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1 EO 12866 Review Draft

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3 BILLING CODE 6560–50–P

4

5

6

7 ENVIRONMENTAL PROTECTION AGENCY

8 40 CFR Parts 704, 710, and 711

9 [EPA–HQ–OPPT–2009–0187; FRL– 8833–5]

10 RIN 2070–AJ43

11 TSCA Inventory Update Reporting Modifications

12

13 AGENCY: Environmental Protection Agency (EPA).

14 ACTION: Final rule.

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

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

17 information on the manufacturing, processing, and use of commercial chemical substances and 

18 mixtures (referred to hereafter as chemical substances) on the TSCA Chemical Substance 

19 Inventory (TSCA Inventory). This includes current information on chemical production volumes,

20 manufacturing sites, and how the chemicals are used. This information helps the Agency 

21 determine whether people or the environment are potentially exposed to reported chemicals. 

22 EPA publishes submitted IUR data that is not Confidential Business Information (CBI). EPA is 

23 amending the IUR rule to require submission of information that will better address Agency and 

24 public information needs, improve the usability and reliability of the reported data, and ensure 

25 that data are available in a timely manner. EPA is requiring electronic reporting of IUR 

26 information and modifying IUR reporting requirements, including certain circumstances that 

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

28 information, and CBI reporting procedures. 

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

30 Register].

31

32 ADDRESSES: EPA has established a docket for this action under docket identification (ID) 

33 number EPA–HQ–OPPT–2009-0187. All documents in the docket are listed in the docket index 

34 available at http://www.regulations.gov. Although listed in the index, some information is not 

35 publicly available, e.g., Confidential Business Information (CBI) or other information whose 

36 disclosure is restricted by statute. Certain other material, such as copyrighted material, is not 

37 placed on the Internet and will be publicly available only in hard copy form. Publicly available 

38 docket materials are available in the electronic docket at http://www.regulations.gov, or, if only 
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39 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 

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

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

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

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

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

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

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

47 the building and returned upon departure.

48

49 FOR FURTHER INFORMATION CONTACT: For technical information contact: Chenise 

50 Farquharson, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, 

51 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–

52 0001; telephone number: 202-564-7768; e-mail address: farquharson.chenise@epa.gov.

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

54 Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCA55 Hotline@epa.gov.

56

57 SUPPLEMENTARY INFORMATION:

58

59 I. Does this Action Apply to Me?

60

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

62 as a byproduct) or import chemical substances listed on the TSCA Inventory (under TSCA 

63 section 3, ―import‖ is included in the definition of manufacture). Potentially affected entities 

64 may include, but are not limited to:

65 • Chemical manufacturers and importers (NAICS codes 325 and 324110; e.g., chemical 

66 manufacturing and processing and petroleum refineries).

67 • Chemical users and processors who, in addition to manufacturers described above, may 

68 manufacture a byproduct chemical substance (NAICS codes 22, 322, 331, and 3344; e.g., 

69 utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other 

70 electronic component manufacturing).

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

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

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

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

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

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

77 CONTACT.

78 II. Background

79

80 A. What Action is the Agency Taking? 
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81 In this action, EPA is promulgating several amendments to the IUR rule, taking into 

82 consideration comments received on the proposal. The amendments were proposed on August 

83 13, 2010 (75 FR 49656)(FRL-8833-5). The amendments contained in this final rule, as well as 

84 the Inventory update provisions of 40 CFR part 710 subpart C unchanged by these amendments, 

85 appear in a new part, 40 CFR part 711. The following is a brief listing of the primary 

86 amendments to the IUR. These amendments are described in more detail in Unit II.E.

87 1. EPA is amending 40 CFR 710.59, which appears in the new part 711 as §711.35, to 

88 require electronic reporting of the IUR data, using an Agency-provided, web-based reporting 

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

90 Exchange (CDX). After the final rule‘s effective date [see DATES], paper submissions will no 

91 longer be accepted.

92 2. EPA is adding a new definition section, which appears in the new part 711 as §711.3; 

93 revising the definition for manufacture and site; and making other needed definitional 

94 modifications and additions.

95 3. EPA is amending 40 CFR 710.53, which appears in the new part 711 as §711.20, to 

96 change the reporting frequency from every 5 years to every 4 years.

97 4. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as §711.8(a), 

98 to modify the method used to determine whether a manufacturer (including importer) is subject 

99 to IUR reporting. The method would be effective after the 2011 IUR submission period. 

100 Subsequent to 2011, reporting is required if the production volume of a chemical substance met 

101 or exceeded the 25,000 pound (lb.) threshold in any calendar year since the last principal 

102 reporting year (e.g., 2010).

103 5. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as §711.15(c), 

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

105 submitters of non-excluded chemical substances to report information in all parts of the IUR 

106 reporting form (Form U). 

107 6. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as §711.8(a), 

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

109 particular TSCA rules and/or orders, thereby requiring manufacturers (including importers) of 

110 such chemical substances to report under the IUR rule, regardless of the production volume. 

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

112 make chemical substances for which an enforceable consent agreement (ECA) to conduct testing 

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

114 from IUR requirements for water, and to remove polymers, which are already fully exempt from 

115 the partially exempt list of chemical substances at 40 CFR 710.46(b)(2)(iv), which appears in the 

116 new part 711 as §711.6(b)(2)(iv). 

117 8. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as §711.15(c), 

118 to modify the reporting requirements for certain manufacturing data elements. Specifically, 

119 manufacturers (including importers) are required to report:
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120 i. The name and address belonging to the parent company. 

121 ii. The current Chemical Abstracts (CA) Index Name, as used to list the chemical 

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

123 iii. The production volume for each of the years since the last principal reporting year. 

124 iv. The volume of a manufactured (including imported) chemical substance used at the 

125 reporting site. 

126 v. Whether an imported chemical substance is physically present at the reporting site.

127 vi. The volume directly exported and not domestically processed or used.

128 vii. When a manufactured chemical substance, such as a byproduct, is being recycled, 

129 remanufactured, reprocessed, or reused.

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

131 processing and use information required by 40 CFR 710.52(c)(4), which appears in the new part 

132 711 as §711.15(b)(4), with the ―known to or reasonably ascertainable by‖ reporting standard. 

133 10. EPA is amending 40 CFR 710.58, which appears in the new part 711 as §711.30, to 

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

135 710.52(c)(4), which appears in the new part 711 as §711.15(b)(4), is claimed as CBI.

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

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

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

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

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

141 appears in the new part 711 as §711.15(b)(4)(i)(B), to replace the 5-digit NAICS codes with 48 

142 Industrial Sectors (IS).

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

144 §711.15(b)(4)(ii), to revise the list of consumer and commercial product categories for the 

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

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

147 workers reasonably likely to be exposed to the subject chemical substance. 

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

149 710.52(c)(3) and (c)(4), which appear in the new part 711 as §§711.15(b)(3) and (b)(4).

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

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

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

153 inventory is known as the TSCA Chemical Substance Inventory (TSCA Inventory). The Agency 
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154 maintains the Master Inventory File as the authoritative list of all the chemical substances 

155 reported to EPA for inclusion on the TSCA Inventory. In 1977, EPA promulgated a rule 

156 published in the Federal Register issue of December 23, 1977 (Ref. 1) under TSCA section 

157 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that 

158 time. In 1986, EPA promulgated the initial IUR rule under TSCA section 8(a) at 40 CFR part 

159 710 published in the Federal Register issue of June 12, 1986 (Ref. 2) to facilitate the periodic 

160 updating of information on chemical substances listed on the TSCA Inventory and to support 

161 activities associated with the implementation of TSCA. In 2003, EPA promulgated extensive 

162 amendments to the IUR rule, published in the Federal Register issue of January 7, 2003 (2003 

163 Amendments) (Ref. 3) to collect exposure-related information associated with the 

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

165 changes.

166 Section 8(a)(1) of TSCA authorizes the EPA Administrator to promulgate rules under 

167 which manufacturers and processors of chemical substances must maintain such records and 

168 submit such information as the EPA Administrator may reasonably require. Section 8(a) of 

169 TSCA generally excludes small manufacturers and processors of chemical substances from the 

170 reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA 

171 section 8(a)(3) to require TSCA section 8(a) reporting from small manufacturers and processors 

172 with respect to any chemical substance that is the subject of a rule proposed or promulgated 

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

174 section 5(e), or that is the subject of relief granted pursuant to a civil action under TSCA section 

175 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer for 

176 purposes of 40 CFR part 710, which appears in the new part, 40 CFR part 711, is found at 40 

177 CFR 704.3. Processors are not currently subject to the rules at 40 CFR part 710, which appears 

178 in the new part 40 CFR part 711.

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

180 copied from the existing IUR regulations in 40 CFR part 710 subpart C that are not substantively 

181 changed as a part of this rulemaking, and the new IUR provisions in this final rule. Failure to 

182 comply fully with any provision of this final rule will be a violation of TSCA section 15 and will 

183 subject the violator to the penalties of TSCA sections 16 and 17.

184

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

186 The IUR rule, as modified by the 2003 Amendments, required U.S. manufacturers 

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

188 of chemical substances manufactured (including imported) during the reporting year in quantities 

189 of 25,000 lb. or greater at any single site they own or control to EPA every five years. IUR data 

190 were collected five times prior to the 2003 Amendments: 1986, 1990, 1994, 1998, and 2002, and 

191 one time after the 2003 Amendments, in 2006. EPA uses the TSCA Inventory and data reported 

192 under the IUR rule to support many TSCA-related activities and to support a number of EPA and 

193 other Federal health, safety, and environmental protection activities. The Agency also makes the 

194 data available to the public, to the extent possible given CBI claims. 
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195 Persons manufacturing (including importing) chemical substances were required to report 

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

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

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

199 included the physical form and maximum concentration of the chemical substance and the 

200 number of potentially exposed workers. Several groups of chemical substances were and will 

201 continue to be generally excluded from IUR reporting requirements: e.g., polymers, 

202 microorganisms, naturally occurring chemical substances, and certain natural gas substances.

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

204 greater manufactured (including imported) during the reporting year at any single site) were 

205 required also to report certain processing and use information for the 2006 submission. This 

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

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

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

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

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

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

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

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

214 the processing and use information, regardless of production volume. Under the previous rule, 

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

216 inorganic chemicals would have no longer been applicable and submitters would have reported 

217 in the same manner as was required for organic chemicals, including processing and use 

218 information. In addition, starting with the 2006 collection and for future collections, specifically 

219 listed petroleum process streams and other specifically listed chemical substances were partially 

220 exempt, and manufacturers of such chemical substances were not required to report processing 

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

222 under the IUR as revised today (including 2011), for as long as the chemical substances remain 

223 on these partial exemption lists §§711.6(b)(1) and (b)(2).

224 Non-confidential data, including both searchable and separately downloadable databases, 

225 and the 2006 IUR data summary report are available to the public on the IUR website 

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

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

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

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

230 needs.

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

232 3. To obtain new and updated information relating to potential exposures to a subset of 

233 chemical substances listed on the TSCA Inventory.
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234 4. To improve the usefulness of the information reported.

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

236 processing and use information is to be reported and adjusting the specific reported information, 

237 the method and frequency of collecting the information, and CBI requirements will accomplish 

238 these goals.

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

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

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

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

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

244 Amendments provided many improvements to the data collected through that rule, and EPA‘s 

245 efforts to use the 2006 IUR data identified areas where further improvements are needed. The 

246 modifications described in this final rule change some of the reporting requirements in an effort 

247 by EPA to ensure the required information is properly reported and that the information in the 

248 Agency‘s database reflects the information provided in the IUR reports; increase the usability of 

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

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

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

252 risk screening capabilities, enabling them to better assess and manage risk, and improve public 

253 awareness of basic information about a large number of chemical substances.

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

255 electronic reporting through the Internet, using the Agency‘s CDX. EPA‘s experience with 

256 populating the IUR database and with using the 2006 IUR data provided insight into how well 

257 both the reporting software and submission methods worked. For instance, because of 

258 validations built into the reporting software, electronic submissions were able to be quickly 

259 assimilated into the IUR database. Other forms of submission required the documents to be 

260 scanned in or hand entered, and resulted in many introduced errors during the data entry process. 

261 Additionally, for the 2006 IUR, certain types of submissions (e.g., joint submissions) could not 

262 be reported electronically. Other problems, such as incorrect chemical identities, delayed the 

263 incorporation of the data into the database, resulting in the Agency‘s inability to begin using the 

264 2006 IUR data and providing public access in a timely manner. The modifications in today‘s 

265 rule associated with reporting methods and changes to the reporting software will better ensure 

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

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

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

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

270 accurate and reliable enough for the Agency to develop screening level assessments. The 2003 

271 amendments to IUR rule supply exposure-related information the Agency did not previously 

272 possess, recognizing that industry has a greater knowledge than EPA about its own operations 

273 and the uses of chemical substances it manufactures and sells.
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274 EPA‘s extensive use of the 2006 IUR data in the Agency‘s Existing Chemicals Program 

275 is consistent with how EPA envisioned the data would be used when the 2003 Amendments were 

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

277 and risk characterizations for high production volume (HPV) chemicals, which are those 

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

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

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

281 action on chemical substances that may pose potential risks to human health or the environment. 

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

283 where the same or similar information to that claimed as CBI was already available to the public. 

284 In several cases, information on production volume and uses for a chemical substance or group 

285 of chemical substances was claimed CBI on Form U, while the same or similar information was 

286 submitted voluntarily by the company without such a claim under the HPV Challenge Program. 

287 In those cases, EPA had previously made the information publicly available through the High 

288 Production Volume Information System (HPVIS) or on EPA‘s Existing Chemicals website. 

289 More detailed CBI substantiation requirements will encourage the correct designation of non290 confidential reported information, thereby facilitating reporting of this information to the public. 

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

292 chemical management program, including the development of new regulatory risk management 

293 actions, the development of Chemical Action Plans targeting the Agency‘s risk management 

294 efforts, requiring the reporting of information needed to understand chemical risks, and 

295 increasing public access to information about chemical substances (Ref. 4). The IUR provides 

296 exposure-related data needed to understand chemical risks. The modifications to the IUR rule 

297 will enhance the capabilities of the Agency to ensure risk management actions are taken on 

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

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

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

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

302 address potential risks posed by chemical substances and provide improved access and 

303 information to the public. 

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

305 available, non-CBI information, therefore increasing the transparency and public accessibility of 

306 the chemical substance use, and exposure information and ensuring consistency with the 

307 President‘s policy goals for government reliance on and public availability of scientific 

308 information.

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

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

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

312 includes both the modified and the unmodified portions of the regulatory text (see 40 CFR part 

313 711). EPA has also developed guidance documents with specific reporting instructions, questions 

314 and answers, and case studies, and intends to conduct a webinar to help potential IUR submitters 

315 become familiar with the revised reporting form (Form U) and amended reporting requirements. 
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316 Guidance documents and information on the webinar are available on the IUR website, 

317 www.epa.gov/iur.

318 A. What technical modifications have been made to the regulatory text? The Agency is 

319 making several technical modification related to moving the regulatory text to its own section in 

320 the CFR. The chemical substances that are covered by the IUR rule are on the Master Inventory 

321 File, which includes chemical substances from the original TSCA Inventory compilation and 

322 those added subsequently through the notice requirements of TSCA section 5. Because the IUR 

323 rule applies to a list of chemical substances included on the original TSCA Inventory plus 

324 additional chemical substances added subsequently, and because the Agency from time to time 

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

326 should be in its own section in the CFR, distinct from both the original TSCA Inventory rules 

327 and from the TSCA section 5 requirements. 

328 1. Move the IUR regulatory text from 40 CFR part 710, subpart C, to 40 CFR part 711 

329 and eliminate subpart divisions. Subpart C of 40 CFR part 710, 40 CFR 710.43 to 710.59, 

330 contains the IUR regulatory text. EPA is moving all of the subpart C text from 40 CFR part 710 

331 to a new 40 CFR part 711 and adding a new scope and compliance section (40 CFR 711.1). 

332 Table 1.—Relocation of 40 CFR 710, Subpart C Provisions

Old CFR Citation New CFR Citation

40 CFR 710.43 40 CFR 711.3

40 CFR 710.45 40 CFR 711.5

40 CFR 710.46 40 CFR 711.6

40 CFR 710.48 40 CFR 711.8

40 CFR 710.49 40 CFR 711.9

40 CFR 710.50 40 CFR 711.10

40 CFR 710.52 40 CFR 711.15

40 CFR 710.53 40 CFR 711.20

40 CFR 710.55 40 CFR 711.22

40 CFR 710.57 40 CFR 711.25

40 CFR 710.58 40 CFR 711.30

40 CFR 710.59 40 CFR 711.35

333
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334 Because all of the text of subpart C was moved to 40 CFR part 711, 40 CFR part 710 no longer 

335 has a subpart C. Neither 40 CFR part 710 nor 40 CFR part 711 have any subparts.

336 2. Consolidate definitions. As part of moving the regulatory text from 40 CFR part 710, 

337 subpart C, to 40 CFR part 711, EPA is consolidating definitions copied from 40 CFR 710.3 and 

338 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropriate definition is already in 

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

340 711.3 was therefore unnecessarily duplicative. The definitions in TSCA section 3 and at 40 CFR 

341 704.3 are incorporated into 40 CFR 711.3, except insofar as 40 CFR 711.3 provides a modified 

342 definition of a term also defined at 40 CFR 704.3.

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

344 the IUR rule, EPA is incorporating the definition of mixture from TSCA section 3. The TSCA 

345 mixture definition differs from the definition in 40 CFR 710.3 and 40 CFR 720.3, the regulations 

346 used to determine the chemical substances listed on the TSCA Inventory, in that it does not 

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

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

349 For this reason, EPA believes it is superfluous to include a specific discussion of hydrates in the 

350 IUR definition of mixture. Please see the instruction manual for additional discussion (Ref. 5).

351 Unit II.E.3 contains further discussions about changes to specific definitions, in relation 

352 to the modifications included in this final rule. A summary of all IUR-related definitions is 

353 available in the docket (Ref. 6).

354 3. Delete non-isolated intermediate definition from 40 CFR 710.3. EPA added a 

355 definition to 40 CFR 710.43 for the term ―non-isolated intermediate‖ as part of the 2003 

356 Amendments. Subsequently, as part of the IUR Revisions Rule published in the Federal 

357 Register issue of December 19, 2005 (Ref. 7), EPA erroneously moved the definition to 40 CFR 

358 710.3 from 40 CFR 710.43. EPA is deleting the definition from 40 CFR 710.3 as this definition 

359 was not associated with the original TSCA Inventory, and therefore does not belong in 40 CFR 

360 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, is incorporated into the 

361 IUR definitions at 40 CFR 711.3.

362 4. Delete subpart B text. EPA is deleting the regulatory text contained in 40 CFR part 

363 710, 40 CFR 710.23 to 710.39 (subpart B). This text refers to IUR submission periods of 2002 

364 and earlier and is obsolete. As noted in 40 CFR 710.1, the Agency expressed its intent to remove 

365 subpart B once the 2002 update was complete.

366 5. Delete superfluous text associated with reporting production volumes. EPA is deleting 

367 the phrase ―provided that the reported figures are within ±10% of the actual volume‖ from the 

368 production volume reporting requirements found in 40 CFR 710.52(c)(3)(iv), which appears in 

369 the new 40 CFR part 711 as 40 CFR 711.15(b)(3)(iv). The revised wording would be ―This 

370 amount must be reported to two significant figures of accuracy.‖ The deleted phrase is 

371 superfluous because any number reported accurately to two significant figures is within 10% of 

372 the correct value.
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373 6. Correct text associated with reporting number of sites and number of workers. EPA is 

374 replacing the phrase ―less than‖ with the phrase ―fewer than‖ in the ranges used to report the 

375 number of workers found in the table in 40 CFR 710.52(c)(3)(v), which appears in the new 40 

376 CFR part 711 as 40 CFR 711.15(b)(3)(vii) and the number of sites found in the table in 40 CFR 

377 710.52(c)(4)(i)(E), which appears in the new 40 CFR part 711 as 40 CFR 711.15(b)(4)(i)(E). 

378 This change makes the phrases describing the ranges grammatically correct.

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

380 use of Agency-provided, web-based reporting software (e-IURweb) and CDX to submit the 

381 completed Form U to the Agency. After the final rule‘s effective date, EPA will no longer 

382 accept paper submissions or electronic media (i.e., as a file on a CD-ROM) for any IUR 

383 submission. 

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

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

386 submissions using CDX; this requirement predates today‘s final rule. EPA has modified the 

387 2006 electronic signature agreement (ESA) form to identify more clearly the individual(s) 

388 required to sign the agreement (Ref. 8). Each IUR submission must have an authorized official 

389 associated with the submission, who is the person signing the certification statement and 

390 submitting the IUR report via CDX. The authorized official must complete both an ESA and the 

391 CDX registration process. Companies can access the reporting software upon completion of their 

392 CDX registration. The instruction manual and other guidance materials are available on EPA‘s 

393 website at www.epa.gov/iur. 

394 C. What definitions have been modified or added to clarify the reporting requirements?

395 As part of developing the definition section for 40 CFR part 711, EPA is modifying six 

396 definitions associated with the IUR rule and adding four new definitions. In 40 CFR 704.3 and 

397 40 CFR 710.3, EPA is also modifying the definition of importer by removing the citation to 19 

398 CFR 1.11. 

399 1. Manufacture and manufacturer. To improve the information submitted through the 

400 IUR rule, EPA is modifying the definition of manufacture by incorporating elements from the 40 

401 CFR 720.3 definition for manufacturer. The Agency is also adding a simple definition for the 

402 term manufacturer to 40 CFR 711.3. In addition to the change to the definition of manufacture, 

403 EPA is adding a paragraph (c) to the regulation at 40 CFR 711.22 to clarify the reporting 

404 relationship between the contracting company and the toll manufacturer. The contracting 

405 company and the toll manufacturer should confer with each other to avoid duplicate reporting, 

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

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

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

409 contracting company and the toll manufacturer should determine among themselves who should 

410 submit the required report for the site. EPA also added ―per site‖ in two places in paragraph (c) 

411 to specify that there is supposed to be one report per chemical, per site. See Unit III.3.b. for 

412 further discussion of the site for contract manufacturing situations.

413 This final rule defines the term manufacture under the IUR to mean ―to manufacture, 

414 produce, or import, for commercial purposes. Manufacture includes the extraction, for 
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415 commercial purposes, of a component chemical substance from a previously existing chemical 

416 substance or a complex combination of substances. When a chemical substance, manufactured 

417 other than by import, is:

418 (1) Produced exclusively for another person who contracts for such production, and (2) 

419 that other person specifies the identity of the chemical substance and controls the total amount 

420 produced and the basic technology for the plant process, that chemical substance is 

421 comanufactured by the producing manufacturer and the person contracting for such production.‖

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

423 manufactures a chemical substance.‖

424 2. Site. EPA is amending the definition of site to clarify that the importer‘s site must be a 

425 U.S. address; accommodate manufacturing under contract; and accommodate portable 

426 manufacturing units. See Unit III10. for a further discussion of this final rule as it relates to 

427 importers. 

428 This final rule defines the term site under the IUR to mean ―a contiguous property unit. 

429 Property divided only by a public right-of-way shall be considered one site. More than one plant 

430 may be located on a single site.

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

432 site is the location where the chemical substance is physically manufactured.

433 (2) The site for an importer who imports a chemical substance described in 40 CFR 711.5 

434 is the U.S. site of the operating unit within the person's organization that is directly responsible 

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

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

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

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

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

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

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

442 Exchange (CDX) and e-IURweb. The Agency is adding these terms to provide clarity to the 

443 requirement for electronic reporting of IUR data. The term CDX means ―EPA‘s centralized 

444 electronic document receiving system, or its successors.‖ The term e-IURweb means the 

445 ―electronic, web-based IUR software provided by EPA for the completion and submission of the 

446 IUR data.‖

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

448 commercial use and consumer use in order to make them more consistent with the definitions 

449 developed collaboratively by the United States and Canada. See Unit II.E.6.h. for further 

450 information. While the definitions for these two terms differ in their precise wording from the 

451 Canadian version (to preserve the use of terminology defined in IUR and related regulations), 

452 EPA does not expect the basic application of these two terms to differ from the basic application 

453 of the Canadian definitions (Ref. 9). The term commercial use means ―the use of a chemical 
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454 substance or a mixture containing a chemical substance (including as part of an article) in a 

455 commercial enterprise providing saleable goods or services.‖ Examples included in the 40 CFR 

456 710.43 definition have been eliminated. The slightly modified definition of consumer use is ―the 

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

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

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

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

461 defined industrial use and did not define industrial function. The inclusion of both definitions 

462 provides clarity for the industrial processing and use reporting requirements and makes the 

463 Agency‘s requirements consistent with those collaboratively developed with Canada (Ref. 9). 

464 Additional discussion of those requirements is in Unit III.E.6.g. With this final rule, industrial 

465 function means ―the intended physical or chemical characteristic for which a chemical substance 

466 or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, 

467 or article; repackaged; or used.‖

468 5. Principal reporting year and submission period. As described in Unit II.A., EPA is 

469 changing the reporting cycle from every 5 years to every 4 years and requiring the reporting of 

470 production volumes for each calendar year since the last principal reporting year. EPA is 

471 modifying the terms reporting year and submission period to reflect these changes.

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

473 ―information‖ with ―manufacturing, processing and use data.‖ These changes are to indicate 

474 that the principal reporting year is the year in which most of the reported data are based. Under 

475 the final rule, the principal reporting year is the latest complete calendar year preceding the 

476 submission period. Additionally, EPA is removing the reference to ―the calendar year at 5–year 

477 intervals thereafter‖ and removing the reference to ―calendar year 2005.‖ With these changes, 

478 the term principal reporting year is defined as ―the latest complete calendar year preceding the 

479 submission period.‖

480 The term submission period is modified by deleting the phrase ―generated during the 

481 reporting year.‖ With this change, the definition of submission period reflects that data for years 

482 in addition to the principal reporting year would be reported. With this change, the definition of 

483 submission period means ―the period in which manufacturing, processing, and use data are 

484 submitted to EPA.‖

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

486 reporting frequency to every 4 years. The Agency has determined that reporting every 5 years is 

487 too infrequent and believes that returning reporting to every 4 years will provide data sufficiently 

488 current to meet Agency and public needs. After the 2011 reporting cycle, the next reporting 

489 under the IUR rule will occur in 2015. The submission period will continue to occur in the year 

490 following the principal reporting year. 

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

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

493 (including importing) site. EPA has made three changes related to the reporting thresholds:
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494 Determination of whether you meet the 25,000 lb. threshold.

495 Elimination of the 300,000 lb. threshold for reporting information in Part III of 

496 Form U.

497 Elimination of the 25,000 lb. threshold for certain chemical substances.

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

499 For the 2011 submission period, manufacturers (including importers) are required to report under 

500 the IUR rule if they manufacture (including import) a chemical substance listed on the TSCA 

501 Inventory during the principal reporting year (i.e., 2010 for the 2011 submission period); the 

502 chemical substance is not otherwise exempt; and the associated production volume (domestically 

503 manufactured plus imported volumes) at a site met or exceeded 25,000 lb. during the principal 

504 reporting year (i.e.., 2010 for the 2011 submission period).

505 For submission periods subsequent to the 2011 submission period, the determination of 

506 the need to report is based on whether, for any calendar year since the last principal reporting 

507 year, a chemical substance was manufactured (including imported) at a site in production 

508 volumes of 25,000 lb. or greater. For example, for the 2015 submission period, it would be 

509 necessary to examine the annual production volumes for the calendar years 2011 to 2014 for the 

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

511 any calendar year during that four year period, then it would be necessary to report the chemical 

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

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

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

515 submission would contain detailed information based on the production volume during the 2014 

516 calendar year and production volume information only for the years 2011 through 2013. See Unit 

517 III.D.1 of the proposed rule preamble for further discussion. 

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

519 substances, even larger production volume chemical substances, often experience wide 

520 fluctuations in production volume from year to year. (See Unit III.D.1 in proposed rule.) This 

521 can result in the production volume of a chemical substance exceeding the threshold for several 

522 years, then falling below the threshold during the IUR principal reporting year. EPA believes 

523 that using production volume reporting for all years since the last principal reporting year to 

524 determine reporting obligations will yield a much more accurate picture of the chemical 

525 substances currently in commerce, ensuring proper review under EPA‘s risk screening, 

526 assessment, and management activities and providing better information to the public. This issue 

527 is addressing further in Unit V.C. of this preamble as well as the response to public comments 

528 (Ref. 13). 

529 2. Elimination of the 300,000 lb. threshold for processing and use information. EPA is 

530 eliminating the 300,000 lb. threshold for processing and use information, thereby requiring all 

531 submitters of non-excluded chemical substances to report information in all parts of Form U. 

532 EPA is eliminating this reporting threshold in order to collect information necessary to complete 

533 screening-level exposure characterizations for IUR reportable chemical substances. The 

534 exposure information is an essential part of developing risk evaluations and, based on its 
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535 experience in using this information, the Agency believes that collecting this exposure 

536 information is critical to its mission of characterizing exposure, identifying potential risks, and 

537 noting uncertainties for these lower production volume chemical substances. In addition, this 

538 change will provide the public with information on a greater number of chemical substances.

539 3. Elimination of the 25,000 lb. threshold for certain regulated chemical substances. EPA 

540 is eliminating the 25,000 lb. reporting threshold for certain chemical substances that are the 

541 subject of particular TSCA rules and/or orders and requiring manufacturers (including importers) 

542 of such chemical substances to report under the IUR rule, regardless of the production volume. 

543 EPA is eliminating the 25,000 lb. threshold for those chemical substances that are:

544 • The subject of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 

545 6,

546 • The subject of an order issued under TSCA section 5(e) or 5(f), or

547 • The subject of relief that has been granted under a civil action under TSCA section 5 or 

548 7.

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

550 demonstrated high interest to the Agency. EPA is promulgating this change to ensure the 

551 availability of current information when the Agency has expressed a concern in the form of 

552 regulatory action on those chemical substances, regardless of the production volume. EPA will 

553 use the IUR data associated with these regulated chemical substances to monitor chemical 

554 substance production and compliance with the rules.

555 Under this final rule, for the 2011 submission period, a manufacturer (including importer) 

556 of such chemical substances is required to report information on the manufacturing, processing, 

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

558 quantity of these chemical substances during the principal reporting year (i.e., 2010) and must 

559 report the production volumes for each year from 2006 to 2010 and the full manufacturing, 

560 processing, and use information for 2010. 

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

562 chemical substances is required to report information on the manufacturing, processing, and use 

563 of the chemical substances if that person manufactured (including imported) any quantity of 

564 these chemical substances during any of the years since the last principal reporting year, 

565 including quantities under 25,000 lb. For 2015 reporting, the manufacturer must consider the 

566 manufacture or import during the years 2011 through 2014; must report the production volumes 

567 for each year from 2011 to 2014; and must report the full manufacturing, processing, and use 

568 information for 2014. 

569 In the IUR proposal, EPA specifically sought comment on whether circumstances 

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

571 include the proposal of certain rules for the chemical, under TSCA section 5(a)(2), 5(b)(4), or 6. 

572 EPA explained that such an approach would more closely parallel the exception language in the 

573 introductory paragraph to 40 CFR 711.6 and in 40 CFR 711.9. (See Unit III.D.3 of the preamble 

574 of the proposal, at 75 FR 49664). Including these types of proposed rules in the list of triggering 
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575 circumstances is also more consistent with reporting obligations under other parts of TSCA, such 

576 as 12(b). Among other situations, reporting under TSCA 12(b) is required when any rule under 

577 section 5 or 6 is proposed or promulgated. In response to the comments received, EPA has 

578 determined that chemical substances subject to a rule proposed under TSCA section 5(a)(2), 

579 5(b)(4), or 6 will be excepted from the 25,000 lb. reporting threshold, and thus will be reportable 

580 at any production volume. See Unit V.C.2. of this preamble for further discussion. 

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

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

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

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

585 chemical substances for which IUR reporting is not required (40 CFR 711.6(a)(1)). However, 

586 three polymers were previously listed in the partially exempt list of chemical substances at 40 

587 CFR 710.46(b)(2)(iv): Starch (CASRN 9005–25–8), Dextrin (CASRN 9004–53–9), and 

588 Maltodextrin (CASRN 9050–36–6). EPA has removed from the partially exempt list of 

589 chemical substances at 40 CFR 711.6(b)(2)(iv) these three chemical substances which, as 

590 polymers, are fully exempt from reporting.

591 3. Chemical substances that are the subject of an Enforceable Consent Agreement (ECA) 

592 are ineligible for exemptions. EPA may enter into an ECA, pursuant to procedures at 40 CFR 

593 part 790, with a manufacturer of a chemical substance to obtain testing where a consensus exists

594 among EPA, affected manufacturers and/or processors, and interested members of the public 

595 concerning the need for and scope of testing. Chemical substances that are the subject of an 

596 ECA are now included in the list of chemical substances that are ineligible for an IUR 

597 exemption, in the introductory paragraph of 40 CFR 711.6, along with the other chemical 

598 substances that are likewise not eligible for an IUR exemption. The paragraph states that a 

599 chemical substance ―is not exempted from any of the reporting requirements of this part if that 

600 substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 

601 of the Act, or is the subject of a consent agreement developed under the procedures of 40 CFR 

602 part 790, or is the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject 

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

604 G. What changes have been made to reportable data elements? 1. Parent company and 

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

606 Dun & Bradstreet D-U-N-S® (D&B) number to identify the company associated with the plant 

607 site, and also to report the site name, address, and D&B number. If the company associated with 

608 the plant site does not have a D&B number, the manufacturer (including importer) must obtain 

609 one for the company. Likewise, if the plant site does not have a D&B number, the manufacturer 

610 (including importer) must obtain one for the site. EPA received a variety of questions 

611 concerning the correct company name to report during the 2006 IUR submission period. EPA is 

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

613 company name provided be the parent company name. EPA believes this change will reduce 

614 confusion by making this reporting requirement consistent with the Toxic Release Inventory 

615 (TRI) requirements for parent company name. For further clarification regarding the correct 

616 parent company name and the distinction between domestic (U.S.) and foreign parent company, 
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617 in particular for the small business determination, please refer to the ―Instructions for 2011 

618 Inventory Update Reporting‖ (Ref. 5). The 2006 IUR submissions from different reporting sites 

619 contained varying D&B numbers for parent companies that appeared to be the same company. 

620 In order to better identify when reporting sites are under the same parent company, EPA is 

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

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

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

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

625 questions EPA may have about the reported chemical substance. In the proposed rule, EPA had 

626 stated that the technical contact should be a person located at the manufacturing (including 

627 importing) site. EPA has decided, however, to not impose limitations on where the technical 

628 contact can be located. Therefore, companies may use their discretion in selecting a technical 

629 contact or multiple technical contacts, as provided by the new e-IURweb software. Submitters 

630 should consider, in selecting the technical contact, that EPA may have follow-up questions about 

631 an IUR submission, one or more years after the submission date. 

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

633 identity for each subject chemical substance. 

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

635 Name currently used to list the chemical substance on the TSCA Inventory as the chemical name 

636 reported for IUR. The reporting software will be directly linked to the nonconfidential portion of 

637 the TSCA Inventory through the Agency‘s Substance Registry Services (SRS) database, which 

638 lists all chemical substances on the TSCA Inventory. This link will enable submitters to select 

639 the correct CA Index Name for their reportable chemical(s) from SRS. EPA believes that using 

640 SRS to select the chemical name as currently listed on the TSCA Inventory will greatly reduce 

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

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

643 substances. Manufacturers (including importers) are allowed to supply, as part of a joint 

644 submission, an alternate chemical name, and in the case of importers, a trade name, in those 

645 instances where a supplier will not disclose to the submitter the specific chemical name of the 

646 imported TSCA Inventory chemical substance or a reactant used to manufacture the TSCA 

647 Inventory chemical substance. In these cases, the manufacturer (including importer) and the 

648 supplier may report the information required in this part in a joint submission. In order to clarify 

649 this requirement, EPA is amending 40 CFR part 711.15(b)(3)(i), to state that the importer must 

650 ask the supplier of the confidential chemical substance to directly provide EPA with the correct 

651 chemical identity, in a joint submission with the manufacturer. Similarly, in the event a 

652 manufacturer submitting a Form U cannot provide the whole chemical identity because the 

653 reportable chemical substance is manufactured using a reactant having an unknown specific 

654 chemical identity claimed as confidential by its supplier, the manufacturer must ask that the 

655 supplier directly provide to EPA the correct chemical identity of the confidential reactant in a 

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

657 importer) of its obligation to report information that it actually knows or can reasonably 

658 ascertain. See Unit III.10 for additional information regarding joint submissions. Detailed 

659 instructions regarding joint submissions are included in the instructions manual included in the 

660 docket (Ref. 5). 
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661 b. Chemical identifying number. As part of the chemical identity, submitters provide a 

662 chemical identifying number associated with the correct CA Index Name, as described in Unit 

663 II.E.7.c.i. EPA is requiring that submitters report only the CASRN as a chemical identifying 

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

665 chemical substances, EPA is requiring that submitters report only the TSCA Accession Number 

666 as a chemical identifying number. EPA is removing the Pre-manufacture Notification (PMN) 

667 number as an allowed chemical identifying number because each TSCA Inventory chemical 

668 substance has either (or both) a CASRN or a TSCA Accession Number, which are likely to be 

669 already known to the submitter. Submitters who, in the past, have reported using the PMN 

670 number of a confidential substance can identify the TSCA Accession Number from SRS by 

671 searching on the PMN number. Those submitters who are not able to identify the TSCA 

672 Accession Number by searching SRS may contact EPA in writing, if necessary, to learn the 

673 TSCA Accession Number assigned when the Notice of Commencement (NOC) was submitted to 

674 the Agency. Specific information is included in the Instructions for Reporting manual.

675 c. Chemical identity for substances listed on the confidential portion of the TSCA 

676 Inventory. In cases where a chemical is listed on the confidential portion of the TSCA Inventory, 

677 submitters are to report the chemical‘s Accession Number and generic name, which are listed on 

678 the non-confidential portion of the TSCA Inventory and are included in SRS. In order to 

679 continue to protect the confidentiality of the underlying specific chemical identification 

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

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

682 confidentiality claim for the underlying CASRN and specific chemical name on the confidential 

683 portion of the TSCA Inventory (the Accession Number and generic chemical name remain non684 confidential). Failure to identify the chemical identity as CBI and complete the upfront 

685 substantiation will waive any CBI claim to the chemical identity and will result in the transfer of 

686 the chemical from the confidential portion of the TSCA Inventory to the non-confidential, 

687 publicly releasable, portion of the TSCA Inventory.

688

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

690 production volume information for each chemical substance for which they submit an IUR 

691 report. EPA has made a number of changes to the reporting of production volume and associated 

692 information. 

693 a. Report production volume for each of the years since the last principal reporting year. 

694 EPA is requiring reporting of production volume for each year since the last IUR principal 

695 reporting year. Thus, for the 2011submission period, manufacturers (including importers) of a 

696 chemical at or above the 25,000 lb. threshold during the principal reporting year will report the 

697 production volume of that chemical substance for each of the following calendar years: 2010, 

698 2009, 2008, 2007, and 2006. Collecting the production volume for multiple years will provide 

699 greater detail than the current once-every-reporting cycle snapshot.

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

701 production volume will continue to be reported separately on the same report. EPA review and 

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

703 multiple reports for the same chemical substance, at times reporting the information associated 
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704 with domestic manufacturing and importing in different reports. Submitters should complete 

705 only one report for each chemical substance.

706 b. Volume of chemical substance used on-site. EPA is requiring that submitters report the 

707 volume of a manufactured (including imported) chemical substance used at the reporting site. 

708 The requirement to report the volume used on-site is replacing the requirement to indicate that 

709 the chemical substance is site-limited. Under this final rule, either domestically manufactured or 

710 imported chemical substances can be reported as used at the reporting site.

711 c. Indicate whether imported chemical substances are physically at reporting site. EPA is 

712 adding a requirement to indicate whether an imported chemical substance is physically at the 

713 reporting site. Often, the site reporting an imported chemical substance never physically 

714 receives the chemical substance, but instead ships it directly to another location such as a 

715 warehouse, a processing or use site, or a customer‘s site. 

716 d. Report volume exported. EPA is adding a requirement to report the production volume 

717 directly exported and not domestically processed or used. This will allow EPA to better identify 

718 the proportion of the production volume accounted for by the processing and use reporting, given 

719 that such downstream reporting is not required for directly exported chemical substances.

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

721 or reused. In the proposed rule, EPA sought comment on adding a checkbox indicating whether 

722 a manufactured chemical substance was recycled, remanufactured, reprocessed, reused, or 

723 reworked. In response to the comments received, EPA has determined that the term ―reworked‖ 

724 may be interpreted and applied too broadly to provide the type of information that EPA needs to 

725 collect and has removed ―reworked‖ from the list of recycling synonyms, but has chosen to 

726 otherwise finalize this reporting requirement as proposed. Consequently, EPA is adding a 

727 requirement to indicate whether a manufactured chemical substance, such as a byproduct, is to be 

728 recycled, remanufactured, reprocessed, or reused. Submitters should indicate whether their 

729 manufactured chemical substance, which otherwise would be disposed of as a waste, is being 

730 removed from the waste stream and has a commercial purpose (i.e., it is being recycled, 

731 remanufactured, reprocessed, or reused). Indicating that a manufactured chemical, such as a 

732 byproduct, is to be recycled, remanufactured, reprocessed, or reused does not affect the reporting 

733 requirements associated with any chemical substance manufactured from the byproduct. See 

734 Unit II.F.2. for detailed information on byproduct reporting.

735 6. Concentration ranges. EPA is eliminating gaps in the ranges used to report 

736 concentration in 40 CFR 711.15(b)(3) and (4)). The ranges are now:

737 • Less than 1% by weight.

738 • At least 1% but less than 30% by weight.

739 • At least 30% but less than 60% by weight.

740 • At least 60% but less than 90% by weight.

741 • At least 90% by weight.
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742 7. Industrial processing and use information reporting. EPA is revising the list of 

743 industrial function categories and replacing the NAICS codes with industrial sector categories, as 

744 described in sections i. and ii.

745 a. Industrial function categories. EPA is revising the list of industrial function categories 

746 by combining categories that lead to common exposure scenarios and adding categories where 

747 the Agency believes the existing categories do not adequately describe potential uses. EPA 

748 worked with Environment Canada and Health Canada to develop the set of categories, which 

749 will be used by both the United States and Canada for inventory reporting (Ref. 9).

750 EPA is adding eight new industrial function categories and deleting six existing 

751 categories from the previous list; the total number of industrial function categories has increased 

752 to 35. Also, EPA is renaming several of the industrial function categories to provide a more 

753 informative description of the function of chemical substances that should be reported in that 

754 category. Lastly, EPA is requiring that if a submitter selects the category ―Other,‖ the submitter 

755 must provide its own description of the industrial function of the chemical substance. EPA is 

756 using the industrial function categories listed in Table 1 of this unit:

757 Table 1.—Codes for Reporting Industrial Function Categories

Code Category

U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents

U008 Dyes

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
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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)

758

759 b. Industrial sectors. EPA is replacing the 5–digit NAICS codes with 48 IS codes (Ref. 

760 10). The sectors were adapted from the European Union‘s (EU‘s) ―Guidance on Information 

761 Requirements and Chemical Safety Assessment.‖ The IS codes divide the entire range of 

762 NAICS codes into sectors so that there is a sector corresponding to any NAICS code (see the 

763 Instructions for Reporting). The use of the sectors will reduce the number of unique 

764 combinations, thereby increasing the usability of the data, and also reducing the IUR reporting 

765 burden.

766 EPA is using the 48 sectors listed in Table 2 of this unit:

767 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
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IS22 Plastics Material and Resin Manufacturing

IS23 Synthetic Rubber Manufacturing

IS24 Organic Fiber Manufacturing

IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

IS26 Pharmaceutical and Medicine Manufacturing

IS27 Paint and Coating Manufacturing

IS28 Adhesive Manufacturing

IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing

IS30 Printing Ink Manufacturing

IS31 Explosives Manufacturing

IS32 Custom Compounding of Purchased Resins

IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing

IS34 All Other Chemical Product and Preparation Manufacturing

IS35 Plastics Product Manufacturing

IS36 Rubber Product Manufacturing

IS37 Non-metallic Mineral Product Manufacturing (includes clay, glass, cement, 

concrete, lime, gypsum, and other non-metallic mineral product 

manufacturing)

IS38 Primary Metal Manufacturing

IS39 Fabricated Metal Product Manufacturing

IS40 Machinery Manufacturing

IS41 Computer and Electronic Product Manufacturing

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)

768

769 When the category reported for the IS code is ―Other,‖ the submitter is required to 

770 provide a written description of the use of the chemical substance, which may include the 

771 NAICS code.

772 8. Consumer and commercial use reporting. EPA is making four changes to the 

773 consumer and commercial information required to be reported: 

774 • Revising and expanding the list of consumer and commercial product categories.

775 • Requiring the provision of a description when the product category ―Other‖ is reported.

776 • Identifying whether the use is a consumer or a commercial use, or both.

777 • Reporting the number of commercial workers reasonably likely to be exposed while 

778 using the reported chemical substance.
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779 Reporting associated with children‘s use, the maximum concentration, and the percent 

780 production volume remains unchanged.

781 a. Consumer and commercial product categories. EPA is revising the list of consumer 

782 and commercial product categories by combining categories that lead to common exposure 

783 scenarios and adding categories that were not adequately described in the initial set of categories. 

784 EPA worked with Environment Canada and Health Canada to develop the categories. 

785 Harmonized categories will facilitate consistent reporting of chemical substance use information 

786 by industry in the United States and Canada (Ref. 9).

787 The list includes 33 product categories, including ―Other.‖ Examples of new categories 

788 which have been added include explosive materials, building/construction products not covered 

789 elsewhere, and air care products. The glass and ceramic products category had relatively few 

790 IUR submissions in 2006 and overlaps with the new categories, and so has been eliminated. 

791 Also, several of the consumer and commercial product categories have been renamed to better 

792 describe the products that should be reported in those categories. In addition to revising the 

793 overall product categories, narrower definitions and expanded lists of examples of products in 

794 which the chemical substance would be used will be added to each category descriptor. The 

795 examples were selected to include items that could have fit into other categories in order to 

796 address the overlap inherent in any product category list. The product categories were then 

797 placed into several broader groupings, e.g., ―Chemicals with Agriculture and Outdoor Uses‖ 

798 based on the similarities of products. EPA believes that the user will find the current groupings 

799 easier to use than the alphabetical listing used for the 2006 IUR. EPA is also requiring that if a 

800 submitter chooses the product category ―Other,‖ the submitter must include a text description for 

801 the consumer and commercial product containing the chemical substance. 

802 EPA is using the consumer and commercial product categories listed in Table 3 of this 

803 unit:

804 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
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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)

805

806 b. Designation of consumer or commercial use. EPA is requiring submitters to designate, 

807 via a checkbox, whether the indicated product category is a consumer or a commercial use, or 

808 both. 

809 c. Number of commercial workers reasonably likely to be exposed. EPA is requiring that 

810 submitters report the total number of commercial workers, including those at sites not under the 

811 submitter‘s control, that are reasonably likely to be exposed while using the reportable chemical 

812 substance, with respect to each commercial use. The approximate number of workers should be 

813 reported using the same definitions and ranges used for manufacturing and industrial processing 

814 and use workers required by 40 CFR 711.15(b)(3)(vii) and (4)(i)(F), respectively. The ranges 

815 are:

816 • Fewer than 10 workers.

817 • At least 10 but fewer than 25 workers.

818 • At least 25 but fewer than 50 workers.

819 • At least 50 but fewer than 100 workers.

820 • At least 100 but fewer than 500 workers.
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821 • At least 500 but fewer than 1,000 workers.

822 • At least 1,000 but fewer than 10,000 workers.

823 • At least 10,000 workers.

824 H. What changes have been made to the standard for the reporting of processing and use 

825 information? In order to collect more complete information regarding industrial processing and 

826 use, and commercial and consumer use of chemicals, EPA is, in 40 CFR 711.15(b)(4), replacing 

827 the ―readily obtainable‖ reporting standard used for reporting under 40 CFR 710.52(c)(4) with 

828 the ―known to or reasonably ascertainable by‖ reporting standard set forth under TSCA section 

829 8(a)(2). This is the same standard that applied to the reporting of information described in the 

830 regulations at 40 CFR 710.52(c)(1), (c)(2), and (c)(3) for the 2006 IUR submission, and this 

831 standard continues to apply to the reporting of such information under 40 CFR 711.15(b)(1), 

832 (b)(2), and (b)(3). This standard covers all information in a person‘s possession or control, plus 

833 all information that a reasonable person similarly situated might be expected to possess, control, 

834 or know. EPA would like to clarify that submitters are not required to conduct customer surveys 

835 under this standard, but to the extent that reasonable efforts to analyze or synthesize already836 available customer surveys may inform processing and use information that is reported, the 

837 information is generally ―reasonably ascertainable.‖ EPA‘s reporting software permits submitters 

838 to enter ―NKRA‖ on Form U to address circumstances where the information is not known to or 

839 reasonably ascertainable by the submitter. 

840 I. What changes have been made to requirements for making CBI claims? EPA is making 

841 several changes to the requirements for claiming information as confidential. Submitters may 

842 claim certain information reported under the IUR as CBI in accordance with 40 CFR part 2 and 

843 IUR rules at 40 CFR 711.30. Claims of confidentiality may be made for chemical identity, site 

844 identity, and processing and use information, and submitters must substantiate these claims at the 

845 time information is submitted to EPA. EPA‘s procedures for handling information claimed as 

846 confidential are set forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to 

847 review confidentiality claims carefully to ensure that the information in question falls within the 

848 parameters of TSCA section 14. EPA cautions submitters that they may be subject to criminal 

849 penalties under 18 U.S.C. § 1001 if they knowingly and willfully make a false statement in 

850 connection with the assertion of a CBI claim. CBI claims should be limited to only those data 

851 elements the release of which would likely cause substantial harm to the business‘ competitive 

852 position. Interested persons are reminded that with regard to chemical substance use 

853 information, EPA is interested in aggregated, general uses, not detailed uses associated with 

854 specific customers.

855 To claim information as confidential, a submitter must indicate its claim by both 

856 checking the appropriate box and signing the certification statement on the reporting form, and 

857 may also be required (depending on the data element) to provide substantiation of the claim at 

858 the time it is made. A submitter must indicate its claims at the time the information is submitted. 

859 If a submitter fails to follow these procedures, EPA may release the information to the public 

860 without further notice to the submitter. By signing the certification statement the submitter 

861 attests to the secrecy and value of the information for which confidentiality claims have been 

862 asserted.
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863 1. Chemical identity CBI claims. There is no substantive change to submitters' ability to 

864 make confidentiality claims for chemical identity in the IUR. As in the past, a submitter may 

865 assert a claim of confidentiality for the identity of the reported chemical substance only when the 

866 chemical is listed on the confidential portion of the TSCA Inventory. Submitters who assert a 

867 confidentiality claim for chemical identity must also provide substantiation for the claim at time 

868 of filing. See 40 CFR 711.30(b).

869

870 However, in response to comment, this final rule incorporates some changes to the 

871 process that must be used to in making this type of CBI claim. The proposed rule, at 40 CFR 

872 711.15(a)(3)(i), provided that ―[a] submitter under this part may use an EPA-designated TSCA 

873 Accession Number for a confidential chemical substance in lieu of a CASRN when a CASRN is 

874 not known to or reasonably ascertainable by the submitter.‖ In the proposed rule, EPA also 

875 noted that up to 5% of the reports submitted under the 2006 IUR contained chemical identity 

876 problems. EPA therefore proposed to require that submitters report using the CA Index Name 

877 currently used to list the chemical substance on the TSCA inventory. EPA further indicated that 

878 it would incorporate CASRNs and CA Index Names into the e-IURweb software, to the extent 

879 possible without jeopardizing confidentiality claims. EPA believes that selecting chemical 

880 identity from a pre-populated list, rather than keying in the chemical identity information, will 

881 significantly improve the accuracy and consistency of submitted reports.

882

883 EPA received several comments from industry groups requesting that the e-IURweb 

884 software incorporate security safeguards to adequately protect CBI. In light of the security 

885 concerns expressed in public comments, EPA has decided not to incorporate CASRNs and CA 

886 Index Names for chemicals on the confidential portion of the TSCA Inventory into the portions 

887 of the e-IURweb software that will be publicly accessible. However, EPA still believes it is 

888 important to require that all chemical identities be selected from a pre-populated list, to avoid 

889 repeating the chemical identity problems experienced with the 2006 IUR. Therefore, 40 CFR 

890 711.15(a)(3)(i) has been revised in this final rule to require that submitters who wish to report 

891 chemical substances listed on the confidential portion of the TSCA Inventory use the chemical‘s 

892 TSCA Accession Number and generic name. Requiring the use of accession numbers and 

893 generic names will allow EPA to adequately protect confidential CASRNs and CA Index Names 

894 (by omitting them from the pre-populated selection list) while still obtaining the improvements 

895 in reporting accuracy it sought in the proposed rule.

896

897 In SRS, a submitter can readily find a cross-reference list that displays the Accession 

898 Number, generic chemical name, and the PMN case number (or for an initial Inventory 

899 substance, the Inventory reporting form number) for any confidential chemical substance listed 

900 on the Inventory. Submitters who wish to retain the CBI claim for the chemical substance 

901 identified by the Accession number must assert and substantiate the claim at time of filing. 

902 Submitters who do not wish to retain the CBI claim for the chemical substance identity, and who 

903 wish the substance to be listed on the public portion of the TSCA Inventory, should not assert a 

904 CBI claim or provide substantiation. Submitters who fail to follow the required procedures for 

905 asserting CBI claims for chemical identity will waive the claims, and EPA may release the 

906 information without further notice to the submitter. See the regulatory text at 40 CFR 711.30(e). 

907 
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908 2. Upfront substantiation for processing and use information CBI claims. Under the IUR, 

909 a submitter may assert a claim of confidentiality for data associated with the processing and use 

910 of its chemical substance if the submitter has reason to believe that release of the information 

911 would reveal trade secrets, or confidential commercial or financial information, as provided by 

912 TSCA section 14 and 40 CFR part 2. Under this final rule, EPA is requiring upfront 

913 substantiation for CBI claims for processing and use information.

914 In order to submit a claim of confidentiality for processing and use information data 

915 elements, the submitter is required (in addition to signing the certification statement) to both 

916 check the appropriate box on the reporting form and substantiate the claim in writing, within the 

917 reporting software, by answering certain questions provided in 40 CFR 711.30(d). EPA revised 

918 the substantiation question at 40 CFR 711.30(d)(1)(ii), respecting competitive harm, to include 

919 harmful effect ―to your customer‘s competitive position.‖ Where a submitter fails to submit 

920 substantiation of the processing and use CBI claim in accordance with the applicable rules (i.e., 

921 the submitter does not provide an answer to all the required questions associated with the claim 

922 on the Form U it submits via e-IURweb), EPA will consider the information not subject to a 

923 confidentiality claim and may make the information available to the public without further notice 

924 to the submitter.

925 3. Prohibition of confidentiality claims for data elements identified as “not known or 

926 reasonably ascertainable.” EPA is prohibiting claims of confidentiality pertaining to the 

927 designation that information is ―not known or reasonably ascertainable.‖ As described in Unit 

928 II.A., for the 2011 and future IUR collections, submitters will be required to report processing 

929 and use information to the extent that it is known to or reasonably ascertainable by them. 

930 For the 2006 IUR collection, EPA observed that, on occasion, processing and use 

931 information was claimed as confidential when a submitter determined that the information was 

932 not readily obtainable. Section 14 of TSCA limits the disclosure of information entitled to 

933 confidential treatment under Exemption 4 of the Freedom of Information Act (FOIA). EPA has 

934 considered the NKRA designation and its relationship to a potential CBI or trade secret claim. 

935 Given that a NKRA assertion is an assertion that no information is available, the Agency does 

936 not believe that the designation conveys trade secret or confidential commercial or financial 

937 information. 

938 J. What changes specifically affect importers?

939 1. Importer site address. Submitters report IUR data on chemical substances that they 

940 manufacture domestically and that they import into the United States. Previously, the 

941 regulations defining the site for importer reporting were found in both the definition for site in 40 

942 CFR 710.3 and in paragraph 40 CFR 710.48(b). EPA is eliminating unnecessary duplication in 

943 the IUR regulation by moving the additional information regarding the importer site from 40 

944 CFR 710.48(b) into a revised definition for site at 40 CFR 711.3, as described in Unit II.F.3.b., 

945 and eliminating 40 CFR 710.48(b).

946 In addition, EPA has observed that submitters occasionally use a foreign address as the 

947 site address for the importer. EPA now is requiring that submitters report a U.S. site address, by 

948 modifying the definition for site to state specifically that the site must be a U.S. site. The U.S. 
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949 address of an agent acting on behalf of the importer, and authorized to accept service of process 

950 for the importer, may be reported as the importer‘s site address if the operating unit that is 

951 directly responsible for importing the chemical substance and that controls the import transaction 

952 has no U.S. address. The Agency expects that all importers will have a U.S. site, as defined in 

953 the 40 CFR 711.3 definition for site, because, under Customs regulations at 19 CFR 141.18, a 

954 non-resident corporation is not permitted to enter merchandise for consumption unless it has a 

955 resident agent in the State where the port of entry is located, who is authorized to accept service 

956 of process against the corporation.

957 2. Joint submissions. For purposes of IUR, submitters are allowed to report the IUR 

958 information jointly with the foreign supplier of a reportable chemical substance whose chemical 

959 identity is unknown to the importer. Previously, joint submissions could not be made 

960 electronically. EPA is now requiring that submitters use CDX and e-IURweb for preparation and 

961 submission of joint submissions. See 40 CFR 711.15(b)(3)(i)(C). Therefore, the authorized 

962 officials of the jointly submitting companies will need to register with CDX in order to submit a 

963 joint report to EPA.

964 Importers may not know the specific chemical identity of a chemical substance because 

965 the foreign supplier chooses to keep it confidential. In such a situation, the importer must use e966 IURweb to ask the foreign supplier to submit the chemical identity information directly to EPA 

967 through a joint report. To submit a joint report, the importer completes the majority of the 

968 required information, and supplies a trade name or other designation to identify the chemical 

969 substance, and provides contact information for the foreign supplier. The importer then uses e970 IURweb to contact the foreign supplier and request that the foreign supplier report the specific 

971 chemical identity information directly to EPA. The importer must submit a copy of such request 

972 to EPA, along with the rest of its IUR submission for the chemical substance. As a general 

973 matter, EPA expects that importers will supply the information described at 40 CFR 

974 711.15(b)(3)(i)(A), rather than an ―NKRA‖ designation, when importers do not know the 

975 confidential chemical identity of a chemical substance they import. EPA believes that an NKRA 

976 designation would generally only be appropriate in the unlikely event that an importer did not 

977 know, and could not reasonably ascertain, the information needed to link its submission with a 

978 secondary report from the supplier.

979 In an acceptable joint submission, the secondary submitter supplies the chemical identity, 

980 as well as its technical contact and company information, and provides the primary submitter‘s 

981 site information. EPA will not accept joint submissions that are not submitted electronically 

982 using e-IURweb and CDX. All information will be saved by the reporting software and both 

983 submissions will be matched based upon company and chemical information. Once the forms are 

984 linked, EPA will process the joint submission as one report for the reported chemical substance. 

985 See the guidance manual, available on EPA‘s website at www.epa.gov/iur, for detailed 

986 instructions on submitting a joint report.

987 IV. What clarifications have been made to reporting requirements?

988 1. Clarification of the Relationship Between Company Name and Site Identity CBI 

989 Claims. Under the IUR, submitters are able to separately claim as CBI the company name and 

990 site identity associated with a chemical substance for which they are reporting under the IUR. 
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991 The submitter is required to provide an upfront substantiation for CBI claims for the site identity. 

992 EPA believes there is some confusion as to what is considered confidential when such claims are 

993 made, and is taking this opportunity to provide clarification.

994 The CBI claim protects the link between the company and/or site identity and the 

995 particular chemical substance. If the company or site identity associated with a particular 

996 chemical substance is not claimed as CBI, EPA may make that information available to the 

997 public without further notice to the submitter. EPA will not impute the existence of a CBI claim 

998 for company identity or for site identity from a CBI claim associated with a different chemical 

999 substance.

1000 Company and site identity CBI claims are separate claims, and in some cases one type of 

1001 claim may be justified while the other is not. Therefore, a submitter is permitted to assert its CBI 

1002 claim for the company identity, the site identity, or both the company and site identity. Such 

1003 claims must be made for each chemical substance for which such claims are being made. 

1004 Because the circumstances for each chemical substance can vary, the IUR rule does not allow for 

1005 blanket claims covering all chemicals in a site‘s IUR report. 

1006 Likewise, the submitter must provide separately the required upfront substantiation for 

1007 the site identity CBI claims associated with each chemical substance. For instance, if the 

1008 submitter is reporting for five chemical substances and wishes to claim its site information 

1009 confidential for three of the five chemical substances, it must assert the claim and provide 

1010 separate upfront substantiation three times, once for each of the three chemical substances. 

1011 EPA has also observed that submitters sometimes claim only their company identity, and 

1012 not their site identity, as confidential. If the site identity for a particular chemical substance is 

1013 not claimed as CBI, or is claimed but not substantiated pursuant to 40 CFR 711.30(c), EPA may 

1014 make that information available to the public without further notice to the submitter. EPA will 

1015 not impute the existence of a CBI claim for site identity from a CBI claim for company identity, 

1016 even if the company name appears within the site identity information. To help ensure that 

1017 submitters consider this issue, the e-IURweb reporting software provides a warning whenever 

1018 the company identity is claimed as CBI for a particular chemical substance and the site identity is 

1019 not also claimed as CBI for that chemical substance.

1020 2. Explanation of Byproduct Reporting. During the 2006 submission period, EPA 

1021 received questions about the requirements for reporting byproducts. The questions included 

1022 whether byproduct manufacturers (including importers) were required to report the byproducts 

1023 under the IUR rule. Based on those and subsequent inquiries, and from the public comments 

1024 from the proposed rule, it is apparent that scope of the IUR obligation to report byproducts is not 

1025 well understood by industry. The scope of byproduct reporting has become a particularly 

1026 pertinent issue because (by the terms of the 2003 Amendments to the IUR) inorganic chemicals 

1027 are now no longer exempt from reporting under IUR, including (beginning with the 2011 IUR) 

1028 the information collection requirements for processing and use information. Inorganic chemicals 

1029 are often recycled, thereby triggering the need to report a byproduct substance that is recycled. 

1030 In an effort to further clarify reporting obligations, EPA is providing additional information on 

1031 byproduct reporting, including circumstances under which reporting is not required, in the 

1032 instruction manual and in other guidance materials included in the docket for this final rule 
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1033 (Refs. 5, 11, and 12) and on EPA‘s website at www.epa.gov/iur. For purposes of IUR, a 

1034 byproduct is a chemical substance produced without a separate commercial intent during the 

1035 manufacture, processing, use or disposal of another chemical substance or mixture (40 CFR 

1036 704.3). Thus, for example, when a chemical substance or mixture is used for the purpose of 

1037 manufacturing an article, and that manufacture results in the production of a different chemical 

1038 substance, that different chemical substance is a byproduct for purposes of the IUR. Chemical 

1039 substances that are byproducts of the manufacture, processing, use, or disposal of another 

1040 chemical substance or mixture, like any other manufactured chemical substances, are subject to 

1041 IUR reporting if they are listed in the TSCA Inventory, are not otherwise excluded from 

1042 reporting, and their manufacturer is not specifically exempted from IUR reporting requirements.

1043 The 40 CFR 704.3 definition of manufacture for commercial purposes states that 

1044 ―[m]anufacture for commercial purposes also applies to substances that are produced 

1045 coincidentally during the manufacture, processing, use, or disposal of another substance or 

1046 mixture, including both byproducts that are separated from that other substance or mixture and 

1047 impurities that remain in that substance or mixture. Such byproducts and impurities may, or may 

1048 not, in themselves have commercial value. They are nonetheless produced for the purpose of 

1049 obtaining a commercial advantage since they are part of the manufacture of a chemical product 

1050 for a commercial purpose.‖ Thus, byproducts of the manufacture, processing, use, or disposal of 

1051 another chemical substance or mixture for a commercial purpose are themselves both 

1052 ―manufactured‖ and ―manufactured for commercial purposes.‖ Also, considering the overall 

1053 context of this definition, EPA interprets ―chemical product‖ broadly to include any product of 

1054 the manufacturing, processing, use, or disposal of another chemical substance or mixture, other 

1055 than a byproduct.

1056

1057 Byproducts that are manufactured (including imported) in volumes of 25,000 lb. or more 

1058 at a single site are potentially subject to IUR requirements. However, 40 CFR 711.10(c) 

1059 excludes from reporting those chemical substances meeting the requirements of 40 CFR 

1060 720.30(g) or (h). Manufacturers (including importers) of byproducts are not required to report 

1061 the manufacture (including import) of a byproduct if the byproduct is not used for commercial 

1062 purposes. See 40 CFR 720.30(h)(2). Thus, even where a byproduct is manufactured (including 

1063 imported) for a commercial purpose, if the byproduct is not subsequently put to use for another 

1064 commercial purpose, the byproduct is excluded from IUR reporting. Furthermore, if the 

1065 byproduct‘s ―only commercial purpose is for use by public or private organizations that: (1) burn 

1066 it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract 

1067 component chemical substances from it for commercial purposes,‖ 40 CFR 720.30(g), that 

1068 byproduct is also excluded from IUR reporting. This exclusion applies only to the byproduct; it 

1069 does not apply to the component chemical substances extracted from the byproduct.

1070 Some manufacturers (including importers) of byproducts have expressed a belief that a 

1071 chemical substance that is regulated by another EPA program, such as under the Resource 

1072 Conservation and Recovery Act (RCRA), or that is exempt from certain requirements by the 

1073 other program based on certain treatments or disposals, should not be required to be reported for 

1074 IUR purposes. However, under this rule, when such chemical substances have a commercial 

1075 purpose not exempted by 40 CFR 720.30(g), the manufacturer (including importer) of such a 
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1076 chemical substance may have IUR reporting obligations, and is not relieved of those obligations 

1077 based on exemptions under other laws.

1078 V. Public Comments

1079 EPA carefully considered the comments it received on the proposed IUR modifications. 

1080 Major comments are discussed below. Additional comment summaries and more detailed 

1081 responses, including responses to most of the additional issues that EPA requested comment on, 

1082 are contained in the  ̳ ̳Summary of EPA‘s Responses to Public Comments Submitted in Response 

1083 to Proposed TSCA Inventory Update Reporting Modifications‘‘ (Ref. 13).

1084

1085 A. General Comments

1086

1087 1. Justification for Proposed Modifications. Several commenters supported many of 

1088 EPA‘s proposed reporting changes, stating that the changes will facilitate EPA‘s ability to track 

1089 chemicals used and made in the United States, which would strengthen EPA‘s ability to identify 

1090 chemicals for further assessment. They also noted that the IUR data not only supports activities 

1091 under EPA authorities, but is also used by other Federal agencies, the states, and other interested 

1092 stakeholders to identify potential chemicals of concern. Other commenters expressed the view 

1093 that EPA has not provided adequate justification supporting the Agency‘s need for the IUR data 

1094 and has not sufficiently tailored the requested information to meet EPA‘s goals. One commenter 

1095 did not agree that the modifications will increase the ―usability of collected information‖ or 

1096 ―focus reporting‖ on what is ―most needed‖ by EPA. Another commenter mentioned that the 

1097 Agency does not explain how the existing IUR fails to meet these goals or why an IUR 

1098 expansion is needed to carry out its Congressionally-mandated TSCA duties. Additionally, 

1099 commenters suggested that EPA should clearly indicate how the IUR data will be utilized in 

1100 programs that systematically review hazard and exposure of existing chemicals. 

1101

1102 EPA has an obligation under TSCA to protect human health and the environment from 

1103 unreasonable risks associated with chemicals under its jurisdiction. EPA is amending the IUR 

1104 rule to improve and enhance data reporting requirements under IUR reporting beyond that 

1105 required during the 2006 reporting cycle. There were problems associated with many 2006 IUR 

1106 data submissions that severely limited EPA‘s ability to screen chemicals for exposure and risks 

1107 and to make data available to the public. These problems included the fact that many 

1108 submissions were incomplete or improperly completed, contained invalid chemical identities, 

1109 and/or inappropriately or incorrectly claimed certain data elements as CBI. EPA anticipates that 

1110 today‘s amendments will (1) ensure the required information is properly reported and that the 

1111 information in the Agency‘s database reflects the information provided in the IUR reports; (2) 

1112 increase the usability of the collected information; (3) increase the availability of information for 

1113 the public; and (4) focus reporting on information that is most needed by the Agency. 

1114 Additionally, EPA believes that the modifications to the rule will supply manufacturing and 

1115 processing and use information the Agency did not previously possess and should be accurate 

1116 and reliable enough to develop screening level assessments. 

1117

1118 Data collected under the IUR will be used in a wide variety of programs fundamental to 

1119 fulfilling the Agency‘s TSCA statutory mandate. EPA believes that the IUR data is the most 

1120 basic data set that will give EPA and the public an understanding of the volume of chemicals 

1121 produced or imported into the United States, how the chemicals are or may be used, and the 
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1122 types of exposures (occupational, consumer, environmental, etc.) potentially associated with the 

1123 chemicals. Many chemicals are exempted from reporting under the IUR rule, which further 

1124 tailors IUR requirements to EPA‘s information needs. Data about production volume, 

1125 exposures, and/or environmental releases are required to make some of the findings necessary to 

1126 require testing under section 4, and helps EPA to prioritize chemicals for further data gathering 

1127 or risk management action. The Agency‘s Existing Chemicals program will use the IUR data to

1128 assess whether the Agency needs additional data about the hazards or exposures to a particular 

1129 chemical under sections 4 or 8 of TSCA, and may use IUR data to inform risk management 

1130 actions such as those identified in TSCA Sections 5 and 6. EPA‘s extensive use of the 2006 IUR 

1131 data in the Agency‘s Existing Chemicals Program is consistent with how EPA envisioned the 

1132 data would be used when the 2003 Amendments were promulgated. For example, in 2007, the 

1133 Agency began to develop and post screening-level hazard, exposure, and risk characterizations 

1134 for HPV chemicals, which are those chemicals produced nationally at aggregated volumes of one 

1135 million lb. or more per year. In developing these characterizations, EPA identified areas where 

1136 the IUR data could be improved and enhanced. The amendments in today‘s final rule will allow 

1137 EPA to better identify and take follow-up action on chemical substances that may pose potential 

1138 risks to human health or the environment. More detailed discussions are in the Responses to 

1139 Comments document (Ref. 13). 

1140

1141 2. Transitioning to 2011. Commenters stated the new requirements are overly 

1142 burdensome and unrealistic considering the time constraints. Another commenter stated there 

1143 would be insufficient time for collecting and verifying data, conducting quality checks, or 

1144 completing the necessary paperwork for the report. Many commenters suggested that EPA 

1145 should extend the IUR submission deadline by several months and make the changes that are 

1146 finalized effective in the next reporting period. 

1147

1148 EPA disagrees that transitioning into the new 2011 requirements is overly burdensome 

1149 and unrealistic. EPA believes that the four month submission period provides sufficient time to 

1150 collect and submit the required data, and that steps taken by the Agency provided the opportunity 

1151 for companies to gain an understanding of the submission process and to prepare their internal 

1152 electronic systems as needed. For example, EPA was asked by several companies and trade 

1153 organizations to provide an overview of the reporting software. Acknowledging that companies 

1154 were concerned about the time needed to develop their internal databases to collect the required 

1155 information, on November 30, 2010, the Agency held an informational workshop and webinar to 

1156 help companies develop a better understanding of the CDX registration process and the e1157 IURweb electronic reporting tool. A recording of the workshop and a summary of the questions 

1158 and answers is available on the IUR website (www.epa.gov/iur). EPA used stakeholders‘ 

1159 comments from the workshop and additional comments obtained during the tool‘s beta-test to 

1160 help ensure the tool would address the needs of the submitters. The Agency plans to conduct a 

1161 training webinar shortly after the publication of this final rule to provide detailed instructions on 

1162 the reporting requirements and on using the reporting software, e-IURweb, to complete and 

1163 submit Form U. Finally, to the extent that the timing of the next submission period actually 

1164 presents a substantial obstacle to the submission of any particular data element, notwithstanding 

1165 EPA‘s efforts to familiarize submitters with the draft and final reporting software, and EPA‘s 

1166 post-promulgation efforts to familiarize submitters with the reporting requirements, the IUR 
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1167 reporting standard of ―known to or reasonably ascertainable‖ addresses such circumstances 

1168 without the need for a delay in implementation (see Unit V.E.1.). 

1169

1170 One commenter suggested that EPA continue under the old IUR rule for this submission 

1171 period. The Agency does not agree that it should revert to the existing 2006 IUR rule because the 

1172 enhancements addressed in the proposal will significantly increase the amount of exposure 

1173 information available to the public and Agency. The new and updated information collected 

1174 under this final rule will increase the Agency‘s ability to understand exposure concerns. EPA 

1175 will be better able to identify steps needed to manage risks associated with chemical substances. 

1176 In addition, requiring the use of electronic reporting will help ensure that data are available in a 

1177 timely manner and it will reduce data entry errors, thereby increasing the usability and reliability 

1178 of the data for EPA and other federal agencies as well as help fulfill the Administrator‘s 

1179 commitment to increase public access to information on chemicals.

1180

1181 3. EPA’s use of IUR data. The Agency received comments related to how IUR data can 

1182 best be used to assist in assessing, prioritizing, and taking action on chemicals that pose 

1183 unreasonable risks. Commenters stated that the current IUR was sufficient for EPA to use as a 

1184 screening tool for the prioritization of chemicals in commerce, and that EPA should use the 

1185 Agency‘s wide variety of regulatory tools and authorities to collect more detailed information. 

1186 Commenters also expressed interest in providing input on using the IUR and the Agency‘s 

1187 prioritization process. 

1188

1189 EPA disagrees that the current IUR is sufficient for its purposes. Between August 2007 

1190 and mid-2009, EPA developed screening-level hazard, exposure, and risk characterizations for 

1191 some chemicals produced or imported in quantities of 25,000 pounds or greater a year. Based on 

1192 those characterizations, EPA developed either a risk-based prioritization (RBP) or a hazard1193 based prioritization (HBP) for individual chemicals or a group of chemicals that were similar in 

1194 some way, e.g., structure, properties, toxicity. Those prioritizations did not constitute definitive 

1195 determinations regarding hazard, risk, or the sufficiency of available information for any 

1196 regulatory purpose, but were rather initial evaluations of data and understanding currently 

1197 available to EPA. EPA‘s experience using the IUR information to develop the prioritizations 

1198 was that the 2006 IUR data were not sufficient to provide the needed exposure-related 

1199 information. When EPA was developing RBPs for its HPV chemicals, it needed both hazard and 

1200 exposure screening-level information. Lacking sufficient exposure information, EPA found it 

1201 necessary in many cases to make assumptions about exposure and the resulting prioritization 

1202 decision was primarily hazard-based, as opposed to risk-based, as evidenced by statements in 

1203 many of the RBP as well as HBP documents that EPA developed (available at 

1204 http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML) that further 

1205 information on exposure was needed to confirm the prioritization. Thus the exposure 

1206 information provided in the 2006 IUR reporting did not provide EPA with sufficient information 

1207 to prioritize chemicals for which it generally possessed a base set of hazard data. Therefore, for 

1208 some of the RBPs the next steps indicated that additional exposure information would be 

1209 necessary to validate the prioritizations before determining whether any further action was 

1210 needed. In developing these characterizations, EPA identified areas where the IUR data 

1211 collection should be improved and enhanced. These improvements, which are reflected in the 

1212 modifications to the reporting requirements in the current rule, will allow EPA to better prioritize 
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1213 chemicals for further assessment as well as make appropriate risk management decisions for 

1214 follow-up action on chemical substances that may pose potential risks to human health or the 

1215 environment.

1216

1217 EPA is considering using other regulatory tools and authorities to collect more in-depth 

1218 information, but believes the IUR is the correct mechanism for the data collection finalized in 

1219 this notice. EPA also is considering ways to obtain public input on its use of the IUR data and its 

1220 chemical prioritization process, as suggested by the commenters.

1221

1222 4. Canada’s prioritization approach. Some commenters recommended that EPA adopt 

1223 Canada‘s prioritization approach. EPA assumes that the commenters were referring to the 

1224 Domestic Substances List Categorization that Canada completed in 2006. The DSL 

1225 Categorization was a statutorily mandated risk-based prioritization which required review of 

1226 both hazard and exposure information for 23,000 chemicals in a very short period of time. 

1227 Health Canada was required to identify chemicals presenting human health hazards as well as the 

1228 greatest potential for exposure to Canadians. Even though categorization was a legally mandated 

1229 process with a deadline for consideration of all chemicals on the DSL, Health Canada felt that 

1230 production volume alone was not a sufficient surrogate for exposure and developed a complex 

1231 process for the exposure portion that required extensive literature review, input of information 

1232 from industry, and used some of the types of data that EPA is requesting for the 2011 IUR 

1233 reporting period (Ref. 14). 

1234

1235 Based on its review of hazard and IUR data collected on HPV and medium production 

1236 volume (MPV) chemicals, EPA also believes that using large production volume as the sole 

1237 surrogate for exposure is not sufficient to identify chemicals of highest concern. Some of the 

1238 risk-based prioritizations of HPV chemicals resulted in low priority decisions for the HPV 

1239 chemicals that were low hazard, used in closed systems and consumed as intermediates. On the 

1240 other hand, some of the MPV chemicals were identified as potentially high or medium priority, 

1241 because they had high or medium hazard and would present high or medium risk concerns if they 

1242 had widespread exposure or dispersive uses. The only way for the Agency to move from 

1243 prioritizations based primarily on hazard to truly risk-based prioritization is for it to receive 

1244 regularly updated information on exposure and use for chemical substances being made and used

1245 in the United States. The chemical manufacturing industry has indicated in several ways, 

1246 including in comments on the proposed rule, that it supports risk-based as opposed to hazard1247 based prioritization. A commenter also noted that industry strongly supports risk-based 

1248 decisions and for that reason needs to provide robust production, processing and use data. 

1249

1250 B. Comments on Electronic Reporting

1251

1252 EPA received various comments on the proposed requirement to use the reporting 

1253 software, e-IURweb, to submit all IUR submissions. In general, comments were submitted on the 

1254 reporting software, phasing-in electronic reporting registering with CDX, and electronic 

1255 signatures. See Section B. in the Responses to Comments document (Ref. 13) for further 

1256 discussion on electronic reporting. 

1257
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1258 1. Comments on the reporting software and phasing-in electronic reporting. In general, 

1259 commenters supported electronic reporting. Some commenters suggested that the Agency 

1260 develop a phased-in process for electronic reporting, in order to provide more time for 

1261 companies to become familiar with the new format and to develop their own data systems. Some 

1262 commenters wanted to be able to upload data via an XML file into the web-based tool. The 

1263 requirement to use electronic submissions over the internet was a concern for some commenters. 

1264

1265 EPA, based on its experience collecting and managing the 2006 IUR reports, has 

1266 concluded that mandatory electronic reporting is a critical next step for collection of the 2011 

1267 data. Optional electronic reporting for the 2006 IUR provided the Agency with experience 

1268 relating to both industry and Agency needs, and the Agency has applied this experience in the 

1269 course of developing of the 2011 electronic reporting tool (e-IURweb). For example, the use of 

1270 a web-based solution for the 2011 IUR will eliminate many of the software compatibility and 

1271 firewall setting issues that were encountered during the 2006 submission period. In addition, the 

1272 2011 e-IURweb utilizes other Agency systems, such as SRS, enabling the submitter to readily 

1273 select the chemical identity in the correct format, thereby eliminating problems relating to the 

1274 previous need to type or write in the chemical name. With these enhancements, EPA believes 

1275 the use of e-IURweb will substantially reduce error rates and burden; consequently, EPA does 

1276 not believe it is necessary to have another optional electronic reporting period.

1277

1278 In addition, the Agency‘s CDX service is increasingly being used by a variety of 

1279 programs, as the Agency moves toward comprehensive electronic reporting. EPA is continually 

1280 looking for ways to improve CDX, to better address submitter and Agency needs. For example, 

1281 the EPA has developed an eTSCA registration for CDX which, when fully implemented, will 

1282 eliminate the need to register separately for eIUR and ePMN. For the 2011 eIUR, ePMN 

1283 registrations using the current eTSCA are acceptable eIUR registrations. 

1284

1285 The Agency believes that commenters‘ concerns regarding mandatory use of the new 

1286 electronic reporting tool reflect a lack of understanding of the tool‘s capabilities and 

1287 enhancements. The reporting tool provides the ability to submit data in an XML format and 

1288 includes enhancements to CDX that are designed to allow for multi-user capabilities and 

1289 otherwise facilitate electronic reporting. EPA has provided training opportunities and guidance 

1290 materials to facilitate electronic reporting, as well as product testing opportunities, to alleviate 

1291 particular commenters‘ concerns. 

1292

1293 For example, the Agency held an informational workshop and webinar in November 

1294 2010. The workshop was designed help companies develop a better understanding of the CDX 

1295 registration process and the e-IURweb electronic reporting tool. In early January, 2011, EPA 

1296 provided a draft XML schema, allowing companies to ensure their internal systems will be able 

1297 to directly upload data to the e-IURweb. In addition, EPA invited several companies to test e1298 IURweb. EPA invited each company to identify areas where it believed the reporting tool could 

1299 be improved. A recording of the workshop, summary questions and answers, the final schema, 

1300 and additional webinar training that provides detailed instructions of using the reporting tool are 

1301 available on the IUR website, www.epa.gov/IUR. In 2011, EPA intends to hold further training 

1302 and outreach sessions at which industry representatives may express remaining questions and 

1303 concerns regarding the operation of e-IURweb software, which EPA will address.
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1304

1305 Electronic reporting was first offered as an option for the 2006 IUR. As explained in the 

1306 preamble to the proposed rule and the Responses to Comments document, there were many 

1307 problems, errors, and delays associated with paper submissions of the 2006 IUR data, which 

1308 make the continued use of paper reporting highly inefficient and therefore undesirable. In light 

1309 of the substantial disadvantages associated with allowing paper submissions, and the reporting 

1310 tool improvements and training opportunities outlined in this unit (and explained in greater detail 

1311 in the proposed rule and the Responses to Comments document) EPA does not believe it is 

1312 reasonable to phase in electronic reporting over another reporting period and is confident that 

1313 submitters will be able to successfully use the e-IURweb tool to electronically report under the 

1314 IUR rule in 2011.

1315

1316 2. Comments on registering with CDX and providing electronic signatures. Commenters 

1317 thought the modified Electronic Signature Authority Form, in particular the need for multiple 

1318 notarized signatures, was burdensome and unnecessary. Commenters stated that there should be 

1319 more than one individual with an electronic signature and that multiple persons may need to be 

1320 able to input and submit IUR data for a company‘s U.S. sites. The commenters noted that the 

1321 actual preparer/drafter would rarely be the signatory. Another respondent noted that companies 

1322 should be allowed, but not required, to have the same authorized official for the PMN and IUR 

1323 submission. 

1324

1325 As with PMN electronic submissions, multiple people from the same site or company are 

1326 able to register with CDX and participate in completing the site‘s Form U. Although one 

1327 individual will be designated as an authorized official who will sign and submit the completed 

1328 Form U, the e-IURweb tool allows for more than one individual to edit a submission. 

1329 Ultimately, EPA‘s goal is to provide one electronic signature agreement across all TSCA 

1330 programs and is exploring the reuse of e-signatures issued under the e-PMN program as well as 

1331 other EPA programs. Regarding notarized signatures, EPA has determined that requiring a 

1332 notarized signature as part of the electronic signature agreement is no longer necessary. 

1333

1334 C. Comments on Reporting Thresholds

1335

1336 1. Method for determining whether you must report. EPA proposed to modify the method 

1337 used to determine whether a person is subject to IUR reporting. The new method requires 

1338 persons to report under the IUR if they manufactured (including imported) 25,000 lb. or more of 

1339 a chemical substance at any single site in any calendar year since the last principal reporting 

1340 year, (note: there is no production volume threshold for certain chemicals, see 40 CFR 711.8(b)). 

1341 This method becomes effective after the 2011 IUR submission period. 

1342

1343 Several commenters believed the change is appropriate and should be implemented for 

1344 the 2015 reporting cycle. They noted that the new requirement is essential to effectively capture 

1345 the substantial year-to–year fluctuation in production/import volumes that was missed in past 

1346 IUR reporting cycles, thereby skewing the picture of how many and which chemicals are 

1347 actually in commerce at a given time and what levels of production or import. One commenter 

1348 went further to say that the modification would eliminate gaps and uncertainties in the 

1349 information collected under the current IUR that result from infrequent collections and reporting 
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1350 of data. Another said that this will keep manufacturers from disguising their actual output by 

1351 producing certain specialty chemicals only in years that are not currently subject to IUR 

1352 reporting. Two commenters supported the change but opposed the proposal to delay 

1353 implementation until the 2015 reporting cycle, because it further delay the ability to obtain 

1354 accurate annual production information.

1355

1356 In contrast, others had mixed opinions or did not think the change was needed. Some 

1357 commenters felt that unless the value of collecting and analyzing retroactive data could be 

1358 clearly demonstrated such that the resource for the Agency and regulatory community can be

1359 justified, EPA should retain the single reporting year and current threshold. Some commenters 

1360 stated that EPA had not shown special utility for the information generated. Another commenter 

1361 believes that there is no significant incremental benefit to require reporting from companies that 

1362 produce or import less than 25,000 lb. of a reportable chemical substance for four out of five 

1363 years. 

1364

1365 The Agency realizes that the new multi-year consideration of production volume will 

1366 increase reporting burden on industry, but believes that there is sufficient evidence that wide 

1367 fluctuations in production volumes from year to year indicate the past IUR reporting was not 

1368 accurately characterizing the chemical production. As EPA noted in the proposed rule preamble, 

1369 production volumes of chemical substances vacillating above and below reporting thresholds in 

1370 different IUR reporting periods resulted in a change of approximately 30% in the composition of 

1371 the chemicals being reported from one IUR reporting period to the next. For example, EPA 

1372 prepared a prioritization document for the Butenedioic Acid Dialkyl Esters Cluster, which 

1373 consists of 10 butenedioic acid dialkyl esters, seven of which were MPVs and three HPVs in 

1374 2006 (Ref. 15). Three of the chemicals have had fluctuating production volumes above and 

1375 below one million pounds. In 1990 and 1994 when the HPV Challenge program was being 

1376 developed, the CASRNs 68921-51-7, 141-05-9, and 624-48-6 had production volumes below 

1377 one million pounds and so were not included in the HPV Challenge for completion of SIDS 

1378 datasets. In 1998 and 2006, CASRN 68921-51-7‘s production volumes have been above one 

1379 million pounds, making it an HPV in those years. In 2002, CASRNs 141-05-9 and 624-48-6 had 

1380 production volumes above one million pounds. In part because of their fluctuating production 

1381 volumes, neither SIDS datasets nor consistent exposure and use information were available for 

1382 these chemicals and so they were included in a cluster for an HBP as opposed to an RBP. One 

1383 commenter also submitted an analysis of the degree of fluctuation of chemicals and production 

1384 volumes in the 2002 and 2006 IUR reporting years. This analysis found that about 32% of the 

1385 organic chemicals reported in 2002, including 400 HPVs, were not reported for 2006 and that 

1386 about 26% of the chemicals reported in 2006, including more than 200 organic HPVs, were not 

1387 reported in 2002.

1388

1389 In addition, in comments submitted to the Agency in response to other programs, industry 

1390 representatives expressed concern that short reporting determination periods would drastically 

1391 misrepresent the chemical substances that currently are in commerce. They stated they 

1392 manufactured or imported some chemical substances only occasionally, and that these chemical 

1393 substances would not be captured if the reporting covered too short a period. The proposed rule 

1394 preamble provides a more detailed discussion of these comments (see 75 FR 49664). 

1395
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1396 EPA believes that most sites will be able to gather production volume information 

1397 without a substantial effort. In many instances, production volumes for recent past years are 

1398 tracked under standard business practices. For example, EPA believes it is standard business 

1399 practice for a company to furnish records of recent operations in the case of a proposed sale or 

1400 merger, and that companies therefore typically retain such records so as to be prepared for such 

1401 eventualities. EPA also notes that in the case that prior years‘ production volume information is 

1402 not known to or reasonably ascertainable by the submitter (EPA expects that such cases would 

1403 be extremely rare), those data would not be subject to reporting under the IUR and therefore 

1404 would not trigger an obligation to report Furthermore, persons who have submitted a PMN to 

1405 the Agency‘s New Chemicals program are required to maintain records of production volume for 

1406 the first 3 years of production or import, including but not limited to the names, addresses of any 

1407 person to whom the substance is distributed ( info includes any distributed) . They must be 

1408 maintained for 5 years from the date of commencement of manufacture or import (See 720.78).

1409 EPA expects that many companies would also track production volumes for planning, marketing, 

1410 and sales projection purposes. Several TSCA regulations, such as 5(a)(2) SNURs and 5(e) 

1411 orders also require that production volume records be kept for five years for certain chemicals, 

1412 and several commenters indicated that they archived these records. 

1413

1414 2. Elimination of the 300,000 lb. threshold. The Agency received a substantial number of 

1415 comments on the elimination of the 300,000 lb. threshold for reporting processing and use 

1416 information. Comments submitted on various topics are described in this unit. 

1417

1418 a. Increased numbers of covered chemical substances. Commenters asserted that the 

1419 influx of inorganic chemicals, coupled with the threshold change for processing and use 

1420 information, will result in a substantial increase in the amount of data being submitted to the 

1421 Agency. Commenters felt that EPA staff will need significant time to compile, review, and 

1422 analyze the data submitted. One commenter suggested the Agency use a phased-in approach to 

1423 adequately collect and process the increased information. 

1424

1425 While it is true that the amount of data in the IUR reports is expected to increase 

1426 substantially in the 2011 and subsequent reporting years, EPA is better prepared now than it was 

1427 for the 2006 IUR to compile, review, and analyze the anticipated increase of data. With the new 

1428 e-IURweb electronic tool, large amounts of data will be able to be submitted with less difficulty 

1429 on the part of the submitter, and will be more readily organized, analyzed, and made available to 

1430 the public by the Agency. In addition, the use of SRS for identifying chemical substances and 

1431 validation process built into the e-IURweb tool will eliminate most or all of the problems EPA 

1432 had with missing information (which necessitated phone calls and emails to submitters), and 

1433 manual entry of data, which was time-consuming and resulted in many mistakes. Given the 

1434 requirement for mandatory electronic submissions and the corresponding improvements to the e1435 IURweb tool, the Agency is confident that the increase in data submissions will be easily 

1436 managed for this reporting period, and both EPA and the public will quickly have a useable set 

1437 of exposure-related IUR data. 

1438

1439 b. Reporting Burden. Numerous commenters were concerned about the increased 

1440 reporting burden, particularly for smaller companies, and the complexity of IUR Form U Part III. 

1441 One commenter stated that EPA should assess the benefits of the additional reporting 
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1442 requirements to establish a cost justification of the proposal. Other commenters were concerned 

1443 that the lowered threshold would increase the number of imported mixtures and that it would be 

1444 difficult to calculate and aggregate across products for lower volume chemicals. 

1445

1446 EPA analyzed the potential impacts of this requirement to all submitters, including 

1447 potential burden to small businesses, in the Economic Analysis (Ref. 19). EPA recognizes that 

1448 reducing the reporting threshold for processing and use information increases the reporting 

1449 burden for this reporting cycle, but the cost to industry will decrease in all future reporting 

1450 cycles. 

1451

1452 EPA disagrees with comments suggesting that the requirement may have a 

1453 disproportionate effect on smaller companies (commenters suggested that smaller companies are 

1454 more likely to manufacture below the 300,000 lb. threshold that is being eliminated.) The 

1455 quantity of a chemical that is manufactured (including imported) at a site is not necessarily 

1456 dependent on the number of employees, which is the criteria by which a company is considered 

1457 to be small. For example, a highly automated facility could produce large volumes of a chemical 

1458 substance with a relatively small number of employees. Additionally, as noted in the Economic 

1459 Analysis, the Agency determined that because the small businesses affected by today‘s final rule 

1460 actually have average sales of more than $11 million, and because any potentially affected 

1461 companies with sales of $1.02 million or less (the level at which the cost-to-sales ratio of the 

1462 final rule would exceed 1%) would generally be exempt from reporting obligations under the 

1463 IUR, small entities will not be significantly affected by today‘s final amendments to the IUR 

1464 rule.

1465

1466 EPA recognizes that, with the elimination of the 300,000 lb. threshold, importers may 

1467 face an increase in burden to identify more component chemicals contained within more 

1468 imported mixtures. However, ,EPA disagrees that importers are unprepared to conduct a 

1469 reasonable inquiry as to the specific chemicals they import in mixtures. Importers have long been

1470 responsible for certifying that their imported chemical substances, including those chemical 

1471 substances present as part of mixtures, are in compliance with TSCA (See 19 CFR 12.119). 

1472 Furthermore, importers have long been required to provide chemical specific information as to 

1473 the constituents of imported mixtures under the IUR (see the definition of ―importer‖ at 40 CFR 

1474 704.3 and the note at 40 CFR 710.4(c)(2)) and under the PMN program (40 CFR 720.30(b). 

1475 Furthermore, importers are often required to report chemical specific information regarding 

1476 imported mixtures under other EPA-administered statutes, such as the Emergency Planning and 

1477 Community Right-To-Know Act (EPCRA) and the Resource Conservation and Recovery Act 

1478 (RCRA). While reporting under the IUR differs in many significant respects from reporting 

1479 under the EPCRA and RCRA programs, in all cases the importer is required to know the identify 

1480 of the chemical substances they import. EPA notes that one commenter described, in detail, its 

1481 practice of accounting for component chemical substances in imported mixtures. The 

1482 commenter stated that ―[w]ith the advent of REACH we recently implemented an application 

1483 that is capable of tracking volumes of individual substances in mixtures and summing them up 

1484 over a period of time. The system automatically looks at the current formulation of any product 

1485 that is crossing a border and adds the volume of each component to the cumulative total for that 

1486 substance‖ (Ref. 18). EPA expects that the burden associated with reporting these chemicals will 

1487 decline in reporting periods subsequent to 2011, as additional recordkeeping procedures are put 
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1488 into practice. Finally, EPA notes that a chemical substance that is imported solely in small 

1489 quantities for research and development, as an impurity, as part of an article, or in certain other 

1490 forms, see 40 CFR 720.30(g) and (h), is not subject to the IUR reporting requirements. See 40 

1491 CFR 711.10. 

1492

1493 c. Justification for data. Several commenters strongly supported EPA‘s proposed change, 

1494 stating that the information is essential for the completion of prioritizations for IUR reportable 

1495 chemical substances; is critical for evaluating the potential for release of and exposure to 

1496 chemicals in commerce; and that the information requested is basic, screening-level data that 

1497 should be required for all reported chemicals. Additional commenters generally supported the 

1498 changes, but wanted the change to take effect after the 2011 reporting cycle. Other commenters 

1499 had concerns about the value of the information that is reported in Part III. One commenter 

1500 stated that EPA has not made public documentation of the past use of this information to address 

1501 screening and prioritization of chemicals. Another commenter believes that EPA should provide 

1502 more specificity on its needs and explain why other, more tailored, options do not provide the 

1503 necessary data. 

1504

1505 EPA‘s information needs have changed since the last major amendment of the IUR rule 

1506 in 2003. Production volume changes from year to year, so chemicals can easily fluctuate above 

1507 and below a relatively high reporting threshold, such as the previous 300,000 lb. threshold for 

1508 reporting processing and use, making it difficult for EPA to collect regular exposure information 

1509 on many chemicals. Requiring the reporting of processing and use information on an expanded 

1510 list of chemicals will assist the Agency and others in screening potential exposures and risks 

1511 resulting from industrial chemical operations and commercial and consumer uses of chemical 

1512 substances. The information will also help to provide an accurate and readily available source of, 

1513 as noted in Unit V.A.1, basic exposure-related information for a subset of chemicals listed on the 

1514 TSCA Inventory. Furthermore, collection of this data is consistent with the Administrator‘s 

1515 strong commitment to provide the public with more information on a greater number of 

1516 chemicals.

1517

1518 As mentioned in the preamble of the proposed rule and as explained in Units V.A.3 and 

1519 V.A.4 herein, the data reported in 2006 did not provide an adequate amount of exposure-related 

1520 information, especially for HPV chemicals. When attempting to use the 2006 IUR data for its 

1521 screening level exposure assessments, EPA found that numerous chemicals previously identified 

1522 as HPVs were reported in amounts classifying them as MPV chemicals, below the 300,000 lb. 

1523 cut off, and thus processing and use information was not provided for chemicals for which EPA 

1524 had a relatively complete hazard data set from the HPV Challenge. For example, an RBP was 

1525 prepared for the Chlorobenzenes Category, which consisted of four chlorobenzenes sponsored 

1526 under the HPV Challenge (Ref. 18). Only one of the four substances, 1,3-dichloro benzene 

1527 (CASRN 541-73-1), was considered high priority; however, because it was an MPV chemical in 

1528 2006, no exposure and use data was available from the IUR reporting, so the high priority 

1529 determination was based on high human health hazard and assumptions made about exposure. 

1530

1531 The 2006 IUR data did not provide sufficient information on moderate production 

1532 volume (MPV) chemicals for use by the Agency‘s Existing Chemicals Program. Screening 

1533 chemical risks generally requires a combination of both hazard and exposure information. 
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1534 Because most MPV chemicals were produced below the 300,000 lb. reporting threshold, EPA 

1535 did not have exposure information available from the 2006 IUR and therefore, developed hazard 

1536 based prioritizations which were supported by a screening level hazard characterization and 

1537 consideration of very limited exposure and use data. The lack of information on exposure and 

1538 use was especially problematic in those instances where the screening level hazard 

1539 characterization identified either a medium or high hazard. Basic hazard data is easier to find in 

1540 existing databases; however, specific exposure data is needed to make a priority determination 

1541 risk-based. EPA believes that the lower reporting threshold will provide more exposure-related 

1542 information on a greater number of MPV chemicals.

1543

1544 EPA disagrees with the comment that it has not made public documentation of the past 

1545 use of processing and use information to address screening and prioritization of chemicals. As 

1546 discussed above in Unit V.A.3, EPA used 2006 IUR data starting in 2007 in its development of 

1547 RBPs and HBPs which it has made available on its website. More recently, the Existing 

1548 Chemicals Program used the IUR database when developing the Chemical Action Plans. For 

1549 some Action Plan chemicals, the 2006 IUR data were not sufficiently complete to be useful. An 

1550 example is the Action Plan for Dyes Derived from Benzidine and Its Congeners, where the 

1551 substances of concern are known or reasonably anticipated human carcinogens; however, those 

1552 listed were produced in amounts below the 300,000 lb. threshold and so little exposure data was 

1553 reported. Based on IUR data from prior reporting periods, some of the other dyes had been 

1554 reported in the 10,000 to 25,000 lb. range, but there was no 2006 IUR data available to determine 

1555 whether these chemicals were still being used in amounts beyond the small amounts used as 

1556 analytical reagents. The Action Plans are available on EPA‘s web site at 

1557 http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html.

1558

1559 By lowering the reporting threshold for processing and use information, EPA is 

1560 increasing consistency for the IUR with reporting requirements of the TRI program. Under the 

1561 TRI program, chemicals that are not chemicals of special concern listed at 40 CFR section 

1562 372.28 (e.g., mercury, lead) are required to be reported if they are manufactured or processed in 

1563 volumes of 25,000 lb. or more annually or otherwise used in volumes of 10,000 lb. or more 

1564 annually. Though the chemicals on the TRI toxic chemical list may be different from those 

1565 reported under the IUR, an analysis showed that over 80 percent of the sites that reported under 

1566 the 2006 IUR also reported under TRI in 2006. Given that there is some overlap in the 

1567 companies that report and the information collected on activities and uses of chemicals under 

1568 both programs, EPA believes that many companies are already accustomed to reporting on lower 

1569 volume chemicals. 

1570

1571 d. Lack of data for chemical substances. Several commenters noted that the 2010 

1572 reporting year will be over by the time the rule is finalized, and companies would not have had 

1573 the opportunity to establish systems for collecting the information for chemicals in the 25,000 to 

1574 300,000 lb. range. Other commenters asserted that EPA was seeking data that are limited or 

1575 unavailable because manufacturers do not know how their chemicals are used by their customers 

1576 downstream from the manufacturing. Another commenter asserted that the lowered threshold 

1577 will not enhance the quality or integrity of the resulting IUR data due to uncertainties in making 

1578 estimates. 

1579
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1580 EPA recognizes that submitters may not always have detailed information about how the 

1581 chemical(s) they manufacture (including import) are used. As a result, submitters will be 

1582 required only to report this information to the extent that it is known or can be reasonably 

1583 ascertained. Based on its experience with the New Chemicals Program, discussions with industry 

1584 about voluntary risk management programs, and industry‘s various self-regulation initiatives, the 

1585 Agency believes that most submitters have at least some basic information about downstream 

1586 uses, such as the information that is required by the IUR rule. 

1587

1588 EPA acknowledges that the final rule will be published shortly before the start of the 

1589 submission period. EPA does not anticipate that the quality of the data collected in 2011 will 

1590 significantly decrease due to the timing of the amendment to the reporting threshold. Many of the 

1591 reporting elements are the same as in past IUR reporting periods, and EPA notes that the rule 

1592 affords sufficient flexibility to account for those circumstances in which information is truly 

1593 unknown and not reasonably ascertainable. The Agency believes that the data will be of 

1594 sufficient reliability for use by the Agency and others for purposes such as screening-level risk 

1595 assessments and prioritization.

1596

1597 3. Eliminate 25,000 lb. threshold for selected substances. EPA proposed to eliminate the 

1598 25,000 lb. reporting threshold for certain chemical substances subject to particular TSCA rules 

1599 and/or orders and to require manufacturers (including importers) of such chemical substances to 

1600 report under the IUR, regardless of the production volume. Comments submitted on various 

1601 topics are described in this unit.

1602

1603 a. Burden. One commenter stated that companies not expecting this significant change 

1604 will be unprepared to gather required information. Several commenters expressed the view that 

1605 the requirement will increase the burden upon industry without any real benefit to the 

1606 environment and will create a situation where manufacturers are responsible for knowing all 

1607 byproducts of their process, no matter how small. Others felt that enacting this requirement 

1608 without a de minimis concentration threshold would add an unnecessary additional layer of 

1609 complexity to IUR analysis and would result in each reporting entity responsible for a far greater 

1610 number of Form U submittals. 

1611

1612 The Agency believes it is unlikely that recordkeeping practices were not already in place 

1613 for companies to track the volumes of the chemicals they are manufacturing. EPA analyzed the 

1614 potential impacts of this requirement to submitters and recognizes that eliminating the 25,000 lb 

1615 threshold for these substances increases the reporting burden (see the Economic Analysis). 

1616 However, the burden of reporting will be ameliorated by the use of electronic reporting. 

1617

1618 EPA disagrees that the increased burden will not yield any real benefit and agrees with 

1619 the commenters who supported eliminating the 25,000 pound threshold for certain TSCA-subject 

1620 chemicals so that more useful information would be received. Chemical substances that are the 

1621 subject of particular TSCA rules and/or orders are of demonstrated high interest to the Agency. 

1622 Receipt of up-to-date exposure and use information on these chemicals, regardless of production 

1623 volume, will help EPA as it develops risk management strategies for those chemicals subject to 

1624 proposed rules. Additionally, EPA will use the IUR data as it monitors chemical substance 

1625 production and compliance with the rules. The new requirement will also contribute to the 
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1626 Administrator‘s commitment to increase the availability of chemical information to the public. 

1627 EPA expects instances when the required information is not known or reasonably ascertainable 

1628 will decline substantially in reporting cycles subsequent to 2011, as additional recordkeeping 

1629 procedures are put into practice.

1630

1631 b. Imports and Mixtures. Commenters thought this requirement will be difficult to meet 

1632 in practice, particularly for imported chemicals or mixtures. One commenter felt the requirement 

1633 would create a needle-in-a-haystack situation in which a company would need to examine all 

1634 chemicals and/or mixtures imported, regardless of the concentration of the chemical or volume 

1635 of the import. Other commenters believed that importers would have great difficulty knowing 

1636 that low-concentration ingredients are present in formulated mixtures, especially when they are 

1637 not subject to inclusion on a label or Material Safety Data Sheets (MSDS).

1638

1639 EPA recognizes that eliminating the 25,000 lb. reporting threshold may, in some 

1640 instances, make it more difficult for importers to determine the production information for 

1641 component chemical substances in imported products. However, the IUR incorporates a number 

1642 of exemptions that address the ―needle-in-a-haystack‖ concern expressed by the commenter. 

1643 IUR reporting is not required for a chemical substance that is imported solely in small quantities 

1644 for research and development, as an impurity, as part of an article, or in certain other forms. See 

1645 40 CFR 711.10, 40 CFR 720.30(g) and (h). Furthermore, for the reasons discussed in Unit 

1646 II.D.5., companies should be accustomed to reporting chemical specific information to EPA 

1647 because the Agency has always sought information on individual chemical substances in 

1648 mixtures under the IUR and PMN programs. Similar to the requirement to report processing and 

1649 use information for lower volume chemicals (see Unit E.5.b), EPA believes that instances where 

1650 this information is not known or reasonably ascertainable will decline substantially for reporting 

1651 periods subsequent to 2011 as additional recordkeeping procedures are established.

1652

1653 c. List of subject chemical substances. Commenters suggested that EPA provide an up1654 to-date list of the chemical substances impacted at the beginning of the information collection 

1655 year to ensure more accurate and complete reporting. EPA provides just such a list. It is titled 

1656 ―Chemical Substances that are the Subject of Certain TSCA Orders, Proposed or Final TSCA 

1657 Rules, or Relief Granted under Civil Actions.‖ It can be found in Appendix C of the Instructions 

1658 for Reporting Guidance Document. The pertinent chemicals are listed both by CASRNs (for 

1659 non-confidential chemical substances) or by Accession Numbers (for confidential substances) 

1660 that are the subject of a rule. This document, which will be updated for the 2011 IUR reporting, 

1661 is available in the docket for this final rule and on EPA‘s IUR website at www.epa.gov/iur. This 

1662 list is intended to be a helpful information resource, but it is not legally determinative of the 

1663 status of any particular chemical substance.

1664

1665 d. Reporting for chemicals subject to a proposed rule. Some commenters supported 

1666 EPA‘s suggestion to eliminate the 25,000 lb. threshold for certain chemical substances that are 

1667 the subject of a rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6. Another commenter 

1668 believed it was inappropriate to impose expanded reporting requirements on substances subject 

1669 to proposed rules which might not be finalized.

1670
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1671 The Agency agrees with the commenters who stated that if chemicals that would 

1672 typically be exempted from reporting are subject of a rule proposed under TSCA Section 5(a)(2), 

1673 5(b)(4) or 6, the reporting threshold should be eliminated and the chemicals should be reported 

1674 despite the lower volumes produced. The Agency disagrees with the commenter who argued that 

1675 the elimination of the reporting threshold should not be triggered by the mere issuance of a 

1676 proposed rule for a chemical. The latter commenter suggested that it would be inappropriate to 

1677 collect more detailed information on such a chemical until the proposed rule had been fully 

1678 vetted and analyzed, noting that finalization can often take a number of years. However, EPA 

1679 believes that the issuance of one of the proposed rules described above represents an appropriate 

1680 circumstance to trigger enhanced information collection under the IUR. EPA issues a proposed 

1681 rule under TSCA sections 5, or 6 only after making findings that a chemical substance or some 

1682 specified use of a chemical substance presents some level of concern. Precisely because the

1683 regulatory status of the chemical would be under analysis and because there might be an 

1684 opportunity for a fuller IUR dataset to help inform that analysis and the development of risk 

1685 management actions, EPA believes it is appropriate for the elimination of the reporting threshold 

1686 to be triggered at rule proposal. Furthermore, those chemicals that are the subject of a rule 

1687 proposed under sections 5(a)(2), 5(b)(4), or 6 are of demonstrated high interest to the Agency. In 

1688 an effort to better understand the extent of manufacture, use, and potential exposure to such 

1689 chemicals, EPA believes it is appropriate to eliminate the 25,000 lb. threshold for reporting on 

1690 their manufacture.

1691

1692 e. De minimis threshold volume. EPA asked for comment on whether a de minimis

1693 production volume threshold should be set for these chemical substances. Some commenters 

1694 opposed setting a new de minimis threshold. Other commenters suggested a variety of methods 

1695 for establishing a de minimis threshold. Specifically, one commenter recommended that EPA set 

1696 a de minimis threshold of 2,500 lb., similar to the European REACH regulation‘s registration 

1697 threshold of 2,200 lb. One commenter thought a de minimis volume should be set on a chemical1698 by-chemical basis for chemicals for which EPA needs specific information. Another commenter 

1699 felt that there should be no threshold level for persistent, bioaccumulative, or toxic chemicals 

1700 (PBTs). Other commenters thought the reporting threshold volume should be kept at 25,000 lb. 

1701

1702 The Agency agrees with the commenters who opposed setting a de minimis level. While 

1703 a 2,500 lb. de minimis threshold level would harmonize more closely with the European REACH 

1704 regulations‘ reporting threshold, the two programs are not completely analogous, e.g., REACH 

1705 does not require periodic reporting. EPA also believes that setting a de minimis threshold on a 

1706 chemical-by-chemical basis or special thresholds for PBTs or carcinogens would require more 

1707 time and resources than are presently available. Chemicals regulated or proposed for regulation 

1708 under the rules listed in 40 CFR 711.8(b) are of demonstrated high interest to the Agency, and 

1709 may present unreasonable risks at even relatively low concentrations. At this time, EPA does not 

1710 have an informed basis to set a uniform de minimis concentration (such as the 1% or 0.1% 

1711 concentrations suggested by the commenter) for these chemicals. However, if an importer does 

1712 not know, or can‘t reasonably ascertain that a particular chemical is present in a mixture, they are 

1713 not required to report it. 

1714

1715 D. Comments on Specific Data Elements

1716
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1717 1. Parent company and site identity. During the 2006 submission period, submitters 

1718 indicated that further clarification was needed to identify the correct company name for reporting 

1719 purposes. Based on these previous comments, EPA has determined that the parent company‘s 

1720 name, address, and Dun and Bradstreet Number is necessary to provide clarity as to which 

1721 company name to use for reporting under the IUR. This reporting requirement, at 40 CFR 

1722 711.15(b)(2)(ii), is consistent with the Toxic Release Inventory (TRI) requirements for parent 

1723 company name and it will help to better identify reporting sites that are under the same parent 

1724 company. EPA provides further clarification regarding the correct domestic (U.S.) parent 

1725 company name in the ―Instructions for 2011 Inventory Update Reporting (Ref. 5). 

1726

1727 2. Technical contact. EPA requested comment on requiring that the technical contact be 

1728 a person knowledgeable about the reported chemical substance and be located at the 

1729 manufacturing (including importing) site. Several commenters stated that companies should be 

1730 able to use their discretion in identifying the most appropriate contact or contacts. They believe 

1731 that the technical contact need not be physically located at the reporting site, and that information 

1732 may be more reasonably generated by a corporate contact rather than a technical contact at the 

1733 production site. Some commenters said that the technical contact should be an employee of the 

1734 submitting company.

1735

1736 EPA agrees with commenters who stated that companies should use their discretion in 

1737 selecting a technical contact or multiple technical contacts, as permitted by the new e-IURweb 

1738 software. However, EPA believes that a technical contact must be someone who can answer 

1739 detailed follow-up questions that EPA may have regarding the submission. EPA has found that 

1740 technical contacts not at the reporting site generally are less knowledgeable about the submission 

1741 or chemical and therefore may not be able to discuss follow-up questions. Also, it has been 

1742 EPA's general experience that short-term contractors have not been suitable technical contacts, 

1743 because they may no longer be under contract with the submitting company when EPA contacts 

1744 them a year or more after the submission is made.

1745

1746 3. Correct chemical name. 

1747

1748 a. Comments on imported chemicals and joint submissions. EPA received several 

1749 comments regarding its proposal to require that importers ensure that their supplier completes the 

1750 joint reporting of the CA Index Name currently used to list the chemical substance on the TSCA 

1751 Inventory. The comments indicated that it would be difficult for an importer to require that 

1752 another party complete a joint submission because foreign suppliers are not subject to the same 

1753 Federal regulations as U.S. companies, compliance with U.S. regulations is not their top priority, 

1754 and in some cases they are slow to comply. 

1755

1756 EPA agrees with the commenters that its proposed joint submission procedures for 

1757 importers, which required the importer to ensure that a foreign supplier prepared a secondary 

1758 submission on its behalf, presented implementation difficulties. This is because, as the 

1759 commenters suggested, the foreign supplier may not be subject to any direct legal obligation to

1760 provide the information to EPA. The Agency also notes that this issue extends to the regulations 

1761 at 40 CFR 711.15(b)(3)(i)(B), as there may be circumstances in which the manufacture of a 

1762 chemical substance is reportable under the IUR, yet the supplier of a reactant used in 
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46

1763 manufacturing that chemical substance would not have an independent legal obligation to report 

1764 the chemical identity of the reactant under the IUR. 

1765

1766 Therefore, the Agency has modified the regulatory requirements at 40 CFR 

1767 711.15(b)(3)(i) to reflect the primary submitter‘s underlying obligation to provide what it knows 

1768 or can reasonably ascertain respecting the identity of a chemical substance subject to reporting. 

1769 The joint submission requirement is no longer to ensure that suppliers provide secondary 

1770 submissions to EPA, but to properly ask that they do so. Consistent with 40 CFR 

1771 711.15(b)(3)(i), a request for a secondary submission to EPA must be prepared using e-IURweb, 

1772 include instructions for electronically submitting the information to EPA, and explain how to 

1773 provide a clear reference to the primary submission. Documentation of the request to the 

1774 supplier must be submitted to EPA along with the rest of the primary submission. 

1775

1776 Finally, EPA has also modified the regulatory requirements to more clearly reflect, see 

1777 proposal at 75 FR 49666, that they only apply in cases where a supplier will not reveal the 

1778 pertinent chemical identity information to the submitter. In the event that a manufacturer 

1779 (including importer) actually knows the chemical identity of a chemical substance subject to IUR 

1780 reporting, the manufacturer must provide that information irrespective of a supplier‘s 

1781 confidentiality claims. EPA has modified the substantiation question at 40 CFR 711.30(b)(1)(i) 

1782 to include information about harm to the submitter‘s competitive position ―or to your supplier‘s 

1783 competitive position.‖ 

1784

1785 b. Comments on reporting (International Union of Pure and Applied Chemistry) IUPAC 

1786 names as an alternate. A commenter recommended allowing IUPAC names as a substitute for 

1787 CA Index Names for discrete chemicals, because the IUPAC nomenclature provides the exact 

1788 chemical structure and because the commenter was concerned that submitters would be required 

1789 to go through a particular fee-based service to obtain CA Index Names for chemicals. 

1790

1791 The Agency disagrees that IUPAC names should be allowed as a substitute for CA Index 

1792 Names in reporting discrete chemicals for the IUR. Chemicals are listed on the TSCA Inventory 

1793 using CA Index Names, and only chemicals listed on the TSCA Inventory are to be reported for 

1794 IUR. The requirement for using CA Index names is directly related to positively identifying the 

1795 listed TSCA Inventory substance. Using a different nomenclature for the purposes of reporting 

1796 for IUR could create confusion, both for Industry and for EPA. 

1797

1798 Additionally, there will generally be no need for submitters to use a fee-based service to 

1799 obtain the CA Index Name and corresponding CASRN for IUR reporting purposes. As part of 

1800 the electronic reporting process for the IUR, submitters will be able to easily connect 

1801 electronically from the IUR reporting software directly to the Agency's SRS database in order to 

1802 obtain CA Index Names and corresponding CASRNs for all of their non-confidential chemical 

1803 substances on the TSCA Inventory. These data can then be electronically copied back to the 

1804 IUR reporting tool. 

1805

1806 4. Chemical Identifying Number. Some commenters were opposed to removing the PMN 

1807 number as an allowed identifying number, suggesting that the Agency might be inundated with 

1808 requests for Accession Numbers, and that for historical products, this may pose an extra burden 
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1809 for both industry and EPA. It was suggested that the Agency provide a cross-reference list of 

1810 PMN numbers to Accession Numbers so that the information can be easily obtained without 

1811 additional burden on industry and the Agency.

1812

1813 The Agency has added PMN numbers to the SRS listing to provide a cross-reference list, 

1814 as suggested by the commenters. The e-IURweb reporting tool allows the user to search SRS 

1815 using the PMN number in order to populate the IUR report with the pertinent chemical 

1816 identification information for confidential chemical substances listed on the Inventory. 

1817

1818 There are certain circumstances where a submitter occasionally may not be sure of the 

1819 particular PMN case number and Accession Number the Agency has assigned to one of its 

1820 confidential substances, such that the submitter would not be able to definitely determine this 

1821 solely from searching in the SRS. This could happen, for example, if the substance were 

1822 originally reported as part of a consolidated PMN and the submitter did not learn from EPA 

1823 which particular case number in the consolidated PMN number sequence corresponds to which 

1824 of the several reported confidential substances. This could also happen if a certain PMN 

1825 represented a mixture of two or more confidential substances, such that multiple Accession 

1826 Numbers were assigned to the different substances reported in that single PMN, and the 

1827 submitter didn't already request the particular Accession Numbers from EPA for the individual 

1828 chemical substances comprising that multi-component type of PMN. In such circumstances, a 

1829 submitter should contact EPA in writing, well before initiating IUR reporting, to obtain the 

1830 required Accession Numbers from the Agency. The Agency will respond to such inquiries in as 

1831 timely a manner as possible. It is the responsibility of the submitter to contact the EPA for such 

1832 information in sufficient time to allow for the Agency to respond. 

1833

1834 5. Production volume

1835

1836 a. Report production volume for each year. EPA requested comment on the requirement 

1837 to report production volume for each of the five years since the last IUR principal reporting year. 

1838 Comments submitted on various topics are described in this unit. 

1839

1840 i. Insufficient time to collect data. Most commenters stated that companies were prepared 

1841 to compile and report the required information for the 2010 reporting year; some companies 

1842 indicated, however, that they had not established systems to collect and compile information for 

1843 2006-2009. One commenter was concerned that the short period of time given by EPA to collect 

1844 the information will result in significantly decreased data quality and reliability. Another 

1845 commenter said that most companies archive data after 18-24 months. Some found it confusing 

1846 that the threshold to determine the need to report in the 2015 cycle would change to include 

1847 production data from previous years, but that the reporting of production data from previous 

1848 years would take effect in the 2011 cycle.

1849

1850 EPA acknowledges that there will be submitters for whom certain information for 2006 

1851 to 2009 will not be known or reasonably ascertainable. However, EPA believes it is unlikely that 

1852 normal business practices would not include tracking the volumes of the chemicals a company 

1853 was manufacturing, at least for a few years. In many instances, production volumes for recent 

1854 past months and years are tracked under standard business practices. For example, several TSCA 
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1855 regulations, such as 5(a)(2) SNURs and 5(e) orders, require that production volume records be 

1856 kept for five years for certain chemicals, and several commenters indicated that they archived 

1857 these records. EPA does not anticipate that the quality of the data reported will decrease because 

1858 of the new reporting requirement, particularly for the data elements that are not new. EPA 

1859 believes that the data will be of sufficient reliability for use by the Agency and others for 

1860 purposes such as screening-level risk assessments and prioritization. To the extent that required 

1861 information is indeed not known or reasonably ascertainable, EPA expects such circumstances to 

1862 be less frequent in reporting periods subsequent to 2011, as additional recordkeeping procedures 

1863 are put into practice.

1864

1865 ii. Reporting burden. Several commenters stated that the requirement is overly 

1866 burdensome, especially for chemical importers and manufacturers who (according to the 

1867 commenters) will need to analyze all products to track the volumes of all component chemicals. 

1868 Another commenter acknowledges that, while the burden of reporting the data for each principal 

1869 reporting year was minor, the information would be of little value to the Agency. On the other 

1870 hand, one commenter stated that this requirement could increase the burden by at least three fold. 

1871 Another commenter said that in some cases, businesses have no need to capture past production 

1872 volumes. One commenter asserted that many companies will consider the production volume in 

1873 every year to be CBI and will take the necessary steps to request CBI coverage of this 

1874 information. The commenter acknowledged that the information will still be available to EPA for 

1875 consideration, but was concerned that the burden on EPA of keeping the information confidential 

1876 will increase substantially due to the potential number of CBI claims. 

1877

1878 EPA‘s burden estimates represent the average burden across all sites for providing 

1879 production volumes. As such, commenters should be aware that their particular circumstance 

1880 may not be average and therefore the estimate may not accurately reflect their own, individual, 

1881 circumstance. However, because the estimate represents an average across all sites, EPA is 

1882 confident that the estimate does reflect the average burden and, when taken as a whole 

1883 encompasses the range of burdens faced by submitters.

1884

1885 In addition, some comments identified a misunderstanding of the reporting requirements. 

1886 For example, one commenter stated that many electronics manufacturers have never considered 

1887 themselves to be engaged in chemical manufacturing when they recycle their spent chemicals, 

1888 and therefore have not been collecting and tracking the production volume of each component 

1889 chemical substance comprising their byproducts. As described elsewhere in this Unit, 

1890 accounting for the manufacture of a byproduct does not necessarily entail accounting for each 

1891 individual component chemical substance in the byproduct. Therefore, EPA believes the 

1892 commenter is overestimating the burden associated with developing production volume 

1893 information. In any event, it is not a new requirement that byproduct manufacturers are subject 

1894 to the IUR—that is an established feature of the IUR that predates the amendments being 

1895 finalized in this rule. The Agency does expect that the reporting burden will decrease in reporting 

1896 cycles beyond 2011, as submitters put additional recordkeeping procedures into practice. While 

1897 more CBI claims may increase EPA‘s burden slightly, the Economic Analysis estimates the 

1898 amendments will save EPA approximately $180,000 in the first reporting year through 

1899 efficiencies from electronic reporting. CBI claims on production volumes are unlikely to create 

1900 any significant burden beyond what is estimated in the Economic Analysis. Inappropriate CBI 
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49

1901 claims will, however, prevent valuable information about chemical manufacture (including 

1902 import) from becoming publicly available. 

1903

1904 iii. Retroactive reporting. Several commenters expressed concerns asserting that EPA 

1905 retroactively is requiring historical data and that the requirement for past production information 

1906 was beyond the scope of EPA‘s TSCA authority for IUR reporting. Another commenter said it 

1907 was not feasible to accurately produce this historical data for the many byproducts that 

1908 companies produce and send for recycling, primarily because manufacturers did not know they 

1909 needed to have such data gathering mechanisms in place. 

1910

1911 EPA disagrees with commenters‘ suggestion that reporting information on past 

1912 production constitutes an imposition of retroactive reporting requirements. While the rule 

1913 establishes new requirements to report production volumes from several previous years prior to 

1914 the finalization of the rule, it does not alter the reporting requirements for the 2006 reporting 

1915 cycle, or any other prior reporting cycles. Neither does the final rule establish a new legal 

1916 requirement to have taken some particular recordkeeping action in the past. Instead, it holds 

1917 submitters to a prospective standard of reasonableness. EPA acknowledges that for the 2011 

1918 reporting period, some companies may neither know nor be able to reasonably ascertain all of the 

1919 newly requested information. However, EPA does not expect such circumstances to be prevalent 

1920 in 2011, and it would expects such circumstances will further decline in reporting periods 

1921 subsequent to 2011, as additional recordkeeping procedures are put into practice.

1922

1923 iv. Alternate approaches. Several commenters recommended that EPA delay the 

1924 implementation of the reporting requirement until the next reporting cycle to allow companies 

1925 sufficient time to prepare for the additional data collection effort. A few commenters suggested 

1926 that burden would be reduced if companies reported in ranges or provided best estimates. Other 

1927 commenters suggested that reporting be limited to a subset of industries or chemicals, based on 

1928 criteria to focus on data collection and evaluation activities that are more valuable to the Agency. 

1929 Examples of criteria include substances with a history of fluctuations in chemical manufacture 

1930 and import practices or substances that are considered hazardous. With the advent of REACH, 

1931 one commenter said they recently implemented an application that is capable of tracking 

1932 volumes of individual substances in mixtures and summing them up over a period of time. 

1933

1934 EPA disagrees that a delay is needed to allow submitters time to gather the information. 

1935 As discussed in Unit V.B, production volumes can vary significantly over a five year reporting 

1936 cycle and it is not uncommon for chemicals to rise above or fall below the reporting threshold 

1937 each reporting cycle. As some commenters pointed out, the requirement is essential to effectively 

1938 capture the substantial year-to-year fluctuations that occur in manufactured volumes that were 

1939 found to be missing in past IUR reporting cycles (Ref EDF comments). EPA does not believe it 

1940 practicable to provide a definitive list of chemicals with a ―known history of fluctuations.‖ The 

1941 Agency does not have such a list, and believes that because year to year fluctuation could be 

1942 caused by such a wide variety of circumstances, including circumstances such as economic 

1943 changes and manufacturing practices, that developing and maintaining such a list is not only not 

1944 practicable, but confining that list to substances with a ―history‖ of fluctuations would not 

1945 capture the industry variability that EPA is seeking. 

1946
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1947 EPA also disagrees that reporting production volume in ranges or estimates would 

1948 provide data of comparable value. Though EPA requires some of the IUR information to be 

1949 reported in specified ranges, EPA sees little value in allowing submitters to report the production 

1950 volumes in ranges or estimates, or requiring the information for only chemicals that are 

1951 hazardous. EPA believes that a higher level of confidence in data accuracy will be achieved by 

1952 requiring specific numeric data. It is important to note that EPA is interested in exposure and use 

1953 data on all chemicals that are not exempted from IUR reporting. Especially since there is a 

1954 multi-year gap between IUR submission periods, the mere fact that a chemical is not known to 

1955 be hazardous at this time does not mean that EPA is not interested in exposures and uses of that 

1956 chemical. Under a contrary policy, EPA would potentially need to wait several years before 

1957 obtaining the basic exposure information necessary to determine whether a hazardous chemical 

1958 may present an unreasonable risk (since the collection of screening-level exposure information 

1959 would not be triggered until hazard data had been assessed). In summary, after considering the 

1960 suggestions, EPA believes its decision to collect multi-year production volume under the 2011 

1961 IUR is still sound.

1962

1963 b. Volume of chemical substances used on site. One commenter stated that this data 

1964 element was essential to improving accuracy and utility of the reported production volume and 

1965 two commenters stated they thought there was no value in this data element and that the Agency 

1966 should retain the site-limited check box because, the commenters stated, it was more informative 

1967 for screening-level risk assessment. Five commenters expressed confusion about the 

1968 requirements of reporting this data element. Specific concerns included a concern about 

1969 duplicative reporting for this data element and the industrial processing and use information for 

1970 chemicals used on-site; whether this applied to chemicals used in synthesis or also to chemicals 

1971 that were repackaged; and the need to identify the amount of a chemical present on site during a 

1972 specific time period. 

1973

1974 Some of the commenters have misunderstood this data element, which provides more 

1975 detailed and clearer information than did the previous site-limited check box. Previously, 

1976 submitters checked a box to indicate that a reported chemical substance was site limited – in

1977 other words, that it was both manufactured and used on the site. Some submitters misreported, 

1978 identifying an imported chemical as site-limited (a situation that is not possible because the 

1979 imported chemical, by definition, is brought onto the site from outside of the U.S., and therefore 

1980 is not physically manufactured and used at the reporting site) or reporting the same substance 

1981 twice, once for the volume that is site limited and once for the volume that is sent off site. 

1982 Because of this confusion, EPA replaced the site-limited check box with reporting the volume of 

1983 the chemical production volume reported on the form that is used on the site. For example, if 

1984 50,000 lb. of a substance was manufactured and used on the same site, the submitter would 

1985 report 50,000 lb. for domestically manufactured and 50,000 lb. for the volume used on-site. If 

1986 70,000 lb. of a substance was manufactured, 25,000 lb. was used on-site and 45,000 lb. was 

1987 shipped to a different site, the submitter would report 70,000 lb. for domestically manufactured 

1988 and 25,000 lb. for the volume used on-site. If a site imported 30,000 lb. and used it at the import 

1989 site, the submitter would report 30,000 lb. for imported production volume and 30,000 lb. for the 

1990 volume used on-site. If a site imported 100,000 lb. and shipped it to an alternate site, the 

1991 submitter would report 100,000 lb. for imported production volume and 0 lb. for the volume used 

1992 on-site. As these examples illustrate, the submitter is not identifying the amount of a chemical 
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1993 on-site during a particular time period, but rather that amount of a chemical that is manufactured 

1994 (including imported) and used at the same site.

1995

1996 Commenters also asked for clarification regarding the activities considered to be ―used at 

1997 the reporting site.‖ For a domestically manufactured substance, if the volume would have been 

1998 considered to be site-limited, then the substance is used on site. If the substance is domestically 

1999 manufactured, temporarily stored, and then packaged for shipment off of the site, that volume 

2000 would not be considered ―used at the reporting site.‖ For an imported substance, any use at the 

2001 importing site (e.g. consumed in a reaction or crosslinked or cured in an article) would be 

2002 considered ―used at the reporting site.‖

2003

2004 EPA does not believe reporting the portion of the production volume that is both 

2005 manufactured and used on site will result in duplicative reporting. Even with the previous site2006 limited check box, submitters provided information about the use of a chemical in both the 

2007 manufacturing and industrial processing and use sections of the IUR Form U. The information 

2008 reported under the manufacturing section identifies that this substance is processed or used at 

2009 that particular site and reports the number of workers associated with the manufacture of that 

2010 substance. In the same report, the information reported under the industrial processing and use 

2011 section provides more details about how the chemical is processed or use and, in the event that a 

2012 substance has a use identified by the same combination of use, function, and NAICS code by 

2013 another site, the production volumes, sites, and workers would be combined with the information 

2014 describing the other sites‘ processing or uses.

2015

2016 c. Report volume exported. The majority of the comments against reporting the volume 

2017 directly exported stated that capturing the volumes for each chemical in each exported product 

2018 was difficult and burdensome. These comments indicated a misunderstanding of the reporting 

2019 requirement, and EPA believes that a better understanding will eliminate those concerns. For the 

2020 chemical substance that was manufactured and is being reported, the submitter is to report the 

2021 volume of that chemical substance that is directly exported. If the chemical is processed in any 

2022 way (e.g., combined with other substances to form a mixture), the chemical is not directly 

2023 exported. Also, if a chemical is sent to a distributor who then exports it, the chemical is not 

2024 directly exported. In both of these examples, the manufacturer would instead report either the 

2025 processing to form a mixture or the transfer to a distributor under the processing and use portion 

2026 of the IUR reporting form. ―Directly Exported‖ and ―Domestically Processed or Used‖ are 

2027 mutually exclusive designations; only one designation applies to any particular portion of the 

2028 production volume.

2029

2030 6. Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, 

2031 reused or reworked. EPA received several comments on the proposal to add a checkbox 

2032 indicating whether a manufactured chemical substance was or is expected to be recycled, 

2033 including remanufactured, reprocessed, reused, or reworked. Some commenters were supportive 

2034 of adding this reporting element, but several of the commenters were concerned that the term 

2035 ―recycle‖ has been difficult to define in other programs, indicated confusion about EPA‘s 

2036 purpose in including the checkbox, and expressed doubt that this data element would yield useful 

2037 information. 

2038
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2039 EPA intends that this checkbox would be used by manufacturers to indicate whether a 

2040 chemical substance they manufactured, such as a byproduct, which might otherwise be disposed 

2041 of as waste, was or is expected to be recycled. EPA also included the terms remanufactured, 

2042 reprocessed, reused, or reworked, intending to capture a broad array of similar, and perhaps 

2043 synonymous, activities by which a substance (that would otherwise be disposed of as waste) may 

2044 be put to use. EPA is interested in the exposures from these activities, and believes that having 

2045 more information about which chemicals are being recycled will help the Agency to refine future 

2046 IUR reporting requirements (i.e., if EPA knows enough about exposures to a chemical from an 

2047 on-site recycling use, EPA could consider an exemption in the future). 

2048

2049 EPA also believes that this information would help the Agency to identify where this 

2050 activity is already occurring, and could be used to recognize companies, industries, and sectors 

2051 that are using ―green‖ practices. This information would also help to identify sectors where 

2052 recycling is not occurring, providing useful data to measure the effectiveness of various EPA 

2053 programs, such as the Resource Conservation Challenge (RCC) Program, and informing other 

2054 Agency efforts to encourage practices that reduce waste. EPA disagrees that a precise definition 

2055 of ―recycle‖ is needed to make this data element useful for the purposes that EPA has identified. 

2056 Submitters should simply indicate, to the extent that they know or can reasonably ascertain, 

2057 whether the reported volume of the substance that they manufactured, which would otherwise be 

2058 disposed of as waste, was or is expected to be recycled, remanufactured, reprocessed, or reused, 

2059 as those terms are understood by the submitter. 

2060

2061 One commenter indicated that many chemicals are ―reworked‖ in many industrial 

2062 processes, at least at some point, so this box would be checked so often that it would provide 

2063 little meaningful data. EPA agrees that the term may be interpreted and applied too broadly to 

2064 provide the type of information that EPA is trying to collect, so has removed ―reworked‖ from 

2065 the list of recycling synonyms. Two commenters expressed concern that revealing whether a 

2066 substance they manufactured was recycled would reveal confidential business information. In 

2067 such a situation, the submitter will be able to claim the information as confidential. Another 

2068 commenter suggested that EPA collect information about recycling under a separate rule. EPA 

2069 disagrees that this would be an efficient way to collect the desired information. A separate 

2070 rulemaking for one ―yes or no‖ data element would be extremely inefficient and needlessly time2071 consuming for both the Agency and industry, particularly when the IUR rule already provides a 

2072 suitable vehicle to collect chemical manufacturing, processing, and use information.

2073

2074 7. Industrial processing and use information

2075

2076 a. Industrial function categories. The Agency received several comments regarding 

2077 revising the list of industrial function categories for processing and use information. Some 

2078 commenters were in favor of the changes and supported EPA‘s efforts to work collaboratively 

2079 with Canada to align the categories. Other commenters said that this would require additional 

2080 effort by the regulated community to assign the new codes, and a clear explanation of the 

2081 changes with the reporting instructions, e.g., a ―read across‖ of old and new codes, including 

2082 additional definitions to ensure that activities are consistently coded across companies. 

2083 Commenters stated that providing a description for ―other‖ will be challenging, may not provide 

2084 useful information (e.g., due to lack of information from the downstream customers), and would 
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2085 require additional burden to report. One commenter felt that the list of industrial function 

2086 category codes is too limited for inorganic chemicals, and suggested that the Agency add an IFC 

2087 code for ―Solid Manufacturing Materials.‖ The comment stated that such a code would alleviate 

2088 the need to address many industrial uses in the "other" category, thereby reducing reporting 

2089 burden.

2090

2091 EPA agrees with the commenters that a table indicating the relationship between the 2006 

2092 IFC codes and the new 2011 IFC codes would be useful, along with clear definitions for each 

2093 code. Such information is contained in the 2011 IUR Instructions for Reporting. 

2094

2095 EPA also recognizes that the requirement to report a description when the submitter 

2096 selects the IFC code ―Other‖ may be more burdensome than for the other IFC codes, but expects 

2097 any increase to be minor. The descriptive information is essential to enable users of the data to 

2098 estimate potential exposures associated with the overall processing or use of the chemical, of 

2099 which the function is an important component. The Agency‘s experience with the 2006 IUR 

2100 data was that the category of ―other,‖ with no further description, was insufficient for the data to 

2101 be of much use. 

2102

2103 EPA disagrees with the suggestion to include a ―Solid Manufacturing Materials‖ IFC 

2104 code and believes such a code will not accurately describe the industrial function of the chemical 

2105 substance. In addition, EPA believes the proposed list of IFC codes covers the majority of the 

2106 industrial functions. This belief is based on the past experience of both the U.S. 2006 IUR and 

2107 Canadian reporting. However, EPA does recognize that it did not collect such information for 

2108 inorganic chemicals in the past, and therefore will use the written description for ―Other‖ to help 

2109 evaluate and improve the inclusiveness of future IFC codes, including those applicable to 

2110 inorganic chemicals.

2111

2112 b. Industrial sectors. EPA proposed to replace the five digit NAICS code with a new 

2113 code, Industrial Sector (IS), to describe the industrial setting. Some commenters were in favor of 

2114 this change, noting that using code harmonized with Canadian codes would be helpful to both 

2115 industry and data users. Other commenters stated that many companies have already begun the 

2116 process of data collection based on the former system, which has precedent. The commenters 

2117 believe NAICS codes are the classification system with which industry and regulators are most 

2118 familiar, and in some cases, the IS codes are less descriptive than the NAICS codes. Commenters 

2119 also asserted that the Agency should recognize that these changes will result in increased 

2120 reporting burden and time.

2121

2122 EPA disagrees with the commenters that the use of IS codes in place of the NAICS codes 

2123 will present increased burden on industry. The IS codes simply group together similar NAICS 

2124 codes while still providing the sufficient differentiation needed to differentiate overall industrial 

2125 processing and use scenarios. The IS codes span the entire range of NAICS codes and can be 

2126 translated from known NAICS codes. Both the e-IURweb reporting tool and the 2011 IUR 

2127 Instructions for Reporting contain cross-walk tables for submitters to use to determine the proper 

2128 IS code, based on the NAICS code information they may already have collected. 

2129
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2130 Information on the Agency‘s development of the IS codes is described in the technical 

2131 support document ―Inventory Update Reporting (IUR) Technical Support Document 

2132 Replacement of 5-digit NAICS Codes with Industrial Sector (IS) Codes‖ (EPA-HQ-OPPT-2009-

2133 0187-0005). In developing the IS codes, EPA considered the level of detail required for 

2134 developing use and exposure scenarios, the number of 2006 IUR submissions using the code, the 

2135 code definition, and the level of difficulty required in reporting more detailed codes. 

2136 Submissions to the 2006 IUR reported over 340 unique five-digit NAICS codes. In the 2006 

2137 IUR, the three-code combination of processing and use (P/U) code, NAICS code, and IFC codes 

2138 resulted in a large number of possible exposure scenarios that could be reported. Although not all 

2139 of the NAICS codes are applicable to chemical manufacturing and processing, the 2006 IUR 

2140 database has over 2,300 unique combinations of P/U, NAICS, and IFC. Many of the NAICS 

2141 codes reported are from similar industries that would have similar exposure scenarios. 

2142

2143 EPA agrees that the new IS codes are less descriptive than NAICS codes, but believes the 

2144 reduction in specificity will not adversely affect, and will actually improve, the Agency‘s ability 

2145 to use the processing and use data for screening-level purposes. The large number of unique 

2146 combinations increases the difficulty and time required to sort and classify chemicals since EPA 

2147 would either need to develop exposure scenarios for each unique combination or determine 

2148 which three-code combinations have similar exposure scenarios and can be grouped together. 

2149 By replacing the NAICS codes with the IS code, the number of potential three-code 

2150 combinations is reduced from in excess of 100,000 possible combinations to 7,920 combinations. 

2151 Based on information collected from the last reporting cycle the number of combinations 

2152 actually reported would be significantly less. Additionally, the IS codes will more closely align 

2153 to the EU Sector of Use codes which will allow EPA to compare U.S. data with that collected by 

2154 the European Union.

2155

2156 8. Consumer and commercial use

2157

2158 a. Consumer and commercial product categories. Many commenters supported revising 

2159 the list of consumer and commercial product categories for consumer and commercial use 

2160 information. Those commenters stated that harmonizing codes with Canada, revising the product 

2161 categories, and requiring descriptive information when the ―other‖ category is reported are 

2162 essential to improving the consumer and commercial data. The commenters stated also that 

2163 these changes will provide a better understanding of how chemicals are used in downstream 

2164 products and will help facilitate consistent reporting of chemical use information in the United 

2165 States and Canada. Other commenters wanted more explanation as to why the categories are 

2166 being revised and requested that the Agency provide more descriptive information for each 

2167 product category, including a table identifying how the new categories relate to the previous 

2168 categories. Some commenters stated that providing a description for the category ―other‖ will be 

2169 challenging and may not provide useful information. One commenter stated that the Agency 

2170 should not further complicated downstream reporting, noting that was already challenging to 

2171 choose the top ten categories for substances with a large number of uses. 

2172

2173 EPA appreciates the support for the harmonized consumer and commercial product 

2174 categories, and agrees that the changes finalized in this rule will improve the IUR data. As 

2175 described in Unit III.G.8.a., information from data collected during the 2006 IUR and from 
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2176 Canada was used to develop a more useable listing of product categories. EPA eliminated 

2177 categories for which few chemicals were reported, added categories identified as needed, and 

2178 eliminated overlap in categories. In addition, some categories were renamed to better match 

2179 their definitions, other categories descriptors were improved, and categories were grouped to 

2180 allow for easier identification. EPA believes these changes will make reporting easier for the 

2181 submitter, and does not agree that these changes result in more complicated reporting. The 

2182 Agency is providing more detailed descriptive information in the 2011 IUR Instructions for 

2183 Reporting and other guidance materials. 

2184 EPA recognizes that the requirement to report a description when the submitter selects 

2185 the product code ―Other‖ may be more burdensome than for the other product codes, but expects 

2186 any increase to be minor. The descriptive information is essential to enable users of the data to 

2187 estimate potential exposures associated with the consumer or commercial use of the chemical. 

2188 The Agency‘s experience with the 2006 IUR data was that the category of ―other,‖ with no 

2189 further description, was insufficient for the data to be of much use.

2190

2191 b. Designation of consumer or commercial use. Commenters had mixed viewpoints 

2192 regarding the need to designate whether the indicated product category is consumer use, 

2193 commercial use, or both. One commenter strongly in support of making this designation stated 

2194 that such distinctions are critical to EPA‘s ability to assess exposure at even the most basic level. 

2195 Others didn‘t oppose the added designation, but did ask for further clarification between 

2196 consumer and commercial uses. Commenters opposing the added designation stated that they 

2197 were too removed from the consumer and commercial uses to have a clear understanding of the 

2198 uses at that level of distinction, especially for commodity chemicals with a large number of uses. 

2199 One commenter said suppliers to formulated products were less likely to know the distinction 

2200 because of the confidentiality of the downstream user formulations. 

2201

2202 The intent of the consumer and commercial use data element is to clearly identify the 

2203 exposed populations. These two populations (i.e., consumers and commercial workers) are very 

2204 different from each other, and the ability to distinguish uses between the two enables better 

2205 exposure-based screening of chemicals. EPA recognizes that submitters may not always have 

2206 detailed information about how the chemical(s) they make are used and to what extent they are 

2207 used. However, EPA believes a manufacturer generally has a certain awareness of the 

2208 downstream uses of chemicals it manufactures and sells, even if it does not control its customers‘ 

2209 sites, and can report this information, based on what is known to or reasonably ascertainable by 

2210 the submitter. 

2211

2212 c. Number of commercial workers. Commenters strongly opposed EPA‘s proposal to 

2213 require that submitters report the number of commercial workers reasonably likely to be exposed 

2214 while using a product containing a reportable substance. Most commenters indicated that they 

2215 do not have sufficient information about the work practices of eventual commercial users to 

2216 estimate this number, that such information is not typically shared upstream, and that any such 

2217 data EPA received would be, at best, an educated guess. It was suggested that the Agency rely on 

2218 worker statistics from the Bureau of Labor as it conducts risk assessments, or gather additional 

2219 data under a separate TSCA Section 8(a) rule.

2220
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2221 EPA is requiring this information to better assess the size of the commercial population in 

2222 screening risk assessments. In the past, the Agency has used the Bureau of Labor Statistics for 

2223 general workers statistics to conduct chemical-specific risk assessments; however, these worker 

2224 statistics, which are industry-specific, overestimate the exposures associated with a chemical 

2225 because a chemical is likely to be used by only a portion of the industry. Identifying chemical2226 specific worker populations for downstream activities will fill this gap for the Agency. The 

2227 knowledge of a chemical‘s uses in industry and the respective commercial population potentially 

2228 affected by their uses provides the Agency a more complete picture of the potential risks 

2229 associated with a chemical.

2230

2231 EPA recognizes that submitters may not always have detailed information about how the 

2232 chemical(s) they manufacture are used and to what extent they are used in commercial 

2233 enterprises. However, EPA believes that a manufacturer generally has a certain awareness of 

2234 downstream uses of chemicals it manufactures and sells, even if it does not control its customers‘ 

2235 sites. Based on its experience with the PMN program, many stakeholder meetings, discussions 

2236 about voluntary risk management programs, and industry‘s various self-regulation initiatives, the 

2237 Agency believes that most submitters can report on downstream uses, including the information 

2238 that would be reported under IUR, based on what is known to or reasonably ascertainable by the 

2239 submitter. To reduce the burden in reporting, the IUR provides that the number of commercial 

2240 workers need only be reported in ranges, and the ranges are the same as for manufacturing and 

2241 industrial workers. Reporting in ranges will lessen the reporting burden when the precise 

2242 number of workers for multiple end uses is not known. Although this may result in some 

2243 uncertainty in the data reported, the chemical manufacturer or importer has fulfilled his 

2244 obligation by providing information to the extent it is known or reasonably ascertainable. EPA 

2245 believes that the data will be sufficiently reliable for the Agency and others to use for screening2246 level risk assessments and prioritization. 

2247

2248 E. Definitions and Clarification Requests

2249

2250 1. Changing the reporting standard for processing and use information to “known to or 

2251 reasonably ascertainable.” A number of commenters requested further clarification (beyond that 

2252 offered in Section 4.0 of the Reporting Instructions) of the scope of pre-reporting inquiry that 

2253 would be required under the ―known to or reasonably ascertainable by‖ reporting standard. 

2254 Specifically, the commenters requested further clarification of how this reporting standard would 

2255 apply in the case of information reported under 40 CFR 711.15(b)(4) (―specific information 

2256 related to processing and use‖). The commenters also expressed some confusion about how this 

2257 standard would differ from the ―not readily obtainable standard,‖ previously applicable to such 

2258 reporting, and whether the change of standard indicates that ―extensive file searches and 

2259 customer surveys‖ would now be expected of submitters. Other commenters from the chemical 

2260 industry expressed their understanding that the change in reporting standard only altered the 

2261 level of diligence with which submitters must search for information within their own 

2262 organization. They requested confirmation that, as under the ―not readily obtainable‖ standard, 

2263 submitters would not be required to conduct customer surveys in order to assemble data for 

2264 purposes of inventory update reporting. 

2265
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2266 The term ―known to or reasonably ascertainable by‖ is defined at 40 CFR 704.3. It 

2267 means ―all information in a person‘s possession or control, plus all information that a reasonable 

2268 person similarly situated might be expected to possess, control, or know.‖ By contrast, ―readily 

2269 obtainable‖ information does not even cover all the information in a submitter‘s possession or 

2270 control. As defined for the 2006 IUR, it was limited to what was known by certain 

2271 ―management and supervisory employees of the submitter.‖ See 68 FR 879 (2003). Under the 

2272 ―known to or reasonably ascertainable by‖ standard, a submitter must therefore ascertain what it 

2273 knows about the processing and use of a chemical substance it manufactures, without confining 

2274 its inquiry to what is known to managerial and supervisory employees. The inquiry must be as 

2275 extensive as a reasonable person, similarly situated, might be expected to perform. Information 

2276 derived from customer surveys or other customer contacts, like any other information, would be 

2277 ―known to or reasonably ascertainable by‖ to the submitter if it is available after a reasonably 

2278 extensive inquiry.

2279

2280 EPA agrees that further clarification would be useful regarding what is ―reasonably 

2281 ascertainable‖ to submitters about processing and use information because this component of the 

2282 reporting standard potentially may require submitters to obtain information previously unknown 

2283 to them, for the purposes of reporting. This would occur if a submitter knows less than that what 

2284 is reasonably ascertainable to it. EPA is therefore offering the following further guidance 

2285 regarding the interpretation of this term.

2286

2287 For many of the reasons identified by industry commenters (e.g., the expense and burden 

2288 of surveying customers, and uncertainty as to the extent to which customers will respond to such 

2289 surveys), EPA agrees that if particular information cannot be developed or reasonably estimated 

2290 without conducting further customer surveys, it is generally not ―reasonably ascertainable‖ to the 

2291 submitter for purposes of the IUR. However, to the extent that customer surveys are already in 

2292 the submitter‘s possession or control, and to the extent that reasonable efforts to locate or analyze 

2293 those surveys may result in additional processing and use information (or reasonable estimates of 

2294 such information), the information is generally ―reasonably ascertainable.‖

2295

2296 A number of commenters requested that EPA specify the precise degree of effort required 

2297 of manufacturers if they must survey their customers to generate data for the IUR; e.g., how far 

2298 down the chain of commerce must such inquiries go? How persistent must the manufacturer be 

2299 in seeking such information? As described earlier, EPA does not anticipate that the IUR will 

2300 generally require any degree of effort to survey customers. However, where surveys have 

2301 already been performed, and the results are already in the submitters‘ possession or control, EPA 

2302 expects that submissions will be informed by the submitters‘ reasonable efforts to identify and 

2303 interpret the results.

2304

2305 A number of commenters objected to the ―known to or reasonably ascertainable by‖ 

2306 standard on the grounds that it was subjective or too vague to be appropriately applied to the 

2307 collection of processing and use information outside of the submitter‘s direct control. Other 

2308 commenters objected to the standard‘s reference to what a reasonable person similarly situated 

2309 ―might‖ be expected to possess, control, or know. They suggested that the standard be amended 

2310 to what a reasonable person ―should‖ be expected to know. 

2311
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2312 EPA does not agree that the ―known to or reasonably ascertainable‖ standard is 

2313 subjective or excessively vague. The standard is set forth in EPA‘s statutory authority to collect 

2314 information under Section 8(a) of TSCA, and EPA‘s definition is consistent with Congressional 

2315 intent to establish an objective standard: ―The conferees intend that the  ̳reasonably 

2316 ascertainable‘ standard be an objective rather than a subjective one. Thus, the manufacturer or 

2317 processor must provide information of which a reasonable person similarly situated might be 

2318 expected to have knowledge.‖ H.R. Rep. 94-1679 at 80 (1976). Thus, whether a particular level 

2319 of diligence meets this standard does not depend on the submitter‘s subjective view of what 

2320 seems a reasonable person ―should‖ be expected to know. It turns on an objective question: the 

2321 level of diligence that a reasonable person, similarly situated, might expect to undertake. EPA 

2322 believes it is appropriate to define the standard consistently for all persons reporting under 

2323 Section 8(a) of TSCA, and that the existing definition appropriately reflects Congressional intent. 

2324 Finally, EPA does not think the standard of objective reasonableness will be unfamiliar to 

2325 submitters. It is incorporated into a wide variety of legal standards under state and federal law, 

2326 and in the 2006 IUR it applied to all aspects of the information collection other than processing 

2327 and use information. 

2328

2329 2. Clarifications to byproduct reporting. a. Concern that new byproduct reporting 

2330 requirements are being added. In general, some commenters asserted that EPA‘s explanation of 

2331 the IUR byproduct-related reporting requirements reflect new requirements, inconsistent with 

2332 current byproduct exemptions. 

2333

2334 EPA is clarifying, not enlarging, the reporting requirements for byproducts, which have 

2335 been in place for decades. Byproducts are defined at 40 CFR 704.3, under an existing definition 

2336 that has been in place since 1988. The reporting exemptions for byproducts at 720.30(g) and (h)) 

2337 (cross referenced at 40 CFR 711.10) have been in place since 1983. While this final rule is 

2338 modifying the applicable definition of ―manufacture,‖ the pertinent language (providing that 

2339 manufacture includes ―the extraction, for commercial purposes, of a component chemical 

2340 substance from a previously existing chemical substance or complex combination of chemical 

2341 substances‖) is identical in all material respects to language found in the definition of 

2342 ―manufacturer‖ at 40 CFR 704.3 That language has been in force, and applicable to the IUR, 

2343 since 1988.

2344

2345 In 1983, EPA promulgated a rule that made clear (for subsequent IUR and PMN 

2346 purposes) that the reporting exemption for the manufacture of byproducts is only potentially 

2347 applicable to the manufacture of the byproduct and would in no case apply to the manufacture of 

2348 component substances extracted from the byproduct. 40 CFR 720.30(g)(3). Furthermore, it has 

2349 been the Agency‘s position since at least 1991 that, in order for byproduct manufacture to qualify 

2350 for the 720.30(g)(3) exemption, ―the component to be extracted must be already existing as a 

2351 distinct chemical substance in the waste stream.‖ (Ref.20). When the chemical substance present 

2352 in the byproduct and the chemical substance extracted from the byproduct are distinct chemical 

2353 substances, neither the manufacture of the byproduct nor the manufacture of the extracted 

2354 chemical substance qualify for the 720.30(g)(3) exemption.

2355

2356 The guidance docketed with today‘s notice, which explains existing byproducts reporting 

2357 requirements under the IUR, is consistent with past guidance issued in connection with the IUR 
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59

2358 and TSCA new chemicals program. For example: In a 2002 response to public comments on a 

2359 previous proposed amendment to the TSCA Inventory Update Rule (see 2003 final rule 

2360 published at 68 FR 848, Ref. 18), EPA explained that ―distillation, extraction, refining, and 

2361 similar activities may result in the manufacture of a chemical substance.‖ In a 2006 letter to the 

2362 Aluminum Association, EPA described a circumstance in which the extraction of aluminum 

2363 from aluminum dross byproduct constituted the reportable manufacture of aluminum, while 

2364 cautioning that if the aluminum is ―chemically changed during the extraction process,‖ then not 

2365 only the extracted aluminum but also the dross byproduct would be reportable under the IUR 

2366 (Ref. 21). In 2008, EPA provided similar guidance by letter to IPC, another trade group (Ref. 

2367 22). 

2368

2369 Due to the 2003 expansion of the IUR reporting requirements to inorganic chemicals, 

2370 many companies have recently become aware of their status as chemical manufacturers when 

2371 they recycle their waste materials. Instead of disposing of those waste materials, the 

2372 manufacturers return them to commerce by recycling the materials – either themselves or 

2373 through a third party. Recycling may be beneficial for many reasons: it conserves resources, 

2374 may reduce the expense of purchasing new raw or starting materials, may reduce the reliance of 

2375 the United States on foreign suppliers of raw materials, reduces the need for landfill or other 

2376 disposal sites, and returns a waste to commerce. However, many recycling activities fit the 

2377 TSCA and IUR rule definition of manufacture, and are likely to be considered ―manufacture for 

2378 a commercial purpose.‖ EPA has finalized the draft IUR guidance documents that were 

2379 published with the proposed rule. These documents include examples of many common 

2380 manufacturing scenarios to assist individuals in determining whether their company is 

2381 manufacturing a chemical that needs to be reported under the IUR (Refs. 11 and 12). 

2382

2383 b. Concerns about the IUR byproduct reporting requirements, in relation to RCRA and 

2384 the Toxics Release Inventory. Some commenters asserted that byproducts should be regulated, if 

2385 at all, under RCRA and/or reported under TRI, and should not subject to IUR reporting 

2386 requirements. One commenter suggested that EPA revisit the entire issue of the management of 

2387 recycled materials to determine the appropriate roles for the TSCA and RCRA programs. Some 

2388 commenters also asserted that reporting under IUR presents a disincentive for recycling.

2389

2390 In broad terms, the purpose of TSCA sections 8 (governing the IUR) and 5 (governing 

2391 PMN reporting) is to understand the universe of chemicals in commerce in the United States. 

2392 (Section 5 also provides EPA with the ability to control for risks of new chemicals before they 

2393 are placed into commerce.) The IUR requires reporting of manufacture, processing, and use 

2394 information for chemicals in commerce, and exemptions exist for those substances or 

2395 manufacturing activities for which EPA has a low current interest. With limited exception, such 

2396 as those included in 40 CFR 720.30, all chemical substances in commerce in the United States 

2397 are to be listed on the TSCA Inventory; companies can trigger the addition of a chemical 

2398 substance to the Inventory by filing a PMN and meeting certain other requirements. 

2399

2400 RCRA is focused on waste – it is concerned with the generation, transportation, 

2401 treatment, storage, and disposal of hazardous wastes and the management of non-hazardous solid 

2402 wastes. RCRA is also focused on waste minimization, phasing out land disposal of hazardous 

2403 waste, corrective action for releases, and recycling. EPA notes that while RCRA or other 
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2404 statutes may exempt a certain chemical from reporting requirements based on certain treatments 

2405 or disposals, RCRA exemptions do not apply to TSCA reporting obligations, and, given the 

2406 different purposes of RCRA reporting and the TSCA IUR rule, are not necessarily relevant to 

2407 IUR reporting. It is important to note that finding a commercial use for a substance previously 

2408 treated as a waste under RCRA can relieve the manufacturer of that substance from some RCRA 

2409 requirements, but may then subject that manufacturer to TSCA reporting requirements. EPA is 

2410 aware that, in certain circumstances, reporting under both RCRA and TSCA may be required. It 

2411 is the Agency‘s intention to identify and address such circumstances, retaining reporting under 

2412 the rule that best fits Agency needs. However, it is important to note that the TSCA program is 

2413 working with the RCRA program -- the application of RCRA regulations varies state-by-state, 

2414 and recent changes to RCRA regulations have not been adopted by all states. Therefore the 

2415 overlap between RCRA reporting and IUR reporting may vary depending upon the state in which 

2416 a submitter‘s site is located. 

2417

2418 A similar situation exists for some sites that meet the requirements to report under both 

2419 TRI and IUR. The TRI program goal is to provide communities with information about toxic 

2420 chemical releases and waste management, and the TRI reporting requirements are designed to 

2421 address that goal. Because the IUR program goals differ, the specific information collected 

2422 under each program is not the same. Where a person must report for both for the same site, EPA 

2423 and the public will have a broader picture of the exposure scenarios at that site, including 

2424 environmental releases from that site; while the two information collections may be 

2425 complementary, neither is an adequate substitute for the other. A more in-depth discussion is 

2426 provided in the Responses to Comments document (Ref. 13). 

2427

2428 EPA believes that commenters‘ concern that reporting under IUR would be a disincentive 

2429 to recycle reflects certain misunderstandings of the IUR requirements. The Agency expects that 

2430 revised byproduct guidance materials, as well as EPA‘s responses to the comments concerning, 

2431 for instance, byproduct chemical identification requirements, will help to alleviate the majority 

2432 of those concerns. EPA believes that many factors play into whether a company chooses to 

2433 recycle, including the value of the recovered materials, the expense of disposal, desire to 

2434 maintain or build a ―green‖ reputation, technical limitations or flexibility, state and local 

2435 requirements or incentives, and the incentives offered or requirements imposed by other federal 

2436 laws (such as RCRA). EPA strongly believes that the benefits of recycling usually outweigh the 

2437 burden associated with IUR reporting for these materials, and, just as with any other chemical 

2438 whose manufacture must be reported under the IUR, production volume, worker exposure and 

2439 other IUR data collected on byproduct chemicals supports the Agency‘s mandate to protect 

2440 human health and the environment. 

2441

2442 c. Concerns about how to identify the byproduct chemical and with reporting both the 

2443 byproduct and a substance extracted from the byproduct.

2444 Commenters stated that it is very difficult to identify the chemicals in a byproduct mixture, and 

2445 that the mixture can vary over time, depending upon the specific manufacturing situation. 

2446 Commenters also argued that there would be duplicative reporting by the byproduct 

2447 manufacturer and the recycler/processor who extracted a component chemical substance from 

2448 the byproduct mixture.

2449
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2450 The comments reflect a misperception that characterizing the identity of complex 

2451 chemical substances, as are found in or comprise many byproducts, necessarily involves a 

2452 detailed analysis of the ―individual components of the chemical substance.‖ In reality, a 

2453 byproduct may be listed in the Inventory as a single chemical substance that represents, for 

2454 TSCA purposes, what may be a complex composition of chemicals. In this way, the chemical 

2455 identity of a byproduct may represent a chemical process stream. Complex chemical substances 

2456 are listed (or can be listed) on the Inventory as chemical substances of Unknown or Variable 

2457 composition, Complex reaction products and Biological materials (―UVCB‖ substances). As 

2458 described by the commenters, the byproduct ―mixture‖ is often complex and varies over time, 

2459 making the identification of the individual components a very difficult task. This description 

2460 itself indicates that the proper identification of such a reaction product is as a UVCB substance. 

2461 As stated in EPA‘s on-line guidance, ―Each combination of substances resulting from a reaction 

2462 is considered by the Agency to be either (1) a mixture, composed of two or more well-defined 

2463 chemical substances to be named and listed separately, or (2) a reaction product, to be listed as a 

2464 single chemical substance, using one name that collectively describes the products, or, failing 

2465 that, the reactants used to make the products. ― (see 

2466 http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt ) Situations may exist where the 

2467 byproduct substance is actually a mixture, but as further described in the aforementioned 

2468 guidance, ―A combination of products resulting from a chemical reaction is considered a mixture 

2469 provided that all of the component product substances are unambiguously identified and are 

2470 represented as forming each time the reaction is run.‖ 

2471

2472 UVCB substances in some cases include an Inventory definition to further describe the 

2473 substance. Here is one example from EPA‘s on-line guidance (see 

2474 http://www.epa.gov/oppt/newchems/pubs/uvcb.txt):

2475

2476 Dust, iron-ore, sinter 

2477 CASRN 69012-53-9 

2478 Definition: Dust generated during the making, breaking and handling of sinter which is 

2479 recovered through the use of pollution abatement equipment. 

2480

2481 A byproduct manufacturer, therefore, would potentially report the UVCB name for the 

2482 byproduct composition, while the subsequent recycler of the byproduct would potentially report 

2483 the specific chemical identity of the substance they chemically manufacture from the byproduct. 

2484 EPA does not agree that such reporting is duplicative, because reporting will fall into one of 

2485 following two scenarios. If the chemical substance manufactured from the UVCB byproduct is 

2486 already present as a constituent of the UVCB byproduct, then the byproduct manufacturer need

2487 not report the byproduct that is sent for such processing/recycling. If the chemical substance 

2488 manufactured from the UVCB byproduct is distinct from any chemical substance present in the 

2489 UVCB byproduct as a constituent, then the separate reporting by the byproduct manufacturer and 

2490 the processor/recycler reflects a change in chemical composition. Either way, there is no 

2491 duplication of reporting between the manufacturer of the UVCB byproduct and the 

2492 processor/recycler. As a general matter, if there is to be appropriate stewardship of potential 

2493 chemicals risks, EPA believes that chemical manufacturers, processors, and users should know 

2494 and understand the identities of chemicals they handle.

2495
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2496 Some commenters stated that many byproduct mixtures in the metals industry are 

2497 processed to recover the metal values and indicated that the metal value should be considered a 

2498 component chemical substance (i.e., that if Nickel (II) hydroxide (Ni(OH)2) is present in a 

2499 byproduct mixture, then the elemental substance Nickel (Ni) should be considered the 

2500 component chemical substance). EPA disagrees with this statement. (See Ref. 20 for a 

2501 precedent from a 1991 prenotice communication.) Under TSCA, Ni(OH)2 and elemental Ni are 

2502 two different chemical substances, with separate listings on the TSCA Inventory. If the 

2503 byproduct contains Ni(OH)2 but not elemental Ni, only Ni(OH)2 is considered a component 

2504 chemical substance of the byproduct. The manufacture of elemental Ni from either the Ni(OH)2

2505 –bearing byproduct (or Ni(OH)2 itself) results in a potential need to report under IUR. That is, if 

2506 the extracted component substance is an oxide and used as an intermediate to form an elemental 

2507 metal, then both the oxide and elemental metal are subject to reporting by their manufacturer(s). 

2508 Note that information pertaining to manufacture of a chemical substance need only be reported to 

2509 the extent that the information is known to or reasonably ascertainable by the submitter. 

2510

2511 A second example of a metal-containing byproduct is:

2512

2513 Electrolytes, copper-manufg., spent 

2514 CASRN 69012-54-0

2515 Definition: Spent copper sulfate electrolyte consisting of copper sulfate and sulfuric acid 

2516 resulting from the electrolytic refining of copper. 

2517

2518 This spent material is a UVCB substance that is likely to be recycled. If the only 

2519 commercial purpose for this spent material is to extract the component chemical substance 

2520 copper sulfate, then the manufacture of the spent material is exempted from reporting (but the 

2521 manufacture of the copper sulfate [via extraction from the byproduct] is subject to reporting). 

2522 On the other hand, if the spent material is used directly to manufacture elemental copper, then 

2523 both the spent material and the elemental copper are subject to reporting under the IUR by their 

2524 respective manufacturers, because elemental copper is not a component chemical substance in 

2525 the spent material byproduct.

2526

2527 d. Concerns regarding determining when a byproduct is manufactured.

2528 Commenters stated that clarification is needed regarding purification and extraction and when a 

2529 chemical is considered manufactured versus purified. Commenters asserted that where there is 

2530 no change in chemical identity, only a change in purity, a chemical should not be considered 

2531 manufactured, regardless of the method of purification. 

2532

2533 Much of the commenters‘ confusion regarding the differences between purification and 

2534 extraction appears to concern whether extraction or purification involves a change in chemical 

2535 identity; the potential for a change in chemical identity is closely linked with the proper 

2536 identification of the manufactured substance, as described in the previous comment response. 

2537 Where there is no change in chemical identity but rather just a change in purity (an impure 

2538 chemical substance correctly identified for TSCA purposes as ―substance A,‖ for example, 

2539 undergoing purification to a more pure form of ―substance A‖), the Agency agrees with the 

2540 commenter that, for purposes of IUR, the chemical is not being manufactured. The substance 

2541 that appears on the Inventory may actually represent a category consisting of the same chemical 
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2542 substance in various degrees of purity. For example, if a company manufactures a specific, 

2543 discrete chemical substance at 90% purity and it is correctly identified as that discrete substance 

2544 (not having a UVCB name), then increasing the purity of the substance (such that it retains its 

2545 chemical identity) is considered purification and, for purposes of IUR, such purification is not 

2546 considered manufacture. 

2547

2548 Note, however, that the extraction of component chemical substances from certain 

2549 complex byproduct mixtures or process streams (i.e., UVCB substances), is not considered 

2550 purification, because the complex byproduct mixture and the extracted substance do not have the 

2551 same chemical identity. For example, a manufacturing process involving the use of solvent A 

2552 results in the manufacture of a spent solvent. As a variable, complex mixture of solvent A, 

2553 finished product, unreacted reactants, individual byproduct substances, and other impurities, the 

2554 spent solvent is considered to be a UVCB substance. It is not unusual for the manufacture to 

2555 extract solvent A from this UVCB substance. In such a case, the extracted solvent A is 

2556 considered to be manufactured, and therefore is reportable for purposes of IUR. When the spent 

2557 solvent is a byproduct whose only commercial purpose is the extraction of a component chemical 

2558 substance, solvent A, the byproduct exemption at 40 CFR 720(g)(3) can be applied and the spent 

2559 solvent byproduct does not need to be reported. The extracted solvent A is nevertheless 

2560 reportable for purposes of IUR.

2561

2562 3. Definitions of Manufacture and manufacturer. EPA received several comments on the 

2563 definition of ―manufacture,‖ asserting that the definition of manufacture included in the proposed 

2564 rule was inconsistent with past definitions, over-broad, and confusing. 

2565

2566 EPA disagrees, except with respect to minor typographical errors noted below. EPA 

2567 consolidated existing definitions into a single ―manufacture‖ definition to reduce confusion. 

2568 EPA also added a very short clarifying definition that ―a manufacturer is a person who 

2569 manufactures a chemical substance,‖ to direct the reader to the relevant language in the 

2570 definition of ―manufacture,‖ and to avoid confusion with an existing definition of 

2571 ―manufacturer‖ in 704.3. The definition of ―manufacture‖ is consistent with established 

2572 regulatory and statutory definitions, and is sufficiently flexible to accommodate the actual 

2573 allocation of knowledge between toll manufacturers and contracting companies. EPA has 

2574 separately addressed the comments received relating to the extraction of component chemical 

2575 substances. (See the discussion on reporting byproducts and recycling elsewhere in this Unit.) 

2576

2577 The first part of the definition of manufacture in today‘s final rule is as follows: 

2578 ―Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture 

2579 includes the extraction, for commercial purposes, of a component chemical substance from a 

2580 previously existing chemical substance or complex combination of substances.‖ It is similar to 

2581 the definitions of ―manufacture‖ and ―manufacturer‖ used for past IUR reporting. For example, 

2582 the definition of manufacturer in effect for the 2006 IUR reporting period is in 40 CFR 704.3: 

2583 ―Manufacturer means a person who imports, produces, or manufactures a chemical substance. A 

2584 person who extracts a component chemical substance from a previously existing chemical 

2585 substance or a complex combination of substances is a manufacturer of that component chemical 

2586 substance.‖ The two similar definitions of ―manufacture‖ in effect for the 2006 IUR reporting 

2587 period were found in 40 CFR 710.3 (―to manufacture, produce, or import for commercial 
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64

2588 purposes,‖ and 40 CFR 704.3 (―to manufacture for commercial purposes‖). The Part 711 

2589 definition of ―manufacture‖ is also consistent with the established definition of ―manufacturer‖ 

2590 used for purposes of PMN reporting, at 40 CFR 720.3. Existing Part 704.3, which was not 

2591 modified in today‘s final rule, also includes a definition of manufacture: ―Manufacture means to 

2592 manufacture for commercial purposes,‖ and a definition of ―manufacture for commercial 

2593 purposes‖ that makes clear that byproducts produced during manufacturer are also 

2594 ―manufactured for a commercial purpose.‖ 

2595

2596 The definition of ―manufacture‖ in today‘s final rule is also similar to and consistent with 

2597 TSCA‘s definition of ―manufacture‖ at Section 3: ―‘manufacture‘ means to import in the 

2598 customs territory of the United States, produce, or manufacture,‖ and Section 8: (―For purposes 

2599 of this section, the term ―manufacture‖ . . . mean[s] manufacture . . . for commercial purposes.‖) 

2600

2601 The second part of the definition, as noted in the preamble to the proposed rule, adds an 

2602 explanation, derived from the definition of ―manufacturer‖ in Part 720, of the conditions under 

2603 which a contract manufacturer would be considered to ―manufacture,‖ and therefore be 

2604 responsible for IUR reporting. Persons contracting with a toll manufacturer and toll 

2605 manufacturers are now considered to be co-joint manufacturers of what is produced at the toll 

2606 manufacturer‘s site. Consistent with 40 CFR 711.22(c), such parties should coordinate amongst 

2607 themselves to submit a single report, rather than duplicative individual reports, respecting what 

2608 they have co-manufactured. The joint submission mechanism, under 40 CFR 711.15(b)(3)(i), is 

2609 not available to co-joint manufacturers. The joint submission mechanism addresses distinct 

2610 circumstances: those in which one party is the manufacturer/importer, and a second party (not a 

2611 manufacturer of the chemical substance in question) possesses confidential information needed 

2612 to determine the chemical identity of what the first party has manufactured/imported. In the final 

2613 rule, EPA uses the term ―co-manufactured‖ rather than the proposed term ―jointly 

2614 manufactured.‖ This change of terminology is intended to avoid confusion between the 

2615 reporting provisions at 40 CFR 711.22(c) and those at 40 CFR 711.15(b)(3)(i).

2616

2617 EPA notes that one change to the definition of ―manufacture‖ was made to correct a 

2618 typographical error in the definition as proposed and to address a comment that the definition 

2619 used confusing syntax. The word ―and‖ should have been included between the paragraphs 

2620 numbered (1) and (2), and the text should have been formatted differently, to make clear that the 

2621 conditions in paragraph (1), and the conditions in paragraph (2) (up to the comma), must both be 

2622 satisfied before a chemical substance will be considered ―co-manufactured‖ by the producing 

2623 manufacturer (i.e., the toll manufacturer) and the person contracting for such production (i.e., the 

2624 contracting company).

2625

2626 Several commenters suggested that the toll manufacturer should be primarily or solely 

2627 responsible for IUR reporting, or expressed concern that the rule would compel contracting 

2628 companies to submit information on behalf of toll manufacturers. Another commenter supported 

2629 the assignment of responsibility as proposed. Some commenters also suggested that EPA should 

2630 ―acknowledge the complexity of contractual mechanisms and not offer a blanket,  ̳one size fits 

2631 all‘ requirement for reporting responsibilities.‖ 

2632
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65

2633 EPA agrees that a diversity of contractual arrangements may exist, and notes that there 

2634 was nothing in the proposed IUR rule to prevent toll and contracting manufacturers from sharing 

2635 information and agreeing between themselves that one or the other will undertake all or a portion 

2636 of the work associated with IUR reporting for a given chemical, though comments indicated that 

2637 there was some confusion caused by EPA‘s assignment of ―primary‖ responsibility for reporting 

2638 to the contracting manufacturer (see 40 CFR 711.22(c)). EPA expects that in most instances, a 

2639 person that contracts with a toll manufacturer will generally know more about the particular 

2640 chemical substances, and will usually be a better position to report on industrial processing and 

2641 use of a substance, and on commercial and consumer uses of products containing the substance. 

2642 Similarly, EPA expects that the toll manufacturer will generally be in a better position to report 

2643 on the number of workers and other information about their plant. In light of the contracting 

2644 company‘s control over the ―total amount produced and the basic technology for the plant 

2645 process,‖ and based on EPA‘s expectations of the relative knowledge of the contracting 

2646 company, EPA initially indicated, in proposed section 711.22(c), that the contracting company 

2647 would be ―primarily responsible‖ for IUR reporting. However, given the confusion introduced 

2648 by indicating that one party or the other is ―primarily‖ responsible for reporting, and not wishing 

2649 to interfere in contractual agreements to the contrary, EPA has decided not to allocate ―primary‖ 

2650 responsibility to either party in the final rule. Conforming changes have been made to section 

2651 711.22(c) in this final rule. However, the enforceability of the rule requires EPA to specify the 

2652 persons who are legally responsible for reporting. In fairness, EPA has chosen to make both 

2653 parties responsible for reporting on the chemical substances they have co-manufactured, as 

2654 specified in the proposed rule. 

2655

2656 4. Definition of Site. Several commenters asserted that the proposed revision to the 

2657 definition of ―site‖ would force different companies that are at the same site to report together. 

2658 EPA disagrees with this assertion. In the proposal, EPA added explanations to accommodate 

2659 manufacturing under contract and for portable manufacturing units, and clarified that an 

2660 importer‘s site must be a US address. The definition of site used in the past, at 40 CFR 710.3, 

2661 was not otherwise significantly changed. The old definition states that ―Site means a contiguous 

2662 property unit. Property divided only by a public right-of-way will be considered one site. There 

2663 may be more than one manufacturing plant on a single site. ...‖ This portion of the definition 

2664 was retained, with slight wording change (―More than one plant may be located on a single 

2665 site.‖), in the proposed rule. 

2666

2667 The statement ―More than one plant may be located on a single site‖ is meant to guide 

2668 companies that have multiple plants at one site to sum production volumes and other IUR2669 reportable data across all of their plants at one site and produce one report for each reportable 

2670 substance at each site (not at each plant). The definition does not require different companies 

2671 located at the same site to report together.

2672

2673 5. Processing and use-related definitions. EPA received comments in favor of the 

2674 amended definitions for commercial and consumer use. However, a commenter indicated that the

2675 definitions of "industrial," "commercial," "function," and "use," were unclear and referred to 

2676 problems in reporting both product- and substance-level information. EPA appreciates the 

2677 support for the amending the terms commercial and consumer use to harmonize the definitions 

2678 developed by the U.S. and Canada. 
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2679

2680 EPA feels the terms industrial and commercial are adequately defined. To clarify, EPA 

2681 defines industrial function as ―the intended physical or chemical characteristic for which a 

2682 chemical substance or mixture is consumed as a reactant; incorporated into a formulation, 

2683 mixture, reaction product, or article; repackaged; or used.‖ This definition can be found in the 

2684 document ―IUR Modifications Rule: Development of Definitions for 40 CFR 711.3‖, which is 

2685 located in EPA IUR docket (EPA-HQ-OPPT-2009-0187-0032) and will be part of the proposed 

2686 regulation changes. EPA also notes that the terms ―use‖, ―industrial use,‖ ―consumer use,‖ and 

2687 ―commercial use‖ have already been in use for IUR and were previously defined in 40 CFR Part 

2688 710.43 (relocated in today‘s final rule to 711.3).

2689

2690 F. Confidential Business Information

2691

2692 1. Release of information not validly claimed as CBI. The Agency received comments 

2693 about the proposed change to make information claimed as CBI available to the public without 

2694 further notice to the submitter, in the circumstance that the required substantiation is not 

2695 submitted with the claim. Opponents of the change are concerned that a reporting error could 

2696 result in public release of legitimate CBI. They suggested notifying the submitter if further 

2697 substantiation is needed prior to releasing data to the public. The commenters are in favor of a 

2698 warning system that would allow submitters time to provide additional substantiation on CBI 

2699 claims before the Agency determines the data is non-CBI and releases it as public information.

2700

2701 There are three situations during which the Agency will release IUR information claimed 

2702 as CBI without further notice to the submitter. First is the circumstance that a CBI claim is made 

2703 for the identity of a chemical already listed on the non-confidential portion of the Master 

2704 Inventory File. Any such CBI claims were invalid under the previous IUR regulations 

2705 (applicable to the 2006 and earlier submission periods). 

2706

2707 The second is the circumstance that a submission lacks the certification required under 40 

2708 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a certification stating that the submitted 

2709 information has been completed in compliance with the requirements of this part and that the 

2710 confidentiality claims made on the Form U are true and correct. The certification must be signed 

2711 and dated by the authorized official for the submitter company, and provide that person‘s name, 

2712 official title, and e-mail address. Consistent with this regulatory provision, the e-IUR software is 

2713 designed to entirely block the submission of a Form U lacking an appropriate certification. 

2714

2715 The third is the circumstance that a particular CBI claim is not accompanied by upfront 

2716 substantiation required under 40 CFR 711.30(b),(c),or (d) (e.g., upfront substantiation of 

2717 processing and use information). The e-IURweb reporting tool is designed to protect against a 

2718 company not providing an upfront substantiation. When a CBI claim is made and substantiation 

2719 is required, the reporting tool will open the substantiation question page. Should the submitter 

2720 choose not to complete the substantiation at that time, or to only partially complete it, the 

2721 validation portion of the tool will again alert the submitter to the need for substantiation. The 

2722 tool also includes warnings that information with unsubstantiated CBI claims will be released 

2723 without further notice to the submitter. EPA believes these reminders provide sufficient notice 

2724 to the submitter of the need to substantiate these claims. 
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2725

2726 2 . Upfront substantiation for processing and use information. The Agency received 

2727 comments both for and against the proposed upfront substantiation requirement when processing 

2728 and use information is claimed as confidential. Commenters opposing the proposed change 

2729 explained that processing and use information is often considered confidential by customers to 

2730 protect their competitive positions in the market. Commenters voiced concern that the proposed 

2731 change will impact their ability to remain competitive or will reduce innovation. These 

2732 commenters were concerned that the manufacturers of the chemical substances would not 

2733 correctly identify CBI associated with downstream uses, and that confidentiality agreements 

2734 between the chemical manufacturer and the downstream users would not provide sufficient 

2735 substantiation for the processing and use information. The Agency believes that the processing 

2736 and use information in the publicly-released IUR reports is sufficiently agglomerated to address 

2737 these concerns. However, the Agency also recognizes that there are circumstances when the 

2738 release of information about a particular use could harm the competitive position of the 

2739 submitter‘s customer. Therefore, EPA has modified the substantiation question at proposed 40 

2740 CFR 711.30(d)(1)(ii) to include information about harm to the submitter‘s competitive position 

2741 ―or to your customer‘s competitive position.‖ EPA also notes that under its confidentiality 

2742 regulations, the Agency normally solicits input from all affected businesses when making a final 

2743 confidentiality determination respecting information claimed as CBI.

2744

2745 Some commenters stated that providing written explanations for multiple scenarios would 

2746 be burdensome. Another commenter argued, however, that requiring such explanations will help 

2747 to limit CBI claims to information that in fact warrants protection as a legitimate trade secret. 

2748 The commenter asserted that the frequency with which site information was claimed as CBI 

2749 dropped from 28% to 7% after EPA added an upfront substantiation requirement for that data 

2750 element, and suggested that the drop represented an elimination of ―excessive‖ trade secrecy 

2751 claims.

2752

2753 The Agency recognizes that there is a burden associated with providing written 

2754 explanations. However, based on the significant number of CBI claims for processing and use 

2755 information in the last information collection, EPA believes that allowing submitters to assert 

2756 CBI claims merely by checking a box encourages submitters to assert such claims without 

2757 sufficiently considering whether there is a basis for the claim. While EPA believes that such 

2758 claims are appropriate under certain circumstances, the Agency wants to ensure that all such 

2759 claims are carefully considered and only information that is truly confidential, the release of 

2760 which would substantially injure the competitive position of the submitter, is claimed as CBI. A 

2761 substantiation requirement for such claims helps ensure that this consideration takes place.

2762

2763 3. Prohibition of confidentiality claims for data elements designated as “not known or 

2764 reasonably ascertainable.” Commenters agreed with prohibiting CBI claims for processing and 

2765 use information when designated as ―not known or reasonably ascertainable." The primary 

2766 reason cited by supporters was that the proposed change will reduce the potential for 

2767 unwarranted CBI claims.

2768

2769 G. Administrative Comments

2770
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2771 1. Changes to reporting frequency. The Agency received comments regarding the 

2772 proposed change to increase the IUR reporting frequency from every 5 years to every 4 years. 

2773 Some commenters suggested a change to the reporting frequency would still present a burden to 

2774 industry and that EPA has not provided adequate justification to warrant or support any increase 

2775 in the reporting frequency. Other commenters expressed support for the return to the reporting 

2776 frequency of every 4 years but some felt that to increase the frequency further would be 

2777 problematic. Additional commenters suggesting even more frequent reporting cycles and these 

2778 comments are addressed in more detail in the  ̳ ̳Summary of EPA‘s Responses to Public 

2779 Comments Submitted in Response to Proposed TSCA Inventory Update Reporting 

2780 Modifications‘‘ (Ref. 13).

2781

2782 In the 2003 IUR Amendments, EPA changed its reporting requirement from every 4 

2783 years to every 5 years to lessen the burden associated with complying with the amendments. 

2784 However, EPA has decided to return to the reporting frequency of every 4 years, in order to 

2785 better meet Agency needs. EPA has determined that reporting every 5 years is too infrequent, 

2786 and does not provide enough data to sufficiently cover the Agency's and public's needs. As 

2787 discussed in Unit III.D.1 of the proposed rule, many chemical substances, even larger volume 

2788 chemical substances, often experience wide fluctuations in manufacturing volume from year to 

2789 year. This can result in the production volume of a chemical substance exceeding the threshold 

2790 for several years, then falling below the threshold during the IUR principal reporting year. A

2791 review of the previous reporting under the IUR indicates an approximately 30% change in the 

2792 chemicals that are reported from one reporting period to the next. Therefore, the 1–year snapshot 

2793 of production volume does not provide an accurate picture of the chemical substances in 

2794 commerce, and may provide an erroneous view of the exposure scenarios associated with a 

2795 particular chemical substance. In addition, EPA has been criticized for using outdated 

2796 information, which will be remedied with more frequent reporting. As such, EPA has determined 

2797 that the value gained through obtaining more current and useful data is essential to fulfilling the 

2798 Agency‘s statutory obligations under TSCA, and outweighs the incremental burden to 

2799 submitters. 

2800

2801 2. Delete superfluous text regarding production volume. The Agency received comments 

2802 on the proposal to delete superfluous text associated with reporting production volumes, in 

2803 particular the +/- 10 percent standard of precision. All commenters opposed changing the 

2804 current language. Several commenters indicated that reporting accurately to two significant 

2805 figures is not equivalent to reporting to a precision of +/- 10%. One commenter indicated that, if 

2806 reporting to two significant figures, at higher production volumes there would be a narrower 

2807 allowable range of variation.

2808

2809 EPA is replacing ―provided that the reported figures are within +/-10% of the actual 

2810 volume‖ currently found in 40 CFR 710.52(c)(3)(iv) with ―This amount must be reported to two 

2811 significant figures of accuracy.‖ The deleted phrase is superfluous because any number reported 

2812 accurately to two significant figures is within 10% of the correct value. EPA recognizes some 

2813 commenters‘ concern that this will result in a sliding precision scale between 1% and 10% that is 

2814 solely based on the reported digits. However, EPA believes that reporting to two significant 

2815 figures will maintain a balance between data needs for exposure screening and the industry 

2816 burden associated with data collection. In the 2006 IUR data collection, nearly all manufacturers 

2817 reported production volumes in greater precision (i.e., more significant figures) than is required 
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69

2818 for 2011 reporting. Based on years of experience assessing chemical risks through programs 

2819 such as the New Chemicals Program, the Agency believes requiring reporting to two or more 

2820 significant figures is appropriate to facilitate the Agency‘s initial exposure screens of chemicals, 

2821 and to prioritize and make basic risk management decisions about those chemicals of greatest 

2822 concern. Those decisions then can prompt more detailed assessments as necessary. 

2823

2824 H. Economic Impact Estimates

2825

2826 1. General burden comments. The Agency received a number of comments expressing 

2827 concerns about the Economic Analysis (Ref. 19); the majority of which suggest that the Agency 

2828 has significantly underestimated the effort required to collect, organize, verify and report IUR 

2829 data. Commenters disagreed with EPA‘s burden estimates for several proposed modifications to 

2830 the rule, including the retroactive reporting of production volumes, reporting on imported 

2831 mixtures, mandatory electronic submission, the lowering of the threshold for downstream 

2832 processing and use information, the change in the standard of reporting from ―readily obtainable‖ 

2833 to ―known to or reasonably ascertainable by‖, and the change in the reporting cycle from every 

2834 five to every four years. Several commenters asserted that the reporting burden will increase to 

2835 between two and six times the burden for reporting in 2006. However, few commenters provided 

2836 specific reasons for why they believe that the Agency‘s estimates were low, and no commenters 

2837 provided any analytical basis for revising EPA‘s estimates or substantiated their alternative 

2838 estimates. The Agency has used the best available data to estimate the burden associated with the 

2839 modifications to the IUR rule, and disagrees with the commenters. The burden estimates 

2840 presented in the economic analysis are reasonable estimates for the average IUR submitter. 

2841

2842 a. Identification of affected entities. In general, commenters stated that the Economic 

2843 Analysis does not identify all affected entities, and EPA has inaccurately assumed that the 

2844 proposed rule will affect only chemical manufacturers. Another commenter noted that a wide 

2845 range of industries manufacture byproducts, so to accurately estimate the burden of the proposed 

2846 rule, EPA must identify all affected industries and facilities. The commenter further stated that 

2847 byproducts sent for recycling are new chemicals reportable under the IUR rule and the Economic 

2848 Analysis fails to identify these manufacturers.

2849

2850 The Economic Analysis assumes that all companies manufacturing or importing 

2851 chemicals annually in amounts of 25,000 lb. or greater that are listed on the TSCA Inventory will 

2852 report under this rule. Chemical users and processors who may manufacture a byproduct 

2853 chemical substance for a commercial purpose, e.g., utilities, paper manufacturers, primary metal 

2854 manufacturers, and semiconductor and other electronic component manufacturers (NAICS codes 

2855 22, 322, 331, and 3344), are considered to be chemical manufacturers for the purposes of the 

2856 IUR rule. Sites that manufactured a byproduct in a volume above the 25,000 lb. threshold during 

2857 the 2006 reporting cycle were required to report under IUR, and therefore are included in the 

2858 2006 baseline estimates. 

2859

2860 b. Total industry compliance determination burden. Commenters made a number of 

2861 specific points regarding the compliance determination burden. According to one commenter, 

2862 provisions requiring reporting of more data for many chemicals, replacing NAICS codes with 

2863 European IS codes, and requiring upfront substantiation for CBI claims for Part III information 

2864 will contribute to the increased effort required to report. 
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70

2865

2866 EPA disagrees that the Economic Analysis underestimates the reporting costs and 

2867 burdens of today‘s IUR amendments as asserted by the commenters. EPA does agree that many 

2868 of the amended rule requirements, including provisions requiring reporting of more data for 

2869 many chemicals, replacing NAICS codes with Industrial Sector codes, and requiring upfront 

2870 substantiation for CBI claims for Part III information, will cause an increase in burden and cost. 

2871 While EPA does state throughout the EA that the burdens and costs may be overestimated, the 

2872 analysis also says that they may be underestimated. The statements regarding limitations of the 

2873 study serve to make the analysis more transparent. EPA does not have the ability to take into 

2874 account the effects of individual company circumstances concerning downsizing, growth, 

2875 mergers and acquisitions, on estimates of reporting burden and cost, as mentioned by one 

2876 commenter. 

2877

2878 Several commenters assert that EPA has underestimated the burden associated with IUR 

2879 compliance determination by estimating the burden on a per-report basis. According to the 

2880 comments, this methodology does not capture the burden associated with tracking, screening, 

2881 and keeping records for chemicals that ultimately are not required to be reported to IUR because 

2882 they are manufactured or imported in quantities below the reporting threshold. 

2883

2884 Compliance determination occurs on a per-site basis and is based on a manufacturer 

2885 (including importer) determining that it manufactures at least one chemical at or above the 

2886 threshold, thus necessitating that the site complete and submit a Form U. The Economic Analysis 

2887 assumes all sites that report to the IUR incur the same average cost for compliance determination 

2888 regardless of the number of chemicals reported. EPA expects that it is standard company practice 

2889 to track and maintain records of production volumes for all chemicals manufactured at a given 

2890 site. Therefore, EPA expects that the burden associated with compliance determination should 

2891 not be substantial. The commenters appear to have misinterpreted EPA‘s compliance 

2892 determination burden to include the burden of actually reporting for the chemicals subject to the 

2893 IUR, but this is not the case. See Section 4.2.2 of Ref. 19 for further clarification. 

2894

2895 Finally, EPA notes that the IUR does not require submitters to retain documentation 

2896 showing that particular chemicals did not need to be included in a given year‘s report. In 

2897 addition, once a submitter has made a compliance determination that it has reporting obligations 

2898 under the IUR, it can rely on production volume information already reasonably available, in the 

2899 ordinary course of business, to determine that particular chemicals do not need to be reported 

2900 under the IUR. For this reason, EPA believes it is unreasonable to attribute to the rule the costs 

2901 of tracking, screening, and keeping records of the various production volumes of chemicals that 

2902 ultimately are not required to be reported to IUR because they are below the reporting threshold.

2903

2904 c. Underlying assumptions and data: baseline costs. Commenters question the baseline 

2905 number of reports EPA used in calculating baseline costs. One commenter questions whether 

2906 EPA‘s estimate included inorganic substances. Another commenter questions whether EPA has 

2907 adjusted the baseline estimates to account for new manufacturing facilities that never previously 

2908 reported under the IUR rule, the elimination the 300,000 lb. threshold for processing and use 

2909 data, and the change in the method of determining the eligibility to report. 

2910
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71

2911 The 2006 IUR submission data provide the best estimate for the number of reports that 

2912 would be submitted under the baseline scenario. The baseline scenario in the Economic Analysis 

2913 assumes no changes have been made to the 2006 reporting requirements. This cost is used as a 

2914 basis on which to calculate the incremental cost of the rule. Therefore, in the baseline, the 

2915 number of reports should not be adjusted to account for any proposed modifications. The 

2916 Economic Analysis does estimate the additional number of Part III reports that will be submitted 

2917 as a result of today‘s final rule amendments, including the elimination of the 300,000 lb. 

2918 threshold (see Section 4.4.4 of Ref. 19), as well as the additional number of reports submitted as 

2919 a result of the change in the method of determining the eligibility to report (see Section 4.4.3 of 

2920 Ref. 19). In addition, the Economic Analysis accounts for rule familiarization costs for any new 

2921 companies submitting data (see Section 4.2.2 of Ref. 19). The 2006 data do include reports for 

2922 inorganic chemicals, because while inorganic chemical manufacturers were exempt from 

2923 submitting downstream processing and use information in the 2006 reporting cycle, they were 

2924 required to submit Parts I and II of Form U, and therefore are included in the baseline number of 

2925 reports. 

2926

2927 G. Request for Comment on Additional Issues. EPA requested comment on several 

2928 additional topics in Unit V of the preamble to the proposal, at p. 49676. The comment summaries 

2929 and responses to these issues are contained in the ―Summary of EPA‘s Responses to Public 

2930 Comments Submitted in Response to Proposed TSCA Inventory Update Reporting Modifications 

2931 Rule‖ (Ref 13). 

2932

2933 IV. References

2934 As indicated under ADDRESSES, a docket has been established for this rulemaking 

2935 under docket ID number EPA–HQ–OPPT–2009–0187. The following is a listing of the 

2936 documents that are specifically referenced in this document. The docket includes these 

2937 documents and other information considered by EPA in developing this final rule, including 

2938 documents that are referenced within the documents that are included in the docket, even if the 

2939 referenced document is not physically located in the docket. For assistance in locating these 

2940 other documents, please consult the technical person listed under FOR FURTHER 

2941 INFORMATION CONTACT.

2942 1. EPA. Inventory Reporting Regulations; Final rule. Federal Register (42 FR 64572, 

2943 December 23, 1977) (FRL–817–1).

2944 2. EPA. Partial Updating of TSCA Inventory Data Base; Production and Site Reports; 

2945 Final rule. Federal Register (51 FR 21438, June 12, 1986) (FRL–2973–3).

2946 3. EPA. TSCA Inventory Update Rule Amendments; Final rule. Federal Register (68 FR 

2947 848, January 7, 2003) (FRL–6767–4).

2948 4. EPA. OPPT. Enhancing EPA's Chemical Management Program. Available on-line at: 

2949 http//www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html.

2950 5. EPA. Instructions for 2011 Inventory Update Reporting, July 2010. 
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72

2951 6. EPA. OPPT. IUR Modifications Rule: Development of Definitions for Proposed 40 

2952 CFR 711.3. July 8, 2010.

2953 7. EPA. TSCA Inventory Update Reporting Revisions; Final rule. Federal Register (70 

2954 FR 75059, December 19, 2005) (FRL–7743–9).

2955 8. EPA. OPPT. Electronic Signature Agreement. August 2009.

2956 9. EPA/Environment Canada/Health Canada, Overview of Harmonized U.S.-Canada 

2957 Industrial Function and Consumer and Commercial Product Codes for Chemical Inventory 

2958 Reporting. June 2009, Revised November 2009.

2959 10. EPA. OPPT. Summary of EPA‘s Responses to Public Comments Submitted in 

2960 Response to Proposed TSCA Inventory Update Reporting Modifications Rule. Federal Register 

2961 (75 FR 49656, August 13, 2010) (FRL-8833-5).

2962 11. EPA. OPPT. EETD. Inventory Update Reporting (IUR) Technical Support Document 

2963 — Replacement of 5–digit NAICS Codes with Industrial Sector (IS) Codes. October 2009.

2964 12. EPA. OPPT. Fact Sheet: Recycling and the TSCA Inventory of Chemical Substances 

2965 Premanufacture Notification and Inventory Update Reporting Requirements. July 2010.

2966 13. EPA. OPPT. Q&A Document: Recycling and the TSCA Inventory of Chemical 

2967 Substances Premanufacture Notification and Inventory Update Reporting Requirements. July 

2968 2010.

2969 14. Proposal for Priority Setting for Existing Substances on the Domestic Substances List 

2970 under the Canadian Environmental Protection Act, 1999. Greatest Potential for Human 

2971 Exposure, Canada, 2003.

2972 15. EPA. OPPT. Screening-Level Hazard Characterization and Prioritization Document. 

2973 March 2009. Available on-line at: 

2974 http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP_Marc

2975 h%202009.pdf.

2976 16. EPA. OPPT. Economics, Exposure and Technology Division (EETD). Economic 

2977 Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule. July 20, 2010.

2978 17. NOVA Chemicals, Letter to Docket ID No. EPA-HQ-OPPT-2009-0187, from Linda 

2979 Santry. October 7, 2010.

2980 18. EPA. OPPT. Initial Risk-Based Prioritization of High Production Volume (HPV) 

2981 Chemicals. April 2009. Available on-line at : 

2982 http://www.epa.gov/chemrtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.pdf.

2983 19. Environmental Defense Fund, Letter to Docket # EPA-HQ-OPPT-2009-0187 (on 

2984 behalf of 32 organizations), from Richard Denison, PhD, October 12, 2010.
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73

2985 20. Prenotice Communication Letter from Mary E. Cushmac, EPA, July 29, 1991. 

2986 21. Letter from Susan Sharkey, EPA, to Robert P. Strieter, The Aluminum Association, 

2987 October 24, 2006. 

2988 22. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC, August 27, 2008. 

2989 V. Statutory and Executive Order Reviews

2990

2991 A. Executive Order 12866

2992 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 

2993 October 4, 1993), this action has been designated a ―significant regulatory action‖ by the Office 

2994 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 

2995 under Executive Order 12866 and any changes made in response to OMB recommendations have 

2996 been documented in the docket for this action.

2997 In addition, EPA has prepared an economic analysis of the potential impacts associated 

2998 with this action. A copy of this economic analysis, entitled, Economic Analysis for the Inventory 

2999 Update Reporting (IUR) Modifications Rule (Ref. 19), is available in the docket and is briefly 

3000 summarized in this unit. The Agency, in promulgating this rule, is required under TSCA to 

3001 consider the potential costs and benefits associated with IUR. The analysis was therefore used by 

3002 the decision-makers to help in the selection of the final rule requirements presented in this 

3003 document. 

3004

3005 The amendments in this rule affect the number of reports submitted during a submission 

3006 period, the burden to prepare a report, and the reporting frequency. EPA estimates that the 

3007 combined impact of all the amendments will increase the total burden and cost to industry 

3008 associated with IUR reporting.

3009 In its Economic Analysis, EPA estimated industry cost and burden on a per-report and a 

3010 per-site basis and at the industry level. Industry cost and burden are incurred by performing 

3011 activities to comply with the amendments, including compliance determination, rule 

3012 familiarization, preparation and submission of reports, and recordkeeping.

3013 On a per-report basis, EPA estimated incremental increases of 4.28 hours and $350 for a 

3014 site to complete a partial report for one chemical substance and 17.38 hours and $1,408 to 

3015 complete a full report for one chemical substance, in the first reporting cycle after the effective 

3016 date of the rule amendments. A partial report includes Parts I and II of Form U. A full report 

3017 includes Parts I, II, and III of Form U. For future reporting cycles, EPA estimated incremental 

3018 increases of 3.28 hours and $275 for a site to complete a partial report for one chemical 

3019 substance and 12.98 hours and $1,075 to complete a full report for one chemical substance.

3020 As a result of the amendments, EPA estimates that the average site will submit 

3021 approximately 2.01 fewer partial reports and 2.98 additional full reports in a submission period. 

3022 For the average site, this will increase the burden by 341 hours during the first reporting cycle 

3023 and 264 hours for all subsequent reporting cycles. EPA estimates that the average site will incur 
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3024 a net cost increase of $22,493 during the first reporting cycle and $17,517 during all future 

3025 reporting cycles.

3026 At the industry level for all sites submitting a Form U, EPA estimates a net total burden 

3027 increase of 1.39 million hours in the first reporting cycle, and 1.21 million hours for all 

3028 subsequent reporting cycles. EPA estimates a net cost increase of $91.87 million in the first 

3029 reporting cycle of the rule, and $79.29 million in all subsequent reporting cycles. When the 

3030 reporting cycle costs are averaged over the four–year reporting cycle, the average annualized 

3031 increase in industry cost attributable to the amendments is approximately $21.61 million over a 

3032 25–year period (at a 3% discount rate).

3033 EPA estimates that the Agency will experience a reduction in both burden and cost to 

3034 administer the IUR rule as a result of the amendments. Specifically, EPA expects to experience a 

3035 net burden reduction of 1,721 hours in the first reporting cycle and all subsequent reporting 

3036 cycles. The Agency estimates it will experience a net savings of $179,600 during each reporting 

3037 cycle. This information will be reflected in the ICR that is submitted every three years to OMB 

3038 under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. 

3039 EPA believes that this final rule represents an appropriate balance between the burden 

3040 placed on industry to provide information and the Agency‘s need for that information to fill its 

3041 statutory obligations and fulfill its mission under TSCA and, as part of that mission, to provide 

3042 information needed by other agencies (OSHA, NIOSH, CPSC, etc.). 

3043

3044 B. Paperwork Reduction Act

3045 The information collection requirements in 40 CFR part 710 related to the submission of 

3046 Form Us are already approved by OMB under PRA. That ICR has been assigned EPA ICR No. 

3047 1884 and OMB control no. 2070–0162. Because this final rule involves new or revised 

3048 information collection activities that require additional OMB approval, EPA has prepared an 

3049 addendum to the currently approved ICR (Ref. 20). An agency may not conduct or sponsor, and 

3050 a person is not required to respond to an information collection request subject to PRA, unless it 

3051 displays a currently valid OMB control number. The OMB control numbers for EPA‘s 

3052 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 

3053 the form or survey).

3054 Under PRA, the term ―burden‖ is interpreted as the total time, effort, or financial 

3055 resources expended by people to generate, maintain, retain, disclose, or provide information to or 

3056 for a Federal agency. This includes the time needed by regulated entities to review instructions 

3057 and to develop, acquire, install, and use technology and systems to collect, validate, verify, and 

3058 disclose information. Time taken to adjust existing ways to comply with any previously 

3059 applicable instructions and requirements and to train personnel to respond to the information 

3060 collection task is also included. In this analysis, total industry burden hours represent the sum of 

3061 time spent on reporting and on other administrative activities. Industry respondents will spend 

3062 time on the following activities associated with the IUR rule: Compliance determination, rule 

3063 familiarization, preparation and submission of reports, and recordkeeping.
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3064 As presented in the Economic Analysis (Ref. 19) and the addendum ICR, EPA estimates 

3065 that the final rule would generate a total incremental industry burden of 1.39 million hours in the 

3066 first reporting cycle. The burden for a site to complete a full IUR report for one chemical 

3067 substance is estimated to be 140.38 hours, which includes an incremental burden increase of 

3068 17.38 hours over the current estimated burden. The burden for a site to complete a partial IUR 

3069 report for one chemical substance is estimated to be 57.36 hours, which includes an incremental 

3070 burden increase of 5.28 hours over the current estimated burden. For future reporting cycles, 

3071 EPA estimates that the final rule would create a total incremental industry burden of 1.21 million 

3072 hours. The burden to complete a full report is estimated to be 95.03 hours, which is an 

3073 incremental increase of 12.98 hours over the current estimated future burden. The burden for a 

3074 partial report is estimated to be 29.40 hours, which is an incremental increase of 3.28 hours over 

3075 the current estimate. 

3076 C. Regulatory Flexibility Act

3077 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 

3078 the Agency hereby certifies that this action will not have a significant adverse economic impact 

3079 on a substantial number of small entities. The Agency‘s basis is briefly summarized here and is 

3080 detailed in the Economic Analysis (Ref. 19).

3081 Under RFA, small entities include small businesses, small organizations, and small 

3082 governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, 

3083 small entity is defined as:

3084 1. A small business, as defined by the SBA's regulations at 13 CFR 121.201. The SBA 

3085 definitions typically are based upon either a sales or an employment level, depending on the 

3086 nature of the industry. Companies engaged in chemical manufacturing (NAICS Code 325) or 

3087 petroleum refining (NAICS Code 324110) are the most likely to report under the IUR rule. These 

3088 employee size standards range from 500 employees to 1,500 employees for NAICS Codes 325 

3089 and 324110.

3090 2. A small governmental jurisdiction that is a government of a city, county, town, school 

3091 district, or special district with a population of less than 50,000.

3092 3. A small organization that is any not-for-profit enterprise which is independently owned 

3093 and operated and is not dominant in its field. 

3094 Since the regulated community does not include small governmental jurisdictions or small not3095 for-profit organizations, the analysis focuses on small businesses.

3096 The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 

3097 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and 

3098 less than 100,000 lb. production of any given chemical substance at a site; or annual sales of less 

3099 than $4 million. This exemption is maintained in today‘s final amendments. A small business 

3100 would be required to report under the final rule, however, if it produces any chemical substance 

3101 that is the subject of a regulation proposed or promulgated under TSCA section 4, 5(b)(4), or 6, 

3102 or that is the subject of an order under TSCA section 5(e), or that is the subject of relief that has 
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3103 been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also 

3104 report voluntarily.

3105 EPA analyzed potential small business impacts from this final rule using both the SBA 

3106 employee size standards and the TSCA sales-based definition of small business. EPA estimates 

3107 that 466 small firms potentially would be affected by this final rule using the employment-based 

3108 definition, and 280 small firms potentially would be affected using the sales-based definition. 

3109 Based on costs annualized over a four–year period and average sales data for the parent 

3110 companies, EPA estimated that the cost-to-sales ratio of the final rule would be less than 0.1% 

3111 for an average small company subject to the rule. For a company to have a cost-to-sales ratio 

3112 larger than 1%, company sales would have to be less than $1.02 million. Because the small 

3113 businesses affected by the final rule have average sales of more than $412.7 million under the 

3114 employment-based definition, and $11.8 million under the sales-based definition, small entities 

3115 will not be affected by the amendments to the IUR rule at a cost-to-sales ratio of greater than 1% 

3116 (Ref. 19).

3117 D. Unfunded Mandates Reform Act

3118 This action does not contain any Federal mandates for State, local, or tribal governments 

3119 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 

3120 (UMRA), 2 U.S.C. 1531–1538. EPA has determined that this regulatory action will not result in 

3121 annual expenditures of $100 million or more for State, local, and tribal governments, in the 

3122 aggregate, or for the private sector. The costs associated with this action are briefly described in 

3123 Unit V.A., and is contained in the Economic Analysis (Ref. 19).

3124 Based on EPA's past experience, State, local, and tribal governments have not been 

3125 affected by this reporting requirement, and EPA does not have any reason to believe that any 

3126 State, local, or tribal government will be affected by this final rule. As such, EPA has determined 

3127 that this final rule does not impose any enforceable duty, contain any unfunded mandate, or 

3128 otherwise have any effect on small governments. Accordingly, this final rule is not subject to the 

3129 requirements of sections 202, 203, or 205 of UMRA.

3130 E. Executive Order 13132

3131 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 

3132 EPA has determined that this final rule does not have federalism implications because it will not 

3133 have substantial direct effects on the States, on the relationship between the national government 

3134 and the States, or on the distribution of power and responsibilities among the various levels of 

3135 government, as specified in the Executive Order. This final rule simply amends the IUR rule in 

3136 several ways to provide information to better address Agency and public information needs, 

3137 improve the usability and reliability of the reported data, and ensure that data are available in a 

3138 timely manner. Because EPA has no information to indicate that any State or local government 

3139 manufactures or processes the chemical substances covered by this action, the final rule does not 

3140 apply directly to States and localities and will not affect State and local governments. Thus, 

3141 Executive Order 13132 does not apply to the final rule.

3142 F. Executive Order 13175
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3143 As required by Executive Order 13175, entitled Consultation and Coordination with 

3144 Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 

3145 final rule does not have tribal implications because it will not have any effect on tribal 

3146 governments, on the relationship between the Federal Government and the Indian tribes, or on 

3147 the distribution of power and responsibilities between the Federal Government and Indian tribes, 

3148 as specified in the Order. Thus, Executive Order 13175 does not apply to this final rule.

3149 G. Executive Order 13045

3150 EPA interprets Executive Order 13045, entitled Protection of Children from 

3151 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 

3152 those regulatory actions that concern health or safety risks, such that the analysis required under 

3153 section 5–501 of Executive Order 13045 has the potential to influence the regulation. This 

3154 action is not subject to Executive Order 13045 because it does not establish an environmental 

3155 standard intended to mitigate health or safety risks. Nevertheless, the information obtained by 

3156 the reporting required by this final rule will be used to inform the Agency‘s decision making 

3157 process regarding chemical substances to which children may be disproportionately exposed. 

3158 This information will also assist the Agency and others in determining whether the chemical 

3159 substances in this final rule present potential risks, allowing the Agency and others to take 

3160 appropriate action to investigate and mitigate those risks.

3161 H. Executive Order 13211

3162 This action is not a ―significant energy action‖ as defined in Executive Order 13211, 

3163 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 

3164 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 

3165 the supply, distribution, or use of energy as described in the Executive Order.

3166 I. National Technology Transfer and Advancement Act

3167 Since this action does not involve any technical standards, section 12(d) of the National 

3168 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 

3169 12(d) (15 U.S.C. 272 note), does not apply to this action.

3170 J. Executive Order 12898

3171 The final rule does not have an adverse impact on the environmental and health 

3172 conditions in low-income and minority communities that require special consideration by the 

3173 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 

3174 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 

3175 The Agency believes that the information collected under this final rule will assist EPA and 

3176 others in determining the potential hazards and risks associated with the chemical substances 

3177 covered by the rule. Because the IUR rule is an information collection requirement, the 

3178 information that will become available through the rule will enable the Agency to target 

3179 educational, regulatory, or enforcement activities towards industries or chemical substances that 

3180 pose the greatest risks and/or to target programs for geographic areas that are at the highest risk. 

3181 Thus, the information to be gathered under the rule will help EPA make decisions that will 

3182 benefit potentially at-risk communities, some of which may be disadvantaged.
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3183 The final rule is directed at manufacturers (including importers) of chemical substances. 

3184 All consumers of these chemical products and all workers who come into contact with these 

3185 chemical substances could benefit if data regarding the chemical substances‘ health and 

3186 environmental effects were developed. Therefore, it does not appear that the costs and the 

3187 benefits of the final rule will be disproportionately distributed across different geographic 

3188 regions or among different categories of individuals.

3189 IV. Congressional Review Act

3190

3191 The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule 

3192 may take effect, the agency promulgating the rule must submit a rule report to each House of the 

3193 Congress and the Comptroller General of the United States. EPA will submit a report containing 

3194 this rule and other required information to the U.S. Senate, the U.S. House of Representatives, 

3195 and the Comptroller General of the United States prior to publication of the rule in the Federal 

3196 Register. This rule is not a ―major rule‖ as defined by 5 U.S.C. 804(2).

3197

3198 List of Subjects in 40 CFR Parts 704, 710, and 711

3199 Environmental protection, Chemicals, Confidential Business Information (CBI), 

3200 Hazardous materials, Imports, Reporting and recordkeeping requirements.

3201 Dated: ______________________

3202 ________________________________________________

3203 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

3204

3205 Therefore, 40 CFR chapter I is amended as follows:

3206 PART 704—[AMENDED]

3207 1. The authority citation for part 704 continues to read as follows:

3208 Authority: 15 U.S.C. 2607(a).

3209 § 704.3 [Amended]

3210 2. In § 704.3, remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (1)(ii) of the 

3211 definition importer.

3212 PART 710—COMPILATION OF THE TSCA CHEMICAL INVENTORY

3213 3. The authority citation for part 710 continues to read as follows:

3214 Authority: 15 U.S.C. 2607(a).
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3215 4. Revise the heading for part 710 to read as set forth above.

3216 5. Remove the heading ―Subpart A—General Provisions.‖

3217 6. Revise paragraph (b) of § 710.1 to read as follows:

3218 § 710.1 Scope and compliance.

3219 * * * * *

3220 (b) This part applies to the activities associated with the compilation of the TSCA Chemical 

3221 Substance Inventory (TSCA Inventory) and the update of information on a subset of the 

3222 chemical substances included on the TSCA Inventory.

3223 * * * * *

3224 7. Section 710.3 is amended as follows:

3225 i. Remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (2) of the definition importer.

3226 ii. Remove the definition non-isolated intermediate.

3227 iii. Revise the introductory text of the section to read as follows:

3228 § 710.3 Definitions.

3229 For purposes of this part: 

3230 * * * * *

3231 Subpart B §§ 710.23–710.39 [Removed]

3232 8. Remove subpart B, consisting of §§ 710.23–710.39.

3233 Subpart C §§ 710.43–710.59 [Removed]

3234 9. Remove subpart C, consisting of §§ 710.43–710.59.

3235 10. Add new part 711 to subchapter R to read as follows:

3236 PART 711—TSCA INVENTORY UPDATE REPORTING REQUIREMENTS

3237 Sec.

3238

3239 711.1 Scope and compliance.

3240 711.3 Definitions.

3241 711.5 Chemical substances for which information must be reported.

3242 711.6 Chemical substances for which information is not required.

3243 711.8 Persons who must report.

3244 711.9 Persons not subject to this part.

3245 711.10 Activities for which reporting is not required.

3246 711.15 Reporting information to EPA.
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3247 711.20 When to report.

3248 711.22 Duplicative reporting.

3249 711.25 Recordkeeping requirements.

3250 711.30 Confidentiality claims.

3251 711.35 Electronic filing.

3252

3253 Authority: 15 U.S.C. 2607(a).

3254

3255 § 711.1 Scope and compliance.

3256 (a) This part specifies reporting and recordkeeping procedures under section 8(a) of the 

3257 Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain manufacturers (including 

3258 importers) of chemical substances. Section 8(a) of TSCA authorizes the EPA Administrator to 

3259 require reporting of information necessary for administration of TSCA, including issuing 

3260 regulations for the purpose of compiling and keeping current the TSCA Chemical Substance 

3261 Inventory (TSCA Inventory) manufactured or processed in the United States as required by 

3262 TSCA section 8(b). In accordance with TSCA section 8(b), EPA amends the TSCA Inventory to 

3263 include new chemical substances manufactured (including imported) in the United States and 

3264 reported under TSCA section 5(a)(1). EPA also revises the categories of chemical substances 

3265 and makes other amendments as appropriate.

3266 (b) This part applies to the activities associated with the periodic update of information 

3267 on a subset of the chemical substances included on the TSCA Inventory.

3268 (c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit

3269 information required under this part. In addition, TSCA section 15(3) makes it unlawful for any 

3270 person to fail to keep, and permit access to, records required by this part. Section 16 of TSCA 

3271 provides that any person who violates a provision of TSCA section 15 is liable to the United 

3272 States for a civil penalty and may be criminally prosecuted. Pursuant to TSCA section 17, the 

3273 Federal Government may seek judicial relief to compel submission of TSCA section 8(a) 

3274 information and to otherwise restrain any violation of TSCA section 15. (EPA does not intend to 

3275 concentrate its enforcement efforts on insignificant clerical errors in reporting.)

3276 (d) Each person who reports under this part must maintain records that document 

3277 information reported under this part and, in accordance with TSCA, permit access to, and the 

3278 copying of, such records by EPA officials.

3279 § 711.3 Definitions.

3280 The definitions in this section and the definitions in TSCA section 3 apply to this part. In 

3281 addition, the definitions in 40 CFR 704.3 also apply to this part, except the definitions 

3282 manufacture and manufacturer in 40 CFR 704.3.

3283 CDX or Central Data Exchange means EPA's centralized electronic document receiving 

3284 system, or its successors.
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3285 Commercial use means the use of a chemical substance or a mixture containing a 

3286 chemical substance (including as part of an article) in a commercial enterprise providing saleable 

3287 goods or services.

3288 Consumer use means the use of a chemical substance or a mixture containing a chemical 

3289 substance (including as part of an article) when sold to or made available to consumers for their 

3290 use.

3291 e-IURweb means the electronic, web-based IUR software provided by EPA for the 

3292 completion and submission of the IUR data.

3293 Industrial function means the intended physical or chemical characteristic for which a 

3294 chemical substance or mixture is consumed as a reactant; incorporated into a formulation, 

3295 mixture, reaction product, or article; repackaged; or used.

3296 Industrial use means use at a site at which one or more chemical substances or mixtures 

3297 are manufactured (including imported) or processed.

3298 Intended for use by children means the chemical substance or mixture is used in or on a 

3299 product that is specifically intended for use by children age 14 or younger. A chemical substance 

3300 or mixture is intended for use by children when the submitter answers ―yes‖ to at least one of the 

3301 following questions for the product into which the submitter's chemical substance or mixture is 

3302 incorporated:

3303 (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended 

3304 for children age 14 or younger?

3305 (2) Does the manufacturer of the product state through product labeling or other written 

3306 materials that the product is intended for or will be used by children age 14 or younger?

3307 (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 

3308 younger?

3309 Manufacture means to manufacture, produce, or import, for commercial purposes. 

3310 Manufacture includes the extraction, for commercial purposes, of a component chemical 

3311 substance from a previously existing chemical substance or complex combination of chemical 

3312 substances. When a chemical substance, manufactured other than by import, is:

3313 (1) Produced exclusively for another person who contracts for such production, and

3314 (2) that other person specifies the identity of the chemical substance and controls the total 

3315 amount produced and the basic technology for the plant process, that chemical substance is co3316 manufactured by the producing manufacturer and the person contracting for such production.

3317 Manufacturer means a person who manufactures a chemical substance.

3318 Master Inventory File means EPA's comprehensive list of chemical substances which 

3319 constitutes the TSCA Inventory compiled under TSCA section 8(b). It includes chemical 
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3320 substances reported under 40 CFR part 710 and substances reported under 40 CFR part 720 for 

3321 which a Notice of Commencement of Manufacture or Import has been received under 40 CFR 

3322 720.120.

3323 Principal reporting year means the latest complete calendar year preceding the 

3324 submission period.

3325 Reasonably likely to be exposed means an exposure to a chemical substance which, under 

3326 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 

3327 or use of the chemical substance, is more likely to occur than not to occur. Such exposures would 

3328 normally include, but would not be limited to, activities such as charging reactor vessels, 

3329 drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and 

3330 transfers, and analytical operations. Covered exposures include exposures through any route of 

3331 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical 

3332 exposures.

3333 Repackaging means the physical transfer of a chemical substance or mixture, as is, from 

3334 one container to another container or containers in preparation for distribution of the chemical 

3335 substance or mixture in commerce.

3336 Reportable chemical substance means a chemical substance described in § 711.5.

3337 Site means a contiguous property unit. Property divided only by a public right-of-way 

3338 shall be considered one site. More than one manufacturing plant may be located on a single site.

3339 (1) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the 

3340 site is the location where the chemical substance is physically manufactured.

3341 (2) The site for an importer who imports a chemical substance described in § 711.5 is the 

3342 U.S. site of the operating unit within the person's organization that is directly responsible for 

3343 importing the chemical substance. The import site, in some cases, may be the organization's 

3344 headquarters in the United States. If there is no such operating unit or headquarters in the United 

3345 States, the site address for the importer is the U.S. address of an agent acting on behalf of the 

3346 importer who is authorized to accept service of process for the importer.

3347 (3) For portable manufacturing units sent to different locations from a single distribution 

3348 center, the distribution center shall be considered the site.

3349 Site-limited means a chemical substance is manufactured and processed only within a site 

3350 and is not distributed for commercial purposes as a chemical substance or as part of a mixture or 

3351 article outside the site. Imported chemical substances are never site-limited. Although a site3352 limited chemical substance is not distributed for commercial purposes outside the site at which it 

3353 is manufactured and processed, the chemical substance is considered to have been manufactured 

3354 and processed for commercial purposes.

3355 Submission period means the period in which the manufacturing, processing, and use data 

3356 are submitted to EPA.
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3357 Use means any utilization of a chemical substance or mixture that is not otherwise 

3358 covered by the terms manufacture or process. Relabeling or redistributing a container holding a 

3359 chemical substance or mixture where no repackaging of the chemical substance or mixture 

3360 occurs does not constitute use or processing of the chemical substance or mixture.

3361 § 711.5 Chemical substances for which information must be reported.

3362 Any chemical substance that is in the Master Inventory File at the beginning of a 

3363 submission period described in § 711.20, unless the chemical substance is specifically excluded 

3364 by § 711.6.

3365 § 711.6 Chemical substances for which information is not required.

3366 The following groups or categories of chemical substances are exempted from some or 

3367 all of the reporting requirements of this part, with the following exception: A chemical substance 

3368 described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of 

3369 the reporting requirements of this part if that chemical substance is the subject of a rule proposed 

3370 or promulgated under TSCA section 4, 5(a)(2), 5(b)(4), or 6, or is the subject of a consent 

3371 agreement developed under the procedures of 40 CFR part 790, or is the subject of an order 

3372 issued under TSCA section 5(e) or 5(f), or is the subject of relief that has been granted under a 

3373 civil action under TSCA section 5 or 7.

3374 (a) Full exemptions. The following categories of chemical substances are exempted from 

3375 the reporting requirements of this part.

3376 (1) Polymers—(i) Any chemical substance described with the word fragments ―*polym,‖ 

3377 ―*alkyd,‖ or ―*oxylated‖ in the Chemical Abstracts (CA) Index Name in the Master Inventory 

3378 File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may 

3379 precede, or follow, the character string defined.

3380 (ii) Any chemical substance that is identified in the Master Inventory File as siloxane and 

3381 silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a 

3382 polysaccharide (starch, cellulose, gum), rubber, or lignin.

3383 (iii) This exclusion does not apply to a polymeric substance that has been hydrolyzed, 

3384 depolymerized, or otherwise chemically modified, except in cases where the intended product of 

3385 this reaction is totally polymeric in structure.

3386 (2) Microorganisms. Any combination of chemical substances that is a living organism, 

3387 and that meets the definition of ―microorganism‖ at 40 CFR 725.3. Any chemical substance 

3388 produced from a living microorganism is reportable under this part unless otherwise excluded.

3389 (3) Naturally occurring chemical substances. Any naturally occurring chemical 

3390 substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is determined in 

3391 each case by the specific activities of the person who manufactures the chemical substance in 

3392 question. Some chemical substances can be manufactured both as described in 40 CFR 710.4(b) 

3393 and by means other than those described in 40 CFR 710.4(b). If a person described in § 711.8 

3394 manufactures a chemical substance by means other than those described in 40 CFR 710.4(b), the 
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3395 person must report regardless of whether the chemical substance also could have been produced 

3396 as described in 40 CFR 710.4(b). Any chemical substance that is produced from such a naturally 

3397 occurring chemical substance described in 40 CFR 710.4(b) is reportable unless otherwise 

3398 excluded.

3399 (4) Certain forms of natural gas and water. Chemical substances with the following 

3400 CASRN: CASRN 64741–48–6, natural gas (petroleum), raw liq. mix; CASRN 68919–39–1, 

3401 natural gas condensates; CASRN 8006–61–9, gasoline, natural; CASRN 68425–31–0, gasoline 

3402 (natural gas), natural; CASRN 8006–14–2, natural gas; CASRN 68410–63–9, natural gas, dried; 

3403 and CASRN 7732–18–5, water.

3404 (b) Partial exemptions. The following groups of chemical substances are partially 

3405 exempted from the reporting requirements of this part (i.e., the information described in §

3406 711.15(b)(4) need not be reported for these chemical substances). Such chemical substances are 

3407 not excluded from the other reporting requirements under this part.

3408 (1) Petroleum process streams. EPA has designated the chemical substances listed in 

3409 Table 1 of this paragraph by CASRN, as partially exempt from reporting under the IUR.

3410 Table 1.—CAS Registry Numbers of Partially Exempt Chemical Substances Termed 

3411 ―Petroleum Process Streams‖ for Purposes of Inventory Update Reporting

CASRN Product

8002–05–9 Petroleum

8002–74–2 Paraffin waxes and hydrocarbon waxes

8006–20–0 Fuel gases, low and medium B.T.U.

8008–20–6 Kerosine (petroleum)

8009–03–8 Petrolatum

8012–95–1 Paraffin oils

8030–30–6 Naphtha

8032–32–4 Ligroine

8042–47–5 White mineral oil (petroleum)

8052–41–3 Stoddard solvent

8052–42–4 Asphalt

61789–60–4 Pitch

63231–60–7 Paraffin waxes and hydrocarbon waxes, microcryst.

64741–41–9 Naphtha (petroleum), heavy straight-run

64741–42–0 Naphtha (petroleum), full-range straight-run

64741–43–1 Gas oils (petroleum), straight-run

64741–44–2 Distillates (petroleum), straight-run middle

64741–45–3 Residues (petroleum), atm. tower

64741–46–4 Naphtha (petroleum), light straight-run

64741–47–5 Natural gas condensates (petroleum)

64741–49–7 Condensates (petroleum), vacuum tower

64741–50–0 Distillates (petroleum), light paraffinic

64741–51–1 Distillates (petroleum), heavy paraffinic
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64741–52–2 Distillates (petroleum), light naphthenic

64741–53–3 Distillates (petroleum), heavy naphthenic

64741–54–4 Naphtha (petroleum), heavy catalytic cracked

64741–55–5 Naphtha (petroleum), light catalytic cracked

64741–56–6 Residues (petroleum), vacuum

64741–57–7 Gas oils (petroleum), heavy vacuum

64741–58–8 Gas oils (petroleum), light vacuum

64741–59–9 Distillates (petroleum), light catalytic cracked

64741–60–2 Distillates (petroleum), intermediate catalytic cracked

64741–61–3 Distillates (petroleum), heavy catalytic cracked

64741–62–4 Clarified oils (petroleum), catalytic cracked

64741–63–5 Naphtha (petroleum), light catalytic reformed

64741–64–6 Naphtha (petroleum), full-range alkylate

64741–65–7 Naphtha (petroleum), heavy alkylate

64741–66–8 Naphtha (petroleum), light alkylate

64741–67–9 Residues (petroleum), catalytic reformer fractionator

64741–68–0 Naphtha (petroleum), heavy catalytic reformed

64741–69–1 Naphtha (petroleum), light hydrocracked

64741–70–4 Naphtha (petroleum), isomerization

64741–73–7 Distillates (petroleum), alkylate

64741–74–8 Naphtha (petroleum), light thermal cracked

64741–75–9 Residues (petroleum), hydrocracked

64741–76–0 Distillates (petroleum), heavy hydrocracked

64741–77–1 Distillates (petroleum), light hydrocracked

64741–78–2 Naphtha (petroleum), heavy hydrocracked

64741–79–3 Coke (petroleum)

64741–80–6 Residues (petroleum), thermal cracked

64741–81–7 Distillates (petroleum), heavy thermal cracked

64741–82–8 Distillates (petroleum), light thermal cracked

64741–83–9 Naphtha (petroleum), heavy thermal cracked

64741–84–0 Naphtha (petroleum), solvent-refined light

64741–85–1 Raffinates (petroleum), sorption process

64741–86–2 Distillates (petroleum), sweetened middle

64741–87–3 Naphtha (petroleum), sweetened

64741–88–4 Distillates (petroleum), solvent-refined heavy paraffinic

64741–89–5 Distillates (petroleum), solvent-refined light paraffinic

64741–90–8 Gas oils (petroleum), solvent-refined

64741–91–9 Distillates (petroleum), solvent-refined middle

64741–92–0 Naphtha (petroleum), solvent-refined heavy

64741–95–3 Residual oils (petroleum), solvent deasphalted

64741–96–4 Distillates (petroleum), solvent-refined heavy naphthenic

64741–97–5 Distillates (petroleum), solvent-refined light naphthenic

64741–98–6 Extracts (petroleum), heavy naphtha solvent

64741–99–7 Extracts (petroleum), light naphtha solvent

64742–01–4 Residual oils (petroleum), solvent-refined
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64742–03–6 Extracts (petroleum), light naphthenic distillate solvent

64742–04–7 Extracts (petroleum), heavy paraffinic distillate solvent

64742–05–8 Extracts (petroleum), light paraffinic distillate solvent

64742–06–9 Extracts (petroleum), middle distillate solvent

64742–07–0 Raffinates (petroleum), residual oil decarbonization

64742–08–1 Raffinates (petroleum), heavy naphthenic distillate decarbonization

64742–09–2 Raffinates (petroleum), heavy paraffinic distillate decarbonization

64742–10–5 Extracts (petroleum), residual oil solvent

64742–11–6 Extracts (petroleum), heavy naphthenic distillate solvent

64742–12–7 Gas oils (petroleum), acid-treated

64742–13–8 Distillates (petroleum), acid-treated middle

64742–14–9 Distillates (petroleum), acid-treated light

64742–15–0 Naphtha (petroleum), acid-treated

64742–16–1 Petroleum resins

64742–18–3 Distillates (petroleum), acid-treated heavy naphthenic

64742–19–4 Distillates (petroleum), acid-treated light naphthenic

64742–20–7 Distillates (petroleum), acid-treated heavy paraffinic

64742–21–8 Distillates (petroleum), acid-treated light paraffinic

64742–22–9 Naphtha (petroleum), chemically neutralized heavy

64742–23–0 Naphtha (petroleum), chemically neutralized light

64742–24–1 Sludges (petroleum), acid

64742–25–2 Lubricating oils (petroleum), acid-treated spent

64742–26–3 Hydrocarbon waxes (petroleum), acid-treated

64742–27–4 Distillates (petroleum), chemically neutralized heavy paraffinic

64742–28–5 Distillates (petroleum), chemically neutralized light paraffinic

64742–29–6 Gas oils (petroleum), chemically neutralized

64742–30–9 Distillates (petroleum), chemically neutralized middle

64742–31–0 Distillates (petroleum), chemically neutralized light

64742–32–1 Lubricating oils (petroleum), chemically neutralized spent

64742–33–2 Hydrocarbon waxes (petroleum), chemically neutralized

64742–34–3 Distillates (petroleum), chemically neutralized heavy naphthenic

64742–35–4 Distillates (petroleum), chemically neutralized light naphthenic

64742–36–5 Distillates (petroleum), clay-treated heavy paraffinic

64742–37–6 Distillates (petroleum), clay-treated light paraffinic

64742–38–7 Distillates (petroleum), clay-treated middle

64742–39–8 Neutralizing agents (petroleum), spent sodium carbonate

64742–40–1 Neutralizing agents (petroleum), spent sodium hydroxide

64742–41–2 Residual oils (petroleum), clay-treated

64742–42–3 Hydrocarbon waxes (petroleum), clay-treated microcryst.

64742–43–4 Paraffin waxes (petroleum), clay-treated

64742–44–5 Distillates (petroleum), clay-treated heavy naphthenic

64742–45–6 Distillates (petroleum), clay-treated light naphthenic

64742–46–7 Distillates (petroleum), hydrotreated middle

64742–47–8 Distillates (petroleum), hydrotreated light

64742–48–9 Naphtha (petroleum), hydrotreated heavy
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64742–49–0 Naphtha (petroleum), hydrotreated light

64742–50–3 Lubricating oils (petroleum), clay-treated spent

64742–51–4 Paraffin waxes (petroleum), hydrotreated

64742–52–5 Distillates (petroleum), hydrotreated heavy naphthenic

64742–53–6 Distillates (petroleum), hydrotreated light naphthenic

64742–54–7 Distillates (petroleum), hydrotreated heavy paraffinic

64742–55–8 Distillates (petroleum), hydrotreated light paraffinic

64742–56–9 Distillates (petroleum), solvent-dewaxed light paraffinic

64742–57–0 Residual oils (petroleum), hydrotreated

64742–58–1 Lubricating oils (petroleum), hydrotreated spent

64742–59–2 Gas oils (petroleum), hydrotreated vacuum

64742–60–5 Hydrocarbon waxes (petroleum), hydrotreated microcryst.

64742–61–6 Slack wax (petroleum)

64742–62–7 Residual oils (petroleum), solvent-dewaxed

64742–63–8 Distillates (petroleum), solvent-dewaxed heavy naphthenic

64742–64–9 Distillates (petroleum), solvent-dewaxed light naphthenic

64742–65–0 Distillates (petroleum), solvent-dewaxed heavy paraffinic

64742–67–2 Foots oil (petroleum)

64742–68–3 Naphthenic oils (petroleum), catalytic dewaxed heavy

64742–69–4 Naphthenic oils (petroleum), catalytic dewaxed light

64742–70–7 Paraffin oils (petroleum), catalytic dewaxed heavy

64742–71–8 Paraffin oils (petroleum), catalytic dewaxed light

64742–72–9 Distillates (petroleum), catalytic dewaxed middle

64742–73–0 Naphtha (petroleum), hydrodesulfurized light

64742–75–2 Naphthenic oils (petroleum), complex dewaxed heavy

64742–76–3 Naphthenic oils (petroleum), complex dewaxed light

64742–78–5 Residues (petroleum), hydrodesulfurized atmospheric tower

64742–79–6 Gas oils (petroleum), hydrodesulfurized

64742–80–9 Distillates (petroleum), hydrodesulfurized middle

64742–81–0 Kerosine (petroleum), hydrodesulfurized

64742–82–1 Naphtha (petroleum), hydrodesulfurized heavy

64742–83–2 Naphtha (petroleum), light steam-cracked

64742–85–4 Residues (petroleum), hydrodesulfurized vacuum

64742–86–5 Gas oils (petroleum), hydrodesulfurized heavy vacuum

64742–87–6 Gas oils (petroleum), hydrodesulfurized light vacuum

64742–88–7 Solvent naphtha (petroleum), medium aliph.

64742–89–8 Solvent naphtha (petroleum), light aliph.

64742–90–1 Residues (petroleum), steam-cracked

64742–91–2 Distillates (petroleum), steam-cracked

64742–92–3 Petroleum resins, oxidized

64742–93–4 Asphalt, oxidized

64742–94–5 Solvent naphtha (petroleum), heavy arom.

64742–95–6 Solvent naphtha (petroleum), light arom.

64742–96–7 Solvent naphtha (petroleum), heavy aliph.

64742–97–8 Distillates (petroleum), oxidized heavy
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64742–98–9 Distillates (petroleum), oxidized light

64742–99–0 Residual oils (petroleum), oxidized

64743–00–6 Hydrocarbon waxes (petroleum), oxidized

64743–01–7 Petrolatum (petroleum), oxidized

64743–02–8 Alkenes, C>10 .alpha.-

64743–03–9 Phenols (petroleum)

64743–04–0 Coke (petroleum), recovery

64743–05–1 Coke (petroleum), calcined

64743–06–2 Extracts (petroleum), gas oil solvent

64743–07–3 Sludges (petroleum), chemically neutralized

64754–89–8 Naphthenic acids (petroleum), crude

64771–71–7 Paraffins (petroleum), normal C>10

64771–72–8 Paraffins (petroleum), normal C5-20

67254–74–4 Naphthenic oils

67674–12–8 Residual oils (petroleum), oxidized, compounds with triethanolamine

67674–13–9 Petrolatum (petroleum), oxidized, partially deacidified

67674–15–1 Petrolatum (petroleum), oxidized, Me ester

67674–16–2 Hydrocarbon waxes (petroleum), oxidized, partially deacidified

67674–17–3 Distillates (petroleum), oxidized light, compounds with triethanolamine

67674–18–4 Distillates (petroleum), oxidized light, Bu esters

67891–79–6 Distillates (petroleum), heavy arom.

67891–80–9 Distillates (petroleum), light arom.

67891–81–0 Distillates (petroleum), oxidized light, potassium salts

67891–82–1 Hydrocarbon waxes (petroleum), oxidized, compounds with 

ethanolamine

67891–83–2 Hydrocarbon waxes (petroleum), oxidized, compounds with 

isopropanolamine

67891–85–4 Hydrocarbon waxes (petroleum), oxidized, compounds with 

triisopropanolamine

67891–86–5 Hydrocarbon waxes (petroleum), oxidized, compds. with 

diisopropanolamine

68131–05–5 Hydrocarbon oils, process blends

68131–49–7 Aromatic hydrocarbons, C6-10, acid-treated, neutralized

68131–75–9 Gases (petroleum), C3-4

68153–22–0 Paraffin waxes and Hydrocarbon waxes, oxidized

68187–57–5 Pitch, coal tar-petroleum

68187–58–6 Pitch, petroleum, arom.

68187–60–0 Hydrocarbons, C4, ethane-propane-cracked

68307–98–2 Tail gas (petroleum), catalytic cracked distillate and catalytic cracked 

naphtha fractionation absorber

68307–99–3 Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer

68308–00–9 Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, 

hydrogen sulfide-free

68308–01–0 Tail gas (petroleum), cracked distillate hydrotreater stripper

68308–02–1 Tail gas (petroleum), distn., hydrogen sulfide-free
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

89

68308–03–2 Tail gas (petroleum), gas oil catalytic cracking absorber

68308–04–3 Tail gas (petroleum), gas recovery plant

68308–05–4 Tail gas (petroleum), gas recovery plant deethanizer

68308–06–5 Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized 

naphtha fractionator, acid-free

68308–07–6 Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, 

hydrogen sulfide-free

68308–08–7 Tail gas (petroleum), isomerized naphtha fractionation stabilizer

68308–09–8 Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen 

sulfide-free

68308–10–1 Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen 

sulfide-free

68308–11–2 Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer

68308–12–3 Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen 

sulfide-free

68308–27–0 Fuel gases, refinery

68333–22–2 Residues (petroleum), atmospheric

68333–23–3 Naphtha (petroleum), heavy coker

68333–24–4 Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine

68333–25–5 Distillates (petroleum), hydrodesulfurized light catalytic cracked

68333–26–6 Clarified oils (petroleum), hydrodesulfurized catalytic cracked

68333–27–7 Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked

68333–28–8 Distillates (petroleum), hydrodesulfurized heavy catalytic cracked

68333–29–9 Residues (petroleum), light naphtha solvent extracts

68333–30–2 Distillates (petroleum), oxidized heavy thermal cracked

68333–81–3 Alkanes, C4-12

68333–88–0 Aromatic hydrocarbons, C9-17

68334–30–5 Fuels, diesel

68409–99–4 Gases (petroleum), catalytic cracked overheads

68410–00–4 Distillates (petroleum), crude oil

68410–05–9 Distillates (petroleum), straight-run light

68410–12–8 Distillates (petroleum), steam-cracked, C5-10 fraction, high-temp. 

stripping products with light steam-cracked petroleum naphtha C5 

fraction polymers

68410–71–9 Raffinates (petroleum), catalytic reformer ethylene glycol-water 

countercurrent exts.

68410–96–8 Distillates (petroleum), hydrotreated middle, intermediate boiling

68410–97–9 Distillates (petroleum), light distillate hydrotreating process, low-boiling

68410–98–0 Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer 

overheads

68411–00–7 Alkenes, C>8

68425–29–6 Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasolineblending

68425–33–2 Petrolatum (petroleum), oxidized, barium salt

68425–34–3 Petrolatum (petroleum), oxidized, calcium salt
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

90

68425–35–4 Raffinates (petroleum), reformer, Lurgi unit-sepd.

68425–39–8 Alkenes, C>10 .alpha.-, oxidized

68441–09–8 Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. 

polyethylene, oxidized

68459–78–9 Alkenes, C18-24 .alpha.-, dimers

68475–57–0 Alkanes, C1-2

68475–58–1 Alkanes, C2-3

68475–59–2 Alkanes, C3-4

68475–60–5 Alkanes, C4-5

68475–61–6 Alkenes, C5, naphtha-raffinate pyrolyzate-derived

68475–70–7 Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived

68475–79–6 Distillates (petroleum), catalytic reformed depentanizer

68475–80–9 Distillates (petroleum), light steam-cracked naphtha

68476–26–6 Fuel gases

68476–27–7 Fuel gases, amine system residues

68476–28–8 Fuel gases, C6-8 catalytic reformer

68476–29–9 Fuel gases, crude oil distillates

68476–30–2 Fuel oil, no. 2

68476–31–3 Fuel oil, no. 4

68476–32–4 Fuel oil, residues-straight-run gas oils, high-sulfur

68476–33–5 Fuel oil, residual

68476–34–6 Fuels, diesel, no. 2

68476–39–1 Hydrocarbons, aliph.-arom.-C4-5-olefinic

68476–40–4 Hydrocarbons, C3-4

68476–42–6 Hydrocarbons, C4-5

68476–43–7 Hydrocarbons, C4-6, C5-rich

68476–44–8 Hydrocarbons, C>3

68476–45–9 Hydrocarbons, C5-10 arom. conc., ethylene-manuf.-by-product

68476–46–0 Hydrocarbons, C3-11, catalytic cracker distillates

68476–47–1 Hydrocarbons, C2-6, C6-8 catalytic reformer

68476–49–3 Hydrocarbons, C2-4, C3-rich

68476–50–6 Hydrocarbons, C≥5, C5-6-rich

68476–52–8 Hydrocarbons, C4, ethylene-manuf.-by-product

68476–53–9 Hydrocarbons, C≥20, petroleum wastes

68476–54–0 Hydrocarbons, C3-5, polymn. unit feed

68476–55–1 Hydrocarbons, C5-rich

68476–56–2 Hydrocarbons, cyclic C5 and C6

68476–77–7 Lubricating oils, refined used

68476–81–3 Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts

68476–84–6 Petroleum products, gases, inorg.

68476–85–7 Petroleum gases, liquefied

68476–86–8 Petroleum gases, liquefied, sweetened

68477–25–8 Waste gases, vent gas, C1-6

68477–26–9 Wastes, petroleum

68477–29–2 Distillates (petroleum), catalytic reformer fractionator residue, high-
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

91

boiling

68477–30–5 Distillates (petroleum), catalytic reformer fractionator residue, 

intermediate-boiling

68477–31–6 Distillates (petroleum), catalytic reformer fractionator residue, lowboiling

68477–33–8 Gases (petroleum), C3-4, isobutane-rich

68477–34–9 Distillates (petroleum), C3-5, 2-methyl-2-butene-rich

68477–35–0 Distillates (petroleum), C3-6, piperylene-rich

68477–36–1 Distillates (petroleum), cracked steam-cracked, C5-18 fraction

68477–38–3 Distillates (petroleum), cracked steam-cracked petroleum distillates

68477–39–4 Distillates (petroleum), cracked stripped steam-cracked petroleum 

distillates, C8-10 fraction

68477–40–7 Distillates (petroleum), cracked stripped steam-cracked petroleum 

distillates, C10-12 fraction

68477–41–8 Gases (petroleum), extractive, C3-5, butadiene-butene-rich

68477–42–9 Gases (petroleum), extractive, C3-5, butene-isobutylene-rich

68477–44–1 Distillates (petroleum), heavy naphthenic, mixed with steam-cracked 

petroleum distillates C5-12 fraction

68477–47–4 Distillates (petroleum), mixed heavy olefin vacuum, heart-cut

68477–48–5 Distillates (petroleum), mixed heavy olefin vacuum, low-boiling

68477–53–2 Distillates (petroleum), steam-cracked, C5-12 fraction

68477–54–3 Distillates (petroleum), steam-cracked, C8-12 fraction

68477–55–4 Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light 

steam-cracked petroleum naphtha C5 fraction

68477–58–7 Distillates (petroleum), steam-cracked petroleum distillates, C5-18 

fraction

68477–59–8 Distillates (petroleum), steam-cracked petroleum distillates 

cyclopentadiene conc.

68477–60–1 Extracts (petroleum), cold-acid

68477–61–2 Extracts (petroleum), cold-acid, C4-6

68477–62–3 Extracts (petroleum), cold-acid, C3-5, butene-rich

68477–63–4 Extracts (petroleum), reformer recycle

68477–64–5 Gases (petroleum), acetylene manuf. off

68477–65–6 Gases (petroleum), amine system feed

68477–66–7 Gases (petroleum), benzene unit hydrodesulfurizer off

68477–67–8 Gases (petroleum), benzene unit recycle, hydrogen-rich

68477–68–9 Gases (petroleum), blend oil, hydrogen-nitrogen-rich

68477–69–0 Gases (petroleum), butane splitter overheads

68477–70–3 Gases (petroleum), C2-3

68477–71–4 Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-

rich acid-free

68477–72–5 Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3-5-

rich

68477–73–6 Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-

rich acid-free
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

92

68477–74–7 Gases (petroleum), catalytic cracker

68477–75–8 Gases (petroleum), catalytic cracker, C1-5-rich

68477–76–9 Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2-4-

rich

68477–77–0 Gases (petroleum), catalytic reformed naphtha stripper overheads

68477–79–2 Gases (petroleum), catalytic reformer, C1-4-rich

68477–80–5 Gases (petroleum), C6-8 catalytic reformer recycle

68477–81–6 Gases (petroleum), C6-8 catalytic reformer

68477–82–7 Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich

68477–83–8 Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed

68477–84–9 Gases (petroleum), C2-return stream

68477–85–0 Gases (petroleum), C4-rich

68477–86–1 Gases (petroleum), deethanizer overheads

68477–87–2 Gases (petroleum), deisobutanizer tower overheads

68477–88–3 Gases (petroleum), deethanizer overheads, C3-rich

68477–89–4 Distillates (petroleum), depentanizer overheads

68477–90–7 Gases (petroleum), depropanizer dry, propene-rich

68477–91–8 Gases (petroleum), depropanizer overheads

68477–92–9 Gases (petroleum), dry sour, gas-concn.-unit-off

68477–93–0 Gases (petroleum), gas concn. reabsorber distn.

68477–94–1 Gases (petroleum), gas recovery plant depropanizer overheads

68477–95–2 Gases (petroleum), Girbatol unit feed

68477–96–3 Gases (petroleum), hydrogen absorber off

68477–97–4 Gases (petroleum), hydrogen-rich

68477–98–5 Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen rich

68477–99–6 Gases (petroleum), isomerized naphtha fractionater, C4-rich, hydrogen 

sulfide- free

68478–00–2 Gases (petroleum), recycle, hydrogen-rich

68478–01–3 Gases (petroleum), reformer make-up, hydrogen-rich

68478–02–4 Gases (petroleum), reforming hydrotreater

68478–03–5 Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich

68478–04–6 Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich

68478–05–7 Gases (petroleum), thermal cracking distn.

68478–08–0 Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc.

68478–10–4 Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-

cycloalkadiene conc.

68478–12–6 Residues (petroleum), butane splitter bottoms

68478–13–7 Residues (petroleum), catalytic reformer fractionator residue distn.

68478–15–9 Residues (petroleum), C6-8 catalytic reformer

68478–16–0 Residual oils (petroleum), deisobutanizer tower

68478–17–1 Residues (petroleum), heavy coker gas oil and vacuum gas oil

68478–18–2 Residues (petroleum), heavy olefin vacuum

68478–19–3 Residual oils (petroleum), propene purifn. splitter

68478–20–6 Residues (petroleum), steam-cracked petroleum distillates 

cyclopentadiene conc., C4-cyclopentadiene-free
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

93

68478–22–8 Tail gas (petroleum), catalytic cracked naphtha stabilization absorber

68478–24–0 Tail gas (petroleum), catalytic cracker, catalytic reformer and 

hydrodesulfurizer combined fractionater

68478–25–1 Tail gas (petroleum), catalytic cracker refractionation absorber

68478–26–2 Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer

68478–27–3 Tail gas (petroleum), catalytic reformed naphtha separator

68478–28–4 Tail gas (petroleum), catalytic reformed naphtha stabilizer

68478–29–5 Tail gas (petroleum), cracked distillate hydrotreater separator

68478–30–8 Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator

68478–31–9 Tail gas (petroleum), isomerized naphtha fractionates, hydrogen sulfidefree

68478–32–0 Tail gas (petroleum), saturate gas plant mixed stream, C4-rich

68478–33–1 Tail gas (petroleum), saturate gas recovery plant, C1-2-rich

68478–34–2 Tail gas (petroleum), vacuum residues thermal cracker

68512–61–8 Residues (petroleum), heavy coker and light vacuum

68512–62–9 Residues (petroleum), light vacuum

68512–78–7 Solvent naphtha (petroleum), light arom., hydrotreated

68512–91–4 Hydrocarbons, C3-4-rich, petroleum distillates

68513–02–0 Naphtha (petroleum), full-range coker

68513–03–1 Naphtha (petroleum), light catalytic reformed, arom.-free

68513–11–1 Fuel gases, hydrotreater fractionation, scrubbed

68513–12–2 Fuel gases, saturate gas unit fractionater-absorber overheads

68513–13–3 Fuel gases, thermal cracked catalytic cracking residue

68513–14–4 Gases (petroleum), catalytic reformed straight-run naphtha stabilizer 

overheads

68513–15–5 Gases (petroleum), full-range straight-run naphtha dehexanizer off

68513–16–6 Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich

68513–17–7 Gases (petroleum), light straight-run naphtha stabilizer off

68513–18–8 Gases (petroleum), reformer effluent high-pressure flash drum off

68513–19–9 Gases (petroleum), reformer effluent low-pressure flash drum off

68513–62–2 Disulfides, C5-12-alkyl

68513–63–3 Distillates (petroleum), catalytic reformed straight-run naphtha overheads

68513–65–5 Butane, branched and linear

68513–66–6 Residues (petroleum), alkylation splitter, C4-rich

68513–67–7 Residues (petroleum), cyclooctadiene bottoms

68513–68–8 Residues (petroleum), deethanizer tower

68513–69–9 Residues (petroleum), steam-cracked light

68513–74–6 Waste gases, ethylene oxide absorber-reactor

68514–15–8 Gasoline, vapor-recovery

68514–29–4 Hydrocarbons, amylene feed debutanizer overheads non-extractable 

raffinates

68514–31–8 Hydrocarbons, C1-4

68514–32–9 Hydrocarbons, C10 and C12, olefin-rich

68514–33–0 Hydrocarbons, C12 and C14, olefin-rich

68514–34–1 Hydrocarbons, C9-14, ethylene-manuf.-by-product
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

94

68514–35–2 Hydrocarbons, C14-30, olefin-rich

68514–36–3 Hydrocarbons, C1-4, sweetened

68514–37–4 Hydrocarbons, C4-5-unsatd.

68514–38–5 Hydrocarbons, C4-10-unsatd.

68514–39–6 Naphtha (petroleum), light steam-cracked, isoprene-rich

68514–79–4 Petroleum products, hydrofiner-powerformer reformates

68515–25–3 Benzene, C1-9-alkyl derivs.

68515–26–4 Benzene, di-C12-14-alkyl derivs.

68515–27–5 Benzene, di-C10-14-alkyl derivs., fractionation overheads, heavy ends

68515–28–6 Benzene, di-C10-14-alkyl derivs., fractionation overheads, light ends

68515–29–7 Benzene, di-C10-14-alkyl derivs., fractionation overheads, middle cut

68515–30–0 Benzene, mono-C20-48-alkyl derivs.

68515–32–2 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms

68515–33–3 Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, heavy ends

68515–34–4 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, heavy ends

68515–35–5 Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, light ends

68515–36–6 Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, light ends

68516–20–1 Naphtha (petroleum), steam-cracked middle arom.

68526–52–3 Alkenes, C6

68526–53–4 Alkenes, C6-8, C7-rich

68526–54–5 Alkenes, C7-9, C8-rich

68526–55–6 Alkenes, C8-10, C9-rich

68526–56–7 Alkenes, C9-11, C10-rich

68526–57–8 Alkenes, C10-12, C11-rich

68526–58–9 Alkenes, C11-13, C12-rich

68526–77–2 Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum

68526–99–8 Alkenes, C6-9 .alpha.-

68527–00–4 Alkenes, C8-9 .alpha.-

68527–11–7 Alkenes, C5

68527–13–9 Gases (petroleum), acid, ethanolamine scrubber

68527–14–0 Gases (petroleum), methane-rich off

68527–15–1 Gases (petroleum), oil refinery gas distn. off

68527–16–2 Hydrocarbons, C1-3

68527–18–4 Gas oils (petroleum), steam-cracked

68527–19–5 Hydrocarbons, C1-4, debutanizer fraction

68527–21–9 Naphtha (petroleum), clay-treated full-range straight-run

68527–22–0 Naphtha (petroleum), clay-treated light straight-run

68527–23–1 Naphtha (petroleum), light steam-cracked arom.

68527–26–4 Naphtha (petroleum), light steam-cracked, debenzenized

68527–27–5 Naphtha (petroleum), full-range alkylate, butane-contg.

68553–00–4 Fuel oil, no. 6

68553–14–0 Hydrocarbons, C8-11

68602–79–9 Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads

68602–81–3 Distillates, hydrocarbon resin prodn. higher boiling

68602–82–4 Gases (petroleum), benzene unit hydrotreater depentenizer overheads
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

95

68602–83–5 Gases (petroleum), C1-5, wet

68602–84–6 Gases (petroleum), secondary absorber off, fluidized catalytic cracker 

overheads fractionater

68602–96–0 Distillates (petroleum), oxidized light, strong acid components, compds. 

with diethanolamine

68602–97–1 Distillates (petroleum), oxidized light, strong acid components, sodium 

salts

68602–98–2 Distillates (petroleum), oxidized light, strong acid components

68602–99–3 Distillates (petroleum), oxidized light, strong acid-free

68603–00–9 Distillates (petroleum), thermal cracked naphtha and gas oil

68603–01–0 Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimercontg.

68603–02–1 Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized

68603–03–2 Distillates (petroleum), thermal cracked naphtha and gas oil, extractive

68603–08–7 Naphtha (petroleum), arom.-contg.

68603–09–8 Hydrocarbon waxes (petroleum), oxidized, calcium salts

68603–10–1 Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts

68603–11–2 Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

68603–12–3 Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts

68603–13–4 Petrolatum (petroleum), oxidized, ester with sorbitol

68603–14–5 Residual oils (petroleum), oxidized, calcium salts

68603–31–6 Alkenes, C10, tert-amylene concentrator by-product

68603–32–7 Alkenes, C15-20 .alpha.-, isomerized

68606–09–7 Fuel gases, expander off

68606–10–0 Gasoline, pyrolysis, debutanizer bottoms

68606–11–1 Gasoline, straight-run, topping-plant

68606–24–6 Hydrocarbons, C4, butene concentrator by-product

68606–25–7 Hydrocarbons, C2-4

68606–26–8 Hydrocarbons, C3

68606–27–9 Gases (petroleum), alkylation feed

68606–28–0 Hydrocarbons, C5 and C10-aliph. and C6-8-arom.

68606–31–5 Hydrocarbons, C3-5, butadiene purifn. by-product

68606–34–8 Gases (petroleum), depropanizer bottoms fractionation off

68606–36–0 Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product

68607–11–4 Petroleum products, refinery gases

68607–30–7 Residues (petroleum), topping plant, low-sulfur

68608–56–0 Waste gases, from carbon black manuf.

68647–60–9 Hydrocarbons, C>4

68647–61–0 Hydrocarbons, C4-5, tert-amylene concentrator by-product

68647–62–1 Hydrocarbons, C4-5, butene concentrator by-product, sour

68650–36–2 Aromatic hydrocarbons, C8, o -xylene-lean

68650–37–3 Paraffin waxes (petroleum), oxidized, sodium salts

68782–97–8 Distillates (petroleum), hydrofined lubricating-oil

68782–98–9 Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg.

68782–99–0 Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-
*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

96

contg.

68783–00–6 Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc.

68783–01–7 Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc.

68783–02–8 Extracts (petroleum), intermediate clarified oil solvent, condensed-ringarom.-contg.

68783–04–0 Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent

68783–05–1 Gases (petroleum), ammonia-hydrogen sulfide, water-satd.

68783–06–2 Gases (petroleum), hydrocracking low-pressure separator

68783–07–3 Gases (petroleum), refinery blend

68783–08–4 Gas oils (petroleum), heavy atmospheric

68783–09–5 Naphtha (petroleum), catalytic cracked light distd.

68783–12–0 Naphtha (petroleum), unsweetened

68783–13–1 Residues (petroleum), coker scrubber, condensed-ring-arom.-contg.

68783–15–3 Alkenes, C6-7 .alpha.-

68783–61–9 Fuel gases, refinery, sweetened

68783–62–0 Fuel gases, refinery, unsweetened

68783–64–2 Gases (petroleum), catalytic cracking

68783–65–3 Gases (petroleum), C2-4, sweetened

68783–66–4 Naphtha (petroleum), light, sweetened

68814–47–1 Waste gases, refinery vent

68814–67–5 Gases (petroleum), refinery

68814–87–9 Distillates (petroleum), full-range straight-run middle

68814–89–1 Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted

68814–90–4 Gases (petroleum), platformer products separator off

68814–91–5 Alkenes, C5-9 .alpha.-

68855–57–2 Alkenes, C6-12 .alpha.-

68855–58–3 Alkenes, C10-16 .alpha.-

68855–59–4 Alkenes, C14-18 .alpha.-

68855–60–7 Alkenes, C14-20 .alpha.-

68911–58–0 Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off

68911–59–1 Gases (petroleum), hydrotreated sour kerosine flash drum

68915–96–8 Distillates (petroleum), heavy straight-run

68915–97–9 Gas oils (petroleum), straight-run, high-boiling

68918–69–4 Petrolatum (petroleum), oxidized, zinc salt

68918–73–0 Residues (petroleum), clay-treating filter wash

68918–93–4 Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts

68918–98–9 Fuel gases, refinery, hydrogen sulfide-free

68918–99–0 Gases (petroleum), crude oil fractionation off

68919–00–6 Gases (petroleum), dehexanizer off

68919–01–7 Gases (petroleum), distillate unifiner desulfurization stripper off

68919–02–8 Gases (petroleum), fluidized catalytic cracker fractionation off

68919–03–9 Gases (petroleum), fluidized catalytic cracker scrubbing secondary 

absorber off

68919–04–0 Gases (petroleum), heavy distillate hydrotreater desulfurization stripper 

off
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68919–05–1 Gases (petroleum), light straight run gasoline fractionation stabilizer off

68919–06–2 Gases (petroleum), naphtha unifiner desulfurization stripper off

68919–07–3 Gases (petroleum), platformer stabilizer off, light ends fractionation

68919–08–4 Gases (petroleum), preflash tower off, crude distn.

68919–09–5 Gases (petroleum), straight-run naphtha catalytic reforming off

68919–10–8 Gases (petroleum), straight-run stabilizer off

68919–11–9 Gases (petroleum), tar stripper off

68919–12–0 Gases (petroleum), unifiner stripper off

68919–15–3 Hydrocarbons, C6-12, benzene-recovery

68919–16–4 Hydrocarbons, catalytic alkylation, by-products, C3-6

68919–17–5 Hydrocarbons, C12-20, catalytic alkylation by-products

68919–19–7 Gases (petroleum), fluidized catalytic cracker splitter residues

68919–20–0 Gases (petroleum), fluidized catalytic cracker splitter overheads

68919–37–9 Naphtha (petroleum), full-range reformed

68920–06–9 Hydrocarbons, C7-9

68920–07–0 Hydrocarbons, C`10-linear

68920–64–9 Disulfides, di-C1-2-alkyl

68921–07–3 Distillates (petroleum), hydrotreated light catalytic cracked

68921–08–4 Distillates (petroleum), light straight-run gasoline fractionation stabilizer 

overheads

68921–09–5 Distillates (petroleum), naphtha unifiner stripper

68921–67–5 Hydrocarbons, ethylene-manuf.-by-product distn. residues

68952–76–1 Gases (petroleum), catalytic cracked naphtha debutanizer

68952–77–2 Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer

68952–78–3 Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation 

stabilizer, hydrogen sulfide-free

68952–79–4 Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator

68952–80–7 Tail gas (petroleum), straight-run naphtha hydrodesulfurizer

68952–81–8 Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha 

absorber

68952–82–9 Tail gas (petroleum), thermal cracked hydrocarbon fractionation 

stabilizer, petroleum coking

68953–80–0 Benzene, mixed with toluene, dealkylation product

68955–27–1 Distillates (petroleum), petroleum residues vacuum

68955–28–2 Gases (petroleum), light steam-cracked, butadiene conc.

68955–31–7 Gases (petroleum), butadiene process, inorg.

68955–32–8 Natural gas, substitute, steam-reformed desulfurized naphtha

68955–33–9 Gases (petroleum), sponge absorber off, fluidized catalytic cracker and 

gas oil desulfurizer overhead fractionation

68955–34–0 Gases (petroleum), straight-run naphtha catalytic reformer stabilizer 

overhead

68955–35–1 Naphtha (petroleum), catalytic reformed

68955–36–2 Residues (petroleum), steam-cracked, resinous

68955–76–0 Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich

68955–96–4 Disulfides, dialkyl and di-Ph, naphtha sweetening
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68956–47–8 Fuel oil, isoprene reject absorption

68956–48–9 Fuel oil, residual, wastewater skimmings

68956–52–5 Hydrocarbons, C4-8

68956–54–7 Hydrocarbons, C4-unsatd.

68956–55–8 Hydrocarbons, C5-unsatd.

68956–70–7 Petroleum products, C5-12, reclaimed, wastewater treatment

68988–79–4 Benzene, C10-12-alkyl derivs., distn. residues

68988–99–8 Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. 

scrubber residues

68989–88–8 Gases (petroleum), crude distn. and catalytic cracking

68990–35–2 Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich

68991–49–1 Alkanes, C10-13, arom.-free desulfurized

68991–50–4 Alkanes, C14-17, arom.-free desulfurized

68991–51–5 Alkanes, C10-13, desulfurized

68991–52–6 Alkenes, C10-16

69013–21–4 Fuel oil, pyrolysis

69029–75–0 Oils, reclaimed

69430–33–7 Hydrocarbons, C6-30

70024–88–3 Ethene, thermal cracking products

70528–71–1 Distillates (petroleum), heavy distillate solvent ext. heart-cut

70528–72–2 Distillates (petroleum), heavy distillate solvent ext. vacuum overheads

70528–73–3 Residues (petroleum), heavy distillate solvent ext. vacuum

70592–76–6 Distillates (petroleum), intermediate vacuum

70592–77–7 Distillates (petroleum), light vacuum

70592–78–8 Distillates (petroleum), vacuum

70592–79–9 Residues (petroleum), atm. tower, light

70693–00–4 Hydrocarbon waxes (petroleum), oxidized, sodium salts

70693–06–0 Aromatic hydrocarbons, C9-11

70913–85–8 Residues (petroleum), solvent-extd. vacuum distilled atm. residuum

70913–86–9 Alkanes, C18-70

70955–08–7 Alkanes, C4-6

70955–09–8 Alkenes, C13-14 .alpha.-

70955–10–1 Alkenes, C15-18 .alpha.-

70955–17–8 Aromatic hydrocarbons, C12-20

71243–66–8 Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, 

potassium salts

71302–82–4 Hydrocarbons, C5-8, Houdry butadiene manuf. by-product

71329–37–8 Residues (petroleum), catalytic cracking depropanizer, C4-rich

71808–30–5 Tail gas (petroleum), thermal cracking absorber

72230–71–8 Distillates (petroleum), cracked steam-cracked, C5-17 fraction

72623–83–7 Lubricating oils (petroleum), C>25, hydrotreated bright stock-based

72623–84–8 Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, 

contg. solvent deasphalted residual oil

72623–85–9 Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, 

high-viscosity
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72623–86–0 Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based

72623–87–1 Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based

73138–65–5 Hydrocarbon waxes (petroleum), oxidized, magnesium salts

92045–43–7 Lubricating oils (petroleum), hydrocracked non-arom. solvent 

deparaffined

92045–58–4 Naphtha (petroleum), isomerization, C6-fraction

92062–09–4 Slack wax (petroleum), hydrotreated

93762–80–2 Alkenes, C15-18

98859–55–3 Distillates (petroleum), oxidized heavy, compds. with diethanolamine

98859–56–4 Distillates (petroleum), oxidized heavy, sodium salts

101316–73–8 Lubricating oils (petroleum), used, non-catalytically refined

164907–78–2 Extracts (petroleum), asphaltene-low vacuum residue solvent

164907–79–3 Residues (petroleum), vacuum, asphaltene-low

178603–63–9 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C10-25

178603–64–0 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C15-30, branched and cyclic

178603–65–1 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C20-40, branched and cyclic

178603–66–2 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C25-55, branched and cyclic

212210–93–0 Solvent naphtha (petroleum), heavy arom., distn. residues

221120–39–4 Distillates (petroleum), cracked steam-cracked, C5-12 fraction

445411–73–4 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized, 

hydrogenated, C10-25, branched and cyclic

3412

3413 (2) Specific exempted chemical substances—(i) Exemption. EPA has determined that, at 

3414 this time, the information in § 711.15(b)(4) associated with the chemical substances listed in 

3415 paragraph (b)(2)(iv) of this section is of low current interest.

3416 (ii) Considerations. In making its determination of whether this partial exemption should 

3417 apply to a particular chemical substance, EPA will consider the totality of information available

3418 for the chemical substance in question, including but not limited to, one or more of the following 

3419 considerations:

3420 (A) Whether the chemical substance qualifies or has qualified in past IUR collections for 

3421 the reporting of the information described in § 711.15(b)(4) (i.e., at least one site manufactures 

3422 300,000 pounds (lb.) or more of the chemical substance).

3423 (B) The chemical substance's chemical and physical properties or potential for 

3424 persistence, bioaccumulation, health effects, or environmental effects (considered independently 

3425 or together).

3426 (C) The information needs of EPA, other Federal agencies, tribes, States, and local 

3427 governments, as well as members of the public.
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3428 (D) The availability of other complementary risk screening information.

3429 (E) The availability of comparable processing and use information.

3430 (F) Whether the potential risks of the chemical substance are adequately managed.

3431 (iii) Amendments. EPA may amend the chemical substance list in paragraph (b)(2)(iv) of 

3432 this section on its own initiative or in response to a request from the public based on EPA's 

3433 determination of whether the information in § 711.15(b)(4) is of low interest.

3434 (A) Any person may request that EPA amend the chemical substance list in Table 2 in 

3435 paragraph (b)(2)(iv) of this section. Your request must be in writing and must be submitted to the 

3436 following address: OPPT IUR Submission Coordinator (Mail Code 7407M), Attention: 

3437 Inventory Update Reporting, Office of Pollution Prevention and Toxics, Environmental 

3438 Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. Requests must 

3439 identify the chemical substance in question, as well as its CASRN or other chemical 

3440 identification number as identified in § 711.15(b)(3)(i), and must contain a written rationale for 

3441 the request that provides sufficient specific information, addressing the considerations listed in §

3442 711.6(b)(2)(ii), including cites and relevant documents, to demonstrate to EPA that the collection 

3443 of the information in § 711.15(b)(4) for the chemical substance in question either is or is not of 

3444 low current interest. If a request related to a particular chemical substance is resubmitted, any 

3445 subsequent request must clearly identify new information contained in the request. EPA may 

3446 request other information that it believes necessary to evaluate the request. EPA will issue a 

3447 written response to each request within 120 days of receipt of the request, and will maintain 

3448 copies of these responses in a docket that will be established for each reporting cycle.

3449 (B) As needed, the Agency will initiate rulemaking to make revisions to Table 2 in 

3450 paragraph (b)(2)(iv) of this section.

3451 (C) To assist EPA in reaching a decision regarding a particular request prior to a given 

3452 principal reporting year, requests must be submitted to EPA no later than 12 months prior to the 

3453 start of the next principal reporting year.

3454 (iv) List of chemical substances. EPA has designated the chemical substances listed in 

3455 Table 2 of this paragraph by CASRN, as partially exempt from reporting under the IUR.

3456 Table 2.—CASRN of Partially Exempt Chemical Substances 

CASRN Chemical

50–70–4 D-Glucitol

50–81–7 L-Ascorbic acid

50–99–7 D-Glucose

56–81–5 1,2,3-Propanetriol

56–87–1 L-Lysine

57–50–1 .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl

58–95–7 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-

4,8,12- trimethyltridecyl]-, acetate, (2R)-
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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
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8029–43–4 Syrups, hydrolyzed starch

11103–57–4 Vitamin A

12075–68–2 Aluminum, di-.mu.-chlorochlorotriethyldi12542–85–7 Aluminum, trichlorotrimethyldi16291–96–6 Charcoal

26836–47–5 D-Glucitol, monooctadecanoate

61789–44–4 Fatty acids, castor-oil

61789–97–7 Tallow

61789–99–9 Lard

64147–40–6 Castor oil, dehydrated

64755–01–7 Fatty acids, tallow, calcium salts

65996–63–6 Starch, acid-hydrolyzed

65996–64–7 Starch, enzyme-hydrolyzed

67701–01–3 Fatty acids, C12-18

68002–85–7 Fatty acids, C14-22 and C16-22-unsatd.

68131–37–3 Syrups, hydrolyzed starch, dehydrated

68188–81–8 Grease, poultry

68308–36–1 Soybean meal

68308–54–3 Glycerides, tallow mono-, di- and tri-, hydrogenated

68334–00–9 Cottonseed oil, hydrogenated

68334–28–1 Fats and glyceridic oils, vegetable, hydrogenated

68409–76–7 Bone meal, steamed

68424–45–3 Fatty acids, linseed-oil

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.

3457

3458 § 711.8 Persons who must report.
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3459 Except as provided in § 711.9 and § 711.10, the following persons are subject to the 

3460 requirements of this part. Persons must determine whether they must report under this section for 

3461 each chemical substance that they manufacture (including import) at an individual site.

3462 (a) Persons subject to recurring reporting—(1) For the 2011 submission period, any 

3463 person who manufactured (including imported) for commercial purposes 25,000 lb. (11,340 

3464 kilogram (kg)) or more of a chemical substance described in § 711.5 at any single site owned or 

3465 controlled by that person during the principal reporting year (i.e., calendar year 2010) is subject 

3466 to reporting.

3467 (2) For the submission periods subsequent to the 2011 submission period, any person 

3468 who manufactured (including imported) for commercial purposes 25,000 lb. (11,340 kg) or more 

3469 of a chemical substance described in § 711.5 at any single site owned or controlled by that 

3470 person during any calendar year since the last principal reporting year (e.g., for the 2015

3471 submission period, consider calendar years 2011, 2012, 2013, and 2014, given that 2010 was the 

3472 last principal reporting year).

3473 (b) Exceptions. Any person who manufactured (including imported) for commercial 

3474 purposes any chemical substance that is the subject of a rule proposed or promulgated under 

3475 TSCA section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 

3476 5(e), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 

3477 7 is subject to reporting for that chemical substance, regardless of the production volume.

3478 § 711.9 Persons not subject to this part.

3479 A person described in § 711.8 is not subject to the requirements of this part if that person 

3480 qualifies as a small manufacturer as that term is defined in 40 CFR 704.3. Notwithstanding this 

3481 exclusion, a person who qualifies as a small manufacturer is subject to this part with respect to 

3482 any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 

3483 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 5(e), or is the subject 

3484 of relief that has been granted under a civil action under TSCA section 5 or 7.

3485 § 711.10 Activities for which reporting is not required.

3486 A person described in § 711.8 is not subject to the requirements of this part with respect 

3487 to any chemical substance described in § 711.5 that the person solely manufactured or imported 

3488 under the following circumstances:

3489 (a) The person manufactured or imported the chemical substance described in § 711.5 

3490 solely in small quantities for research and development.

3491 (b) The person imported the chemical substance described in § 711.5 as part of an article.

3492 (c) The person manufactured the chemical substance described in § 711.5 in a manner 

3493 described in 40 CFR 720.30(g) or (h).

3494 § 711.15 Reporting information to EPA.
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3495 For the 2011 submission period, any person who must report under this part, as described 

3496 in § 711.8, must submit the information described in this section for each chemical substance 

3497 described in § 711.5 that the person manufactured (including imported) for commercial purposes 

3498 in an amount of 25,000 lb. (11,340 kg) or more (or lower volume for chemical substances subject 

3499 to the rules, orders, or actions described in § 711.8(b)) at any one site during the principal 

3500 reporting year (i.e., calendar year 2010). For the submission periods subsequent to the 2011 

3501 submission period, any person who must report under this part, as described in § 711.8(b), must 

3502 submit the information described in this section for each chemical substance described in § 711.5 

3503 that the person manufactured (including imported) for commercial purposes in an amount of 

3504 25,000 lb. (11,340 kg) or more (or lower volume for chemical substances subject to the rules, 

3505 orders, or actions described in § 711.8(b)) at any one site during any calendar year since the last 

3506 principal reporting year (e.g., for the 2015 submission period, consider calendar years 2011, 

3507 2012, 2013, and 2014, since 2010 was the last principal reporting year). The principal reporting 

3508 year for each submission period is the previous calendar year (e.g., the principal reporting year 

3509 for the 2015 submission period is calendar year 2014). For all submission periods, a separate 

3510 report must be submitted for each chemical substance at each site for which the submitter is 

3511 required to report. A submitter of information under this part must report information as 

3512 described in this section to the extent that such information is known to or reasonably 

3513 ascertainable by that person.

3514 (a) Reporting information to EPA. Any person who reports information to EPA must do 

3515 so using the e-IURweb reporting software provided by EPA at the address set forth in § 711.35. 

3516 The submission must include all information described in paragraph (b) of this section. Persons 

3517 must submit a separate Form U for each site for which the person is required to report. The e3518 IURweb reporting software is described in the instructions available from EPA at the website set 

3519 forth in § 711.35.

3520 (b) Information to be reported. Manufacturers (including importers) of a reportable 

3521 chemical substance in an amount of 25,000 lb. (11,340 kg) or more at a site during any calendar 

3522 year since the last principal reporting year must report the information described in this section. 

3523 As described in § 711.6(b)(1) and (b)(2), manufacturers of certain chemical substances are not 

3524 required to report the information described in paragraph (b)(4) of this section.

3525 (1) A certification statement signed and dated by an authorized official of the submitter 

3526 company. Persons reporting must submit this information using e-IURweb as described in §

3527 711.35. The authorized official must certify that the submitted information has been completed 

3528 in compliance with the requirements of this part and that the confidentiality claims made on the 

3529 Form U are true and correct. The certification must be signed and dated by the authorized 

3530 official for the submitter company, and provide that person‘s name, official title, and e-mail 

3531 address.

3532 (2) Company and plant site information. The following currently correct company and 

3533 plant site information must be reported for each site at which at least 25,000 lb. (11,340 kg) of a 

3534 reportable chemical substance is manufactured (including imported) during any calendar year 

3535 since the last principal reporting year (see § 711.3 for the ―site‖ for importers):
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3536 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter 

3537 under this part must obtain a Dun and Bradstreet Number for the parent company if none exists.

3538 (ii) The name of a person who will serve as technical contact for the submitter company, 

3539 and who will be able to answer questions about the information submitted by the company to 

3540 EPA, the contact person's full mailing address, telephone number, and e-mail address.

3541 (iii) The name and full street address of each site. A submitter under this part must 

3542 include the appropriate Dun and Bradstreet Number for each plant site reported, and the county 

3543 or parish (or other jurisdictional indicator) in which the plant site is located. A submitter under 

3544 this part must obtain a Dun and Bradstreet Number for the site reported if none exists.

3545 (3) Specific information for chemical substances manufactured in amounts of 25,000 lb. 

3546 or more. The following chemical-specific information must be reported for each reportable 

3547 chemical substance manufactured (including imported) at each site in amounts of 25,000 lb. 

3548 (11,340 kg) or more during any calendar year since the last principal reporting year:

3549 (i) The specific, currently correct Chemical Abstracts (CA) Index name as used to list the 

3550 chemical substance on the TSCA Inventory and the correct corresponding Chemical Abstracts 

3551 Service (CAS) Registry Number (CASRN) for each reportable chemical substance at each site. A 

3552 submitter under this part may use an EPA-designated TSCA Accession Number for a chemical 

3553 substance in lieu of a CASRN when a CASRN is not known to or reasonably ascertainable by 

3554 the submitter. Submitters who wish to report chemical substances listed on the confidential 

3555 portion of the TSCA Inventory will need to report the substance using a TSCA Accession 

3556 Number. 

3557 In addition to reporting the number itself, submitters must specify the type of number they are 

3558 reporting by selecting from among the codes in Table 3 of this paragraph.

3559 Table 3.—Codes to Specify Type of Chemical Identifying Number

Code Number Type

A Accession Number

C Chemical Abstracts Service Registry Number (CASRN)

3560

3561

3562 (A) If an importer submitting a report cannot provide the information specified in §

3563 711.15(b)(3)(i) of this section because it is unknown to the importer and claimed as confidential 

3564 by the supplier of the chemical substance or mixture, the importer must use e-IURweb to ask the 

3565 supplier to provide the correct chemical identity information directly to EPA in a joint 

3566 submission. Such request must include instructions for submitting chemical identity information 

3567 electronically, using e-IURweb and CDX (see § 711.35), and for clearly referencing the 

3568 importer's submission. Contact information for the supplier, a trade name or other designation 

3569 for the chemical substance or mixture, and a copy of the request to the supplier must be included 

3570 with the importer‘s submission respecting the chemical substance.
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3571 (B) If a manufacturer submitting a report cannot provide the information specified in §

3572 711.15(b)(3)(i) of this section because the reportable chemical substance is manufactured using a 

3573 reactant having a specific chemical identity that is unknown to the manufacturer and claimed as 

3574 confidential by its supplier, the manufacturer must use e-IURweb to ask the supplier of the 

3575 confidential reactant to provide the correct chemical identity of the confidential reactant directly 

3576 to EPA in a joint submission. Such request must include instructions for submitting chemical 

3577 identity information electronically using e-IURweb and CDX (see § 711.35), and for clearly 

3578 referencing the manufacturer's submission. Contact information for the supplier, a trade name or 

3579 other designation for the chemical substance, and a copy of the request to the supplier must be 

3580 included with the importer‘s submission respecting the chemical substance.

3581 (C) EPA will only accept joint submissions that are submitted electronically using e3582 IURweb and CDX (see § 711.35) and that clearly reference the primary submission to which 

3583 they refer.

3584 (ii) For the principal reporting year only, a statement indicating, for each reportable 

3585 chemical substance at each site, whether the chemical substance is manufactured in the United 

3586 States, imported into the United States, or both manufactured in the United States and imported 

3587 into the United States.

3588 (iii) For the principal reporting year, the total annual volume (in pounds) of each 

3589 reportable chemical substance domestically manufactured and imported at each site. The total 

3590 annual domestically manufactured volume (not including imported volume) and the total annual 

3591 imported volume must be separately reported. This amount must be reported to two significant 

3592 figures of accuracy. For each complete calendar year since the last principal reporting year, the 

3593 total annual volume (domestically manufactured and imported volumes in pounds) of each 

3594 reportable chemical substance at each site.

3595 (iv) For the principal reporting year only, the volume used on site and the volume 

3596 exported of each reportable chemical substance domestically manufactured and imported at each 

3597 site. This amount must be reported to two significant figures of accuracy.

3598 (v) For the principal reporting year only, a designation indicating, for each imported 

3599 reportable chemical substance at each site, whether the imported chemical substance is 

3600 physically present at the reporting site.

3601 (vi) For the principal reporting year only, a designation indicating, for each reportable 

3602 chemical substance at each site, whether the chemical substance is being recycled, 

3603 remanufactured, reprocessed, reused, or otherwise used for a commercial purpose instead of 

3604 being disposed of as a waste or included in a waste stream.

3605 (vii) For the principal reporting year only, the total number of workers reasonably likely 

3606 to be exposed to each reportable chemical substance at each site. For each reportable chemical 

3607 substance at each site, the submitter must select from among the ranges of workers listed in 

3608 Table 4 of this paragraph and report the corresponding code (i.e., W1 through W8):

3609 Table 4.—Codes for Reporting Number of Workers Reasonably Likely To Be Exposed
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Code Range

W1 Fewer than 10 workers

W2 At least 10 but fewer than 25 workers

W3 At least 25 but fewer than 50 workers

W4 At least 50 but fewer than 100 workers

W5 At least 100 but fewer than 500 workers

W6 At least 500 but fewer than 1,000 workers

W7 At least 1,000 but fewer than 10,000 workers

W8 At least 10,000 workers

3610

3611 (viii) For the principal reporting year only, the maximum concentration, measured by 

3612 percentage of weight, of each reportable chemical substance at the time it is sent off-site from 

3613 each site. If the chemical substance is site-limited, you must report the maximum concentration, 

3614 measured by percentage of weight of the reportable chemical substance at the time it is reacted 

3615 on-site to produce a different chemical substance. This information must be reported regardless 

3616 of the physical form(s) in which the chemical substance is sent off-site/reacted on-site. For each 

3617 chemical substance at each site, select the maximum concentration of the chemical substance 

3618 from among the ranges listed in Table 5 of this paragraph and report the corresponding code (i.e., 

3619 M1 through M5):

3620 Table 5.—Codes for Reporting Maximum Concentration of Chemical Substance

Code Concentration Range (% weight)

M1 Less than 1% by weight

M2 At least 1 but less than 30% by weight

M3 At least 30 but less than 60% by weight

M4 At least 60 but less than 90% by weight

M5 At least 90% by weight

3621

3622 (ix) For the principal reporting year only, the physical form(s) of the reportable chemical 

3623 substance as it is sent off-site from each site. If the chemical substance is site-limited, you must 

3624 report the physical form(s) of the reportable chemical substance at the time it is reacted on-site to 

3625 produce a different chemical substance. For each chemical substance at each site, the submitter 

3626 must report as many physical forms as applicable from among the physical forms listed in this 

3627 unit:

3628 (A) Dry powder.

3629 (B) Pellets or large crystals.

3630 (C) Water- or solvent-wet solid.

3631 (D) Other solid.

3632 (E) Gas or vapor.

3633 (F) Liquid.
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3634 (x) For the principal reporting year only, submitters must report the percentage, rounded 

3635 off to the closest 10%, of total production volume of the reportable chemical substance, reported 

3636 in response to paragraph (b)(3)(iii) of this section, that is associated with each physical form 

3637 reported under paragraph (b)(3)(ix) of this section. 

3638 (4) Specific information related to processing and use. Persons subject to paragraph 

3639 (b)(3) of this section must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) 

3640 of this section for each reportable chemical substance at sites under their control and at sites that 

3641 receive a reportable chemical substance from the submitter directly or indirectly (including 

3642 through a broker/distributor, from a customer of the submitter, etc.). Information reported in 

3643 response to this paragraph must be reported for the principal reporting year only and only to the 

3644 extent that it is known to or reasonably ascertainable by the submitter. Information required to be 

3645 reported under this paragraph is limited to domestic (i.e., within the customs territory of the 

3646 United States) processing and use activities. If information responsive to a given data 

3647 requirement under this paragraph, including information in the form of an estimate, is not known 

3648 or reasonably ascertainable, the submitter is not required to respond to the requirement.

3649 (i) Industrial processing and use information—(A) A designation indicating the type of 

3650 industrial processing or use operation(s) at each site that receives a reportable chemical 

3651 substance from the submitter site directly or indirectly (whether the recipient site(s) are 

3652 controlled by the submitter site or not). For each chemical substance, report the letters which 

3653 correspond to the appropriate processing or use operation(s) listed in Table 6 of this paragraph. A 

3654 particular designation may need to be reported more than once, to the extent that a submitter 

3655 reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that applies to a given 

3656 designation under this paragraph.

3657 Table 6.—Codes for Reporting Type of Industrial Processing or Use Operation

Designation Operation

PC Processing as a reactant

PF Processing—incorporation into formulation, mixture or reaction 

product

PA Processing—incorporation into article

PK Processing—repackaging

U Use—non-incorporative activities

3658

3659 (B) A code indicating the sector(s) that best describe the industrial activities associated 

3660 with each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this 

3661 section. For each chemical substance, report the code that corresponds to the appropriate 

3662 sector(s) listed in Table 7 of this paragraph. A particular sector code may need to be reported 

3663 more than once, to the extent that a submitter reports more than one industrial function code 

3664 (under paragraph (b)(4)(i)(C) of this section) that applies to a given sector code under this 

3665 paragraph.

3666 Table 7.—Codes for Reporting Industrial Sectors

Code Sector Description
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IS1 Agriculture, Forestry, Fishing and Hunting

IS2 Oil and Gas Drilling, Extraction, and support activities

IS3 Mining (except Oil and Gas) and support activities

IS4 Utilities

IS5 Construction

IS6 Food, beverage, and tobacco product manufacturing

IS7 Textiles, apparel, and leather manufacturing

IS8 Wood Product Manufacturing

IS9 Paper Manufacturing

IS10 Printing and Related Support Activities

IS11 Petroleum Refineries

IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing

IS13 Petroleum Lubricating Oil and Grease Manufacturing

IS14 All other Petroleum and Coal Products Manufacturing

IS15 Petrochemical Manufacturing

IS16 Industrial Gas Manufacturing

IS17 Synthetic Dye and Pigment Manufacturing

IS18 Carbon Black Manufacturing

IS19 All Other Basic Inorganic Chemical Manufacturing

IS20 Cyclic Crude and Intermediate Manufacturing

IS21 All Other Basic Organic Chemical Manufacturing

IS22 Plastics Material and Resin Manufacturing

IS23 Synthetic Rubber Manufacturing

IS24 Organic Fiber Manufacturing

IS25 Pesticide, Fertilizer, and Other Agricultural Chemical 

Manufacturing

IS26 Pharmaceutical and Medicine Manufacturing

IS27 Paint and Coating Manufacturing

IS28 Adhesive Manufacturing

IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing

IS30 Printing Ink Manufacturing

IS31 Explosives Manufacturing

IS32 Custom Compounding of Purchased Resins

IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing

IS34 All Other Chemical Product and Preparation Manufacturing

IS35 Plastics Product Manufacturing

IS36 Rubber Product Manufacturing

IS37 Non-metallic Mineral Product Manufacturing (includes clay, glass, 

cement, concrete, lime, gypsum, and other non-metallic mineral 

product manufacturing)

IS38 Primary Metal Manufacturing

IS39 Fabricated Metal Product Manufacturing

IS40 Machinery Manufacturing

IS41 Computer and Electronic Product Manufacturing

IS42 Electrical Equipment, Appliance, and Component Manufacturing
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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)

3667

3668 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s) from 

3669 Table 8 of this paragraph must be selected to designate the industrial function category(ies) that 

3670 best represents the specific manner in which the chemical substance is used. A particular 

3671 industrial function category may need to be reported more than once, to the extent that a 

3672 submitter reports more than one industrial processing or use operation/sector combination (under 

3673 paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given industrial function 

3674 category under this paragraph. If more than 10 unique combinations of industrial processing or 

3675 use operations/sector/industrial function categories apply to a chemical substance, submitters 

3676 need only report the 10 unique combinations for the chemical substance that cumulatively 

3677 represent the largest percentage of the submitter's production volume for that chemical 

3678 substance, measured by weight. If none of the listed industrial function categories accurately 

3679 describes a use of a chemical substance, the category ―Other‖ may be used, and must include a 

3680 description of the use.

3681 Table 8.—Codes for Reporting Industrial Function Categories

Code Category

U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents

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
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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)

3682

3683 (D) The estimated percentage, rounded off to the closest 10%, of total production volume 

3684 of the reportable chemical substance associated with each combination of industrial processing 

3685 or use operation, sector, and industrial function category. Where a particular combination of 

3686 industrial processing or use operation, sector, and industrial function category accounts for less 

3687 than 5% of the submitter's site's total production volume of a reportable chemical substance, the 

3688 percentage must not be rounded off to 0% if the production volume attributable to that industrial 

3689 processing or use operation, sector, and industrial function category combination is 25,000 lb. 

3690 (11,340 kg) or more during the reporting year. Instead, in such a case, submitters must report the 

3691 percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the 

3692 reportable chemical substance associated with the particular combination of industrial processing 

3693 or use operation, sector, and industrial function category.

3694 (E) For each combination of industrial processing or use operation, sector, and industrial 

3695 function category, the submitter must estimate the number of sites at which each reportable 

3696 chemical substance is processed or used. For each combination associated with each chemical 

3697 substance, the submitter must select from among the ranges of sites listed in Table 9 of this 

3698 paragraph and report the corresponding code (i.e., S1 through S7):

3699 Table 9.—Codes for Reporting Numbers of Sites

Code Range

S1 Fewer than 10 sites

S2 at least 10 but fewer than 25 sites

S3 at least 25 but fewer than 100 sites

S4 at least 100 but fewer than 250 sites

S5 at least 250 but fewer than 1,000 sites

S6 at least 1,000 but fewer than 10,000 sites

S7 at least 10,000 sites

3700
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3701 (F) For each combination of industrial processing or use operation, sector, and industrial 

3702 function category, the submitter must estimate the number of workers reasonably likely to be 

3703 exposed to each reportable chemical substance. For each combination associated with each 

3704 chemical substance, the submitter must select from among the worker ranges listed in paragraph 

3705 (b)(3)(ii) of this section and report the corresponding code (i.e., W1 though W8).

3706 (ii) Consumer and commercial use information—(A) Using the codes listed in Table 10 

3707 of this paragraph, submitters must designate the consumer and commercial product category or 

3708 categories that best describe the consumer and commercial products in which each reportable 

3709 chemical substance is used (whether the recipient site(s) are controlled by the submitter site or 

3710 not). If more than 10 codes apply to a chemical substance, submitters need only report the 10 

3711 codes for the chemical substance that cumulatively represent the largest percentage of the 

3712 submitter's production volume for that chemical, measured by weight. If none of the listed 

3713 consumer and commercial product categories accurately describes the consumer and commercial 

3714 products in which each reportable chemical substance is used, the category ―Other‖ may be used, 

3715 and must include a description of the use.

3716 Table 10.—Codes for Reporting Consumer and Commercial Product Categories

Code Category

Chemical Substances in Furnishing, Cleaning, Treatment Care Products

C101 Floor Coverings 

C102 Foam Seating and Bedding Products 

C103 Furniture and Furnishings not covered elsewhere

C104 Fabric, Textile, and Leather Products not covered elsewhere 

C105 Cleaning and Furnishing Care Products 

C106 Laundry and Dishwashing Products

C107 Water Treatment Products 

C108 Personal Care Products 

C109 Air Care Products

C110 Apparel and Footwear Care Products

Chemical Substances in Construction, Paint, Electrical, and Metal Products

C201 Adhesives and Sealants 

C202 Paints and Coatings

C203 Building/Construction Materials - Wood and Engineered Wood Products

C204 Building/Construction Materials not covered elsewhere

C205 Electrical and Electronic Products 

C206 Metal Products not covered elsewhere

C207 Batteries

Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products

C301 Food Packaging

C302 Paper Products

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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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)

3717

3718 (B) An indication, within each consumer and commercial product category reported 

3719 under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use.

3720 (C) Submitters must determine, within each consumer and commercial product category 

3721 reported under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable 

3722 chemical substance manufactured (including imported) by the submitter is present in (for 

3723 example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a 

3724 component in the paint on a toy) any consumer products intended for use by children age 14 or 

3725 younger, regardless of the concentration of the chemical substance remaining in or on the 

3726 product. Submitters must select from the following options: The chemical substance is used in or 

3727 on any consumer products intended for use by children, the chemical substance is not used in or 

3728 on any consumer products intended for use by children, or information as to whether the 

3729 chemical substance is used in or on any consumer products intended for use by children is not 

3730 known to or reasonably ascertainable by the submitter.

3731 (D) The estimated percentage, rounded off to the closest 10%, of the submitter's site's 

3732 total production volume of the reportable chemical substance associated with each consumer and 

3733 commercial product category. Where a particular consumer and commercial product category 

3734 accounts for less than 5% of the total production volume of a reportable chemical substance, the 

3735 percentage must not be rounded off to 0% if the production volume attributable to that 

3736 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 

3737 reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the 

3738 closest 1%, of the submitter's site's total production volume of the reportable chemical substance 

3739 associated with the particular consumer and commercial product category.

3740 (E) Where the reportable chemical substance is used in consumer or commercial 

3741 products, the estimated typical maximum concentration, measured by weight, of the chemical 

3742 substance in each consumer and commercial product category reported under paragraph 

3743 (b)(4)(ii)(A) of this section. For each chemical substance in each commercial and consumer 

3744 product category reported under paragraph (b)(4)(ii)(A) of this section, submitters must select 

3745 from among the ranges of concentrations listed in Table 5 in paragraph (b)(3)(viii) of this section 

3746 and report the corresponding code (i.e., M1 through M5).
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3747 (F) Where the reportable chemical substance is used in a commercial product, the 

3748 submitter must estimate the number of commercial workers reasonably likely to be exposed to 

3749 each reportable chemical substance. For each combination associated with each substance, the 

3750 submitter must select from among the worker ranges listed in Table 4 in paragraph (b)(3)(vii) of 

3751 this section and report the corresponding code (i.e., W1 though W8).

3752 § 711.20 When to report.

3753 All information reported to EPA in response to the requirements of this part must be 

3754 submitted during an applicable submission period from June 1 to September 30 at 4–year 

3755 intervals, beginning in 2011. Any person described in § 711.8(a) must report during each 

3756 submission period for each chemical substance described in § 711.5 that the person 

3757 manufactured (including imported) during any calendar year since the last principal reporting 

3758 year (e.g., for the 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 

3759 2010, since 2005 was the last principal reporting year).

3760 § 711.22 Duplicative reporting.

3761 (a) With regard to TSCA section 8(a) rules. Any person subject to the requirements of 

3762 this part who previously has complied with reporting requirements of a rule under TSCA section 

3763 8(a) by submitting the information described in § 711.15 for a chemical substance described in §

3764 711.5 to EPA, and has done so within 1 year of the start of a submission period described in §

3765 711.20, is not required to report again on the manufacture of that chemical substance at that site 

3766 during that submission period.

3767 (b) With regard to importers. This part requires that only one report be submitted on each 

3768 import transaction involving a chemical substance described in § 711.5. When two or more 

3769 persons are involved in a particular import transaction and each person meets the Agency's 

3770 definition of ―importer‖ as set forth in 40 CFR 704.3, they may determine among themselves 

3771 who should submit the required report; if no report is submitted as required under this part, EPA 

3772 will hold each such person liable for failure to report.

3773 (c) Toll manufacturers and persons contracting with a toll manufacturer. This part 

3774 requires that only one report per site be submitted on each chemical substance described in §

3775 711.5. When a company contracts with a toll manufacturer to manufacture a chemical substance, 

3776 and each party meets the Agency's definition of ―manufacturer‖ as set forth in § 711.3, they may 

3777 determine among themselves who should submit the required report for that site. However, both 

3778 the contracting company and the toll manufacturer are liable if no report is made.

3779 § 711.25 Recordkeeping requirements.

3780 Each person who is subject to the reporting requirements of this part must retain records 

3781 that document any information reported to EPA. Records relevant to reporting during a 

3782 submission period must be retained for a period of 5 years beginning on the last day of the 

3783 submission period. Submitters are encouraged to retain their records longer than 5 years to 

3784 ensure that past records are available as a reference when new submissions are being generated.

3785 § 711.30 Confidentiality claims.
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3786 (a) Confidentiality claims. Any person submitting information under this part may assert 

3787 a business confidentiality claim for the information at the time it is submitted. Any such 

3788 confidentiality claims must be made at the time the information is submitted. Confidentiality 

3789 claims cannot be made when a response is left blank or designated as not known or reasonably 

3790 ascertainable. These claims will apply only to the information submitted with the claim. New 

3791 confidentiality claims, if appropriate, must be asserted with regard to information submitted 

3792 during a different submission period. Guidance for asserting confidentiality claims is provided in 

3793 the instructions identified in § 711.35. Information claimed as confidential in accordance with 

3794 this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2.

3795 (b) Chemical identity. A person may assert a claim of confidentiality for the chemical 

3796 identity of a specific chemical substance only if the identity of that chemical substance is treated 

3797 as confidential in the Master Inventory File as of the time the report is submitted for that 

3798 chemical substance under this part. The following steps must be taken to assert a claim of 

3799 confidentiality for the identity of a reportable chemical substance:

3800 (1) The submitter must submit with the report detailed written answers to the following 

3801 questions signed and dated by an authorized official.

3802 (i) What harmful effects to your competitive position, if any, or to your supplier‘s 

3803 competitive position, do you think would result from the identity of the chemical substance being 

3804 disclosed in connection with reporting under this part? How could a competitor use such 

3805 information? Would the effects of disclosure be substantial? What is the causal relationship 

3806 between the disclosure and the harmful effects?

3807 (ii) How long should confidential treatment be given? Until a specific date, the 

3808 occurrence of a specific event, or permanently? Why?

3809 (iii) Has the chemical substance been patented? If so, have you granted licenses to others 

3810 with respect to the patent as it applies to the chemical substance? If the chemical substance has 

3811 been patented and therefore disclosed through the patent, why should it be treated as 

3812 confidential?

3813 (iv) Has the identity of the chemical substance been kept confidential to the extent that 

3814 your competitors do not know it is being manufactured or imported for a commercial purpose by 

3815 anyone?

3816 (v) Is the fact that the chemical substance is being manufactured (including imported) for 

3817 a commercial purpose available to the public, for example in technical journals, libraries, or 

3818 State, local, or Federal agency public files?

3819 (vi) What measures have been taken to prevent undesired disclosure of the fact that the 

3820 chemical substance is being manufactured (including imported) for a commercial purpose?

3821 (vii) To what extent has the fact that this chemical substance is manufactured (including 

3822 imported) for commercial purposes been revealed to others? What precautions have been taken 

3823 regarding these disclosures? Have there been public disclosures or disclosures to competitors?
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3824 (viii) Does this particular chemical substance leave the site of manufacture (including 

3825 import) in any form, e.g., as product, effluent, emission? If so, what measures have been taken to 

3826 guard against the discovery of its identity?

3827 (ix) If the chemical substance leaves the site in a product that is available to the public or 

3828 your competitors, can the chemical substance be identified by analysis of the product?

3829 (x) For what purpose do you manufacture (including import) the substance?

3830 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent 

3831 confidentiality determinations regarding this chemical substance? If so, please attach copies of 

3832 such determinations.

3833 (2) If any of the information contained in the answers to the questions listed in paragraph 

3834 (b)(1) of this section is asserted to contain confidential business information (CBI), the submitter 

3835 must clearly identify the information that is claimed confidential by marking the specific 

3836 information on each page with a label such as ―confidential business information,‖ ―proprietary,‖ 

3837 or ―trade secret.‖

3838 (c) Site identity. A submitter may assert a claim of confidentiality for a site only if the 

3839 linkage of the site with a reportable chemical substance is confidential and not publicly available. 

3840 The following steps must be taken to assert a claim of confidentiality for a site identity:

3841 (1) The submitter must submit with the report detailed written answers to the following 

3842 questions signed and dated by an authorized official:

3843 (i) Has site information been linked with a chemical identity in any other Federal, State, 

3844 or local reporting scheme? For example, is the chemical identity linked to a facility in a filing 

3845 under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, 

3846 namely through a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the 

3847 linkage claimed as confidential in any of these instances?

3848 (ii) What harmful effect, if any, to your competitive position do you think would result 

3849 from the identity of the site and the chemical substance being disclosed in connection with 

3850 reporting under this part? How could a competitor use such information? Would the effects of 

3851 disclosure be substantial? What is the causal relationship between the disclosure and the harmful 

3852 effects?

3853 (2) If any of the information contained in the answers to the questions listed in paragraph 

3854 (c)(1) of this section is asserted to contain CBI, the submitter must clearly identify the 

3855 information that is claimed confidential by marking the specific information on each page with a 

3856 label such as ―confidential business information,‖ ―proprietary,‖ or ―trade secret.‖

3857 (d) Processing and use information. A submitter may assert a claim of confidentiality for 

3858 each data element required by § 711.15(b)(4) only if the linkage of the information with a 

3859 reportable chemical substance is confidential and not publicly available. The following steps 

3860 must be taken to assert a claim of confidentiality for each data element, individually, required by 

3861 § 711.15(b)(4):
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3862 (1) The submitter must submit with the report detailed written answers to the following 

3863 questions signed and dated by an authorized official:

3864 (i) Is the identified use of this chemical substance publicly known? For example, is 

3865 information on the use available in advertisements or other marketing materials, professional 

3866 journals or other similar materials, or in non-confidential mandatory or voluntary government 

3867 filings or publications? Has your company ever provided use information on the chemical 

3868 substance that was not claimed as confidential?

3869 (ii) What harmful effect, if any, to your competitive position or to your customer‘s 

3870 competitive position do you think would result from the information reported as required by §

3871 711.15(b)(4) and the chemical substance being disclosed in connection with reporting under this 

3872 part? How could a competitor use such information? Would the effects of disclosure be 

3873 substantial? What is the causal relationship between the disclosure and the substantial harmful 

3874 effects?

3875 (2) If any of the information contained in the answers to the questions listed in paragraph 

3876 (d)(1) of this section is asserted to contain CBI, the submitter must clearly identify the 

3877 information that is claimed confidential by marking the specific information on each page with a 

3878 label such as ―confidential business information,‖ ―proprietary,‖ or ―trade secret.‖

3879 (e) No claim of confidentiality. If no claim of confidentiality is indicated on Form U 

3880 submitted to EPA under this part; if Form U lacks the certification required by § 

3881 711.15(b)(1); if confidentiality claim substantiation required under paragraphs (b), (c), and (d) of 

3882 this section is not submitted with Form U; or if the identity of a chemical substance listed on the 

3883 non-confidential portion of the Master Inventory File is claimed as confidential, EPA may make 

3884 the information available to the public without further notice to the submitter.

3885 § 711.35 Electronic filing.

3886 (a) You must use e-IURweb to complete and submit Form U; EPA Form 7740–8. 

3887 Submissions may only be made as set forth in this section.

3888 (b) Submissions must be sent electronically to EPA via CDX.

3889 (c) Access e-IURweb and instructions, as follows:

3890 (1) By website. Go to the EPA Inventory Update Reporting Internet homepage at 

3891 http://www.epa.gov/iur and follow the appropriate links.

3892 (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554–1404 or TSCA3893 Hotline@epa.gov for a CD-ROM containing the instructions.