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1 EO12866_IUR ModificationNPRM_2010-01-28.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 Agency-provided e-IUR reporting software to submit 

140 IUR reports through the Internet to EPA’s Central Data Exchange (CDX). After the final rule’s 

141 effective date, paper submissions would no longer be accepted. 

142 

143 Second, EPA is proposing to enhance the manufacturing data and the processing and use 

144 data reported. 

145 

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

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

148 additions. 

149 

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

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

152 

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

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

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

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

157 (e.g., 2005). 

158 

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

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

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

162 

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

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

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

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

167 
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168 Eighth, EPA is proposing to amend 40 CFR 710.46 (proposed 40 CFR 711.6) to make 

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

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

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

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

173 

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

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

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

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

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

179 Inventory, as part of the chemical identity. 

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

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

182 used at the reporting site. 

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

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

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

186 

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

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

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

190 

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

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

193 710.52(c)(4) (proposed 40 CFR 711.12(c)(4)) is claimed as confidential business information 

194 (CBI). 

195 

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

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

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

199 

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

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

202 710.52(c)(4)(i)(C) (proposed 40 CFR 711.12(c)(4)(i)(C)) to replace the five-digit North 

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

204 

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

206 12(c)(4)(ii)) to revise the list of consumer and commercial product categories for the reporting of 

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

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

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

210 

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

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

213 

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

215 EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep 
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216 current an inventory of chemical substances manufactured or processed in the United States. This 

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

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

219 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA 

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

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

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

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

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

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

226 

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

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

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

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

231 manufacturers and processors of chemical substances from the reporting requirements 

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

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

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

235 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 

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

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

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

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

240 

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

242 

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

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

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

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

247 710, subpart C). IUR data were collected five times prior to the 2003 Amendments: in 1986, 

248 1990, 1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. EPA uses the 

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

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

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

252 the extent possible given confidential business information claims. 

253 

254 Persons manufacturing or importing chemical substances are required to report 

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

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

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

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

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

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

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

262 

263 Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lb. or 
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264 greater manufactured (including imported) during the reporting year at any single site) are 

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

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

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

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

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

270 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

287 

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

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

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

291 

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

293 

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

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

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

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

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

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

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

301 information, and CBI requirements will accomplish these goals. 

302 

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

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

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

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

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

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

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

310 improvements are needed. The modifications described in this proposed rule would change 

311 some of the reporting requirements in an effort by EPA to (1) ensure the required information is 
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312 properly reported and that the information in the Agency’s database reflects the information 

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

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

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

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

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

318 substances. 

319 

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

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

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

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

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

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

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

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

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

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

330 2006 IUR data and providing public access. The proposed modifications associated with 

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

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

333 

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

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

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

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

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

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

340 uses of chemicals it manufactures and sells. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

355 the High Production Volume Information System (HPVIS) or on EPA’s Existing Chemicals 

356 website. Correct designation of reported information as non-confidential will facilitate reporting 

357 of this information to the public. 
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358 

359 These proposed modifications to the IUR rule would enhance the capabilities of the 

360 Agency to ensure risk management actions are taken on chemicals posing the greatest concern. 

361 More in-depth reporting of the processing and use data, more careful consideration of the need 

362 for confidentiality claims, and adjustments to the specific data elements are important aspects of 

363 this action. By enhancing the data supplied to the Agency, EPA expects to more effectively and 

364 expeditiously identify and address potential risks posed by chemicals and provide improved 

365 access and information to the public. 

366 

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

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

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

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

371 information. 

372 

373 III. Modifications Affecting All Manufacturers (Including Importers) 

374 

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

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

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

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

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

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

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

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

383 

384 Persons making an IUR submission would be required to use e-IUR, the Agency385 provided software designed to complete Form U (the IUR reporting form) and submit the 

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

387 2011 e-IUR will be similar in format to the 2006 e-IUR, and will include changes associated 

388 with the proposed amendments that are finalized and improved validation checks. A more 

389 detailed description of e-IUR and the electronic submission process is provided in Unit III.B. 

390 

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

392 action. 

393 

394 A. Technical Modifications to the Regulatory Text 

395 

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

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

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

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

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

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

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

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

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

405 rule should be in its own section in the Code of Federal Regulations (CFR), distinct from both 
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406 the original TSCA Inventory rules and from the TSCA section 5 requirements. 

407 

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

409 eliminating subpart divisions. 

410 

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

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

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

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

415 710.46 would become § 711.6; § 710.48 would become § 711.8; § 710.49 would become § 

416 711.9; § 710.50 would become § 711.10; § 710.52 would become § 711.12; § 710.53 would 

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

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

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

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

421 

422 2. Consolidation of definitions. 

423 

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

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

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

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

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

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

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

431 

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

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

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

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

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

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

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

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

440 include hydrates separately in the definition of mixture. The Agency would continue to include 

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

442 

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

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

445 the docket. (Ref. 3) 

446 

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

448 

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

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

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

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

453 as this definition was not associated with the original Inventory, and therefore does not belong in 
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454 40 CFR 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, would be 

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

456 

457 4. Deleting Subpart B text. 

458 

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

460 710.39 (subpart B). This text refers to IUR submission periods of 2002 and earlier and is 

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

462 2002 update was complete. 

463 

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

465 

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

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

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

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

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

471 percent of the correct value. 

472 

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

474 

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

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

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

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

479 phrases describing the ranges grammatically correct. 

480 

481 B. Method of submission. 

482 

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

484 IUR information to EPA, will be June 1 to September 30, 2011. The Agency will make e-IUR 

485 and associated guidance materials available to submitters prior to the start of the submission 

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

487 

488 EPA is proposing to require the mandatory use of Agency-provided reporting software (e489 IUR) to complete the IUR Form U and the Central Data Exchange (CDX) to submit the 

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

491 authorized signature agreement. 

492 

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

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

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

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

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

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

499 an electronic system. 

500 

501 Due mostly to the time and resources needed to review and correct submitter- and 
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502 scanning-related errors associated with non-electronic submissions, EPA required over two years 

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

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

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

506 2008 without information on approximately five percent of the reported chemicals due to the 

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

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

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

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

511 could lead to the inadvertent disclosure of confidential information or to the non-release of non512 confidential information. 

513 

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

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

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

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

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

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

520 guidance documents. 

521 

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

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

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

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

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

527 data prior to entering it into the database. 

528 

529 EPA believes the proposed requirement to use e-IUR to report electronically would 

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

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

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

533 and the public. 

534 

535 1. Updated e-IUR reporting software 

536 

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

538 electronically during the 2006 IUR submission period (see www.epa.gov/iur). The 2011 e-IUR 

539 would feature several enhancements over the 2006 e-IUR. These improvements include a 

540 sophisticated validation system, which would alert users when a required field on the form is 

541 either missing information or contains certain kinds of potentially incorrect information. Other 

542 updates are expected to include automated chemical identity checks, automated company and 

543 site identity checks, and the facilitation of joint submissions and amendments. For the 2011 e544 IUR, EPA is also considering a free web-based application in place of, or in addition to, free 

545 downloadable software. 

546 

547 2. Require electronic submissions over the Internet 

548 

549 EPA is proposing to require that manufacturers (including importers) submit their IUR 
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550 reports to the Agency through CDX via the Internet. EPA would require that all submissions be 

551 generated using e-IUR, as described in Unit III.B.1. Electronic submissions would ensure that 

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

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

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

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

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

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

558 

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

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

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

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

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

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

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

566 

567 3. Electronic Signature process 

568 

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

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

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

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

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

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

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

576 

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

578 during the 2006 IUR electronic reporting. For 2011 IUR reports, EPA is modifying the 2006 

579 ESA to identify more clearly the individual(s) required to sign the agreement. The Agency is 

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

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

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

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

584 registration process. 

585 

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

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

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

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

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

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

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

593 additional information electronically. 

594 

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

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

597 site may want to use the same authorized official for both Premanufacture Notice (PMN) 
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598 submissions and IUR submissions. EPA is interested in obtaining comments on this approach. 

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

600 PMN submission be the same person? 

601 

602 C. Modifications to Selected Definitions

603 

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

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

606 704.3 and 40 CFR 710.3, EPA is also proposing to modify the definition of importer by 

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

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

609 importer. 

610 

611 1. Manufacture and Manufacturer 

612 

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

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

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

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

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

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

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

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

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

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

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

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

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

626 terms found at 40 CFR 704.3, the Agency is also proposing to add a simple definition for the 

627 term manufacturer to 40 CFR 711.3. In addition to the proposed change to the definition of 

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

629 711.15 to clarify the reporting relationship between the contracting company and the toll 

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

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

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

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

634 reporting. 

635 

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

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

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

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

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

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

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

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

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

645 person who manufactures a chemical substance.” 
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646 

647 2. Site 

648 

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

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

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

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

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

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

655 pertaining to the toll manufacturer’s site. 

656 

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

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

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

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

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

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

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

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

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

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

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

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

669 for situations similar to those presented as examples. 

670 

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

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

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

674 

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

676 location where the chemical substance is physically manufactured. 

677 

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

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

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

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

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

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

684 

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

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

687 

688 3. Electronic-Reporting Related Definitions 

689 

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

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

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

693 document receiving system, or its successors, including associated instructions for registering to 
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694 submit electronic documents.” The new definition would make the term consistent with the new 

695 PMN definition. The term e-IUR means the “electronic-IUR software provided by EPA for the 

696 completion and submission of the IUR Form U report.” 

697 

698 4. Processing and Use-Related Definitions 

699 

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

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

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

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

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

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

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

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

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

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

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

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

712 product would be removed. 

713 

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

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

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

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

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

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

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

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

722 

723 5. Principal Reporting Year and Submission Period 

724 

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

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

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

728 reporting year and submission period to reflect these changes. 

729 

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

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

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

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

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

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

736 2005.” With these changes, the term principal reporting year would be defined as “the calendar 

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

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

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

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

741 reporting year.” 
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742 

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

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

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

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

747 use data are submitted to EPA.” 

748 

749 D. Modifications to Reporting Thresholds 

750 

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

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

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

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

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

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

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

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

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

760 lb. reporting threshold for certain chemicals. 

761 

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

763 requirements. 

764 

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

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

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

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

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

770 associated production volume (domestically manufactured plus imported volumes) met or 

771 exceeded 25,000 lb. for the principal reporting year (e.g., 2005 for the 2006 IUR submission 

772 period). 

773 

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

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

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

777 production volumes of 25,000 lb. or greater. For the 2011 submission period, it would be 

778 necessary to examine the annual production volumes for the years 2006 to 2010 for the site. If 

779 the production volume for a reportable chemical substance was 25,000 lb. or greater for any 

780 calendar year during that five-year period, then it would be necessary to report the chemical 

781 substance, unless it is otherwise exempt. For instance, a subject chemical with production 

782 volumes of 5,000 lb. in 2010 and 35,000 lb. in 2007 would be reported for the 2011 IUR. 

783 Regardless of the 2010 production volume, in this example scenario the 2011 IUR submission 

784 would contain detailed information based on manufacturing during the 2010 calendar year and 

785 production volume information only for the years 2006 through 2009, as described in Unit 

786 III.F.4.i., due to the 2007 production volume. 

787 

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

789 larger volume chemicals, often experience wide fluctuations in manufacturing volume from year 
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790 to year. This can result in the production volume of a chemical exceeding the threshold for 

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

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

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

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

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

796 associated with a particular chemical substance. 

797 

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

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

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

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

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

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

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

805 to exceed one million lb. 

806 

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

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

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

810 industry representatives expressed concern that short reporting determination periods would 

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

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

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

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

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

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

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

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

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

820 with suppliers (Ref. 8). 

821 

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

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

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

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

826 activities and providing better information to the public. 

827 

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

829 

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

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

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

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

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

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

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

837 identifying potential risks, and noting uncertainties for these lower production volume chemicals. 
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838 In addition, this change will provide the public with information on a greater number of 

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

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

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

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

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

844 

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

846 (including imported) at each individual reporting site and was selected with the intention that 

847 exposure-related processing and use information would be collected for HPV chemicals (HPV 

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

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

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

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

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

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

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

855 300,000 lb. threshold was too high to provide sufficient processing and use data for the HPV 

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

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

858 lb. for this action. However, the need to complete characterizations for chemicals manufactured 

859 (including imported) in volumes of 25,000 lb. to 300,000 lb. led the Agency to believe that it 

860 would be best to eliminate the upper threshold and collect full information for all reported 

861 chemicals. 

862 

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

864 

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

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

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

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

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

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

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

872 5(b)(4), or 6 of TSCA; (2) the subject of an order issued under section 5(e) or 5(f) of TSCA, or 

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

874 

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

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

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

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

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

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

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

882 information for 2010. 

883 
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884 Chemicals that are the subject of particular TSCA rules and/or orders are of demonstrated 

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

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

887 

888 E. Changes to Substances Covered by IUR 

889 

890 1. Water 

891 

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

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

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

895 18-5) and to remove water from the petroleum streams partial exemption (40 CFR 710.46(b)(1)). 

896 

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

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

899 submitters. 

900 

901 2. Remove fully exempt polymers from partially exempt list 

902 

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

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

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

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

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

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

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

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

911 are fully exempt from reporting. 

912 

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

914 ineligible for exemptions 

915 

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

917 40 CFR part 790, with a manufacturer of a chemical substance to obtain testing where a 

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

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

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

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

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

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

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

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

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

927 the subject of an ECA ineligible for IUR exemptions. 

928 

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

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

931 710.46 (proposed 40 CFR 711.6) listing the other chemicals that are likewise not eligible for an 
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932 IUR exemption. The paragraph would state that a chemical “is not exempted from any of the 

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

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

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

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

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

938 

939 F. Modifications to Reportable Data Elements 

940 

941 1. Parent Company and Site Identity 

942 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

957 or foreign. 

958 

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

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

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

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

963 

964 2. Technical Contact 

965 

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

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

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

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

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

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

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

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

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

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

976 how to better identify the technical contact. 

977 

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

979 basis. The e-IUR reporting software would allow the identification of several names associated 
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980 with a submission. EPA is interested in any comment or suggestions regarding this 

981 consideration. 

982 

983 3. Chemical Identity 

984 

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

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

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

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

989 the PMN number. 

990 

991 i. Chemical Name 

992 

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

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

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

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

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

998 nomenclature that completely and accurately describes the chemical substance. 

999 

1000 EPA has found, however, that submitters sometimes supply a name that is somewhat 

1001 generic or excludes parts of the specific chemical identity that distinguishes one substance from 

1002 another. EPA’s experience from the 2006 IUR was that up to five percent of the reports 

1003 submitted contained chemical identity problems serious enough that the Agency was unable to 

1004 precisely identify the substance. These problems resulted in the temporary exclusion of the 

1005 information associated with the poorly or erroneously identified chemical from the IUR database 

1006 until the Agency was able to obtain correct and specific chemical identity information from the 

1007 submitter. EPA believes the requirement to use the substance name as currently listed on the 

1008 Inventory will greatly reduce the number of poorly identified substances. EPA intends to include 

1009 the CASRN and CA Index Names as part of e-IUR, to the extent possible without jeopardizing 

1010 confidentiality claims. 

1011 

1012 Manufacturers (including importers) will be allowed to supply an alternate chemical 

1013 name, and in the case of importers, a trade name, in those instances where a supplier will not 

1014 disclose to the submitter the specific chemical name of the imported Inventory substance or a 

1015 reactant used to manufacture the Inventory substance. In these cases, the manufacturer 

1016 (including importer) and the supplier report the information required in this part in a joint 

1017 submission. In order to clarify this requirement, EPA is proposing an amendment to 40 CFR 

1018 710.52(c)(3)(i) (proposed 40 CFR 711.12(b)(3)(i)) to state that the importer must have the 

1019 supplier of the confidential chemical substance directly provide EPA with the correct chemical 

1020 identity, in a joint submission with the manufacturer. Furthermore, in the event the manufacturer 

1021 submitting a report cannot provide the whole chemical identity because the reportable chemical 

1022 substance is manufactured using a reactant having a specific chemical identity claimed as 

1023 confidential by its supplier, the manufacturer must submit a report directly to EPA containing all 

1024 other information known to or reasonably ascertainable by the manufacturer about the chemical 

1025 identity of the reported substance and must ensure that the supplier directly provides to EPA the 

1026 correct chemical identity of the confidential reactant in a joint submission. See Unit 3.I for 

1027 additional information regarding joint submissions. Detailed draft instructions regarding joint 
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1028 submissions are included in the draft Instructions included in the docket. (Ref. 2) EPA is 

1029 interested in any comments regarding the procedure under consideration. 

1030 

1031 ii. Chemical Identifying Number 

1032 

1033 As part of the chemical identity, submitters provide a chemical identifying number 

1034 associated with the correct CA Index Name, as described in Unit III.E.3. For most chemicals, 

1035 the chemical identifying number is the CASRN correctly corresponding to the reported CA 

1036 Index Name. If the CASRN number is not available because the chemical substance is listed on 

1037 the confidential portion of the Inventory and a CASRN does not already exist for that substance, 

1038 the submitter could report either the associated TSCA Accession or PMN number. 

1039 

1040 EPA is proposing to allow submitters to report only the CASRN as a chemical identifying 

1041 number or, in the case of confidential chemical substances, the accession number. Note that in 

1042 cases where a CASRN exists for a confidential chemical, it can be reported instead of the 

1043 accession number and claimed as confidential for purposes of the IUR submission. EPA is 

1044 proposing to remove the PMN number as an allowed chemical identifying number because each 

1045 Inventory substance has either (or both) a CASRN or a TSCA Accession Number, which are 

1046 likely to be already known to the submitter. Furthermore, the Agency has to spend considerably 

1047 more time and effort to access and review reported information that has been identified only by a 

1048 PMN case number. 

1049 

1050 Submitters who, in the past, have reported using the PMN number of a confidential 

1051 substance may contact EPA, if necessary, to learn the TSCA Accession Number assigned when 

1052 the Notice of Commencement (NOC) was submitted to the Agency. 

1053 

1054 4. Production Volume 

1055 

1056 Manufacturers, including importers, are required to report production volume information 

1057 for each chemical substance for which they submit an IUR report. For the 2006 IUR, 

1058 production volume information consisted of the manufactured production volume; the imported 

1059 production volume; an indication of whether the substance was manufactured, imported, or both; 

1060 and an indication of whether the substance was site-limited. In instances where a single site both 

1061 manufactures and imports the same chemical substance, the site was to report the manufactured 

1062 and imported production volumes separately on one report. The combined total production 

1063 volume was then used as the basis for determining the percentage of production volume in other 

1064 areas of the report, such as for the physical form, the industrial process or use, or the consumer 

1065 or commercial use. 

1066 

1067 EPA is proposing a number of changes to the reporting of production volume and 

1068 associated information. The Agency believes these changes would improve the usefulness of the 

1069 information for EPA and others, and would provide clarity for the reporting obligations of the 

1070 submitter. 

1071 

1072 i. Report production volume for each of the years since the last principal 

1073 reporting year. 

1074 

1075 EPA is proposing to require reporting of production volume for each of the five years 
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1076 since the last IUR principal reporting year. Thus, for the 2011 IUR submission period, 

1077 manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would 

1078 report the production volume of that chemical for each of the following calendar years: 2010, 

1079 2009, 2008, 2007, and 2006. This change would provide information EPA and others need as 

1080 stated in Unit III.D. Collecting the production volume for multiple years would provide greater 

1081 detail than the current once-every-five-years snapshot. 

1082 

1083 For the principal reporting year, e.g., 2010, the domestic manufacture and the import 

1084 production volume would continue to be reported separately on the same report. EPA review 

1085 and analysis of the 2006 IUR data has revealed that some submitters are erroneously submitting 

1086 multiple reports for the same chemical, at times reporting the information associated with 

1087 manufacturing and importing in different reports. The submitter should complete only one report 

1088 for each chemical substance. 

1089 

1090 EPA uses production volume data in several important ways. The data help the Agency 

1091 to establish trends in chemical manufacturing; to determine the effectiveness of various Agency 

1092 and other programs; to estimate the magnitude of consumer, worker, and environmental 

1093 exposures; and to determine the costs (and financial impacts) of potential control strategies in 

1094 economic analyses. As discussed in Unit III.D.2., the collection of annual production volume 

1095 data would allow EPA to identify more consistently the HPV chemicals. Voluntary EPA 

1096 programs such as Design for the Environment (DfE) and other pollution prevention programs 

1097 would use the annual production volume data to identify trends and program performance. 

1098 Relying on a single snapshot of annual production volume in each reporting determination period 

1099 hampers EPA’s ability to identify the programs and techniques that are most effective, using 

1100 measurable, readily identifiable production trend data. 

1101 

1102 Unit V of this Preamble contains a series of requests for comments on additional ideas 

1103 under consideration by the Agency. One of the ideas concerns the collection of more than just 

1104 the production volume since the last reporting year. The Agency is interested in comments on 

1105 this matter. Please see Unit V for additional discussion. 

1106 

1107 ii. Volume of chemical substance used on-site. 

1108 

1109 EPA is proposing to require that submitters report the volumes of a manufactured 

1110 (including imported) chemical substance used at the reporting site. The requirement to report the 

1111 volume used on-site is replacing the requirement to indicate that the chemical is site-limited. 

1112 Under this proposal, either domestically manufactured or imported chemicals could be reported 

1113 as used at the reporting site, whereas, under the current reporting requirements, only 

1114 domestically manufactured chemicals, consumed entirely at the site of manufacture, should be 

1115 reported as site-limited. 

1116 

1117 EPA is proposing this change to simplify reporting and to collect information that better 

1118 addresses the Agency’s needs. In the past, submitters sometimes incorrectly reported their 

1119 production volume separately to identify the portion of their chemical that was consumed at the 

1120 site of manufacture. For the 2006 IUR, many submitters continued this practice and erroneously 

1121 filed separate reports to identify that a portion of their production volume was site-limited. 

1122 Filing separate reports resulted in the need to report processing and use information separately 

1123 when the combined production volume was 300,000 lb. or greater. Reporting all production 
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1124 volumes on one report simplifies reporting for such submitters and results in a less complicated 

1125 database, thereby making the data easier to use. In addition, reporting the volume used on-site 

1126 provides valuable information related to potential exposures associated with the on-site volumes, 

1127 providing the Agency with better information for exposure assessments and other data analyses. 

1128 

1129 iii. Indicate whether imported chemicals are physically at reporting site. 

1130 

1131 EPA is proposing to add a requirement to indicate whether an imported chemical is 

1132 physically at the reporting site. Often, the site reporting an imported chemical never physically 

1133 receives the chemical, but instead ships it directly to another location such as a warehouse, a 

1134 processing or use site, or a customer’s site. Identifying whether the chemical is physically at the 

1135 reporting site provides more accurate information for screening-level analyses and other uses of 

1136 the IUR data. 

1137 

1138 iv. Report volume exported. 

1139 

1140 EPA is proposing to add a requirement to report the production volume directly exported 

1141 and not domestically processed or used. This would allow EPA to better identify the proportion 

1142 of the production volume accounted for by the use reporting, given that downstream reporting is 

1143 not required for exported substances. 

1144 

1145 5. Identify whether a chemical is to be recycled, remanufactured, reprocessed, 

1146 reused, or reworked. 

1147 

1148 EPA is proposing to add a requirement to indicate (via a check-box) whether a 

1149 manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, 

1150 reused, or reworked. Submitters would identify that their manufactured chemical, which 

1151 otherwise would be disposed of as a waste, is being removed from the waste stream and has a 

1152 commercial purpose (i.e., it is being recycled, remanufactured, reprocessed, reused, or 

1153 reworked). EPA believes that such information will help the Agency to identify where these 

1154 activities are already occurring, and can be used to encourage such activities. Collecting 

1155 information on whether a chemical is being recycled, remanufactured, reprocessed or reused and 

1156 is not entering the waste stream provides valuable information to EPA and others regarding 

1157 trends in chemical manufacturing. This information also can be used to help determine the 

1158 effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) 

1159 Program. EPA launched the RCC in 2002, implementing Congress’ instruction to prevent 

1160 pollution and conserve natural resources and energy by managing materials more efficiently. 

1161 The RCC Program’s goals include promoting reuse and recycling and reducing chemicals of 

1162 national concern in products and waste. Indicating that a manufactured chemical, such as a 

1163 byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked does not affect 

1164 the reporting requirements associated with any substance manufactured from the byproduct. See 

1165 Unit IV.2 for detailed information on byproduct reporting. 

1166 

1167 6. Concentration ranges. 

1168 

1169 EPA is proposing to eliminate gaps in the ranges used to report concentration in § 710.52(C)(3) 

1170 and (4). The current ranges result in gaps between 30 and 31 percent and 60 and 61 percent. 

1171 The proposed ranges would be: 
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1172 

1173 Less than 1% by weight 

1174 At least 1% but less than 30% by weight 

1175 At least 30% but less than 60% by weight 

1176 At least 60% but less than 90% by weight 

1177 At least 90% by weight 

1178 

1179 7. Industrial processing and use information reporting. 

1180 

1181 In 2003, EPA added industrial processing and use data to the information collected 

1182 through the IUR rule for chemical substances manufactured in quantities of 300,000 lb. or 

1183 greater during the principal reporting year. The industrial processing and use information 

1184 included industrial function categories and North American Industrial Classification System 

1185 (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was 

1186 useful in selecting a scenario that characterizes the frequency, route, and duration of exposure to 

1187 a chemical substance during manufacture, processing, and use of the substance. These data are 

1188 also useful when EPA characterizes the quantity of the chemical substance in wastes and 

1189 emissions entering the environment and for anticipating the environmental media into which 

1190 wastes will be released. The Agency is proposing to revise the list of industrial function 

1191 categories and to replace the NAICS codes with industrial sector categories, as described in 

1192 sections i. and ii. 

1193 

1194 i. Industrial function categories. 

1195 

1196 EPA is proposing to revise the list of industrial function categories by combining 

1197 categories that lead to common exposure scenarios and adding categories where the Agency 

1198 believes the existing categories do not adequately describe potential uses. EPA worked with 

1199 Environment Canada and Health Canada to develop the proposed set of categories, which would 

1200 be used by both the United States and Canada for Inventory reporting. Harmonization of the 

1201 categories for reporting the industrial functions of chemical substances would facilitate the 

1202 exchange of information between EPA and Canadian agencies and could serve as a model to be 

1203 used by Mexico in developing an inventory of chemical substances. In addition, the harmonized 

1204 categories would facilitate consistent reporting of chemical use information by industry in the 

1205 United States and Canada. (Ref. 13) 

1206 

1207 EPA is proposing to add eight new industrial function categories and to delete six 

1208 existing categories from the current list; the total number of industrial function categories would 

1209 increase to 35. Also, EPA is proposing to rename several of the industrial function categories to 

1210 provide a more informative description of the function of chemical substances that should be 

1211 reported in that category. Lastly, EPA is proposing to require that if a submitter selects the 

1212 category “Other,” the submitter must provide its own description of the industrial function of the 

1213 chemical substance. EPA is proposing the following industrial function categories: 

1214 Table 1: Codes for Reporting Industrial Function Categories. 

Code Category

U001 Abrasives 

U002 Adhesives and sealant chemicals 

U003 Adsorbents and absorbents 

U004 Agricultural chemicals (non-pesticidal) 
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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) 

1215 

1216 ii. Industrial Sectors 

1217 

1218 EPA is proposing to replace the five-digit North American Industrial Classification 

1219 System (NAICS) codes with 48 Industrial Sectors (IS). The sectors were adapted from the 

1220 European Union’s (EU’s) “Guidance on information requirements and chemical safety 

1221 assessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sectors 

1222 so that there is a sector corresponding to any NAICS code. The Agency believes this change 

1223 would provide several benefits. First, the sectors would reduce reporting burden because 

1224 submitters would not have to look up the NAICS code. Second, it would encourage more 

1225 complete reporting by using terms that are already familiar to industry. Third, the sectors would 

1226 reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate 

1227 NAICS codes. Fourth, it would reduce the number of codes that could apply to one substance. 

1228 Table 2 lists the proposed sectors. The rationale for selecting the sectors and the link between 

1229 the sectors and the NAICS system is further described in Inventory Update Reporting (IUR) 

1230 Technical Support Document – Replacement of 5-digit NAICS Codes with Industrial Sector 

1231 Codes (Ref. 9). 

1232 

1233 One of the primary purposes of the IUR data collection is to group together similar data 

1234 for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 
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1235 five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial 

1236 processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of 

1237 processing or use code, NAICS code, and industrial function category, in all. This large number 

1238 of unique combinations increases the difficulty and time required by EPA to sort and classify 

1239 chemicals because EPA either would need to develop exposure scenarios for each unique 

1240 combination, or determine which three-code combinations have similar exposure scenarios and 

1241 can be grouped. The use of the sectors would reduce the number of unique combinations, 

1242 thereby increasing the usability of the data, and also reducing the IUR reporting burden. 

1243 

1244 EPA is proposing the following 48 sectors: 

1245 

1246 Table 2: Industrial Sectors. 

Code Sector Description

IS1 Agriculture, Forestry, Fishing and Hunting 

IS2 Oil and Gas Drilling, Extraction, and support activities 

IS3 Mining (except Oil and Gas) and support activities 

IS4 Utilities 

IS5 Construction 

IS6 Food, beverage, and tobacco product manufacturing 

IS7 Textiles, apparel, and leather manufacturing 

IS8 Wood Product Manufacturing 

IS9 Paper Manufacturing 

IS10 Printing and Related Support Activities 

IS11 Petroleum Refineries 

IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing 

IS13 Petroleum Lubricating Oil and Grease Manufacturing 

IS14 All other Petroleum and Coal Products Manufacturing 

IS15 Petrochemical Manufacturing 

IS16 Industrial Gas Manufacturing 

IS17 Synthetic Dye and Pigment Manufacturing 

IS18 Carbon Black Manufacturing 

IS19 All Other Basic Inorganic Chemical Manufacturing 

IS20 Cyclic Crude and Intermediate Manufacturing 

IS21 All Other Basic Organic Chemical Manufacturing 

IS22 Plastics Material and Resin Manufacturing 

IS23 Synthetic Rubber Manufacturing 

IS24 Organic Fiber Manufacturing 

IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing 

IS26 Pharmaceutical and Medicine Manufacturing 

IS27 Paint and Coating Manufacturing 

IS28 Adhesive Manufacturing 

IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing 

IS30 Printing Ink Manufacturing 

IS31 Explosives Manufacturing 

IS32 Custom Compounding of Purchased Resins 

IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing 

IS34 All Other Chemical Product and Preparation Manufacturing 

IS35 Plastics Product Manufacturing 

IS36 Rubber Product Manufacturing 

IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, 

gypsum, and other nonmetallic mineral product manufacturing) 

IS38 Primary Metal Manufacturing 
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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) 

1247 

1248 When the category chosen for the Industrial Sector Code is “Other,” a written description 

1249 of the use of the chemical substance, which may include the NAICS code, would also need to be 

1250 provided. 

1251 

1252 8. Consumer and commercial use reporting 

1253 

1254 In the 2003 Amendments, EPA added a reporting requirement for submitters to include 

1255 information about the consumer and commercial uses of chemicals they reported under the IUR 

1256 rule. For the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured 

1257 in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to ten 

1258 consumer and commercial product categories from a list of 20 categories that correspond to the 

1259 actual use of the chemical substance they are reporting. For each category, submitters also were 

1260 required to indicate whether the chemical was used in a product intended for use by children, to 

1261 report the maximum concentration of the chemical in the product category, and to report the 

1262 percentage of total production volume associated with the product category. 

1263 

1264 EPA is using the information provided by the 2006 IUR reports in the Existing Chemicals 

1265 Program. While the Agency found that the information was useful in identifying when 

1266 consumers and commercial users and children are potentially exposed populations, EPA also 

1267 found that the data had significant limitations concerning the product categories and 

1268 identification of potentially exposed populations. The Agency believes the limitations stem from 

1269 two characteristics of the data: (1) the lack of specificity in the product categories and (2) the 

1270 inability to distinguish between consumer and commercial uses. In addition, because 29 percent 

1271 of the reported categories were for the category “Other,” EPA was constrained in its ability to 

1272 characterize use and exposure scenarios. Also, consumer and commercial uses affect very 

1273 different populations. The reported information was not useful in differentiating these 

1274 populations when characterizing potential exposures. 

1275 

1276 To address these issues, EPA is proposing three changes to the consumer and commercial 

1277 information required to be reported: (1) a revised and expanded list of consumer and 

1278 commercial product categories, (2) the additional requirement to provide a description when the 

1279 product category “Other” is selected, and (3) the identification of whether the use is a consumer 

1280 or a commercial use, or both. Reporting associated with children’s use, the maximum 

1281 concentration, and the percent production volume would remain unchanged. 

1282 

1283 i. Consumer and Commercial Product Categories 

1284 

1285 EPA is proposing to revise the list of consumer and commercial product categories by 
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1286 combining categories that lead to common exposure scenarios and adding categories that were 

1287 not adequately described in the initial set of categories. EPA worked with Environment Canada 

1288 and Health Canada to develop the proposed categories. Harmonized categories for reporting the 

1289 consumer and commercial uses of chemical substances would facilitate the exchange of 

1290 information between EPA and Canadian agencies and would serve as a model to be used by 

1291 Mexico in developing an inventory of chemical substances. In addition, the harmonized 

1292 categories would facilitate consistent reporting of chemical use information by industry in the 

1293 United States and Canada. (Ref. 13) 

1294 

1295 During the development of the revised product category list, EPA and Canada considered 

1296 existing product category schemes, such as the NAICS and REACH categories, but found them 

1297 to be either too detailed or not right for the task at hand. The NAICS categories are defined for 

1298 manufacturing processes, not for consumer and commercial products, and therefore did not 

1299 address the situations of interest. The REACH program collects detailed information on the use 

1300 of chemicals in consumer and commercial products sold in the EU: all of the codes used by 

1301 REACH are represented in the harmonized industrial function and consumer and commercial 

1302 codes. 

1303 

1304 The proposed list includes 33 product categories, including “Other.” Examples of new 

1305 categories which have been added include explosive materials, building/construction products 

1306 not covered elsewhere, and air care products. The glass and ceramic products category had 

1307 relatively few IUR submissions in 2006 and overlaps with proposed new categories, and so has 

1308 been proposed for elimination. Also, several of the consumer and commercial product categories 

1309 would be renamed to better describe the products that should be reported in those categories. 

1310 

1311 EPA believes that expanding the list of consumer and commercial product categories 

1312 would provide persons submitting IUR information with a greater opportunity to characterize the 

1313 product in which chemical substances they manufacture are used and would reduce the number 

1314 of uses reported as “Other.” 

1315 

1316 In addition to revising the overall product categories, narrower definitions and expanded 

1317 lists of examples of products in which the chemical substance would be used would be added to 

1318 each category descriptor. The examples were selected to include items that could have fit into 

1319 other categories in order to address the overlap inherent in any product category list. The 

1320 product categories were then placed into several broader groupings, e.g., “Chemicals with 

1321 Agriculture and Outdoor Uses’ based on the similarities of products. EPA believes that the user 

1322 would find the proposed groupings easier to use than the alphabetical listing used for the 2006 

1323 IUR. 

1324 

1325 EPA is also proposing to require that if a submitter chooses the product category “Other,” 

1326 the submitter must include a text description for the consumer and commercial product 

1327 containing the chemical substance. In the 2006 IUR reports, the category “Other” was reported 

1328 with the greatest frequency, with 1,206 out of a total number of 4,157 reports containing 

1329 consumer and commercial use information, resulting in a reporting rate of 29 percent for the 

1330 category. Although one of EPA’s objectives in revising the consumer and commercial product 

1331 categories was to reduce the reporting frequency of “Other,” EPA believes that in many cases 

1332 where “Other” was reported, submitters may not have selected the correct categories for their 

1333 situation. By requiring the submitters to supply a written description for “Other,” EPA would be 
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1334 able to evaluate and improve the inclusiveness of future consumer and commercial category lists 

1335 or descriptions. In addition, the descriptor information would be more useful than simply the 

1336 selection of “Other” for EPA’s Existing Chemicals and other programs. 

1337 

1338 EPA is proposing the following consumer and commercial product categories: 

1339 

1340 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 

Chemical Substances in Products not Described by Other Codes 

C980 Non-TSCA Use 

C909 Other (specify) 

1341 

1342 ii. Designation of Consumer or Commercial Use 

1343 
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1344 EPA is proposing to require submitters to designate, via a checkbox, whether the 

1345 indicated product category is a consumer or a commercial use, or both. The Agency’s 

1346 experience using the 2006 IUR data identified a need to distinguish between potentially exposed 

1347 consumer and commercial populations. The designation of consumer or commercial use, or 

1348 both, would allow EPA to complete a better characterization of the potentially exposed 

1349 populations. 

1350 

1351 iii. Number of Commercial Workers Reasonably Likely to be Exposed 

1352 

1353 EPA is proposing to require that submitters report the total number of commercial 

1354 workers, including those at sites not under the submitter’s control, that are reasonably likely to 

1355 be exposed while using the reportable chemical substance, with respect to each commercial use. 

1356 The approximate number of workers would be reported using the same definitions and ranges 

1357 used for manufacturing and industrial processing and use workers required by 40 CFR 

1358 710.52(c)(3)(v) and (4)(i)(F) (proposed 40 CFR 711.12(c)(3)(vii) and (4)(i)(F)), respectively. 

1359 The ranges are: 

1360 

1361 Fewer than 10 workers 

1362 At least 10 but fewer than 25 workers 

1363 At least 25 but fewer than 50 workers 

1364 At least 50 but fewer than 100 workers 

1365 At least 100 but fewer than 500 workers 

1366 At least 500 but fewer than 1,000 workers 

1367 At least 1,000 but fewer than 10,000 workers 

1368 At least 10,000 workers 

1369 

1370 Information on the number of commercial workers reasonably likely to be exposed to the 

1371 reportable chemical substance would be used to characterize the commercial population 

1372 reasonably likely to be exposed to the subject chemical substance. The population 

1373 characterization is important to the development of the overall exposure characterization. 

1374 

1375 G. Changes to standard for the reporting of processing and use information 

1376 

1377 In order to collect more complete information regarding the industrial processing and 

1378 industrial, commercial, and consumer use of chemicals, EPA is proposing in § 711.12(c)(4) to 

1379 replace the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) 

1380 in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under 

1381 TSCA for this type of TSCA reporting. TSCA section 8(a)(2) authorizes EPA to require persons 

1382 to report information that is “known to or reasonably ascertainable by” the submitter. This is the 

1383 same standard that currently applies to the reporting of information described in the regulations 

1384 at §§ 710.52(c)(1), (c)(2), and (c)(3), and this standard would continue to apply to the reporting 

1385 of such information under proposed §§ 711.12(c)(1), (c)(2), and (c)(3). It covers all information 

1386 in a person’s possession or control, plus all information that a reasonable person similarly 

1387 situated might be expected to possess, control, or know. The “known to or reasonably 

1388 ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior 

1389 to the 2006 IUR submission period. 

1390 
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1391 EPA is proposing this change because reporting under the “readily obtainable” 

1392 reporting standard did not generate sufficiently complete processing and use information. EPA 

1393 believes the “readily obtainable” reporting standard limited the usefulness of the 2006 IUR 

1394 processing and use data for screening level reviews. In addition, the 2006 IUR response rate for 

1395 the processing and use information did not capture a sufficiently large portion of the production 

1396 volume that the Agency believes actually was used for either industrial processing and use or 

1397 consumer and commercial use. Thirty percent of the reports submitted for the 2006 IUR met the 

1398 requirements (based on type of chemical and production volume) to trigger reporting of 

1399 processing and use information. Of those, almost thirteen percent contained no industrial 

1400 processing and use information and almost half contained no commercial or consumer use 

1401 information. For the reports that did contain some processing and use information, the portion of 

1402 the production volume for which some information was reported is detailed in Table 4. Note that 

1403 an IUR Form U submission contains one or more reports; each report is for a single chemical at a 

1404 single site. 

1405 

1406 Table 4: Percentage of reports providing production volume information related to 

1407 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 

1408 *The percentage is calculated as a fraction of the total number of reports that triggered the need to report processing 

1409 and use information. 

1410 

1411 The Agency believes the percentage of missing processing and use information actually 

1412 is larger than indicated by this analysis. As described in the 2003 Amendments final rule (68 FR 

1413 861), EPA anticipated that, on an individual report basis, the total percentages of production 

1414 volumes associated with the industrial processing or use information may add up to more than 

1415 100 percent of the reported production volume. This could happen because the submitter 

1416 reported on the distribution of a chemical to sites in its control as well as downstream sites, some 

1417 of which were not immediate purchasers from the original manufacturing site. For example, 

1418 consider the scenario where a certain volume of a reported chemical is reported as processed by a 

1419 repackager, sent to another site that adds the chemical to a mixture, and then sent to a 

1420 combination of industrial and commercial users. If the repackaged volume were 100 percent of 

1421 the production volume, the total volume reported for the different processing and use scenarios 

1422 could equal 300 percent of the production volume. EPA expected and anticipated this type of 
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1423 reporting, as each instance of processing or using the chemical created a different exposure 

1424 scenario. As indicated in Table 4, only 12 percent of the reports contained processing and use 

1425 information that equaled or exceeded the production volume for their chemical. EPA expected 

1426 this percentage to be significantly larger. 

1427 

1428 Focusing on the industrial processing and use information, a complete use scenario is 

1429 comprised of three of the IUR data elements: the type of process or use, the NAICS codes, and 

1430 the industrial function code. A report could contain up to ten unique combinations of these three 

1431 data elements (i.e., use scenarios). For the reports required to include processing and use 

1432 information in 2006, submitters reported an average of slightly more than two use scenarios. For 

1433 each unique combination of these three data elements, the manufacturer reports the percent 

1434 production volume, the number of sites, and the number of reasonably likely to be exposed 

1435 workers associated with the use scenario. In 2006, only about half of the reported use scenarios 

1436 also included information for the number of sites, the number of workers, and a production 

1437 volume that was greater than zero. 

1438 

1439 Reports for consumer and commercial use information included a product category, 

1440 and, for that category, whether the chemical is used in products intended for children, the percent 

1441 production volume, and the maximum concentration. A report could contain up to ten product 

1442 categories. For the reports that were required to include processing and use information in 2006, 

1443 submitters reported an average of slightly less than one product category. Much of the consumer 

1444 and commercial information contained data elements reported as not readily obtainable 

1445 (NRO) or were left blank. Specifically, 14 percent of product category information, 24 percent 

1446 of children’s information, and 40 percent of the maximum concentration were either reported as 

1447 NRO or left blank. Overall, fewer than half of the consumer and commercial records (i.e., the 

1448 individually reported product categories and associated information) contained complete data 

1449 (e.g., where none of the data elements contained information reported as zero, NRO, or were left 

1450 blank). 

1451 

1452 This low reporting rate also occurred on an individual chemical basis; 2006 IUR 

1453 submitters did not report processing and use information even though they were required to 

1454 report such information. This happened for 20 percent of the chemicals for which the criteria for 

1455 reporting processing and use information were met. For those chemicals, EPA has no processing 

1456 or use information reported through the IUR rule. 

1457 

1458 For over 30 years, the Agency’s New Chemicals Program has successfully applied the 

1459 “known to or reasonably ascertainable by” reporting standard. (See 40 CFR 720.45) Companies 

1460 have used this standard to report to EPA information about how their chemicals are processed 

1461 and used by submitting more than 30,000 TSCA section 5 Premanufacture Notices (PMNs). 

1462 Because of this experience, EPA believes that companies routinely have more information about 

1463 how their chemicals are processed and used than is reflected in the 2006 IUR data. PMNs 

1464 routinely include extensive, detailed information on how a company’s customers and others 

1465 outside the company’s control will process and use its chemicals. EPA believes that the 

1466 reporting under the Agency’s New Chemical program indicates that companies generally do 

1467 know the intended ultimate uses, as well as the intervening processing steps, for their products. 

1468 In addition, EPA’s experience in the New Chemicals Program indicates that this reporting 

1469 standard generates information sufficient for screening-level reviews. Therefore, the Agency 

1470 believes that using this standard for reporting of IUR industrial processing and industrial, 
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1471 consumer, and commercial use information will improve reporting rates and assist EPA’s efforts 

1472 to characterize chemical uses and to predict potential exposure to these chemicals. 

1473 

1474 The Agency’s experience using the 2006 IUR data to develop exposure 

1475 characterizations, coupled with the limited data EPA was able to publicly release, highlighted the 

1476 incompleteness of the data and lead the Agency to determine that the data are insufficient, even 

1477 for screening level purposes. Effective risk screening by EPA depends on the ability to 

1478 accurately characterize chemical uses and to predict potential exposures. As described in Unit 

1479 II.D, these data are used by EPA to prioritize work on existing chemicals. If the information 

1480 provided does not include these data, EPA must make assumptions about the use of the 

1481 unreported production volume. Incorrect assumptions may lead EPA to designate an 

1482 inappropriately high or low priority level for the chemical, resulting in unnecessary effort and 

1483 resource expenditures for both regulated parties and EPA in cases where more complete data 

1484 would have led the Agency to act differently. 

1485 

1486 For the foregoing reasons, EPA believes that using the reporting standard “known to or 

1487 reasonably ascertainable by” would result in companies reporting more consistent and complete 

1488 processing and use information in their IUR reports, and that the information reported would 

1489 better enable EPA to develop the exposure characterizations needed for the Agency’s screening 

1490 of existing chemicals. 

1491 

1492 H. Amendments to Requirements Concerning Confidential Business Information claims 

1493 

1494 Submitters may currently claim certain information reported under the IUR as confidential 

1495 business information (CBI) in accordance with 40 CFR part 2 and IUR rules at 40 CFR 710.38 

1496 (proposed 40 CFR 711.18). Submitters must assert claims of confidentiality at the time 

1497 information is submitted to EPA. EPA’s procedures for handling information claimed as 

1498 confidential are set forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to 

1499 review confidentiality claims carefully to ensure that the information in question falls within the 

1500 parameters of TSCA section 14. CBI claims should be limited to only those data elements the 

1501 release of which would likely cause substantial harm to the business’ competitive position. 

1502 Interested persons are reminded that with regard to chemical use information, EPA is interested 

1503 in aggregated, general uses, not detailed uses associated with specific customers. 

1504 

1505 To claim information as confidential, a submitter must both indicate its claim by both 

1506 checking the appropriate box and signing the certification statement on the reporting form. A 

1507 submitter must indicate its claims at the time the information is submitted. If a submitter fails to 

1508 follow these procedures, EPA may release the information to the public without further notice to 

1509 the submitter. By signing the certification statement the submitter attests to the secrecy and 

1510 value of the information for which confidentiality claims have been asserted. 

1511 

1512 EPA expects that reducing the number of CBI claims would increase the amount of 

1513 information available to the public and improve the timeliness of its public availability. As a 

1514 result, the Agency would be able to publicly discuss and explain its risk management actions and 

1515 decisions more clearly. Currently, much of the factual and data support for Agency decisions is 

1516 claimed as CBI, which complicates the creation of publicly available documents. The public 

1517 would be better informed and better able to understand and provide meaningful comment on 

1518 Agency actions if less information were unnecessarily or inappropriately claimed as CBI. The 
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1519 Agency would also be able to provide other public and private organizations and individuals with 

1520 better information for making their own decisions. Thus, EPA is proposing the changes 

1521 described in sections H.1., H.2., and H.3. with the belief that the proposed changes would reduce 

1522 the number of unjustifiable CBI claims. 

1523 

1524 1. Chemical identity CBI claims 

1525 

1526 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 

1527 the identity of the reported chemical substance when the chemical is listed on the confidential 

1528 portion of the Master Inventory File and when the submitter provides the required substantiation 

1529 at the time the submitter makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 

1530 40 CFR 711.18(b)). At times a submitter will assert a claim of confidentiality for the chemical 

1531 identity of a substance that is listed on the public portion of the Master Inventory File. EPA is 

1532 proposing that, when this occurs, the Agency may make the information available to the public 

1533 without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e). 

1534 

1535 2. Upfront substantiation for processing and use information CBI claims 

1536 

1537 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 

1538 the processing and use of its chemical if the submitter has reason to believe that release of the 

1539 information would reveal trade secrets, or confidential commercial or financial information, as 

1540 provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made 

1541 confidentiality claims ranging from 25 percent (when considering individual data elements) to 50 

1542 percent (when considering data elements combined into use scenarios) of the reported processing 

1543 and use information. While the Agency does not question that confidentiality claims are 

1544 sometimes necessary, it encourages submitters to consider carefully whether such claims are in 

1545 fact necessary before asserting them. The Agency has identified instances in which submitters 

1546 have claimed the processing and use data as confidential, yet similar if not identical information 

1547 was found in publicly available sources, such as company websites, published Material Safety 

1548 Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s 

1549 HPVIS website (see Unit II.D for more discussion). Note that EPA can take steps to challenge or 

1550 verify confidentiality claims. The Agency believes companies should limit their CBI claims to 

1551 those that they are capable of adequately substantiating. 

1552 

1553 For the 2006 IUR reports, submitters were not required to provide upfront substantiation 

1554 of CBI claims for processing and use data. In these proposed modifications to the IUR rule, EPA 

1555 would require upfront substantiation for CBI claims for this information. 

1556 

1557 EPA believes that many of the CBI claims for processing and use data are inappropriate 

1558 and that the new substantiation requirement would reduce the occurrence of unnecessary claims. 

1559 The high number of confidentiality claims asserted for the reported 2006 IUR reports on 

1560 industrial processing and use information impeded the release of important data. This included 

1561 the number of processing sites, the number of potentially exposed industrial workers, and the 

1562 percent production volume for each industrial processing or use scenario. (Ref. 10) A decrease 

1563 in the number of inappropriate CBI claims under the new substantiation requirement would 

1564 improve EPA’s ability to make current plant site information available to other Federal agencies 

1565 and the public because more information submitted under IUR could be released publicly. 

1566 
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1567 Under this proposed rule, in order to submit a claim of confidentiality for processing and 

1568 use information data elements, the submitter would be required to both check the appropriate box 

1569 on the reporting form and substantiate the claim in writing by answering certain questions 

1570 provided in § 711.18(d) of the proposed rule. Where a submitter fails to substantiate the 

1571 processing and use CBI claim in accordance with the applicable rules, EPA would consider the 

1572 information not subject to a confidentiality claim and may make the information available to the 

1573 public without further notice to the submitter. 

1574 

1575 3. Limitation on confidentiality claims for data elements identified as “not known 

1576 or reasonably ascertainable” 

1577 

1578 Under the IUR rule, submitters provide information on the industrial processing and use 

1579 and consumer and commercial use of the IUR reportable chemicals they manufacture (including 

1580 import). As described in Unit II.A, for the 2011 and future IUR collections, EPA is proposing 

1581 that submitters be required to report this information to the extent that it is known to or 

1582 reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the 

1583 processing and use information to the extent that it was readily obtainable, and were permitted to 

1584 identify when such information was not readily obtainable by entering “NRO.” EPA has 

1585 observed that, on occasion, processing and use information has been claimed as confidential 

1586 when a submitter determined that the information was not readily obtainable. 

1587 

1588 TSCA section 14 limits the disclosure of information entitled to confidential treatment 

1589 under Exemption 4 of FOIA. EPA has considered the NRO designation and its relationship to a 

1590 potential CBI or trade secret claim. Given that a NRO assertion is an assertion that no 

1591 information is available, the Agency does not believe that the designation conveys trade secret or 

1592 confidential commercial or financial information. For this reason, EPA is proposing to prohibit 

1593 claims of confidentiality pertaining to the designation that information is not “known to or 

1594 reasonably ascertainable by” the submitter. EPA solicits comment on this issue. 

1595 

1596 I. Modifications Specifically Affecting Importers 

1597 

1598 Submitters report IUR data on chemicals that they manufacture domestically and that 

1599 they import into the United States. Current IUR regulations provide that the site responsible for 

1600 reporting for imported chemicals is the site of the operating unit that is directly responsible for 

1601 importing the substance and that controls the import transaction. In some cases, the import site 

1602 may be the organization’s headquarters in the United States. The regulations defining the site for 

1603 importer reporting is found in both the definition for site in 40 CFR 710.3 and in paragraph 40 

1604 CFR 710.48(b). 

1605 

1606 EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving 

1607 the additional information regarding the importer site from § 710.48(b) into a revised definition 

1608 for site, as described in Unit III.C.2. of this preamble, and eliminating § 710.48(b). 

1609 

1610 In addition, EPA has observed that submitters occasionally use a foreign address as the 

1611 site address for the importer. EPA now is proposing to require that submitters report a U.S. site 

1612 address, by modifying the definition for site to state specifically that the site must be a U. S. site. 

1613 The U.S. address of an agent acting on behalf of the importer, and authorized to accept service of 

1614 process for the importer, may be reported as the importer’s site address if the operating unit that 
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1615 is directly responsible for importing the substance and that controls the import transaction has no 

1616 U.S. address. The Agency expects that all importers will have a U.S. site, as defined in the 

1617 proposed 40 CFR 711.3 definition for site because, under Customs regulations at 19 CFR 141.18, 

1618 a non-resident corporation is not permitted to enter merchandise for consumption unless it has a 

1619 resident agent in the State where the port of entry is located, who is authorized to accept service 

1620 of process against the corporation. 

1621 

1622 For purposes of IUR, submitters are currently allowed to report the IUR information 

1623 jointly with the foreign manufacturer of the chemical. Importers may not know the specific 

1624 chemical identity of a substance because the foreign supplier chooses to keep it confidential. In 

1625 such a situation, the importer is still responsible for ensuring that the IUR information is 

1626 submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the 

1627 primary submitter, completes the majority of the required information, but supplies a trade name 

1628 or other designation to identify the chemical substance. In addition, the primary submitter 

1629 provides technical contact information for the foreign supplier. The primary submitter then 

1630 contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the 

1631 specific chemical identity information to EPA. In addition to the chemical identity, the 

1632 secondary submitter supplies its technical contact and company information but provides the 

1633 primary submitter’s site information. The secondary submitter should also provide the upfront 

1634 substantiation required for any confidentiality claims for chemical identity. 

1635 

1636 Under this proposed rule, the process would be the same, except that submitters would 

1637 be required to use CDX and e-IUR for preparation and submission of joint submissions. See 

1638 proposed 40 CFR 711.12(b)(3)(i). Previously, joint submissions could not be made 

1639 electronically. In order to submit electronically to EPA via CDX, individuals must first register 

1640 with CDX. Therefore, the authorized officials of the jointly submitting companies would need to 

1641 register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier 

1642 or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., 

1643 the importer’s) authorized official to send joint submissions to EPA. 

1644 

1645 For joint submissions to be submitted electronically, the primary submitter would use e1646 IUR to identify the need to submit a joint report and would identify itself as a primary submitter. 

1647 The primary submitter would then complete his or her portion of the report and provide the 

1648 secondary submitter's company information, along with select information on the chemical 

1649 substance(s) that are manufactured using a chemical substance made by the secondary submitter. 

1650 The primary submitter reports only the volume that it used. A secondary submitter would also 

1651 need to use e-IUR to identify the need to submit a joint report and would identify itself as a 

1652 secondary submitter. It would provide the primary submitter’s company information and its own 

1653 technical contact information, and would identify the chemical substance(s) that is in its product, 

1654 including the percentages. This information would be saved by the reporting tool and both 

1655 submissions would be matched based upon company and chemical information. Once the forms 

1656 are matched, the joint submission would be ready to be processed by EPA. The Agency is 

1657 currently developing the process to submit joint reports electronically and welcomes any 

1658 comments concerning this process. 

1659 

1660 For the 2006 IUR submission period, EPA set aside joint submissions until both reports were 

1661 received and matched. Oftentimes, EPA had no way to determine whether a submission was a 

1662 “joint” submission, which increased the time required for manual processing of the data. EPA 
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1663 anticipates that the use of the reporting tool will help to make joint IUR reporting easier for 

1664 industry and streamline EPA processing of the IUR information submitted in the 2011 

1665 submission period. 

1666 

1667 J. Change to Reporting Frequency 

1668 

1669 Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced 

1670 the reporting frequency from every four years to every five years starting with the 2006 IUR to 

1671 reduce the burden associated with the amended IUR rule. For the reasons described in this 

1672 section, the Agency has determined that reporting every five years is too infrequent, and now is 

1673 proposing to return to reporting every four years. 

1674 

1675 As described in Unit III.D.1, a review of the previous reporting under IUR has revealed an 

1676 approximately 30 percent change in the chemicals that are reported from one submission period 

1677 to the next. While the less frequent reporting does reduce burden, EPA now believes that 

1678 reporting every five years does not provide data sufficiently current to meet Agency and public 

1679 needs. As described in Unit V.2.a, the Agency has been criticized for using outdated 

1680 information. EPA, therefore, also is considering increasing the frequency of reporting to every 

1681 three years, or possibly to annual reporting. The Agency believes that efficiencies are gained 

1682 with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, 

1683 companies would be able to establish standard systems and practices to collect the required 

1684 information. For instance, for annual reporting the Agency estimates that submitters would 

1685 reduce the burden for each reporting cycle by approximately 20 percent. (See Chapter 4 of the 

1686 Economic Analysis, Ref. 11). EPA invites comment on the proposed return to four-year 

1687 reporting intervals, and also on more frequent reporting (i.e., every three years, biennial, or 

1688 annual reporting). Further information is provided in Question 2.a under Unit V, and the various 

1689 reporting frequency alternatives are analyzed in the Economic Analysis. (See Chapter 4 and 

1690 Appendix G of the Economic Analysis, Ref. 11) 

1691 

1692 IV. Clarifications to Reporting Requirements 

1693 

1694 A. Clarification of the relationship between company name and site ID CBI claims 

1695 

1696 Under the IUR, submitters are able to claim as CBI both the company name and site 

1697 identity associated with a chemical for which they are reporting under the IUR. The submitter is 

1698 required to provide an upfront substantiation for CBI claims for the site identification. EPA 

1699 believes there is some confusion as to what is considered confidential when such claims are 

1700 made, and is taking this opportunity to provide clarification. 

1701 

1702 The e-IUR reporting software does not allow for blanket CBI claims for company and 

1703 site identification information, since those are separate claims and in some cases one type of 

1704 claim may be justified while the other is not. Rather, a submitter is permitted to assert its CBI 

1705 claim for the company identity, the site identity, or both the company and site identity associated 

1706 with each chemical for which they are submitting an IUR report. In addition, the submitter must 

1707 provide separately the required upfront substantiation for the site identity CBI claims associated 

1708 with each chemical. For instance, if the submitter is reporting for five chemicals and wishes to 

1709 claim its site information confidential for three of the five chemicals, it must assert the claim and 

1710 provide separate upfront substantiation three times, once for each of the three chemicals. The 
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1711 CBI claim protects the link between the company and/or site identification and the particular 

1712 chemical substance. If the company or site identity associated with a particular chemical is not 

1713 claimed as CBI, EPA may make that information available to the public without further notice to 

1714 the submitter. EPA will not impute the existence of a CBI claim for company identity or for site 

1715 identity from a CBI claim associated with a different chemical. 

1716 

1717 EPA has also observed that submitters sometimes claim only their company identity, and 

1718 not their site identity, as confidential. If the site identity for a particular chemical is not claimed 

1719 as CBI, or is claimed but not substantiated pursuant to 40 CFR 710.58(c) (proposed 40 CFR 

1720 711.18(c)), EPA may make that information available to the public without further notice to the 

1721 submitter. EPA will not impute the existence of a CBI claim for site identity from a CBI claim 

1722 for company identity, even if the company name appears within the site identity information. To 

1723 help ensure that submitters consider this issue, EPA plans to modify the e-IUR reporting 

1724 software so that it will provide a warning whenever the company identity is claimed as CBI for a 

1725 particular chemical and the site ID is not also claimed as CBI for that chemical. 

1726 

1727 B. Explanation of byproduct reporting. 

1728 

1729 During the 2006 submission period, EPA received questions about the requirements for 

1730 reporting byproducts, including whether byproduct manufacturers were required to report the 

1731 byproducts under the IUR rule. These included some questions involving a manufacturer that uses 

1732 a chemical in the production of an article. Such manufacturing may produce a byproduct 

1733 substance that is chemically different from the starting substance; the manufacturer therefore 

1734 may incur reporting obligations under the IUR rule for that byproduct. In light of these and 

1735 similar questions, EPA is providing detailed information on byproduct reporting, including 

1736 circumstances under which reporting is not required, in the draft instruction manual included in 

1737 the docket for this rule. (Ref. 2) 

1738 

1739 For purposes of IUR, a byproduct is a chemical substance produced without a separate 

1740 commercial intent during the manufacture, processing, use or disposal of another chemical 

1741 substance or mixture (40 CFR 704.3). Thus, for example, when a chemical substance or mixture 

1742 is used for the purpose of manufacturing an article, and that manufacture results in the 

1743 production of a different chemical substance, that different chemical substance is a byproduct for 

1744 purposes of the IUR. Chemical substances that are byproducts of the manufacture, processing, 

1745 use, or disposal of another chemical substance or mixture, like any other manufactured chemical 

1746 substances, are subject to IUR reporting if they are manufactured, are listed in EPA’s Master 

1747 Inventory File, are not otherwise excluded from reporting, and their manufacturer is not 

1748 specifically exempted from IUR reporting requirements. 

1749 

1750 For purposes of IUR, a byproduct is “manufactured” only if it is “manufactured for 

1751 commercial purposes.” See TSCA section 8(f). The 40 CFR 704.3 definition of manufacture for 

1752 commercial purposes states that “[m]anufacture for commercial purposes also applies to 

1753 substances that are produced coincidentally during the manufacture, processing, use, or disposal 

1754 of another substance or mixture, including both byproducts that are separated from that other 

1755 substance or mixture and impurities that remain in that substance or mixture. Such byproducts 

1756 and impurities may, or may not, in themselves have commercial value. They are nonetheless 

1757 produced for the purpose of obtaining a commercial advantage since they are part of the 

1758 manufacture of a chemical product for a commercial purpose.” Thus, byproducts of the 
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1759 manufacture, processing, use, or disposal of another substance or mixture for a commercial 

1760 purpose are themselves both "manufactured" and "manufactured for commercial purposes." 

1761 

1762 Byproducts that are manufactured in volumes of 25,000 lb. or more at a single site are 

1763 potentially subject to IUR requirements. However, 40 CFR 710.50(c) (proposed 40 CFR 

1764 711.10(c)) excludes from reporting those substances meeting the requirements of §§ 720.30(g) or 

1765 (h). Manufacturers (including importers) of byproducts are not required to report the 

1766 manufacture of a byproduct if the byproduct is not used for commercial purposes. See 40 CFR 

1767 720.30(h)(2). Thus, even where a byproduct is manufactured for a commercial purpose, if the 

1768 byproduct is not subsequently put to use for another commercial purpose, the byproduct is 

1769 excluded from IUR reporting. Furthermore, if the byproduct’s “only commercial purpose is for 

1770 use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, 

1771 including in a landfill or for enriching soil, or (3) extract component chemical substances from it 

1772 for commercial purposes,” 40 CFR 720.30(g), that byproduct is also excluded from IUR 

1773 reporting. This exclusion applies only to the byproduct; it does not apply to the component 

1774 substances extracted from the byproduct. 

1775 

1776 V. Request for Comment 

1777 

1778 The following is a list of issues on which the Agency is specifically requesting public 

1779 comment, in addition to those noted in Unit III of this preamble. EPA encourages all interested 

1780 persons to submit comments on these issues, and to identify any other relevant issues as well. 

1781 This input will assist the Agency in developing a final rule that successfully addresses 

1782 information needs while minimizing potential reporting burdens associated with the rule. EPA 

1783 requests that commenters making specific recommendations include supporting documentation 

1784 where appropriate. 

1785 

1786 1) As discussed in Unit II.E, EPA is increasing its emphasis on assessing, prioritizing, and 

1787 taking action on existing chemicals that pose unreasonable risks, with particular emphasis on 

1788 protecting children. EPA is interested in receiving comments regarding how to utilize IUR 

1789 data, including how to amend the rule, to best assist in this effort. 

1790 

1791 2) The proposals discussed in Unit III.D.3 would result in a site reporting data on subject 

1792 chemical substances exceeding the 25,000 lb. threshold for any calendar year since the last 

1793 principal reporting year. The site would report manufacturing (including production 

1794 volume), processing, and use information for the principal reporting year (e.g., 2010), as well 

1795 as production volume information for all the years since the last IUR principal reporting year 

1796 (i.e., 2006 through 2009, for principal reporting year 2010). In developing this proposal, 

1797 EPA considered several other reporting options and is seeking comment on these options, 

1798 which are described in paragraph (2)(i) and (2)(ii) of this section. 

1799 

1800 i) EPA is proposing to return the reporting frequency to four years and is considering 

1801 further increasing the frequency to every three years, biennially, or annually. (See 

1802 Ref. 11 for burden and cost information.) More frequent reporting provides more 

1803 current data. Eliminating the five-year wait for current information would address 

1804 concerns that IUR data is outdated and therefore less useful than if it were more 

1805 current. EPA is particularly interested in the annual reporting option for several 

1806 reasons. Annual reporting would enable EPA to better analyze trends, including 
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1807 ascertaining which chemicals are manufactured on a consistent basis, which 

1808 chemicals have wide variations from year to year, and which chemicals are 

1809 increasing or decreasing in volume. Trend analyses measure the success of 

1810 programs and can be used to proactively identify developing issues and generally 

1811 provide a greater insight into the chemical industry. Obtaining this information 

1812 annually, instead of the proposed option of reporting four years of production 

1813 volume at one time, would allow for closer monitoring of trends and the more 

1814 timely feedback on the success of programs than would be possible under the 

1815 proposed option. In addition, annual reporting would provide the opportunity to tie1816 in more closely or actually integrate IUR reporting with the already-required annual 

1817 Toxic Release Inventory (TRI) reporting. 

1818 

1819 ii) EPA is also interested in comments regarding changing the reporting threshold from 

1820 25,000 lb. to 10,000 lb., but is not including this change in the regulatory text 

1821 accompanying this proposal. (See Ref. 11 for burden and cost information.) Prior 

1822 to the 2006 IUR, the threshold for determining the need to report was 10,000 lb., 

1823 therefore this change in the reporting threshold would be a return to the status quo 

1824 for the IUR. The Agency is interested in collecting information on chemicals with 

1825 nationally aggregated production volumes of 25,000 lb. or higher. Because 

1826 chemicals are often manufactured at more that one site, chemicals with site-specific 

1827 production volumes that fall below the 25,000 lb. reporting threshold and therefore 

1828 would not be reported for IUR may have aggregated production volumes of 25,000 

1829 lb. or greater. 

1830 

1831 3) EPA is considering collecting additional exposure-related data, similar to those collected 

1832 under TSCA section 5 (new chemicals program), to enhance the Agency’s capabilities in 

1833 conducting screening-level exposure assessments of chemical substances reported to the 

1834 TSCA Inventory Update. 

1835 

1836 EPA, through its experience in using the IUR exposure-related and use information, has 

1837 learned that the current IUR data are not sufficient for determining quantitative estimates of 

1838 releases of and exposures to chemical substances. As a result of the available 2006 IUR data, 

1839 EPA could develop only qualitative exposure characterizations with relative ranking of low, 

1840 medium or high for characterizing potential exposures to various populations. While the 

1841 usefulness of these data was limited because data were only partially reported (see Unit III.G.), it 

1842 was also limited because the specific data elements, as included in the 2006 IUR, were not 

1843 detailed and comprehensive enough to enable EPA to generate a more robust estimate. For 

1844 instance, the function and use categories used for processing and use information were broad, 

1845 and the reported production volume information was insufficient to identify the volumes of 

1846 chemical used at the manufacturing site or domestically processed or used. The Agency believes 

1847 the proposed rule text changes will improve its ability to identify and manage risks associated 

1848 with existing chemicals, but also believes that supplementary, more in-depth exposure-related 

1849 information (i.e., beyond the elements under the rule text currently accompanying this proposal) 

1850 would substantially improve EPA’s ability to quantify chemical risks. The ability to quantify 

1851 chemical risks would further improve the Agency’s ability to identify and manage those risks. 

1852 EPA therefore believes that, while the changes included in the proposed regulatory text address 

1853 the limitations associated with qualitative characterizations, further changes would be needed to 

1854 enable the more quantitative estimates. 
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1855 

1856 If additional data identified below were to be reported, EPA could use currently available 

1857 assessment tools and methodologies to develop screening-level estimates of chemical 

1858 environmental releases and concentrations to various environmental media (including air, water, 

1859 and land) and exposures to the potentially exposed populations (such as workers, consumers, 

1860 children, and the general population). Examples of the tools and methodologies include the 

1861 Agency's Chemical Screening Tool For Exposures & Environmental Releases (ChemSTEER) 

1862 (Ref. 14) and Exposure and Fate Assessment Screening Tool (EFAST) (Ref. 15). The Agency 

1863 anticipates that the improved screening-level exposure assessments would be similar to what is 

1864 developed for new chemical substances submitted to the Agency for review to identify chemicals 

1865 of concern and potential risk management. The Pre-Manufacturing Notice (PMN) Program 

1866 Form 7710-25 (available at: http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm) was 

1867 used to develop the following list of additional potential exposure-related data elements and their 

1868 brief descriptions: 

1869 

1870 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 

(hours/day). 

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 
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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. 

1871 

1872 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. 

1873 

1874 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 

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 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) For each release, provide the quantity (in pounds) of chemical 
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directly to the environment or b) 

into control technology to the 

environment 

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. 

1875 

1876 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 

controlled by manufacturer 

Indicate whether the sites at which the chemical is processed 

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 
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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. 

1877 

1878 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. 

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. 

1879 

1880 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 media (air, liquid or aqueous 
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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. 

1881 

1882 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 

commercial workers 

Indicate the number of workers in commercial establishments 

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. 

1883 

1884 Consumer Use and Exposure: 

Description of consumer use Describe the consumer use(s) of products containing the 

chemical substance. 

Function of chemical in Describe the function of the chemical in the consumer 
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consumer product 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. 

1885 

1886 EPA is soliciting comment on the data elements identified above. Collecting these data 

1887 would enable the Agency to develop more comprehensive and complete screening assessments 

1888 of the exposures that may be encountered during the manufacture, processing, and use of 

1889 chemicals. The Agency also is interested in whether any additional data elements should be 

1890 collected, and in any other considerations relating to the collection of additional data. Because 

1891 these data elements are based on the data elements included in a PMN submission, EPA believes 

1892 the burden a site would incur to provide these data would be similar to the burden incurred for a 

1893 site to develop a PMN submission. (Ref. 11) 

1894 

1895 EPA is also soliciting comment on the best method to collect these data. The Agency is 

1896 considering three approaches to collect these data from known manufacturers (including 

1897 importers). These approaches are: integrating these data elements into the IUR, promulgating a 

1898 new reporting mechanism under TSCA section 8(a), or using TSCA section 11(c) subpoena 

1899 authority. Integrating these data elements into the IUR would provide a more complete set of 

1900 data, enabling the Agency to identify proactively potential exposure-based chemical risk 

1901 management issues and to provide the public access to an enhanced database. The Agency is 

1902 also soliciting comment on the appropriate scope of an IUR requirement to report these data 

1903 elements. For instance, the scope could be based on chemical identity, and the Agency could 

1904 provide a list of chemicals for which these data would be reported. Alternatively, the scope 

1905 could be based on production volume, and the Agency could identify the production volume 

1906 range for which these data would be reported. 

1907 

1908 As a second option, the Agency is considering promulgating a new reporting mechanism 

1909 under TSCA section 8(a) that would enable the collection of enhanced exposure-related data, 

1910 described in this section, for about 100 chemical substances per year. For instance, EPA could 

1911 notify manufacturers (including importers) of the need to submit additional information, e.g., via 

1912 a Federal Register notice or individually via U.S. mail, with details on the data to report and the 

1913 reporting criteria. (See Ref. 11 for burden and cost information.) This approach would enable 

1914 the Agency to target the collection to those chemicals of current priority for screening-level 

1915 assessment. The Agency also solicits comment on the need to establish a complementing 

1916 recordkeeping requirement. Such a recordkeeping requirement would ensure that the additional 
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1917 data subject to the new reporting mechanism would be more quickly available at the time that 

1918 EPA requested them. However, without advance notice regarding the specific chemicals for 

1919 which information would be required, manufacturers (including importers) of all chemicals 

1920 subject to the IUR would be required to maintain the records. 

1921 

1922 As a third option, EPA considering the use of TSCA section 11(c) subpoena authority to 

1923 collect enhanced exposure-related data. TSCA section 11(c) gives the Agency broad authority to 

1924 collect information for regulatory purposes and would, therefore, allow EPA to require, by 

1925 subpoena, the submission of the enhanced exposure-related data. Among the circumstances in 

1926 which the Agency is considering exercising this subpoena authority are those in which the 

1927 enhanced data elements are not available through other means and are necessary for a more 

1928 effective screening level review of chemical substances on a case by case basis. 

1929 

1930 4) EPA is considering collecting exposure-related information from processors in addition to 

1931 collecting the data from manufacturers. 

1932 

1933 Currently, only manufacturers (including importers) are responsible for providing 

1934 information required by the IUR rule. TSCA section 8(a) enables the Agency also to collect 

1935 information from processors. EPA seeks comment on also requiring processors to report 

1936 processing and use data under the three data collection approaches described above (i.e., by 

1937 modification of the IUR rule, via notification issued under a new data reporting mechanism, or 

1938 using existing subpoena authority). (See Ref. 11 for burden and cost information.) The Agency 

1939 believes that processors may be more familiar with the processing and use of the chemicals than 

1940 manufacturers, and therefore may be able to provide more complete and accurate exposure1941 related data. 

1942 

1943 VI. References

1944 

1945 As indicated under ADDRESSES, a docket has been established for this rulemaking 

1946 under docket ID number EPA-HQ-OPPT-2009-0187. The following is a listing of the 

1947 documents that are specifically referenced in this document. The docket includes these 

1948 documents and other information considered by EPA in developing this proposed rule, including 

1949 documents that are referenced within the documents that are included in the docket, even if the 

1950 referenced document is not physically located in the docket. For assistance in locating these 

1951 other documents, please consult the technical contact listed under FOR FURTHER 

1952 INFORMATION CONTACT. 

1953 

1954 1. U.S. EPA, Memorandum to EPA Employees from Lisa P. Jackson, Administrator, 

1955 January 23, 2009, Located at: 

1956 http://www.epa.gov/administrator/memotoemployees.html. 

1957 

1958 2. U.S. EPA, “Draft Instructions for 2011 Inventory Update Reporting,” October 2009. 

1959 

1960 3. U.S. EPA, “IUR Modifications Rule: Development of Definitions for proposed 40 CFR 

1961 711.3,” OPPT, August 2009. 

1962 

1963 4. U.S. EPA, “Electronic Signature Agreement,” OPPT, August 2009. 

1964 
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1965 5. U.S. EPA, “Development of CDX Workflow for Electronic Toxic Substances Control 

1966 Act (eTSCA) Submissions: Draft User Guide” (Version 1.0), CDX, November13, 2008. 

1967 

1968 6. American Petroleum Institute, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785; 

1969 EPA-HQ-OPPT-2008-0807 from Howard J. Feldman, December 8, 2008. 

1970 

1971 7. Proctor & Gamble, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785, from Julie 

1972 Froelicher, January 23, 2009. 

1973 

1974 8. Synthetic Organic Chemical Manufacturers Association, Comments submitted to Docket 

1975 ID No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009. 

1976 

1977 9. U.S. EPA, “Inventory Update Reporting (IUR) Technical Support Document – 

1978 Replacement of 5-digit NAICS Codes with Industrial Sectors.” OPPT/EETD, August 

1979 2009. 

1980 

1981 10. U.S. EPA, “2006 Inventory Update Reporting: Data Summary,” OPPT, EPA report 

1982 number 740S08001, December 2008. Located at: 

1983 http://www.epa.gov/opptintr/iur/pubs/2006_data_summary.pdf. 

1984 

1985 11. U.S. EPA, “Draft Economic Analysis for the Proposed IUR Modifications Rule,” 

1986 OPPT/EETD, January 2010. 

1987 

1988 12. U.S. EPA, “Addendum to Information Collection Request 1884.04,” OMB control 

1989 number 2070-0162, OPPT, September 2009. 

1990 

1991 13. U.S. EPA/Environment Canada/Health Canada, “Overview of Harmonized U.S.-Canada 

1992 Industrial Function and Consumer and Commercial Product Codes for Chemical 

1993 Inventory Reporting,” September 2009. 

1994 

1995 14. U.S. EPA, “Chemical Screening Tool For Exposures & Environmental Releases.” 

1996 Located at: http://www.epa.gov/oppt/exposure/pubs/chemsteer.htm, September 2009. 

1997 

1998 15. U.S. EPA, “Exposure and Fate Assessment Screening Tool.” Located at: 

1999 http://www.epa.gov/oppt/exposure/pubs/efast.htm, September 2009. 

2000 

2001 VII. Statutory and Executive Order Reviews 

2002 A. Regulatory Review 

2003 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

2004 October 4, 1993), this action has been designated a “significant regulatory action” by the Office 

2005 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 

2006 under Executive Order 12866 and any changes made in response to OMB recommendations have 

2007 been documented in the docket for this action. 

2008 

2009 In addition, EPA has prepared an economic analysis of the potential impacts associated 

2010 with this action. A copy of this economic analysis, entitled, Draft Economic Analysis for the 

2011 Proposed Inventory Update Reporting (IUR) Modifications Rule (Ref. 11), is available in the 
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2012 docket and is briefly summarized in this Unit of the preamble. The amendments in this proposal 

2013 affect the number of reports submitted during a submission period, the burden to prepare a 

2014 report, and the reporting frequency. EPA estimates that the combined impact of all the proposed 

2015 amendments will increase the total burden and cost to industry associated with IUR reporting. 

2016 

2017 In its economic analysis, EPA estimated industry cost and burden on a per-report and a 

2018 per-site basis and at the industry level. Industry cost and burden are incurred by performing 

2019 activities to comply with the proposed amendments, including compliance determination, rule 

2020 familiarization, preparation and submission of reports, and recordkeeping. 

2021 

2022 On a per-report basis, EPA estimated incremental increases of 5.2 hours and $410 for a 

2023 site to complete a partial report for one chemical and 18.3 hours and $1,468 to complete a full 

2024 report for one chemical, in the first submission cycle after the effective date of the proposed rule 

2025 amendments. A partial report includes Parts I and II of Form U. A full report includes Parts I, II 

2026 and III of Form U. For future submission cycles, EPA estimated incremental increases of 3.4 

2027 hours and $284 for a site to complete a partial report for one chemical and 13.1 hours and $1,084 

2028 to complete a full report for one chemical. 

2029 

2030 As a result of the proposed amendments, EPA estimates that the average site will submit 

2031 approximately 2.01 fewer partial reports and 2.98 more full reports in a submission period. For 

2032 the average site, this will increase the burden by 342 hours during the first submission cycle and 

2033 264 hours for all subsequent submission cycles. EPA estimates that the average site will incur a 

2034 net cost increase of $22,553 during the first submission cycle and $17,526 during all future 

2035 submission cycles. 

2036 

2037 At the industry level for all sites submitting a Form U, EPA estimates a net total burden 

2038 increase of 1.56 million hours in the first submission year, and 1.21 million hours for all 

2039 subsequent submission years. EPA estimates a net cost increase of $103.70 million in the first 

2040 submission cycle of the rule, and $79.31 million in all subsequent submission cycles. When the 

2041 submission cycle costs, which would be incurred once every four years under the proposed rule, 

2042 are spread over the proposed four-year reporting cycle, the average annualized increase in 

2043 industry cost attributable to the proposed amendments is approximately $26.27 million over a 

2044 20-year period (at a 3% discount rate). 

2045 

2046 EPA estimates that the Agency will experience a reduction in both burden and cost to 

2047 administer the IUR rule as a result of the proposed amendments. Specifically, EPA expects to 

2048 experience a net burden reduction of 1,704 hours in the first submission cycle and all subsequent 

2049 submission cycles. The Agency estimates it will experience a net savings of $177,683 during 

2050 each submission cycle. This information will be reflected in the Information Collection Request 

2051 (ICR) that is submitted every three years to OMB under the Paperwork Reduction Act (PRA), 44 

2052 U.S.C. 3501 et seq. 

2053 B. Paperwork Reduction Act 

2054 

2055 The information collection requirements in 40 CFR part 710 related to the submission of 

2056 Form Us are already approved by OMB under the PRA. That ICR has been assigned EPA ICR 

2057 No. 1884 and OMB control No. 2070-0162. Because this rule involves new or revised 

2058 information collection activities that require additional OMB approval, EPA has prepared an 
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2059 addendum to the currently approved ICR (Ref. 12). An agency may not conduct or sponsor, and 

2060 a person is not required to respond to an information collection request subject to the PRA unless 

2061 it displays a currently valid OMB control number. The OMB control numbers for EPA’s 

2062 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 

2063 the form or survey). 

2064 

2065 Under the PRA, the term “burden” is interpreted as the total time, effort, or financial 

2066 resources expended by people to generate, maintain, retain, disclose, or provide information to or 

2067 for a federal agency. This includes the time needed by regulated entities to review instructions 

2068 and to develop, acquire, install, and use technology and systems to collect, validate, verify, and 

2069 disclose information. Time taken to adjust existing ways to comply with any previously 

2070 applicable instructions and requirements and to train personnel to respond to the information 

2071 collection task is also included. In this analysis, total industry burden hours represent the sum of 

2072 time spent on reporting and on other administrative activities. Industry respondents will spend 

2073 time on the following activities associated with the IUR rule: compliance determination, rule 

2074 familiarization, preparation and submission of reports, and recordkeeping. 

2075 As presented in the economic analysis (Ref. 11) and the addendum ICR (Ref. 12), EPA 

2076 estimates that the proposed rule would create a total incremental industry burden of 1.56 million 

2077 hours, if all proposed amendments are finalized as proposed. The burden for a site to complete a 

2078 full report for IUR for one chemical is estimated to be 141.33 hours, which is an incremental 

2079 burden increase of 18.33 hours over the current estimated burden. The burden for a site to 

2080 complete a partial report for IUR for one chemical is estimated to be 58.31 hours, which is an 

2081 incremental burden increase of 5.23 hours over the current estimated burden. For future 

2082 reporting cycles, the burden for a full report is estimated to be 95.17 hours, which is an 

2083 incremental increase of 13.11 hours over the current estimated future burden and for a partial 

2084 report is estimated to be 29.54 hours, which is an incremental increase of 3.41 hours over the 

2085 current estimate. 

2086 

2087 To comment on the Agency's need for this information, the accuracy of the provided 

2088 burden estimates, and any suggested methods for minimizing respondent burden, EPA has 

2089 established a docket for this proposed rule, which includes this ICR, under docket ID number 

2090 EPA-HQ-OPPT-2009-0187. Submit any comments related to the ICR to EPA and OMB. See 

2091 ADDRESSES for where to submit comments to EPA. Send comments to OMB at the Office of 

2092 Information and Regulatory Affairs, Office of Management and Budget, 725 17th St, N.W., 

2093 Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is required to make a 

2094 decision concerning the ICR between 30 and 60 days after [insert date of publication in the

2095 Federal Register], a comment to OMB is best assured of having its full effect if OMB receives 

2096 it by [Insert date 30 days after publication in the Federal Register]. The final rule will respond 

2097 to any OMB or public comments on the information collection requirements contained in this 

2098 proposed rule. 

2099 

2100 C. Small Entity Impacts 

2101 

2102 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 

2103 the Agency hereby certifies that this action will not have a significant adverse economic impact 

2104 on a substantial number of small entities. The Agency’s basis is briefly summarized here and is 

2105 detailed in the economic analysis (Ref. 11). 

2106 
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2107 Under the RFA, small entities include small businesses, small organizations, and small 

2108 governmental jurisdictions. For purposes of assessing the impacts of today's rule on small 

2109 entities, small entity is defined as: (1) a small business, as defined by the Small Business 

2110 Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction 

2111 that is a government of a city, county, town, school district or special district with a population of 

2112 less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is 

2113 independently owned and operated and is not dominant in its field. Since the regulated 

2114 community does not include small governmental jurisdictions or small not-for-profit 

2115 organizations, the analysis focuses on small businesses. 

2116 

2117 The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 

2118 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and 

2119 less than 100,000 lb. production of any given chemical at a site; or annual sales of less than $4 

2120 million. This exemption is maintained in the proposed amendments. A small business would be 

2121 required to report under the proposed rule, however, if it produces any chemical substance that is 

2122 the subject of a regulation proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that 

2123 is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been 

2124 granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report 

2125 voluntarily. 

2126 

2127 EPA analyzed potential small business impacts from this rule using both the SBA 

2128 employee size standards and the TSCA sales-based definition of small business. EPA estimates 

2129 that 503 small firms potentially would be affected by this proposed rule using the employment2130 based definition, and 280 small firms potentially would be affected using the sales-based 

2131 definition. Based on costs annualized over a four-year period and average sales data for the 

2132 parent companies, EPA estimated that the cost-to-sales ratio of the proposed rule would be less 

2133 than 0.1 percent for an average small company subject to the rule. For a company to have a cost2134 to-sales ratio larger than one percent, company sales would have to be less than $1.25 million. 

2135 Because the small businesses affected by the proposed rule have average sales of more than 

2136 $412.7 million under the employment-based definition, and $11.8 million under the sales-based 

2137 definition, small entities will not be affected by the proposed amendments to the IUR rule at a 

2138 cost-to-sales ratio of greater than one percent (Ref. 11). 

2139 EPA continues to be interested in the potential impacts of this proposed rule on small 

2140 entities and welcomes comments on issues related to such impacts. 

2141 

2142 D. Unfunded Mandates 

2143 

2144 This action does not contain any Federal mandates for State, local, or tribal governments 

2145 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 

2146 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in 

2147 annual expenditures of $100 million or more for State, local, and tribal governments, in the 

2148 aggregate, or for the private sector. The analysis of the costs associated with this action are 

2149 briefly described in Unit VII.A., and is contained in the economic analysis (Ref. 11). 

2150 

2151 Based on EPA's past experience, State, local, and tribal governments have not been 

2152 affected by this reporting requirement, and EPA does not have any reason to believe that any 

2153 State, local, or tribal government will be affected by this rulemaking. As such, EPA has 

2154 determined that this regulatory action does not impose any enforceable duty, contain any 
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2155 unfunded mandate, or otherwise have any affect on small governments. Accordingly, this rule is 

2156 not subject to the requirements of sections 202, 203 or 205 of UMRA. 

2157 E. Federalism 

2158 

2159 Pursuant to Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 

2160 1999), EPA has determined that this proposed rule does not have federalism implications 

2161 because it will not have substantial direct effects on the states, on the relationship between the 

2162 national government and the states, or on the distribution of power and responsibilities among 

2163 the various levels of government, as specified in the Order. This rule simply amends the 

2164 Inventory Update Reporting rule in several ways to provide information to better address Agency 

2165 and public information needs, improve the usability and reliability of the reported data, and 

2166 ensure that data are available in a timely manner. Because EPA has no information to indicate 

2167 that any state or local government manufactures or processes the chemical substances covered by 

2168 this action, the proposed rule does not apply directly to states and localities and will not affect 

2169 state and local governments. Thus, Executive Order 13132 does not apply to the proposed rule. 

2170 

2171 F. Tribal Implications 

2172 

2173 As required by Executive Order 13175, entitled Consultation and Coordination with 

2174 Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 

2175 proposed rule does not have tribal implications because it will not have any affect on tribal 

2176 governments, on the relationship between the Federal government and the Indian tribes, or on the 

2177 distribution of power and responsibilities between the Federal government and Indian tribes, as 

2178 specified in the Order. Thus, Executive Order 13175 does not apply to this rule. 

2179 

2180 G. Children’s Health 

2181 

2182 EPA interprets Executive Order 13045, entitled Protection of Children from 

2183 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 

2184 those regulatory actions that concern health or safety risks, such that the analysis required under 

2185 section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action

2186 is not subject to Executive Order 13045 because it does not establish an environmental standard 

2187 intended to mitigate health or safety risks. Nevertheless, the information obtained by the 

2188 reporting required by this rule will be used to inform the Agency’s decision-making process 

2189 regarding chemicals to which children may be disproportionately exposed. This information will 

2190 also assist the Agency and others in determining whether the chemicals in this proposed rule 

2191 present potential risks, allowing the Agency and others to take appropriate action to investigate 

2192 and mitigate those risks.

2193 H. Energy Effects 

2194 

2195 This action is not a “significant energy action” as defined in Executive Order 13211, 

2196 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

2197 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 

2198 the supply, distribution, or use of energy as described in the Order. 

2199 
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2200 I. Technical Standards 

2201 

2202 Since this action does not involve any technical standards, section 12(d) of the National 

2203 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 

2204 12(d) (15 U.S.C. 272 note), does not apply to this action. 

2205 J. Environmental Justice 

2206 

2207 The proposed rule does not have an adverse impact on the environmental and health 

2208 conditions in low-income and minority communities that require special consideration by the 

2209 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 

2210 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

2211 The Agency believes that the information collected under this proposed rule, if finalized, will 

2212 assist EPA and others in determining the potential hazards and risks associated with the 

2213 chemicals covered by the rule. Because the IUR rule is an information collection requirement, 

2214 the information that will become available through the rule will enable the Agency to target 

2215 educational, regulatory, or enforcement activities towards industries or chemicals that pose the 

2216 greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the 

2217 information to be gathered under the rule will help EPA make decisions that will benefit 

2218 potentially at-risk communities, some of which may be disadvantaged. 

2219 The proposed rule is directed at manufacturers or importers of chemicals. All consumers 

2220 of these chemical products and all workers who come into contact with these chemicals could 

2221 benefit if data regarding the chemicals’ health and environmental effects were developed. 

2222 Therefore, it does not appear that the costs and the benefits of the proposed rule will be 

2223 disproportionately distributed across different geographic regions or among different categories 

2224 of individuals. 

2225 List of Subjects in 40 CFR part 704 

2226 

2227 Environmental protection, Chemicals, Chemical Substance, Confidential business 

2228 information, Hazardous substances, Imports, Reporting and recordkeeping requirements. 

2229 List of Subjects in 40 CFR part 710 

2230 

2231 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 

2232 Reporting and recordkeeping requirements. 

2233 List of Subjects in 40 CFR part 711 

2234 

2235 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 

2236 Reporting and recordkeeping requirements. 

2237 Dated: ________ 

2238 

2239 ________________ 

2240 Assistant Administrator for Prevention, Pesticides and Toxic Substances. 
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2241 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 

2242 PART 704--[AMENDED] 

2243  1. Part 704 is amended as follows: 

2244  a. The authority citation for part 704 would continue to read as follows: 

2245 Authority: 15 U.S.C. 2607(a) 

2246 

2247  b. Section 704.3 is amended by removing the phrase “(as defined in 19 CFR 1.11)” in the 

2248 definition for importer. 

2249 PART 710--[AMENDED] 

2250  2. Part 710 is amended as follows: 

2251  a. The authority citation for part 710 would continue to read as follows: 

2252 Authority: 15 U.S.C. 2607(a) 

2253 

2254  b. By revising the heading for part 710 to read: 

2255 

2256 “Part 710—Compilation of the TSCA Chemical Inventory” 

2257 

2258  c. By removing the heading for “Subpart A”. 

2259 

2260  d. By removing the term “subpart” and in its place add the term “part” everywhere it appears 

2261 in §§ 710.1, 710.3 and 710.4. 

2262 

2263  e. In § 710.1(b), by removing the text “The Inventory Update regulations were amended in 

2264 2002...The Agency intends to remove subpart B from the CFR once the 2002 update is 

2265 complete.” 

2266 

2267  f. Section 710.3 is amended as follows: 

2268 

2269 (i) By replacing the introductory text with the phrase “For purposes of this part:” 

2270 (ii) By removing the phrase “(as defined in 19 CFR 1.11)” in the definition for importer.

2271 (iii) By removing the definition for non-isolated intermediate. 

2272  g. By removing Subpart B, consisting of §§ 710.23 - 710.39 and Subpart C, consisting of §§ 

2273 710.43 - 710.59. 

2274 

2275  3. A new part 711 is added to read as follows: 

2276 

2277 PART 711 – TSCA INVENTORY UPDATE REPORTING REQUIREMENTS 

2278 

2279 Sec. 
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2280 § 711.1 Scope and compliance. 

2281 § 711.3 Definitions. 

2282 § 711.5 Chemical substances for which information must be reported. 

2283 § 711.6 Chemical substances for which information is not required. 

2284 § 711.8 Persons who must report. 

2285 § 711.9 Persons not subject to this part. 

2286 § 711.10 Activities for which reporting is not required. 

2287 § 711.12 Reporting information to EPA. 

2288 § 711.13 When to report. 

2289 § 711.15 Duplicative reporting. 

2290 § 711.17 Recordkeeping requirements. 

2291 § 711.18 Confidentiality. 

2292 § 711.19 General. 

2293 

2294 Authority: 15 U.S.C. 2607(a). 

2295 

2296 § 711.1 Scope and compliance.

2297 (a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic 

2298 Substances Control Act (15 U.S.C. 2607(a)) (TSCA) for certain manufacturers (including 

2299 importers) of chemical substances. Section 8(a) authorizes the Administrator to require reporting 

2300 of information necessary for administration of the Act, including issuing regulations for the 

2301 purpose of compiling and keeping current the Inventory of chemical substances manufactured or 

2302 processed in the United States as required by section 8(b) of the Act. In accordance with section 

2303 8(b), EPA amends the Inventory to include new chemical substances manufactured (including 

2304 imported) in the United States and reported under section 5(a)(1) of the Act. EPA also revises 

2305 the categories of chemical substances and makes other amendments as appropriate. 

2306 (b) The regulations in this part apply to the activities associated with the periodic update of 

2307 information on a subset of the chemical substances included on the Inventory. 

2308 (c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit 

2309 information required under these reporting regulations. In addition, section 15(3) makes it 

2310 unlawful for any person to fail to keep, and permit access to, records required by these 

2311 regulations. Section 16 provides that any person who violates a provision of section 15 is liable 

2312 to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, 

2313 the Government may seek judicial relief to compel submission of section 8(a) information and to 

2314 otherwise restrain any violation of section 15. (EPA does not intend to concentrate its 

2315 enforcement efforts on insignificant clerical errors in reporting.) 

2316 (d) Each person who reports under these regulations must maintain records that document 

2317 information reported under these regulations and, in accordance with the Act, permit access to, 

2318 and the copying of, such records by EPA officials. 

2319 § 711.3 Definitions. 

2320 

2321 All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following 

2322 definitions and the definitions found in § 704.3 of this chapter (except as modified by the 
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2323 following definitions) apply to this part:

2324 Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. 

2325 CDX or Central Data Exchange means EPA's centralized electronic document receiving system, 

2326 or its successors, including associated instructions for registering to submit electronic 

2327 documents. 

2328 Commercial use means the use of a chemical substance or a mixture containing a chemical 

2329 substance (including as part of an article) in a commercial enterprise providing saleable goods or 

2330 services. 

2331 Consumer use means the use of a chemical substance or a mixture containing a chemical 

2332 substance (including as part of an article) when sold to or made available to consumers for their 

2333 use. 

2334 e-IUR means the electronic-IUR software provided by EPA for the completion and submission 

2335 of the IUR Form U report. 

2336 

2337 Industrial function means the intended physical or chemical characteristic for which a chemical 

2338 substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, 

2339 reaction product, or article; repackaged; or used. 

2340 

2341 Industrial use means use at a site at which one or more chemical substances or mixtures are 

2342 manufactured (including imported) or processed. 

2343 

2344 Intended for use by children means the chemical substance or mixture is used in or on a product 

2345 that is specifically intended for use by children age 14 or younger. A chemical substance or 

2346 mixture is intended for use by children when the submitter answers “yes” to at least one of the 

2347 following questions for the product into which the submitter's chemical substance or mixture is 

2348 incorporated: 

2349 

2350 (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended 

2351 for children age 14 or younger? 

2352 

2353 (2) Does the manufacturer of the product state through product labeling or other written 

2354 materials that the product is intended for or will be used by children age 14 or younger? 

2355 

2356 (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 

2357 younger? 

2358 Manufacture means to manufacture, produce, or import for commercial purposes. Manufacture 

2359 includes the extraction, for commercial purposes, of a component chemical substance from an 

2360 already existing chemical substance or complex combination of substances. The manufacture of 

2361 a chemical substance by a manufacturer is also the manufacture of a chemical substance by a 

2362 person who contracts for such manufacturing, where (1) the manufacturer manufactures or 

2363 produces the substance exclusively for that person, and (2) that person specifies the identity of 
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2364 the substance and controls the total amount produced and the basic technology for the plant 

2365 process. 

2366 Manufacturer means a person who manufactures a chemical substance. 

2367 

2368 Master Inventory File means EPA's comprehensive list of chemical substances which constitute 

2369 the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes 

2370 substances reported under part 710 of this chapter and substances reported under part 720 of this 

2371 chapter for which a Notice of Commencement of Manufacture or Import has been received under 

2372 §720.120 of this chapter. 

2373 Principal reporting year means the calendar year in which manufacturing, processing, and use 

2374 activities associated with the data reported to EPA during an IUR submission period occur. 

2375 Production volume for manufacturing activities in other years of the reporting cycle may also be 

2376 reportable during the submission period, but full manufacturing, processing, and use data are 

2377 reported only for activities during the principal reporting year. 

2378 Reasonably likely to be exposed means an exposure to a chemical substance which, under 

2379 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 

2380 or use of the chemical substance, is more likely to occur than not to occur. Such exposures would 

2381 normally include, but would not be limited to, activities such as charging reactor vessels, 

2382 drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and 

2383 transfers, and analytical operations. Covered exposures include exposures through any route of 

2384 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical 

2385 exposures. 

2386 

2387 Repackaging means the physical transfer of a chemical substance or mixture, as is, from one 

2388 container to another container or containers in preparation for distribution of the chemical 

2389 substance or mixture in commerce. 

2390 

2391 Reportable chemical substance means a chemical substance described in §711.5. 

2392 Site means a contiguous property unit. Property divided only by a public right-of-way shall be 

2393 considered one site. More than one plant may be located on a single site. 

2394 (a) For substances manufactured under contract, i.e., by a toll manufacturer, the site is the 

2395 location where the chemical substance is physically manufactured. 

2396 

2397 (b)The site for an importer who imports a chemical substance described in §711.5 is the 

2398 U.S. site of the operating unit within the person's organization that is directly responsible 

2399 for importing the substance. The import site, in some cases, may be the organization's 

2400 headquarters in the United States. If there is no such operating unit or headquarters in the 

2401 United States, the site address for the importer is the U.S. address of an agent acting on 

2402 behalf of the importer who is authorized to accept service of process for the importer. 

2403 (c) For portable manufacturing units sent out to different locations from a single 

2404 distribution center, the distribution center shall be considered the site. 
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2405 Site-limited means a chemical substance is manufactured and processed only within a site and is 

2406 not distributed for commercial purposes as a substance or as part of a mixture or article outside 

2407 the site. Imported substances are never site-limited. Although a site-limited chemical substance is 

2408 not distributed for commercial purposes outside the site at which it is manufactured and 

2409 processed, the substance is considered to have been manufactured and processed for commercial 

2410 purposes. 

2411 Submission period means the period in which the manufacturing, processing, and use data are 

2412 submitted to EPA. 

2413 Use means any utilization of a chemical substance or mixture that is not otherwise covered by 

2414 the terms manufacture or process. Relabeling or redistributing a container holding a chemical 

2415 substance or mixture where no repackaging of the chemical substance or mixture occurs does not 

2416 constitute use or processing of the chemical substance or mixture. 

2417 § 711.5 Chemical substances for which information must be reported. 

2418 

2419 Any chemical substance which is in the Master Inventory File at the beginning of a submission 

2420 period described in §711.13, unless the chemical substance is specifically excluded by §711.6. 

2421 § 711.6 Chemical substances for which information is not required. 

2422 The following groups or categories of chemical substances are exempted from some or all of the 

2423 reporting requirements of this part, with the following exception: A chemical substance 

2424 described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of 

2425 the reporting requirements of this part if that substance is the subject of a rule proposed or 

2426 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 

2427 agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order 

2428 issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under 

2429 a civil action under section 5 or 7 of the Act. 

2430 (a) Full exemptions. The following categories of chemical substances are exempted from the 

2431 reporting requirements of this subpart. 

2432 (1) Polymers. (i) Any chemical substance described with the word fragments “*polym*”, 

2433 “*alkyd”, or “*oxylated” in the Chemical Abstracts (CA) Index Name in the Master Inventory 

2434 File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may 

2435 precede, or follow, the character string defined. 

2436 (ii) Any chemical substance which is identified in the Master Inventory File as siloxane and 

2437 silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a 

2438 polysaccharide (starch, cellulose, gum), rubber, or lignin. 

2439 

2440 (iii) This exclusion does not apply to a polymeric substance that has been hydrolyzed, 

2441 depolymerized, or otherwise chemically modified, except in cases where the intended product of 

2442 this reaction is totally polymeric in structure. 

2443 

2444 (2) Microorganisms. Any combination of chemical substances that is a living organism, and that 
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2445 meets the definition of “microorganism” at §725.3 of this chapter. Any chemical substance 

2446 produced from a living microorganism is reportable under this subpart unless otherwise 

2447 excluded. 

2448 

2449 (3) Naturally occurring chemical substances. Any naturally occurring chemical substance, as 

2450 described in §710.4(b). The applicability of this exclusion is determined in each case by the 

2451 specific activities of the person who manufactures the substance in question. Some chemical 

2452 substances can be manufactured both as described in §710.4(b) and by means other than those 

2453 described in §710.4(b). If a person described in §711.8 manufactures a chemical substance by 

2454 means other than those described in §710.4(b), the person must report regardless of whether the 

2455 substance also could have been produced as described in §710.4(b). Any chemical substance that 

2456 is produced from such a naturally occurring chemical substance described in §710.4(b) is 

2457 reportable unless otherwise excluded. 

2458 (4) Certain forms of natural gas and water. Chemical substances with the following Chemical 

2459 Abstract Service (CAS) Registry Numbers: CASRN 64741–48–6, Natural gas (petroleum), raw 

2460 liq. mix; CASRN 68919–39–1, Natural gas condensates; CASRN 8006–61–9, Gasoline, natural; 

2461 CASRN 68425–31–0, Gasoline (natural gas), natural; CASRN 8006–14–2, Natural gas; CASRN 

2462 68410–63–9, Natural gas, dried; and CASRN 7732-18-5, Water. 

2463 (b) Partial exemptions. The following groups of chemical substances are partially exempted 

2464 from the reporting requirements of this part (i.e., the information described in §711.12(c)(4) need 

2465 not be reported for these substances). Such chemical substances are not excluded from the other 

2466 reporting requirements under this part. 

2467 

2468 (1) Petroleum process streams. EPA has designated the following chemical substances, listed by 

2469 CAS Number, as partially exempt from reporting under the IUR. 

2470 

2471 CAS Numbers of Partially Exempt Chemical Substances Termed “Petroleum Process 

2472 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. 

2473 

2474 (2) Specific exempted chemical substances —(i) Exemption. EPA has determined that, at this 

2475 time, the information in §711.12(c)(4) associated with the chemicals listed in paragraph 

2476 (b)(2)(iv) of this section is of low current interest. 

2477 

2478 (ii) Considerations. In making its determination of whether this partial exemption should apply 

2479 to a particular chemical substance, EPA will consider the totality of information available for the 

2480 chemical substance in question, including but not limited to, one or more of the following 

2481 considerations: 

2482 

2483 (A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of 

2484 the information described in §711.12(c)(4) (i.e., at least one site manufactures 300,000 pounds or 
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2485 more of the chemical). 

2486 

2487 (B) The chemical substance's chemical and physical properties or potential for persistence, 

2488 bioaccumulation, health effects, or environmental effects (considered independently or together). 

2489 

2490 (C) The information needs of EPA, other federal agencies, tribes, states, and local governments, 

2491 as well as members of the public. 

2492 

2493 (D) The availability of other complementary risk screening information. 

2494 

2495 (E) The availability of comparable processing and use information. 

2496 

2497 (F) Whether the potential risks of the chemical substance are adequately managed. 

2498 

2499 (iii) Amendments. EPA may amend the chemical list in paragraph (b)(2)(iv) of this section on its 

2500 own initiative or in response to a request from the public based on EPA's determination of 

2501 whether the information in §711.12(c)(4) is of low interest. 

2502 

2503 (A) Any person may request that EPA amend the chemical list in paragraph (b)(2)(iv) of this 

2504 section. Your request must be in writing and must be submitted to the address provided in 

2505 §711.19(d). Requests must identify the chemical in question, as well as its CAS number or other 

2506 chemical identification number as identified in §711.12(c)(3)(i), and must contain a written 

2507 rationale for the request that provides sufficient specific information, addressing the 

2508 considerations listed in §711.6(b)(2)(ii), including cites and relevant documents, to demonstrate 

2509 to EPA that the collection of the information in §711.12(c)(4) for the chemical in question either 

2510 is or is not of low current interest. If a request related to a particular chemical is resubmitted, any 

2511 subsequent request must clearly identify new information contained in the request. EPA may 

2512 request other information that it believes necessary to evaluate the request. EPA will issue a 

2513 written response to each request within 120 days of receipt of the request, and will maintain 

2514 copies of these responses in a public docket that will be established for each reporting cycle. 

2515 

2516 (B) As needed, the Agency will initiate rulemaking to make revisions to the list in paragraph 

2517 (b)(2)(iv) of this section. 

2518 

2519 (C) To assist EPA in reaching a decision regarding a particular request prior to a given principal 

2520 reporting year, requests must be submitted to EPA no later than 12 months prior to the start of 

2521 the next principal reporting year. 

2522 

2523 (iv) List of chemical substances. EPA has designated the following chemical substances, listed 

2524 by CAS Number, as partially exempt from reporting under the IUR. 

2525 

2526 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 

56–81–5 1,2,3-Propanetriol 

56–87–1 L-Lysine 

57–50–1 .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl 
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CAS No. Chemical 

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 

61789–44–4 Fatty acids, castor-oil 

61789–97–7 Tallow 

61789–99–9 Lard 
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CAS No. Chemical 

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. 

2527 

2528 § 711.8 Persons who must report. 

2529 

2530 Except as provided in §§711.9 and 711.10, the following persons are subject to the requirements 

2531 of this subpart. Persons must determine whether they must report under this section for each 

2532 chemical substance that they manufacture (including import) at an individual site. 

2533 

2534 (a) Persons subject to recurring reporting. Any person who manufactured (including imported) 

2535 for commercial purposes 25,000 lb. (11,340 kg) or more of a chemical substance described in 

2536 §711.5 at any single site owned or controlled by that person at any time during any calendar year 

2537 since the last principal reporting year (e.g., for the 2011 submission period, consider calendar 

2538 years 2006, 2007, 2008, 2009, and 2010). 

2539 

2540 (b) Exceptions. Any person who manufactured (including imported) for commercial purposes 

2541 any chemical substance that is the subject of a rule proposed or promulgated under section 

2542 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 

2543 Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of 

2544 the Act is subject to reporting for that chemical, regardless of the production volume. 

2545 
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2546 § 711.9 Persons not subject to this part. 

2547 

2548 A person described in §711.8 is not subject to the requirements of this subpart if that person 

2549 qualifies as a small manufacturer as that term is defined in §704.3 of this chapter. 

2550 Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this 

2551 subpart with respect to any chemical substance that is the subject of a rule proposed or 

2552 promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under 

2553 section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under 

2554 section 5 or 7 of the Act. 

2555 

2556 § 711.10 Activities for which reporting is not required. 

2557 

2558 A person described in §711.8 is not subject to the requirements of this subpart with respect to 

2559 any chemical substance described in §711.5 that the person solely manufactured or imported 

2560 under the following circumstances: 

2561 

2562 (a) The person manufactured or imported the chemical substance described in §711.5 solely in 

2563 small quantities for research and development. 

2564 

2565 (b) The person imported the chemical substance described in §711.5 as part of an article. 

2566 

2567 (c) The person manufactured the chemical substance described in §711.5 in a manner described 

2568 in §720.30(g) or (h) of this chapter. 

2569 

2570 § 711.12 Reporting information to EPA. 

2571 Any person who must report under this part, as described in §711.8, must submit the information 

2572 described in this section for each chemical substance described in §711.5 that the person 

2573 manufactured (including imported) for commercial purposes in an amount of 25,000 lb. (11,340 

2574 kg) or more (or lower volume for chemicals subject to the rules, orders, or actions described in 

2575 711.8(c)) at any one site during any calendar year since the last principal reporting year (i.e., for 

2576 the 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 2010). A 

2577 separate report must be submitted for each chemical substance at each site for which the 

2578 submitter is required to report. A submitter of information under this part must report 

2579 information as described in this section to the extent that such information is known to or 

2580 reasonably ascertainable by that person. 

2581 (a) Reporting information to EPA. Any person who reports information to EPA must do so using 

2582 the e-IUR reporting software provided by EPA at the address set forth in §711.19. The 

2583 submission must include all information described in paragraph (b) of this section. Persons must 

2584 submit a separate form for each site for which the person is required to report. The e-IUR 

2585 reporting software is described in the instruction booklet available from EPA at the address set 

2586 forth in §711.19. 

2587 (b) Information to be reported. Manufacturers (including importers) of a reportable chemical 

2588 substance in an amount of 25,000 lbs. (11,340 kg) or more at a site any calendar year since the 

2589 last principal reporting year must report the information described in this section. As described in 

2590 §711.6(b)(1) and (b)(2), manufacturers of certain chemicals are not required to report the 
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2591 information described in paragraph (b)(4) of this section. 

2592 

2593 (1) A certification statement signed and dated by an authorized official of the submitter 

2594 company. Persons reporting must submit this information using e-IUR as described in §711.19. 

2595 The authorized official must certify that the submitted information has been completed in 

2596 compliance with the requirements of the rule and that the confidentiality claims made on the 

2597 form are true and correct. The certification must be signed and dated by the authorized official 

2598 for the submitter company, and provide that person’s name, official title, and e-mail address. 

2599 

2600 (2) Company and plant site information. The following company and plant site information must 

2601 be reported for each site at which at least 25,000 lbs. (11,340 kg) of a reportable chemical 

2602 substance is manufactured (including imported) during any calendar year since the last principal 

2603 reporting year (see §711.3 for the “site” for importers): 

2604 

2605 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter under this 

2606 part must obtain a Dun and Bradstreet Number for the parent company if none exists. 

2607 

2608 (ii) The name of a person who will serve as technical contact for the submitter company, and 

2609 who will be able to answer questions about the information submitted by the company to EPA, 

2610 the contact person's full mailing address, telephone number and e-mail address. 

2611 

2612 (iii) The name and full street address of each site. A submitter under this subpart must include 

2613 the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish 

2614 (or other jurisdictional indicator) in which the plant site is located. A submitter under this part 

2615 must obtain a Dun and Bradstreet Number for the site reported if none exists. 

2616 

2617 (3) Specific information for chemicals manufactured in amounts of 25,000 lbs. or more. The 

2618 following chemical-specific information must be reported for each reportable chemical substance 

2619 manufactured at (including imported into) each site in amounts of 25,000 lbs. (11,340 kg) or 

2620 more during any calendar year since the last principal reporting year: 

2621 (i) The specific, currently correct Chemical Abstracts (CA) Index name as used to list the 

2622 chemical substance in the TSCA Inventory and the correct corresponding CAS Registry Number 

2623 (CASRN) for each reportable chemical substance at each site. A submitter under this part may 

2624 use an EPA-designated TSCA Accession Number for a confidential substance in lieu of a 

2625 CASRN when a CASRN is not known to or reasonably ascertainable by the submitter. In 

2626 addition to reporting the number itself, submitters must specify the type of number they are 

2627 reporting by selecting from among the following codes 

2628 Codes to Specify Type of Chemical Identifying Number 

Codes Number Type 

A Accession Number 

C CAS Registry Number 

2629 

2630 (a) If an importer submitting a report cannot provide all the information specified in 

2631 §711.12(b) of this section because it is claimed as confidential by the supplier of the chemical 

2632 substance, the importer must have the supplier provide the correct chemical identity information 
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2633 directly to EPA in a joint submission, electronically using e-IUR and via CDX (see §711.19 of 

2634 this part), and which clearly references the importer's submission. 

2635 

2636 (b) If a manufacturer submitting a report cannot provide all the information specified in 

2637 §711.12(b) of this section because the reportable chemical substance is manufactured using a 

2638 reactant having a specific chemical identity claimed as confidential by its supplier, the 

2639 manufacturer must submit a report directly to EPA containing all the information known to or 

2640 reasonably ascertainable by the manufacturer about the chemical identity of the reported 

2641 substance. In addition, the manufacturer must ensure that the supplier of the confidential reactant 

2642 provide the correct chemical identity of the confidential reactant directly to EPA in a joint 

2643 submission, electronically using e-IUR and via CDX (see §711.19 of this part), and which 

2644 clearly references the manufacture's submission. 

2645 (ii) A statement indicating, for each reportable chemical substance at each site, whether the 

2646 substance is manufactured in the United States, imported into the United States, or both 

2647 manufactured in the United States and imported into the United States. 

2648 (iii) For each calendar year since the last principal reporting year, the total annual volume (in 

2649 pounds) of each reportable chemical substance domestically manufactured and imported at each 

2650 site. The total annual domestically manufactured volume (not including imported volume) and 

2651 the total annual imported volume must be separately reported. This amount must be reported to 

2652 two significant figures of accuracy. 

2653 (iv) For the principal reporting year only, the volume used on site and the volume exported of 

2654 each reportable chemical substance domestically manufactured and imported at each site. This 

2655 amount must be reported to two significant figures of accuracy. 

2656 (v) A designation indicating, for each imported reportable chemical substance at each site, 

2657 whether the imported chemical substance is physically present at the reporting site. 

2658 (vi) A designation indicating, for each reportable chemical substance at each site, whether the 

2659 substance is being recycled, reused, remanufactured, reprocessed, reworked, or otherwise used 

2660 for a commercial purpose instead of being disposed of as a waste or included in a waste stream. 

2661 (vii) The total number of workers reasonably likely to be exposed to each reportable chemical 

2662 substance at each site. For each reportable substance at each site, the submitter must select from 

2663 among the ranges of workers listed in the following table and report the corresponding code (i.e., 

2664 W1 through W8): 

2665 

2666 Codes for Reporting Number of Workers Reasonably Likely To Be Exposed 

Codes Range 

W1 Less 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 
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2667 

2668 (viii) The maximum concentration, measured by percentage of weight, of each reportable 

2669 chemical substance at the time it is sent off-site from each site. If the chemical is site-limited, 

2670 you must report the maximum concentration, measured by percentage of weight, of the 

2671 reportable chemical substance at the time it is reacted on-site to produce a different chemical 

2672 substance. This information must be reported regardless of the physical form(s) in which the 

2673 substance is sent off-site/reacted on-site. For each substance at each site, select the maximum 

2674 concentration of the substance from among the ranges listed in the following table and report the 

2675 corresponding code (i.e., M1 through M5): 

2676 

2677 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 

2678 

2679 (ix) The physical form(s) of the reportable chemical substance as it is sent off-site from each site. 

2680 If the chemical is site-limited, you must report the physical form(s) of the reportable chemical 

2681 substance at the time it is reacted on-site to produce a different chemical substance. For each 

2682 substance at each site, the submitter must report as many physical forms as apply from among 

2683 the physical forms listed below: 

2684 

2685 (A) Dry powder. 

2686 

2687 (B) Pellets or large crystals. 

2688 

2689 (C) Water- or solvent-wet solid. 

2690 

2691 (D) Other solid. 

2692 

2693 (E) Gas or vapor. 

2694 

2695 (F) Liquid. 

2696 

2697 (x) Submitters must report the percentage, rounded off to the closest 10%, of total production 

2698 volume of the reportable chemical substance, for the principal reporting year only, reported in 

2699 response to paragraph (c)(3) (iii) of this section, that is associated with each physical form 

2700 reported under paragraph (c)(3) (ix) of this section. 

2701 

2702 (4) Specific information related to processing and use. Persons subject to paragraph (b)(4) of this 

2703 section must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this section 

2704 for each reportable chemical substance at sites under their control and at sites that receive a 

2705 reportable chemical substance from the submitter directly or indirectly (including through a 

2706 broker/distributor, from a customer of the submitter, etc.). Information reported in response to 

2707 this paragraph must be reported only to the extent that it is known to or reasonably ascertainable 

2708 by the submitter. Information required to be reported under this paragraph is limited to domestic 
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2709 (i.e., within the customs territory of the United States) processing and use activities. If 

2710 information responsive to a given data requirement under this paragraph, including information 

2711 in the form of an estimate, is not known or reasonably ascertainable, the submitter is not required 

2712 to respond to the requirement. 

2713 

2714 (i) Industrial processing and use information. (A) A designation indicating the type of industrial 

2715 processing or use operation(s) at each site that receives a reportable substance from the submitter 

2716 site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). 

2717 For each chemical substance, report the letters which correspond to the appropriate processing or 

2718 use operation(s). A particular designation may need to be reported more than once, to the extent 

2719 that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that 

2720 applies to a given designation under this paragraph. 

2721 

2722 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 

2723 (B) A code indicating the sector(s) which best describe the industrial activities associated with 

2724 each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this section. 

2725 For each chemical substance, report the code that corresponds to the appropriate sector(s). A 

2726 particular sector code may need to be reported more than once, to the extent that a submitter 

2727 reports more than one industrial function code (under paragraph (b)(4)(i)(C) of this section) that 

2728 applies to a given sector code under this paragraph. 

2729 Codes for Reporting Industrial Sectors 

Code Sector Description 

IS1 Agriculture, Forestry, Fishing and Hunting 

IS2 Oil and Gas Drilling, Extraction, and support activities 

IS3 Mining (except Oil and Gas) and support activities 

IS4 Utilities 

IS5 Construction 

IS6 Food, beverage, and tobacco product manufacturing 

IS7 Textiles, apparel, and leather manufacturing 

IS8 Wood Product Manufacturing 

IS9 Paper Manufacturing 

IS10 Printing and Related Support Activities 

IS11 Petroleum Refineries 

IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing 

IS13 Petroleum Lubricating Oil and Grease Manufacturing 

IS14 All other Petroleum and Coal Products Manufacturing 

IS15 Petrochemical Manufacturing 

IS16 Industrial Gas Manufacturing 

IS17 Synthetic Dye and Pigment Manufacturing 

IS18 Carbon Black Manufacturing 

IS19 All Other Basic Inorganic Chemical Manufacturing 
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Code Sector Description 

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) 

2730 

2731 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s) from the 

2732 following list must be selected to designate the industrial function category(ies) that best 

2733 represents the specific manner in which the chemical substance is used. A particular industrial 

2734 function category may need to be reported more than once, to the extent that a submitter reports 

2735 more than one industrial processing or use operation/sector combination (under paragraphs 

2736 (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given industrial function category 

2737 under this paragraph. If more than 10 unique combinations of industrial processing or use 

2738 operations/sector/industrial function categories apply to a chemical substance, submitters need 

2739 only report the 10 unique combinations for the chemical substance that cumulatively represent 

2740 the largest percentage of the submitter's production volume for that chemical, measured by 

2741 weight. If none of the listed industrial function categories accurately describes a use of a 

2742 chemical substance, the category “Other” may be used, and must include a description of the use. 

2743 Codes for Reporting Industrial Function Categories 

Codes Category 

U001 Abrasives 

U002 Adhesives and sealant chemicals 
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Codes Category 

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 
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Codes Category 

U033 Laboratory chemicals 

U034 Paint additives and coating additives not described by other categories 

U999 Other (specify) 

2744 

2745 (D) The estimated percentage, rounded off to the closest 10%, of total production volume of the 

2746 reportable chemical substance associated with each combination of industrial processing or use 

2747 operation, sector and industrial function category. Where a particular combination of industrial 

2748 processing or use operation, sector and industrial function category accounts for 5% or less of the 

2749 submitter's site's total production volume of a reportable chemical substance, the percentage must 

2750 not be rounded off to zero percent if the production volume attributable to that industrial 

2751 processing or use operation, sector and industrial function category combination is 25,000 lb. 

2752 (11,340 kg.) or more during the reporting year. Instead, in such a case, submitters must report the 

2753 percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the 

2754 reportable chemical substance associated with the particular combination of industrial processing 

2755 or use operation, sector and industrial function category. 

2756 

2757 (E) For each combination of industrial processing or use operation, sector and industrial function 

2758 category, the submitter must estimate the number of sites at which each reportable chemical 

2759 substance is processed or used. For each combination associated with each substance, the 

2760 submitter must select from among the ranges of sites listed in the following table and report the 

2761 corresponding code (i.e., S1 through S7): 

2762 

2763 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 

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 

2764 

2765 (F) For each combination of industrial processing or use operation, sector and industrial function 

2766 category, the submitter must estimate the number of workers reasonably likely to be exposed to 

2767 each reportable chemical substance. For each combination associated with each substance, the 

2768 submitter must select from among the worker ranges listed in paragraph (b)(3)(v) of this section 

2769 and report the corresponding code (i.e., W1 though W8). 

2770 

2771 (ii) Consumer and commercial use information. (A) Using the codes listed in this paragraph, 

2772 submitters must designate the consumer and commercial product category or categories that best 

2773 describe the consumer and commercial products in which each reportable chemical substance is 

2774 used (whether the recipient site(s) are controlled by the submitter site or not). If more than 10 

2775 codes apply to a chemical substance, submitters need only report the 10 codes for the chemical 

2776 substance that cumulatively represent the largest percentage of the submitter's production volume 

2777 for that chemical, measured by weight. If none of the listed consumer and commercial product 
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2778 categories accurately describes the consumer and commercial products in which each reportable 

2779 chemical substance is used, the category “Other” may be used, and must include a description of 

2780 the use. 

2781 

2782 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 

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 
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Codes Category 

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)

2783 

2784 (B) An indication, within each consumer and commercial product category reported under 

2785 paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use. 

2786 

2787 (C) Submitters must determine, within each consumer and commercial product category reported 

2788 under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical 

2789 substance manufactured (including imported) by the submitter is present in (for example, a 

2790 plasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on a 

2791 toy) any consumer products intended for use by children up to the age of 14, regardless of the 

2792 concentration of the substance remaining in or on the product. Submitters must select from the 

2793 following options: the chemical substance is used in or on any consumer products intended for 

2794 use by children, the chemical substance is not used in or on any consumer products intended for 

2795 use by children, or information as to whether the chemical substance is used in or on any 

2796 consumer products intended for use by children is not known to or reasonably ascertainable by 

2797 the submitter. 

2798 

2799 (D) The estimated percentage, rounded off to the closest 10%, of the submitter's site's total 

2800 production volume of the reportable chemical substance associated with each consumer and 

2801 commercial product category. Where a particular consumer and commercial product category 

2802 accounts for 5% or less of the total production volume of a reportable chemical substance, the 

2803 percentage must not be rounded off to zero percent if the production volume attributable to that 

2804 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 

2805 reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the 

2806 closest 1%, of the submitter's site's total production volume of the reportable chemical substance 

2807 associated with the particular consumer and commercial product category. 

2808 

2809 (E) Where the reportable chemical substance is used in consumer or commercial products, the 

2810 estimated typical maximum concentration, measured by weight, of the chemical substance in 
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2811 each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this 

2812 section. For each substance in each commercial and consumer product category reported under 

2813 paragraph (b)(4)(ii)(A) of this section, submitters must select from among the ranges of 

2814 concentrations listed in the table in paragraph (b)(3)(viii) of this section and report the 

2815 corresponding code (i.e., M1 through M5). 

2816 

2817 (F) Where the reportable chemical substance is used in a commercial product, the submitter must 

2818 estimate the number of commercial workers reasonably likely to be exposed to each reportable 

2819 chemical substance. For each combination associated with each substance, the submitter must 

2820 select from among the worker ranges listed in paragraph (b)(3)(vii) of this section and report the 

2821 corresponding code (i.e., W1 though W8). 

2822 

2823 § 711.13 When to report. 

2824 

2825 All information reported to EPA in response to the requirements of this subpart must be 

2826 submitted during an applicable submission period from June 1 to September 30 at 4–year 

2827 intervals, beginning in 2011. Any person described in §711.8(a) must report during each 

2828 submission period for each chemical substance described in §711.5 that the person manufactured 

2829 (including imported) during any calendar year since the last principal reporting year (e.g., for the 

2830 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 2010, since 2005 

2831 was the last principal reporting year). 

2832 

2833 § 711.15 Duplicative reporting. 

2834 

2835 (a) With regard to section 8(a) rules. Any person subject to the requirements of this part who 

2836 previously has complied with reporting requirements of a rule under section 8(a) of the Act by 

2837 submitting the information described in §711.12 for a chemical substance described in §711.5 to 

2838 EPA, and has done so within 1 year of the start of a submission period described in §711.13, is 

2839 not required to report again on the manufacture of that substance at that site during that 

2840 submission period. 

2841 

2842 (b) With regard to importers. This part requires that only one report be submitted on each import 

2843 transaction involving a chemical substance described in §711.5. When two or more persons are 

2844 involved in a particular import transaction and each person meets the Agency's definition of 

2845 “importer” as set forth in §704.3 of this chapter, they may determine among themselves who 

2846 should submit the required report; if no report is submitted as required under this part, EPA will 

2847 hold each such person liable for failure to report. 

2848 

2849 (c) Toll manufacturers and persons contracting with a toll manufacturer. This part requires that 

2850 only one report be submitted on each chemical substance described in §711.5. When a company 

2851 contracts with a toll manufacturer to manufacture a chemical substance, and each party meets the 

2852 Agency's definition of “manufacturer” as set forth in §711.3, the contracting company is 

2853 primarily responsible for the IUR submission. In the event the contracting company does not 

2854 report, the toll manufacturer must report. Both the contracting company and the toll 

2855 manufacturer are liable if no report is made. 

2856 

2857 § 711.17 Recordkeeping requirements. 

2858 
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2859 Each person who is subject to the reporting requirements of this subpart must retain records that 

2860 document any information reported to EPA. Records relevant to reporting during a submission 

2861 period must be retained for a period of 5 years beginning on the last day of the submission 

2862 period. Submitters are encouraged to retain their records longer than 5 years to ensure that past 

2863 records are available as a reference when new submissions are being generated. 

2864 

2865 § 711.18 Confidentiality. 

2866 

2867 (a) Any person submitting information under this subpart may assert a business confidentiality 

2868 claim for the information at the time it is submitted. Any such confidentiality claims must be 

2869 made at the time the information is submitted. Confidentiality claims cannot be made when a 

2870 response is left blank or an indication of not known to or reasonably ascertainable by is provided. 

2871 These claims will apply only to the information submitted with the claim. New confidentiality 

2872 claims, if appropriate, must be asserted with regard to information submitted during a different 

2873 submission period. Guidance for asserting confidentiality claims is provided in the instructions 

2874 identified in §711.19. Information claimed as confidential in accordance with this section will be 

2875 treated and disclosed in accordance with the procedures in part 2 of this chapter. 

2876 

2877 (b) Chemical identity. A person may assert a claim of confidentiality for the chemical identity of 

2878 a specific chemical substance only if the identity of that substance is treated as confidential in the 

2879 Master Inventory File as of the time the report is submitted for that substance under this subpart. 

2880 The following steps must be taken to assert a claim of confidentiality for the identity of a 

2881 reportable chemical substance: 

2882 

2883 (1) The submitter must submit with the report detailed written answers to the following questions 

2884 signed and dated by an authorized official. 

2885 

2886 (i) What harmful effects to your competitive position, if any, do you think would result from the 

2887 identity of the chemical substance being disclosed in connection with reporting under this 

2888 subpart? How could a competitor use such information? Would the effects of disclosure be 

2889 substantial? What is the causal relationship between the disclosure and the harmful effects? 

2890 

2891 (ii) How long should confidential treatment be given? Until a specific date, the occurrence of a 

2892 specific event, or permanently? Why? 

2893 

2894 (iii) Has the chemical substance been patented? If so, have you granted licenses to others with 

2895 respect to the patent as it applies to the chemical substance? If the chemical substance has been 

2896 patented and therefore disclosed through the patent, why should it be treated as confidential? 

2897 

2898 (iv) Has the identity of the chemical substance been kept confidential to the extent that your 

2899 competitors do not know it is being manufactured or imported for a commercial purpose by 

2900 anyone? 

2901 

2902 (v) Is the fact that the chemical substance is being manufactured (including imported) for a 

2903 commercial purpose available to the public, for example in technical journals, libraries, or State, 

2904 local, or Federal agency public files? 

2905 

2906 (vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical 
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2907 substance is being manufactured (including imported) for a commercial purpose? 

2908 

2909 (vii) To what extent has the fact that this chemical substance is manufactured (including 

2910 imported) for commercial purposes been revealed to others? What precautions have been taken 

2911 regarding these disclosures? Have there been public disclosures or disclosures to competitors? 

2912 

2913 (viii) Does this particular chemical substance leave the site of manufacture (including import) in 

2914 any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard 

2915 against the discovery of its identity? 

2916 

2917 (ix) If the chemical substance leaves the site in a product that is available to the public or your 

2918 competitors, can the substance be identified by analysis of the product? 

2919 

2920 (x) For what purpose do you manufacture (including import) the substance? 

2921 

2922 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality 

2923 determinations regarding this chemical substance? If so, please attach copies of such 

2924 determinations. 

2925 

2926 (2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) 

2927 of this section is asserted to contain confidential business information, the submitter must clearly 

2928 identify the information that is claimed confidential by marking the specific information on each 

2929 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

2930 

2931 (c) Site identity. A submitter may assert a claim of confidentiality for a site only if the linkage of 

2932 the site with a reportable chemical is confidential and not publicly available. The following steps 

2933 must be taken to assert a claim of confidentiality for a site identity: 

2934 

2935 (1) The submitter must submit with the report detailed written answers to the following questions 

2936 signed and dated by an authorized official: 

2937 

2938 (i) Has site information been linked with a chemical identity in any other Federal, state or local 

2939 reporting scheme? For example, is the chemical identity linked to a facility in a filing under the 

2940 Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through 

2941 a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed 

2942 as confidential in any of these instances? 

2943 

2944 (ii) What harmful effect, if any, to your competitive position do you think would result from the 

2945 identity of the site and the chemical substance being disclosed in connection with reporting under 

2946 this subpart? How could a competitor use such information? Would the effects of disclosure be 

2947 substantial? What is the causal relationship between the disclosure and the harmful effects? 

2948 

2949 (2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) 

2950 of this section is asserted to contain confidential business information, the submitter must clearly 

2951 identify the information that is claimed confidential by marking the specific information on each 

2952 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

2953 (d) Processing and Use information. A submitter may assert a claim of confidentiality for each 

2954 data element required by 711.12(b)(4) only if the linkage of the information with a reportable 
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2955 chemical is confidential and not publicly available. The following steps must be taken to assert a 

2956 claim of confidentiality for each data element, individually, required by 711.12(b)(4): 

2957 (1) The submitter must submit with the report detailed written answers to the following questions 

2958 signed and dated by an authorized official: 

2959 (i) Is the identified use of this chemical publicly known? For example, is information on the use 

2960 available in advertisements or other marketing materials, professional journals or other similar 

2961 materials, or in non-confidential mandatory or voluntary government filings or publications? Has 

2962 your company ever provided use information on the chemical that was not claimed as 

2963 confidential? 

2964 (ii) What harmful effect, if any, to your competitive position do you think would result from the 

2965 information reported as required by 711.12(b)(4) and the chemical substance being disclosed in 

2966 connection with reporting under this part? How could a competitor use such information? Would 

2967 the effects of disclosure be substantial? What is the causal relationship between the disclosure 

2968 and the substantial harmful effects? 

2969 (2) If any of the information contained in the answers to the questions listed in paragraph (d)(1) 

2970 of this section is asserted to contain confidential business information, the submitter must clearly 

2971 identify the information that is claimed confidential by marking the specific information on each 

2972 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 

2973 (e) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this 

2974 subpart; if the reporting form lacks the certification required by 711.12(b)(1); if confidentiality 

2975 claim substantiation required under paragraphs (b), (c), and (d) of this section is not submitted 

2976 with the reporting form; or if the identity of a chemical substance listed on the public portion of 

2977 the Master Inventory File was claimed as confidential, EPA may make the information available 

2978 to the public without further notice to the submitter. 

2979 

2980 § 711.19 General. 

2981 

2982 (a) You must use e-IUR to complete and submit the form identified as “Form U,” EPA Form 

2983 7740-8. Submissions may only be made as set forth in this section. 

2984 (b) Submissions must be sent electronically to EPA via CDX. 

2985 (c) Obtain e-IUR and instructions, as follows: 

2986 

2987 (1) By website. Go to the EPA Inventory Update Reporting Internet home page at 

2988 http://www.epa.gov/iur and follow the appropriate links. 

2989 

2990 (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554–1404 or TSCA2991 Hotline@epa.gov for a CD-ROM containing the software and instructions. 

2992 

2993 [FR Doc. 09–????? Filed ??–??–09; 8:45 am] 

2994 BILLING CODE 6560–50–S

2995 

2996 

2997