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1 MARKUP-EO12866_IUR ModificationNPRM_2010-01-28_revised_2010-07-14.doc 

2 

3 ENVIRONMENTAL PROTECTION AGENCY 

4 

5 Environmental Protection Agency 

6 

7 40 CFR Parts 704, 710 and 711 

8 

9 [EPA–HQ–OPPT–2009–0187; FRL–XXXX–X] 

10 

11 RIN 2070–AJ43 

12 

13 TSCA Inventory Update Reporting Modifications 

14 

15 AGENCY: Environmental Protection Agency (EPA). 

16 ACTION: Proposed Rule. 

17 SUMMARY: EPA proposes to amend the Toxic Substances Control Act (TSCA) Inventory 

18 Update Reporting (IUR) rule, thereby providing improved information for EPA to better identify 

19 and, where appropriate, take steps to manage risks associated with chemical substances. 

20 Additionally, improved information would be available for the public. The IUR rule, 

21 promulgated under section 8(a) of TSCA, requires manufacturers (including importers) of certain 

22 chemical substances on the TSCA Inventory of Chemical Substances to report information about 

23 the manufacturing (including import), processing, and use of those chemical substances. EPA is 

24 proposing to require electronic reporting of IUR information and to modify IUR reporting 

25 requirements, including certain circumstances that trigger reporting, the specific data to be 

26 reported, the reporting standard for processing and use information, and Confidential Business 

27 Information (CBI) reporting procedures. These modifications would provide information to 

28 better address Agency and public information needs, improve the usability and reliability of the 

29 reported data, and ensure that data are available in a timely manner. 

30 

31 DATES: Comments must be received on or before [insert date [60] days after date of 

32 publication in the Federal Register]. 

33 ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–

34 HQ–OPPT–2009-0187, by one of the following methods: 

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

36 for submitting comments. 

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

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

39 20460–0001. 

40 • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 

41 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–

42 2009-0187. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 

43 holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only 
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44 accepted during the DCO’s normal hours of operation, and special arrangements should be made 

45 for deliveries of boxed information. 

46 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–2009-0187. 

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

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

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

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

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

52 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 

53 will not know your identity or contact information unless you provide it in the body of your 

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

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

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

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

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

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

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

61 any form of encryption, and be free of any defects or viruses. For additional information about 

62 EPA’s public docket, visit the EPA Docket Center homepage at 

63 http://www.epa.gov/epahome/dockets.htm. 

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

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

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

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

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

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

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

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

72 through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public 

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

74 0280. Docket visitors are required to show photographic identification, pass through a metal 

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

76 and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all 

77 times in the building and returned upon departure. 

78 FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 

79 Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of 

80 Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 

81 NW., Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: TSCA82 Hotline@epa.gov. 

83 For technical information contact: Susan Sharkey, Chemical Control Division (7405M), 

84 Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 

85 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8789; e86 mail address: sharkey.susan@epa.gov. 

87 SUPPLEMENTARY INFORMATION: 
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88 

89 I. General Information 

90 A. Does this Action Apply to Me? 

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

92 as a byproduct) or import chemical substances and mixtures listed on the TSCA Inventory. 

93 Potentially affected entities may include, but are not limited to: 

94  Chemical manufacturers and importers (NAICS code 325 and 324110; e.g., chemical 

95 manufacturing and processing and petroleum refineries) 

96  Chemical users and processors who may manufacture a byproduct chemical substance 

97 (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal 

98 manufacturing, and semiconductor and other electronic component manufacturing) 

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

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

101 could also be affected. The North American Industrial Classification System (NAICS) codes 

102 have been provided to assist you and others in determining whether this action might apply to 

103 certain entities. If you have any questions regarding the applicability of this action to a particular 

104 entity, consult the technical person listed under FOR FURTHER INFORMATION 

105 CONTACT. 

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

107 1. Submitting CBI. Do not submit confidential business information (CBI) to EPA 

108 through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 

109 to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of 

110 the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the 

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

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

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

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

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

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

117 heading, Federal Register date and page number). 

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

119 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 

120 iii. Explain why you agree or disagree; suggest alternatives and substitute language for 

121 your requested changes. 

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

123 used. 

124 v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 
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125 sufficient detail to allow for it to be reproduced. 

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

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

128 threats. 

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

130 II. Background 

131 A. What Action is the Agency Taking?

132 In this action, EPA is proposing several amendments to the current IUR rule 

133 requirements, including moving the IUR rule text from 40 CFR part 710, subpart C to a new part 

134 in 40 CFR part 711. Where applicable, the current regulatory text reference is followed by a 

135 parenthetical containing the proposed new reference. These amendments are described in more 

136 detail in Unit III. 

137 

138 First, EPA is proposing to amend 40 CFR 710.59 (proposed 40 CFR 711.19) to require 

139 electronic reporting of the IUR data, using an Agency-provided, web-based e-IUR reporting 

140 software (e-IURweb) to submit IUR reports through the Internet to EPA’s Central Data 

141 Exchange (CDX). After the final rule’s effective date, paper submissions would no longer be 

142 accepted. 

143 

144 Second, EPA is proposing to enhance the reported manufacturing, data and the

145 processing, and use data reported. 

146 

147 Third, EPA is proposing a new definition section in proposed 40 CFR 711.3, revisions to 

148 the definition for manufacture and site, and other needed definitional modifications and 

149 additions. 

150 

151 Fourth, EPA is proposing to amend 40 CFR 710.53 (proposed 40 CFR 711.13) to change 

152 the reporting frequency from every five years to every four years. 

153 

154 Fifth, EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 711.8(a)) to 

155 modify the method used to determine whether a manufacture or importer is subject to IUR 

156 reporting. Reporting would be required if the production volume of a chemical substance met or 

157 exceeded the 25,000 lb. threshold in any calendar year since the last principal reporting year 

158 (e.g., 2005). 

159 

160 Sixth, EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 711.12(c)) to 

161 eliminate the 300,000 lb. threshold for processing and use information, thereby requiring all 

162 reporters of non-excluded substances to report information in all parts of the IUR Form U. 

163 

164 Seventh, EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 711.8(a)) to 

165 eliminate the 25,000 lb. threshold for certain chemical substances that are the subject of 

166 particular TSCA rules and/or orders and to require manufacturers (including importers) of such 

167 chemicals to report under the IUR rule, regardless of the production volume. 
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168 

169 Eighth, EPA is proposing to amend 40 CFR 710.46 (proposed 40 CFR 711.6) to make 

170 chemical substances for which an enforceable consent agreement (ECA) to conduct testing has 

171 been made under 40 CFR part 790 ineligible for exemptions, to provide a full exemption from 

172 IUR requirements for water, and to remove polymers that are already fully exempt from the 

173 partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv) (proposed 40 CFR 711.6(b)(2)(iv)). 

174 

175 Ninth, EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 711.12(c)) to 

176 modify the reporting requirements of certain manufacturing data elements. Specifically, 

177 manufacturers (including importers) would be required to report: 

178 1. The name and address belonging to the parent company. 

179 2. The current Chemical Abstracts (CA) Index Name, as used to list the substance in the 

180 Inventory, as part of the chemical identity. 

181 3. The production volume for each of the years since the last principal reporting year. 

182 4. The production volume of a manufactured (including imported) chemical substance 

183 used at the reporting site. 

184 5. Whether an imported chemical is physically present at the reporting site. 

185 6. The production volume directly exported and not domestically processed or used. 

186 7. When a manufactured chemical, such as a byproduct, is being recycled. 

187 

188 Tenth, EPA is proposing to replace the “readily obtainable” reporting standard used for 

189 the reporting of processing and use information required by 40 CFR 710.52(c)(4) (proposed 40 

190 CFR 711.12(c)(4)) with the “known to or reasonably ascertainable by” reporting standard. 

191 

192 Eleventh, EPA is proposing to amend 40 CFR 710.58 (proposed 40 CFR 711.18) to 

193 require upfront substantiation when processing and use information required by 40 CFR 

194 710.52(c)(4) (proposed 40 CFR 711.12(c)(4)) is claimed as confidential business information 

195 (CBI). 

196 

197 Twelfth, EPA is proposing to disallow confidentiality claims for processing and use data 

198 elements identified as not “known to or reasonably ascertainable by” (40 CFR 710.52(c)(4) 

199 (proposed 40 CFR 711.12(c)(4))). 

200 

201 Thirteenth, EPA is proposing to revise the list of industrial function categories for the 

202 reporting of processing and use information. EPA is also proposing to amend 40 CFR 

203 710.52(c)(4)(i)(C) (proposed 40 CFR 711.12(c)(4)(i)(C)) to replace the five-digit North 

204 American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). 

205 

206 Fourteenth, EPA is proposing to amend 40 CFR 710.52(c)(4)(ii) (proposed 40 CFR 711. 

207 12(c)(4)(ii)) to revise the list of consumer and commercial product categories for the reporting of 

208 consumer and commercial use information. EPA is also proposing to require the separate 

209 reporting for consumer or commercial categories and reporting of the number of commercial 

210 workers reasonably likely to be exposed to the subject chemical. 

211 

212 Fifteenth, EPA is proposing to eliminate the gaps in the ranges used to report 

213 concentration in 40 CFR 710.52(c)(3) and (4) (proposed 40 CFR 711.12(c)(3) and (4)). 

214 

215 B. What is the Agency's Authority for Taking this Action? 
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216 EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep 

217 current an inventory of chemical substances manufactured or processed in the United States. This 

218 inventory is known as the TSCA Chemical Substance Inventory (the TSCA Inventory). In 1977, 

219 EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 

220 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA 

221 promulgated the initial IUR rule under TSCA section 8(a) at 40 CFR part 710 (51 FR 21438, 

222 June 12, 1986) to facilitate the periodic updating of information on chemicals listed on the TSCA 

223 Inventory and to support activities associated with the implementation of TSCA. In 2003, EPA 

224 promulgated extensive amendments to the IUR rule (68 FR 848, January 7, 2003) (2003 

225 Amendments) to collect exposure-related information associated with the manufacturing, 

226 processing, and use of eligible chemical substances and to make certain other changes. 

227 

228 TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate rules under 

229 which manufacturers and processors of chemical substances and mixtures (collectively referred 

230 to hereinafter as chemical substances) must maintain such records and submit such information 

231 as the Administrator may reasonably require. TSCA section 8(a) generally excludes small 

232 manufacturers and processors of chemical substances from the reporting requirements 

233 established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to 

234 require TSCA section 8(a) reporting from small manufacturers and processors with respect to 

235 any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 

236 4, 5(b)(4), or 6, or that is the subject of an order in effect under TSCA section 5(e), or that is the 

237 subject of relief granted pursuant to a civil action under TSCA section 5 or 7. The standard for 

238 determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 

239 (proposed 40 CFR part 711) is found at 40 CFR 704.3. Processors are not currently subject to 

240 the rules at 40 CFR part 710 (proposed 40 CFR part 711). 

241 

242 C. What is the Current Inventory Update Reporting (IUR) Rule? 

243 

244 The IUR rule, as modified by the 2003 Amendments, requires U.S. manufacturers 

245 (including importers) of chemicals listed on the TSCA Inventory to report to EPA every five 

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

247 year in quantities of 25,000 lb. or greater at any single site they own or control (see 40 CFR part 

248 710, subpart C). IUR data were collected five times prior to the 2003 Amendments: in 1986, 

249 1990, 1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. EPA uses the 

250 TSCA Inventory and data reported under the IUR rule to support many TSCA-related activities 

251 and to provide overall support for a number of EPA and other federal health, safety, and 

252 environmental protection activities. The Agency also makes the data available to the public, to 

253 the extent possible given confidential business information claims. 

254 

255 Persons manufacturing or importing chemical substances are required to report 

256 information such as company name, site location and other identifying information, production 

257 volume of the reportable chemical substance, and exposure-related information associated with 

258 the manufacture of each reportable chemical substance. This exposure-related information 

259 includes the physical form and maximum concentration of the chemical substance and the 

260 number of potentially exposed workers (40 CFR 710.52). Several groups of chemical substances 

261 are generally excluded from IUR reporting requirements: e.g., polymers, microorganisms, 

262 naturally occurring chemical substances, and certain natural gas substances (40 CFR 710.46). 

263 
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264 Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lb. or 

265 greater manufactured (including imported) during the reporting year at any single site) are 

266 required also to report certain processing and use information (40 CFR 710.52(c)(4)). This 

267 information includes process or use category; NAICS code; industrial function category; percent 

268 production volume associated with each process or use category; number of use sites; number of 

269 potentially exposed workers; and consumer/commercial information such as use category, use in 

270 or on products intended for use by children, and maximum concentration. 

271 

272 The 2006 submission was the first instance where manufacturers (including importers) 

273 of inorganic chemical substances were required to report under the IUR rule. For the 2006 

274 submission only, inorganic chemical substances were partially exempted from the IUR rule, and 

275 manufacturers of such chemicals were required to report the manufacturing information and not 

276 the processing and use information, regardless of production volume. A partial exemption means 

277 that a submitter is exempt from the processing and use reporting requirements described in 40 

278 CFR 710.52(c)(4). Under the current rule, for future collections (i.e., for 2011 or 2016 IUR 

279 collections, etc.), the partial exemption for inorganic chemicals will no longer be applicable and 

280 submitters will report in the same manner as is required for organic chemicals, including 

281 processing and use information (40 CFR 710.46(b)(3)). In addition, starting with the 2006 

282 collection and for future collections, specifically listed petroleum process streams and other 

283 specifically listed chemical substances are partially exempt, and manufacturers of such 

284 substances are not required to report processing and use information. These partial exemptions 

285 will continue in subsequent submission periods (including 2011), for as long as the chemical 

286 substances remain on these partial exemption lists (40 CFR 710.46(b)(1) and (b)(2) (proposed 40 

287 CFR 711.6(b)(1) and (b)(2))). 

288 

289 Non-confidential data, including both searchable and separately downloadable 

290 databases, and a 2006 IUR data summary report are available for public use on the IUR website 

291 (http://www.epa.gov/iur). 

292 

293 D. Why is the Agency Proposing Changes in the IUR Rule? 

294 

295 EPA is proposing to modify the IUR rule to meet four primary goals: (1) to tailor the 

296 information collected to better meet the Agency’s overall information needs; (2) to increase its 

297 ability to effectively provide public access to the information; (3) to obtain new and updated 

298 information relating to potential exposures to a subset of chemical substances listed on the TSCA 

299 Inventory; and (4) to improve the usefulness of the information reported. EPA believes that 

300 expanding the range of chemicals for which comprehensive information is to be reported and 

301 adjusting the specific reported information, the method and frequency of collecting the 

302 information, and CBI requirements will accomplish these goals. 

303 

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

305 “adequate data should be developed with respect to the effect of chemical substances and 

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

307 responsibility of those who manufacture and those who process such chemical substances and 

308 mixtures” (TSCA section 2(b)(1)). Modifications to the IUR requirements by the 2003 

309 Amendments (68 FR 848, January 7, 2003) provided many improvements to the data collected 

310 through this rule, and EPA’s efforts to use the 2006 IUR data have identified areas where further 

311 improvements are needed. The modifications described in this proposed rule would change 
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312 some of the reporting requirements in an effort by EPA to (1) ensure the required information is 

313 properly reported and that the information in the Agency’s database reflects the information 

314 provided in the IUR reports, (2) increase the usability of the collected information, (3) increase 

315 the availability of information for the public, and (4) focus reporting on information that is most 

316 needed by the Agency. In addition, these proposed changes will enable EPA and other Federal 

317 agencies to improve their risk screening capabilities, enabling them to better assess and manage 

318 risk, and improving public awareness of basic information about a large number of chemical 

319 substances. 

320 

321 EPA provided reporting software for the 2006 IUR submission period and encouraged 

322 electronic reporting through the Internet, using the Agency’s Central Data Exchange (CDX). 

323 EPA’s experience with populating the IUR database and with using the 2006 IUR data provided 

324 insight into how well both the reporting software and submission methods worked. For instance, 

325 because of validations built into the reporting software, electronic submissions were able to be 

326 quickly assimilated into the IUR database. Other forms of submission required the documents to 

327 be scanned in or hand entered, and resulted in many introduced errors during the data entry 

328 process. Additionally, for 2006 IUR, certain types of submissions (e.g., joint submissions) could 

329 not be reported electronically. Other problems, such as incorrect chemical identities, delayed the 

330 incorporation of the data into the database, resulting in the Agency’s inability to begin using the 

331 2006 IUR data and providing public access. The proposed modifications associated with 

332 reporting methods and changes to the reporting software will better ensure the information 

333 reported to the Agency is accurate and in compliance with the IUR requirements. 

334 

335 During the development of the 2003 Amendments, the Agency considered the data 

336 accuracy and reliability needed for screening level exposure analyses and took several steps to 

337 ensure the IUR data met those needs. Screening level data need not be precise, but should be 

338 accurate and reliable enough for the Agency to develop screening level assessments. The 

339 amended IUR rule supplies exposure-related information the Agency did not previously possess, 

340 recognizing that industry has a greater knowledge than EPA about its own operations and the 

341 uses of chemicals it manufactures and sells. 

342 EPA’s extensive use of the 2006 IUR data in the Agency’s Existing Chemicals Program 

343 is representative of how EPA envisioned the data would be used when the 2003 Amendments 

344 were promulgated. In 2007, the Agency began to develop and post screening-level hazard, 

345 exposure, and risk characterizations for high production volume (HPV) chemicals, which are 

346 those chemicals produced nationally at aggregated volumes of one million lb. or more per year. 

347 In developing these characterizations, EPA identified areas where the IUR data collection can be 

348 improved and enhanced. Improvements would allow EPA to better identify and take follow-up 

349 action on chemicals that may pose potential risks to human health or the environment. 

350 During its review of the IUR data, EPA identified numerous examples of CBI claims on 

351 the IUR form where the same or similar information to that claimed as CBI was already available 

352 to the public. In several cases, information on production volume and uses for a chemical or 

353 group of chemicals was claimed CBI on the IUR form, while the same or similar information 

354 was submitted voluntarily by the company without such a claim under the HPV Challenge 

355 Program. In those cases, EPA had previously made the information publicly available through 

356 the High Production Volume Information System (HPVIS) or on EPA’s Existing Chemicals 
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357 website. Correct designation of reported information as non-confidential will facilitate reporting 

358 of this information to the public. 

359 

360 EPA Administrator Lisa P. Jackson has made it a priority to strengthen the Agency’s 

361 chemicals management program, including the development of new Regulatory Risk 

362 Management Actions, the development of Chemical Action Plans targeting the Agency’s risk 

363 management efforts, requiring the reporting of information needed to understand chemical risks, 

364 and increasing public access to information about chemicals (see 

365 http://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html). The IUR provides 

366 exposure-related data needed to understand chemical risks. These proposed modifications to the 

367 IUR rule would enhance the capabilities of the Agency to ensure risk management actions are 

368 taken on chemicals posing which may pose the greatest concern. More in-depth reporting of the 

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

370 adjustments to the specific data elements are important aspects of this action. By enhancing the 

371 data supplied to the Agency, EPA expects to more effectively and expeditiously identify and 

372 address potential risks posed by chemicals and provide improved access and information to the 

373 public. 

374 

375 An important and anticipated result of this action is that EPA would receive more 

376 publicly available, non-CBI information, therefore increasing the transparency and public 

377 accessibility of the chemical use and exposure information and ensuring consistency with the 

378 President’s policy goals for government reliance on and public availability of scientific 

379 information. 

380 

381 III. Modifications Affecting All Manufacturers (Including Importers) 

382 

383 As discussed in detail in Unit III.C. of this preamble, under this proposal, sites that 

384 manufactured (including imported) a reportable chemical substance in quantities of 25,000 lb. or 

385 more in any calendar year since the last IUR principal reporting year (e.g., 2005) would be 

386 required to complete all manufacturing (including production volume), processing, and use 

387 information for the principal reporting year (e.g., 2010), plus production volume information for 

388 all the preceding years since the last IUR principal reporting year (e.g., 2006 through 2009, for 

389 the principal reporting year 2010). Draft detailed instructions for completing the IUR 

390 submission are available in the docket established for this rulemaking. (Ref. 2) 

391 

392 Persons making an IUR submission would be required to use e-IURweb, the Agency393 provided web-based software designed to complete Form U (the IUR reporting form) and submit 

394 the information electronically over the Internet, through EPA’s Central Data Exchange (CDX). 

395 The 2011 e-IURweb will be similar in format to the 2006 e-IUR downloadable software, and will 

396 include changes associated with the proposed amendments that are finalized and improved 

397 validation checks. A more detailed description of e-IURweb and the electronic submission 

398 process is provided in Unit III.B. 

399 

400 The following discussion describes the proposed changes to the IUR rule contained in this 

401 action. 

402 

403 A. Technical Modifications to the Regulatory Text 

404 
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405 Currently, 40 CFR part 710 contains three subparts. Subpart A contains regulatory text 

406 associated with the original compilation of the TSCA Inventory; Subpart B contains regulatory 

407 text associated with the IUR rule covering the update reporting in 2002; and Subpart C contains 

408 the regulatory text associated with the IUR rule for 2006 and beyond. The chemicals that are 

409 covered by the IUR rule are on the Master Inventory File, which includes chemicals from the 

410 original Inventory compilation and those added subsequently through the notice requirements of 

411 section 5 of TSCA. Because the IUR rule applies to a list of chemicals included in the original 

412 Inventory plus additional chemicals added subsequently, and because the Agency from time to 

413 time has modified the IUR rule, the Agency believes the regulatory text associated with the IUR 

414 rule should be in its own section in the Code of Federal Regulations (CFR), distinct from both 

415 the original TSCA Inventory rules and from the TSCA section 5 requirements. Where EPA is 

416 proposing to update the location of existing regulatory provisions, or to otherwise update 

417 regulatory provisions in a non-substantive fashion (e.g., to update cross-references to reflect the 

418 movement of referenced provisions) EPA does not thereby reopen the substance of such 

419 provisions for public comment, except where public comment is expressly requested.

420 

421 1. Moving the IUR regulatory text from Part 710 subpart C to Part 711 and 

422 eliminating subpart divisions. 

423 

424 Subpart C of 40 CFR part 710, §§ 710.43 to 710.59, contains the IUR regulatory text. EPA 

425 is proposing to move all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part 711 

426 and would add a new Scope and Compliance section (40 CFR 711.1). Specific sections would 

427 be moved as follows: § 710.43 would become § 711.3; § 710.45 would become § 711.5; § 

428 710.46 would become § 711.6; § 710.48 would become § 711.8; § 710.49 would become § 

429 711.9; § 710.50 would become § 711.10; § 710.52 would become § 711.12; § 710.53 would 

430 become § 711.13; § 710.55 would become § 711.15; § 710.57 would become § 711.17; § 710.58 

431 would become § 711.18; and § 710.59 would become § 711.19. Because all of the text of 

432 Subpart C would be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a 

433 Subpart C. Neither part 710 or part 711 would have any subparts. 

434 

435 2. Consolidation of definitions. 

436 

437 As part of moving the regulatory text from 40 CFR part 710, subpart C to 40 CFR part 711, 

438 EPA is proposing to consolidate definitions copied from 40 CFR 710.3 and those currently found 

439 at 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropriate definition is already 

440 in place in section 3 of TSCA or at 40 CFR 704.3, and an additional definition of the term in 40 

441 CFR 711.3 would therefore be unnecessarily duplicative. The definitions in section 3 of TSCA 

442 and at 40 CFR 704.3 would be incorporated by reference into 40 CFR 711.3, except insofar as 40 

443 CFR 711.3 provides a modified definition of a term also defined at 40 CFR 704.3. 

444 

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

446 the IUR rule, EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. 

447 The TSCA mixture definition differs from the definition in 40 CFR 710.3 and 40 CFR 720.3, the 

448 regulations used to determine the chemicals listed on the Inventory, in that it does not 

449 specifically address hydrates. While hydrates are not addressed specifically in the definition, a 

450 hydrate is a mixture of water and an anhydrous chemical substance. As with mixtures in 

451 general, the individual components of the mixture may be separately reportable at the time of 

452 their manufacture or import. EPA believes, for purposes of the IUR rule, it is not necessary to 

Comment [s1]: Added as 

per outcome of elevation 
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453 include hydrates separately in the definition of mixture. The Agency would continue to include 

454 such a discussion in the Instructions. (Ref. 2) 

455 

456 Unit III.C. contains further discussions about changes to specific definitions, in relation to the 

457 modifications included in this proposal. A summary of all IUR-related definitions is available in 

458 the docket. (Ref. 3) 

459 

460 3. Delete non-isolated intermediate definition from 710.3. 

461 

462 EPA added a definition to 40 CFR 710.43 for the term “non-isolated intermediate” as part of 

463 the 2003 Amendments (68 FR 848, January 7, 2003). Subsequently, as part of the IUR 

464 Revisions Rule (70 FR 75059, December 19, 2005), EPA erroneously moved the definition to 40 

465 CFR 710.3 from 40 CFR 710.43. EPA is proposing to delete the definition from 40 CFR 710.3 

466 as this definition was not associated with the original Inventory, and therefore does not belong in 

467 40 CFR 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, would be 

468 incorporated by reference into the IUR definitions at proposed 40 CFR 711.3. 

469 

470 4. Deleting Subpart B text. 

471 

472 EPA is proposing to delete the regulatory text contained in 40 CFR part 710, §§ 710.23 to 

473 710.39 (subpart B). This text refers to IUR submission periods of 2002 and earlier and is 

474 obsolete. As noted in § 710.1, the Agency expressed its intent to remove subpart B once the 

475 2002 update was complete. 

476 

477 5. Deleting superfluous text associated with reporting production volumes. 

478 

479 EPA is proposing to delete the phrase “provided that the reported figures are within ±10% of 

480 the actual volume” from the production volume reporting requirements currently found in 40 

481 CFR 710.52(c)(3)(iv) (proposed 40 CFR711.12(b)(3)(iv)). The revised wording would be “This 

482 amount must be reported to two significant figures of accuracy.” The deleted phrase is 

483 superfluous because any number reported accurately to two significant figures is within ten 

484 percent of the correct value. 

485 

486 6. Correcting text associated with reporting number of sites and number of workers. 

487 

488 EPA is proposing to replace the phrase “less than” with the phrase “fewer than” in the ranges 

489 used to report the number of workers currently found in the table in 40 CFR 710.52(c)(3)(v) 

490 (proposed 40 CFR 711.12(c)(3)(vii)) and the number of sites currently found in the table in 40 

491 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 711.12(). This proposed change would make the 

492 phrases describing the ranges grammatically correct. 

493 

494 B. Method of submission. 

495 

496 The upcoming IUR submission period, during which submitters will be required to report the 

497 IUR information to EPA, will be June 1 to September 30, 2011. The Agency will make e498 IURweb and associated guidance materials available to submitters prior to the start of the 

499 submission period. Draft instructions are included in the docket for this proposed rule. 

500 
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501 EPA is proposing to require the mandatory use of Agency-provided, web-based reporting 

502 software (e-IURweb) to complete the IUR Form U and the Central Data Exchange (CDX) to 

503 submit the completed Form U to the Agency. Users of CDX are required to register and to 

504 submit an authorized signature agreement. 

505 

506 EPA accepted 2006 IUR submissions in several ways. Submissions could be completed and 

507 delivered electronically via the Internet and CDX, or submissions could be completed on paper 

508 or electronic media (i.e., as a file on a CD) and delivered by mail or a delivery service. 

509 Approximately one-third of the submissions were made electronically, and EPA was able to 

510 immediately process and quickly begin to use the information from those electronic submissions. 

511 Submissions sent as a file on a CD were printed and, along with paper submissions, scanned into 

512 an electronic system. 

513 

514 Due mostly to the time and resources needed to review and correct submitter- and 

515 scanning-related errors associated with non-electronic submissions, EPA required over two years 

516 to validate and process the data from the 2006 IUR. The Agency had to take extra steps in order 

517 to correct the data during that period, such as accessing the original submission instead of the 

518 information in the IUR database. In addition, EPA released the public database in December 

519 2008 without information on approximately five percent of the reported chemicals due to the 

520 high error rate experienced with the 2006 IUR data collection and receipt. A large number of 

521 errors were created through the scanning process and required correction by hand, which was 

522 very labor intensive. The introduced errors included incorrectly scanned chemical identities and 

523 indications of whether a data element was claimed CBI. An incorrectly recorded CBI claim 

524 could lead to the inadvertent disclosure of confidential information or to the non-release of non525 confidential information. 

526 

527 EPA also detected significant errors not related to scanning on a substantial number of 

528 reporting forms and faced difficulties resolving issues pertaining to submissions with incorrect 

529 chemical identification information. Some of the errors included submitters not specifically 

530 identifying a chemical substance, providing chemical names and CAS Registry Numbers that did 

531 not match, or providing a CAS Registry Number that did not exist. Often, the submitted data did 

532 not conform to the reporting requirements described and explained in the IUR rule and 2006 

533 guidance documents. 

534 

535 The 2006 IUR reporting software provided by the Agency contained a validation program 

536 designed to identify certain errors prior to submission. Sometimes a submitter used the software 

537 to prepare a submission, but printed the reporting form prior to completing the validation check 

538 because it was not able to pass the validation. Such reports typically contained incomplete or 

539 incorrect information, and EPA needed to contact the submitter or take other steps to correct the 

540 data prior to entering it into the database. 

541 

542 EPA believes the proposed requirement to use e-IURweb to report electronically would 

543 eliminate problems related to the scanning of paper documents, incorrect chemical identities, and 

544 other errors introduced by the submitter. These errors substantially delayed the availability of 

545 the IUR information to both internal EPA programs, such as the Existing Chemicals Program, 

546 and the public. 

547 

548 1. Updated e-IURweb reporting software 
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549 

550 EPA developed e-IUR reporting software for use in preparing and submitting reports 

551 electronically during the 2006 IUR submission period (see 

552 http://www.epa.gov/iur/tools/software.html). For the 2011 submission period, EPA will provide 

553 a free web-based application in place of the 2006 downloadable software. The 2011 e-IURweb 

554 software will would feature several enhancements over the 2006 e-IUR software. These 

555 improvements include a sophisticated validation system, which would alert users when a 

556 required field on the form is either missing information or contains certain kinds of potentially 

557 incorrect information. Other updates are expected to include automated chemical identity checks, 

558 automated company and site identity checks, and the facilitation of joint submissions and 

559 amendments. For the 2011 e-IUR, EPA is also considering a free web-based application in place 

560 of, or in addition to, free downloadable software.

561 

562 2. Require electronic submissions over the Internet 

563 

564 EPA is proposing to require that manufacturers (including importers) submit their IUR 

565 reports to the Agency through CDX via the Internet. EPA would require that all submissions be 

566 generated using e-IURweb, as described in Unit III.B.1. Electronic submissions would ensure 

567 that IUR data will have completed a basic validation check, could be quickly incorporated into a 

568 database and ready for immediate Agency use, and would not be subject to subsequent data entry 

569 errors. Furthermore, EPA believes the required use of e-IURweb and CDX would reduce the 

570 reporting burden on industry by reducing both the cost and the time required to review, edit and 

571 transmit data to the Agency. After the final rule’s effective date, EPA would no longer accept 

572 paper submissions or electronic media (i.e., as a file on a CD) for any IUR submission. 

573 

574 EPA is proposing that submission of IUR data through CDX become EPA’s required 

575 submission method for several reasons. Electronic submission enables EPA to notify the 

576 submitter that the Agency has received its submission, it reduces reporting errors, and it enables 

577 data to be available for Agency and public use more quickly. During the comment period for the 

578 renewal of the Information Collection Request (ICR) (73 FR 51805, September 5, 2008), EPA 

579 received positive comments regarding the use of CDX, the encrypted Internet submission 

580 process, and the ability to use a secure electronic signature method to submit IUR reports. 

581 

582 EPA requests comment on whether there are circumstances in which a company may not 

583 have Internet access to report IUR data electronically

584 

585 3. Electronic Signature process 

586 

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

588 submitter must first register with CDX. CDX registration is a requirement for all electronic 

589 submissions using CDX and is not being introduced with this proposal. During the 2006 IUR, 

590 submitters were required to complete an electronic signature agreement (ESA) and to submit the 

591 agreement in hard copy with a wet ink signature to EPA in order to complete the CDX 

592 registration. (Ref. 4) There was confusion among some submitters regarding the correct identity 

593 of the individual eligible to register for CDX and the individual required to sign the ESA. 

594 

595 EPA is making changes to the registration process in order to address problems identified 

596 during the 2006 IUR electronic reporting. For 2011 IUR reports, EPA is modifying the 2006 
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597 ESA to identify more clearly the individual(s) required to sign the agreement. The Agency is 

598 developing an ESA process similar to that planned for New Chemical Program electronic 

599 submissions. (Ref. 5) Each IUR submission must have an authorized official associated with the 

600 submission, who is the person signing the certification statement and submitting the IUR report 

601 via CDX. The authorized official would need to complete both an ESA and the CDX 

602 registration process. 

603 

604 EPA is requesting comment on whether some reporting sites may need or desire to have 

605 more than one individual complete an electronic signature agreement, so that other individuals 

606 could add information to the IUR submission. The other individual may be a paid employee of 

607 the company, an outside consultant for the company, or an authorized representative agent for 

608 the company. While this individual would not be able to sign the certification statement required 

609 for the initial IUR submission, he or she would be able to provide additional information, if 

610 needed, using CDX. For 2006 and prior IUR submissions, submitters were not able to provide 

611 additional information electronically. 

612 

613 EPA is considering developing a single Electronic Signature Agreement and CDX 

614 registration process that would be applicable to all TSCA programs. EPA believes a company or 

615 site may want to use the same authorized official for both Premanufacture Notice (PMN) 

616 submissions and IUR submissions. EPA is interested in obtaining comments on this approach. 

617 For example, would the authorized official responsible for signing both an IUR submission and a 

618 PMN submission be the same person? 

619 

620 C. Modifications to Selected Definitions

621 

622 As part of developing the definition section for 40 CFR part 711, EPA is proposing to 

623 modify six definitions associated with the IUR rule and to add four new definitions. In 40 CFR 

624 704.3 and 40 CFR 710.3, EPA is also proposing to modify the definition of importer by 

625 removing the citation to 19 CFR 1.11. The citation, which would correctly read 19 CFR 101.1, is 

626 not needed for this definition because it does not add additional information to the definition of 

627 importer. 

628 

629 1. Manufacture and Manufacturer 

630 

631 In order to improve the information submitted through the IUR rule, EPA is proposing to 

632 modify the definition of manufacture by incorporating elements from the 40 CFR 720.3 

633 definition for manufacturer. The proposed 40 CFR 711.3 definition of manufacture would allow 

634 persons contracting with a toll manufacturer to report the chemical physically manufactured at 

635 the toll manufacturer’s site. Under the proposed definition of site, the site information would be 

636 the toll manufacturer’s site (see Unit III.C.2.). Adopting this definition would allow the person 

637 contracting for the manufacture of a chemical substance to report the information on the 

638 industrial processing and use of a chemical substance and on the consumer and commercial uses 

639 of a product containing the chemical substance. Information on the uses of a chemical substance 

640 is often unavailable to a toll manufacturer who produces a chemical substance for another 

641 person. EPA is proposing to include a modified definition of manufacture in 40 CFR part 711 

642 instead of adopting the definition of manufacturer from 40 CFR 720.3 because the IUR rule does 

643 not use the term manufacturer. In order to avoid any confusion with the definitions of these 

644 terms found at 40 CFR 704.3, the Agency is also proposing to add a simple definition for the 
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645 term manufacturer to 40 CFR 711.3. In addition to the proposed change to the definition of 

646 manufacture, EPA is proposing to add a paragraph (c) to the proposed regulation at 40 CFR 

647 711.15 to clarify the reporting relationship between the contracting company and the toll 

648 manufacturer. The contracting company is primarily responsible for the IUR reporting, but in 

649 the event the contracting company does not report, the toll manufacturer must report. Both the 

650 contracting company and the toll manufacturer are liable if no report is made. Note that the 

651 contracting company and the toll manufacturer should confer with each other to avoid duplicate 

652 reporting. 

653 

654 With this proposal, the term manufacture therefore would be defined under the IUR rule 

655 to mean “to manufacture, produce, or import for commercial purposes. Manufacture includes the 

656 extraction, for commercial purposes, of a component chemical substance from a previously 

657 existing chemical substance or a complex combination of substances. When a substance, 

658 manufactured other than by import, is (1) produced exclusively for another person who contracts 

659 for such production, and (2) that other person specifies the identity of the substance and controls 

660 the total amount produced and the basic technology for the plant process, that substance is jointly 

661 manufactured by the producing manufacturer and the person contracting for such production.” 

662 Also with this proposal, the term manufacturer would be defined under the IUR rule to mean “a 

663 person who manufactures a chemical substance.” 

664 

665 2. Site 

666 

667 EPA is proposing to amend the definition of site to: (1) clarify that the importer’s site must 

668 be a U.S. address, (2) accommodate manufacturing under contract, and (3) accommodate 

669 portable manufacturing units. See Unit III.I for a further discussion of this proposal as it relates 

670 to importers. As described in Unit III.C.1., the proposed 40 CFR 711.3 definition of 

671 manufacture would allow persons contracting with a toll manufacturer to report the chemical 

672 physically manufactured at the toll manufacturer’s site and the site identification information 

673 pertaining to the toll manufacturer’s site. 

674 

675 EPA identified the need to accommodate portable manufacturing units during the 2006 IUR 

676 submission period. Two examples of portable manufacturing units are tanks used to manufacture 

677 calcium hydroxide slurry for use in building construction and road and highway projects, and 

678 tanks used to mix anhydrous ammonia and water to manufacture ammonium hydroxide prior to 

679 application to agricultural lands. EPA is interested in including chemical manufacturing that is, 

680 for instance, performed by road crews or is occurring at construction sites at which chemicals are 

681 mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifiers. 

682 The site of physical manufacturing could change on a frequent basis. Manufacturers would 

683 report the aggregated production volume for all of the portable manufacturing units sent out to 

684 different locations from a single distribution center. The address of the distribution center would 

685 be reported as the site location. EPA is interested in comments on whether the proposed 

686 definition addressing portable manufacturing units would result in reporting, under the IUR rule, 

687 for situations similar to those presented as examples. 

688 

689 With this proposal, the term site would be defined under the IUR rule to mean “a contiguous 

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

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

692 
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693 (a) For substances manufactured under contract, i.e., by a toll manufacturer, the site is the 

694 location where the chemical substance is physically manufactured. 

695 

696 (b) The site for an importer who imports a chemical substance described in §711.5 is the U.S. 

697 site of the operating unit within the person's organization that is directly responsible for 

698 importing the substance. The import site, in some cases, may be the organization's 

699 headquarters in the United States. If there is no such operating unit or headquarters in the 

700 United States, the site address for the importer is the U.S. address of an agent acting on 

701 behalf of the importer who is authorized to accept service of process for the importer. 

702 

703 (c) For portable manufacturing units sent out to different locations from a single distribution 

704 center, the distribution center shall be considered the site.” 

705 

706 3. Electronic-Reporting Related Definitions 

707 

708 EPA is proposing to add two new terms, Central Data Exchange (CDX) and electronic 

709 IUR (e-IURweb). The Agency is adding these terms to provide clarity to the proposed 

710 requirement for electronic reporting of IUR data. The term CDX means “EPA’s centralized 

711 electronic document receiving system, or its successors, including associated instructions for 

712 registering to submit electronic documents.” The new definition would make the term consistent 

713 with the new PMN definition. The term e-IURweb means the “electronic, web-based- IUR 

714 software provided by EPA for the completion and submission of the IUR Form U report.” 

715 

716 4. Processing and Use-Related Definitions 

717 

718 EPA is proposing to amend the definitions of the terms commercial use and consumer use

719 in order to make them more consistent with the definitions developed collaboratively by the 

720 United States and Canada. See Unit III.F.8 for further information. The proposed definitions for 

721 these two terms differ in wording from the Canadian version to ensure the use of terminology 

722 defined in IUR and related regulations, and EPA believes the basic application of these two 

723 terms would not differ from the basic application of the Canadian definitions. (Ref. 13) The term 

724 commercial use would mean “the use of a chemical substance or a mixture containing a chemical 

725 substance (including as part of an article) in a commercial enterprise providing saleable goods or 

726 services.” Examples included in the § 710.43 definition would be eliminated. The slightly 

727 modified definition of consumer use would be “the use of a chemical substance or a mixture 

728 containing a chemical substance (including as part of an article) when sold to or made available 

729 to consumers for their use.” The restrictions associated with where a consumer would use the 

730 product would be removed. 

731 

732 EPA is proposing to add a definition for the term industrial function. For the 2006 IUR, 

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

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

735 would make the Agency’s requirements consistent with those collaboratively developed with 

736 Canada. (Ref. 13) Additional discussion of those requirements is in Unit III.F.7. With this 

737 proposal, industrial function would mean “the intended physical or chemical characteristic for 

738 which a chemical substance or mixture is consumed as a reactant; incorporated into a 

739 formulation, mixture, reaction product, or article; repackaged; or used.” 

740 
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741 5. Principal Reporting Year and Submission Period 

742 

743 As described in Unit II.A, EPA is proposing to change the reporting cycle from every 

744 five years to every four years and to require the reporting of production volumes for each 

745 calendar year since the last principal reporting year. EPA is proposing to modify the terms 

746 reporting year and submission period to reflect these changes. 

747 

748 The term reporting year would be modified to add the term “principal” and to replace 

749 the word “information” with “manufacturing, processing and use data.” These changes are to 

750 indicate that the principal reporting year is the year in which most of the reported data are based. 

751 Under the current proposal, the principal reporting year is the latest complete calendar year 

752 proceeding the submission period. Additionally, EPA is proposing to remove the reference to 

753 “the calendar year at 5-year intervals thereafter” and to remove the reference to “calendar year 

754 2005.” With these changes, the term principal reporting year would be defined as “the calendar 

755 year in which manufacturing, processing, and use activities associated with the data reported to 

756 EPA during an IUR submission period occur. Production volume for manufacturing activities in 

757 other years of the reporting cycle may also be reportable during the submission period, but full 

758 manufacturing, processing, and use data are reported only for activities during the principal 

759 reporting year.” 

760 

761 The term submission period would be modified by deleting the phrase “generated during the 

762 reporting year.” With this change, the definition of submission period would reflect that data for 

763 years in addition to the principal reporting year would be reported. With this change, the 

764 definition of submission period would mean “the period in which manufacturing, processing, and 

765 use data are submitted to EPA.” 

766 

767 D. Modifications to Reporting Thresholds 

768 

769 Reporting thresholds are used to determine when IUR reporting is required for a subject 

770 chemical at a manufacturing (including importing) site. Every person manufacturing (including 

771 importing) a non-excluded substance at or above the 25,000 lb. threshold is required to report 

772 information in Parts I. and II. of the IUR Form U. Beginning with the 2006 IUR submission 

773 period, every person manufacturing (including importing) a non-excluded substance at or above 

774 the 300,000 lb. threshold was required to report information in Part III. of Form U, unless the 

775 substance was partially exempt. EPA is proposing three changes related to the reporting 

776 thresholds: (1) determination of whether you meet the 25,000 lb. threshold, (2) elimination of 

777 the 300,000 lb. threshold for reporting information in Part III, and (3) elimination of the 25,000 

778 lb. reporting threshold for certain chemicals. 

779 

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

781 requirements. 

782 

783 Currently, a one-year snap shot of manufacturing (including importing) is used to determine 

784 the need to report for the IUR rule. The method used to make the reporting determination 

785 involves identifying that a person manufactured (including imported) a chemical substance listed 

786 on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR 

787 submission period); that the chemical substance was not otherwise exempt; and that the 

788 associated production volume (domestically manufactured plus imported volumes) met or 
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789 exceeded 25,000 lb. for the principal reporting year (e.g., 2005 for the 2006 IUR submission 

790 period). 

791 

792 EPA is proposing to modify the method used to determine whether a person is subject to IUR 

793 reporting. The proposed method would be to determine whether, for any calendar year since the 

794 last principal reporting year, a chemical was manufactured (including imported) at a site in 

795 production volumes of 25,000 lb. or greater. . The proposed method would be effective after 

796 the 2011 submission period. 

797 

798 For example, assume the next submission period occurs in 2015. The principal reporting 

799 year for the 2011 submission period is calendar year 2010. Therefore, for the 2015 submission 

800 period, it would be necessary to examine the annual production volumes for the years 2011 to 

801 2014 for the site. If the production volume for a reportable chemical substance were 25,000 lb. or 

802 greater for any calendar year during that four-year period, then it would be necessary to report 

803 the chemical substance, unless it is otherwise exempt. For instance, a subject chemical with 

804 production volumes of 5,000 lb. in 2014 and 35,000 lb. in 2012 would be reported for the 2015 

805 IUR. Regardless of the 2014 production volume, in this example scenario the 2015 IUR 

806 submission would contain detailed information based on manufacturing during the 2014 calendar 

807 year and production volume information only for the years 2011 through 2013, as described in 

808 Unit III.F.4.i.

809 For the 2011 submission period, it would be necessary to examine the annual production 

810 volumes for the years 2006 to 2010 for the site. If the production volume for a reportable 

811 chemical substance was 25,000 lb. or greater for any calendar year during that five-year period, 

812 then it would be necessary to report the chemical substance, unless it is otherwise exempt. For 

813 instance, a subject chemical with production volumes of 5,000 lb. in 2010 and 35,000 lb. in 2007 

814 would be reported for the 2011 IUR. Regardless of the 2010 production volume, in this example 

815 scenario the 2011 IUR submission would contain detailed information based on manufacturing 

816 during the 2010 calendar year and production volume information only for the years 2006 

817 through 2009, as described in Unit III.F.4.i., due to the 2007 production volume.

818 

819 EPA is proposing this change because of the mounting evidence that many chemicals, even 

820 larger volume chemicals, often experience wide fluctuations in manufacturing volume from year 

821 to year. This can result in the production volume of a chemical exceeding the threshold for 

822 several years, then falling below the threshold during the IUR principal reporting year. 

823 Consequently, previous IUR reporting has resulted in a change of approximately 30 percent in 

824 the composition of the chemicals being reported from one submission period to the next. 

825 Therefore, the one-year snapshot of production volume does not provide an accurate picture of 

826 the chemicals in commerce, and may provide an erroneous view of the exposure scenarios 

827 associated with a particular chemical substance. 

828 

829 An example of the wide fluctuations in manufacturing volume is found in the Agency’s HPV 

830 Challenge Program (described in Unit III.D.1). In this program, IUR data were used to 

831 determine the HPV chemicals, or the chemicals with nationally aggregated production volumes 

832 of one million lb. or more. As the HPV Challenge Program progressed, the Agency chose not to 

833 pursue certain chemicals because new IUR reporting indicated that the nationally aggregated 

834 production volume had dropped below one million lb. However, based on the latest IUR, the 

835 production volume for some of the chemicals the Agency was no longer pursuing had risen again 

836 to exceed one million lb. 
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837 

838 Industry representatives have provided further evidence that capturing production volume for 

839 only the principal reporting year is resulting in the omission of information on chemicals in 

840 current production. In comments submitted to the Agency in response to other programs, the 

841 industry representatives expressed concern that short reporting determination periods would 

842 drastically misrepresent the chemicals that currently are in commerce. Industry representatives 

843 stated they manufactured or imported some chemicals only occasionally, and that these 

844 chemicals would not be captured if the reporting covered too short a period. Comments included 

845 statements such as “A longer time frame is necessary to capture the sporadically produced 

846 chemicals... As such, a ‘snapshot’ in time may not adequately identify the complete inventory 

847 requirements...” (Ref. 6). Another commenter agreed “a longer timeframe to report chemicals 

848 would capture those chemicals that undergo periodic manufacture based upon customer-driven 

849 demand or other factors (e.g., variation in availability or cost of raw materials, cost of substitute 

850 materials, etc.)” (Ref. 7) or chemicals that are used infrequently and upon request when working 

851 with suppliers (Ref. 8). 

852 

853 In light of these comments and EPA’s own experiences, the Agency believes that using 

854 production volume reporting for all years since the last principal reporting year to determine 

855 reporting obligations would yield a much more accurate picture of the chemicals currently in 

856 commerce, ensuring proper review under EPA’s risk screening, assessment, and management 

857 activities and providing better information to the public. EPA presents the estimated increase in 

858 industry costs and burden associated with this proposed amendment in section 4.4.3 of the 

859 economic analysis. (Ref. 11)

860 

861 EPA requests comments on alternatives that would provide an equally accurate picture of 

862 chemical production, and whether 25,000 lb. in any one year is the appropriate reporting 

863 threshold. EPA also requests comment on whether this change should apply only to the certain 

864 regulated chemicals (see subsection 3 below).

865 

866 2. Eliminate 300,000 lb. threshold for processing and use information. 

867 

868 EPA is proposing to eliminate the 300,000 lb. threshold for processing and use 

869 information, thereby requiring all reporters of non-excluded substances to report information in 

870 all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to 

871 collect information necessary to complete screening-level exposure characterizations for all IUR 

872 reportable chemicals. The exposure information is an essential part of developing risk 

873 evaluations and, based on its experience in using this information, the Agency believes that 

874 collecting this exposure information is critical to its mission of characterizing exposure, 

875 identifying potential risks, and noting uncertainties for these lower production volume chemicals. 

876 In addition, this change will provide the public with information on a greater number of 

877 chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA 

878 acknowledged the value of information for chemical substances manufactured in lower volumes 

879 and stated that if the Agency were to find it necessary in the future, it would collect information 

880 on chemical substances at reporting thresholds below the thresholds that were introduced in that 

881 action (i.e., 25,000 lb. and 300,000 lb.). 

882 

883 The current 300,000 lb. threshold applies to each reportable chemical manufactured 

884 (including imported) at each individual reporting site and was selected with the intention that 
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885 exposure-related processing and use information would be collected for HPV chemicals (HPV 

886 being defined as a national aggregate production volume, potentially from a number of 

887 manufacturing sites, of greater than 1,000,000 lb. per year). When EPA promulgated the 2003 

888 Amendments, the Agency believed a 300,000 lb. per year site-specific reporting threshold would 

889 capture sufficient exposure-related information for substantially all HPV chemicals. However, 

890 based on the 2006 data, approximately 23% of the reports submitted for known HPV chemicals 

891 had reported production volumes below the 300,000 lb. threshold, and consequently did not 

892 contain exposure-related processing and use information. Therefore, EPA believes that the 

893 300,000 lb. threshold was too high to provide sufficient processing and use data for the HPV 

894 chemicals. The Agency explored setting the threshold for reporting processing and use 

895 information to an alternate level between the basic reporting threshold of 25,000 lb. and 300,000 

896 lb. for this action, and requests comment on alternate levels. However, the need to complete 

897 characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 

898 300,000 lb. in any year led the Agency to believe that it would be best to eliminate the upper 

899 threshold and collect full information for all reported chemicals. EPA presents the estimated 

900 increase in industry costs and burden associated with this proposed amendment in section 4.4.4 

901 of the economic analysis. (Ref. 11)

902 

903 3. Elimination of the 25,000 lb. threshold for certain regulated chemicals. 

904 

905 EPA is proposing to eliminate the 25,000 lb. reporting threshold for certain chemical 

906 substances that are the subject of particular TSCA rules and/or orders and to require 

907 manufacturers (including importers) of such chemicals to report under the IUR rule, regardless of 

908 the production volume. This provision will ensure the availability of current information when 

909 EPA has expressed a concern in the form of regulatory action on those chemical substances, 

910 regardless of the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for 

911 those chemicals that are: (1) the subject of a rule proposed or promulgated under section 5(a)(2), 

912 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA, or 

913 (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA. 

914 

915 Under this proposal, a manufacturer, including importer, of such chemical substances 

916 would be required to report information on the manufacturing, processing, and use of the 

917 chemical substances if it manufactured (including imported) any quantity of these chemical 

918 substances during any of the years since the last principal reporting year, including quantities 

919 under 25,000 lb. For 2011 reporting, the manufacturer would need to consider the manufacture 

920 or import during the years 2006 through 2010; would report the production volumes for each 

921 year from 2006 to 2010; and would report the full manufacturing, processing, and use 

922 information for 2010. 

923 

924 Chemicals that are the subject of particular TSCA rules and/or orders are of demonstrated 

925 high interest to the Agency. EPA will use the IUR data associated with these regulated 

926 chemicals to monitor chemical production and compliance with the rules. 

927 

928 EPA requests comment on whether these chemicals should include those that are subject of a 

929 rule proposed under section 5(a)(2), 5(b)(4), or 6 of TSCA, thereby more closely paralleling the exception 

930 language in the introductory paragraph to 40 CFR 710.46 (proposed section 711.6) and in 40 CFR 710.49 

931 (proposed section 711.9).

932 
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933 EPA presents the estimated increase in industry costs and burden associated with this 

934 proposed amendment in section 4.4.5 of the economic analysis. (Ref. 11).

935 

936 EPA requests comment on whether a de minimus production volume threshold should be 

937 set for these chemicals. EPA also requests comment on how best to set such a de minimus 

938 threshold.

939 

940 E. Changes to Substances Covered by IUR 

941 

942 1. Water 

943 

944 Naturally occurring water is excluded from reporting under the IUR rule, but 

945 manufactured water, which is not naturally occurring, is a reportable substance. EPA is 

946 proposing to fully exempt all (both naturally occurring and manufactured) water (CASRN 7732-

947 18-5) and to remove water from the petroleum streams partial exemption (40 CFR 710.46(b)(1)). 

948 

949 EPA received approximately 43 IUR reports for water during the 2006 submission 

950 period. Therefore, this proposed exemption would likely result in a burden reduction for IUR 

951 submitters. 

952 

953 2. Remove fully exempt polymers from partially exempt list 

954 

955 Polymers are a class of chemical substances for which IUR reporting is not required (40 

956 CFR 710.46(a)(1)) (proposed 40 CFR 711.6(a)(1)). However, three polymers are listed in the 

957 partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv): Starch (CASRN 9005-25-8), 

958 Dextrin (CASRN 9004-53-9), and Maltodextrin (CASRN 9050-36-6). Improperly including 

959 substances that meet the IUR definition of a polymer in the partially exempt list of chemicals 

960 may be confusing to submitters and may lead to unnecessary reporting for these substances. 

961 EPA is proposing to amend the partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv) 

962 (proposed 40 CFR 711.6(b)(2)) to remove these three chemical substances which, as polymers, 

963 are fully exempt from reporting. 

964 

965 3. Making chemicals that are the subject of an Enforceable Consent Agreement 

966 ineligible for exemptions 

967 

968 EPA may enter into an enforceable consent agreement (ECA), pursuant to procedures at 

969 40 CFR part 790, with a manufacturer of a chemical substance to obtain testing where a 

970 consensus exists among EPA, affected manufacturers and/or processors, and interested members 

971 of the public concerning the need for and scope of testing. Chemicals covered by ECAs are of 

972 demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, 

973 processing, and use of substances under such agreements, and therefore is proposing to require 

974 that such substances be reported for IUR purposes, regardless of whether the substance otherwise 

975 meets the requirements listed in 40 CFR 710.46 (proposed 40 CFR 711.6) as an exempt or 

976 partially exempt chemical substance. This provision will ensure the availability of current 

977 information if EPA has expressed a concern in the form of an ECA on any substance otherwise 

978 excluded from the IUR rule. EPA is therefore proposing to make chemical substances that are 

979 the subject of an ECA ineligible for IUR exemptions. 

980 
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981 With this proposal, chemicals that are the subject of an ECA would be included in the list 

982 of chemicals that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 

983 710.46 (proposed 40 CFR 711.6) listing the other chemicals that are likewise not eligible for an 

984 IUR exemption. The paragraph would state that a chemical “is not exempted from any of the 

985 reporting requirements of this part if that substance is the subject of a rule proposed or 

986 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 

987 agreement developed under the procedures of 40 CFR part 790, or is the subject of an order 

988 issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under 

989 a civil action under section 5 or 7 of the Act.” 

990 

991 F. Modifications to Reportable Data Elements 

992 

993 1. Parent Company and Site Identity 

994 

995 Manufacturers (including importers) are required to report the company name and Dun 

996 and Bradstreet (D&B) number to identify the company associated with the plant site, and also to 

997 report the site name, address, and D&B number. If the company associated with the plant site 

998 does not have a D&B number, the manufacturer must obtain a D&B number for the company. 

999 Likewise, if the plant site does not have a D&B number, the manufacturer must obtain a D&B 

1000 number for the site. EPA received a variety of questions concerning the correct company name 

1001 to report during the 2006 IUR submission period. EPA is now clarifying what is meant by 

1002 company name, by proposing to require that the company name provided be the ultimate 

1003 domestic parent company name. EPA believes this change will reduce confusion by making this 

1004 reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent 

1005 company name. The requirement that the ultimate domestic parent company name be reported 

1006 does not affect the determination of small business status, which is not limited to domestic 

1007 companies. Persons covered by the IUR rule should continue to base small business 

1008 determinations on the ultimate parent company, regardless of whether that company is domestic 

1009 or foreign. 

1010 

1011 The 2006 IUR submissions from different reporting sites contained varying D&B 

1012 numbers for parent companies that appeared to be the same company. In order to better identify 

1013 when reporting sites are under the same parent company, EPA is proposing to include the 

1014 address as well as the D&B number of the parent company. 

1015 

1016 2. Technical Contact 

1017 

1018 Manufacturers (including importers) are required to provide a technical contact for their 

1019 IUR submission. The technical contact must be a person who can answer questions EPA may 

1020 have about the reported chemical substance and should be a person located at the manufacturing 

1021 site. Based on EPA’s experience with contacting the reported technical contact with follow-up 

1022 questions concerning 2006 IUR submissions, reporters often provide the names of individuals 

1023 who are not directly connected to the reporting site, and therefore, are not knowledgeable about 

1024 either the chemical or the submission. EPA has also seen situations where the technical contact 

1025 is a contracted employee who is able to address subsequent concerns only if he or she remains 

1026 under contract. Note that EPA may raise follow-up questions about an IUR submission, possibly 

1027 years after the submission date. EPA is interested in any comments or suggestions regarding 

1028 how to better identify the technical contact. 
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1029 

1030 EPA is considering allowing multiple technical contacts on a chemical-by-chemical 

1031 basis. The e-IURweb reporting software would allow the identification of several names 

1032 associated with a submission. EPA is interested in any comment or suggestions regarding this 

1033 consideration. 

1034 

1035 3. Chemical Identity 

1036 

1037 Manufacturers, including importers, are required to submit the correct chemical identity 

1038 for each subject chemical substance. For the 2006 IUR, the correct chemical identity included a 

1039 specific chemical name and a corresponding identifying number. The identifying number could 

1040 be the Chemical Abstracts Service Registry Number (CASRN), the TSCA Accession Number, or 

1041 the number assigned to the chemical’s Premanufacture Notice (“ PMN number”). 

1042 

1043 i. Chemical Name 

1044 

1045 EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name 

1046 currently used to list the substance in the Inventory as the chemical name reported for IUR. 

1047 Currently submitters are required to report a specific chemical name, with no further elaboration 

1048 in the regulatory text. The Instructions for Reporting presently state that manufacturers should 

1049 use CA Index Names or, if CA Index Names are not available, manufacturers should use 

1050 nomenclature that completely and accurately describes the chemical substance. 

1051 

1052 EPA has found, however, that submitters sometimes supply a name that is somewhat 

1053 generic or excludes parts of the specific chemical identity that distinguishes one substance from 

1054 another. EPA’s experience from the 2006 IUR was that up to five percent of the reports 

1055 submitted contained chemical identity problems serious enough that the Agency was unable to 

1056 precisely identify the substance. These problems resulted in the temporary exclusion of the 

1057 information associated with the poorly or erroneously identified chemical from the IUR database 

1058 until the Agency was able to obtain correct and specific chemical identity information from the 

1059 submitter. EPA believes the requirement to use the substance name as currently listed on the 

1060 Inventory will greatly reduce the number of poorly identified substances. EPA intends to include 

1061 the CASRN and CA Index Names as part of e-IURweb, to the extent possible without 

1062 jeopardizing confidentiality claims. 

1063 

1064 Manufacturers (including importers) will be allowed to supply an alternate chemical 

1065 name, and in the case of importers, a trade name, in those instances where a supplier will not 

1066 disclose to the submitter the specific chemical name of the imported Inventory substance or a 

1067 reactant used to manufacture the Inventory substance. In these cases, the manufacturer 

1068 (including importer) and the supplier report the information required in this part in a joint 

1069 submission. In order to clarify this requirement, EPA is proposing an amendment to 40 CFR 

1070 710.52(c)(3)(i) (proposed 40 CFR 711.12(b)(3)(i)) to state that the importer must have the 

1071 supplier of the confidential chemical substance directly provide EPA with the correct chemical 

1072 identity, in a joint submission with the manufacturer. Furthermore, in the event the manufacturer 

1073 submitting a report cannot provide the whole chemical identity because the reportable chemical 

1074 substance is manufactured using a reactant having a specific chemical identity claimed as 

1075 confidential by its supplier, the manufacturer must submit a report directly to EPA containing all 

1076 other information known to or reasonably ascertainable by the manufacturer about the chemical 
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1077 identity of the reported substance and must ensure that the supplier directly provides to EPA the 

1078 correct chemical identity of the confidential reactant in a joint submission. See Unit 3.I for 

1079 additional information regarding joint submissions. Detailed draft instructions regarding joint 

1080 submissions are included in the draft Instructions included in the docket. (Ref. 2) EPA is 

1081 interested in any comments regarding the procedure under consideration. 

1082 

1083 ii. Chemical Identifying Number 

1084 

1085 As part of the chemical identity, submitters provide a chemical identifying number 

1086 associated with the correct CA Index Name, as described in Unit III.FE.3. For most chemicals, 

1087 the chemical identifying number is the CASRN correctly corresponding to the reported CA 

1088 Index Name. If the CASRN number is not available because the chemical substance is listed on 

1089 the confidential portion of the Inventory and a CASRN does not already exist for that substance, 

1090 the submitter could report either the associated TSCA Accession or PMN number. 

1091 

1092 EPA is proposing to allow submitters to report only the CASRN as a chemical identifying 

1093 number or, in the case of confidential chemical substances, the accession number. Note that in 

1094 cases where a CASRN exists for a confidential chemical, it can be reported instead of the 

1095 accession number and claimed as confidential for purposes of the IUR submission. EPA is 

1096 proposing to remove the PMN number as an allowed chemical identifying number because each 

1097 Inventory substance has either (or both) a CASRN or a TSCA Accession Number, which are 

1098 likely to be already known to the submitter. Furthermore, the Agency has to spend considerably 

1099 more time and effort to access and review reported information that has been identified only by a 

1100 PMN case number. 

1101 

1102 Submitters who, in the past, have reported using the PMN number of a confidential 

1103 substance may contact EPA, if necessary, to learn the TSCA Accession Number assigned when 

1104 the Notice of Commencement (NOC) was submitted to the Agency. 

1105 

1106 4. Production Volume 

1107 

1108 Manufacturers, including importers, are required to report production volume information 

1109 for each chemical substance for which they submit an IUR report. For the 2006 IUR, 

1110 production volume information consisted of the manufactured production volume; the imported 

1111 production volume; an indication of whether the substance was manufactured, imported, or both; 

1112 and an indication of whether the substance was site-limited. In instances where a single site both 

1113 manufactures and imports the same chemical substance, the site was to report the manufactured 

1114 and imported production volumes separately on one report. The combined total production 

1115 volume was then used as the basis for determining the percentage of production volume in other 

1116 areas of the report, such as for the physical form, the industrial process or use, or the consumer 

1117 or commercial use. 

1118 

1119 EPA is proposing a number of changes to the reporting of production volume and 

1120 associated information. The Agency believes these changes would improve the usefulness of the 

1121 information for EPA and others, and would provide clarity for the reporting obligations of the 

1122 submitter. 

1123 

1124 i. Report production volume for each of the years since the last principal 
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1125 reporting year. 

1126 

1127 EPA is proposing to require reporting of production volume for each of the five years 

1128 since the last IUR principal reporting year. Thus, for the 2011 IUR submission period, 

1129 manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would 

1130 report the production volume of that chemical for each of the following calendar years: 2010, 

1131 2009, 2008, 2007, and 2006. This change would provide information EPA and others need as 

1132 stated in Unit III.D. Collecting the production volume for multiple years would provide greater 

1133 detail than the current once-every-five-years snapshot. 

1134 

1135 For the principal reporting year, e.g., 2010, the domestic manufacture and the import 

1136 production volume would continue to be reported separately on the same report. EPA review 

1137 and analysis of the 2006 IUR data has revealed that some submitters are erroneously submitting 

1138 multiple reports for the same chemical, at times reporting the information associated with 

1139 manufacturing and importing in different reports. The submitter should complete only one report 

1140 for each chemical substance. 

1141 

1142 EPA uses production volume data in several important ways. The data help the Agency 

1143 to establish trends in chemical manufacturing; to determine the effectiveness of various Agency 

1144 and other programs; to estimate the magnitude of consumer, worker, and environmental 

1145 exposures; and to determine the costs (and financial impacts) of potential control strategies in 

1146 economic analyses. As discussed in Unit III.D.2., the collection of annual production volume 

1147 data would allow EPA to identify more consistently the HPV chemicals. Voluntary EPA 

1148 programs such as Design for the Environment (DfE) and other pollution prevention programs 

1149 would use the annual production volume data to identify trends and program performance. 

1150 Relying on a single snapshot of annual production volume in each reporting determination period 

1151 hampers EPA’s ability to identify the programs and techniques that are most effective, using 

1152 measurable, readily identifiable production trend data. 

1153 

1154 Unit V of this Preamble contains a series of requests for comments on additional ideas 

1155 under consideration by the Agency. One of the ideas concerns the collection of more than just 

1156 the production volume since the last reporting year. The Agency is interested in comments on 

1157 this matter. Please see Unit V for additional discussion. 

1158 

1159 ii. Volume of chemical substance used on-site. 

1160 

1161 EPA is proposing to require that submitters report the volumes of a manufactured 

1162 (including imported) chemical substance used at the reporting site. The requirement to report the 

1163 volume used on-site is replacing the requirement to indicate that the chemical is site-limited. 

1164 Under this proposal, either domestically manufactured or imported chemicals could be reported 

1165 as used at the reporting site, whereas, under the current reporting requirements, only 

1166 domestically manufactured chemicals, consumed entirely at the site of manufacture, should be 

1167 reported as site-limited. 

1168 

1169 EPA is proposing this change to simplify reporting and to collect information that better 

1170 addresses the Agency’s needs. In the past, submitters sometimes incorrectly reported their 

1171 production volume separately to identify the portion of their chemical that was consumed at the 

1172 site of manufacture. For the 2006 IUR, many submitters continued this practice and erroneously 
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1173 filed separate reports to identify that a portion of their production volume was site-limited. 

1174 Filing separate reports resulted in the need to report processing and use information separately 

1175 when the combined production volume was 300,000 lb. or greater. Reporting all production 

1176 volumes on one report simplifies reporting for such submitters and results in a less complicated 

1177 database, thereby making the data easier to use. In addition, reporting the volume used on-site 

1178 provides valuable information related to potential exposures associated with the on-site volumes, 

1179 providing the Agency with better information for exposure assessments and other data analyses. 

1180 

1181 iii. Indicate whether imported chemicals are physically at reporting site. 

1182 

1183 EPA is proposing to add a requirement to indicate whether an imported chemical is 

1184 physically at the reporting site. Often, the site reporting an imported chemical never physically 

1185 receives the chemical, but instead ships it directly to another location such as a warehouse, a 

1186 processing or use site, or a customer’s site. Identifying whether the chemical is physically at the 

1187 reporting site provides more accurate information for screening-level analyses and other uses of 

1188 the IUR data. 

1189 

1190 iv. Report volume exported. 

1191 

1192 EPA is proposing to add a requirement to report the production volume directly exported 

1193 and not domestically processed or used. This would allow EPA to better identify the proportion 

1194 of the production volume accounted for by the use reporting, given that downstream reporting is 

1195 not required for exported substances. 

1196 

1197 5. Identify whether a chemical is to be recycled, remanufactured, reprocessed, 

1198 reused, or reworked. 

1199 

1200 EPA is proposing to add a requirement to indicate (via a check-box) whether a 

1201 manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, 

1202 reused, or reworked. Submitters would identify that their manufactured chemical, which 

1203 otherwise would be disposed of as a waste, is being removed from the waste stream and has a 

1204 commercial purpose (i.e., it is being recycled, remanufactured, reprocessed, reused, or 

1205 reworked). EPA believes that such information will help the Agency to identify where these 

1206 activities are already occurring, and can be used to encourage such activities. Collecting 

1207 information on whether a chemical is being recycled, remanufactured, reprocessed or reused and 

1208 is not entering the waste stream provides valuable information to EPA and others regarding 

1209 trends in chemical manufacturing. This information also can be used to help determine the 

1210 effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) 

1211 Program. EPA launched the RCC in 2002, implementing Congress’ instruction to prevent 

1212 pollution and conserve natural resources and energy by managing materials more efficiently. 

1213 The RCC Program’s goals include promoting reuse and recycling and reducing chemicals of 

1214 national concern in products and waste. Indicating that a manufactured chemical, such as a 

1215 byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked does not affect 

1216 the reporting requirements associated with any substance manufactured from the byproduct. See 

1217 Unit IV.B2 for detailed information on byproduct reporting. 

1218 

1219 6. Concentration ranges. 

1220 
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1221 EPA is proposing to eliminate gaps in the ranges used to report concentration in § 710.52(C)(3) 

1222 and (4). The current ranges result in gaps between 30 and 31 percent and 60 and 61 percent. 

1223 The proposed ranges would be: 

1224 

1225 Less than 1% by weight 

1226 At least 1% but less than 30% by weight 

1227 At least 30% but less than 60% by weight 

1228 At least 60% but less than 90% by weight 

1229 At least 90% by weight 

1230 

1231 7. Industrial processing and use information reporting. 

1232 

1233 In 2003, EPA added industrial processing and use data to the information collected 

1234 through the IUR rule for chemical substances manufactured in quantities of 300,000 lb. or 

1235 greater during the principal reporting year. The industrial processing and use information 

1236 included industrial function categories and North American Industrial Classification System 

1237 (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was 

1238 useful in selecting a scenario that characterizes the frequency, route, and duration of exposure to 

1239 a chemical substance during manufacture, processing, and use of the substance. These data are 

1240 also useful when EPA characterizes the quantity of the chemical substance in wastes and 

1241 emissions entering the environment and for anticipating the environmental media into which 

1242 wastes will be released. The Agency is proposing to revise the list of industrial function 

1243 categories and to replace the NAICS codes with industrial sector categories, as described in 

1244 sections i. and ii. 

1245 

1246 i. Industrial function categories. 

1247 

1248 EPA is proposing to revise the list of industrial function categories by combining 

1249 categories that lead to common exposure scenarios and adding categories where the Agency 

1250 believes the existing categories do not adequately describe potential uses. EPA worked with 

1251 Environment Canada and Health Canada to develop the proposed set of categories, which would 

1252 be used by both the United States and Canada for Inventory reporting. Harmonization of the 

1253 categories for reporting the industrial functions of chemical substances would facilitate the 

1254 exchange of information between EPA and Canadian agencies and could serve as a model to be 

1255 used by Mexico in developing an inventory of chemical substances. In addition, the harmonized 

1256 categories would facilitate consistent reporting of chemical use information by industry in the 

1257 United States and Canada. (Ref. 13) 

1258 

1259 EPA is proposing to add eight new industrial function categories and to delete six 

1260 existing categories from the current list; the total number of industrial function categories would 

1261 increase to 35. Also, EPA is proposing to rename several of the industrial function categories to 

1262 provide a more informative description of the function of chemical substances that should be 

1263 reported in that category. Lastly, EPA is proposing to require that if a submitter selects the 

1264 category “Other,” the submitter must provide its own description of the industrial function of the 

1265 chemical substance. EPA is proposing the following industrial function categories: 

1266 Table 1: Codes for Reporting Industrial Function Categories. 

Code Category
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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 

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) 

1267 

1268 ii. Industrial Sectors 

1269 

1270 EPA is proposing to replace the five-digit North American Industrial Classification 

1271 System (NAICS) codes with 48 Industrial Sectors (IS). The sectors were adapted from the 

1272 European Union’s (EU’s) “Guidance on information requirements and chemical safety 

1273 assessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sectors 

1274 so that there is a sector corresponding to any NAICS code. The Agency believes this change 

1275 would provide several benefits. First, the sectors would reduce reporting burden because 

1276 submitters would not have to look up the NAICS code. Second, it would encourage more 

1277 complete reporting by using terms that are already familiar to industry. Third, the sectors would 

1278 reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate 

1279 NAICS codes. Fourth, it would reduce the number of codes that could apply to one substance. 

1280 Table 2 lists the proposed sectors. The rationale for selecting the sectors and the link between 

1281 the sectors and the NAICS system is further described in Inventory Update Reporting (IUR) 

1282 Technical Support Document – Replacement of 5-digit NAICS Codes with Industrial Sector 
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1283 Codes (Ref. 9). 

1284 

1285 One of the primary purposes of the IUR data collection is to group together similar data 

1286 for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 

1287 five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial 

1288 processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of 

1289 processing or use code, NAICS code, and industrial function category, in all. This large number 

1290 of unique combinations increases the difficulty and time required by EPA to sort and classify 

1291 chemicals because EPA either would need to develop exposure scenarios for each unique 

1292 combination, or determine which three-code combinations have similar exposure scenarios and 

1293 can be grouped. The use of the sectors would reduce the number of unique combinations, 

1294 thereby increasing the usability of the data, and also reducing the IUR reporting burden. 

1295 

1296 EPA is proposing the following 48 sectors: 

1297 

1298 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 
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IS35 Plastics Product Manufacturing 

IS36 Rubber Product Manufacturing 

IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, 

gypsum, and other nonmetallic mineral product manufacturing) 

IS38 Primary Metal Manufacturing 

IS39 Fabricated Metal Product Manufacturing 

IS40 Machinery Manufacturing 

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) 

1299 

1300 When the category chosen for the Industrial Sector Code is “Other,” a written description 

1301 of the use of the chemical substance, which may include the NAICS code, would also need to be 

1302 provided. 

1303 

1304 8. Consumer and commercial use reporting 

1305 

1306 In the 2003 Amendments, EPA added a reporting requirement for submitters to include 

1307 information about the consumer and commercial uses of chemicals they reported under the IUR 

1308 rule. For the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured 

1309 in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to ten 

1310 consumer and commercial product categories from a list of 20 categories that correspond to the 

1311 actual use of the chemical substance they are reporting. For each category, submitters also were 

1312 required to indicate whether the chemical was used in a product intended for use by children, to 

1313 report the maximum concentration of the chemical in the product category, and to report the 

1314 percentage of total production volume associated with the product category. 

1315 

1316 EPA is using the information provided by the 2006 IUR reports in the Existing Chemicals 

1317 Program. While the Agency found that the information was useful in identifying when 

1318 consumers and commercial users and children are potentially exposed populations, EPA also 

1319 found that the data had significant limitations concerning the product categories and 

1320 identification of potentially exposed populations. The Agency believes the limitations stem from 

1321 two characteristics of the data: (1) the lack of specificity in the product categories and (2) the 

1322 inability to distinguish between consumer and commercial uses. In addition, because 29 percent 

1323 of the reported categories were for the category “Other,” EPA was constrained in its ability to 

1324 characterize use and exposure scenarios. Also, consumer and commercial uses affect very 

1325 different populations. The reported information was not useful in differentiating these 

1326 populations when characterizing potential exposures. 

1327 

1328 To address these issues, EPA is proposing three four changes to the consumer and 

1329 commercial information required to be reported: (1) a revised and expanded list of consumer 

1330 and commercial product categories, (2) the additional requirement to provide a description when 

1331 the product category “Other” is selected, and (3) the identification of whether the use is a 

1332 consumer or a commercial use, or both, and (4) the number of commercial workers reasonably 

1333 likely to be exposed while using the reportable chemical substance. Reporting associated with 
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1334 children’s use, the maximum concentration, and the percent production volume would remain 

1335 unchanged. 

1336 

1337 i. Consumer and Commercial Product Categories 

1338 

1339 EPA is proposing to revise the list of consumer and commercial product categories by 

1340 combining categories that lead to common exposure scenarios and adding categories that were 

1341 not adequately described in the initial set of categories. EPA worked with Environment Canada 

1342 and Health Canada to develop the proposed categories. Harmonized categories for reporting the 

1343 consumer and commercial uses of chemical substances would facilitate the exchange of 

1344 information between EPA and Canadian agencies and would serve as a model to be used by 

1345 Mexico in developing an inventory of chemical substances. In addition, the harmonized 

1346 categories would facilitate consistent reporting of chemical use information by industry in the 

1347 United States and Canada. (Ref. 13) 

1348 

1349 During the development of the revised product category list, EPA and Canada considered 

1350 existing product category schemes, such as the NAICS and REACH categories, but found them 

1351 to be either too detailed or not right for the task at hand. The NAICS categories are defined for 

1352 manufacturing processes, not for consumer and commercial products, and therefore did not 

1353 address the situations of interest. The REACH program collects detailed information on the use 

1354 of chemicals in consumer and commercial products sold in the EU: all of the codes used by 

1355 REACH are represented in the harmonized industrial function and consumer and commercial 

1356 codes. 

1357 

1358 The proposed list includes 33 product categories, including “Other.” Examples of new 

1359 categories which have been added include explosive materials, building/construction products 

1360 not covered elsewhere, and air care products. The glass and ceramic products category had 

1361 relatively few IUR submissions in 2006 and overlaps with proposed new categories, and so has 

1362 been proposed for elimination. Also, several of the consumer and commercial product categories 

1363 would be renamed to better describe the products that should be reported in those categories. 

1364 

1365 EPA believes that expanding the list of consumer and commercial product categories 

1366 would provide persons submitting IUR information with a greater opportunity to characterize the 

1367 product in which chemical substances they manufacture are used and would reduce the number 

1368 of uses reported as “Other.” 

1369 

1370 In addition to revising the overall product categories, narrower definitions and expanded 

1371 lists of examples of products in which the chemical substance would be used would be added to 

1372 each category descriptor. The examples were selected to include items that could have fit into 

1373 other categories in order to address the overlap inherent in any product category list. The 

1374 product categories were then placed into several broader groupings, e.g., “Chemicals with 

1375 Agriculture and Outdoor Uses’ based on the similarities of products. EPA believes that the user 

1376 would find the proposed groupings easier to use than the alphabetical listing used for the 2006 

1377 IUR. 

1378 

1379 EPA is also proposing to require that if a submitter chooses the product category “Other,” 

1380 the submitter must include a text description for the consumer and commercial product 

1381 containing the chemical substance. In the 2006 IUR reports, the category “Other” was reported 
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1382 with the greatest frequency, with 1,206 out of a total number of 4,157 reports containing 

1383 consumer and commercial use information, resulting in a reporting rate of 29 percent for the 

1384 category. Although one of EPA’s objectives in revising the consumer and commercial product 

1385 categories was to reduce the reporting frequency of “Other,” EPA believes that in many cases 

1386 where “Other” was reported, submitters may not have selected the correct categories for their 

1387 situation. By requiring the submitters to supply a written description for “Other,” EPA would be 

1388 able to evaluate and improve the inclusiveness of future consumer and commercial category lists 

1389 or descriptions. In addition, the descriptor information would be more useful than simply the 

1390 selection of “Other” for EPA’s Existing Chemicals and other programs. 

1391 

1392 EPA is proposing the following consumer and commercial product categories: 

1393 

1394 Table 3: 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 

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 
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Chemical Substances in Products not Described by Other Codes 

C980 Non-TSCA Use 

C909 Other (specify) 

1395 

1396 ii. Designation of Consumer or Commercial Use 

1397 

1398 EPA is proposing to require submitters to designate, via a checkbox, whether the 

1399 indicated product category is a consumer or a commercial use, or both. The Agency’s 

1400 experience using the 2006 IUR data identified a need to distinguish between potentially exposed 

1401 consumer and commercial populations. The designation of consumer or commercial use, or 

1402 both, would allow EPA to complete a better characterization of the potentially exposed 

1403 populations. 

1404 

1405 iii. Number of Commercial Workers Reasonably Likely to be Exposed 

1406 

1407 EPA is proposing to require that submitters report the total number of commercial 

1408 workers, including those at sites not under the submitter’s control, that are reasonably likely to 

1409 be exposed while using the reportable chemical substance, with respect to each commercial use. 

1410 The approximate number of workers would be reported using the same definitions and ranges 

1411 used for manufacturing and industrial processing and use workers required by 40 CFR 

1412 710.52(c)(3)(v) and (4)(i)(F) (proposed 40 CFR 711.12(c)(3)(vii) and (4)(i)(F)), respectively. 

1413 The ranges are: 

1414 

1415 Fewer than 10 workers 

1416 At least 10 but fewer than 25 workers 

1417 At least 25 but fewer than 50 workers 

1418 At least 50 but fewer than 100 workers 

1419 At least 100 but fewer than 500 workers 

1420 At least 500 but fewer than 1,000 workers 

1421 At least 1,000 but fewer than 10,000 workers 

1422 At least 10,000 workers 

1423 

1424 Information on the number of commercial workers reasonably likely to be exposed to the 

1425 reportable chemical substance would be used to characterize the commercial population 

1426 reasonably likely to be exposed to the subject chemical substance. The population 

1427 characterization is important to the development of the overall exposure characterization. 

1428 

1429 EPA requests comment on the ability of submitters to provide this data with reasonable 

1430 accuracy for each commercial use to which a chemical may be applied. Do submitters have 

1431 sufficient information about the work practices of eventual commercial users to estimate this 

1432 number? Note that the ranges proposed for commercial workers are the same as those ranges 

1433 used for reporting manufacturing and industrial workers. Are these ranges also applicable to 

1434 commercial workers?

1435 

1436 G. Changes to standard for the reporting of processing and use information 

1437 

1438 In order to collect more complete information regarding the industrial processing and 

1439 industrial, commercial, and consumer use of chemicals, EPA is proposing in § 711.12(c)(4) to 
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1440 replace the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) 

1441 in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under 

1442 TSCA for this type of TSCA reporting. TSCA section 8(a)(2) authorizes EPA to require persons 

1443 to report information that is “known to or reasonably ascertainable by” the submitter. This is the 

1444 same standard that currently applies to the reporting of information described in the regulations 

1445 at §§ 710.52(c)(1), (c)(2), and (c)(3), and this standard would continue to apply to the reporting 

1446 of such information under proposed §§ 711.12(c)(1), (c)(2), and (c)(3). It covers all information 

1447 in a person’s possession or control, plus all information that a reasonable person similarly 

1448 situated might be expected to possess, control, or know. The “known to or reasonably 

1449 ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior 

1450 to the 2006 IUR submission period. 

1451 

1452 EPA is proposing this change because reporting under the “readily obtainable” 

1453 reporting standard did not generate sufficiently complete processing and use information. EPA 

1454 believes the “readily obtainable” reporting standard limited the usefulness of the 2006 IUR 

1455 processing and use data for screening level reviews. In addition, theThe 2006 IUR response rate 

1456 for the processing and use information did not capture a sufficiently large portion of the 

1457 production volume that the Agency believes actually was used for either industrial processing 

1458 and use or consumer and commercial use. Thirty percent of the reports submitted for the 2006 

1459 IUR met the requirements (based on type of chemical and production volume) to trigger 

1460 reporting of processing and use information. Of those, almost thirteen percent contained no 

1461 industrial processing and use information and almost half contained no commercial or consumer 

1462 use information. For the reports that did contain some processing and use information, the 

1463 portion of the production volume for which some information was reported is detailed in Table 4. 

1464 Note that an IUR Form U submission contains one or more reports; each report is for a single 

1465 chemical at a single site. 

1466 

1467 Table 4: Percentage of reports providing production volume information related to 

1468 processing and use of chemicals reported for the 2006 IUR. 

Extent of Processing and/or Use Information 

Provided Based on Production Volume Reporting 

Industrial 

Processing and Use 

(% of reports*) 

Consumer and 

Commercial Use 

(% of reports*) 

No processing and use information reported 13 46

Processing and/or use information provided, but the 

associated % PV information reported as zero, NRO, or 

left blank 

6 12 

% PV associated with the reported processing and/or 

use information accounted for more than 0% but less 

than 50% of the manufactured (including imported) 

production volume 

4 7 

% PV associated with the reported processing and/or 

use information accounted for 50% but less than 100% 

of the manufactured (including imported) production 

volume 

65 32 

% PV associated with the reported processing and/or 

use information accounted for 100% or more of the 

manufactured (including imported) production volume 

12 3 

1469 *The percentage is calculated as a fraction of the total number of reports that triggered the need to report processing 

1470 and use information. 

1471 
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1472 The Agency believes the percentage of missing processing and use information actually 

1473 is larger than indicated by this analysis. As described in the 2003 Amendments final rule (68 FR 

1474 861), EPA anticipated that, on an individual report basis, the total percentages of production 

1475 volumes associated with the industrial processing or use information may add up to more than 

1476 100 percent of the reported production volume. This could happen because the submitter 

1477 reported on the distribution of a chemical to sites in its control as well as downstream sites, some 

1478 of which were not immediate purchasers from the original manufacturing site. For example, 

1479 consider the scenario where a certain volume of a reported chemical is reported as processed by a 

1480 repackager, sent to another site that adds the chemical to a mixture, and then sent to a 

1481 combination of industrial and commercial users. If the repackaged volume were 100 percent of 

1482 the production volume, the total volume reported for the different processing and use scenarios 

1483 could equal 300 percent of the production volume. EPA expected and anticipated this type of 

1484 reporting, as each instance of processing or using the chemical created a different exposure 

1485 scenario. As indicated in Table 4, only 12 percent of the reports contained processing and use 

1486 information that equaled or exceeded the production volume for their chemical. EPA expected 

1487 this percentage to be significantly larger. 

1488 

1489 Focusing on the industrial processing and use information, a complete use scenario is 

1490 comprised of three of the IUR data elements: the type of process or use, the NAICS codes, and 

1491 the industrial function code. A report could contain up to ten unique combinations of these three 

1492 data elements (i.e., use scenarios). For the reports required to include processing and use 

1493 information in 2006, submitters reported an average of slightly more than two use scenarios. For 

1494 each unique combination of these three data elements, the manufacturer reports the percent 

1495 production volume, the number of sites, and the number of reasonably likely to be exposed 

1496 workers associated with the use scenario. In 2006, only about half of the reported use scenarios 

1497 also included information for the number of sites, the number of workers, and a production 

1498 volume that was greater than zero. 

1499 

1500 Reports for consumer and commercial use information included a product category, 

1501 and, for that category, whether the chemical is used in products intended for children, the percent 

1502 production volume, and the maximum concentration. A report could contain up to ten product 

1503 categories. For the reports that were required to include processing and use information in 2006, 

1504 submitters reported an average of slightly less than one product category. Much of the consumer 

1505 and commercial information contained data elements reported as not readily obtainable 

1506 (NRO) or were left blank. Specifically, 14 percent of product category information, 24 percent 

1507 of children’s information, and 40 percent of the maximum concentration were either reported as 

1508 NRO or left blank. Overall, fewer than half of the consumer and commercial records (i.e., the 

1509 individually reported product categories and associated information) contained complete data 

1510 (e.g., where none of the data elements contained information reported as zero, NRO, or were left 

1511 blank). 

1512 

1513 This low reporting rate also occurred on an individual chemical basis; 2006 IUR 

1514 submitters did not report processing and use information even though they were required to 

1515 report such information. This happened for 20 percent of the chemicals for which the criteria for 

1516 reporting processing and use information were met. For those chemicals, EPA has no processing 

1517 or use information reported through the IUR rule. 

1518 
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1519 EPA is proposing this change to the reporting standard because reporting under the 

1520 “readily obtainable” reporting standard did not generate sufficiently complete processing and use 

1521 information, which limited the usefulness of the 2006 IUR processing and use data for screening 

1522 level reviews. EPA believes the “readily obtainable” reporting standard was a major reason for 

1523 the small amount of reporting processing and use data.

1524 

1525 For over 30 years, the Agency’s New Chemicals Program has successfully applied the 

1526 “known to or reasonably ascertainable by” reporting standard. (See 40 CFR 720.45) Companies 

1527 have used this standard to report to EPA information about how their chemicals are processed 

1528 and used by submitting more than 30,000 TSCA section 5 Premanufacture Notices (PMNs). 

1529 Because of this experience, EPA believes that companies routinely have more information about 

1530 how their chemicals are processed and used than is reflected in the 2006 IUR data. PMNs 

1531 routinely include extensive, detailed information on how a company’s customers and others 

1532 outside the company’s control will process and use its chemicals. EPA believes that the 

1533 reporting under the Agency’s New Chemical program indicates that companies generally do 

1534 know the intended ultimate uses, as well as the intervening processing steps, for their products. 

1535 In addition, EPA’s experience in the New Chemicals Program indicates that this reporting 

1536 standard generates information sufficient for screening-level reviews. Therefore, the Agency 

1537 believes that using this standard for reporting of IUR industrial processing and industrial, 

1538 consumer, and commercial use information will improve reporting rates and assist EPA’s efforts 

1539 to characterize chemical uses and to predict potential exposure to these chemicals. 

1540 

1541 The Agency’s experience using the 2006 IUR data to develop exposure 

1542 characterizations, coupled with the limited data EPA was able to publicly release, highlighted the 

1543 incompleteness of the data and lead the Agency to determine that the data are insufficient, even 

1544 for screening level purposes. Examples of documents using EPA’s exposure characterizations 

1545 can be found on the Agency’s web site, at 

1546 http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML. Effective risk 

1547 screening by EPA depends on the ability to accurately characterize chemical uses and to predict 

1548 potential exposures. As described in Unit II.D, these data are used by EPA to prioritize work on 

1549 existing chemicals. If the information provided does not include these data, EPA must make 

1550 assumptions about the use of the unreported production volume. Incorrect assumptions may lead 

1551 EPA to designate an inappropriately high or low priority level for the chemical, resulting in 

1552 unnecessary effort and resource expenditures for both regulated parties and EPA in cases where 

1553 more complete data would have led the Agency to act differently. 

1554 

1555 For the foregoing reasons, EPA believes that using the reporting standard “known to or 

1556 reasonably ascertainable by” would result in companies reporting more consistent and complete 

1557 processing and use information in their IUR reports, and that the information reported would 

1558 better enable EPA to develop the exposure characterizations needed for the Agency’s screening 

1559 of existing chemicals. EPA requests comment on whether and how this change will affect 

1560 submitter behavior and the degree to which the quality of submissions will be improved.

1561 

1562 H. Amendments to Requirements Concerning Confidential Business Information claims 

1563 

1564 Submitters may currently claim certain information reported under the IUR as confidential 

1565 business information (CBI) in accordance with 40 CFR part 2 and IUR rules at 40 CFR 710.38 

1566 (proposed 40 CFR 711.18). Submitters must assert claims of confidentiality at the time 
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1567 information is submitted to EPA. EPA’s procedures for handling information claimed as 

1568 confidential are set forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to 

1569 review confidentiality claims carefully to ensure that the information in question falls within the 

1570 parameters of TSCA section 14. CBI claims should be limited to only those data elements the 

1571 release of which would likely cause substantial harm to the business’ competitive position. 

1572 Interested persons are reminded that with regard to chemical use information, EPA is interested 

1573 in aggregated, general uses, not detailed uses associated with specific customers. 

1574 

1575 To claim information as confidential, a submitter must both indicate its claim by both 

1576 checking the appropriate box and signing the certification statement on the reporting form. A 

1577 submitter must indicate its claims at the time the information is submitted. If a submitter fails to 

1578 follow these procedures, EPA may release the information to the public without further notice to 

1579 the submitter. By signing the certification statement the submitter attests to the secrecy and 

1580 value of the information for which confidentiality claims have been asserted. 

1581 

1582 EPA expects that reducing the number of CBI claims would increase the amount of 

1583 information available to the public and improve the timeliness of its public availability. As a 

1584 result, the Agency would be able to publicly discuss and explain its risk management actions and 

1585 decisions more clearly. Currently, much of the factual and data support for Agency decisions is 

1586 claimed as CBI, which complicates the creation of publicly available documents. The public 

1587 would be better informed and better able to understand and provide meaningful comment on 

1588 Agency actions if less information were unnecessarily or inappropriately claimed as CBI. The 

1589 Agency would also be able to provide other public and private organizations and individuals with 

1590 better information for making their own decisions. Thus, EPA is proposing the changes 

1591 described in sections H.1., H.2., and H.3. with the belief that the proposed changes would reduce 

1592 the number of unjustifiable CBI claims without hindering legitimate CBI claims. 

1593 

1594 1. Chemical identity CBI claims 

1595 

1596 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 

1597 the identity of the reported chemical substance when the chemical is listed on the confidential 

1598 portion of the Master Inventory File and when the submitter provides the required substantiation 

1599 at the time the submitter makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 

1600 40 CFR 711.18(b)). At times a submitter will assert a claim of confidentiality for the chemical 

1601 identity of a substance that is listed on the public portion of the Master Inventory File. Where 

1602 the identity of a chemical substance is already contained on the public portion of the TSCA 

1603 Chemical Substances Inventory, which is publicly available from the National Technical 

1604 Information Service, EPA's website 

1605 (http://www.epa.gov/opptintr/newchems/pubs/invntory.htm#files) and other sources, EPA 

1606 believes that the identity itself, even assuming it might otherwise be CBI, as well as any 

1607 information that might be derived from it about processes or portions, has already been 

1608 disclosed. EPA is proposing that, when this occurs, the Agency may make the information 

1609 available to the public without further notice to the submitter. See the proposed regulatory text 

1610 at 40 CFR 711.18(e).

1611 

1612 This action is part of a broader effort to increase transparency and provide more valuable 

1613 information to the public by identifying programs where non-CBI may have been claimed and 

1614 treated as CBI in the past. See 75 FR 3462, published on January 21, 2010, for a similar change 
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1615 concerning CBI claims of certain chemical identities submitted under TSCA Section 8(e).

1616 

1617 2. Upfront substantiation for processing and use information CBI claims 

1618 

1619 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 

1620 the processing and use of its chemical if the submitter has reason to believe that release of the 

1621 information would reveal trade secrets, or confidential commercial or financial information, as 

1622 provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made 

1623 confidentiality claims ranging from 25 percent (when considering individual data elements) to 50 

1624 percent (when considering data elements combined into use scenarios) of the reported processing 

1625 and use information. While the Agency does not question that confidentiality claims are 

1626 sometimes necessary, it encourages submitters to consider carefully whether such claims are in 

1627 fact necessary before asserting them. The Agency has identified instances in which submitters 

1628 have claimed the processing and use data as confidential, yet similar if not identical information 

1629 was found in publicly available sources, such as company websites, published Material Safety 

1630 Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s 

1631 HPVIS website (see Unit II.D for more discussion). Note that EPA can take steps to challenge or 

1632 verify confidentiality claims, but . Tthe Agency believes companies should limit their CBI 

1633 claims to those that they are capable of adequately substantiating. 

1634 

1635 For the 2006 IUR reports, submitters were not required to provide upfront substantiation 

1636 of CBI claims for processing and use data. In these proposed modifications to the IUR rule, EPA 

1637 would require upfront substantiation for CBI claims for this information. 

1638 

1639 EPA believes that many of the CBI claims for processing and use data are inappropriate 

1640 and that the new substantiation requirement would reduce the occurrence of unnecessary claims. 

1641 The high number of confidentiality claims asserted for the reported 2006 IUR reports on 

1642 industrial processing and use information impeded the release of important data. This included 

1643 the number of processing sites, the number of potentially exposed industrial workers, and the 

1644 percent production volume for each industrial processing or use scenario. (Ref. 10) A decrease 

1645 in the number of inappropriate CBI claims under the new substantiation requirement would 

1646 improve EPA’s ability to make current plant site information available to other Federal agencies 

1647 and the public because more information submitted under IUR could be released publicly. 

1648 

1649 Under this proposed rule, in order to submit a claim of confidentiality for processing and 

1650 use information data elements, the submitter would be required to both check the appropriate box 

1651 on the reporting form and substantiate the claim in writing by answering certain questions 

1652 provided in § 711.18(d) of the proposed rule. Where a submitter fails to substantiate the 

1653 processing and use CBI claim in accordance with the applicable rules (i.e., the submitter does not 

1654 provide an answer to the required questions), EPA would consider the information not subject to 

1655 a confidentiality claim and may make the information available to the public without further 

1656 notice to the submitter. 

1657 

1658 3. Limitation on confidentiality claims for data elements identified as “not known 

1659 or reasonably ascertainable” 

1660 

1661 Under the IUR rule, submitters provide information on the industrial processing and use 

1662 and consumer and commercial use of the IUR reportable chemicals they manufacture (including 
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1663 import). As described in Unit II.A, for the 2011 and future IUR collections, EPA is proposing 

1664 that submitters be required to report this information to the extent that it is known to or 

1665 reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the 

1666 processing and use information to the extent that it was readily obtainable, and were permitted to 

1667 identify when such information was not readily obtainable by entering “NRO.” EPA has 

1668 observed that, on occasion, processing and use information has been claimed as confidential 

1669 when a submitter determined that the information was not readily obtainable. 

1670 

1671 TSCA section 14 limits the disclosure of information entitled to confidential treatment 

1672 under Exemption 4 of FOIA. EPA has considered the NRO designation and its relationship to a 

1673 potential CBI or trade secret claim. Given that a NRO assertion is an assertion that no 

1674 information is available, the Agency does not believe that the designation conveys trade secret or 

1675 confidential commercial or financial information. For this reason, EPA is proposing to prohibit 

1676 claims of confidentiality pertaining to the designation that information is not “known to or 

1677 reasonably ascertainable by” the submitter. EPA solicits comment on this issue. 

1678 

1679 I. Modifications Specifically Affecting Importers 

1680 

1681 Submitters report IUR data on chemicals that they manufacture domestically and that 

1682 they import into the United States. Current IUR regulations provide that the site responsible for 

1683 reporting for imported chemicals is the site of the operating unit that is directly responsible for 

1684 importing the substance and that controls the import transaction. In some cases, the import site 

1685 may be the organization’s headquarters in the United States. The regulations defining the site for 

1686 importer reporting is found in both the definition for site in 40 CFR 710.3 and in paragraph 40 

1687 CFR 710.48(b). 

1688 

1689 EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving 

1690 the additional information regarding the importer site from § 710.48(b) into a revised definition 

1691 for site, as described in Unit III.C.2. of this preamble, and eliminating § 710.48(b). 

1692 

1693 In addition, EPA has observed that submitters occasionally use a foreign address as the 

1694 site address for the importer. EPA now is proposing to require that submitters report a U.S. site 

1695 address, by modifying the definition for site to state specifically that the site must be a U. S. site. 

1696 The U.S. address of an agent acting on behalf of the importer, and authorized to accept service of 

1697 process for the importer, may be reported as the importer’s site address if the operating unit that 

1698 is directly responsible for importing the substance and that controls the import transaction has no 

1699 U.S. address. The Agency expects that all importers will have a U.S. site, as defined in the 

1700 proposed 40 CFR 711.3 definition for site because, under Customs regulations at 19 CFR 141.18, 

1701 a non-resident corporation is not permitted to enter merchandise for consumption unless it has a 

1702 resident agent in the State where the port of entry is located, who is authorized to accept service 

1703 of process against the corporation. 

1704 

1705 For purposes of IUR, submitters are currently allowed to report the IUR information 

1706 jointly with the foreign manufacturer of the chemical. Importers may not know the specific 

1707 chemical identity of a substance because the foreign supplier chooses to keep it confidential. In 

1708 such a situation, the importer is still responsible for ensuring that the IUR information is 

1709 submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the 

1710 primary submitter, completes the majority of the required information, but supplies a trade name 
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1711 or other designation to identify the chemical substance. In addition, the primary submitter 

1712 provides technical contact information for the foreign supplier. The primary submitter then 

1713 contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the 

1714 specific chemical identity information to EPA. In addition to the chemical identity, the 

1715 secondary submitter supplies its technical contact and company information but provides the 

1716 primary submitter’s site information. The secondary submitter should also provide the upfront 

1717 substantiation required for any confidentiality claims for chemical identity. 

1718 

1719 Under this proposed rule, the process would be the same, except that submitters would 

1720 be required to use CDX and e-IURweb for preparation and submission of joint submissions. See 

1721 proposed 40 CFR 711.12(b)(3)(i). Previously, joint submissions could not be made 

1722 electronically. In order to submit electronically to EPA via CDX, individuals must first register 

1723 with CDX. Therefore, the authorized officials of the jointly submitting companies would need to 

1724 register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier 

1725 or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., 

1726 the importer’s) authorized official to send joint submissions to EPA. 

1727 

1728 For joint submissions to be submitted electronically, the primary submitter would use e1729 IURweb to identify the need to submit a joint report and would identify itself as a primary 

1730 submitter. The primary submitter would then complete his or her portion of the report and 

1731 provide the secondary submitter's company information, along with select information on the 

1732 chemical substance(s) that are manufactured using a chemical substance made by the secondary 

1733 submitter. The primary submitter reports only the volume that it used. A secondary submitter 

1734 would also need to use e-IURweb to identify the need to submit a joint report and would identify 

1735 itself as a secondary submitter. It would provide the primary submitter’s company information 

1736 and its own technical contact information, and would identify the chemical substance(s) that is in 

1737 its product, including the percentages. This information would be saved by the reporting tool 

1738 and both submissions would be matched based upon company and chemical information. Once 

1739 the forms are matched, the joint submission would be ready to be processed by EPA. The 

1740 Agency is currently developing the process to submit joint reports electronically and welcomes 

1741 any comments concerning this process. 

1742 

1743 For the 2006 IUR submission period, EPA set aside joint submissions until both reports were 

1744 received and matched. Oftentimes, EPA had no way to determine whether a submission was a 

1745 “joint” submission, which increased the time required for manual processing of the data. EPA 

1746 anticipates that the use of the reporting tool will help to make joint IUR reporting easier for 

1747 industry and streamline EPA processing of the IUR information submitted in the 2011 

1748 submission period. 

1749 

1750 J. Change to Reporting Frequency 

1751 

1752 Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced 

1753 the reporting frequency from every four years to every five years starting with the 2006 IUR to 

1754 reduce the burden associated with the amended IUR rule. For the reasons described in this 

1755 section, the Agency has determined that reporting every five years is too infrequent, and now is 

1756 proposing to return to reporting every four years. 

1757 

1758 As described in Unit III.D.1, a review of the previous reporting under IUR has revealed an 
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1759 approximately 30 percent change in the chemicals that are reported from one submission period 

1760 to the next. While the less frequent reporting does reduce burden, EPA now believes that 

1761 reporting every five years does not provide data sufficiently current to meet Agency and public 

1762 needs. As described in Unit V.2.a3.i, the Agency has been criticized for using outdated 

1763 information. For instance, in its “Across the Pond” publication, the Environmental Defense 

1764 Fund (EDF) stated “Given the dynamic nature of the chemical market, both from year to year 

1765 and between 2005 and the present, some of the data we report here on chemicals, their 

1766 production/import volumes and their associated companies may well have changed.” (See 

1767 http://www.edf.org/documents/8538_Across_Pond_Report.pdf). EPA, therefore, also is 

1768 considering increasing the frequency of reporting to every three years, or possibly to annual 

1769 reporting. The Agency believes that efficiencies are gained with more frequent reporting, both 

1770 for the submitter and for EPA. With more frequent reporting, companies would be able to 

1771 establish standard systems and practices to collect the required information. For instance, for 

1772 annual reporting the Agency estimates that submitters would reduce the burden for each 

1773 reporting cycle by approximately 20 percent. (See Chapter 4 of the Economic Analysis, Ref. 11). 

1774 EPA invites comment on the proposed return to four-year reporting intervals, and also on more 

1775 frequent reporting (i.e., every three years, biennial, or annual reporting). Further information is 

1776 provided in Question 2.a3.i under Unit V, and the various reporting frequency alternatives are 

1777 analyzed in the Economic Analysis. (See Chapter 4 and Appendix G of the Economic Analysis, 

1778 Ref. 11) 

1779 

1780 IV. Clarifications to Reporting Requirements 

1781 

1782 A. Clarification of the relationship between company name and site ID CBI claims 

1783 

1784 Under the IUR, submitters are able to claim as CBI both the company name and site 

1785 identity associated with a chemical for which they are reporting under the IUR. The submitter is 

1786 required to provide an upfront substantiation for CBI claims for the site identification. EPA 

1787 believes there is some confusion as to what is considered confidential when such claims are 

1788 made, and is taking this opportunity to provide clarification. 

1789 

1790 The e-IURweb reporting software does not allow for blanket CBI claims for company 

1791 and site identification information, since those are separate claims and in some cases one type of 

1792 claim may be justified while the other is not. Rather, a submitter is permitted to assert its CBI 

1793 claim for the company identity, the site identity, or both the company and site identity associated 

1794 with each chemical for which they are submitting an IUR report. In addition, the submitter must 

1795 provide separately the required upfront substantiation for the site identity CBI claims associated 

1796 with each chemical. For instance, if the submitter is reporting for five chemicals and wishes to 

1797 claim its site information confidential for three of the five chemicals, it must assert the claim and 

1798 provide separate upfront substantiation three times, once for each of the three chemicals. The 

1799 CBI claim protects the link between the company and/or site identification and the particular 

1800 chemical substance. If the company or site identity associated with a particular chemical is not 

1801 claimed as CBI, EPA may make that information available to the public without further notice to 

1802 the submitter. EPA will not impute the existence of a CBI claim for company identity or for site 

1803 identity from a CBI claim associated with a different chemical. 

1804 

1805 EPA has also observed that submitters sometimes claim only their company identity, and 

1806 not their site identity, as confidential. If the site identity for a particular chemical is not claimed 
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1807 as CBI, or is claimed but not substantiated pursuant to 40 CFR 710.58(c) (proposed 40 CFR 

1808 711.18(c)), EPA may make that information available to the public without further notice to the 

1809 submitter. EPA will not impute the existence of a CBI claim for site identity from a CBI claim 

1810 for company identity, even if the company name appears within the site identity information. To 

1811 help ensure that submitters consider this issue, EPA plans to modify the e-IURweb reporting 

1812 software so that it will provide a warning whenever the company identity is claimed as CBI for a 

1813 particular chemical and the site ID is not also claimed as CBI for that chemical. 

1814 

1815 B. Explanation of byproduct reporting. 

1816 

1817 During the 2006 submission period, EPA received questions about the requirements for 

1818 reporting byproducts, including whether byproduct manufacturers were required to report the 

1819 byproducts under the IUR rule. These included some questions involving a manufacturer that uses 

1820 a chemical in the production of an article. Such manufacturing may produce a byproduct 

1821 substance that is chemically different from the starting substance; the manufacturer therefore 

1822 may incur reporting obligations under the IUR rule for that byproduct. The Small Business 

1823 Administration (SBA) also communicated with EPA about related issues and questions, 

1824 including ideas on how they could be potentially addressed (Ref. 18). Generally, the concerns 

1825 included how to identify byproduct chemical substances, especially when such substances were 

1826 complex and variable mixtures; concerns about the manufacturer's ability to determine the 

1827 recycler's use of the byproduct; and identifying the need to report, especially when the 

1828 manufacturer does not consider itself a chemical manufacturer. In light of these and similar 

1829 questions, EPA is providing detailed further additional information on byproduct reporting, 

1830 including circumstances under which reporting is not required, in the draft instruction manual

1831 and in other guidance materials included in the docket for this rule. (Refs. 2, 16, and 17) in an 

1832 effort to further clarify reporting obligations.

1833 

1834 For purposes of IUR, a byproduct is a chemical substance produced without a separate 

1835 commercial intent during the manufacture, processing, use or disposal of another chemical 

1836 substance or mixture (40 CFR 704.3). Thus, for example, when a chemical substance or mixture 

1837 is used for the purpose of manufacturing an article, and that manufacture results in the 

1838 production of a different chemical substance, that different chemical substance is a byproduct for 

1839 purposes of the IUR. Chemical substances that are byproducts of the manufacture, processing, 

1840 use, or disposal of another chemical substance or mixture, like any other manufactured chemical 

1841 substances, are subject to IUR reporting if they are manufactured, are listed in EPA’s Master 

1842 Inventory File, are not otherwise excluded from reporting, and their manufacturer is not 

1843 specifically exempted from IUR reporting requirements. 

1844 

1845 For purposes of IUR, a byproduct is “manufactured” only if it is “manufactured for 

1846 commercial purposes.” See TSCA section 8(f). The 40 CFR 704.3 definition of manufacture for 

1847 commercial purposes states that “[m]anufacture for commercial purposes also applies to 

1848 substances that are produced coincidentally during the manufacture, processing, use, or disposal 

1849 of another substance or mixture, including both byproducts that are separated from that other 

1850 substance or mixture and impurities that remain in that substance or mixture. Such byproducts 

1851 and impurities may, or may not, in themselves have commercial value. They are nonetheless 

1852 produced for the purpose of obtaining a commercial advantage since they are part of the 

1853 manufacture of a chemical product for a commercial purpose.” Thus, byproducts of the 
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1854 manufacture, processing, use, or disposal of another substance or mixture for a commercial 

1855 purpose are themselves both "manufactured" and "manufactured for commercial purposes."

1856 

1857 As with all manufactured chemicals, IUR information on byproduct chemicals is of 

1858 interest to the EPA because such exposure-related information is not otherwise available, and it 

1859 is necessary for the Agency to manage risks associated with these chemicals, to fulfill its 

1860 mandate of protecting human health and the environment. EPA does not believe byproducts 

1861 inherently pose lower exposures or risks than other manufactured chemicals. 

1862 

1863 Byproducts that are manufactured in volumes of 25,000 lb. or more at a single site are 

1864 potentially subject to IUR requirements. However, 40 CFR 710.50(c) (proposed 40 CFR 

1865 711.10(c)) excludes from reporting those substances meeting the requirements of §§ 720.30(g) or 

1866 (h). Manufacturers (including importers) of byproducts are not required to report the 

1867 manufacture of a byproduct if the byproduct is not used for commercial purposes. See 40 CFR 

1868 720.30(h)(2). Thus, even where a byproduct is manufactured for a commercial purpose, if the 

1869 byproduct is not subsequently put to use for another commercial purpose, the byproduct is 

1870 excluded from IUR reporting. Furthermore, if the byproduct’s “only commercial purpose is for 

1871 use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, 

1872 including in a landfill or for enriching soil, or (3) extract component chemical substances from it 

1873 for commercial purposes,” 40 CFR 720.30(g), that byproduct is also excluded from IUR 

1874 reporting. This exclusion applies only to the byproduct; it does not apply to the component 

1875 substances extracted from the byproduct. 

1876 

1877 Some manufacturers of byproducts have expressed a belief that a substance that is 

1878 regulated by another EPA program, such as the Resource Conservation and Recovery Act 

1879 (RCRA), or that is exempt from certain requirements by the other program based on certain 

1880 treatments or disposals, should not be required to be reported for IUR purposes. However, when 

1881 such substances have a commercial purpose not exempted by 40 CFR 710.50(c) (proposed 40 

1882 CFR 711.10(c)), the manufacturer of such a substance does need to consider IUR requirements. 

1883 

1884 EPA requests comment on the draft guidance documents included in the docket for this 

1885 rule and on how best to inform companies that may not consider themselves to be manufacturers 

1886 of chemical substances of their potential need to report. In addition, EPA requests comment on 

1887 how the substantive modifications of the IUR described in this proposed rule could be further 

1888 modified to minimize reporting burden and costs for byproduct manufacturers and recyclers, 

1889 while still collecting the exposure-related information needed to fulfill EPA’s mandate. 

1890 

1891 

1892 V. Request for Comment 

1893 

1894 EPA requests comment on all substantive modifications of the IUR described in this 

1895 proposed rule, all available alternatives that bear on such modifications, and the economic 

1896 analysis prepared in support of this proposed rule (Ref. 11). The fFollowing is a list of

1897 additional issues on which the Agency is specifically requesting public comment, in addition to 

1898 those noted in Unit III of this preamble. EPA encourages all interested persons to submit 

1899 comments on these issues, and to identify any other relevant issues as well. This input will assist 

1900 the Agency in developing a final rule that successfully addresses information needs while 

1901 minimizing potential reporting burdens associated with the rule. EPA requests that commenters 
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1902 making specific recommendations include supporting documentation where appropriate. 

1903 

1904 1) EPA anticipates promulgating a final rule by the spring of 2011. Recognizing that this would 

1905 be shortly before the next scheduled submission period (scheduled to run from June 1, 2011 

1906 through September 30, 2011), EPA solicits comment on the transition to new IUR 

1907 requirements. Specifically, EPA would conduct the 2011 reporting based on the full set of 

1908 data elements specified in this proposed rule (if finalized as proposed). and domestic 

1909 manufacturing and import volume information from the calendar years since the previous 

1910 principal reporting year (e.g., reporting in 2011 information based on years 2006, 2007, 

1911 2008, 2009, and 2010), or as specified in the final rule. Further reporting cycles would then 

1912 recur every four years (or other interval as specified in the final rule), along the same lines 

1913 and with the addition of determining compliance obligations based on manufacturing and 

1914 import volume from the calendar years since the previous principal reporting year (e.g., 

1915 reporting in 2015 information based on years 2011, 2012, 2013, and 2014). EPA is also 

1916 considering changing the existing 2011 submission period to another four-month period later 

1917 in 2011.

1918 

1919 2) As discussed in Unit II.E, EPA is increasing its emphasis on assessing, prioritizing, and 

1920 taking action on existing chemicals that pose unreasonable risks, with particular emphasis on 

1921 protecting children. EPA is interested in receiving comments regarding how to utilize use

1922 IUR data, including how to amend the rule, to best assist in this effort. Similarly, EPA seeks 

1923 comment on how to tailor more narrowly the substantive modifications to the IUR contained 

1924 in this proposal so as to avoid gathering information which EPA or the public would not be 

1925 able to use.

1926 

1927 3) Through the IUR, EPA collects information on chemicals for which the Agency is most 

1928 likely to have an interest. Accordingly, to minimize reporting burdens, EPA developed 

1929 exemptions from the IUR. From time to time, EPA adjusts these reporting exemptions in 

1930 order to address its chemical management program needs. 

1931 

1932 In response to public comments received in response to the 1985 proposed IUR rule (50 

1933 FR 9944, March 12, 1985), EPA established certain exclusions from these exemptions (51 FR 

1934 21438, June 12, 1986). The exclusions were to ensure the Agency receives IUR information on 

1935 chemical substances that are of interest to the Agency. The introductory paragraph to 40 CFR 

1936 710.46 (proposed 711.6) identifies that chemical substances that are the subject of proposed or 

1937 promulgated section 4, 5(a)(2), 5(b)(4), or 6 rules are excluded from the chemical substance 

1938 exemptions listed in the section. The introductory paragraph to 40 CFR 710.49 (proposed 711.9) 

1939 identifies that small manufacturers of chemical substances that are the subject of proposed or 

1940 promulgated section 4, 5(b)(4), or 6 rules are excluded from the small manufacturer exemption 

1941 listed in the section. 

1942 

1943 As identified in Unit II.D., EPA's Administrator has made it a priority to strengthen the 

1944 Agency’s chemicals management program. EPA uses IUR information on proposed rule 

1945 chemicals to inform final regulations, especially with respect to accurately responding to public 

1946 comments; to determine the need for actions supplementing proposed rules, such as voluntary 

1947 programs; to provide up-to-date, definitive identities of companies manufacturing (including 

1948 importing) chemicals potentially subject to a final rule; and to provide up-to-date, accurate 

1949 information to the public about chemical substances for which the Agency has expressed an 

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1950 interest. For example, five chemicals were excluded from the final OSHA dermal test rule (69 

1951 FR 22402, April 6, 2004) because IUR data collected indicated that there was no longer 

1952 substantial production. 

1953 

1954 EPA is interested in receiving comments on whether EPA should continue to include 

1955 chemical substances that are the subject of proposed rules in the list of exclusions at 40 CFR 

1956 710.46 (proposed 711.6) and 40 CFR 710.49 (proposed 711.9). If the proposed rule exclusion 

1957 were no longer available, should EPA consider removing some or all of the reporting 

1958 exemptions? This would allow EPA to obtain information on those chemicals for which it is 

1959 considering analysis or regulation, but which would otherwise be exempt. EPA also is interested 

1960 in receiving comments on whether the Agency should: (1) add new exclusions to reporting 

1961 exemptions; (2) entirely eliminate certain reporting exemptions under circumstances other than 

1962 those described in the previous paragraph; or (3) leave the exclusions from the reporting 

1963 exemptions unchanged. 

1964 

1965 3)4) The proposals discussed in Unit III.D.3 1 would result in a site reporting data on subject 

1966 chemical substances exceeding the 25,000 lb. threshold for any calendar year since the last 

1967 principal reporting year. The site would report manufacturing (including production 

1968 volume), processing, and use information for the principal reporting year (e.g., 2010), as well 

1969 as production volume information for all the years since the last IUR principal reporting year 

1970 (i.e., 2006 through 2009, for principal reporting year 2010). In developing this proposal, 

1971 EPA considered several other reporting options and is seeking comment on these options, 

1972 which are described in paragraph (23)(i), (3)(ii), and (23)(iii) of this section. 

1973 

1974 i) EPA is proposing to return the reporting frequency to four years and is 

1975 considering further increasing the frequency to every three years, biennially, or 

1976 annually. (See Ref. 11 for burden and cost information.) More frequent reporting 

1977 provides more current data. Eliminating the five-year wait for current information 

1978 would address concerns that IUR data is outdated and therefore less useful than if it 

1979 were more current. EPA is particularly interested in the annual reporting option for 

1980 several reasons. Annual reporting would enable EPA to better analyze trends, 

1981 including ascertaining which chemicals are manufactured on a consistent basis, 

1982 which chemicals have wide variations from year to year, and which chemicals are 

1983 increasing or decreasing in volume. Trend analyses measure the success of 

1984 programs and can be used to proactively identify developing issues and generally 

1985 provide a greater insight into the chemical industry. Obtaining this information 

1986 annually, instead of the proposed option of reporting four years of production 

1987 volume at one time, would allow for closer monitoring of trends and the more 

1988 timely feedback on the success of programs than would be possible under the 

1989 proposed option. , although if processing and use data changes little year-on-year, 

1990 it could significantly raise the burden of the IUR on submitters without providing 

1991 EPA or the public with information benefits. In addition, annual reporting would 

1992 provide the opportunity to tie-in more closely or actually integrate IUR reporting 

1993 with the already-required annual Toxic Release Inventory (TRI) reporting. 

1994 

1995 ii) EPA requests comment on whether the reporting frequency should remain five 

1996 years and whether the proposed requirement for annual production data resolves 

1997 concerns that IUR data is outdated for its intended purpose. What is the marginal 

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1998 value of processing and use data gathered every four years versus every five years? 

1999 

2000 ii)iii) EPA is also interested in comments regarding changing the reporting 

2001 threshold from 25,000 lb. to 10,000 lb., but is not including this change in the 

2002 regulatory text accompanying this proposal. (See Ref. 11 for burden and cost 

2003 information.) Prior to the 2006 IUR, the threshold for determining the need to 

2004 report was 10,000 lb., therefore this change in the reporting threshold would be a 

2005 return to the status quo for the IUR. The Agency is interested in collecting 

2006 information on chemicals with nationally aggregated production volumes of 25,000 

2007 lb. or higher. Because chemicals are often manufactured at more that one site, 

2008 chemicals with site-specific production volumes that fall below the 25,000 lb. 

2009 reporting threshold and therefore would not be reported for IUR may have 

2010 aggregated production volumes of 25,000 lb. or greater. Are there other thresholds 

2011 (higher or lower) that might be appropriate? 

2012 

2013 5) EPA requests comment on the draft economic analysis to evaluate whether the proposed 

2014 collection of information is necessary for the proper performance of the functions of the 

2015 Agency, including whether the information will have practical utility. 

2016 

2017 6) EPA requests comment on the accuracy of the Agency's estimate of the burden of the 

2018 proposed collection of information, including the validity of the methodology and 

2019 assumptions used. 

2020 

2021 7) EPA requests comment on how the portions of substantive proposed revisions to the IUR 

2022 proposed for substantive revision could be further modified to enhance the quality, utility, 

2023 and clarity of the information to be collected. 

2024 

2025 8) EPA requests comment on how best to minimize the burden of collecting information from 

2026 those persons required to respond, including through the use of appropriate automated, 

2027 electronic, mechanical, or other technological collection techniques or other forms of 

2028 information technology, e.g., permitting electronic submission of responses.

2029 

2030 8)9) EPA is considering collecting additional exposure-related data, similar to those collected 

2031 under TSCA section 5 (new chemicals program), to enhance the Agency’s capabilities in 

2032 conducting screening-level exposure assessments of chemical substances reported to the 

2033 TSCA Inventory Update. 

2034 

2035 EPA, through its experience in using the IUR exposure-related and use information, has 

2036 learned that the current IUR data are not sufficient for determining quantitative estimates of 

2037 releases of and exposures to chemical substances. As a result of the available 2006 IUR data, 

2038 EPA could develop only qualitative exposure characterizations with relative ranking of low, 

2039 medium or high for characterizing potential exposures to various populations. While the 

2040 usefulness of these data was limited because data were only partially reported (see Unit III.G.), it 

2041 was also limited because the specific data elements, as included in the 2006 IUR, were not 

2042 detailed and comprehensive enough to enable EPA to generate a more robust estimate. For 

2043 instance, the function and use categories used for processing and use information were broad, 

2044 and the reported production volume information was insufficient to identify the volumes of 

2045 chemical used at the manufacturing site or domestically processed or used. The Agency believes 

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2046 the proposed rule text changes will improve its ability to identify and manage risks associated 

2047 with existing chemicals, but also believes that supplementary, more in-depth exposure-related 

2048 information (i.e., beyond the elements under the rule text currently accompanying this proposal) 

2049 would substantially improve EPA’s ability to quantify chemical risks. The ability to quantify 

2050 chemical risks would further improve the Agency’s ability to identify and manage those risks. 

2051 EPA therefore believes that, while the changes included in the proposed regulatory text address 

2052 the limitations associated with qualitative characterizations, further changes would be needed to 

2053 enable the more quantitative estimates. 

2054 

2055 If additional data identified below were to be reported, EPA could use currently available 

2056 assessment tools and methodologies to develop screening-level estimates of chemical 

2057 environmental releases and concentrations to various environmental media (including air, water, 

2058 and land) and exposures to the potentially exposed populations (such as workers, consumers, 

2059 children, and the general population). Examples of the tools and methodologies include the 

2060 Agency's Chemical Screening Tool For Exposures & Environmental Releases (ChemSTEER) 

2061 (Ref. 14) and Exposure and Fate Assessment Screening Tool (EFAST) (Ref. 15). The Agency 

2062 anticipates that the improved screening-level exposure assessments would be similar to what is 

2063 developed for new chemical substances submitted to the Agency for review to identify chemicals 

2064 of concern and potential risk management. The Pre-Manufacturing Notice (PMN) Program 

2065 Form 7710-25 (available at: http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm) was 

2066 used to develop the following list of additional potential exposure-related data elements and their 

2067 brief descriptions: 

2068 

2069 Manufacturing Process: 

Description of manufacturing 

process 

Provide a process flow diagram which describes the 

manufacturing operations involving the chemical substance. 

“Manufacturing operation” means a functional step in which 

substances undergo chemical changes and/or changes in 

location, temperature, pressure, physical state, or similar 

characteristics. Include steps in which the substance is 

formulated into gels, mixtures, suspensions, solutions, etc. 

and in which the substance is transferred into interim storage 

or shipping containers. Indicate in your diagram the entry 

and exit points of the chemical substance. Number all points 

from which the chemical substance will be released to the 

environment or to control equipment, including small or 

intermittent releases (e.g. some cleaning releases, drum 

residues, etc.) and trace amounts of the substance. 

Continuous or batch process Indicate whether the chemical substance is manufactured in 

discrete batches or is produced by continuously adding 

reactants and removing the reaction product. 

Amount of substance produced 

per day or per batch 

If the chemical substance is produced in discrete batches, 

indicate the amount of the substance in pounds produced in 

each batch; if the substance is produced in a continuous 

process, indicate the amount of substance in pounds 

manufactured each day. 

Batch or daily run time If the chemical substance is produced in discrete batches, 

indicate the batch time (hours/batch); if the substance is 

produced in a continuous process, indicate the daily run time 

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Days of operation per year or 

number of batches per year 

If the chemical substance is produced in discrete batches, 

indicate the number of batches per year necessary to produce 

the reported production volume; if the chemical substance is 

produced in a continuous process, indicate the number of 

days of operation per year needed to produce the reported 

production volume. 

Unit operations List the unit operations needed to produce the chemical 

substance. Unit operation means a functional step in 

manufacturing, processing, or use operation where substances 

undergo chemical changes, or changes in temperature, 

pressure, physical state, concentration, purity, or similar 

characteristics. Examples of unit operations include 

blending, distillation, filtration, and drying. 

Storage and shipping containers List the types of containers used to transport or store the 

chemical substance and their capacity. Examples of 

containers include 1-liter bottles, 5-gallon pails, 55-gallon 

drums, 200-pound totes, 5000-gallon tank trucks, and 20,000-

gallon railcars. 

2070 

2071 Manufacturing Worker Exposures: 

Worker activities Describe each specific activity in the operation during which 

workers may be exposed to the chemical substance. Such 

activities may include charging reactor vessels, sampling for 

quality control, transferring substances from one container to 

another, changing filters, filling drums, loading and loading 

tank cars or trucks, etc. Activities must be described even 

when workers wear protective equipment. 

Duration and frequency of 

worker exposure 

For each worker activity, enter the maximum duration in 

hours per day and number of days per year that any one 

worker will engage in the activity during a normal work day 

based on the reported production volume. 

Physical form For each worker activity, indicate the physical form of the 

substance at the time of exposure. 

Maximum concentration For each worker activity, indicate the maximum 

concentration of the substance in the product at the time of 

exposure. 

Personal protective equipment 

and engineering controls used by 

workers 

For each worker activity, identify the specific types of 

protective equipment and engineering controls that will be 

employed to protect the worker from potential exposure to the 

chemical substance, e.g., gloves, goggles, protective garment, 

local ventilation, respirator, etc. 

Worker monitoring data 

available 

Indicate whether monitoring data on occupational exposure of 

workers is available. 

Summary of occupational 

exposure monitoring included 

Indicate whether a summary of occupational exposure 

monitoring data is included. Summary should include 

information on the # of workers involved, # of samples taken, 

types of samples (area or personal), average and standard 

deviations of exposure. 

2072 

2073 Manufacturing Releases to the Environment: 

Release source (or release point) For each point of release containing the chemical substance, 

identify and describe the point in the process description at 
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which the release occurs (e.g. releases due to spillage, 

residues, separation losses, and other sources from each batch 

or each day). 

Media and type of release For each release, indicate the type (gas or vapor, aqueous or 

liquid solution, or solid) and media (stack air, fugitive air, 

surface water, on-site or off-site land or incineration, POTW,

or other (specify)) which describes the release stream 

containing the chemical.media (air, liquid or aqueous 

solution, solid) and type of release [stack air, fugitive air, 

surface water, on-site or off-site land or incineration, POTW 

or other (specify)] of a release stream containing the chemical 

substance.

Quantity of substance released a) 

directly to the environment or b) 

into control technology to the 

environment 

For each release, provide the quantity (in pounds) of chemical 

substance released a) directly to the environment or b) into 

control technology to the environment in pounds per day for 

continuous operation or pounds per batch for batch 

operations. 

Control technology For each release, describe the type of technology used to 

control the release of the substance to the environment. 

Examples of control technologies include carbon filter, 

scrubber and biological treatment (primary, secondary, etc.). 

Efficiency of control technology Indicate the established efficiency of the control technology 

in removing or destroying the chemical substance. 

Destination of release For aqueous releases containing the chemical substance, 

indicate whether release enters a navigable waterway, a 

publicly-owned treatment works (POTW), or other. Identify 

the name of the POTW and/or NPDES # as appropriate. For 

other releases, indicate whether the release goes to a 

municipal or hazardous waste landfill, a commercial 

incinerator, enters the atmosphere, or is otherwise disposed 

(specify). 

Additional release related 

information attached 

Indicate whether a description of the releases, calculations or 

monitoring data on the quantities of releases, or additional 

information on control technologies and/or treatment is 

attached. 

2074 

2075 Industrial Processing or Use Activities: 

Description of Processing or Use Provide a process flow diagram which describes the 

processing or use operation involving the chemical substance. 

“Unit operation” means a functional step in which substances 

undergo chemical changes and/or changes in location, 

temperature, pressure, physical state, or similar 

characteristics. Include steps in which the substance is 

formulated into gels, mixtures, suspensions, solutions, etc. 

and in which the substance is transferred into interim storage 

or shipping containers. Indicate in your diagram the entry 

and exit points of the chemical substance. Number all points 

from which the chemical substance will be released to the 

environment or to control equipment, including small or 

intermittent releases (e.g. some cleaning releases, drum 

residues, etc.) and trace amounts of the substance. 

Processing or use at sites Indicate whether the sites at which the chemical is processed 
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controlled by manufacturer or used are owned by the manufacturer or others. 

Continuous or batch process Indicate whether the industrial process in which the chemical 

is processed or used in a batch or continuous process. 

Amount of substance processed 

per day or per batch 

Provide the amount of the substance in pounds processed or 

used per batch for batch operation or processed or used per 

day for continuous operation, respectively. 

Batch or daily run time If the chemical substance is processed in discrete batches, 

indicate the batch time (hours/batch); if the substance is 

processed in a continuous process, indicate the daily run time 

(hours/day). 

Days of operation per year or 

number of batches per year 

If the chemical substance is processed in discrete batches, 

indicate the number of batches per year necessary to process 

the reported production volume; if the chemical substance is 

produced in a continuous process, indicate the number of 

days of operation per year needed to process the reported 

production volume. 

Unit operations List the unit operations needed to process the chemical 

substance. Unit operation means a functional step in 

manufacturing, processing, or use operation where substances 

undergo chemical changes, or changes in temperature, 

pressure, physical state, concentration, purity, or similar 

characteristics. Examples of unit operations include 

blending, distillation, filtration, and drying. 

Storage and shipping containers 

used 

List the types of containers used to transport or store the 

chemical substance and their capacity. Examples of 

containers include 1-liter bottles, 5-gallon pails, 55-gallon 

drums, 5,000-gallon tank trucks, and 20,000-gallon railcars. 

2076 

2077 Industrial Processing or Use Occupational Exposures: 

Worker activities Describe each specific activity in the operation during which 

workers may be exposed to the chemical substance. Such 

activities may include charging reactor vessels, sampling for 

quality control, transferring substances from one container to 

another, changing filters, filling drums, loading and loading 

tank cars or trucks, etc. Activities must be described even 

when workers wear protective equipment. 

Duration and frequency of 

worker exposure 

For each worker activity, provide the maximum duration in 

hours per day and the number of days per year during which 

any one worker will engage in the activity during a normal 

work day during in processing or use. 

Physical form For each worker activity, indicate the physical form of the 

substance at the time of exposure. 

Maximum concentration For each worker activity, indicate the maximum 

concentration of the substance in the product at the time of 

exposure. 

Personal protective equipment 

and engineering controls used by 

workers 

For each worker activity, identify the specific types of 

protective equipment and engineering controls that will be 

employed to protect the worker from potential exposure to the 

chemical substance, e.g., gloves, goggles, protective garment, 

local ventilation, respirator, etc. 

Worker monitoring data 

available 

Indicate whether monitoring data on occupational exposure of 

workers is available. 
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Summary of occupational 

exposure monitoring included 

Indicate whether a summary of occupational exposure 

monitoring data is included. Summary should include 

information on the # of workers involved, # of samples taken, 

types of samples (area or personal), average and standard 

deviations of exposure. 

2078 

2079 Industrial Processing or Use Releases to the Environment: 

Release source (or point) For each point of release containing the chemical substance, 

identify and describe the point in the process description at 

which the release occurs (e.g. releases due to spillage, 

residues, separation losses, and other sources from each batch 

or each day). 

Media and type of release For each release, indicate the type (gas or vapor, aqueous or 

liquid solution, or solid) and media (stack air, fugitive air, 

surface water, on-site or off-site land or incineration, POTW,

or other (specify)) which describes the release stream 

containing the chemical.media (air, liquid or aqueous 

solution, solid) and type of release [stack air, fugitive air, 

surface water, on-site or off-site land or incineration, POTW 

or other (specify)] of a release stream containing the chemical 

substance.

Quantity of substance released a) 

directly to the environment or b) 

into control technology to the 

environment 

For each release, provide the quantity (in pounds) of chemical 

substance released a) directly to the environment or b) into 

control technology to the environment in pounds per day for 

continuous operation or pounds per batch for batch 

operations. 

Control technology For each release, describe the type of technology used to 

control the release of the substance to the environment. 

Examples of control technologies include carbon filter, 

scrubber and biological treatment (primary, secondary, etc.). 

Efficiency of control technology Indicate the established efficiency of the control technology 

in removing or destroying the chemical substance. 

Destination of release For aqueous releases containing the chemical substance, 

indicate whether release enters a navigable waterway, a 

publicly-owned treatment works (POTW), or other. Identify 

the name of the POTW and/or NPDES # as appropriate. For 

other releases, indicate whether the release goes to a 

municipal or hazardous waste landfill, a commercial 

incinerator, enters the atmosphere, or is otherwise disposed 

(specify). 

Additional release related 

information attached 

Indicate whether a description of the releases, calculations or 

monitoring data on the quantities of releases, or additional 

information on control technologies and/or treatment is 

attached. 

2080 

2081 Commercial Use Occupational Exposure: 

Description of commercial use Describe the commercial use(s) of products containing the 

chemical substance. 

Function of chemical in 

commercial product 

Describe the function of the chemical in the commercial 

product, e.g., dispersive dye, solvent, stabilizer, hardener, 

plasticizer, filler, etc. 

Number of potentially exposed Indicate the number of workers in commercial establishments 
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commercial workers who are reasonably likely to be exposed to the chemical 

substance. 

Physical form of commercial 

product 

Indicate the physical form of the product containing the 

chemical substance. 

Method of commercial product 

application 

Describe the application method (e.g. sprayed applied via 

pump sprayer or aerosols, poured or applied manually) of the 

product containing the chemical substance and whether the 

commercial use is destructive, contained, dispersive, etc. 

Duration and frequency of 

commercial product use 

Indicate the duration of use, e.g. 5 minutes or less, 30 

minutes or less, 1 hour or less, etc. and frequency of 

commercial use, e.g. used more than once a day, used once a 

day, used several times a week, etc. 

2082 

2083 Consumer Use and Exposure: 

Description of consumer use Describe the consumer use(s) of products containing the 

chemical substance. 

Function of chemical in 

consumer product 

Describe the function of the chemical in the consumer 

product, e.g., dispersive dye, solvent, stabilizer, hardener, 

plasticizer, filler, etc. 

Number of potentially exposed 

consumers 

Indicate the number of consumers reasonably likely to be 

exposed to the chemical substance. 

Physical form of consumer 

product(s) containing the 

chemical substance 

Indicate the physical form, e.g., gel, foam, powder, etc. of the 

consumer product containing the chemical substance. 

Method of consumer product 

application 

Describe the application of the consumer product containing 

the chemical substance, for example, chemicals in products 

that will be sprayed via pump sprayer or aerosols; products 

that are poured, mixed, applied by hand/mechanical device; 

chemicals that can be released via diffusion, evaporation, 

abrasion, etc., from articles; or chemicals that are 

incorporated into articles with no potential for release, etc. 

Duration and frequency of 

consumer product use 

Indicate the duration of consumer use, e.g., used for 5 

minutes or less, 30 minutes or less, less than 1 hour, etc. and 

frequency of consumer use, e.g. used more than once a day, 

used once a day, used several times a week, etc. 

2084 

2085 EPA is soliciting comment on the data elements identified above. Collecting these data 

2086 would enable the Agency to develop more comprehensive and complete screening assessments 

2087 of the exposures that may be encountered during the manufacture, processing, and use of 

2088 chemicals. The Agency also is interested in whether any additional data elements should be 

2089 collected, and in any other considerations relating to the collection of additional data. Because 

2090 these data elements are based on the data elements included in a PMN submission, EPA believes 

2091 the burden a site would incur to provide these data for each chemical would be similar to the 

2092 burden incurred for a site to develop a single PMN submission, almost doubling the burden of 

2093 the IUR program. EPA presents the estimated increase in industry costs and burden associated 

2094 with change in Appendix H of the economic analysis. (Ref. 11) 

2095 

2096 EPA is also soliciting comment on the best method to collect these data. The Agency is 

2097 considering three approaches to collect these data from known manufacturers (including 

2098 importers). These approaches are: integrating these data elements into the IUR, promulgating a 

2099 new reporting mechanism under TSCA section 8(a), or using TSCA section 11(c) subpoena 
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2100 authority. Integrating these data elements into the IUR would provide a more complete set of 

2101 data, enabling the Agency to identify proactively potential exposure-based chemical risk 

2102 management issues and to provide the public access to an enhanced database. The Agency is 

2103 also soliciting comment on the appropriate scope of an IUR requirement to report these data 

2104 elements. For instance, the scope could be based on chemical identity, and the Agency could 

2105 provide a list of chemicals for which these data would be reported. Alternatively, the scope 

2106 could be based on production volume, and the Agency could identify the production volume 

2107 range for which these data would be reported. 

2108 

2109 As a second option, the Agency is considering promulgating a new reporting mechanism 

2110 under TSCA section 8(a) that would enable the collection of enhanced exposure-related data, 

2111 described in this section, for about 100 chemical substances per year. For instance, EPA could 

2112 notify manufacturers (including importers) of the need to submit additional information, e.g., via 

2113 a Federal Register notice or individually via U.S. mail, with details on the data to report and the 

2114 reporting criteria. (See Ref. 11 for burden and cost information.) This approach would enable 

2115 the Agency to target the collection to those chemicals of current priority for screening-level 

2116 assessment. The Agency also solicits comment on the need to establish a complementing 

2117 recordkeeping requirement. Such a recordkeeping requirement would ensure that the additional 

2118 data subject to the new reporting mechanism would be more quickly available at the time that 

2119 EPA requested them. However, without advance notice regarding the specific chemicals for 

2120 which information would be required, manufacturers (including importers) of all chemicals 

2121 subject to the IUR would be required to maintain the records. 

2122 

2123 As a third option, EPA considering the use of TSCA section 11(c) subpoena authority to 

2124 collect enhanced exposure-related data. TSCA section 11(c) gives the Agency broad authority to 

2125 collect information for regulatory purposes and would, therefore, allow EPA to require, by 

2126 subpoena, the submission of the enhanced exposure-related data. Among the circumstances in 

2127 which the Agency is considering exercising this subpoena authority are those in which the 

2128 enhanced data elements are not available through other means and are necessary for a more 

2129 effective screening level review of chemical substances on a case by case basis. 

2130 

2131 94) EPA is considering collecting exposure-related information from processors in addition to 

2132 collecting the data from manufacturers. 

2133 

2134 Currently, only manufacturers (including importers) are responsible for providing 

2135 information required by the IUR rule. TSCA section 8(a) enables the Agency also to collect 

2136 information from processors. EPA seeks comment on also requiring processors to report 

2137 processing and use data under the three data collection approaches described above (i.e., by 

2138 modification of the IUR rule, via notification issued under a new data reporting mechanism, or 

2139 using existing subpoena authority). (See Ref. 11 for burden and cost information.) The Agency 

2140 believes that processors may be more familiar with the processing and use of the chemicals than 

2141 manufacturers, and therefore may be able to provide more complete and accurate exposure2142 related data. 

2143 

2144 VI. References

2145 

2146 As indicated under ADDRESSES, a docket has been established for this rulemaking 

2147 under docket ID number EPA-HQ-OPPT-2009-0187. The following is a listing of the 
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2148 documents that are specifically referenced in this document. The docket includes these 

2149 documents and other information considered by EPA in developing this proposed rule, including 

2150 documents that are referenced within the documents that are included in the docket, even if the 

2151 referenced document is not physically located in the docket. For assistance in locating these 

2152 other documents, please consult the technical contact listed under FOR FURTHER 

2153 INFORMATION CONTACT. 

2154 

2155 1. U.S. EPA, Memorandum to EPA Employees from Lisa P. Jackson, Administrator, 

2156 January 23, 2009, Located at: 

2157 http://www.epa.gov/administrator/memotoemployees.html. 

2158 

2159 2. U.S. EPA, “Draft Instructions for 2011 Inventory Update Reporting,” October 2009. 

2160 

2161 3. U.S. EPA, “IUR Modifications Rule: Development of Definitions for proposed 40 CFR 

2162 711.3,” OPPT, August 2009. 

2163 

2164 4. U.S. EPA, “Electronic Signature Agreement,” OPPT, August 2009. 

2165 

2166 5. U.S. EPA, “Development of CDX Workflow for Electronic Toxic Substances Control 

2167 Act (eTSCA) Submissions: Draft User Guide” (Version 1.0), CDX, November13, 2008. 

2168 

2169 6. American Petroleum Institute, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785; 

2170 EPA-HQ-OPPT-2008-0807 from Howard J. Feldman, December 8, 2008. 

2171 

2172 7. Proctor & Gamble, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785, from Julie 

2173 Froelicher, January 23, 2009. 

2174 

2175 8. Synthetic Organic Chemical Manufacturers Association, Comments submitted to Docket 

2176 ID No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009. 

2177 

2178 9. U.S. EPA, “Inventory Update Reporting (IUR) Technical Support Document – 

2179 Replacement of 5-digit NAICS Codes with Industrial Sectors.” OPPT/EETD, August 

2180 2009. 

2181 

2182 10. U.S. EPA, “2006 Inventory Update Reporting: Data Summary,” OPPT, EPA report 

2183 number 740S08001, December 2008. Located at: 

2184 http://www.epa.gov/opptintr/iur/pubs/2006_data_summary.pdf. 

2185 

2186 11. U.S. EPA, “Draft Economic Analysis for the Proposed IUR Modifications Rule,” 

2187 OPPT/EETD, January 2010. 

2188 

2189 12. U.S. EPA, “Addendum to Information Collection Request 1884.04,” OMB control 

2190 number 2070-0162, OPPT, September 2009. 

2191 

2192 13. U.S. EPA/Environment Canada/Health Canada, “Overview of Harmonized U.S.-Canada 

2193 Industrial Function and Consumer and Commercial Product Codes for Chemical 

2194 Inventory Reporting,” September 2009. 

2195 
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2196 14. U.S. EPA, “Chemical Screening Tool For Exposures & Environmental Releases.” 

2197 Located at: http://www.epa.gov/oppt/exposure/pubs/chemsteer.htm, September 2009. 

2198 

2199 15. U.S. EPA, “Exposure and Fate Assessment Screening Tool.” Located at: 

2200 http://www.epa.gov/oppt/exposure/pubs/efast.htm, September 2009. 

2201 

2202 16. U.S. EPA, “Fact Sheet: Recycling and the TSCA Inventory of Chemical Substances 

2203 Premanufacture Notification and Inventory Update Reporting Requirements.” OPPT, 

2204 May 2010.

2205 

2206 17. U.S. EPA, “Q&A Document: Recycling and the TSCA Inventory of Chemical 

2207 Substances Premanufacture Notification and Inventory Update Reporting Requirements.” 

2208 OPPT, May 2010

2209 

2210 18. Small Business Administration, “TSCA IUR Byproducts Reporting v_1 02_18_10.doc” 

2211 e-mail to Wendy Cleland-Hamnett, U.S. EPA, from Keith Holman, SBA. March 9, 2010.

2212 

2213 VII. Statutory and Executive Order Reviews 

2214 A. Regulatory Review 

2215 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

2216 October 4, 1993), this action has been designated a “significant regulatory action” by the Office 

2217 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 

2218 under Executive Order 12866 and any changes made in response to OMB recommendations have 

2219 been documented in the docket for this action. 

2220 

2221 In addition, EPA has prepared an economic analysis of the potential impacts associated 

2222 with this action. A copy of this economic analysis, entitled, Draft Economic Analysis for the 

2223 Proposed Inventory Update Reporting (IUR) Modifications Rule (Ref. 11), is available in the 

2224 docket and is briefly summarized in this Unit of the preamble. The amendments in this proposal 

2225 affect the number of reports submitted during a submission period, the burden to prepare a 

2226 report, and the reporting frequency. EPA estimates that the combined impact of all the proposed 

2227 amendments will increase the total burden and cost to industry associated with IUR reporting. 

2228 

2229 In its economic analysis, EPA estimated industry cost and burden on a per-report and a 

2230 per-site basis and at the industry level. Industry cost and burden are incurred by performing 

2231 activities to comply with the proposed amendments, including compliance determination, rule 

2232 familiarization, preparation and submission of reports, and recordkeeping. 

2233 

2234 On a per-report basis, EPA estimated incremental increases of 5.24.28 hours and $410

2235 350 for a site to complete a partial report for one chemical and 18.317.38 hours and $1,468 408

2236 to complete a full report for one chemical, in the first submission reporting cycle after the 

2237 effective date of the proposed rule amendments. A partial report includes Parts I and II of Form 

2238 U. A full report includes Parts I, II and III of Form U. For future submission reporting cycles, 

2239 EPA estimated incremental increases of 3.43.28 hours and $284 275 for a site to complete a 

2240 partial report for one chemical and 13.112.98 hours and $1,084 075 to complete a full report for 

2241 one chemical. 

2242 
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2243 As a result of the proposed amendments, EPA estimates that the average site will submit 

2244 approximately 2.01 fewer partial reports and 2.98 more additional full reports in a submission 

2245 period. For the average site, this will increase the burden by 342 341 hours during the first 

2246 submission reporting cycle and 264 hours for all subsequent submission reporting cycles. EPA 

2247 estimates that the average site will incur a net cost increase of $22,553 493 during the first 

2248 submission reporting cycle and $17,526 517 during all future submission reporting cycles. 

2249 

2250 At the industry level for all sites submitting a Form U, EPA estimates a net total burden 

2251 increase of 1.56 39 million hours in the first submission yearreporting cycle, and 1.21 million 

2252 hours for all subsequent submission yearsreporting cycles. EPA estimates a net cost increase of 

2253 $103.7091.87 million in the first submission reporting cycle of the rule, and $79.31 29 million in 

2254 all subsequent submission reporting cycles. When the submission reporting cycle costs, which 

2255 would be incurred once every four years under the proposed rule, are spread averaged over the 

2256 proposed four-year reporting cycle, the average annualized increase in industry cost attributable 

2257 to the proposed amendments is approximately $26.2721.61 million over a 250-year period (at a 

2258 3% discount rate). 

2259 

2260 EPA estimates that the Agency will experience a reduction in both burden and cost to 

2261 administer the IUR rule as a result of the proposed amendments. Specifically, EPA expects to 

2262 experience a net burden reduction of 1,704 721 hours in the first submission reporting cycle and 

2263 all subsequent submission reporting cycles. The Agency estimates it will experience a net 

2264 savings of $177,683179,600 during each submission reporting cycle. This information will be 

2265 reflected in the Information Collection Request (ICR) that is submitted every three years to OMB 

2266 under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. 

2267 B. Paperwork Reduction Act 

2268 

2269 The information collection requirements in 40 CFR part 710 related to the submission of 

2270 Form Us are already approved by OMB under the PRA. That ICR has been assigned EPA ICR 

2271 No. 1884 and OMB control No. 2070-0162. Because this rule involves new or revised 

2272 information collection activities that require additional OMB approval, EPA has prepared an 

2273 addendum to the currently approved ICR (Ref. 12). An agency may not conduct or sponsor, and 

2274 a person is not required to respond to an information collection request subject to the PRA unless 

2275 it displays a currently valid OMB control number. The OMB control numbers for EPA’s 

2276 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 

2277 the form or survey). 

2278 

2279 Under the PRA, the term “burden” is interpreted as the total time, effort, or financial 

2280 resources expended by people to generate, maintain, retain, disclose, or provide information to or 

2281 for a federal agency. This includes the time needed by regulated entities to review instructions 

2282 and to develop, acquire, install, and use technology and systems to collect, validate, verify, and 

2283 disclose information. Time taken to adjust existing ways to comply with any previously 

2284 applicable instructions and requirements and to train personnel to respond to the information 

2285 collection task is also included. In this analysis, total industry burden hours represent the sum of 

2286 time spent on reporting and on other administrative activities. Industry respondents will spend 

2287 time on the following activities associated with the IUR rule: compliance determination, rule 

2288 familiarization, preparation and submission of reports, and recordkeeping. 
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2289 As presented in the economic analysis (Ref. 11) and the addendum ICR (Ref. 12), EPA 

2290 estimates that the proposed rule would create a total incremental industry burden of 1.56 39

2291 million hours in the first reporting cycle, if all proposed amendments are finalized as proposed. 

2292 The burden for a site to complete a full IUR report for IUR for one chemical is estimated to be 

2293 140.381.33 hours, which is an incremental burden increase of 17.388.33 hours over the current 

2294 estimated burden. The burden for a site to complete a partial IUR report for IUR for one 

2295 chemical is estimated to be 57.368.31 hours, which is an incremental burden increase of 5.283

2296 hours over the current estimated burden. For future reporting cycles, EPA estimates that the 

2297 proposed rule would create a total incremental industry burden of 1.21 million hours. Tthe 

2298 burden for a full report is estimated to be 95.0317 hours, which is an incremental increase of 

2299 12.983.11 hours over the current estimated future burden. The burden and for a partial report is 

2300 estimated to be 29.54 40 hours, which is an incremental increase of 3.2841 hours over the current 

2301 estimate. 

2302 

2303 To comment on the Agency's need for this information, the accuracy of the provided 

2304 burden estimates, and any suggested methods for minimizing respondent burden, EPA has 

2305 established a docket for this proposed rule, which includes this ICR, under docket ID number 

2306 EPA-HQ-OPPT-2009-0187. Submit any comments related to the ICR to EPA and OMB. See 

2307 ADDRESSES for where to submit comments to EPA. Send comments to OMB at the Office of 

2308 Information and Regulatory Affairs, Office of Management and Budget, 725 17th St, N.W., 

2309 Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is required to make a 

2310 decision concerning the ICR between 30 and 60 days after [insert date of publication in the

2311 Federal Register], a comment to OMB is best assured of having its full effect if OMB receives 

2312 it by [Insert date 30 days after publication in the Federal Register]. The final rule will respond 

2313 to any OMB or public comments on the information collection requirements contained in this 

2314 proposed rule. 

2315 

2316 C. Small Entity Impacts 

2317 

2318 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 

2319 the Agency hereby certifies that this action will not have a significant adverse economic impact 

2320 on a substantial number of small entities. The Agency’s basis is briefly summarized here and is 

2321 detailed in the economic analysis (Ref. 11). 

2322 

2323 Under the RFA, small entities include small businesses, small organizations, and small 

2324 governmental jurisdictions. For purposes of assessing the impacts of today's rule on small 

2325 entities, small entity is defined as: (1) a small business, as defined by the Small Business 

2326 Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction 

2327 that is a government of a city, county, town, school district or special district with a population of 

2328 less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is 

2329 independently owned and operated and is not dominant in its field. Since the regulated 

2330 community does not include small governmental jurisdictions or small not-for-profit 

2331 organizations, the analysis focuses on small businesses. 

2332 

2333 The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 

2334 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and 

2335 less than 100,000 lb. production of any given chemical at a site; or annual sales of less than $4 

2336 million. This exemption is maintained in the proposed amendments. A small business would be 
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2337 required to report under the proposed rule, however, if it produces any chemical substance that is 

2338 the subject of a regulation proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that 

2339 is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been 

2340 granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report 

2341 voluntarily. 

2342 

2343 EPA analyzed potential small business impacts from this rule using both the SBA 

2344 employee size standards and the TSCA sales-based definition of small business. EPA estimates 

2345 that 503 466 small firms potentially would be affected by this proposed rule using the 

2346 employment-based definition, and 280 small firms potentially would be affected using the sales2347 based definition. Based on costs annualized over a four-year period and average sales data for the 

2348 parent companies, EPA estimated that the cost-to-sales ratio of the proposed rule would be less 

2349 than 0.1 percent for an average small company subject to the rule. For a company to have a cost2350 to-sales ratio larger than one percent, company sales would have to be less than $1.025 million. 

2351 Because the small businesses affected by the proposed rule have average sales of more than 

2352 $412.7 million under the employment-based definition, and $11.8 million under the sales-based 

2353 definition, small entities will not be affected by the proposed amendments to the IUR rule at a 

2354 cost-to-sales ratio of greater than one percent (Ref. 11). 

2355 EPA continues to be interested in the potential impacts of this proposed rule on small 

2356 entities and welcomes comments on issues related to such impacts. 

2357 

2358 D. Unfunded Mandates 

2359 

2360 This action does not contain any Federal mandates for State, local, or tribal governments 

2361 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 

2362 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in 

2363 annual expenditures of $100 million or more for State, local, and tribal governments, in the 

2364 aggregate, or for the private sector. The analysis of the costs associated with this action are 

2365 briefly described in Unit VII.A., and is contained in the economic analysis (Ref. 11). 

2366 

2367 Based on EPA's past experience, State, local, and tribal governments have not been 

2368 affected by this reporting requirement, and EPA does not have any reason to believe that any 

2369 State, local, or tribal government will be affected by this rulemaking. As such, EPA has 

2370 determined that this regulatory action does not impose any enforceable duty, contain any 

2371 unfunded mandate, or otherwise have any affect on small governments. Accordingly, this rule is 

2372 not subject to the requirements of sections 202, 203 or 205 of UMRA. 

2373 E. Federalism 

2374 

2375 Pursuant to Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 

2376 1999), EPA has determined that this proposed rule does not have federalism implications 

2377 because it will not have substantial direct effects on the states, on the relationship between the 

2378 national government and the states, or on the distribution of power and responsibilities among 

2379 the various levels of government, as specified in the Order. This rule simply amends the 

2380 Inventory Update Reporting rule in several ways to provide information to better address Agency 

2381 and public information needs, improve the usability and reliability of the reported data, and 

2382 ensure that data are available in a timely manner. Because EPA has no information to indicate 

2383 that any state or local government manufactures or processes the chemical substances covered by 
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2384 this action, the proposed rule does not apply directly to states and localities and will not affect 

2385 state and local governments. Thus, Executive Order 13132 does not apply to the proposed rule. 

2386 

2387 F. Tribal Implications 

2388 

2389 As required by Executive Order 13175, entitled Consultation and Coordination with 

2390 Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 

2391 proposed rule does not have tribal implications because it will not have any affect on tribal 

2392 governments, on the relationship between the Federal government and the Indian tribes, or on the 

2393 distribution of power and responsibilities between the Federal government and Indian tribes, as 

2394 specified in the Order. Thus, Executive Order 13175 does not apply to this rule. 

2395 

2396 G. Children’s Health 

2397 

2398 EPA interprets Executive Order 13045, entitled Protection of Children from 

2399 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 

2400 those regulatory actions that concern health or safety risks, such that the analysis required under 

2401 section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action

2402 is not subject to Executive Order 13045 because it does not establish an environmental standard 

2403 intended to mitigate health or safety risks. Nevertheless, the information obtained by the 

2404 reporting required by this rule will be used to inform the Agency’s decision-making process 

2405 regarding chemicals to which children may be disproportionately exposed. This information will 

2406 also assist the Agency and others in determining whether the chemicals in this proposed rule 

2407 present potential risks, allowing the Agency and others to take appropriate action to investigate 

2408 and mitigate those risks.

2409 H. Energy Effects 

2410 

2411 This action is not a “significant energy action” as defined in Executive Order 13211, 

2412 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

2413 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 

2414 the supply, distribution, or use of energy as described in the Order. 

2415 

2416 I. Technical Standards 

2417 

2418 Since this action does not involve any technical standards, section 12(d) of the National 

2419 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 

2420 12(d) (15 U.S.C. 272 note), does not apply to this action. 

2421 J. Environmental Justice 

2422 

2423 The proposed rule does not have an adverse impact on the environmental and health 

2424 conditions in low-income and minority communities that require special consideration by the 

2425 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 

2426 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

2427 The Agency believes that the information collected under this proposed rule, if finalized, will 

2428 assist EPA and others in determining the potential hazards and risks associated with the 

2429 chemicals covered by the rule. Because the IUR rule is an information collection requirement, 
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2430 the information that will become available through the rule will enable the Agency to target 

2431 educational, regulatory, or enforcement activities towards industries or chemicals that pose the 

2432 greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the 

2433 information to be gathered under the rule will help EPA make decisions that will benefit 

2434 potentially at-risk communities, some of which may be disadvantaged. 

2435 The proposed rule is directed at manufacturers or importers of chemicals. All consumers 

2436 of these chemical products and all workers who come into contact with these chemicals could 

2437 benefit if data regarding the chemicals’ health and environmental effects were developed. 

2438 Therefore, it does not appear that the costs and the benefits of the proposed rule will be 

2439 disproportionately distributed across different geographic regions or among different categories 

2440 of individuals. 

2441 List of Subjects in 40 CFR part 704 

2442 

2443 Environmental protection, Chemicals, Chemical Substance, Confidential business 

2444 information, Hazardous substances, Imports, Reporting and recordkeeping requirements. 

2445 List of Subjects in 40 CFR part 710 

2446 

2447 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 

2448 Reporting and recordkeeping requirements. 

2449 List of Subjects in 40 CFR part 711 

2450 

2451 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 

2452 Reporting and recordkeeping requirements. 

2453 Dated: ________ 

2454 

2455 ________________ 

2456 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.Assistant 

2457 Administrator for Prevention, Pesticides and Toxic Substances.
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2458 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

2459 PART 704--[AMENDED] 

2460  1. Part 704 is amended as follows: 

2461  a. The authority citation for part 704 would continue to read as follows: 

2462 Authority: 15 U.S.C. 2607(a) 

2463 

2464  b. Section 704.3 is amended by removing the phrase “(as defined in 19 CFR 1.11)” in the 

2465 definition for importer. 

2466 PART 710--[AMENDED] 

2467  2. Part 710 is amended as follows: 

2468  a. The authority citation for part 710 would continue to read as follows: 

2469 Authority: 15 U.S.C. 2607(a) 

2470 

2471  b. By revising the heading for part 710 to read: 

2472 

2473 “Part 710—Compilation of the TSCA Chemical Inventory” 

2474 

2475  c. By removing the heading for “Subpart A”. 

2476 

2477  d. By removing the term “subpart” and in its place add the term “part” everywhere it appears 

2478 in §§ 710.1, 710.3 and 710.4. 

2479 

2480  e. In § 710.1(b), by removing the text “The Inventory Update regulations were amended in 

2481 2002...The Agency intends to remove subpart B from the CFR once the 2002 update is 

2482 complete.” 

2483 

2484  f. Section 710.3 is amended as follows: 

2485 

2486 (i) By replacing the introductory text with the phrase “For purposes of this part:” 

2487 (ii) By removing the phrase “(as defined in 19 CFR 1.11)” in the definition for importer.

2488 (iii) By removing the definition for non-isolated intermediate. 

2489  g. By removing Subpart B, consisting of §§ 710.23 - 710.39 and Subpart C, consisting of §§ 

2490 710.43 - 710.59. 

2491 

2492  3. A new part 711 is added to read as follows: 

2493 

2494 PART 711 – TSCA INVENTORY UPDATE REPORTING REQUIREMENTS 

2495 

2496 Sec. 
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2497 § 711.1 Scope and compliance. 

2498 § 711.3 Definitions. 

2499 § 711.5 Chemical substances for which information must be reported. 

2500 § 711.6 Chemical substances for which information is not required. 

2501 § 711.8 Persons who must report. 

2502 § 711.9 Persons not subject to this part. 

2503 § 711.10 Activities for which reporting is not required. 

2504 § 711.12 Reporting information to EPA. 

2505 § 711.13 When to report. 

2506 § 711.15 Duplicative reporting. 

2507 § 711.17 Recordkeeping requirements. 

2508 § 711.18 Confidentiality. 

2509 § 711.19 General. 

2510 

2511 Authority: 15 U.S.C. 2607(a). 

2512 

2513 § 711.1 Scope and compliance.

2514 (a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic 

2515 Substances Control Act (15 U.S.C. 2607(a)) (TSCA) for certain manufacturers (including 

2516 importers) of chemical substances. Section 8(a) authorizes the Administrator to require reporting 

2517 of information necessary for administration of the Act, including issuing regulations for the 

2518 purpose of compiling and keeping current the Inventory of chemical substances manufactured or 

2519 processed in the United States as required by section 8(b) of the Act. In accordance with section 

2520 8(b), EPA amends the Inventory to include new chemical substances manufactured (including 

2521 imported) in the United States and reported under section 5(a)(1) of the Act. EPA also revises 

2522 the categories of chemical substances and makes other amendments as appropriate. 

2523 (b) The regulations in this part apply to the activities associated with the periodic update of 

2524 information on a subset of the chemical substances included on the Inventory. 

2525 (c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit 

2526 information required under these reporting regulations. In addition, section 15(3) makes it 

2527 unlawful for any person to fail to keep, and permit access to, records required by these 

2528 regulations. Section 16 provides that any person who violates a provision of section 15 is liable 

2529 to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, 

2530 the Government may seek judicial relief to compel submission of section 8(a) information and to 

2531 otherwise restrain any violation of section 15. (EPA does not intend to concentrate its 

2532 enforcement efforts on insignificant clerical errors in reporting.) 

2533 (d) Each person who reports under these regulations must maintain records that document 

2534 information reported under these regulations and, in accordance with the Act, permit access to, 

2535 and the copying of, such records by EPA officials. 

2536 § 711.3 Definitions. 

2537 

2538 All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following 

2539 definitions and the definitions found in § 704.3 of this chapter (except as modified by the 
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2540 following definitions) apply to this part:

2541 Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. 

2542 CDX or Central Data Exchange means EPA's centralized electronic document receiving system, 

2543 or its successors, including associated instructions for registering to submit electronic 

2544 documents. 

2545 Commercial use means the use of a chemical substance or a mixture containing a chemical 

2546 substance (including as part of an article) in a commercial enterprise providing saleable goods or 

2547 services. 

2548 Consumer use means the use of a chemical substance or a mixture containing a chemical 

2549 substance (including as part of an article) when sold to or made available to consumers for their 

2550 use. 

2551 e-IURweb means the electronic, web-based -IUR software provided by EPA for the completion 

2552 and submission of the IUR Form U report. 

2553 

2554 Industrial function means the intended physical or chemical characteristic for which a chemical 

2555 substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, 

2556 reaction product, or article; repackaged; or used. 

2557 

2558 Industrial use means use at a site at which one or more chemical substances or mixtures are 

2559 manufactured (including imported) or processed. 

2560 

2561 Intended for use by children means the chemical substance or mixture is used in or on a product 

2562 that is specifically intended for use by children age 14 or younger. A chemical substance or 

2563 mixture is intended for use by children when the submitter answers “yes” to at least one of the 

2564 following questions for the product into which the submitter's chemical substance or mixture is 

2565 incorporated: 

2566 

2567 (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended 

2568 for children age 14 or younger? 

2569 

2570 (2) Does the manufacturer of the product state through product labeling or other written 

2571 materials that the product is intended for or will be used by children age 14 or younger? 

2572 

2573 (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 

2574 younger? 

2575 Manufacture means to manufacture, produce, or import for commercial purposes. Manufacture 

2576 includes the extraction, for commercial purposes, of a component chemical substance from an 

2577 alreadya previously existing chemical substance or complex combination of substances. When a 

2578 substance, manufactured other than by import, is (1) produced exclusively for another person 

2579 who contracts for such production, and (2) that other person specifies the identity of the 

2580 substance and controls the total amount produced and the basic technology for the plant process, 

2581 that substance is jointly manufactured by the producing manufacturer and the person contracting 
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2582 for such production. The manufacture of a chemical substance by a manufacturer is also the 

2583 manufacture of a chemical substance by a person who contracts for such manufacturing, where 

2584 (1) the manufacturer manufactures or produces the substance exclusively for that person, and (2) 

2585 that person specifies the identity of the substance and controls the total amount produced and the 

2586 basic technology for the plant process.

2587 Manufacturer means a person who manufactures a chemical substance. 

2588 

2589 Master Inventory File means EPA's comprehensive list of chemical substances which constitute 

2590 the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes 

2591 substances reported under part 710 of this chapter and substances reported under part 720 of this 

2592 chapter for which a Notice of Commencement of Manufacture or Import has been received under 

2593 §720.120 of this chapter. 

2594 Principal reporting year means the latest complete calendar year in which manufacturing, 

2595 processing, and use activities associated with the data reported to EPA during an IUR submission 

2596 period occur. Production volume for manufacturing activities in other years of the reporting 

2597 cycle may also be reportable during the submission period, but full manufacturing, processing, 

2598 and use data are reported only for activities during the principal reporting yearpreceding the 

2599 submission period. 

2600 Reasonably likely to be exposed means an exposure to a chemical substance which, under 

2601 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 

2602 or use of the chemical substance, is more likely to occur than not to occur. Such exposures would 

2603 normally include, but would not be limited to, activities such as charging reactor vessels, 

2604 drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and 

2605 transfers, and analytical operations. Covered exposures include exposures through any route of 

2606 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical 

2607 exposures. 

2608 

2609 Repackaging means the physical transfer of a chemical substance or mixture, as is, from one 

2610 container to another container or containers in preparation for distribution of the chemical 

2611 substance or mixture in commerce. 

2612 

2613 Reportable chemical substance means a chemical substance described in §711.5. 

2614 Site means a contiguous property unit. Property divided only by a public right-of-way shall be 

2615 considered one site. More than one plant may be located on a single site. 

2616 (a) For substances manufactured under contract, i.e., by a toll manufacturer, the site is the 

2617 location where the chemical substance is physically manufactured. 

2618 

2619 (b)The site for an importer who imports a chemical substance described in §711.5 is the 

2620 U.S. site of the operating unit within the person's organization that is directly responsible 

2621 for importing the substance. The import site, in some cases, may be the organization's 

2622 headquarters in the United States. If there is no such operating unit or headquarters in the 

2623 United States, the site address for the importer is the U.S. address of an agent acting on 

2624 behalf of the importer who is authorized to accept service of process for the importer. 
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2625 (c) For portable manufacturing units sent out to different locations from a single 

2626 distribution center, the distribution center shall be considered the site. 

2627 Site-limited means a chemical substance is manufactured and processed only within a site and is 

2628 not distributed for commercial purposes as a substance or as part of a mixture or article outside 

2629 the site. Imported substances are never site-limited. Although a site-limited chemical substance is 

2630 not distributed for commercial purposes outside the site at which it is manufactured and 

2631 processed, the substance is considered to have been manufactured and processed for commercial 

2632 purposes. 

2633 Submission period means the period in which the manufacturing, processing, and use data are 

2634 submitted to EPA. 

2635 Use means any utilization of a chemical substance or mixture that is not otherwise covered by 

2636 the terms manufacture or process. Relabeling or redistributing a container holding a chemical 

2637 substance or mixture where no repackaging of the chemical substance or mixture occurs does not 

2638 constitute use or processing of the chemical substance or mixture. 

2639 § 711.5 Chemical substances for which information must be reported. 

2640 

2641 Any chemical substance which is in the Master Inventory File at the beginning of a submission 

2642 period described in §711.13, unless the chemical substance is specifically excluded by §711.6. 

2643 § 711.6 Chemical substances for which information is not required. 

2644 The following groups or categories of chemical substances are exempted from some or all of the 

2645 reporting requirements of this part, with the following exception: A chemical substance 

2646 described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of 

2647 the reporting requirements of this part if that substance is the subject of a rule proposed or 

2648 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 

2649 agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order 

2650 issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under 

2651 a civil action under section 5 or 7 of the Act. 

2652 (a) Full exemptions. The following categories of chemical substances are exempted from the 

2653 reporting requirements of this subpart. 

2654 (1) Polymers. (i) Any chemical substance described with the word fragments “*polym*”, 

2655 “*alkyd”, or “*oxylated” in the Chemical Abstracts (CA) Index Name in the Master Inventory 

2656 File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may 

2657 precede, or follow, the character string defined. 

2658 (ii) Any chemical substance which is identified in the Master Inventory File as siloxane and 

2659 silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a 

2660 polysaccharide (starch, cellulose, gum), rubber, or lignin. 

2661 

2662 (iii) This exclusion does not apply to a polymeric substance that has been hydrolyzed, 

2663 depolymerized, or otherwise chemically modified, except in cases where the intended product of 
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2664 this reaction is totally polymeric in structure. 

2665 

2666 (2) Microorganisms. Any combination of chemical substances that is a living organism, and that 

2667 meets the definition of “microorganism” at §725.3 of this chapter. Any chemical substance 

2668 produced from a living microorganism is reportable under this subpart unless otherwise 

2669 excluded. 

2670 

2671 (3) Naturally occurring chemical substances. Any naturally occurring chemical substance, as 

2672 described in §710.4(b). The applicability of this exclusion is determined in each case by the 

2673 specific activities of the person who manufactures the substance in question. Some chemical 

2674 substances can be manufactured both as described in §710.4(b) and by means other than those 

2675 described in §710.4(b). If a person described in §711.8 manufactures a chemical substance by 

2676 means other than those described in §710.4(b), the person must report regardless of whether the 

2677 substance also could have been produced as described in §710.4(b). Any chemical substance that 

2678 is produced from such a naturally occurring chemical substance described in §710.4(b) is 

2679 reportable unless otherwise excluded. 

2680 (4) Certain forms of natural gas and water. Chemical substances with the following Chemical 

2681 Abstract Service (CAS) Registry Numbers: CASRN 64741–48–6, Natural gas (petroleum), raw 

2682 liq. mix; CASRN 68919–39–1, Natural gas condensates; CASRN 8006–61–9, Gasoline, natural; 

2683 CASRN 68425–31–0, Gasoline (natural gas), natural; CASRN 8006–14–2, Natural gas; CASRN 

2684 68410–63–9, Natural gas, dried; and CASRN 7732-18-5, Water. 

2685 (b) Partial exemptions. The following groups of chemical substances are partially exempted 

2686 from the reporting requirements of this part (i.e., the information described in §711.12(c)(4) need 

2687 not be reported for these substances). Such chemical substances are not excluded from the other 

2688 reporting requirements under this part. 

2689 

2690 (1) Petroleum process streams. EPA has designated the following chemical substances, listed by 

2691 CAS Number, as partially exempt from reporting under the IUR. 

2692 

2693 CAS Numbers of Partially Exempt Chemical Substances Termed “Petroleum Process 

2694 Streams” for Purposes of Inventory Update Reporting 

The table currently in § 710.46(b)(1) will be moved to this location its entirety, 

excluding only the line directly after the heading, which reads: 

“7732–18–5 Water” 

This is a very long table and, to avoid confusing reviewers, has not been replicated 

in the draft document. 

2695 

2696 (2) Specific exempted chemical substances —(i) Exemption. EPA has determined that, at this 

2697 time, the information in §711.12(c)(4) associated with the chemicals listed in paragraph 

2698 (b)(2)(iv) of this section is of low current interest. 

2699 

2700 (ii) Considerations. In making its determination of whether this partial exemption should apply 

2701 to a particular chemical substance, EPA will consider the totality of information available for the 

2702 chemical substance in question, including but not limited to, one or more of the following 

2703 considerations: 
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2704 

2705 (A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of 

2706 the information described in §711.12(c)(4) (i.e., at least one site manufactures 300,000 pounds or 

2707 more of the chemical). 

2708 

2709 (B) The chemical substance's chemical and physical properties or potential for persistence, 

2710 bioaccumulation, health effects, or environmental effects (considered independently or together). 

2711 

2712 (C) The information needs of EPA, other federal agencies, tribes, states, and local governments, 

2713 as well as members of the public. 

2714 

2715 (D) The availability of other complementary risk screening information. 

2716 

2717 (E) The availability of comparable processing and use information. 

2718 

2719 (F) Whether the potential risks of the chemical substance are adequately managed. 

2720 

2721 (iii) Amendments. EPA may amend the chemical list in paragraph (b)(2)(iv) of this section on its 

2722 own initiative or in response to a request from the public based on EPA's determination of 

2723 whether the information in §711.12(c)(4) is of low interest. 

2724 

2725 (A) Any person may request that EPA amend the chemical list in paragraph (b)(2)(iv) of this 

2726 section. Your request must be in writing and must be submitted to the address provided in 

2727 §711.19(d). Requests must identify the chemical in question, as well as its CAS number or other 

2728 chemical identification number as identified in §711.12(c)(3)(i), and must contain a written 

2729 rationale for the request that provides sufficient specific information, addressing the 

2730 considerations listed in §711.6(b)(2)(ii), including cites and relevant documents, to demonstrate 

2731 to EPA that the collection of the information in §711.12(c)(4) for the chemical in question either 

2732 is or is not of low current interest. If a request related to a particular chemical is resubmitted, any 

2733 subsequent request must clearly identify new information contained in the request. EPA may 

2734 request other information that it believes necessary to evaluate the request. EPA will issue a 

2735 written response to each request within 120 days of receipt of the request, and will maintain 

2736 copies of these responses in a public docket that will be established for each reporting cycle. 

2737 

2738 (B) As needed, the Agency will initiate rulemaking to make revisions to the list in paragraph 

2739 (b)(2)(iv) of this section. 

2740 

2741 (C) To assist EPA in reaching a decision regarding a particular request prior to a given principal 

2742 reporting year, requests must be submitted to EPA no later than 12 months prior to the start of 

2743 the next principal reporting year. 

2744 

2745 (iv) List of chemical substances. EPA has designated the following chemical substances, listed 

2746 by CAS Number, as partially exempt from reporting under the IUR. 

2747 

2748 CAS Numbers of Partially Exempt Chemical Substances Under §711.6(b)(2) 

CAS No. Chemical 

50–70–4 D-Glucitol 

50–81–7 L-Ascorbic acid 

50–99–7 D-Glucose 
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CAS No. Chemical 

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 

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 
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CAS No. Chemical 

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 

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. 

2749 

2750 § 711.8 Persons who must report. 

2751 

2752 Except as provided in §§711.9 and 711.10, the following persons are subject to the requirements 

2753 of this subpart. Persons must determine whether they must report under this section for each 

2754 chemical substance that they manufacture (including import) at an individual site. 

2755 

2756 (a) Persons subject to recurring reporting. (i) For the 2011 submission period, any person who 

2757 manufactured (including imported) for commercial purposes 25,000 lb. (11,340 kg) or more of a 

2758 chemical substance described in §711.5 at any single site owned or controlled by that person at 

2759 any time during the principal reporting year (i.e., calendar year 2010) is subject to reporting. (ii) 

2760 For the submission periods subsequent to the 2011 submission period, aAny person who 

2761 manufactured (including imported) for commercial purposes 25,000 lb. (11,340 kg) or more of a 

2762 chemical substance described in §711.5 at any single site owned or controlled by that person at 

2763 any time during any calendar year since the last principal reporting year (e.g., for the 20151

2764 submission period, consider calendar years 20062011, 20072012, 20082013, 2009, and 20140, 

2765 given that 2010 was the last principal reporting year). 
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2766 

2767 (b) Exceptions. Any person who manufactured (including imported) for commercial purposes 

2768 any chemical substance that is the subject of a rule proposed or promulgated under section 

2769 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the 

2770 Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of 

2771 the Act is subject to reporting for that chemical, regardless of the production volume. 

2772 

2773 § 711.9 Persons not subject to this part. 

2774 

2775 A person described in §711.8 is not subject to the requirements of this subpart if that person 

2776 qualifies as a small manufacturer as that term is defined in §704.3 of this chapter. 

2777 Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this 

2778 subpart with respect to any chemical substance that is the subject of a rule proposed or 

2779 promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under 

2780 section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under 

2781 section 5 or 7 of the Act. 

2782 

2783 § 711.10 Activities for which reporting is not required. 

2784 

2785 A person described in §711.8 is not subject to the requirements of this subpart with respect to 

2786 any chemical substance described in §711.5 that the person solely manufactured or imported 

2787 under the following circumstances: 

2788 

2789 (a) The person manufactured or imported the chemical substance described in §711.5 solely in 

2790 small quantities for research and development. 

2791 

2792 (b) The person imported the chemical substance described in §711.5 as part of an article. 

2793 

2794 (c) The person manufactured the chemical substance described in §711.5 in a manner described 

2795 in §720.30(g) or (h) of this chapter. 

2796 

2797 § 711.12 Reporting information to EPA. 

2798 For the 2011 submission period, any person who must report under this part, as described in 

2799 §711.8, must submit the information described in this section for each chemical substance 

2800 described in §711.5 that the person manufactured (including imported) for commercial purposes 

2801 in an amount of 25,000 lb. (11,340 kg) or more (or lower volume for chemicals subject to the 

2802 rules, orders, or actions described in 711.8(c)) during the principal reporting year (i.e., calendar 

2803 year 2010). For the submission periods subsequent to the 2011 submission period, anyAny

2804 person who must report under this part, as described in §711.8, must submit the information 

2805 described in this section for each chemical substance described in §711.5 that the person 

2806 manufactured (including imported) for commercial purposes in an amount of 25,000 lb. (11,340 

2807 kg) or more (or lower volume for chemicals subject to the rules, orders, or actions described in 

2808 711.8(c)) at any one site during any calendar year since the last principal reporting year (i.ee.g., 

2809 for the 20151 submission period, consider calendar years 20062011, 20072012, 20082013, 2009, 

2810 and 20140, since 200105 was the last principal reporting year). The principal reporting year for 

2811 each submission period is the previous calendar year (e.g., the principal reporting year for the 

2812 20151 submission period is calendar year 20104). A For all submission periods, a separate report 

2813 must be submitted for each chemical substance at each site for which the submitter is required to 
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2814 report. A submitter of information under this part must report information as described in this 

2815 section to the extent that such information is known to or reasonably ascertainable by that 

2816 person. 

2817 (a) Reporting information to EPA. Any person who reports information to EPA must do so using 

2818 the e-IURweb reporting software provided by EPA at the address set forth in §711.19. The 

2819 submission must include all information described in paragraph (b) of this section. Persons must 

2820 submit a separate form for each site for which the person is required to report. The e-IURweb

2821 reporting software is described in the instruction booklet available from EPA at the address set 

2822 forth in §711.19. 

2823 (b) Information to be reported. Manufacturers (including importers) of a reportable chemical 

2824 substance in an amount of 25,000 lbs. (11,340 kg) or more at a site any calendar year since the 

2825 last principal reporting year must report the information described in this section. As described in 

2826 §711.6(b)(1) and (b)(2), manufacturers of certain chemicals are not required to report the 

2827 information described in paragraph (b)(4) of this section. 

2828 

2829 (1) A certification statement signed and dated by an authorized official of the submitter 

2830 company. Persons reporting must submit this information using e-IURweb as described in 

2831 §711.19. The authorized official must certify that the submitted information has been completed 

2832 in compliance with the requirements of the rule and that the confidentiality claims made on the 

2833 form are true and correct. The certification must be signed and dated by the authorized official 

2834 for the submitter company, and provide that person’s name, official title, and e-mail address. 

2835 

2836 (2) Company and plant site information. The following currently correct company and plant site 

2837 information must be reported for each site at which at least 25,000 lbs. (11,340 kg) of a 

2838 reportable chemical substance is manufactured (including imported) during any calendar year 

2839 since the last principal reporting year (see §711.3 for the “site” for importers): 

2840 

2841 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter under this 

2842 part must obtain a Dun and Bradstreet Number for the parent company if none exists. 

2843 

2844 (ii) The name of a person who will serve as technical contact for the submitter company, and 

2845 who will be able to answer questions about the information submitted by the company to EPA, 

2846 the contact person's full mailing address, telephone number and e-mail address. 

2847 

2848 (iii) The name and full street address of each site. A submitter under this subpart must include 

2849 the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish 

2850 (or other jurisdictional indicator) in which the plant site is located. A submitter under this part 

2851 must obtain a Dun and Bradstreet Number for the site reported if none exists. 

2852 

2853 (3) Specific information for chemicals manufactured in amounts of 25,000 lbs. or more. The 

2854 following chemical-specific information must be reported for each reportable chemical substance 

2855 manufactured at (including imported into) each site in amounts of 25,000 lbs. (11,340 kg) or 

2856 more during any calendar year since the last principal reporting year: 

2857 (i) The specific, currently correct Chemical Abstracts (CA) Index name as used to list the 

2858 chemical substance in the TSCA Inventory and the correct corresponding CAS Registry Number 
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2859 (CASRN) for each reportable chemical substance at each site. A submitter under this part may 

2860 use an EPA-designated TSCA Accession Number for a confidential substance in lieu of a 

2861 CASRN when a CASRN is not known to or reasonably ascertainable by the submitter. In 

2862 addition to reporting the number itself, submitters must specify the type of number they are 

2863 reporting by selecting from among the following codes 

2864 Codes to Specify Type of Chemical Identifying Number 

Codes Number Type 

A Accession Number 

C CAS Registry Number 

2865 

2866 (Aa) If an importer submitting a report cannot provide all the information specified in 

2867 §711.12(b) of this section because it is claimed as confidential by the supplier of the chemical 

2868 substance, the importer must have the supplier provide the correct chemical identity information 

2869 directly to EPA in a joint submission, electronically using e-IUR and via CDX (see §711.19 of 

2870 this part), and which clearly references the importer's submission. 

2871 

2872 (Bb) If a manufacturer submitting a report cannot provide all the information specified in 

2873 §711.12(b) of this section because the reportable chemical substance is manufactured using a 

2874 reactant having a specific chemical identity claimed as confidential by its supplier, the 

2875 manufacturer must submit a report directly to EPA containing all the information known to or 

2876 reasonably ascertainable by the manufacturer about the chemical identity of the reported 

2877 substance. In addition, the manufacturer must ensure that the supplier of the confidential reactant 

2878 provide the correct chemical identity of the confidential reactant directly to EPA in a joint 

2879 submission, electronically using e-IURweb and via CDX (see §711.19 of this part), and which 

2880 clearly references the manufacture's submission. 

2881 (ii) For the principal reporting year only, aA statement indicating, for each reportable chemical 

2882 substance at each site, whether the substance is manufactured in the United States, imported into 

2883 the United States, or both manufactured in the United States and imported into the United States. 

2884 (iii) For each complete calendar year since the last principal reporting year, the total annual 

2885 volume (in pounds) of each reportable chemical substance domestically manufactured and 

2886 imported at each site. The total annual domestically manufactured volume (not including 

2887 imported volume) and the total annual imported volume must be separately reported. This 

2888 amount must be reported to two significant figures of accuracy. 

2889 (iv) For the principal reporting year only, the volume used on site and the volume exported of 

2890 each reportable chemical substance domestically manufactured and imported at each site. This 

2891 amount must be reported to two significant figures of accuracy. 

2892 (v) For the principal reporting year only, aA designation indicating, for each imported reportable 

2893 chemical substance at each site, whether the imported chemical substance is physically present at 

2894 the reporting site. 

2895 (vi) For the principal reporting year only, aA designation indicating, for each reportable chemical 

2896 substance at each site, whether the substance is being recycled, reused, remanufactured, 
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2897 reprocessed, reworked, or otherwise used for a commercial purpose instead of being disposed of 

2898 as a waste or included in a waste stream. 

2899 (vii) For the principal reporting year only, tThe total number of workers reasonably likely to be 

2900 exposed to each reportable chemical substance at each site. For each reportable substance at each 

2901 site, the submitter must select from among the ranges of workers listed in the following table and 

2902 report the corresponding code (i.e., W1 through W8): 

2903 

2904 Codes for Reporting Number of Workers Reasonably Likely To Be Exposed 

Codes Range 

W1 Less 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 

2905 

2906 (viii) For the principal reporting year only, tThe maximum concentration, measured by 

2907 percentage of weight, of each reportable chemical substance at the time it is sent off-site from 

2908 each site. If the chemical is site-limited, you must report the maximum concentration, measured 

2909 by percentage of weight, of the reportable chemical substance at the time it is reacted on-site to 

2910 produce a different chemical substance. This information must be reported regardless of the 

2911 physical form(s) in which the substance is sent off-site/reacted on-site. For each substance at 

2912 each site, select the maximum concentration of the substance from among the ranges listed in the 

2913 following table and report the corresponding code (i.e., M1 through M5): 

2914 

2915 Codes for Reporting Maximum Concentration of Chemical Substance 

Codes 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 

2916 

2917 (ix) For the principal reporting year only, tThe physical form(s) of the reportable chemical 

2918 substance as it is sent off-site from each site. If the chemical is site-limited, you must report the 

2919 physical form(s) of the reportable chemical substance at the time it is reacted on-site to produce a 

2920 different chemical substance. For each substance at each site, the submitter must report as many 

2921 physical forms as apply from among the physical forms listed below: 

2922 

2923 (A) Dry powder. 

2924 

2925 (B) Pellets or large crystals. 

2926 

2927 (C) Water- or solvent-wet solid. 

2928 
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2929 (D) Other solid. 

2930 

2931 (E) Gas or vapor. 

2932 

2933 (F) Liquid. 

2934 

2935 (x) For the principal reporting year only, sSubmitters must report the percentage, rounded off to 

2936 the closest 10%, of total production volume of the reportable chemical substance, for the 

2937 principal reporting year only, reported in response to paragraph (c)(3) (iii) of this section, that is 

2938 associated with each physical form reported under paragraph (c)(3) (ix) of this section. 

2939 

2940 (4) Specific information related to processing and use. Persons subject to paragraph (b)(43) of 

2941 this section must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this 

2942 section for each reportable chemical substance at sites under their control and at sites that receive 

2943 a reportable chemical substance from the submitter directly or indirectly (including through a 

2944 broker/distributor, from a customer of the submitter, etc.). Information reported in response to 

2945 this paragraph must be reported for the principal reporting year only and only to the extent that it 

2946 is known to or reasonably ascertainable by the submitter. Information required to be reported 

2947 under this paragraph is limited to domestic (i.e., within the customs territory of the United States) 

2948 processing and use activities. If information responsive to a given data requirement under this 

2949 paragraph, including information in the form of an estimate, is not known or reasonably 

2950 ascertainable, the submitter is not required to respond to the requirement. 

2951 

2952 (i) Industrial processing and use information. (A) A designation indicating the type of industrial 

2953 processing or use operation(s) at each site that receives a reportable substance from the submitter 

2954 site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). 

2955 For each chemical substance, report the letters which correspond to the appropriate processing or 

2956 use operation(s). A particular designation may need to be reported more than once, to the extent 

2957 that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that 

2958 applies to a given designation under this paragraph. 

2959 

2960 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 

2961 (B) A code indicating the sector(s) which best describe the industrial activities associated with 

2962 each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this section. 

2963 For each chemical substance, report the code that corresponds to the appropriate sector(s). A 

2964 particular sector code may need to be reported more than once, to the extent that a submitter 

2965 reports more than one industrial function code (under paragraph (b)(4)(i)(C) of this section) that 

2966 applies to a given sector code under this paragraph. 

2967 Codes for Reporting Industrial Sectors 

Code Sector Description 
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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 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, 

concrete, lime, gypsum, and other nonmetallic mineral product manufacturing) 

IS38 Primary Metal Manufacturing 

IS39 Fabricated Metal Product Manufacturing 

IS40 Machinery Manufacturing 

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) 

2968 
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2969 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s) from the 

2970 following list must be selected to designate the industrial function category(ies) that best 

2971 represents the specific manner in which the chemical substance is used. A particular industrial 

2972 function category may need to be reported more than once, to the extent that a submitter reports 

2973 more than one industrial processing or use operation/sector combination (under paragraphs 

2974 (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given industrial function category 

2975 under this paragraph. If more than 10 unique combinations of industrial processing or use 

2976 operations/sector/industrial function categories apply to a chemical substance, submitters need 

2977 only report the 10 unique combinations for the chemical substance that cumulatively represent 

2978 the largest percentage of the submitter's production volume for that chemical, measured by 

2979 weight. If none of the listed industrial function categories accurately describes a use of a 

2980 chemical substance, the category “Other” may be used, and must include a description of the use.

2981 

2982 Codes for Reporting Industrial Function Categories 

Codes 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 

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 
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Codes Category 

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) 

2983 

2984 (D) The estimated percentage, rounded off to the closest 10%, of total production volume of the 

2985 reportable chemical substance associated with each combination of industrial processing or use 

2986 operation, sector and industrial function category. Where a particular combination of industrial 

2987 processing or use operation, sector and industrial function category accounts for 5% or less of the 

2988 submitter's site's total production volume of a reportable chemical substance, the percentage must 

2989 not be rounded off to zero percent if the production volume attributable to that industrial 

2990 processing or use operation, sector and industrial function category combination is 25,000 lb. 

2991 (11,340 kg.) or more during the reporting year. Instead, in such a case, submitters must report the 

2992 percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the 

2993 reportable chemical substance associated with the particular combination of industrial processing 

2994 or use operation, sector and industrial function category. 

2995 

2996 (E) For each combination of industrial processing or use operation, sector and industrial function 

2997 category, the submitter must estimate the number of sites at which each reportable chemical 

2998 substance is processed or used. For each combination associated with each substance, the 

2999 submitter must select from among the ranges of sites listed in the following table and report the 

3000 corresponding code (i.e., S1 through S7): 

3001 

3002 Codes for Reporting Numbers of Sites 

Codes Range 

S1 less than 10 sites 

S2 at least 10 but fewer than 25 sites 

S3 at least 25 but fewer than 100 sites 
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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 

3003 

3004 (F) For each combination of industrial processing or use operation, sector and industrial function 

3005 category, the submitter must estimate the number of workers reasonably likely to be exposed to 

3006 each reportable chemical substance. For each combination associated with each substance, the 

3007 submitter must select from among the worker ranges listed in paragraph (b)(3)(v) of this section 

3008 and report the corresponding code (i.e., W1 though W8). 

3009 

3010 (ii) Consumer and commercial use information. (A) Using the codes listed in this paragraph, 

3011 submitters must designate the consumer and commercial product category or categories that best 

3012 describe the consumer and commercial products in which each reportable chemical substance is 

3013 used (whether the recipient site(s) are controlled by the submitter site or not). If more than 10 

3014 codes apply to a chemical substance, submitters need only report the 10 codes for the chemical 

3015 substance that cumulatively represent the largest percentage of the submitter's production volume 

3016 for that chemical, measured by weight. If none of the listed consumer and commercial product 

3017 categories accurately describes the consumer and commercial products in which each reportable 

3018 chemical substance is used, the category “Other” may be used, and must include a description of 

3019 the use. 

3020 

3021 Codes for Reporting Consumer and Commercial Product Categories 

Codes 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 
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Codes Category 

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, 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)

3022 

3023 (B) An indication, within each consumer and commercial product category reported under 

3024 paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use. 

3025 

3026 (C) Submitters must determine, within each consumer and commercial product category reported 

3027 under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical 

3028 substance manufactured (including imported) by the submitter is present in (for example, a 

3029 plasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on a 

3030 toy) any consumer products intended for use by children up to the age of 14, regardless of the 

3031 concentration of the substance remaining in or on the product. Submitters must select from the 
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3032 following options: the chemical substance is used in or on any consumer products intended for 

3033 use by children, the chemical substance is not used in or on any consumer products intended for 

3034 use by children, or information as to whether the chemical substance is used in or on any 

3035 consumer products intended for use by children is not known to or reasonably ascertainable by 

3036 the submitter. 

3037 

3038 (D) The estimated percentage, rounded off to the closest 10%, of the submitter's site's total 

3039 production volume of the reportable chemical substance associated with each consumer and 

3040 commercial product category. Where a particular consumer and commercial product category 

3041 accounts for 5% or less of the total production volume of a reportable chemical substance, the 

3042 percentage must not be rounded off to zero percent if the production volume attributable to that 

3043 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 

3044 reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the 

3045 closest 1%, of the submitter's site's total production volume of the reportable chemical substance 

3046 associated with the particular consumer and commercial product category. 

3047 

3048 (E) Where the reportable chemical substance is used in consumer or commercial products, the 

3049 estimated typical maximum concentration, measured by weight, of the chemical substance in 

3050 each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this 

3051 section. For each substance in each commercial and consumer product category reported under 

3052 paragraph (b)(4)(ii)(A) of this section, submitters must select from among the ranges of 

3053 concentrations listed in the table in paragraph (b)(3)(viii) of this section and report the 

3054 corresponding code (i.e., M1 through M5). 

3055 

3056 (F) Where the reportable chemical substance is used in a commercial product, the submitter must 

3057 estimate the number of commercial workers reasonably likely to be exposed to each reportable 

3058 chemical substance. For each combination associated with each substance, the submitter must 

3059 select from among the worker ranges listed in paragraph (b)(3)(vii) of this section and report the 

3060 corresponding code (i.e., W1 though W8). 

3061 

3062 § 711.13 When to report. 

3063 

3064 All information reported to EPA in response to the requirements of this subpart must be 

3065 submitted during an applicable submission period from June 1 to September 30 at 4–year 

3066 intervals, beginning in 2011. Any person described in §711.8(a) must report during each 

3067 submission period for each chemical substance described in §711.5 that the person manufactured 

3068 (including imported) during any calendar year since the last principal reporting year (e.g., for the 

3069 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 2010, since 2005 

3070 was the last principal reporting year). 

3071 

3072 § 711.15 Duplicative reporting. 

3073 

3074 (a) With regard to section 8(a) rules. Any person subject to the requirements of this part who 

3075 previously has complied with reporting requirements of a rule under section 8(a) of the Act by 

3076 submitting the information described in §711.12 for a chemical substance described in §711.5 to 

3077 EPA, and has done so within 1 year of the start of a submission period described in §711.13, is 

3078 not required to report again on the manufacture of that substance at that site during that 

3079 submission period. 
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3080 

3081 (b) With regard to importers. This part requires that only one report be submitted on each import 

3082 transaction involving a chemical substance described in §711.5. When two or more persons are 

3083 involved in a particular import transaction and each person meets the Agency's definition of 

3084 “importer” as set forth in §704.3 of this chapter, they may determine among themselves who 

3085 should submit the required report; if no report is submitted as required under this part, EPA will 

3086 hold each such person liable for failure to report. 

3087 

3088 (c) Toll manufacturers and persons contracting with a toll manufacturer. This part requires that 

3089 only one report be submitted on each chemical substance described in §711.5. When a company 

3090 contracts with a toll manufacturer to manufacture a chemical substance, and each party meets the 

3091 Agency's definition of “manufacturer” as set forth in §711.3, the contracting company is 

3092 primarily responsible for the IUR submission. In the event the contracting company does not 

3093 report, the toll manufacturer must report. Both the contracting company and the toll 

3094 manufacturer are liable if no report is made. 

3095 

3096 § 711.17 Recordkeeping requirements. 

3097 

3098 Each person who is subject to the reporting requirements of this subpart must retain records that 

3099 document any information reported to EPA. Records relevant to reporting during a submission 

3100 period must be retained for a period of 5 years beginning on the last day of the submission 

3101 period. Submitters are encouraged to retain their records longer than 5 years to ensure that past 

3102 records are available as a reference when new submissions are being generated. 

3103 

3104 § 711.18 Confidentiality. 

3105 

3106 (a) Any person submitting information under this subpart may assert a business confidentiality 

3107 claim for the information at the time it is submitted. Any such confidentiality claims must be 

3108 made at the time the information is submitted. Confidentiality claims cannot be made when a 

3109 response is left blank or an indication of not known to or reasonably ascertainable by is provided. 

3110 These claims will apply only to the information submitted with the claim. New confidentiality 

3111 claims, if appropriate, must be asserted with regard to information submitted during a different 

3112 submission period. Guidance for asserting confidentiality claims is provided in the instructions 

3113 identified in §711.19. Information claimed as confidential in accordance with this section will be 

3114 treated and disclosed in accordance with the procedures in part 2 of this chapter. 

3115 

3116 (b) Chemical identity. A person may assert a claim of confidentiality for the chemical identity of 

3117 a specific chemical substance only if the identity of that substance is treated as confidential in the 

3118 Master Inventory File as of the time the report is submitted for that substance under this subpart. 

3119 The following steps must be taken to assert a claim of confidentiality for the identity of a 

3120 reportable chemical substance: 

3121 

3122 (1) The submitter must submit with the report detailed written answers to the following questions 

3123 signed and dated by an authorized official. 

3124 

3125 (i) What harmful effects to your competitive position, if any, do you think would result from the 

3126 identity of the chemical substance being disclosed in connection with reporting under this 

3127 subpart? How could a competitor use such information? Would the effects of disclosure be 
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3128 substantial? What is the causal relationship between the disclosure and the harmful effects? 

3129 

3130 (ii) How long should confidential treatment be given? Until a specific date, the occurrence of a 

3131 specific event, or permanently? Why? 

3132 

3133 (iii) Has the chemical substance been patented? If so, have you granted licenses to others with 

3134 respect to the patent as it applies to the chemical substance? If the chemical substance has been 

3135 patented and therefore disclosed through the patent, why should it be treated as confidential? 

3136 

3137 (iv) Has the identity of the chemical substance been kept confidential to the extent that your 

3138 competitors do not know it is being manufactured or imported for a commercial purpose by 

3139 anyone? 

3140 

3141 (v) Is the fact that the chemical substance is being manufactured (including imported) for a 

3142 commercial purpose available to the public, for example in technical journals, libraries, or State, 

3143 local, or Federal agency public files? 

3144 

3145 (vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical 

3146 substance is being manufactured (including imported) for a commercial purpose? 

3147 

3148 (vii) To what extent has the fact that this chemical substance is manufactured (including 

3149 imported) for commercial purposes been revealed to others? What precautions have been taken 

3150 regarding these disclosures? Have there been public disclosures or disclosures to competitors? 

3151 

3152 (viii) Does this particular chemical substance leave the site of manufacture (including import) in 

3153 any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard 

3154 against the discovery of its identity? 

3155 

3156 (ix) If the chemical substance leaves the site in a product that is available to the public or your 

3157 competitors, can the substance be identified by analysis of the product? 

3158 

3159 (x) For what purpose do you manufacture (including import) the substance? 

3160 

3161 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality 

3162 determinations regarding this chemical substance? If so, please attach copies of such 

3163 determinations. 

3164 

3165 (2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) 

3166 of this section is asserted to contain confidential business information, the submitter must clearly 

3167 identify the information that is claimed confidential by marking the specific information on each 

3168 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

3169 

3170 (c) Site identity. A submitter may assert a claim of confidentiality for a site only if the linkage of 

3171 the site with a reportable chemical is confidential and not publicly available. The following steps 

3172 must be taken to assert a claim of confidentiality for a site identity: 

3173 

3174 (1) The submitter must submit with the report detailed written answers to the following questions 

3175 signed and dated by an authorized official: 
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3176 

3177 (i) Has site information been linked with a chemical identity in any other Federal, state or local 

3178 reporting scheme? For example, is the chemical identity linked to a facility in a filing under the 

3179 Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through 

3180 a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed 

3181 as confidential in any of these instances? 

3182 

3183 (ii) What harmful effect, if any, to your competitive position do you think would result from the 

3184 identity of the site and the chemical substance being disclosed in connection with reporting under 

3185 this subpart? How could a competitor use such information? Would the effects of disclosure be 

3186 substantial? What is the causal relationship between the disclosure and the harmful effects? 

3187 

3188 (2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) 

3189 of this section is asserted to contain confidential business information, the submitter must clearly 

3190 identify the information that is claimed confidential by marking the specific information on each 

3191 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

3192 (d) Processing and Use information. A submitter may assert a claim of confidentiality for each 

3193 data element required by 711.12(b)(4) only if the linkage of the information with a reportable 

3194 chemical is confidential and not publicly available. The following steps must be taken to assert a 

3195 claim of confidentiality for each data element, individually, required by 711.12(b)(4): 

3196 (1) The submitter must submit with the report detailed written answers to the following questions 

3197 signed and dated by an authorized official: 

3198 (i) Is the identified use of this chemical publicly known? For example, is information on the use 

3199 available in advertisements or other marketing materials, professional journals or other similar 

3200 materials, or in non-confidential mandatory or voluntary government filings or publications? Has 

3201 your company ever provided use information on the chemical that was not claimed as 

3202 confidential? 

3203 (ii) What harmful effect, if any, to your competitive position do you think would result from the 

3204 information reported as required by 711.12(b)(4) and the chemical substance being disclosed in 

3205 connection with reporting under this part? How could a competitor use such information? Would 

3206 the effects of disclosure be substantial? What is the causal relationship between the disclosure 

3207 and the substantial harmful effects? 

3208 (2) If any of the information contained in the answers to the questions listed in paragraph (d)(1) 

3209 of this section is asserted to contain confidential business information, the submitter must clearly 

3210 identify the information that is claimed confidential by marking the specific information on each 

3211 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

3212 (e) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this 

3213 subpart; if the reporting form lacks the certification required by 711.12(b)(1); if confidentiality 

3214 claim substantiation required under paragraphs (b), (c), and (d) of this section is not submitted 

3215 with the reporting form; or if the identity of a chemical substance listed on the public portion of 

3216 the Master Inventory File was claimed as confidential, EPA may make the information available 

3217 to the public without further notice to the submitter. 

3218 

3219 § 711.19 GeneralElectronic Filing. 

3220 

3221 (a) You must use e-IUR to complete and submit the form identified as “Form U,” EPA Form 
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3222 7740-8. Submissions may only be made as set forth in this section. 

3223 (b) Submissions must be sent electronically to EPA via CDX. 

3224 (c) Obtain e-IUR and instructions, as follows: 

3225 

3226 (1) By website. Go to the EPA Inventory Update Reporting Internet home page at 

3227 http://www.epa.gov/iur and follow the appropriate links. 

3228 

3229 (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554–1404 or TSCA3230 Hotline@epa.gov for a CD-ROM containing the software and instructions. 

3231 

3232 [FR Doc. 09–????? Filed ??–??–09; 8:45 am] 

3233 BILLING CODE 6560–50–S

3234 

3235 

3236