinations of industrial processing or use operations/sector/industrial 

4770 function categories apply to a chemical substance, submitters need only report the 10 

4771 unique combinations for the chemical substance that cumulatively represent the largest 

4772 percentage of the submitter's production volume for that chemical substance, measured 

4773 by weight. If none of the listed industrial function categories accurately describes a use of 

4774 a chemical substance, the category ―Other‖ may be used, and must include a description 

4775 of the use.

4776 Table 8.—Codes for Reporting Industrial Function Categories

Code Category

U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents
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U008 Dyes

U009 Fillers

U010 Finishing agents

U011 Flame retardants

U012 Fuels and fuel additives

U013 Functional fluids (closed systems)

U014 Functional fluids (open systems)

U015 Intermediates

U016 Ion exchange agents

U017 Lubricants and lubricant additives

U018 Odor agents

U019 Oxidizing/reducing agents

U020 Photosensitive chemicals

U021 Pigments

U022 Plasticizers

U023 Plating agents and surface treating agents

U024 Process regulators

U025 Processing aids, specific to petroleum production

U026 Processing aids, not otherwise listed

U027 Propellants and blowing agents

U028 Solids separation agents

U029 Solvents (for cleaning or degreasing)

U030 Solvents (which become part of product formulation or 

mixture)

U031 Surface active agents

U032 Viscosity adjustors

U033 Laboratory chemicals

U034 Paint additives and coating additives not described by other 

categories

U999 Other (specify)

4777

4778 (D) The estimated percentage, rounded off to the closest 10%, of total production 

4779 volume of the reportable chemical substance associated with each combination of 

4780 industrial processing or use operation, sector, and industrial function category. Where a 

4781 particular combination of industrial processing or use operation, sector, and industrial 

4782 function category accounts for less than 5% of the submitter's site's total production 

4783 volume of a reportable chemical substance, the percentage must not be rounded off to 0% 

4784 if the production volume attributable to that industrial processing or use operation, sector, 
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4785 and industrial function category combination is 25,000 lb. (11,340 kg) or more during the 

4786 reporting year. Instead, in such a case, submitters must report the percentage, rounded off 

4787 to the closest 1%, of the submitter's site's total production volume of the reportable 

4788 chemical substance associated with the particular combination of industrial processing or 

4789 use operation, sector, and industrial function category.

4790 (E) For each combination of industrial processing or use operation, sector, and 

4791 industrial function category, the submitter must estimate the number of sites at which 

4792 each reportable chemical substance is processed or used. For each combination associated 

4793 with each chemical substance, the submitter must select from among the ranges of sites 

4794 listed in Table 9 of this paragraph and report the corresponding code (i.e., S1 through 

4795 S7):

4796 Table 9.—Codes for Reporting Numbers of Sites

Code Range

S1 Fewer than 10 sites

S2 at least 10 but fewer than 25 sites

S3 at least 25 but fewer than 100 sites

S4 at least 100 but fewer than 250 sites

S5 at least 250 but fewer than 1,000 sites

S6 at least 1,000 but fewer than 10,000 sites

S7 at least 10,000 sites

4797

4798 (F) For each combination of industrial processing or use operation, sector, and 

4799 industrial function category, the submitter must estimate the number of workers 

4800 reasonably likely to be exposed to each reportable chemical substance. For each 

4801 combination associated with each chemical substance, the submitter must select from 

4802 among the worker ranges listed in paragraph (b)(3)(ii) of this section and report the 

4803 corresponding code (i.e., W1 though W8).
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4804 (ii) Consumer and commercial use information—(A) Using the codes listed in 

4805 Table 10 of this paragraph, submitters must designate the consumer and commercial 

4806 product category or categories that best describe the consumer and commercial products 

4807 in which each reportable chemical substance is used (whether the recipient site(s) are 

4808 controlled by the submitter site or not). If more than 10 codes apply to a chemical 

4809 substance, submitters need only report the 10 codes for the chemical substance that 

4810 cumulatively represent the largest percentage of the submitter's production volume for 

4811 that chemical, measured by weight. If none of the listed consumer and commercial 

4812 product categories accurately describes the consumer and commercial products in which 

4813 each reportable chemical substance is used, the category ―Other‖ may be used, and must 

4814 include a description of the use.

4815 Table 10.—Codes for Reporting Consumer and Commercial Product Categories

Code Category

Chemical Substances in Furnishing, Cleaning, Treatment Care Products

C101 Floor Coverings 

C102 Foam Seating and Bedding Products 

C103 Furniture and Furnishings not covered elsewhere

C104 Fabric, Textile, and Leather Products not covered elsewhere 

C105 Cleaning and Furnishing Care Products 

C106 Laundry and Dishwashing Products

C107 Water Treatment Products 

C108 Personal Care Products 

C109 Air Care Products

C110 Apparel and Footwear Care Products

Chemical Substances in Construction, Paint, Electrical, and Metal Products

C201 Adhesives and Sealants 

C202 Paints and Coatings

C203 Building/Construction Materials - Wood and Engineered Wood Products

C204 Building/Construction Materials not covered elsewhere

C205 Electrical and Electronic Products 

C206 Metal Products not covered elsewhere

C207 Batteries

Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products

C301 Food Packaging

C302 Paper Products
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C303 Plastic and Rubber Products not covered elsewhere

C304 Toys, Playground, and Sporting Equipment

C305 Arts, Crafts, and Hobby Materials

C306 Ink, Toner, and Colorant Products

C307 Photographic Supplies, Film, and Photochemicals

Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products

C401 Automotive Care Products

C402 Lubricants and Greases

C403 Anti-Freeze and De-icing Products

C404 Fuels and Related Products

C405 Explosive Materials 

C406 Agricultural Products (non-pesticidal)

C407 Lawn and Garden Care Products

Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)

4816

4817 (B) An indication, within each consumer and commercial product category 

4818 reported under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a 

4819 commercial use.

4820 (C) Submitters must determine, within each consumer and commercial product 

4821 category reported under paragraph (b)(4)(ii)(A) of this section, whether any amount of 

4822 each reportable chemical substance manufactured (including imported) by the submitter 

4823 is present in (for example, a plasticizer chemical substance used to make pacifiers) or on 

4824 (for example, as a component in the paint on a toy) any consumer products intended for 

4825 use by children age 14 or younger, regardless of the concentration of the chemical 

4826 substance remaining in or on the product. Submitters must select from the following 

4827 options: The chemical substance is used in or on any consumer products intended for use 

4828 by children, the chemical substance is not used in or on any consumer products intended 

4829 for use by children, or information as to whether the chemical substance is used in or on 

4830 any consumer products intended for use by children is not known to or reasonably 

4831 ascertainable by the submitter.
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4832 (D) The estimated percentage, rounded off to the closest 10%, of the submitter's 

4833 site's total production volume of the reportable chemical substance associated with each 

4834 consumer and commercial product category. Where a particular consumer and 

4835 commercial product category accounts for less than 5% of the total production volume of 

4836 a reportable chemical substance, the percentage must not be rounded off to 0% if the 

4837 production volume attributable to that commercial and consumer product category is 

4838 25,000 lb. (11,340 kg) or more during the reporting year. Instead, in such a case, 

4839 submitters must report the percentage, rounded off to the closest 1%, of the submitter's 

4840 site's total production volume of the reportable chemical substance associated with the 

4841 particular consumer and commercial product category.

4842 (E) Where the reportable chemical substance is used in consumer or commercial 

4843 products, the estimated typical maximum concentration, measured by weight, of the 

4844 chemical substance in each consumer and commercial product category reported under 

4845 paragraph (b)(4)(ii)(A) of this section. For each chemical substance in each commercial 

4846 and consumer product category reported under paragraph (b)(4)(ii)(A) of this section, 

4847 submitters must select from among the ranges of concentrations listed in Table 5 in 

4848 paragraph (b)(3)(viii) of this section and report the corresponding code (i.e., M1 through 

4849 M5).

4850 (F) Where the reportable chemical substance is used in a commercial product, the 

4851 submitter must estimate the number of commercial workers reasonably likely to be 

4852 exposed to each reportable chemical substance. For each combination associated with 

4853 each substance, the submitter must select from among the worker ranges listed in Table 4 
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4854 in paragraph (b)(3)(vii) of this section and report the corresponding code (i.e., W1 though 

4855 W8).

4856 § 711.20 When to report.

4857 All information reported to EPA in response to the requirements of this part must 

4858 be submitted during an applicable submission period. For the 2012 IUR, the submission 

4859 period is from February 1, 2012 to June 30, 2012. Subsequent recurring submission 

4860 periods are from June 1 to September 30 at 4–year intervals, beginning in 2011. Any 

4861 2016. In each submission period, any person described in § 711.8(a) must report during 

4862 each submission period for each chemical substanceas described in § 711.5 that the 

4863 person manufactured (including imported) during any calendar year since the last 

4864 principal reporting year (e.g., for the 2011 submission period, consider calendar years 

4865 2006, 2007, 2008, 2009, and 2010, since 2005 was the last principal reporting year).this 

4866 part. 

4867 § 711.22 Duplicative reporting.

4868 (a) With regard to TSCA section 8(a) rules. Any person subject to the 

4869 requirements of this part who previously has complied with reporting requirements of a 

4870 rule under TSCA section 8(a) by submitting the information described in § 711.15 for a 

4871 chemical substance described in § 711.5 to EPA, and has done so within 1 year of the 

4872 start of a submission period described in § 711.20, is not required to report again on the 

4873 manufacture of that chemical substance at that site during that submission period.

4874 (b) With regard to importers. This part requires that only one report be submitted 

4875 on each import transaction involving a chemical substance described in § 711.5. When 

4876 two or more persons are involved in a particular import transaction and each person 
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4877 meets the Agency's definition of ―importer‖ as set forth in 40 CFR 704.3, they may 

4878 determine among themselves who should submit the required report; if no report is 

4879 submitted as required under this part, EPA will hold each such person liable for failure to 

4880 report.

4881 (c) Toll manufacturers and persons contracting with a toll manufacturer. This 

4882 part requires that only one report per site be submitted on each chemical substance 

4883 described in § 711.5. When a company contracts with a toll manufacturer to manufacture 

4884 a chemical substance, and each party meets the Agency's definition of ―manufacturer‖ as 

4885 set forth in § 711.3, they may determine among themselves who should submit the 

4886 required report for that site. However, both the contracting company and the toll 

4887 manufacturer are liable if no report is made.

4888 § 711.25 Recordkeeping requirements.

4889 Each person who is subject to the reporting requirements of this part must retain 

4890 records that document any information reported to EPA. Records relevant to reporting 

4891 during a submission period must be retained for a period of 5 years beginning on the last 

4892 day of the submission period. Submitters are encouraged to retain their records longer 

4893 than 5 years to ensure that past records are available as a reference when new 

4894 submissions are being generated.

4895 § 711.30 Confidentiality claims.

4896 (a) Confidentiality claims. Any person submitting information under this part may 

4897 assert a business confidentiality claim for the information at the time it is submitted. Any 

4898 such confidentiality claims must be made at the time the information is submitted. 

4899 Confidentiality claims cannot be made when a response is left blank or designated as not 
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4900 known or reasonably ascertainable. These claims will apply only to the information 

4901 submitted with the claim. New confidentiality claims, if appropriate, must be asserted 

4902 with regard to information submitted during a different submission period. Guidance for 

4903 asserting confidentiality claims is provided in the instructions identified in § 711.35. 

4904 Information claimed as confidential in accordance with this section will be treated and 

4905 disclosed in accordance with the procedures in 40 CFR part 2.

4906 (b) Chemical identity. A person may assert a claim of confidentiality for the 

4907 chemical identity of a specific chemical substance only if the identity of that chemical 

4908 substance is treated as confidential in the Master Inventory File as of the time the report 

4909 is submitted for that chemical substance under this part. The following steps must be 

4910 taken to assert a claim of confidentiality for the identity of a reportable chemical 

4911 substance:

4912 (1) The submitter must submit with the report detailed written answers to the 

4913 following questions signed and dated by an authorized official.

4914 (i) What harmful effects to your competitive position, if any, or to your supplier‘s 

4915 competitive position, do you think would result from the identity of the chemical 

4916 substance being disclosed in connection with reporting under this part? How could a 

4917 competitor use such information? Would the effects of disclosure be substantial? What is 

4918 the causal relationship between the disclosure and the harmful effects?

4919 (ii) How long should confidential treatment be given? Until a specific date, the 

4920 occurrence of a specific event, or permanently? Why?

4921 (iii) Has the chemical substance been patented? If so, have you granted licenses to 

4922 others with respect to the patent as it applies to the chemical substance? If the chemical 
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4923 substance has been patented and therefore disclosed through the patent, why should it be 

4924 treated as confidential?

4925 (iv) Has the identity of the chemical substance been kept confidential to the extent 

4926 that your competitors do not know it is being manufactured or imported for a commercial 

4927 purpose by anyone?

4928 (v) Is the fact that the chemical substance is being manufactured (including 

4929 imported) for a commercial purpose available to the public, for example in technical 

4930 journals, libraries, or State, local, or Federal agency public files?

4931 (vi) What measures have been taken to prevent undesired disclosure of the fact 

4932 that the chemical substance is being manufactured (including imported) for a commercial 

4933 purpose?

4934 (vii) To what extent has the fact that this chemical substance is manufactured 

4935 (including imported) for commercial purposes been revealed to others? What precautions 

4936 have been taken regarding these disclosures? Have there been public disclosures or 

4937 disclosures to competitors?

4938 (viii) Does this particular chemical substance leave the site of manufacture 

4939 (including import) in any form, e.g., as product, effluent, emission? If so, what measures 

4940 have been taken to guard against the discovery of its identity?

4941 (ix) If the chemical substance leaves the site in a product that is available to the 

4942 public or your competitors, can the chemical substance be identified by analysis of the 

4943 product?

4944 (x) For what purpose do you manufacture (including import) the substance?
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4945 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent 

4946 confidentiality determinations regarding this chemical substance? If so, please attach 

4947 copies of such determinations.

4948 (2) If any of the information contained in the answers to the questions listed in 

4949 paragraph (b)(1) of this section is asserted to contain confidential business information 

4950 (CBI), the submitter must clearly identify the information that is claimed confidential by 

4951 marking the specific information on each page with a label such as ―confidential business 

4952 information,‖ ―proprietary,‖ or ―trade secret.‖

4953 (c) Site identity. A submitter may assert a claim of confidentiality for a site only if 

4954 the linkage of the site with a reportable chemical substance is confidential and not 

4955 publicly available. The following steps must be taken to assert a claim of confidentiality 

4956 for a site identity:

4957 (1) The submitter must submit with the report detailed written answers to the 

4958 following questions signed and dated by an authorized official:

4959 (i) Has site information been linked with a chemical identity in any other Federal, 

4960 State, or local reporting scheme? For example, is the chemical identity linked to a facility 

4961 in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) 

4962 section 311, namely through a Material Safety Data Sheet (MSDS)? If so, identify all 

4963 such schemes. Was the linkage claimed as confidential in any of these instances?

4964 (ii) What harmful effect, if any, to your competitive position do you think would 

4965 result from the identity of the site and the chemical substance being disclosed in 

4966 connection with reporting under this part? How could a competitor use such information?
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4967 Would the effects of disclosure be substantial? What is the causal relationship between 

4968 the disclosure and the harmful effects?

4969 (2) If any of the information contained in the answers to the questions listed in 

4970 paragraph (c)(1) of this section is asserted to contain CBI, the submitter must clearly 

4971 identify the information that is claimed confidential by marking the specific information 

4972 on each page with a label such as ―confidential business information,‖ ―proprietary,‖ or 

4973 ―trade secret.‖

4974 (d) Processing and use information. A submitter may assert a claim of 

4975 confidentiality for each data element required by § 711.15(b)(4) only if the linkage of the 

4976 information with a reportable chemical substance is confidential and not publicly 

4977 available. The following steps must be taken to assert a claim of confidentiality for each 

4978 data element, individually, required by § 711.15(b)(4):

4979 (1) The submitter must submit with the report detailed written answers to the 

4980 following questions signed and dated by an authorized official:

4981 (i) Is the identified use of this chemical substance publicly known? For example, 

4982 is information on the use available in advertisements or other marketing materials, 

4983 professional journals or other similar materials, or in non-confidential mandatory or 

4984 voluntary government filings or publications? Has your company ever provided use 

4985 information on the chemical substance that was not claimed as confidential?

4986 (ii) What harmful effect, if any, to your competitive position or to your 

4987 customer‘s competitive position do you think would result from the information reported 

4988 as required by § 711.15(b)(4) and the chemical substance being disclosed in connection 

4989 with reporting under this part? How could a competitor use such information? Would the 
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4990 effects of disclosure be substantial? What is the causal relationship between the 

4991 disclosure and the substantial harmful effects?

4992 (2) If any of the information contained in the answers to the questions listed in 

4993 paragraph (d)(1) of this section is asserted to contain CBI, the submitter must clearly 

4994 identify the information that is claimed confidential by marking the specific information 

4995 on each page with a label such as ―confidential business information,‖ ―proprietary,‖ or 

4996 ―trade secret.‖

4997 (e) No claim of confidentiality. If no claim of confidentiality is indicated on Form 

4998 U submitted to EPA under this part; if Form U lacks the certification required by 

4999 § 711.15(b)(1); if confidentiality claim substantiation required under paragraphs (b), (c), 

5000 and (d) of this section is not submitted with Form U; or if the identity of a chemical 

5001 substance listed on the non-confidential portion of the Master Inventory File is claimed as 

5002 confidential, EPA may make the information available to the public without further 

5003 notice to the submitter.

5004 § 711.35 Electronic filing.

5005 (a) You must use e-IURweb to complete and submit Form U; EPA Form 7740–8. 

5006 Submissions may only be made as set forth in this section.

5007 (b) Submissions must be sent electronically to EPA via CDX.

5008 (c) Access e-IURweb and instructions, as follows:

5009 (1) By website. Go to the EPA Inventory Update Reporting Internet homepage at 

5010 http://www.epa.gov/iur and follow the appropriate links.

5011 (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554–1404 or 

5012 TSCA-Hotline@epa.gov for a CD-ROM containing the instructions.