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1 of 84 MARKUP-EO12866_IUR ModificationNPRM _2010-01-28_revised_2010-07-14.doc 1

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ENVIRONMENTAL PROTECTION AGENCY 3

4 Environmental Protection Agency 5

6 40 CFR Parts 704, 710 and 711 7

8 [EPA–HQ–OPPT–2009–0187; FRL– XXXX

– X ] 9

10

RIN 2070–AJ43 11

12 TSCA Inventory Update Reporting Modifications 13

14

AGENCY: Environmental Protection Agency (EPA). 15

ACTION: Proposed Rule. 16

SUMMARY: EPA proposes to amend the Toxic Substances Control Act (TSCA) Inventory 17 Update Reporting (IUR) rule, thereby providing improved information for EPA to better identify 18 and, where appropriate, take steps to manage risks associated with chemical substances. 19 Additionally, improved information would be available for the public. The IUR rule, 20 promulgated under section 8(a) of TSCA, requires manufacturers (including importers) of certain 21 chemical substances on the TSCA Inventory of Chemical Substances to report information about 22 the manufacturing (including import), processing, and use of those chemical substances. EPA is 23 proposing to require electronic reporting of IUR information and to modify IUR reporting 24 requirements, including certain circumstances that trigger reporting, the specific data to be 25 reported, the reporting standard for processing and use information, and Confidential Business 26 Information (CBI) reporting procedures. These modifications would provide information to 27 better address Agency and public information needs, improve the usability and reliability of the 28 reported data, and ensure that data are available in a timely manner. 29

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DATES: Comments must be received on or before [ insert date [ 60 ] days after date of 31 publication in the Federal Register ]. 32

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA– 33 HQ–OPPT–2009-0187, by one of the following methods: 34

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions 35 for submitting comments. 36

• Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics 37 (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 38

20460–0001. 39

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 40 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT– 41 2009-0187. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 42 holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only 43*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

2 of 84 accepted during the DCO’s normal hours of operation, and special arrangements should be made 44

for deliveries of boxed information. 45

Instructions : Direct your comments to docket ID number EPA–HQ–OPPT–2009-0187. 46 EPA's policy is that all comments received will be included in the docket without change and 47 may be made available on-line at http://www.regulations.gov , including any personal 48 information provided, unless the comment includes information claimed to be Confidential 49 Business Information (CBI) or other information whose disclosure is restricted by statute. Do not 50 submit information that you consider to be CBI or otherwise protected through regulations.gov 51 or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA 52 will not know your identity or contact information unless you provide it in the body of your 53 comment. If you send an e-mail comment directly to EPA without going through 54 regulations.gov, your e-mail address will be automatically captured and included as part of the 55 comment that is placed in the docket and made available on the Internet. If you submit an 56 electronic comment, EPA recommends that you include your name and other contact information 57 in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read 58 your comment due to technical difficulties and cannot contact you for clarification, EPA may not 59 be able to consider your comment. Electronic files should avoid the use of special characters, 60 any form of encryption, and be free of any defects or viruses. For additional information about 61 EPA’s public docket, visit the EPA Docket Center homepage at 62 http://www.epa.gov/epahome/dockets.htm

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Docket : All documents in the docket are listed in the docket index available at 64 http://www.regulations.gov . Although listed in the index, some information is not publicly 65 available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other 66 material, such as copyrighted material, will be publicly available only in hard copy. Publicly 67 available docket materials are available electronically at http://www.regulations.gov , or, if only 68 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 69 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 70 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 71 through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public 72 Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566– 73 0280. Docket visitors are required to show photographic identification, pass through a metal 74 detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine 75 and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all 76 times in the building and returned upon departure. 77

FOR FURTHER INFORMATION CONTACT: For general information contact : Colby 78 Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of 79 Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 80 NW., Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: TSCA81 Hotline@epa.gov

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For technical information contact : Susan Sharkey, Chemical Control Division (7405M), 83 Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 84 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 202-564-8789; e85

mail address: sharkey.susan@epa.gov

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SUPPLEMENTARY INFORMATION: 87*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

3 of 84 88

I. General Information 89

A. Does this Action Apply to Me? 90

You may be potentially affected by this action if you manufacture (including manufacture 91 as a byproduct) or import chemical substances and mixtures listed on the TSCA Inventory. 92 Potentially affected entities may include, but are not limited to: 93

 Chemical manufacturers and importers (NAICS code 325 and 324110; e.g., chemical 94 manufacturing and processing and petroleum refineries) 95

 Chemical users and processors who may manufacture a byproduct chemical substance 96 (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal 97 manufacturing, and semiconductor and other electronic component manufacturing) 98

This listing is not intended to be exhaustive, but rather provides a guide for readers 99 regarding entities likely to be affected by this action. Other types of entities not listed in this unit 100 could also be affected. The North American Industrial Classification System (NAICS) codes 101 have been provided to assist you and others in determining whether this action might apply to 102 certain entities. If you have any questions regarding the applicability of this action to a particular 103 entity, consult the technical person listed under FOR FURTHER INFORMATION 104

CONTACT

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

1. Submitting CBI . Do not submit confidential business information (CBI) to EPA 107 through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 108 to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of 109 the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the 110 specific information that is claimed as CBI. In addition to one complete version of the comment 111 that includes information claimed as CBI, a copy of the comment that does not contain the 112 information claimed as CBI must be submitted for inclusion in the public docket. Information so 113 marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 114

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

i. Identify the document by docket ID number and other identifying information (subject 116 heading, Federal Register date and page number). 117

ii. Follow directions. The Agency may ask you to respond to specific questions or 118 organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 119

iii. Explain why you agree or disagree; suggest alternatives and substitute language for 120 your requested changes. 121

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

used. 123

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in 124*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

4 of 84 sufficient detail to allow for it to be reproduced. 125

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

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

threats. 128

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

II. Background 130

A. What Action is the Agency Taking? 131

In this action, EPA is proposing several amendments to the current IUR rule 132 requirements, including moving the IUR rule text from 40 CFR part 710, subpart C to a new part 133 in 40 CFR part 711. Where applicable, the current regulatory text reference is followed by a 134 parenthetical containing the proposed new reference. These amendments are described in more 135

detail in Unit III. 136

137 First, EPA is proposing to amend 40 CFR 710.59 (proposed 40 CFR 711.19) to require 138 electronic reporting of the IUR data, using an Agency-provided , web-based e

- IUR reporting 139

software (e-IURweb) to submit IUR reports through the Internet to EPA’s Central Data 140 Exchange (CDX). After the final rule’s effective date, paper submissions would no longer be 141 accepted. 142

143 Second, EPA is proposing to enhance the reported manufacturing

, data and the 144 processing

, and use data reported

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

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

additions. 149

150 Fourth, EPA is proposing to amend 40 CFR 710.53 (proposed 40 CFR 711.13) to change 151 the reporting frequency from every five years to every four years. 152

153 Fifth, EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 711.8(a)) to 154 modify the method used to determine whether a manufacture or importer is subject to IUR 155 reporting. Reporting would be required if the production volume of a chemical substance met or 156 exceeded the 25,000 lb. threshold in any calendar year since the last principal reporting year 157 (e.g., 2005). 158

159 Sixth, EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 711.12(c)) to 160 eliminate the 300,000 lb. threshold for processing and use information, thereby requiring all 161 reporters of non-excluded substances to report information in all parts of the IUR Form U. 162

163 Seventh, EPA is proposing to amend 40 CFR 710.48(a) (proposed 40 CFR 711.8(a)) to 164 eliminate the 25,000 lb. threshold for certain chemical substances that are the subject of 165 particular TSCA rules and/or orders and to require manufacturers (including importers) of such 166 chemicals to report under the IUR rule, regardless of the production volume. 167*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

5 of 84 168 Eighth, EPA is proposing to amend 40 CFR 710.46 (proposed 40 CFR 711.6) to make 169

chemical substances for which an enforceable consent agreement (ECA) to conduct testing has 170 been made under 40 CFR part 790 ineligible for exemptions, to provide a full exemption from 171 IUR requirements for water, and to remove polymers that are already fully exempt from the 172 partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv) (proposed 40 CFR 711.6(b)(2)(iv)). 173

174 Ninth, EPA is proposing to amend 40 CFR 710.52(c) (proposed 40 CFR 711.12(c)) to 175 modify the reporting requirements of certain manufacturing data elements. Specifically, 176 manufacturers (including importers) would be required to report: 177

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

2. The current Chemical Abstracts (CA) Index Name, as used to list the substance in the 179 Inventory, as part of the chemical identity. 180

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

4. The production volume of a manufactured (including imported) chemical substance 182 used at the reporting site. 183

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

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

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

187 Tenth, EPA is proposing to replace the “readily obtainable” reporting standard used for 188 the reporting of processing and use information required by 40 CFR 710.52(c)(4) (proposed 40 189 CFR 711.12(c)(4)) with the “known to or reasonably ascertainable by” reporting standard. 190

191 Eleventh, EPA is proposing to amend 40 CFR 710.58 (proposed 40 CFR 711.18) to 192 require upfront substantiation when processing and use information required by 40 CFR 193 710.52(c)(4) (proposed 40 CFR 711.12(c)(4)) is claimed as confidential business information 194 (CBI). 195

196 Twelfth, EPA is proposing to disallow confidentiality claims for processing and use data 197 elements identified as not “known to or reasonably ascertainable by” (40 CFR 710.52(c)(4) 198 (proposed 40 CFR 711.12(c)(4))). 199

200 Thirteenth, EPA is proposing to revise the list of industrial function categories for the 201 reporting of processing and use information. EPA is also proposing to amend 40 CFR 202 710.52(c)(4)(i)(C) (proposed 40 CFR 711.12(c)(4)(i)(C)) to replace the five-digit North 203 American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS). 204

205 Fourteenth, EPA is proposing to amend 40 CFR 710.52(c)(4)(ii) (proposed 40 CFR 711. 206 12(c)(4)(ii)) to revise the list of consumer and commercial product categories for the reporting of 207 consumer and commercial use information. EPA is also proposing to require the separate 208 reporting for consumer or commercial categories and reporting of the number of commercial 209 workers reasonably likely to be exposed to the subject chemical. 210

211 Fifteenth, EPA is proposing to eliminate the gaps in the ranges used to report 212 concentration in 40 CFR 710.52(c)(3) and (4) (proposed 40 CFR 711.12(c)(3) and (4)). 213

214 B. What is the Agency's Authority for Taking this Action? 215*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

6 of 84 EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep 216 current an inventory of chemical substances manufactured or processed in the United States. This 217 inventory is known as the TSCA Chemical Substance Inventory (the TSCA Inventory). In 1977, 218 EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 219 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA 220 promulgated the initial IUR rule under TSCA section 8(a) at 40 CFR part 710 (51 FR 21438, 221 June 12, 1986) to facilitate the periodic updating of information on chemicals listed on the TSCA 222 Inventory and to support activities associated with the implementation of TSCA. In 2003, EPA 223 promulgated extensive amendments to the IUR rule (68 FR 848, January 7, 2003) (2003 224 Amendments) to collect exposure-related information associated with the manufacturing, 225 processing, and use of eligible chemical substances and to make certain other changes. 226

227 TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate rules under 228 which manufacturers and processors of chemical substances and mixtures (collectively referred 229 to hereinafter as chemical substances) must maintain such records and submit such information 230 as the Administrator may reasonably require. TSCA section 8(a) generally excludes small 231 manufacturers and processors of chemical substances from the reporting requirements 232 established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to 233 require TSCA section 8(a) reporting from small manufacturers and processors with respect to 234 any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 235 4, 5(b)(4), or 6, or that is the subject of an order in effect under TSCA section 5(e), or that is the 236 subject of relief granted pursuant to a civil action under TSCA section 5 or 7. The standard for 237 determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 238 (proposed 40 CFR part 711) is found at 40 CFR 704.3. Processors are not currently subject to 239 the rules at 40 CFR part 710 (proposed 40 CFR part 711). 240

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

243 The IUR rule, as modified by the 2003 Amendments, requires U.S. manufacturers 244 (including importers) of chemicals listed on the TSCA Inventory to report to EPA every five 245 years the identity of chemical substances manufactured (including imported) during the reporting 246 year in quantities of 25,000 lb. or greater at any single site they own or control (see 40 CFR part 247 710, subpart C). IUR data were collected five times prior to the 2003 Amendments: in 1986, 248 1990, 1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. EPA uses the 249 TSCA Inventory and data reported under the IUR rule to support many TSCA-related activities 250 and to provide overall support for a number of EPA and other federal health, safety, and 251 environmental protection activities. The Agency also makes the data available to the public, to 252 the extent possible given confidential business information claims. 253

254 Persons manufacturing or importing chemical substances are required to report 255 information such as company name, site location and other identifying information, production 256 volume of the reportable chemical substance, a nd exposure-related information associated with 257 the manufacture of each reportable chemical substance. This exposure-related information 258 includes the physical form and maximum concentration of the chemical substance and the 259 number of potentially exposed workers (40 CFR 710.52). Several groups of chemical substances 260 are generally excluded from IUR reporting requirements: e.g., polymers, microorganisms, 261 naturally occurring chemical substances, and certain natural gas substances (40 CFR 710.46). 262

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7 of 84 Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lb. or 264 greater manufactured (including imported) during the reporting year at any single site) are 265 required also to report certain processing and use information (40 CFR 710.52(c)(4)). This 266 information includes process or use category; NA ICS code; industrial function category; percent 267 production volume associated with each process or use category; number of use sites; number of 268 potentially exposed workers; and consumer/commercial information such as use category, use in 269 or on products intended for use by children, and maximum concentration. 270

271 The 2006 submission was the first instance where manufacturers (including importers) 272 of inorganic chemical substances were required to report under the IUR rule. For the 2006 273 submission only, inorganic chemical substances were partially exempted from the IUR rule, and 274 manufacturers of such chemicals were required to report the manufacturing information and not 275 the processing and use information, regardless of production volume. A partial exemption means 276 that a submitter is exempt from the processing and use reporting requirements described in 40 277 CFR 710.52(c)(4). Under the current rule, for future collections (i.e., for 2011 or 2016 IUR 278 collections, etc.), the partial exemption for inorganic chemicals will no longer be applicable and 279 submitters will report in the same manner as is required for organic chemicals, including 280 processing and use information (40 CFR 710.46(b)(3)). In addition, starting with the 2006 281 collection and for future collections, specificall y listed petroleum process streams and other 282 specifically listed chemical substances are partially exempt, and manufacturers of such 283 substances are not required to report processing and use information. These partial exemptions 284 will continue in subsequent submission periods (including 2011), for as long as the chemical 285 substances remain on these partial exemption lists (40 CFR 710.46(b)(1) and (b)(2) (proposed 40 286 CFR 711.6(b)(1) and (b)(2))). 287

288 Non-confidential data, including both searchable and separately downloadable 289 databases, and a 2006 IUR data summary report are available for public use on the IUR website 290 (http://www.epa.gov/iur). 291

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

294 EPA is proposing to modify the IUR rule to meet four primary goals: (1) to tailor the 295 information collected to better meet the Agency’s overall information needs; (2) to increase its 296 ability to effectively provide public access to the information; (3) to obtain new and updated 297 information relating to potential exposures to a subs et of chemical substances listed on the TSCA 298 Inventory; and (4) to improve the usefulness of the information reported. EPA believes that 299 expanding the range of chemicals for which comprehensive information is to be reported and 300 adjusting the specific reported information, the method and frequency of collecting the 301 information, and CBI requirements will accomplish these goals. 302

303 These goals are supported by a policy outlined in section 2 of TSCA, which is that 304 “adequate data should be developed with respect to the effect of chemical substances and 305 mixtures on health and the environment and that the development of such data should be the 306 responsibility of those who manufacture and those who process such chemical substances and 307 mixtures” (TSCA section 2(b)(1)). Modifications to the IUR requirements by the 2003 308 Amendments (68 FR 848, January 7, 2003) provided many improvements to the data collected 309 through this rule, and EPA’s efforts to use the 2006 IUR data have identified areas where further 310 improvements are needed. The modifications described in this proposed rule would change 311*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

8 of 84 some of the reporting requirements in an effort by EPA to (1) ensure the required information is 312 properly reported and that the information in the Agency’s database reflects the information 313 provided in the IUR reports, (2) increase the usability of the collected information, (3) increase 314 the availability of information for the public, and (4) focus reporting on information that is most 315 needed by the Agency. In addition, these proposed changes will enable EPA and other Federal 316 agencies to improve their risk screening capabi lities, enabling them to better assess and manage 317 risk, and improving public awareness of basic information about a large number of chemical 318

substances. 319

320 EPA provided reporting software for the 2006 IUR submission period and encouraged 321 electronic reporting through the Internet, using the Agency’s Central Data Exchange (CDX). 322 EPA’s experience with populating the IUR database and with using the 2006 IUR data provided 323 insight into how well both the reporting software and submission methods worked. For instance, 324 because of validations built into the reporting software, electronic submissions were able to be 325 quickly assimilated into the IUR database. Other forms of submission required the documents to 326 be scanned in or hand entered, and resulted in many introduced errors during the data entry 327 process. Additionally, for 2006 IUR, certain types of submissions (e.g., joint submissions) could 328 not be reported electronically. Other problems, such as incorrect chemical identities, delayed the 329 incorporation of the data into th e database, resulting in the Agency’s inability to begin using the 330 2006 IUR data and providing public access. The proposed modifications associated with 331 reporting methods and changes to the reporting software will better ensure the information 332 reported to the Agency is accurate and in compliance with the IUR requirements. 333

334 During the development of the 2003 Amendments, the Agency considered the data 335 accuracy and reliability needed for screening level exposure analyses and took several steps to 336 ensure the IUR data met those needs. Screening level data need not be precise, but should be 337 accurate and reliable enough for the Agency to develop screening level assessments. The 338 amended IUR rule supplies exposure-related information the Agency did not previously possess, 339 recognizing that industry has a greater knowledge than EPA about its own operations and the 340

uses of chemicals it manufactures and sells. 341

EPA’s extensive use of the 2006 IUR data in the Agency’s Existing Chemicals Program 342 is representative of how EPA envisioned the data would be used when the 2003 Amendments 343 were promulgated. In 2007, the Agency began to develop and post screening-level hazard, 344 exposure, and risk characterizations for high production volume (HPV) chemicals, which are 345 those chemicals produced nationally at aggregated volumes of one million lb. or more per year. 346 In developing these characterizations, EPA identified areas where the IUR data collection can be 347 improved and enhanced. Improvements would allow EPA to better identify and take follow-up 348 action on chemicals that may pose potential risks to human health or the environment. 349

During its review of the IUR data, EPA identified numerous examples of CBI claims on 350 the IUR form where the same or similar information to that claimed as CBI was already available 351 to the public. In several cases, information on production volume and uses for a chemical or 352 group of chemicals was claimed CBI on the IUR form, while the same or similar information 353 was submitted voluntarily by the company without such a claim under the HPV Challenge 354 Program. In those cases, EPA had previously made the information publicly available through 355 the High Production Volume Information System (HPVIS) or on EPA’s Existing Chemicals 356*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

9 of 84 website. Correct designation of reported information as non-confidential will facilitate reporting 357 of this information to the public. 358

359 EPA Administrator Lisa P. Jackson has made it a priority to strengthen the Agency’s 360 chemicals management program, including the development of new Regulatory Risk 361 Management Actions, the development of Chemical Action Plans targeting the Agency’s risk 362 management efforts, requiring the reporting of information needed to understand chemical risks, 363 and increasing public access to information about chemicals (see 364 http://www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html). The IUR provides 365 exposure-related data needed to understand chemical risks. The se proposed modifications to the 366 IUR rule would enhance the capa bilities of the Agency to ensure risk management actions are 367

taken on chemicals posing which may pose the greatest concern. More in-depth reporting of the 368 processing and use data, more careful consideration of the need for confidentiality claims, and 369 adjustments to the specific data elements are important aspects of this action. By enhancing the 370 data supplied to the Agency, EPA expects to more effectively and expeditiously identify and 371 address potential risks posed by chemicals and provide improved access and information to the 372 public. 373

374 An important and anticipated result of this action is that EPA would receive more 375 publicly available, non-CBI information, therefore increasing the transparency and public 376 accessibility of the chemical use and exposure information and ensuring consistency with the 377 President’s policy goals for government reliance on and public availability of scientific 378

information. 379

380 III. Modifications Affecting All Manufacturers (Including Importers) 381

382 As discussed in detail in Unit III.C. of this preamble, under this proposal, sites that 383 manufactured (including imported) a reportable chemical substance in quantities of 25,000 lb. or 384 more in any calendar year since the last IUR principal reporting year (e.g., 2005) would be 385 required to complete all manufacturing (including production volume), processing, and use 386 information for the principal reporting year (e.g., 2010), plus production volume information for 387 all the preceding years since the last IUR principal reporting year (e.g., 2006 through 2009, for 388 the principal reporting year 2010). Draft detailed instructions for completing the IUR 389 submission are available in the docket established for this rulemaking. (Ref. 2) 390

391 Persons making an IUR submission would be required to use e-IUR web , the Agency392 provided web-based software designed to complete Form U (the IUR reporting form) and submit 393 the information electronically over the Internet, through EPA’s Central Data Exchange (CDX). 394

The 2011 e-IUR web will be similar in format to the 2006 e-IUR downloadable software , and will 395 include changes associated with the proposed amendments that are finalized and improved 396 validation checks. A more detailed description of e-IUR web and the electronic submission 397 process is provided in Unit III.B. 398

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

action. 401

402

A. Technical Modifications to the Regulatory Text 403

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10 of 84 Currently, 40 CFR part 710 contains three subparts. Subpart A contains regulatory text 405 associated with the original compilation of the TSCA Inventory; Subpart B contains regulatory 406 text associated with the IUR rule covering the update reporting in 2002; and Subpart C contains 407 the regulatory text associated with the IUR rule for 2006 and beyond. The chemicals that are 408 covered by the IUR rule are on the Master Inventory File, which includes chemicals from the 409 original Inventory compilation and those added subsequently through the notice requirements of 410 section 5 of TSCA. Because the IUR rule applies to a list of chemicals included in the original 411 Inventory plus additional chemicals added subsequently, and because the Agency from time to 412 time has modified the IUR rule, the Agency believes the regulatory text associated with the IUR 413 rule should be in its own section in the Code of Federal Regulations (CFR), distinct from both 414 the original TSCA Inventory rules and from the TSCA section 5 requirements. Where EPA is 415 proposing to update the location of existing regulatory provisions, or to otherwise update 416 regulatory provisions in a non-substantive fashion (e.g., to update cross-references to reflect the 417 movement of referenced provisions) EPA does not thereby reopen the substance of such 418 provisions for public comment, except where public comment is expressly requested. 419

420

1. Moving the IUR regulatory text from Part 710 subpart C to Part 711 and 421 eliminating subpart divisions. 422

423 Subpart C of 40 CFR part 710, §§ 710.43 to 710.59, contains the IUR regulatory text. EPA 424 is proposing to move all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part 711 425 and would add a new Scope and Compliance section (40 CFR 711.1). Specific sections would 426 be moved as follows: § 710.43 would become § 711.3; § 710.45 would become § 711.5; § 427 710.46 would become § 711.6; § 710.48 would become § 711.8; § 710.49 would become § 428 711.9; § 710.50 would become § 711.10; § 710.52 would become § 711.12; § 710.53 would 429 become § 711.13; § 710.55 would become § 711.15; § 710.57 would become § 711.17; § 710.58 430 would become § 711.18; and § 710.59 would become § 711.19. Because all of the text of 431 Subpart C would be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a 432 Subpart C. Neither part 710 or part 711 would have any subparts. 433

434

2. Consolidation of definitions. 435

436 As part of moving the regulatory text from 40 CFR part 710, subpart C to 40 CFR part 711, 437 EPA is proposing to consolidate definitions copied from 40 CFR 710.3 and those currently found 438 at 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropriate definition is already 439 in place in section 3 of TSCA or at 40 CFR 704.3, and an additional definition of the term in 40 440 CFR 711.3 would therefore be unnecessarily duplicative. The definitions in section 3 of TSCA 441 and at 40 CFR 704.3 would be incorporated by reference into 40 CFR 711.3, except insofar as 40 442 CFR 711.3 provides a modified definition of a term also defined at 40 CFR 704.3. 443

444

The term mixture is defined in both 40 CFR 710.3 and section 3 of TSCA. For purposes of 445 the IUR rule, EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. 446 The TSCA mixture definition differs from the definition in 40 CFR 710.3 and 40 CFR 720.3, the 447 regulations used to determine the chemicals listed on the Inventory, in that it does not 448 specifically address hydrates. While hydrates are not addressed specifically in the definition, a 449 hydrate is a mixture of water and an anhydrous chemical substance. As with mixtures in 450 general, the individual components of the mixture may be separately reportable at the time of 451 their manufacture or import. EPA believes, for purposes of the IUR rule, it is not necessary to 452 Comment [s1]: Added as per outcome of elevation*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

11 of 84 include hydrates separately in the definition of mixture. The Agency would continue to include 453 such a discussion in the Instructions. (Ref. 2) 454

455 Unit III.C. contains further discussions about changes to specific definitions, in relation to the 456 modifications included in this proposal. A summary of all IUR-related definitions is available in 457 the docket. (Ref. 3) 458

459

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

461 EPA added a definition to 40 CFR 710.43 for the term “non-isolated intermediate” as part of 462 the 2003 Amendments (68 FR 848, January 7, 2003). Subsequently, as part of the IUR 463 Revisions Rule (70 FR 75059, December 19, 2005), EPA erroneously moved the definition to 40 464 CFR 710.3 from 40 CFR 710.43. EPA is proposing to delete the definition from 40 CFR 710.3 465 as this definition was not associated with the original Inventory, and therefore does not belong in 466 40 CFR 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, would be 467 incorporated by reference into the IUR definitions at proposed 40 CFR 711.3. 468

469

4. Deleting Subpart B text. 470

471 EPA is proposing to delete the regulatory text contained in 40 CFR part 710, §§ 710.23 to 472 710.39 (subpart B). This text refers to IUR submission periods of 2002 and earlier and is 473 obsolete. As noted in § 710.1, the Agency expressed its intent to remove subpart B once the 474 2002 update was complete. 475

476

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

478 EPA is proposing to delete the phrase “provided that the reported figures are within ±10% of 479 the actual volume” from the production volume reporting requirements currently found in 40 480 CFR 710.52(c)(3)(iv) (proposed 40 CFR711.12(b)(3)(iv)). The revised wording would be “This 481 amount must be reported to two significant figures of accuracy.” The deleted phrase is 482 superfluous because any number reported accurately to two significant figures is within ten 483 percent of the correct value. 484

485

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

487 EPA is proposing to replace the phrase “less th an” with the phrase “fewer than” in the ranges 488 used to report the number of workers currently found in the table in 40 CFR 710.52(c)(3)(v) 489 (proposed 40 CFR 711.12(c)(3)(vii)) and the number of sites currently found in the table in 40 490 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 711.12(). This proposed change would make the 491 phrases describing the ranges grammatically correct. 492

493

B. Method of submission

. 494

495 The upcoming IUR submission period, during which submitters will be required to report the 496 IUR information to EPA, will be June 1 to September 30, 2011. The Agency will make e497

IUR web and associated guidance materials available to submitters prior to the start of the 498 submission period. Draft instructions are included in the docket for this proposed rule. 499

500*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

12 of 84 EPA is proposing to require the mandatory use of Agency-provided , web-based reporting 501 software (e-IUR web ) to complete the IUR Form U and the Central Data Exchange (CDX) to 502 submit the completed Form U to the Agency. Users of CDX are required to register and to 503 submit an authorized signature agreement. 504

505 EPA accepted 2006 IUR submissions in several ways. Submissions could be completed and 506 delivered electronically via the Internet and CDX, or submissions could be completed on paper 507 or electronic media (i.e., as a file on a CD) and delivered by mail or a delivery service. 508 Approximately one-third of the submissions were made electronically, and EPA was able to 509 immediately process and quickly begin to use the information from those electronic submissions. 510 Submissions sent as a file on a CD were printed and, along with paper submissions, scanned into 511 an electronic system. 512

513 Due mostly to the time and resources needed to review and correct submitter- and 514 scanning-related errors associated with non-electronic submissions, EPA required over two years 515 to validate and process the data from the 2006 IUR. The Agency had to take extra steps in order 516 to correct the data during that period, such as accessing the original submission instead of the 517 information in the IUR database. In addition, EPA released the public database in December 518 2008 without information on approximately five percent of the reported chemicals due to the 519 high error rate experienced with the 2006 IUR data collection and receipt. A large number of 520 errors were created through the scanning process and required correction by hand, which was 521 very labor intensive. The introduced errors included incorrectly scanned chemical identities and 522 indications of whether a data element was claimed CBI. An incorrectly recorded CBI claim 523

could lead to the inadvertent disclosure of confidential information or to the non-release of non524

confidential information. 525

526 EPA also detected significant errors not related to scanning on a substantial number of 527 reporting forms and faced difficulties resolving issues pertaining to submissions with incorrect 528 chemical identification information. Some of the errors included submitters not specifically 529 identifying a chemical substance, providing chemical names and CAS Registry Numbers that did 530 not match, or providing a CAS Registry Number that did not exist. Often, the submitted data did 531 not conform to the reporting requirements described and explained in the IUR rule and 2006 532 guidance documents. 533

534 The 2006 IUR reporting software provided by the Agency contained a validation program 535 designed to identify certain errors prior to submission. Sometimes a submitter used the software 536 to prepare a submission, but printed the reporting form prior to completing the validation check 537 because it was not able to pass the validation. Such reports typically contained incomplete or 538 incorrect information, and EPA needed to contact the submitter or take other steps to correct the 539 data prior to entering it into the database. 540

541 EPA believes the proposed requirement to use e-IUR web to report electronically would 542 eliminate problems related to the scanning of paper documents, incorrect chemical identities, and 543 other errors introduced by the submitter. These errors substantially delayed the availability of 544 the IUR information to both internal EPA progr ams, such as the Existing Chemicals Program, 545 and the public. 546

547

1. Updated e-IUR web reporting software 548*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

13 of 84 549 EPA developed e-IUR reporting software for use in preparing and submitting reports 550 electronically during the 2006 IUR submission period (see 551 http:// www.epa.gov/iur /tools/software.html ). For the 2011 submission period, EPA will provide 552 a free web-based application in place of the 2006 downloadable software. The 2011 e-IUR web 553

software will would feature several enhancements over the 2006 e-IUR software . These 554 improvements include a sophisticated validation system, which would alert users when a 555 required field on the form is either missing information or contains certain kinds of potentially 556 incorrect information. Other updates are expected to include automated chemical identity checks, 557 automated company and site identity checks, and the facilitation of joint submissions and 558

amendments. Fo r the 2011 e

- IUR, EPA is also considering a free web

- based application in place 559 of, or in addition to, free downloadable software. 560

561

2. Require electronic submissions over the Internet 562

563 EPA is proposing to require that manufacturers (including importers) submit their IUR 564 reports to the Agency through CDX via the Internet. EPA would require that all submissions be 565 generated using e-IUR web , as described in Unit III.B.1. Electronic submissions would ensure 566 that IUR data will have completed a basic validation check, could be quickly incorporated into a 567 database and ready for immediate Agency use, and would not be subject to subsequent data entry 568

errors. Furthermore, EPA believes the required use of e-IUR web and CDX would reduce the 569 reporting burden on industry by reducing both the cost and the time required to review, edit and 570 transmit data to the Agency. After the final rule’s effective date, EPA would no longer accept 571 paper submissions or electronic media (i.e., as a file on a CD) for any IUR submission. 572

573 EPA is proposing that submission of IUR data through CDX become EPA’s required 574 submission method for several reasons. Electronic submission enables EPA to notify the 575 submitter that the Agency has received its submis sion, it reduces reporting errors, and it enables 576 data to be available for Agency and public use more quickly. During the comment period for the 577 renewal of the Information Collection Request (ICR) (73 FR 51805, September 5, 2008), EPA 578 received positive comments regarding the use of CDX, the encrypted Internet submission 579 process, and the ability to use a secure electronic signature method to submit IUR reports. 580

581 EPA requests comment on whether there are circumstances in which a company may not 582 have Internet access to report IUR data electronically 583

584

3. Electronic Signature process 585

586 In order to submit electronically to EPA via CDX, individuals acting on behalf of the 587 submitter must first register with CDX. CDX registration is a requirement for all electronic 588 submissions using CDX and is not being introduced with this proposal. During the 2006 IUR, 589 submitters were required to complete an electr onic signature agreement (ESA) and to submit the 590 agreement in hard copy with a wet ink signature to EPA in order to complete the CDX 591 registration. (Ref. 4) There was confusion among some submitters regarding the correct identity 592 of the individual eligible to register for CDX and the individual required to sign the ESA. 593

594 EPA is making changes to the registration process in order to address problems identified 595 during the 2006 IUR electronic reporting. For 2011 IUR reports, EPA is modifying the 2006 596*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

14 of 84 ESA to identify more clearly the individual(s) required to sign the agreement. The Agency is 597 developing an ESA process similar to that planned for New Chemical Program electronic 598 submissions. (Ref. 5) Each IUR submission must have an authorized official associated with the 599 submission, who is the person signing the certification statement and submitting the IUR report 600 via CDX. The authorized official would need to complete both an ESA and the CDX 601 registration process. 602

603 EPA is requesting comment on whether some reporting sites may need or desire to have 604 more than one individual complete an electronic signature agreement, so that other individuals 605 could add information to the IUR submission. The other individual may be a paid employee of 606 the company, an outside consultant for the company, or an authorized representative agent for 607 the company. While this individual would not be able to sign the certification statement required 608 for the initial IUR submission, he or she would be able to provide additional information, if 609 needed, using CDX. For 2006 and prior IUR submissions, submitters were not able to provide 610 additional information electronically. 611

612 EPA is considering developing a single Electronic Signature Agreement and CDX 613 registration process that would be applicable to all TSCA programs. EPA believes a company or 614 site may want to use the same authorized official for both Premanufacture Notice (PMN) 615 submissions and IUR submissions. EPA is interested in obtaining comments on this approach. 616 For example, would the authorized official responsible for signing both an IUR submission and a 617 PMN submission be the same person? 618

619

C. Modifications to Selected Definitions 620

621 As part of developing the definition section for 40 CFR part 711, EPA is proposing to 622 modify six definitions associated with the IUR rule and to add four new definitions. In 40 CFR 623 704.3 and 40 CFR 710.3, EPA is also proposing to modify the definition of importer by 624 removing the citation to 19 CFR 1.11. The citation, which would correctly read 19 CFR 101.1, is 625

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

. 627

628

1. Manufacture and Manufacturer 629

630 In order to improve the information submitted through the IUR rule, EPA is proposing to 631 modify the definition of manufacture by incorporating elements from the 40 CFR 720.3 632

definition for manufacturer . The proposed 40 CFR 711.3 definition of manufacture would allow 633 persons contracting with a toll manufacturer to report the chemical physically manufactured at 634 the toll manufacturer’s site. Under the proposed definition of site , the site information would be 635 the toll manufacturer’s site (see Unit III.C.2.). Adopting this definitio n would allow the person 636 contracting for the manufacture of a chemical substance to report the information on the 637 industrial processing and use of a chemical substance and on the consumer and commercial uses 638 of a product containing the chemical substance. Information on the uses of a chemical substance 639 is often unavailable to a toll manufacturer who produces a chemical substance for another 640 person. EPA is proposing to include a modified definition of manufacture in 40 CFR part 711 641 instead of adopting the definition of manufacturer from 40 CFR 720.3 because the IUR rule does 642

not use the term manufacturer . In order to avoid any confusion with the definitions of these 643 terms found at 40 CFR 704.3, the Agency is also proposing to add a simple definition for the 644*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

15 of 84 term manufacturer to 40 CFR 711.3. In addition to the proposed change to the definition of 645 manufacture , EPA is proposing to add a paragraph (c) to the proposed regulation at 40 CFR 646 711.15 to clarify the reporting relationship between the contracting company and the toll 647 manufacturer. The contracting company is primarily responsible for the IUR reporting, but in 648 the event the contracting company does not report, the toll manufacturer must report. Both the 649 contracting company and the toll manufacturer are liable if no report is made. Note that the 650 contracting company and the toll manufacturer should confer with each other to avoid duplicate 651 reporting. 652

653 With this proposal, the term manufacture therefore would be defined under the IUR rule 654 to mean “to manufacture, produce, or import for commercial purposes. Manufacture includes the 655 extraction, for commercial purposes, of a component chemical substance from a previously 656 existing chemical substance or a complex combination of substances. When a substance, 657 manufactured other than by import, is (1) produced exclusively for another person who contracts 658 for such production, and (2) that other person specifies the identity of the substance and controls 659 the total amount produced and the basic technology for the plant process, that substance is jointly 660 manufactured by the producing manufacturer and the person contracting for such production.” 661 Also with this proposal, the term manufacturer would be defined under the IUR rule to mean “a 662 person who manufactures a chemical substance.” 663

664

2. Site 665

666 EPA is proposing to amend the definition of site to: (1) clarify that the importer’s site must 667 be a U.S. address, (2) accommodate manufacturing under contract, and (3) accommodate 668 portable manufacturing units. See Unit III.I for a further discussion of this proposal as it relates 669 to importers. As described in Unit III.C.1., the proposed 40 CFR 711.3 definition of 670 manufacture would allow persons contracting with a toll manufacturer to report the chemical 671 physically manufactured at the toll manufacturer’s site and the site identification information 672 pertaining to the toll manufacturer’s site. 673

674 EPA identified the need to accommodate portable manufacturing units during the 2006 IUR 675 submission period. Two examples of portable manufacturing units are tanks used to manufacture 676 calcium hydroxide slurry for use in building construction and road and highway projects, and 677 tanks used to mix anhydrous ammonia and water to manufacture ammonium hydroxide prior to 678 application to agricultural lands. EPA is interested in including chemical manufacturing that is, 679 for instance, performed by road crews or is occurring at construction sites at which chemicals are 680 mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifiers. 681 The site of physical manufacturing could change on a frequent basis. Manufacturers would 682 report the aggregated production volume for all of the portable manufacturing units sent out to 683 different locations from a single distribution center. The address of the distribution center would 684 be reported as the site location. EPA is interested in comments on whether the proposed 685 definition addressing portable manufacturing units would result in reporting, under the IUR rule, 686 for situations similar to those presented as examples. 687

688 With this proposal, the term site would be defined under the IUR rule to mean “a contiguous 689 property unit. Property divided only by a public right-of-way shall be considered one site. More 690 than one plant may be located on a single site. 691

692*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

16 of 84 (a) For substances manufactured under contract, i.e., by a toll manufacturer, the site is the 693 location where the chemical substance is physically manufactured. 694

695 (b) The site for an importer who imports a chemical substance described in §711.5 is the U.S. 696 site of the operating unit within the person's organization that is directly responsible for 697 importing the substance. The import site, in some cases, may be the organization's 698 headquarters in the United States. If there is no such operating unit or headquarters in the 699 United States, the site address for the importer is the U.S. address of an agent acting on 700 behalf of the importer who is authorized to accept service of process for the importer. 701

702 (c) For portable manufacturing units sent out to different locations from a single distribution 703 center, the distribution center shall be considered the site.” 704

705

3. Electronic-Reporting Related Definitions 706

707 EPA is proposing to add two new terms, Central Data Exchange (CDX) and electronic 708 IUR ( e-IUR web )

. The Agency is adding these terms to provide clarity to the proposed 709 requirement for electronic reporting of IUR data. The term CDX means “EPA’s centralized 710 electronic document receiving system, or its successors, including associated instructions for 711 registering to submit electronic documents.” The new definition would make the term consistent 712

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

- IUR 713 software provided by EPA for the completion and submission of the IUR Form U report.” 714

715

4. Processing and Use-Related Definitions 716

717 EPA is proposing to amend the definitions of the terms c ommercial use and consumer use 718 in order to make them more consistent with the definitions developed collaboratively by the 719 United States and Canada. See Unit III.F.8 for further information. The proposed definitions for 720 these two terms differ in wording from the Canadian version to ensure the use of terminology 721 defined in IUR and related regulations, and EPA believes the basic application of these two 722 terms would not differ from the basic application of the Canadian definitions. (Ref. 13) The term 723

c ommercial use would mean “the use of a chemical substance or a mixture containing a chemical 724 substance (including as part of an article) in a commercial enterprise providing saleable goods or 725 services.” Examples included in the § 710.43 definition would be eliminated. The slightly 726

modified definition of consumer use would be “the use of a chemical substance or a mixture 727 containing a chemical substance (including as part of an article) when sold to or made available 728

to consumers for their use.” The restrictions associated with where a consumer would use the 729 product would be removed. 730

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

EPA defined industrial use and did not define industrial function . The inclusion of both 733 definitions provides clarity for the industrial processing and use reporting requirements and 734 would make the Agency’s requirements consistent with those collaboratively developed with 735 Canada. (Ref. 13) Additional discussion of those requirements is in Unit III.F.7

. With this 736 proposal, industrial function would mean “the intended physical or chemical characteristic for 737 which a chemical substance or mixture is consumed as a reactant; incorporated into a 738 formulation, mixture, reaction product, or article; repackaged; or used.” 739

740*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

17 of 84 5. Principal Reporting Year and Submission Period 741

742 As described in Unit II.A, EPA is proposing to change the reporting cycle from every 743 five years to every four years and to require the reporting of production volumes for each 744 calendar year since the last principal reporting year. EPA is proposing to modify the terms 745 reporting year and submission period to reflect these changes. 746

747

The term reporting year would be modified to add the term “principal” and to replace 748 the word “information” with “manufacturing, processing and use data.” These changes are to 749 indicate that the principal reporting year is the year in which most of the reported data are based. 750 Under the current proposal, the principal reporting year is the latest complete calendar year 751 proceeding the submission period. Additionally, EPA is proposing to remove the reference to 752 “the calendar year at 5-year intervals thereafter” and to remove the reference to “calendar year 753 2005.” With these changes, the term principal reporting year would be defined as “the calendar 754 year in which manufacturing, processing, and use activities associated with the data reported to 755 EPA during an IUR submission period occur. Production volume for manufacturing activities in 756 other years of the reporting cycle may also be reportable during the submission period, but full 757 manufacturing, processing, and use data are reported only for activities during the principal 758 reporting year.” 759

760

The term submission period would be modified by deleting the phrase “generated during the 761 reporting year.” With this change, the definition of submission period would reflect that data for 762 years in addition to the principal reporting year would be reported. With this change, the 763

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

use data are submitted to EPA.” 765

766

D. Modifications to Reporting Thresholds 767

768 Reporting thresholds are used to determine when IUR reporting is required for a subject 769 chemical at a manufacturing (including importing) site. Every person manufacturing (including 770 importing) a non-excluded substance at or above the 25,000 lb. threshold is required to report 771 information in Parts I. and II. of the IUR Form U. Beginning with the 2006 IUR submission 772 period, every person manufacturing (including importing) a non-excluded substance at or above 773 the 300,000 lb. threshold was requir ed to report information in Part III. of Form U, unless the 774 substance was partially exempt. EPA is prop osing three changes related to the reporting 775 thresholds: (1) determination of whether you meet the 25,000 lb. threshold, (2) elimination of 776 the 300,000 lb. threshold for repor ting information in Part III, and (3) elimination of the 25,000 777 lb. reporting threshold for certain chemicals. 778

779

1. Method for determining whether a person is subject to IUR reporting 780 requirements. 781

782 Currently, a one-year snap shot of manufacturing (including importing) is used to determine 783 the need to report for the IUR rule. The method used to make the reporting determination 784 involves identifying that a person manufactured (including imported) a chemical substance listed 785 on the TSCA Inventory during the principal reporting year (e.g., 2005 for the 2006 IUR 786 submission period); that the chemical substance was not otherwise exempt; and that the 787 associated production volume (domestically manufactured plus imported volumes) met or 788*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

18 of 84 exceeded 25,000 lb. for the principal reporting year (e.g., 2005 for the 2006 IUR submission 789 period). 790

791 EPA is proposing to modify the method used to determine whether a person is subject to IUR 792 reporting. The proposed method would be to determine whether, for any calendar year since the 793 last principal reporting year, a chemical was manufactured (including imported) at a site in 794 production volumes of 25,000 lb. or greater.

. The proposed method would be effective after 795 the 2011 submission period. 796

797 For example, assume the next submission period occurs in 2015. The principal reporting 798 year for the 2011 submission period is calendar year 2010. Therefore, for the 2015 submission 799 period, it would be necessary to examine the annual production volumes for the years 2011 to 800 2014 for the site. If the production volume for a reportable chemical substance were 25,000 lb. or 801 greater for any calendar year during that four-year period, then it would be necessary to report 802 the chemical substance, unless it is otherwise exempt. For instance, a subject chemical with 803 production volumes of 5,000 lb. in 2014 and 35,000 lb. in 2012 would be reported for the 2015 804 IUR. Regardless of the 2014 production volume, in this example scenario the 2015 IUR 805 submission would contain detailed information based on manufacturing during the 2014 calendar 806 year and production volume information only for the years 2011 through 2013, as described in 807

Unit III.F.4.i. 808 For the 2011 submission period, it would be necessary to examine the annual production 809 volumes for the ye ars 2006 to 2010 for the site. If the production volume for a reportable 810 chemical substance was 25,000 lb. or greater for any calendar year during that five

- year period, 811 then it would be necessary to report the chemical substance, unless it is otherwise e xempt. For 812 instance, a subject chemical with production volumes of 5,000 lb. in 2010 and 35,000 lb. in 2007 813 would be reported for the 2011 IUR. Regardless of the 2010 production volume, in this example 814

scenario the 2011 IUR submission would contain detai led information based on manufacturing 815 during the 2010 calendar year and production volume information only for the years 2006 816 through 2009, as described in Unit III.F.4.i., due to the 2007 production volume. 817

818 EPA is proposing this change because of the mounting evidence that many chemicals, even 819 larger volume chemicals, often experience wide fluctuations in manufacturing volume from year 820 to year. This can result in the production volume of a chemical exceeding the threshold for 821 several years, then falling below the threshold during the IUR principal reporting year. 822 Consequently, previous IUR reporting has resulted in a change of approximately 30 percent in 823 the composition of the chemicals being reported from one submission period to the next. 824 Therefore, the one-year snapshot of production volume does not provide an accurate picture of 825 the chemicals in commerce, and may provide an erroneous view of the exposure scenarios 826 associated with a particular chemical substance. 827

828 An example of the wide fluctuations in manufacturing volume is found in the Agency’s HPV 829 Challenge Program (described in Unit III.D.1). In this program, IUR data were used to 830 determine the HPV chemicals, or the chemicals with nationally aggregated production volumes 831 of one million lb. or more. As the HPV Challenge Program progressed, the Agency chose not to 832 pursue certain chemicals because new IUR reporting indicated that the nationally aggregated 833 production volume had dropped below one million lb. However, based on the latest IUR, the 834 production volume for some of the chemicals the Agency was no longer pursuing had risen again 835

to exceed one million lb. 836*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

19 of 84 837 Industry representatives have provided further evidence that capturing production volume for 838 only the principal reporting year is resulting in the omission of information on chemicals in 839 current production. In comments submitted to the Agency in response to other programs, the 840 industry representatives expressed concern that short reporting determination periods would 841 drastically misrepresent the chemicals that currently are in commerce. Industry representatives 842 stated they manufactured or imported some chemicals only occasionally, and that these 843 chemicals would not be captured if the reporting covered too short a period. Comments included 844 statements such as “A longer time frame is necessary to capture the sporadically produced 845 chemicals... As such, a ‘snapshot’ in time may not adequately identify the complete inventory 846 requirements...” (Ref. 6). Another commenter agreed “ a longer timeframe to report chemicals 847 would capture those chemicals that undergo periodic manufacture based upon customer-driven 848 demand or other factors (e.g., variation in availability or cost of raw materials, cost of substitute 849 materials, etc.) ” (Ref. 7) or chemicals that are used infrequently and upon request when working 850 with suppliers (Ref. 8). 851

852 In light of these comments and EPA’s own experiences, the Agency believes that using 853 production volume reporting for all years since the last principal reporting year to determine 854 reporting obligations would yield a much more accurate picture of the chemicals currently in 855 commerce, ensuring proper review under EPA’s risk screening, assessment, and management 856 activities and providing better information to the public. EPA presents the estimated increase in 857 industry costs and burden associated with this proposed amendment in section 4.4.3 of the 858 economic analysis. (Ref. 11) 859

860 EPA requests comments on alternatives that would provide an equally accurate picture of 861 chemical production, and whether 25,000 lb. in any one year is the appropriate reporting 862 threshold. EPA also requests comment on whether this change should apply only to the certain 863 regulated chemicals (see subsection 3 below). 864

865

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

867 EPA is proposing to eliminate the 300,000 lb. threshold for processing and use 868 information, thereby requiring all reporters of non-excluded substances to report information in 869 all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to 870 collect information necessary to complete screening-level exposure characterizations for all IUR 871 reportable chemicals. The exposure information is an essential part of developing risk 872 evaluations and, based on its experience in using this information, the Agency believes that 873 collecting this exposure information is critica l to its mission of characterizing exposure, 874 identifying potential risks, and noting uncertainties for these lower production volume chemicals. 875 In addition, this change will provide the public with information on a greater number of 876 chemicals. In the 2003 Amendments final rule (68 FR 848, January 7, 2003), EPA 877 acknowledged the value of information for chemical substances manufactured in lower volumes 878 and stated that if the Agency were to find it necessary in the future, it would collect information 879 on chemical substances at reporting thresholds below the thresholds that were introduced in that 880 action (i.e., 25,000 lb. and 300,000 lb.). 881

882 The current 300,000 lb. threshold applies to each reportable chemical manufactured 883 (including imported) at each individual reporting site and was selected with the intention that 884*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

20 of 84 exposure-related processing and use information would be collected for HPV chemicals (HPV 885 being defined as a national aggregate production volume, potentially from a number of 886 manufacturing sites, of greater than 1,000,000 lb. per year). When EPA promulgated the 2003 887 Amendments, the Agency believed a 300,000 lb. per year site-specific reporting threshold would 888 capture sufficient exposure-related information fo r substantially all HPV chemicals. However, 889 based on the 2006 data, approximately 23% of the reports submitted for known HPV chemicals 890 had reported production volumes below the 300,000 lb. threshold, and consequently did not 891 contain exposure-related processing and use information. Therefore, EPA believes that the 892 300,000 lb. threshold was too high to provide sufficient processing and use data for the HPV 893 chemicals. The Agency explored setting the threshold for reporting processing and use 894 information to an alternate level between the basic reporting threshold of 25,000 lb. and 300,000 895

lb. for this action , and requests comment on alternate levels . However, the need to complete 896 characterizations for chemicals manufactured (including imported) in volumes of 25,000 lb. to 897 300,000 lb. in any year led the Agency to believe that it would be best to eliminate the upper 898 threshold and collect full information for all reported chemicals. EPA presents the estimated 899 increase in industry costs and burden associated with this proposed amendment in section 4.4.4 900 of the economic analysis. (Ref. 11) 901

902

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

904 EPA is proposing to eliminate the 25,000 lb. reporting threshold for certain chemical 905 substances that are the subject of particular TSCA rules and/or orders and to require 906 manufacturers (including importers) of such chemicals to report under the IUR rule, regardless of 907 the production volume. This provision will ensure the availability of current information when 908 EPA has expressed a concern in the form of regulatory action on those chemical substances, 909 regardless of the production volume. EPA is proposing to eliminate the 25,000 lb. threshold for 910 those chemicals that are: (1) the subject of a rule proposed or promulgated under section 5(a)(2), 911 5(b)(4), or 6 of TSCA; (2) the subject of an orde r issued under section 5(e) or 5(f) of TSCA, or 912 (3) the subject of relief that has been granted under a civil action under section 5 or 7 of TSCA. 913

914 Under this proposal, a manufacturer, including importer, of such chemical substances 915 would be required to report information on the manufacturing, processing, and use of the 916 chemical substances if it manufactured (including imported) any quantity of these chemical 917 substances during any of the years since the last principal reporting year, including quantities 918 under 25,000 lb. For 2011 reporting, the manufacturer would need to consider the manufacture 919 or import during the years 2006 through 2010; would report the production volumes for each 920 year from 2006 to 2010; and would report the full manufacturing, processing, and use 921

information for 2010. 922

923 Chemicals that are the subject of particular TS CA rules and/or orders are of demonstrated 924 high interest to the Agency. EPA will use the IUR data associated with these regulated 925 chemicals to monitor chemical production and compliance with the rules. 926

927 EPA requests comment on whether these chemicals should include those that are subject of a 928 rule proposed under section 5(a)(2), 5(b)(4), or 6 of TSCA, thereby more closely paralleling the exception 929 language in the introductory paragraph to 40 CFR 710.46 (proposed section 711.6) and in 40 CFR 710.49 930 (proposed section 711.9). 931

932*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

21 of 84 EPA presents the estimated increase in industry costs and burden associated with this 933 proposed amendment in section 4.4.5 of the economic analysis

. (Ref. 11)

. 934

935 EPA requests comment on whether a de minimus production volume threshold should be 936 set for these chemicals. EPA also requests comment on how best to set such a de minimus 937

threshold. 938

939

E. Changes to Substances Covered by IUR 940

941

1. Water 942

943 Naturally occurring water is excluded from reporting under the IUR rule, but 944 manufactured water, which is not naturally occurring, is a reportable substance. EPA is 945 proposing to fully exempt all (both naturally occurring and manufactured) water (CASRN 7732- 946 18-5) and to remove water from the petroleum streams partial exemption (40 CFR 710.46(b)(1)). 947

948 EPA received approximately 43 IUR reports for water during the 2006 submission 949 period. Therefore, this proposed exemption would likely result in a burden reduction for IUR 950

submitters. 951

952

2. Remove fully exempt polymers from partially exempt list 953

954 Polymers are a class of chemical substances for which IUR reporting is not required (40 955 CFR 710.46(a)(1)) (proposed 40 CFR 711.6(a)(1)). However, three polymers are listed in the 956 partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv): Starch (CASRN 9005-25-8), 957 Dextrin (CASRN 9004-53-9), and Maltodextrin (CASRN 9050-36-6). Improperly including 958 substances that meet the IUR definition of a polymer in the partially exempt list of chemicals 959 may be confusing to submitters and may lead to unnecessary reporting for these substances. 960 EPA is proposing to amend the partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv) 961 (proposed 40 CFR 711.6(b)(2)) to remove these th ree chemical substances which, as polymers, 962 are fully exempt from reporting. 963

964

3. Making chemicals that are the subject of an Enforceable Consent Agreement 965 ineligible for exemptions 966

967 EPA may enter into an enforceable consent agreement (ECA), pursuant to procedures at 968 40 CFR part 790, with a manufacturer of a chemical substance to obtain testing where a 969 consensus exists among EPA, affected manufacturers and/or processors, and interested members 970 of the public concerning the need for and scope of testing. Chemicals covered by ECAs are of 971 demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, 972 processing, and use of substances under such agreements, and therefore is proposing to require 973 that such substances be reported for IUR purposes, regardless of whether the substance otherwise 974 meets the requirements listed in 40 CFR 710.46 (proposed 40 CFR 711.6) as an exempt or 975 partially exempt chemical substance. This provision will ensure the availability of current 976 information if EPA has expressed a concern in the form of an ECA on any substance otherwise 977 excluded from the IUR rule. EPA is therefore proposing to make chemical substances that are 978 the subject of an ECA ineligible for IUR exemptions. 979

980*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

22 of 84 With this proposal, chemicals that are the subject of an ECA would be included in the list 981 of chemicals that are ineligible for an IUR exemption, in the introductory paragraph of 40 CFR 982 710.46 (proposed 40 CFR 711.6) listing the other chemicals that are likewise not eligible for an 983 IUR exemption. The paragraph would state that a chemical “is not exempted from any of the 984 reporting requirements of this part if that substance is the subject of a rule proposed or 985 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 986 agreement developed under the procedures of 40 CFR part 790, or is the subject of an order 987 issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under 988

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

990

F. Modifications to Reportable Data Elements 991

992

1. Parent Company and Site Identity 993

994 Manufacturers (including importers) are required to report the company name and Dun 995 and Bradstreet (D&B) number to identify the company associated with the plant site, and also to 996 report the site name, address, and D&B number. If the company associated with the plant site 997 does not have a D&B number, the manufacturer must obtain a D&B number for the company. 998 Likewise, if the plant site does not have a D&B number, the manufacturer must obtain a D&B 999 number for the site. EPA received a variety of questions concerning the correct company name 1000 to report during the 2006 IUR submission period. EPA is now clarifying what is meant by 1001 company name, by proposing to require that the company name provided be the ultimate 1002 domestic parent company name. EPA believes this change will reduce confusion by making this 1003 reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent 1004 company name. The requirement that the ultimate domestic parent company name be reported 1005 does not affect the determination of small business status, which is not limited to domestic 1006 companies. Persons covered by the IUR rule should continue to base small business 1007 determinations on the ultimate parent company, regardless of whether that company is domestic 1008 or foreign. 1009

1010 The 2006 IUR submissions from different reporting sites contained varying D&B 1011 numbers for parent companies that appeared to be the same company. In order to better identify 1012 when reporting sites are under the same parent company, EPA is proposing to include the 1013 address as well as the D&B number of the parent company. 1014

1015

2. Technical Contact 1016

1017 Manufacturers (including importers) are required to provide a technical contact for their 1018 IUR submission. The technical contact must be a person who can answer questions EPA may 1019 have about the reported chemical substance and should be a person located at the manufacturing 1020 site. Based on EPA’s experience with contacting the reported technical contact with follow-up 1021 questions concerning 2006 IUR submissions, reporters often provide the names of individuals 1022 who are not directly connected to the reporting site, and therefore, are not knowledgeable about 1023

either the chemical or the submission. EPA has also seen situations where the technical contact 1024 is a contracted employee who is able to address subsequent concerns only if he or she remains 1025 under contract. Note that EPA may raise follow-up questions about an IUR submission, possibly 1026 years after the submission date. EPA is interested in any comments or suggestions regarding 1027 how to better identify the technical contact. 1028*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

23 of 84 1029 EPA is considering allowing multiple technical contacts on a chemical-by-chemical 1030

basis. The e-IUR web reporting software would allow the identification of several names 1031 associated with a submission. EPA is interested in any comment or suggestions regarding this 1032

consideration. 1033

1034

3. Chemical Identity 1035

1036 Manufacturers, including importers, are required to submit the correct chemical identity 1037 for each subject chemical substance. For the 2006 IUR, the correct chemical identity included a 1038 specific chemical name and a corresponding identifying number. The identifying number could 1039 be the Chemical Abstracts Service Registry Number (CASRN), the TSCA Accession Number, or 1040

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

. 1041

1042

i. Chemical Name 1043

1044 EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name 1045 currently used to list the substance in the Inve ntory as the chemical name reported for IUR. 1046 Currently submitters are required to report a specific chemical name, with no further elaboration 1047 in the regulatory text. The Instructions for Reporting presently state that manufacturers should 1048 use CA Index Names or, if CA Index Names are not available, manufacturers should use 1049 nomenclature that completely and accurately describes the chemical substance. 1050

1051 EPA has found, however, that submitters sometimes supply a name that is somewhat 1052 generic or excludes parts of the specific chemical identity that distinguishes one substance from 1053 another. EPA’s experience from the 2006 IUR was that up to five percent of the reports 1054 submitted contained chemical identity problems serious enough that the Agency was unable to 1055 precisely identify the substance. These problems resulted in the temporary exclusion of the 1056 information associated with the poorly or erroneously identified chemical from the IUR database 1057 until the Agency was able to obtain correct and specific chemical identity information from the 1058 submitter. EPA believes the requirement to us e the substance name as currently listed on the 1059 Inventory will greatly reduce the number of poorly identified substances. EPA intends to include 1060 the CASRN and CA Index Names as part of e-IUR web , to the extent possible without 1061 jeopardizing confidentiality claims. 1062

1063 Manufacturers (including importers) will be allowed to supply an alternate chemical 1064 name, and in the case of importers, a trade name, in those instances where a supplier will not 1065 disclose to the submitter the specific chemical name of the imported Inventory substance or a 1066 reactant used to manufacture the Inventory substance. In these cases, the manufacturer 1067 (including importer) and the supplier report the information required in this part in a joint 1068 submission. In order to clarify this requirement, EPA is proposing an amendment to 40 CFR 1069 710.52(c)(3)(i) (proposed 40 CFR 711.12(b)(3)(i)) to state that the importer must have the 1070 supplier of the confidential chemical substance directly provide EPA with the correct chemical 1071 identity, in a joint submission with the manufactur er. Furthermore, in the event the manufacturer 1072 submitting a report cannot provide the whole chemical identity because the reportable chemical 1073 substance is manufactured using a reactant having a specific chemical identity claimed as 1074 confidential by its supplier, the manufacturer must submit a report directly to EPA containing all 1075 other information known to or reasonably ascertainable by the manufacturer about the chemical 1076*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

24 of 84 identity of the reported substance and must ensure that the supplier directly provides to EPA the 1077 correct chemical identity of the confidential reactant in a joint submission. See Unit 3.I for 1078 additional information regarding joint submissions. Detailed draft instructions regarding joint 1079 submissions are included in the draft Instructions included in the docket. (Ref. 2) EPA is 1080 interested in any comments regarding the procedure under consideration. 1081

1082

ii. Chemical Identifying Number 1083

1084 As part of the chemical identity, submitters provide a chemical identifying number 1085 associated with the correct CA Index Name, as described in Unit III. F E .3. For most chemicals, 1086 the chemical identifying number is the CASRN correctly corresponding to the reported CA 1087

Index Name. If the CASRN number is not available because the chemical substance is listed on 1088 the confidential portion of the Inventory and a CASRN does not already exist for that substance, 1089 the submitter could report either the asso ciated TSCA Accession or PMN number. 1090

1091 EPA is proposing to allow submitters to report only the CASRN as a chemical identifying 1092 number or, in the case of confidential chemical substances, the accession number. Note that in 1093 cases where a CASRN exists for a confidential chemical, it can be reported instead of the 1094 accession number and claimed as confidential for purposes of the IUR submission. EPA is 1095 proposing to remove the PMN number as an allowed chemical identifying number because each 1096 Inventory substance has either (or both) a CASRN or a TSCA Accession Number, which are 1097 likely to be already known to the submitter. Furthermore, the Agency has to spend considerably 1098 more time and effort to access and review reported information that has been identified only by a 1099

PMN case number. 1100

1101 Submitters who, in the past, have reported using the PMN number of a confidential 1102 substance may contact EPA, if necessary, to learn the TSCA Accession Number assigned when 1103 the Notice of Commencement (NOC) was submitted to the Agency. 1104

1105

4. Production Volume 1106

1107 Manufacturers, including importers, are required to report production volume information 1108 for each chemical substance for which they submit an IUR report. For the 2006 IUR, 1109 production volume information consisted of the manufactured production volume; the imported 1110 production volume; an indication of whether the substance was manufactured, imported, or both; 1111 and an indication of whether the substance was site-limited. In instances where a single site both 1112 manufactures and imports the same chemical substance, the site was to report the manufactured 1113 and imported production volumes separately on one report. The combined total production 1114 volume was then used as the basis for determining the percentage of production volume in other 1115 areas of the report, such as for the physical form , the industrial process or use, or the consumer 1116

or commercial use. 1117

1118 EPA is proposing a number of changes to the reporting of production volume and 1119 associated information. The Agency believes these changes would improve the usefulness of the 1120 information for EPA and others, and would provide clarity for the reporting obligations of the 1121

submitter. 1122

1123

i. Report production volume for each of the years since the last principal 1124*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

25 of 84 reporting year. 1125

1126 EPA is proposing to require reporting of production volume for each of the five years 1127 since the last IUR principal reporting year. Thus, for the 2011 IUR submission period, 1128 manufacturers (including importers) of a chemical at or above the 25,000 lb. threshold would 1129 report the production volume of that chemical for each of the following calendar years: 2010, 1130 2009, 2008, 2007, and 2006. This change would provide information EPA and others need as 1131 stated in Unit III.D. Collecting the production volume for multiple years would provide greater 1132 detail than the current once-every-five-years snapshot. 1133

1134 For the principal reporting year, e.g., 2010, the domestic manufacture and the import 1135 production volume would continue to be reported separately on the same report. EPA review 1136 and analysis of the 2006 IUR data has revealed that some submitters are erroneously submitting 1137 multiple reports for the same chemical, at times reporting the information associated with 1138 manufacturing and importing in different reports. The submitter should complete only one report 1139

for each chemical substance. 1140

1141 EPA uses production volume data in several important ways. The data help the Agency 1142 to establish trends in chemical manufacturing; to determine the effectiveness of various Agency 1143 and other programs; to estimate the magnitude of consumer, worker, and environmental 1144 exposures; and to determine the costs (and financial impacts) of potential control strategies in 1145 economic analyses. As discussed in Unit III.D.2., the collection of annual production volume 1146 data would allow EPA to identify more consistently the HPV chemicals. Voluntary EPA 1147 programs such as Design for the Environmen t (DfE) and other polluti on prevention programs 1148 would use the annual production volume data to identify trends and program performance. 1149 Relying on a single snapshot of annual production volume in each reporting determination period 1150 hampers EPA’s ability to identify the programs and techniques that are most effective, using 1151 measurable, readily identifiable production trend data. 1152

1153 Unit V of this Preamble contains a series of requests for comments on additional ideas 1154 under consideration by the Agency. One of the ideas concerns the collection of more than just 1155 the production volume since the last reporting year. The Agency is interested in comments on 1156

this matter. Please see Unit V for additional discussion. 1157

1158

ii. Volume of chemical substance used on-site. 1159

1160 EPA is proposing to require that submitters report the volumes of a manufactured 1161 (including imported) chemical substance used at th e reporting site. The requirement to report the 1162 volume used on-site is replacing the requirement to indicate that the chemical is site-limited. 1163 Under this proposal, either domestically manufactured or imported chemicals could be reported 1164 as used at the reporting site, whereas, under the current reporting requirements, only 1165 domestically manufactured chemicals, consumed entirely at the site of manufacture, should be 1166 reported as site-limited. 1167

1168 EPA is proposing this change to simplify reporting and to collect information that better 1169 addresses the Agency’s needs. In the past, submitters sometimes incorrectly reported their 1170 production volume separately to identify the portion of their chemical that was consumed at the 1171 site of manufacture. For the 2006 IUR, many submitters continued this practice and erroneously 1172*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

26 of 84 filed separate reports to identify that a portion of their production volume was site-limited. 1173 Filing separate reports resulted in the need to report processing and use information separately 1174 when the combined production volume was 300,000 lb. or greater. Reporting all production 1175 volumes on one report simplifies reporting for such submitters and results in a less complicated 1176 database, thereby making the data easier to use. In addition, reporting the volume used on-site 1177 provides valuable information related to potentia l exposures associated with the on-site volumes, 1178 providing the Agency with better information for exposure assessments and other data analyses. 1179

1180

iii. Indicate whether imported chemicals are physically at reporting site. 1181

1182 EPA is proposing to add a requirement to indicate whether an imported chemical is 1183 physically at the reporting site. Often, the site reporting an imported chemical never physically 1184 receives the chemical, but instead ships it directly to another location such as a warehouse, a 1185 processing or use site, or a customer’s site. Identifying whether the chemical is physically at the 1186 reporting site provides more accurate information for screening-level analyses and other uses of 1187

the IUR data. 1188

1189

iv. Report volume exported. 1190

1191 EPA is proposing to add a requirement to report the production volume directly exported 1192 and not domestically processed or used. This would allow EPA to better identify the proportion 1193 of the production volume accounted for by the use reporting, given that downstream reporting is 1194 not required for exported substances. 1195

1196

5. Identify whether a chemical is to be recycled, remanufactured, reprocessed, 1197 reused, or reworked. 1198

1199 EPA is proposing to add a requirement to indicate (via a check-box) whether a 1200 manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, 1201 reused, or reworked. Submitters would identify that their manufactured chemical, which 1202 otherwise would be disposed of as a waste, is being removed from the waste stream and has a 1203 commercial purpose (i.e., it is being recycled, remanufactured, reprocessed, reused, or 1204 reworked). EPA believes that such information will help the Agency to identify where these 1205 activities are already occurring, and can be used to encourage such activities. Collecting 1206 information on whether a chemical is being recycled, remanufactured, reprocessed or reused and 1207 is not entering the waste stream provides valuable information to EPA and others regarding 1208 trends in chemical manufacturing. This information also can be used to help determine the 1209 effectiveness of various programs, such as EPA’s Resource Conservation Challenge (RCC) 1210 Program. EPA launched the RCC in 2002, implementing Congress’ instruction to prevent 1211 pollution and conserve natural resources and energy by managing materials more efficiently. 1212 The RCC Program’s goals include promoting reuse and recycling and reducing chemicals of 1213 national concern in products and waste. Indicating that a manufactured chemical, such as a 1214 byproduct, is to be recycled, remanufactured, reprocessed, reused, or reworked does not affect 1215 the reporting requirements associated with any substance manufactured from the byproduct. See 1216

Unit IV. B 2 for detailed information on byproduct reporting. 1217

1218

6. Concentration ranges. 1219

1220*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

27 of 84 EPA is proposing to eliminate gaps in the ranges used to report concentration in § 710.52(C)(3) 1221 and (4). The current ranges result in gaps between 30 and 31 percent and 60 and 61 percent. 1222 The proposed ranges would be: 1223

1224 Less than 1% by weight 1225 At least 1% but less than 30% by weight 1226 At least 30% but less than 60% by weight 1227 At least 60% but less than 90% by weight 1228 At least 90% by weight 1229

1230

7. Industrial processing and use information reporting. 1231

1232 In 2003, EPA added industrial processing and use data to the information collected 1233 through the IUR rule for chemical substances manufactured in quantities of 300,000 lb. or 1234 greater during the principal reporting year. The industrial processing and use information 1235 included industrial function categories and No rth American Industrial Classification System 1236 (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was 1237 useful in selecting a scenario that characterizes the frequency, route, and duration of exposure to 1238 a chemical substance during manufacture, processing, and use of the substance. These data are 1239 also useful when EPA characterizes the quantity of the chemical substance in wastes and 1240 emissions entering the environment and for anticipating the environmental media into which 1241 wastes will be released. The Agency is proposing to revise the list of industrial function 1242 categories and to replace the NAICS codes with industrial sector categories, as described in 1243

sections i. and ii. 1244

1245

i. Industrial function categories. 1246

1247 EPA is proposing to revise the list of industrial function categories by combining 1248 categories that lead to common exposure scenarios and adding categories where the Agency 1249 believes the existing categories do not adequately describe potential uses. EPA worked with 1250 Environment Canada and Health Canada to develop the proposed set of categories, which would 1251 be used by both the United States and Canada for Inventory reporting. Harmonization of the 1252 categories for reporting the industrial functions of chemical substances would facilitate the 1253 exchange of information between EPA and Canadian agencies and could serve as a model to be 1254 used by Mexico in developing an inventory of chemical substances. In addition, the harmonized 1255 categories would facilitate consistent reporting of chemical use information by industry in the 1256 United States and Canada. (Ref. 13) 1257

1258 EPA is proposing to add eight new industrial function categories and to delete six 1259 existing categories from the current list; the total number of industrial function categories would 1260 increase to 35. Also, EPA is proposing to rename several of the industrial function categories to 1261 provide a more informative description of the function of chemical substances that should be 1262 reported in that category. Lastly, EPA is proposing to require that if a submitter selects the 1263 category “Other,” the submitter must provide its own description of the industrial function of the 1264 chemical substance. EPA is proposing the following industrial function categories: 1265

Table 1: Codes for Reporting Industrial Function Categories. 1266

Code Category*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

28 of 84 U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents U004 Agricultural chemicals (non-pesticidal) U005 Anti-adhesive agents U006 Bleaching agents U007 Corrosion inhibitors and anti-scaling agents U008 Dyes

U009 Fillers U010 Finishing agents

U011 Flame retardants

U012 Fuels and fuel additives U013 Functional fluids (closed systems) U014 Functional fluids (open systems)

U015 Intermediates U016 Ion exchange agents

U017 Lubricants and lubricant additives U018 Odor agents U019 Oxidizing/reducing agents

U020 Photosensitive chemicals U021 Pigments

U022 Plasticizers U023 Plating agents and surface treating agents U024 Process regulators U025 Processing aids, specific to petroleum production U026 Processing aids, not otherwise listed U027 Propellants and blowing agents U028 Solids separation agents U029 Solvents (for cleaning or degreasing) U030 Solvents (which become part of product formulation or mixture) U031 Surface active agents U032 Viscosity adjustors U033 Laboratory chemicals U034 Paint additives and coating additives not described by other categories U999 Other (specify)

1267

ii. Industrial Sectors 1268

1269 EPA is proposing to replace the five-digit North American Industrial Classification 1270 System (NAICS) codes with 48 Industrial Sector s (IS). The sectors were adapted from the 1271 European Union’s (EU’s) “Guidance on information requirements and chemical safety 1272 assessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sectors 1273 so that there is a sector corresponding to any NAICS code. The Agency believes this change 1274 would provide several benefits. First, the sectors would reduce reporting burden because 1275 submitters would not have to look up the NAICS code. Second, it would encourage more 1276 complete reporting by using terms that are already familiar to industry. Third, the sectors would 1277 reduce the likelihood of errors that result from the selection of miscellaneous or inappropriate 1278 NAICS codes. Fourth, it would reduce the number of codes that could apply to one substance. 1279 Table 2 lists the proposed sectors. The rationale for selecting the sectors and the link between 1280 the sectors and the NAICS system is further described in Inventory Update Reporting (IUR) 1281 Technical Support Document – Replacement of 5-digit NAICS Codes with Industrial Sector 1282*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

29 of 84 Codes (Ref. 9). 1283

1284 One of the primary purposes of the IUR data collection is to group together similar data 1285 for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 1286 five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial 1287 processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of 1288 processing or use code, NAICS code, and industrial function category, in all. This large number 1289 of unique combinations increases the difficulty and time required by EPA to sort and classify 1290 chemicals because EPA either would need to develop exposure scenarios for each unique 1291 combination, or determine which three-code combinations have similar exposure scenarios and 1292 can be grouped. The use of the sectors would reduce the number of unique combinations, 1293 thereby increasing the usability of the data, and also reducing the IUR reporting burden. 1294

1295 EPA is proposing the following 48 sectors: 1296

1297

Table 2: Industrial Sectors. 1298

Code Sector Description IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (except Oil and Gas) and support activities

IS4 Utilities

IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Related Support Activities

IS11 Petroleum Refineries IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing IS13 Petroleum Lubricating Oil and Grease Manufacturing IS14 All other Petroleum and Coal Products Manufacturing IS15 Petrochemical Manufacturing IS16 Industrial Gas Manufacturing IS17 Synthetic Dye and Pigment Manufacturing IS18 Carbon Black Manufacturing IS19 All Other Basic Inorganic Chemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Organic Chemical Manufacturing IS22 Plastics Material and Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic Fiber Manufacturing IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing IS26 Pharmaceutical and Medicine Manufacturing IS27 Paint and Coating Manufacturing IS28 Adhesive Manufacturing IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing IS30 Printing Ink Manufacturing IS31 Explosives Manufacturing IS32 Custom Compounding of Purchased Resins IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing IS34 All Other Chemical Product and Preparation Manufacturing*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

30 of 84 IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other nonmetallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade

IS47 Services IS48 Other (requires additional information)
1299 When the category chosen for the Industrial Sect or Code is “Other,” a written description 1300 of the use of the chemical substance, which may include the NAICS code, would also need to be 1301 provided. 1302

1303

8. Consumer and commercial use reporting 1304

1305 In the 2003 Amendments, EPA added a reporting requirement for submitters to include 1306 information about the consumer and commercial uses of chemicals they reported under the IUR 1307 rule. For the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured 1308 in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to ten 1309 consumer and commercial product categories from a list of 20 categories that correspond to the 1310 actual use of the chemical substance they are reporting. For each category, submitters also were 1311 required to indicate whether the chemical was used in a product intended for use by children, to 1312 report the maximum concentration of the chemical in the product category, and to report the 1313 percentage of total production volume associated with the product category. 1314

1315 EPA is using the information provided by the 2006 IUR reports in the Existing Chemicals 1316 Program. While the Agency found that the information was useful in identifying when 1317 consumers and commercial users and children are potentially exposed populations, EPA also 1318 found that the data had significant limitations concerning the product categories and 1319 identification of potentially exposed populations. The Agency believes the limitations stem from 1320 two characteristics of the data: (1) the lack of specificity in the product categories and (2) the 1321 inability to distinguish between consumer and commercial uses. In addition, because 29 percent 1322 of the reported categories were for the category “Other,” EPA was constrained in its ability to 1323 characterize use and exposure scenarios. Also, consumer and commercial uses affect very 1324 different populations. The reported information was not useful in differentiating these 1325 populations when characterizing potential exposures. 1326

1327 To address these issues, EPA is proposing three four changes to the consumer and 1328 commercial information required to be reported: (1) a revised and expanded list of consumer 1329 and commercial product categories, (2) the additional requirement to provide a description when 1330 the product category “Other” is selected, and (3) the identification of whether the use is a 1331 consumer or a commercial use, or both , and (4) the number of commercial workers reasonably 1332 likely to be exposed while using the reportable chemical substance . Reporting associated with 1333*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

31 of 84 children’s use, the maximum concentration, and the percent production volume would remain 1334 unchanged. 1335

1336

i. Consumer and Commercial Product Categories 1337

1338 EPA is proposing to revise the list of consumer and commercial product categories by 1339 combining categories that lead to common exposure scenarios and adding categories that were 1340 not adequately described in the initial set of ca tegories. EPA worked with Environment Canada 1341 and Health Canada to develop the proposed categories. Harmonized categories for reporting the 1342 consumer and commercial uses of chemical substances would facilitate the exchange of 1343 information between EPA and Canadian agencies and would serve as a model to be used by 1344 Mexico in developing an inventory of chemical substances. In addition, the harmonized 1345 categories would facilitate consistent reporting of chemical use information by industry in the 1346 United States and Canada. (Ref. 13) 1347

1348 During the development of the revised product category list, EPA and Canada considered 1349 existing product category schemes, such as the NAICS and REACH categories, but found them 1350 to be either too detailed or not right for the task at hand. The NAICS categories are defined for 1351 manufacturing processes, not for consumer and commercial products, and therefore did not 1352 address the situations of interest. The REACH program collects detailed information on the use 1353 of chemicals in consumer and commercial products sold in the EU: all of the codes used by 1354 REACH are represented in the harmonized industrial function and consumer and commercial 1355

codes. 1356

1357 The proposed list includes 33 product categories, including “Other.” Examples of new 1358 categories which have been added include explosive materials, building/construction products 1359 not covered elsewhere, and air care products. The glass and ceramic products category had 1360 relatively few IUR submissions in 2006 and overlaps with proposed new categories, and so has 1361 been proposed for elimination. Also, several of the consumer and commercial product categories 1362 would be renamed to better describe the products that should be reported in those categories. 1363

1364 EPA believes that expanding the list of consumer and commercial product categories 1365 would provide persons submitting IUR information with a greater opportunity to characterize the 1366 product in which chemical substances they manufacture are used and would reduce the number 1367 of uses reported as “Other.” 1368

1369 In addition to revising the overall product categories, narrower definitions and expanded 1370 lists of examples of products in which the chemical substance would be used would be added to 1371 each category descriptor. The examples were selected to include items that could have fit into 1372 other categories in order to address the overlap inherent in any product category list. The 1373 product categories were then placed into several broader groupings, e.g., “Chemicals with 1374 Agriculture and Outdoor Uses’ based on the similarities of products. EPA believes that the user 1375 would find the proposed groupings easier to use than the alphabetical listing used for the 2006 1376

IUR. 1377

1378 EPA is also proposing to require that if a submitter chooses the product category “Other,” 1379 the submitter must include a text description for the consumer and commercial product 1380 containing the chemical substance. In the 2006 IUR reports, the category “Other” was reported 1381*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

32 of 84 with the greatest frequency, with 1,206 out of a total number of 4,157 reports containing 1382 consumer and commercial use information, resulting in a reporting rate of 29 percent for the 1383 category. Although one of EPA’s objectives in revising the consumer and commercial product 1384 categories was to reduce the reporting frequency of “Other,” EPA believes that in many cases 1385 where “Other” was reported, submitters may not have selected the correct categories for their 1386 situation. By requiring the submitters to supply a written description for “Other,” EPA would be 1387 able to evaluate and improve the inclusiveness of future consumer and commercial category lists 1388 or descriptions. In addition, the descriptor information would be more useful than simply the 1389 selection of “Other” for EPA’s Existing Chemicals and other programs. 1390

1391 EPA is proposing the following consumer and commercial product categories: 1392

1393 Table 3: Codes for Reporting Consumer and Commercial Product Categories. 1394

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, Pa per, 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*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

33 of 84 Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)
1395

ii. Designation of Consumer or Commercial Use 1396

1397 EPA is proposing to require submitters to designate, via a checkbox, whether the 1398 indicated product category is a consumer or a commercial use, or both

. The Agency’s 1399 experience using the 2006 IUR data identified a need to distinguish between potentially exposed 1400 consumer and commercial populations. The designation of consumer or commercial use, or 1401 both, would allow EPA to complete a better characterization of the potentially exposed 1402 populations. 1403

1404

iii. Number of Commercial Workers Reasonably Likely to be Exposed 1405

1406 EPA is proposing to require that submitters report the total number of commercial 1407 workers, including those at sites not under the submitter’s control, that are reasonably likely to 1408 be exposed while using the reportable chemical substance, with respect to each commercial use. 1409 The approximate number of workers would be reported using the same definitions and ranges 1410 used for manufacturing and industrial processing and use workers required by 40 CFR 1411 710.52(c)(3)(v) and (4)(i)(F) (proposed 40 CFR 711.12(c)(3)(vii) and (4)(i)(F)), respectively. 1412 The ranges are: 1413

1414

Fewer than 10 workers 1415

At least 10 but fewer than 25 workers 1416

At least 25 but fewer than 50 workers 1417

At least 50 but fewer than 100 workers 1418

At least 100 but fewer than 500 workers 1419 At least 500 but fewer than 1,000 workers 1420 At least 1,000 but fewer than 10,000 workers 1421 At least 10,000 workers 1422

1423 Information on the number of commercial workers reasonably likely to be exposed to the 1424 reportable chemical substance would be used to characterize the commercial population 1425 reasonably likely to be exposed to the subject chemical substance. The population 1426 characterization is important to the developmen t of the overall exposure characterization. 1427

1428 EPA requests comment on the ability of submitters to provide this data with reasonable 1429 accuracy for each commercial use to which a chemical may be applied. Do submitters have 1430 sufficient information about the work practices of eventual commercial users to estimate this 1431

number? Note that the ranges proposed for commercial workers are the same as those ranges 1432 used for reporting manufacturing and industrial workers. Are these ranges also applicable to 1433

commercial workers? 1434

1435

G. Changes to standard for the reporting of processing and use information 1436

1437 In order to collect more complete information regarding the industrial processing and 1438 industrial, commercial, and consumer use of chemicals, EPA is proposing in § 711.12(c)(4) to 1439*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

34 of 84 replace the “readily obtainable” reporting standard used for reporting under 40 CFR 710.52(c)(4) 1440 in 2006 with the “known to or reasonably ascertainable by” reporting standard set forth under 1441 TSCA for this type of TSCA reporting. TSCA se ction 8(a)(2) authorizes EPA to require persons 1442 to report information that is “known to or reason ably ascertainable by” the submitter. This is the 1443 same standard that currently applies to the reporting of information described in the regulations 1444 at §§ 710.52(c)(1), (c)(2), and (c)(3), and this standard would continue to apply to the reporting 1445 of such information under proposed §§ 711.12(c)(1), (c)(2), and (c)(3). It covers all information 1446 in a person’s possession or control, plus all information that a reasonable person similarly 1447 situated might be expected to possess, control, or know. The “known to or reasonably 1448 ascertainable by” reporting standard was the only standard used for IUR reporting purposes prior 1449 to the 2006 IUR submission period. 1450

1451 EPA is proposing this change because reporting under the “readily obtainable” 1452 reportin g standard did not generate sufficiently complete processing and use information. EPA 1453 believes the “readily obtainable” reporting standard limited the usefulness of the 2006 IUR 1454 processing and use data for screening level reviews. In addition, the The 2006 IUR response rate 1455 for the processing and use information did not capture a sufficiently large portion of the 1456 production volume that the Agency believes actually was used for either industrial processing 1457 and use or consumer and commercial use. Thirty percent of the reports submitted for the 2006 1458 IUR met the requirements (based on type of chemical and production volume) to trigger 1459 reporting of processing and use information. Of those, almost thirteen percent contained no 1460 industrial processing and use information and almost half contained no commercial or consumer 1461 use information. For the reports that did contain some processing and use information, the 1462 portion of the production volume for which some information was reported is detailed in Table 4. 1463 Note that an IUR Form U submission contains one or more reports; each report is for a single 1464 chemical at a single site. 1465

1466 Table 4: Percentage of reports providing production volume information related to 1467 processing and use of chemicals reported for the 2006 IUR. 1468

Extent of Processing and/or Use Information Provided Based on Production Volume Reporting Industrial Processing and Use

(% of reports*) Consumer and

Commercial Use (% of reports*) No processing and use information reported 13 46 Processing and/or use information provided, but the associated % PV information reported as zero, NRO, or

left blank 6 12

% PV associated with the reported processing and/or

use information accounted for more than 0% but less than 50% of the manufactured (including imported) production volume 4 7

% PV associated with the reported processing and/or

use information accounted for 50% but less than 100% of the manufactured (including imported) production

volume 65 32

% PV associated with the reported processing and/or

use information accounted for 100% or more of the manufactured (including imported) production volume 12 3

* The percentage is calculated as a fractio n of the total number of reports that triggered the need to report processing 1469

and use information. 1470

1471*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

35 of 84 The Agency believes the percentage of missing processing and use information actually 1472 is larger than indicated by this analysis. As described in the 2003 Amendments final rule (68 FR 1473 861), EPA anticipated that, on an individual report basis, the total percentages of production 1474 volumes associated with the industrial processing or use information may add up to more than 1475 100 percent of the reported production volume. This could happen because the submitter 1476 reported on the distribution of a chemical to sites in its control as well as downstream sites, some 1477 of which were not immediate purchasers from the original manufacturing site. For example, 1478 consider the scenario where a certain volume of a reported chemical is reported as processed by a 1479 repackager, sent to another site that adds the chemical to a mixture, and then sent to a 1480 combination of industrial and commercial users. If the repackaged volume were 100 percent of 1481 the production volume, the total volume reported for the different processing and use scenarios 1482 could equal 300 percent of the production volume. EPA expected and anticipated this type of 1483 reporting, as each instance of processing or using the chemical created a different exposure 1484 scenario. As indicated in Table 4, only 12 percent of the reports contained processing and use 1485 information that equaled or exceeded the production volume for their chemical. EPA expected 1486 this percentage to be significantly larger. 1487

1488 Focusing on the industrial processing and use information, a complete use scenario is 1489 comprised of three of the IUR data elements: the type of process or use, the NAICS codes, and 1490 the industrial function code. A report could contain up to ten unique combinations of these three 1491 data elements (i.e., use scenarios). For the reports required to include processing and use 1492 information in 2006, submitters reported an average of slightly more than two use scenarios. For 1493 each unique combination of these three data elements, the manufacturer reports the percent 1494 production volume, the number of sites, and the number of reasonably likely to be exposed 1495 workers associated with the use scenario. In 2006, only about half of the reported use scenarios 1496 also included information for the number of sites, the number of workers, and a production 1497 volume that was greater than zero. 1498

1499 Reports for consumer and commercial use information included a product category, 1500 and, for that category, whether the chemical is used in products intended for children, the percent 1501 production volume, and the maximum concentration. A report could contain up to ten product 1502 categories. For the reports that were required to include processing and use information in 2006, 1503 submitters reported an average of slightly less than one product category. Much of the consumer 1504 and commercial information contained data elements reported as not readily obtainable 1505 (NRO) or were left blank. Specifically, 14 percent of product category information, 24 percent 1506 of children’s information, and 40 percent of the maximum concentration were either reported as 1507 NRO or left blank. Overall, fewer than half of the consumer and commercial records (i.e., the 1508 individually reported product categories and associated information) contained complete data 1509 (e.g., where none of the data elements contained information reported as zero, NRO, or were left 1510 blank). 1511

1512 This low reporting rate also occurred on an individual chemical basis; 2006 IUR 1513 submitters did not report processing and use information even though they were required to 1514 report such information. This happened for 20 percent of the chemicals for which the criteria for 1515 reporting processing and use information were met. For those chemicals, EPA has no processing 1516 or use information reported through the IUR rule. 1517

1518*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

36 of 84 EPA is proposing this change to the reporting standard because reporting under the 1519 “readily obtainable” reporting standard did not generate sufficiently complete processing and use 1520 information, which limited the usefulness of the 2006 IUR processing and use data for screening 1521 level reviews. EPA believes the “readily obtainable” reporting standard was a major reason for 1522 the small amount of reporting processing and use data. 1523

1524 For over 30 years, the Agency’s New Chemicals Program has successfully applied the 1525 “known to or reasonably ascertainable by” reporting standard. (See 40 CFR 720.45) Companies 1526 have used this standard to report to EPA information about how their chemicals are processed 1527 and used by submitting more than 30,000 TSCA section 5 Premanufacture Notices (PMNs). 1528 Because of this experience, EPA believes that companies routinely have more information about 1529 how their chemicals are processed and used than is reflected in the 2006 IUR data. PMNs 1530 routinely include extensive, detailed information on how a company’s customers and others 1531 outside the company’s control will process and use its chemicals. EPA believes that the 1532 reporting under the Agency’s New Chemical program indicates that companies generally do 1533 know the intended ultimate uses, as well as the intervening processing steps, for their products. 1534 In addition, EPA’s experience in the New Chemicals Program indicates that this reporting 1535 standard generates information sufficient for screening-level reviews. Therefore, the Agency 1536 believes that using this standard for reporting of IUR industrial processing and industrial, 1537 consumer, and commercial use information will improve reporting rates and assist EPA’s efforts 1538 to characterize chemical uses and to predict potential exposure to these chemicals. 1539

1540 The Agency’s experience using the 2006 IUR data to develop exposure 1541 characterizations, coupled with the limited data EPA was able to publicly release, highlighted the 1542 incompleteness of the data and lead the Agency to determine that the data are insufficient, even 1543 for screening level purposes. Examples of documents using EPA’s exposure characterizations 1544 can be found on the Agency’s web site, at 1545 http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML. Effective risk 1546 screening by EPA depends on the ability to accurately characterize chemical uses and to predict 1547 potential exposures. As described in Unit II.D, these data are used by EPA to prioritize work on 1548 existing chemicals. If the information provided does not include these data, EPA must make 1549 assumptions about the use of the unreported production volume. Incorrect assumptions may lead 1550 EPA to designate an inappropriately high or low priority level for the chemical, resulting in 1551 unnecessary effort and resource expenditures for both regulated parties and EPA in cases where 1552 more complete data would have led the Agency to act differently. 1553

1554 For the foregoing reasons, EPA believes that using the reporting standard “known to or 1555 reasonably ascertainable by” would result in companies reporting more consistent and complete 1556 processing and use information in their IUR reports, and that the information reported would 1557 better enable EPA to develop the exposure characterizations needed for the Agency’s screening 1558 of existing chemicals. EPA requests comment on whether and how this change will affect 1559 submitter behavior and the degree to which the quality of submissions will be improved. 1560

1561

H. Amendments to Requirements Concerning Confidential Business Information claims 1562

1563 Submitters may currently claim certain information reported under the IUR as confidential 1564 business information (CBI) in accordance with 40 CFR part 2 and IUR rules at 40 CFR 710.38 1565 (proposed 40 CFR 711.18). Submitters must assert claims of confidentiality at the time 1566*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

37 of 84 information is submitted to EPA. EPA’s procedures for handling information claimed as 1567 confidential are set forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to 1568 review confidentiality claims carefully to ensure that the information in question falls within the 1569 parameters of TSCA section 14. CBI claims should be limited to only those data elements the 1570 release of which would likely cause substantial harm to the business’ competitive position. 1571 Interested persons are reminded that with regard to chemical use information, EPA is interested 1572 in aggregated, general uses, not detailed uses associated with specific customers. 1573

1574 To claim information as confidential, a submitter must both indicate its claim by both 1575 checking the appropriate box and signing the certification statement on the reporting form. A 1576

submitter must indicate its claims at the time the information is submitted. If a submitter fails to 1577 follow these procedures, EPA may release the information to the public without further notice to 1578 the submitter. By signing the certification st atement the submitter attests to the secrecy and 1579 value of the information for which confidentiality claims have been asserted. 1580

1581 EPA expects that reducing the number of CBI claims would increase the amount of 1582 information available to the public and improve the timeliness of its public availability. As a 1583 result, the Agency would be able to publicly discuss and explain its risk management actions and 1584 decisions more clearly. Currently, much of the factual and data support for Agency decisions is 1585 claimed as CBI, which complicates the creation of publicly available documents. The public 1586 would be better informed and better able to understand and provide meaningful comment on 1587 Agency actions if less information were unnecessarily or inappropriately claimed as CBI. The 1588 Agency would also be able to provide other public and private organizations and individuals with 1589 better information for making their own decisions. Thus, EPA is proposing the changes 1590 described in sections H.1., H.2., and H.3. with the belief that the proposed changes would reduce 1591 the number of unjustifiable CBI claims without hindering legitimate CBI claims

. 1592

1593 1. Chemical identity CBI claims 1594

1595 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 1596 the identity of the reported chemical substance when the chemical is listed on the confidential 1597 portion of the Master Inventory File and when the submitter provides the required substantiation 1598 at the time the submitter makes the confidentiality assertion. See 40 CFR 710.58(b) (proposed 1599 40 CFR 711.18(b)). At times a submitter will assert a claim of confidentiality for the chemical 1600 identity of a substance that is listed on th e public portion of the Master Inventory File. Where 1601 the identity of a chemical substance is already contained on the public portion of the TSCA 1602 Chemical Substances Inventory, which is publicly available from the National Technical 1603 Information Service, EPA's website 1604 (http://www.epa.gov/opptintr/newchems/pubs/invntory.htm#files) and other sources, EPA 1605 believes that the identity itself, even assuming it might otherwise be CBI, as well as any 1606 information that might be derived from it about processes or portions, has already been 1607

disclosed. EPA is proposing that, when this occurs, the Agency may make the information 1608 available to the public without further notice to the submitter. See the proposed regulatory text 1609 at 40 CFR 711.18(e). 1610

1611 This action is part of a broader effort to increase transparency and provide more valuable 1612 information to the public by identifying programs where non-CBI may have been claimed and 1613 treated as CBI in the past. See 75 FR 3462, published on January 21, 2010, for a similar change 1614*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

38 of 84 concerning CBI claims of certain chemical identities submitted under TSCA Section 8(e). 1615

1616 2. Upfront substantiation for processing and use information CBI claims 1617

1618 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 1619 the processing and use of its chemical if the submitter has reason to believe that release of the 1620 information would reveal trade secrets, or confidential commercial or financial information, as 1621 provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made 1622 confidentiality claims ranging from 25 percent (when considering individual data elements) to 50 1623 percent (when considering data elements combined into use scenarios) of the reported processing 1624 and use information. While the Agency does not question that confidentiality claims are 1625 sometimes necessary, it encourages submitters to consider carefully whether such claims are in 1626 fact necessary before asserting them. The Agency has identified instances in which submitters 1627 have claimed the processing and use data as confidential, yet similar if not identical information 1628 was found in publicly available sources, such as company websites, published Material Safety 1629 Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s 1630 HPVIS website (see Unit II.D for more discussion). Note that EPA can take steps to challenge or 1631 verify confidentiality claims , but . T t he Agency believes companies should limit their CBI 1632 claims to those that they are capable of adequately substantiating. 1633

1634 For the 2006 IUR reports, submitters were not required to provide upfront substantiation 1635 of CBI claims for processing and use data. In these proposed modifications to the IUR rule, EPA 1636 would require upfront substantiation for CBI claims for this information. 1637

1638 EPA believes that many of the CBI claims for processing and use data are inappropriate 1639 and that the new substantiation requirement would reduce the occurrence of unnecessary claims. 1640 The high number of confidentiality claims asserted for the reported 2006 IUR reports on 1641 industrial processing and use information impeded the release of important data. This included 1642 the number of processing sites, the number of potentially exposed industrial workers, and the 1643 percent production volume for each industrial processing or use scenario. (Ref. 10) A decrease 1644 in the number of inappropriate CBI claims under the new substantiation requirement would 1645 improve EPA’s ability to make current plant site information available to other Federal agencies 1646 and the public because more information submitted under IUR could be released publicly. 1647

1648 Under this proposed rule, in order to submit a claim of confidentiality for processing and 1649 use information data elements, the submitter would be required to both check the appropriate box 1650 on the reporting form and substantiate the claim in writing by answering certain questions 1651 provided in § 711.18(d) of the proposed rule. Where a submitter fails to substantiate the 1652 processing and use CBI claim in accordance with the applicable rules (i.e., the submitter does not 1653 provide an answer to the required questions) , EPA would consider the information not subject to 1654 a confidentiality claim and may make the information available to the public without further 1655

notice to the submitter. 1656

1657 3. Limitation on confidentiality claims for data elements identified as “not known 1658 or reasonably ascertainable” 1659

1660 Under the IUR rule, submitters provide information on the industrial processing and use 1661 and consumer and commercial use of the IUR reportable chemicals they manufacture (including 1662*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

39 of 84 import). As described in Unit II.A, for the 2011 and future IUR collections, EPA is proposing 1663 that submitters be required to report this information to the extent that it is known to or 1664 reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the 1665 processing and use information to the extent that it was readily obtainable, and were permitted to 1666 identify when such information was not readily obtainable by entering “NRO.” EPA has 1667 observed that, on occasion, processing and use information has been claimed as confidential 1668

when a submitter determined that the in formation was not readily obtainable. 1669

1670

TSCA section 14 limits the disclosure of information entitled to confidential treatment 1671 under Exemption 4 of FOIA. EPA has considered the NRO designation and its relationship to a 1672 potential CBI or trade secret claim. Given that a NRO assertion is an assertion that no 1673 information is available, the Agency does not believe that the designation conveys trade secret or 1674 confidential commercial or financial information. For this reason, EPA is proposing to prohibit 1675 claims of confidentiality pertaining to the designation that information is not “known to or 1676 reasonably ascertainable by” the submitter. EPA solicits comment on this issue. 1677

1678

I. Modifications Specifically Affecting Importers 1679

1680 Submitters report IUR data on chemicals that they manufacture domestically and that 1681 they import into the United States. Current IUR re gulations provide that the site responsible for 1682 reporting for imported chemicals is the site of the operating unit that is directly responsible for 1683 importing the substance and that controls the import transaction. In some cases, the import site 1684 may be the organization’s headquarters in the United States. The regulations defining the site for 1685 importer reporting is found in both the definition for site in 40 CFR 710.3 and in paragraph 40 1686 CFR 710.48(b). 1687

1688 EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving 1689 the additional information regarding the importer site from § 710.48(b) into a revised definition 1690

for site , as described in Unit III.C.2. of this preamble, and eliminating § 710.48(b). 1691

1692 In addition, EPA has observed that submitters occasionally use a foreign address as the 1693 site address for the importer. EPA now is proposing to require that submitters report a U.S. site 1694 address, by modifying the definition for site to state specifically that the site must be a U. S. site. 1695 The U.S. address of an agent acting on behalf of the importer, and authorized to accept service of 1696 process for the importer, may be reported as the importer’s site address if the operating unit that 1697 is directly responsible for importing the substance and that controls the import transaction has no 1698 U.S. address. The Agency expects that all importers will have a U.S. site, as defined in the 1699 proposed 40 CFR 711.3 definition for site because, under Customs regulations at 19 CFR 141.18, 1700 a non-resident corporation is not permitted to enter merchandise for consumption unless it has a 1701 resident agent in the State where the port of entry is located, who is authorized to accept service 1702 of process against the corporation. 1703

1704 For purposes of IUR, submitters are curr ently allowed to report the IUR information 1705 jointly with the foreign manufacturer of the chemical. Importers may not know the specific 1706 chemical identity of a substance because the foreign supplier chooses to keep it confidential. In 1707 such a situation, the importer is still respon sible for ensuring that the IUR information is 1708 submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the 1709 primary submitter, completes the majority of the required information, but supplies a trade name 1710*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

40 of 84 or other designation to identify the chemical su bstance. In addition, the primary submitter 1711 provides technical contact information for the foreign supplier. The primary submitter then 1712 contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the 1713 specific chemical identity information to EPA. In addition to the chemical identity, the 1714 secondary submitter supplies its technical contact and company information but provides the 1715 primary submitter’s site information. The secondary submitter should also provide the upfront 1716 substantiation required for any confidentiality claims for chemical identity. 1717

1718 Under this proposed rule, the process would be the same, except that submitters would 1719 be required to use CDX and e-IUR web for preparation and submission of joint submissions. See 1720 proposed 40 CFR 711.12(b)(3)(i). Previously, joint submissions could not be made 1721 electronically. In order to submit electronically to EPA via CDX, individuals must first register 1722 with CDX. Therefore, the authorized officials of the jointly submitting companies would need to 1723 register in order to submit their reports to EPA. The secondary submitter (e.g., a foreign supplier 1724 or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., 1725 the importer’s) authorized official to send joint submissions to EPA. 1726

1727 For joint submissions to be submitted electronically, the primary submitter would use e1728

IUR web to identify the need to submit a joint repo rt and would identify itself as a primary 1729 submitter. The primary submitter would then complete his or her portion of the report and 1730 provide the secondary submitter's company information, along with select information on the 1731 chemical substance(s) that are manufactured using a chemical substance made by the secondary 1732 submitter. The primary submitter reports only the volume that it used. A secondary submitter 1733

would also need to use e-IUR web to identify the need to submit a joint report and would identify 1734 itself as a secondary submitter. It would provide the primary submitter’s company information 1735 and its own technical contact information, and would identify the chemical substance(s) that is in 1736 its product, including the percentages. This information would be saved by the reporting tool 1737 and both submissions would be matched based upon company and chemical information. Once 1738 the forms are matched, the joint submission would be ready to be processed by EPA. The 1739 Agency is currently developing the process to submit joint reports electronically and welcomes 1740 any comments concerning this process. 1741

1742 For the 2006 IUR submission period, EPA set aside joint submissions until both reports were 1743 received and matched. Oftentimes, EPA had no way to determine whether a submission was a 1744 “joint” submission, which increased the time required for manual processing of the data. EPA 1745 anticipates that the use of the reporting tool wi ll help to make joint IUR reporting easier for 1746 industry and streamline EPA processing of the IUR information submitted in the 2011 1747 submission period. 1748

1749

J. Change to Reporting Frequency 1750

1751 Prior to the 2003 Amendments, the IUR collection occurred every four years. EPA reduced 1752 the reporting frequency from every four years to every five years starting with the 2006 IUR to 1753

reduce the burden associated with the amended IUR rule. For the reasons described in this 1754 section, the Agency has determined that reporting every five years is too infrequent, and now is 1755 proposing to return to reporting every four years. 1756

1757 As described in Unit III.D.1, a review of the previous reporting under IUR has revealed an 1758*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

41 of 84 approximately 30 percent change in the chemicals that are reported from one submission period 1759 to the next. While the less frequent reporting does reduce burden, EPA now believes that 1760 reporting every five years does not provide data sufficiently current to meet Agency and public 1761

needs. As described in Unit V. 2.a 3.i , the Agency has been criticized for using outdated 1762

information. For instance, in its “Across the Pond” publication, the Environmental Defense 1763 Fund (EDF) stated “Given the dynamic nature of the chemical market, both from year to year 1764 and between 2005 and the present, some of the data we report here on chemicals, their 1765 production/import volumes and their associated companies may well have changed.” (See 1766 http://www.edf.org/documents/8538_Across_Pond_Report.pdf). EPA, therefore, also is 1767 considering increasing the frequency of reporting to every three years, or possibly to annual 1768 reporting. The Agency believes that efficiencies are gained with more frequent reporting, both 1769 for the submitter and for EPA. With more frequent reporting, companies would be able to 1770 establish standard systems and practices to collect the required information. For instance, for 1771 annual reporting the Agency estimates that submitters would reduce the burden for each 1772 reporting cycle by approximately 20 percent. (See Chapter 4 of the Economic Analysis, Ref. 11). 1773 EPA invites comment on the proposed return to four-year reporting intervals, and also on more 1774 frequent reporting (i.e., every three years, biennial, or annual reporting). Further information is 1775 provided in Question 2.a 3.i under Unit V, and the various reporting frequency alternatives are 1776 analyzed in the Economic Analysis. (See Chapter 4 and Appendix G of the Economic Analysis, 1777 Ref. 11) 1778

1779 IV. Clarifications to Reporting Requirements 1780

1781

A. Clarification of the relationship between company name and site ID CBI claims 1782

1783 Under the IUR, submitters are able to claim as CBI both the company name and site 1784 identity associated with a chemical for which they are reporting under the IUR. The submitter is 1785 required to provide an upfront substantiation for CBI claims for the site identification. EPA 1786

believes there is some confusion as to what is considered confidential when such claims are 1787 made, and is taking this opportunity to provide clarification. 1788

1789

The e-IUR web reporting software does not allow for blanket CBI claims for company 1790 and site identification information, since those are separate claims and in some cases one type of 1791 claim may be justified while the other is not. Rather, a submitter is permitted to assert its CBI 1792 claim for the company identity, the site identity, or both the company and site identity associated 1793 with each chemical for which they are submitting an IUR report. In addition, the submitter must 1794 provide separately the required upfront substantiation for the site identity CBI claims associated 1795 with each chemical. For instance, if the submitter is reporting for five chemicals and wishes to 1796 claim its site information confidential for three of the five chemicals, it must assert the claim and 1797 provide separate upfront substantiation three times, once for each of the three chemicals. The 1798 CBI claim protects the link between the company and/or site identification and the particular 1799 chemical substance. If the company or site identity associated with a particular chemical is not 1800 claimed as CBI, EPA may make that information available to the public without further notice to 1801 the submitter. EPA will not impute the existence of a CBI claim for company identity or for site 1802 identity from a CBI claim associated with a different chemical. 1803

1804 EPA has also observed that submitters sometimes claim only their company identity, and 1805 not their site identity, as confidential. If the site identity for a particular chemical is not claimed 1806*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

42 of 84 as CBI, or is claimed but not substantiated pursuant to 40 CFR 710.58(c) (proposed 40 CFR 1807 711.18(c)), EPA may make that information available to the public without further notice to the 1808 submitter. EPA will not impute the existence of a CBI claim for site identity from a CBI claim 1809 for company identity, even if the company name appears within the site identity information. To 1810 help ensure that submitters consider th is issue, EPA plans to modify the e-IUR web reporting 1811 software so that it will provide a warning whenever the company identity is claimed as CBI for a 1812 particular chemical and the site ID is not also claimed as CBI for that chemical. 1813

1814

B. Explanation of byproduct reporting. 1815

1816 During the 2006 submission period, EPA received questions about the requirements for 1817 reporting byproducts, including whether byproduct manufacturers were required to report the 1818 byproducts under the IUR rule. These included some questions involving a manufacturer that uses 1819 a chemical in the production of an article. Such manufacturing may produce a byproduct 1820 substance that is chemically different from the starting substance; the manufacturer therefore 1821 may incur reporting obligations under the IUR rule for that byproduct. The Small Business 1822 Administration (SBA) also communicated with EPA about related issues and questions, 1823 including ideas on how they could be potentially addressed (Ref. 18). Generally, the concerns 1824 included how to identify byproduct chemical substances, especially when such substances were 1825 complex and variable mixtures; concerns about the manufacturer's ability to determine the 1826 recycler's use of the byproduct; and identifying the need to report, especially when the 1827

manufacturer does not consider it self a chemical manufacturer. In light of these and similar 1828 questions, EPA is providing detailed further additional information on byproduct reporting, 1829 including circumstances under which reporting is not required, in the draft instruction manual 1830 and in other guidance materials included in the docket for this rule

. (Ref s . 2 , 16, and 17 ) in an 1831 effort to further clarify reporting obligations. 1832

1833 For purposes of IUR, a byproduct is a chemical substance produced without a separate 1834 commercial intent during the manufacture, proc essing, use or disposal of another chemical 1835 substance or mixture (40 CFR 704.3). Thus, for example, when a chemical substance or mixture 1836 is used for the purpose of manufacturing an article, and that manufacture results in the 1837 production of a different chemical substance, that different chemical substance is a byproduct for 1838 purposes of the IUR. Chemical substances that are byproducts of the manufacture, processing, 1839 use, or disposal of another chemical substance or mixture, like any other manufactured chemical 1840 substances, are subject to IUR reporting if they are manufactured, are listed in EPA’s Master 1841 Inventory File, are not otherwise excluded from reporting, and their manufacturer is not 1842 specifically exempted from IUR reporting requirements. 1843

1844 For purposes of IUR, a byproduct is “manufactured” only if it is “manufactured for 1845 commercial purposes.” See TSCA section 8(f). The 40 CFR 704.3 definition of manufacture for 1846 commercial purposes states that “[m]anufacture for commercial purposes also applies to 1847 substances that are produced coincidentally during the manufacture, processing, use, or disposal 1848 of another substance or mixture, including both byproducts that are separated from that other 1849 substance or mixture and impurities that remain in that substance or mixture. Such byproducts 1850 and impurities may, or may not, in themselves have commercial value. They are nonetheless 1851 produced for the purpose of obtaining a commercial advantage since they are part of the 1852 manufacture of a chemical product for a commercial purpose.” Thus, byproducts of the 1853*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

43 of 84 manufacture, processing, use, or disposal of another substance or mixture for a commercial 1854 purpose are themselves both "manufactured" and "manufactured for commercial purposes." 1855

1856 As with all manufactured chemicals, IUR information on byproduct chemicals is of 1857 interest to the EPA because such exposure-related information is not otherwise available, and it 1858 is necessary for the Agency to manage risks associated with these chemicals, to fulfill its 1859 mandate of protecting human health and the environment. EPA does not believe byproducts 1860 inherently pose lower exposures or risks than other manufactured chemicals. 1861

1862 Byproducts that are manufactured in volumes of 25,000 lb. or more at a single site are 1863 potentially subject to IUR requirements. However, 40 CFR 710.50(c) (proposed 40 CFR 1864 711.10(c)) excludes from reporting those substances meeting the requirements of §§ 720.30(g) or 1865 (h). Manufacturers (including importers) of byproducts are not required to report the 1866 manufacture of a byproduct if the byproduct is not used for commercial purposes. See 40 CFR 1867 720.30(h)(2). Thus, even where a byproduct is manufactured for a commercial purpose, if the 1868 byproduct is not subsequently put to use for another commercial purpose, the byproduct is 1869 excluded from IUR reporting. Furthermore, if the byproduct’s “only commercial purpose is for 1870 use by public or private organizations that (1) burn it as a fuel, (2) dispose of it as a waste, 1871 including in a landfill or for enriching soil, or (3) extract component chemical substances from it 1872 for commercial purposes,” 40 CFR 720.30(g), that byproduct is also excluded from IUR 1873 reporting. This exclusion applies only to the byproduct; it does not apply to the component 1874 substances extracted from the byproduct. 1875

1876 Some manufacturers of byproducts have expressed a belief that a substance that is 1877 regulated by another EPA program, such as the Resource Conservation and Recovery Act 1878 (RCRA), or that is exempt from certain requirements by the other program based on certain 1879 treatments or disposals, should not be required to be reported for IUR purposes. However, when 1880 such substances have a commercial purpose not exempted by 40 CFR 710.50(c) (proposed 40 1881 CFR 711.10(c)), the manufacturer of such a substance does need to consider IUR requirements. 1882

1883 EPA requests comment on the draft guidance documents included in the docket for this 1884

rule and on how best to inform companies that may not consider themselves to be manufacturers 1885 of chemical substances of their potential need to report. In addition, EPA requests comment on 1886 how the substantive modifications of the IUR described in this proposed rule could be further 1887 modified to minimize reporting burden and costs for byproduct manufacturers and recyclers, 1888 while still collecting the exposure-related inform ation needed to fulfill EPA’s mandate. 1889

1890

1891 V. Request for Comment 1892

1893 EPA requests comment on all substantive modifications of the IUR described in this 1894 proposed rule, all available alternatives that bear on such modifications, and the economic 1895 analysis prepared in support of this proposed rule (Ref. 11). T he f F ollowing is a list of 1896

additional issues on which the Agency is specifically requesting public comment , in addition to 1897 those noted in Unit III of this preamble . EPA encourages all interested persons to submit 1898 comments on these issues, and to identify any other relevant issues as well. This input will assist 1899 the Agency in developing a final rule that successfully addresses information needs while 1900 minimizing potential reporting burdens associated with the rule. EPA requests that commenters 1901*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

44 of 84 making specific recommendations include supporting documentation where appropriate. 1902

1903 1) EPA anticipates promulgating a final rule by the spring of 2011. Recognizing that this would 1904 be shortly before the next scheduled submission period (scheduled to run from June 1, 2011 1905 through September 30, 2011), EPA solicits comment on the transition to new IUR 1906 requirements . Specifically, EPA would conduct the 2011 reporting based on the full set of 1907 data elements specified in this proposed rule (if finalized as proposed)

. and domestic 1908 manufacturing and import volume information from the calendar years since the previous 1909 principal reporting year (e.g., reporting in 2011 information based on years 2006, 2007, 1910 2008, 2009, and 20 10), or as specified in the final rule. Further reporting cycles would then 1911 recur every four years (or other interval as specified in the final rule), along the same lines 1912 and with the addition of determining compliance obligations based on manufacturing and 1913 import volume from the calendar years since the previous principal reporting year (e.g., 1914 reporting in 2015 information based on years 2011, 2012, 2013, and 2014). EPA is also 1915 considering changing the existing 2011 submission period to another four-month period later 1916

in 2011. 1917

1918 2) As discussed in Unit II.E, EPA is increasing its emphasis on assessing, prioritizing, and 1919 taking action on existing chemicals that pose unreasonable risks, with particular emphasis on 1920 protecting children. EPA is interested in receiving comments regarding how to utilize use 1921 IUR data, including how to amend the rule, to best assist in this effort. Similarly, EPA seeks 1922 comment on how to tailor more narrowly the substantive modifications to the IUR contained 1923 in this proposal so as to avoid gathering information which EPA or the public would not be 1924

able to use. 1925

1926 3) Through the IUR, EPA collects information on chemicals for which the Agency is most 1927 likely to have an interest. Accordingly, to minimize reporting burdens, EPA developed 1928 exemptions from the IUR. From time to time, EPA adjusts these reporting exemptions in 1929 order to address its chemical management program needs. 1930

1931 In response to public comments received in response to the 1985 proposed IUR rule (50 1932 FR 9944, March 12, 1985), EPA established certain exclusions from these exemptions (51 FR 1933 21438, June 12, 1986). The exclusions were to ensure the Agency receives IUR information on 1934 chemical substances that are of interest to the Agency. The introductory paragraph to 40 CFR 1935 710.46 (proposed 711.6) identifies that chemical substances that are the subject of proposed or 1936 promulgated section 4, 5(a)(2), 5(b)(4), or 6 rules are excluded from the chemical substance 1937 exemptions listed in the section. The introductory paragraph to 40 CFR 710.49 (proposed 711.9) 1938 identifies that small manufacturers of chemical substances that are the subject of proposed or 1939 promulgated section 4, 5(b)(4), or 6 rules are excluded from the small manufacturer exemption 1940

listed in the section. 1941

1942 As identified in Unit II.D., EPA's Administrator has made it a priority to strengthen the 1943 Agency’s chemicals management program. EPA uses IUR information on proposed rule 1944 chemicals to inform final regulations, especially with respect to accurately responding to public 1945 comments; to determine the need for actions supplementing proposed rules, such as voluntary 1946 programs; to provide up-to-date, definitive identities of companies manufacturing (including 1947 importing) chemicals potentially subject to a final rule; and to provide up-to-date, accurate 1948 information to the public about chemical substances for which the Agency has expressed an 1949 Formatted: Bullets and Numbering*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

45 of 84 interest. For example, five chemicals were excl uded from the final OSHA dermal test rule (69 1950 FR 22402, April 6, 2004) because IUR data collected indicated that there was no longer 1951 substantial production. 1952

1953 EPA is interested in receiving comments on whether EPA should continue to include 1954 chemical substances that are the subject of proposed rules in the list of exclusions at 40 CFR 1955 710.46 (proposed 711.6) and 40 CFR 710.49 (proposed 711.9). If the proposed rule exclusion 1956 were no longer available, should EPA consider removing some or all of the reporting 1957 exemptions? This would allow EPA to obtain information on those chemicals for which it is 1958 considering analysis or regulation, but which would otherwise be exempt. EPA also is interested 1959 in receiving comments on whether the Agency should: (1) add new exclusions to reporting 1960 exemptions; (2) entirely eliminate certain reporting exemptions under circumstances other than 1961 those described in the previous paragraph; or (3) leave the exclusions from the reporting 1962 exemptions unchanged. 1963

1964 3) 4) The proposals discussed in Unit III.D. 3 1 would result in a site reporting data on subject 1965 chemical substances exceeding the 25,000 lb. threshold for any calendar year since the last 1966 principal reporting year. The site would report manufacturing (including production 1967 volume), processing, and use information for the principal reporting year (e.g., 2010), as well 1968 as production volume information for all the years since the last IUR principal reporting year 1969 (i.e., 2006 through 2009, for principal reporting year 2010). In developing this proposal, 1970 EPA considered several other reporting options and is seeking comment on these options, 1971 which are described in paragraph ( 2 3 )(i) , (3)(ii), and ( 2 3 )(ii i ) of this section. 1972

1973 i) EPA is proposing to return the reporting frequency to four years and is 1974 considering further increasing the frequency to every three years, biennially, or 1975 annually. (See Ref. 11 for burden and cost information.) More frequent reporting 1976 provides more current data. Eliminating the five-year wait for current information 1977

would address concerns that IUR data is outdated and therefore less useful than if it 1978 were more current. EPA is particularly interested in the annual reporting option for 1979 several reasons. Annual reporting would enable EPA to better analyze trends, 1980 including ascertaining which chemicals are manufactured on a consistent basis, 1981 which chemicals have wide variations from year to year, and which chemicals are 1982 increasing or decreasing in volume. Trend analyses measure the success of 1983 programs and can be used to proactively identify developing issues and generally 1984 provide a greater insight into the chemical industry. Obtaining this information 1985 annually, instead of the proposed option of reporting four years of production 1986 volume at one time, would allow for closer monitoring of trends and the more 1987 timely feedback on the success of programs than would be possible under the 1988 proposed option

. , although if processing and use data changes little year-on-year, 1989 it could significantly raise the burden of the IUR on submitters without providing 1990 EPA or the public with information benefits. In addition, annual reporting would 1991 provide the opportunity to tie-in more closely or actually integrate IUR reporting 1992 with the already-required annual Toxic Release Inventory (TRI) reporting. 1993

1994 ii) EPA requests comment on whether the reporting frequency should remain five 1995 years and whether the proposed requirement for annual production data resolves 1996 concerns that IUR data is outdated for its intended purpose. What is the marginal 1997 Formatted: Bullets and Numbering

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46 of 84 value of processing and use data gathered every four years versus every five years? 1998

1999 ii) iii) EPA is also interested in comments regarding changing the reporting 2000 threshold from 25,000 lb. to 10,000 lb., but is not including this change in the 2001 regulatory text accompanying this proposal. (See Ref. 11 for burden and cost 2002 information.) Prior to the 2006 IUR, the threshold for determining the need to 2003 report was 10,000 lb., therefore this change in the reporting threshold would be a 2004 return to the status quo for the IUR. The Agency is interested in collecting 2005 information on chemicals with nationally aggregated production volumes of 25,000 2006 lb. or higher. Because chemicals are often manufactured at more that one site, 2007 chemicals with site-specific production volumes that fall below the 25,000 lb. 2008 reporting threshold and therefore would not be reported for IUR may have 2009 aggregated production volumes of 25,000 lb. or greater. Are there other thresholds 2010 (higher or lower) that might be appropriate? 2011

2012 5) EPA requests comment on the draft economic analysis to evaluate whether the proposed 2013 collection of information is necessary for the proper performance of the functions of the 2014 Agency, including whether the information will have practical utility. 2015

2016 6) EPA requests comment on the accuracy of the Agency's estimate of the burden of the 2017 proposed collection of information, including the validity of the methodology and 2018 assumptions used. 2019

2020 7) EPA requests comment on how the portions of substantive proposed revisions to the IUR 2021

prop o sed for substantive revision could be further modified to enhance the quality, utility, 2022 and clarity of the information to be collected. 2023

2024 8) EPA requests comment on how best to minimize the burden of collecting information from 2025 those persons required to respond, including through the use of appropriate automated, 2026 electronic, mechanical, or other technological collection techniques or other forms of 2027 information technology, e.g., permitting electronic submission of responses. 2028

2029 8) 9) EPA is considering collecting additional exposure-related data, similar to those collected 2030 under TSCA section 5 (new chemicals program), to enhance the Agency’s capabilities in 2031 conducting screening-level exposure assessments of chemical substances reported to the 2032 TSCA Inventory Update. 2033

2034 EPA, through its experience in using the IUR exposure-related and use information, has 2035 learned that the current IUR data are not sufficient for determining quantitative estimates of 2036 releases of and exposures to chemical substances. As a result of the available 2006 IUR data, 2037 EPA could develop only qualitative exposure characterizations with relative ranking of low, 2038 medium or high for characterizing potential exposures to various populations. While the 2039 usefulness of these data was limited because data were only partially reported (see Unit III.G.), it 2040 was also limited because the specific data elements, as included in the 2006 IUR, were not 2041 detailed and comprehensive enough to enable EPA to generate a more robust estimate. For 2042 instance, the function and use categories used for processing and use information were broad, 2043 and the reported production volume information was insufficient to identify the volumes of 2044 chemical used at the manufacturing site or domestically processed or used . The Agency believes 2045 Formatted: Bullets and Numbering

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47 of 84 the proposed rule text changes will improve its ability to identify and manage risks associated 2046 with existing chemicals, but also believes that supplementary, more in-depth exposure-related 2047 information (i.e., beyond the elements under the rule text currently accompanying this proposal) 2048 would substantially improve EPA’s ability to quantify chemical risks. The ability to quantify 2049 chemical risks would further improve the Agency’s ability to identify and manage those risks. 2050 EPA therefore believes that, while the changes included in the proposed regulatory text address 2051 the limitations associated with qualitative character izations, further changes would be needed to 2052 enable the more quantitative estimates. 2053

2054 If additional data identified below were to be reported, EPA could use currently available 2055 assessment tools and methodologies to develop screening-level estimates of chemical 2056 environmental releases and concentrations to various environmental media (including air, water, 2057 and land) and exposures to the potentially exposed populations (such as workers, consumers, 2058 children, and the general population). Examples of the tools and methodologies include the 2059 Agency's Chemical Screening Tool For Expo sures & Environmental Releases (ChemSTEER) 2060 (Ref. 14) and Exposure and Fate Assessment Sc reening Tool (EFAST) (Ref. 15). The Agency 2061 anticipates that the improved screening-level exposure assessments would be similar to what is 2062 developed for new chemical substances submitted to the Agency for review to identify chemicals 2063 of concern and potential risk management. The Pre-Manufacturing Notice (PMN) Program 2064 Form 7710-25 (available at: http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm) was 2065 used to develop the following list of additional potential exposure-related data elements and their 2066 brief descriptions: 2067

2068 Manufacturing Process: 2069 Description of manufacturing

process Provide a process flow diagram which describes the manufacturing operations involving the chemical substance. “Manufacturing operation” means a functional step in which substances undergo chemical changes and/or changes in location, temperature, pressure, physical state, or similar characteristics. Include steps in which the substance is formulated into gels, mixtures, suspensions, solutions, etc. and in which the substance is transferred into interim storage or shipping containers. Indicate in your diagram the entry and exit points of the chemical substance. Number all points

from which the chemical substance will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the substance. Continuous or batch process Indicate whether the chemical substance is manufactured in discrete batches or is produced by continuously adding reactants and removing the reaction product. Amount of substance produced per day or per batch If the chemical substance is produced in discrete batches, indicate the amount of the substance in pounds produced in each batch; if the substance is produced in a continuous process, indicate the amount of substance in pounds manufactured each day. Batch or daily run time If the chemical substance is produced in discrete batches, indicate the batch time (hours/batch); if the substance is produced in a continuous process, indicate the daily run time (hours/day).*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

48 of 84 Days of operation per year or number of batches per year If the chemical substance is produced in discrete batches, indicate the number of batches per year necessary to produce the reported production volume; if the chemical substance is produced in a continuous process, indicate the number of days of operation per year needed to produce the reported production volume. Unit operations List the unit operations needed to produce the chemical substance. Unit operation means a functional step in manufacturing, processing, or use operation where substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit operations include blending, distillation, filtration, and drying. Storage and shipping containers List the types of containers used to transport or store the chemical substance and their capacity. Examples of

containers include 1-liter bottle s, 5-gallon pails, 55-gallon drums, 200-pound totes, 5000-gallon tank trucks, and 20,000- gallon railcars.

2070 Manufacturing Worker Exposures: 2071 Worker activities Describe each specific activity in the operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality control, transferring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks, etc. Activities must be described even when workers wear protective equipment. Duration and frequency of worker exposure For each worker activity, enter the maximum duration in hours per day and number of days per year that any one worker will engage in the activity during a normal work day based on the reported production volume. Physical form For each worker activity, indicate the physical form of the substance at the time of exposure.

Maximum concentration For each work er activity, indicate the maximum concentration of the substance in the product at the time of

exposure. Personal protective equipment and engineering controls used by

workers For each worker activity, identify the specific types of protective equipment and engine ering controls that will be employed to protect the worker from potential exposure to the chemical substance, e.g., gloves, goggles, protective garment, local ventilation, respirator, etc. Worker monitoring data

available Indicate whether monitoring data on occupational exposure of

workers is available. Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure.

2072 Manufacturing Releases to the Environment: 2073 Release source (or release point) For each point of release containing the chemical substance, identify and describe the point in the process description at*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

49 of 84 which the release occurs (e.g. releases due to spillage, residues, separation losses, and other sources from each batch or each day). Media and type of release For each release, indicate the type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical. media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitive air, surface water, o n

- site or off

- site land or incineration, POTW or other (specify)] of a release stream containing the chemical

substance. Quantity of substance released a) directly to the environment or b) into control technology to the

environment For each release, provide the quantity (in pounds) of chemical substance released a) directly to the environment or b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations. Control technology For each release, describe the type of technology used to

control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treatment (primary, secondary, etc.). Efficiency of control technology Indicate the established efficiency of the control technology in removing or destroying the chemical substance. Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway, a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, indicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

Additional release related

information attached Indicate whether a description of the releases, calculations or monitoring data on the quantities of releases, or additional information on control technologies and/or treatment is

attached.

2074 Industrial Processing or Use Activities: 2075 Description of Processing or Use Provide a process flow diagram which describes the processing or use operation involving the chemical substance. “Unit operation” means a functional step in which substances undergo chemical changes and/or changes in location, temperature, pressure, physical state, or similar characteristics. Include steps in which the substance is formulated into gels, mixtures, suspensions, solutions, etc. and in which the substance is transferred into interim storage or shipping containers. Indicate in your diagram the entry and exit points of the chemical substance. Number all points

from which the chemical substance will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the substance. Processing or use at sites Indicate whether th e sites at which the chemical is processed*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

50 of 84 controlled by manufacturer or used are owned by the manufacturer or others. Continuous or batch process Indicate whether the industrial process in which the chemical is processed or used in a batch or continuous process. Amount of substance processed per day or per batch Provide the amount of the substance in pounds processed or used per batch for batch operation or processed or used per day for continuous operation, respectively. Batch or daily run time If the chemical substance is processed in discrete batches, indicate the batch time (hours/batch); if the substance is processed in a continuous process, indicate the daily run time (hours/day). Days of operation per year or number of batches per year If the chemical substance is processed in discrete batches, indicate the number of batches per year necessary to process the reported production volume; if the chemical substance is produced in a continuous process, indicate the number of days of operation per year needed to process the reported production volume. Unit operations List the unit operations needed to process the chemical substance. Unit operation means a functional step in manufacturing, processing, or use operation where substances undergo chemical changes, or changes in temperature, pressure, physical state, concentration, purity, or similar characteristics. Examples of unit operations include blending, distillation, filtration, and drying. Storage and shipping containers

used List the types of containers used to transport or store the chemical substance and their capacity. Examples of

containers include 1-liter bottle s, 5-gallon pails, 55-gallon drums, 5,000-gallon tank trucks, and 20,000-gallon railcars.

2076 Industrial Processing or Use Occupational Exposures: 2077 Worker activities Describe each specific activity in the operation during which workers may be exposed to the chemical substance. Such activities may include charging reactor vessels, sampling for quality control, transferring substances from one container to another, changing filters, filling drums, loading and loading tank cars or trucks, etc. Activities must be described even when workers wear protective equipment. Duration and frequency of worker exposure For each worker activity, provide the maximum duration in hours per day and the number of days per year during which any one worker will engage in the activity during a normal work day during in processing or use. Physical form For each worker activity, indicate the physical form of the substance at the time of exposure.

Maximum concentration For each work er activity, indicate the maximum concentration of the substance in the product at the time of

exposure. Personal protective equipment and engineering controls used by

workers For each worker activity, identify the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substance, e.g., gloves, goggles, protective garment, local ventilation, respirator, etc. Worker monitoring data

available Indicate whether monitoring data on occupational exposure of

workers is available.*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

51 of 84 Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure.

2078 Industrial Processing or Use Releases to the Environment: 2079 Release source (or point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g. releases due to spillage, residues, separation losses, and other sources from each batch or each day). Media and type of release For each release, indicate the type (gas or vapor, aqueous or liquid solution, or solid) and media (stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (specify)) which describes the release stream containing the chemical. media (air, liqui d or aqueous solution, solid) and type of release [stack air, fugitive air, surface water, on

- site or off

- site land or incineration, POTW or other (specify)] of a release stream containing the chemical

substance. Quantity of substance released a) directly to the environment or b) into control technology to the

environment For each release, provide the quantity (in pounds) of chemical substance released a) directly to the environment or b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations. Control technology For each release, describe the type of technology used to

control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treatment (primary, secondary, etc.). Efficiency of control technology Indicate the established efficiency of the control technology in removing or destroying the chemical substance. Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway, a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, indicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

Additional release related

information attached Indicate whether a description of the releases, calculations or monitoring data on the quantitie s of releases, or additional information on control technologies and/or treatment is

attached.

2080 Commercial Use Occupational Exposure: 2081 Description of commercial use Describe the commercial use(s) of products containing the

chemical substance.

Function of chemical in commercial product Describe the function of the chemical in the commercial product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc. Number of potentially exposed Indicate the number of workers in commercial establishments*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

52 of 84 commercial workers who are reasonably likely to be exposed to the chemical

substance. Physical form of commercial product Indicate the physical form of the product containing the

chemical substance. Method of commercial product application Describe the application method (e.g. sprayed applied via pump sprayer or aerosols, poured or applied manually) of the product containing the chemical substance and whether the commercial use is destructive, contained, dispersive, etc. Duration and frequency of commercial product use Indicate the duration of use, e.g. 5 minutes or less, 30 minutes or less, 1 hour or less, etc. and frequency of commercial use, e.g. used more than once a day, used once a day, used several times a week, etc.

2082 Consumer Use and Exposure: 2083 Description of consumer use Describe the consumer use(s) of products containing the

chemical substance.

Function of chemical in consumer product Describe the function of the chemical in the consumer product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc. Number of potentially exposed

consumers Indicate the number of consumers reasonably likely to be exposed to the chemical substance. Physical form of consumer product(s) containing the

chemical substance Indicate the physical form, e.g., gel, foam, powder, etc. of the consumer product containing the chemical substance.

Method of consumer product application Describe the application of the consumer product containing the chemical substance, for example, chemicals in products that will be sprayed via pump sprayer or aerosols; products that are poured, mixed, applied by hand/mechanical device; chemicals that can be released via diffusion, evaporation, abrasion, etc., from articles; or chemicals that are incorporated into articles with no potential for release, etc. Duration and frequency of consumer product use Indicate the duration of consumer use, e.g., used for 5 minutes or less, 30 minutes or less, less than 1 hour, etc. and frequency of consumer use, e.g. used more than once a day, used once a day, used several times a week, etc.

2084 EPA is soliciting comment on the data elemen ts identified above. Collecting these data 2085 would enable the Agency to develop more comprehensive and complete screening assessments 2086 of the exposures that may be encountered during the manufacture, processing, and use of 2087 chemicals. The Agency also is interested in whether any additional data elements should be 2088 collected, and in any other considerations relating to the collection of additional data. Because 2089 these data elements are based on the data elements included in a PMN submission, EPA believes 2090 the burden a site would incur to provide these data for each chemical would be similar to the 2091 burden incurred for a site to develop a single PMN submission , almost doubling the burden of 2092 the IUR program

. EPA presents the estimated increase in industry costs and burden associated 2093 with change in Appendix H of the economic analysis. (Ref. 11) 2094

2095 EPA is also soliciting comment on the best method to collect these data. The Agency is 2096 considering three approaches to collect these data from known manufacturers (including 2097 importers). These approaches are: integrating these data elements into the IUR, promulgating a 2098 new reporting mechanism under TSCA section 8(a), or using TSCA section 11(c) subpoena 2099*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

53 of 84 authority. Integrating these data elements into the IUR would provide a more complete set of 2100 data, enabling the Agency to identify proactively potential exposure-based chemical risk 2101 management issues and to provide the public access to an enhanced database. The Agency is 2102 also soliciting comment on the appropriate scope of an IUR requirement to report these data 2103 elements. For instance, the scope could be based on chemical identity, and the Agency could 2104 provide a list of chemicals for which these data would be reported. Alternatively, the scope 2105 could be based on production volume, and the Agency could identify the production volume 2106 range for which these data would be reported. 2107

2108 As a second option, the Agency is considering promulgating a new reporting mechanism 2109 under TSCA section 8(a) that would enable the collection of enhanced exposure-related data, 2110 described in this section, for about 100 chemical substances per year. For instance, EPA could 2111 notify manufacturers (including importers) of the need to submit additional information, e.g., via 2112 a Federal Register notice or individually via U.S. mail, with details on the data to report and the 2113 reporting criteria. (See Ref. 11 for burden and cost information.) This approach would enable 2114 the Agency to target the collection to those chemicals of current priority for screening-level 2115 assessment. The Agency also solicits comment on the need to establish a complementing 2116 recordkeeping requirement. Such a recordkeeping requirement would ensure that the additional 2117 data subject to the new reporting mechanism would be more quickly available at the time that 2118 EPA requested them. However, without advance notice regarding the specific chemicals for 2119 which information would be required, manufacturers (including importers) of all chemicals 2120 subject to the IUR would be required to maintain the records. 2121

2122 As a third option, EPA considering the use of TSCA section 11(c) subpoena authority to 2123 collect enhanced exposure-related data. TSCA section 11(c) gives the Agency broad authority to 2124 collect information for regulatory purposes and would, therefore, allow EPA to require, by 2125 subpoena, the submission of the enhanced exposure-related data. Among the circumstances in 2126 which the Agency is considering exercising this subpoena authority are those in which the 2127 enhanced data elements are not available through other means and are necessary for a more 2128 effective screening level review of chemical substances on a case by case basis. 2129

2130

9 4 ) EPA is considering collecting exposure-related information from processors in addition to 2131 collecting the data from manufacturers. 2132

2133 Currently, only manufacturers (including importers) are responsible for providing 2134 information required by the IUR rule. TSCA section 8(a) enables the Agency also to collect 2135 information from processors. EPA seeks comment on also requiring processors to report 2136 processing and use data under the three data collection approaches described above (i.e., by 2137 modification of the IUR rule, via notification issued under a new data reporting mechanism, or 2138 using existing subpoena authority). (See Ref. 11 for burden and cost information.) The Agency 2139 believes that processors may be more familiar with the processing and use of the chemicals than 2140 manufacturers, and therefore may be able to provide more complete and accurate exposure2141

related data. 2142

2143

VI. References 2144

2145

As indicated under ADDRESSES , a docket has been established for this rulemaking 2146 under docket ID number EPA-HQ-OPPT-2009-0187. The following is a listing of the 2147*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

54 of 84 documents that are specifically referenced in this document. The docket includes these 2148 documents and other information considered by EPA in developing this proposed rule, including 2149 documents that are referenced within the documents that are included in the docket, even if the 2150 referenced document is not physically located in the docket. For assistance in locating these 2151 other documents, please consult the technical contact listed under FOR FURTHER 2152

INFORMATION CONTACT

. 2153

2154

1. U.S. EPA, Memorandum to EPA Employees from Lisa P. Jackson, Administrator, 2155 January 23, 2009, Located at: 2156 http://www.epa.gov/administrator/memotoemployees.html

. 2157

2158

2. U.S. EPA, “Draft Instructions for 2011 Inventory Update Reporting,” October 2009. 2159

2160

3. U.S. EPA, “IUR Modifications Rule: Development of Definitions for proposed 40 CFR 2161 711.3,” OPPT, August 2009. 2162

2163

4. U.S. EPA, “Electronic Signature Agreement,” OPPT, August 2009. 2164

2165

5. U.S. EPA, “Development of CDX Workflow for Electronic Toxic Substances Control 2166 Act (eTSCA) Submissions: Draft User Guide” (Version 1.0), CDX, November13, 2008. 2167

2168

6. American Petroleum Institute, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785; 2169 EPA-HQ-OPPT-2008-0807 from Howard J. Feldman, December 8, 2008. 2170

2171

7. Proctor & Gamble, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785, from Julie 2172 Froelicher, January 23, 2009. 2173

2174

8. Synthetic Organic Chemical Manufacturers Association, Comments submitted to Docket 2175 ID No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009. 2176

2177

9. U.S. EPA, “Inventory Update Reporting (IUR) Technical Support Document – 2178 Replacement of 5-digit NAICS Codes with Industrial Sectors.” OPPT/EETD, August 2179

2009. 2180

2181

10. U.S. EPA, “2006 Inventory Update Reporting: Data Summary,” OPPT, EPA report 2182 number 740S08001, December 2008. Located at: 2183 http://www.epa.gov/opptintr/iur/pubs/2006_data_summary.pdf

. 2184

2185

11. U.S. EPA, “Draft Economic Analysis for the Proposed IUR Modifications Rule,” 2186 OPPT/EETD, January 2010. 2187

2188

12. U.S. EPA, “Addendum to Information Collection Request 1884.04,” OMB control 2189 number 2070-0162, OPPT, September 2009. 2190

2191

13. U.S. EPA/Environment Canada/Health Canada, “Overview of Harmonized U.S.-Canada 2192

Industrial Function and Consumer and Commercial Product Codes for Chemical 2193 Inventory Reporting,” September 2009. 2194

2195*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

55 of 84 14. U.S. EPA, “Chemical Screening Tool For Exposures & Environmental Releases.” 2196

Located at: http://www.epa.gov/oppt/exposure/pubs/chemsteer.htm , September 2009. 2197

2198

15. U.S. EPA, “Exposure and Fate Assessment Screening Tool.” Located at: 2199 http://www.epa.gov/oppt/exposure/pubs/efast.htm , September 2009. 2200

2201

16. U.S. EPA, “Fact Sheet: Recycling and the TSCA Inventory of Chemical Substances 2202 Premanufacture Notification and Inventory Update Reporting Requirements.” OPPT, 2203 May 2010. 2204

2205

17. U.S. EPA, “Q&A Document: Recycling and the TSCA Inventory of Chemical 2206 Substances Premanufacture Notification and Inventory Update Reporting Requirements.” 2207 OPPT, May 2010 2208

2209

18. Small Business Administration, “TSCA IUR Byproducts Reporting v_1 02_18_10.doc” 2210 e-mail to Wendy Cleland-Hamnett, U.S. EPA, from Keith Holman, SBA. March 9, 2010. 2211

2212 VII. Statutory and Executive Order Reviews 2213

A. Regulatory Review 2214

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 2215 October 4, 1993), this action has been designated a “significant regulatory action” by the Office 2216 of Management and Budget (OMB). Accordingly, EPA submitted this action to OMB for review 2217 under Executive Order 12866 and any changes made in response to OMB recommendations have 2218

been documented in the docket for this action. 2219

2220 In addition, EPA has prepared an economic analysis of the potential impacts associated 2221 with this action. A copy of this economic analysis, entitled, Draft Economic Analysis for the 2222 Proposed Inventory Update Reporting (IUR) Modifications Rule (Ref. 11), is available in the 2223 docket and is briefly summarized in this Unit of the preamble. The amendments in this proposal 2224 affect the number of reports submitted during a submission period, the burden to prepare a 2225 report, and the reporting frequency. EPA estimates that the combined impact of all the proposed 2226 amendments will increase the total burden and cost to industry associated with IUR reporting. 2227

2228 In its economic analysis, EPA estimated industry cost and burden on a per-report and a 2229 per-site basis and at the industry level. Industry cost and burden are incurred by performing 2230 activities to comply with the proposed amendments, including compliance determination, rule 2231 familiarization, preparation and submission of reports, and recordkeeping. 2232

2233 On a per-report basis, EPA estimated incremental increases of 5.2 4.28 hours and $ 41 0 2234

350 for a site to complete a partial report for one chemical and 18.3 17.38 hours and $1, 46 8 408 2235 to complete a full report for one chemical, in the first submission reporting cycle after the 2236 effective date of the proposed rule amendments. A partial report includes Parts I and II of Form 2237 U. A full report includes Parts I, II and III of Form U. For future submission reporting cycles, 2238

EPA estimated incremental increases of 3.4 3.28 hours and $ 28 4 275 for a site to complete a 2239 partial report for one chemical and 13.1 12.98 hours and $1, 08 4 075 to complete a full report for 2240

one chemical. 2241

2242*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

56 of 84 As a result of the proposed amendments, EPA estimates that the average site will submit 2243 approximately 2.01 fewer partial reports and 2.98 more additional full reports in a submission 2244 period. For the average site, th is will increase the burden by 342 341 hours during the first 2245

submission reporting cycle and 264 hours for all subsequent submission reporting cycles. EPA 2246 estimates that the average site will incur a net cost increase of $22, 55 3 493 during the first 2247

submission reporting cycle and $17, 52 6 517 during all future submission reporting cycles. 2248

2249 At the industry level for all sites submitting a Form U, EPA estimates a net total burden 2250

increase of 1. 5 6 39 million hours in the first submission year reporting cycle , and 1.21 million 2251 hours for all subsequent submission years reporting cycles . EPA estimates a net cost increase of 2252 $ 10 3

. 70 91.87 million in the first submission reporting cycle of the rule, and $79. 3 1 29 million in 2253 all subsequent submission reporting cycles. When the submission reporting cycle costs

, which 2254 would be incurred once every four years under the proposed rule, are spread averaged over the 2255 proposed four-year reporting cycle, the average annualized increase in industry cost attributable 2256 to the proposed amendments is approximately $ 26 .27 21.61 million over a 2 5 0 -year period (at a 2257 3% discount rate). 2258

2259 EPA estimates that the Agency will experience a reduction in both burden and cost to 2260 administer the IUR rule as a result of the proposed amendments. Specifically, EPA expects to 2261 experience a net burden reduction of 1, 704 721 hours in the first submission reporting cycle and 2262 all subsequent submission reporting cycles. The Agency estimates it will experience a net 2263 savings of $ 177,683 179,600 during each submission reporting cycle. This information will be 2264 reflected in the Information Collection Request (I CR) that is submitted every three years to OMB 2265 under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq

. 2266

B. Paperwork Reduction Act 2267

2268 The information collection requirements in 40 CFR part 710 related to the submission of 2269 Form Us are already approved by OMB under the PRA. That ICR has been assigned EPA ICR 2270

No. 1884 and OMB control No. 2070-0162. Because this rule involves new or revised 2271 information collection activities that require additional OMB approval, EPA has prepared an 2272 addendum to the currently approved ICR (Ref. 12). An agency may not conduct or sponsor, and 2273 a person is not required to respond to an inform ation collection request subject to the PRA unless 2274 it displays a currently valid OMB control number. The OMB control numbers for EPA’s 2275 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 2276 the form or survey). 2277

2278 Under the PRA, the term “burden” is interpreted as the total time, effort, or financial 2279 resources expended by people to generate, maintain, retain, disclose, or provide information to or 2280 for a federal agency. This includes the time needed by regulated entities to review instructions 2281 and to develop, acquire, install, and use technology and systems to collect, validate, verify, and 2282 disclose information. Time taken to adjust existing ways to comply with any previously 2283 applicable instructions and requirements and to train personnel to respond to the information 2284 collection task is also included. In this analysis, total industry burden hours represent the sum of 2285 time spent on reporting and on other administrative activities. Industry respondents will spend 2286 time on the following activities associated with the IUR rule: compliance determination, rule 2287 familiarization, preparation and submission of reports, and recordkeeping. 2288*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

57 of 84 As presented in the economic analysis (Ref. 11) and the addendum ICR (Ref. 12), EPA 2289 estimates that the proposed rule would create a total incremental industry burden of 1. 5 6 39 2290

million hours in the first reporting cycle , if all proposed amendments are finalized as proposed. 2291 The burden for a site to complete a full IUR report for IUR for one chemical is estimated to be 2292

14 0.38 1

. 3 3 hours, which is an incremental burden increase of 1 7.38 8.3 3 hours over the current 2293 estimated burden. The burden for a site to complete a partial IUR report for IUR for one 2294

chemical is estimated to be 5 7.36 8.31 hours, which is an incremental burden increase of 5.2 8 3 2295 hours over the current estimated burden. For future reporting cycles, EPA estimates that the 2296 proposed rule would create a total incremental industry burden of 1.21 million hours. T t he 2297 burden for a full report is estimated to be 95. 03 17 hours, which is an incremental increase of 2298

1 2.98 3.11 hours over the current estimated future burden . The burden and for a partial report is 2299

estimated to be 29. 5 4 40 hours, which is an incremental increase of 3. 28 41 hours over the current 2300

estimate. 2301

2302 To comment on the Agency's need for this information, the accuracy of the provided 2303 burden estimates, and any suggested methods for minimizing respondent burden, EPA has 2304 established a docket for this proposed rule, which includes this ICR, under docket ID number 2305 EPA-HQ-OPPT-2009-0187. Submit any comments related to the ICR to EPA and OMB. See 2306

ADDRESSES for where to submit comments to EPA. Send comments to OMB at the Office of 2307 Information and Regulatory Affairs, Office of Management and Budget, 725 17th St, N.W., 2308 Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is required to make a 2309 decision concerning the ICR between 30 and 60 days after [ insert date of publication in the 2310 Federal Register ], a comment to OMB is best assured of having its full effect if OMB receives 2311 it by [ Insert date 30 days after publication in the Federal Register ]. The final rule will respond 2312 to any OMB or public comments on the information collection requirements contained in this 2313 proposed rule. 2314

2315 C. Small Entity Impacts 2316

2317 Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), 2318 the Agency hereby certifies that this action will not have a significant adverse economic impact 2319 on a substantial number of small entities. The Agency’s basis is briefly summarized here and is 2320 detailed in the economic analysis (Ref. 11). 2321

2322 Under the RFA, small entities include small businesses, small organizations, and small 2323 governmental jurisdictions. Fo r purposes of assessing the impacts of today's rule on small 2324 entities, small entity is defined as: (1) a small business, as defined by the Small Business 2325 Administration’s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction 2326 that is a government of a city, county, town, school district or special district with a population of 2327 less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is 2328 independently owned and operated and is not dominant in its field. Since the regulated 2329 community does not include small governmental jurisdictions or small not-for-profit 2330 organizations, the analysis focuses on small businesses. 2331

2332 The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 2333 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and 2334 less than 100,000 lb. production of any given chemical at a site; or annual sales of less than $4 2335 million. This exemption is maintained in the proposed amendments. A small business would be 2336*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

58 of 84 required to report under the proposed rule, however, if it produces any chemical substance that is 2337 the subject of a regulation proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that 2338 is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been 2339 granted pursuant to a civil action under TSCA section 5 or 7. A small business may also report 2340 voluntarily. 2341

2342 EPA analyzed potential small business impacts from this rule using both the SBA 2343 employee size standards and the TSCA sales-based definition of small business. EPA estimates 2344

that 503 466 small firms potentially would be affected by this proposed rule using the 2345 employment-based definition, and 280 small firms potentially would be affected using the sales2346 based definition. Based on costs annualized over a four-year period and average sales data for the 2347 parent companies, EPA estimated that the cost-to-sales ratio of the proposed rule would be less 2348 than 0.1 percent for an average small company subject to the rule. For a company to have a cost2349 to-sales ratio larger than one percent, comp any sales would have to be less than $1. 0 2 5 million. 2350 Because the small businesses affected by the proposed rule have average sales of more than 2351 $412.7 million under the employment-based definition, and $11.8 million under the sales-based 2352 definition, small entities will not be affected by the proposed amendments to the IUR rule at a 2353 cost-to-sales ratio of greater than one percent (Ref. 11). 2354

EPA continues to be interested in the potential impacts of this proposed rule on small 2355 entities and welcomes comments on issues related to such impacts. 2356

2357 D. Unfunded Mandates 2358

2359 This action does not contain any Federal mandates for State, local, or tribal governments 2360 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 2361 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in 2362 annual expenditures of $100 million or more for State, local, and tribal governments, in the 2363 aggregate, or for the private sector. The analysis of the costs associated with this action are 2364 briefly described in Unit VII.A., and is contained in the economic analysis (Ref. 11). 2365

2366 Based on EPA's past experience, State, local, and tribal governments have not been 2367 affected by this reporting requirement, and EPA does not have any reason to believe that any 2368 State, local, or tribal government will be af fected by this rulemaking. As such, EPA has 2369 determined that this regulatory action does not impose any enforceable duty, contain any 2370 unfunded mandate, or otherwise have any affect on small governments. Accordingly, this rule is 2371 not subject to the requirements of sections 202, 203 or 205 of UMRA. 2372

E. Federalism 2373

2374 Pursuant to Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 2375 1999), EPA has determined that this proposed rule does not have federalism implications 2376 because it will not have substantial direct effects on the states, on the relationship between the 2377 national government and the states, or on the distribution of power and responsibilities among 2378 the various levels of government, as specified in the Order. This rule simply amends the 2379 Inventory Update Reporting rule in several ways to provide information to better address Agency 2380 and public information needs, improve the usability and reliability of the reported data, and 2381 ensure that data are available in a timely manner. Because EPA has no information to indicate 2382 that any state or local government manufactures or processes the chemical substances covered by 2383*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

59 of 84 this action, the proposed rule does not apply directly to states and localities and will not affect 2384 state and local governments. Thus, Executive Order 13132 does not apply to the proposed rule. 2385

2386 F. Tribal Implications 2387

2388 As required by Executive Order 13175, entitled Consultation and Coordination with 2389

Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 2390 proposed rule does not have tribal implications because it will not have any affect on tribal 2391 governments, on the relationship between the Federal government and the Indian tribes, or on the 2392 distribution of power and responsibilities between the Federal government and Indian tribes, as 2393 specified in the Order. Thus, Executive Order 13175 does not apply to this rule. 2394

2395

G. Children’s Health 2396

2397 EPA interprets Executive Order 13045, entitled Protection of Children from 2398

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 2399 those regulatory actions that concern health or safety risks, such that the analysis required under 2400 section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action 2401 is not subject to Executive Order 13045 because it does not establish an environmental standard 2402 intended to mitigate health or safety risks. Nevertheless, the information obtained by the 2403 reporting required by this rule will be used to inform the Agency’s decision-making process 2404 regarding chemicals to which children may be disproportionately exposed. This information will 2405 also assist the Agency and others in determining whether the chemicals in this proposed rule 2406 present potential risks, allowing the Agency and others to take appropriate action to investigate 2407 and mitigate those risks. 2408

H. Energy Effects 2409

2410 This action is not a “significant energy action” as defined in Executive Order 13211, 2411

entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 2412

Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 2413 the supply, distribution, or use of energy as described in the Order. 2414

2415

I. Technical Standards 2416

2417 Since this action does not involve any technical standards, section 12(d) of the National 2418 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 2419 12(d) (15 U.S.C. 272 note), does not apply to this action. 2420

J. Environmental Justice 2421

2422 The proposed rule does not have an adverse impact on the environmental and health 2423 conditions in low-income and minority communities that require special consideration by the 2424 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 2425 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 2426 The Agency believes that the information collected under this proposed rule, if finalized, will 2427 assist EPA and others in determining the potential hazards and risks associated with the 2428 chemicals covered by the rule. Because the IUR rule is an information collection requirement, 2429*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

60 of 84 the information that will become available through the rule will enable the Agency to target 2430 educational, regulatory, or enforcement activities towards industries or chemicals that pose the 2431 greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the 2432 information to be gathered under the rule will help EPA make decisions that will benefit 2433 potentially at-risk communities, some of which may be disadvantaged. 2434

The proposed rule is directed at manufacturers or importers of chemicals. All consumers 2435 of these chemical products and all workers who come into contact with these chemicals could 2436 benefit if data regarding the chemicals’ health and environmental effects were developed. 2437 Therefore, it does not appear that the costs and the benefits of the proposed rule will be 2438 disproportionately distributed across different geographic regions or among different categories 2439

of individuals. 2440

List of Subjects in 40 CFR part 704 2441

2442 Environmental protection, Chemicals, Chemical Substance, Confidential business 2443 information, Hazardous substances, Imports, Reporting and recordkeeping requirements. 2444

List of Subjects in 40 CFR part 710 2445

2446 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 2447 Reporting and recordkeeping requirements. 2448

List of Subjects in 40 CFR part 711 2449

2450 Environmental protection, Chemicals, Chemical Substance, Hazardous materials, 2451 Reporting and recordkeeping requirements. 2452

Dated: ________ 2453

2454

________________ 2455 Assistant Administrator, Office of Chemical Safety and Pollution Prevention. Assistant 2456 Administrator for Prevention, Pesticides and Toxic Substances

. 2457*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

61 of 84 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 2458

PART 704--[AMENDED] 2459

 1. Part 704 is amended as follows: 2460

 a. The authority citation for part 704 would continue to read as follows: 2461

Authority: 15 U.S.C. 2607(a) 2462

2463

 b. Section 704.3 is amended by removing the phrase “(as defined in 19 CFR 1.11)” in the 2464

definition for importer. 2465

PART 710--[AMENDED] 2466

 2. Part 710 is amended as follows: 2467

 a. The authority citation for part 710 would continue to read as follows: 2468

Authority: 15 U.S.C. 2607(a) 2469

2470

 b. By revising the heading for part 710 to read: 2471

2472 “Part 710—Compilation of the TSCA Chemical Inventory” 2473

2474

 c. By removing the heading for “Subpart A”. 2475

2476

 d. By removing the term “subpart” and in its place add the term “part” everywhere it appears 2477 in §§ 710.1, 710.3 and 710.4. 2478

2479

 e. In § 710.1(b), by removing the text “The Inventory Update regulations were amended in 2480 2002...The Agency intends to remove subpart B from the CFR once the 2002 update is 2481 complete.” 2482

2483

 f. Section 710.3 is amended as follows: 2484

2485 (i) By replacing the introductory text with the phrase “For purposes of this part:” 2486

(ii) By removing the phrase “(as defined in 19 CFR 1.11)” in the definition for importer. 2487

(iii) By removing the definition for non-isolated intermediate

. 2488

 g. By removing Subpart B, consisting of §§ 710.23 - 710.39 and Subpart C, consisting of §§ 2489

710.43 - 710.59. 2490

2491

 3. A new part 711 is added to read as follows: 2492

2493

PART 711 – TSCA INVENTORY UPDA TE REPORTING REQUIREMENTS 2494

2495

Sec. 2496*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

62 of 84 § 711.1 Scope and compliance. 2497 § 711.3 Definitions. 2498 § 711.5 Chemical substances for which information must be reported. 2499 § 711.6 Chemical substances for which information is not required. 2500 § 711.8 Persons who must report. 2501 § 711.9 Persons not subject to this part. 2502 § 711.10 Activities for which reporting is not required. 2503 § 711.12 Reporting information to EPA. 2504 § 711.13 When to report. 2505 § 711.15 Duplicative reporting. 2506 § 711.17 Recordkeeping requirements. 2507 § 711.18 Confidentiality. 2508 § 711.19 General. 2509

2510 Authority: 15 U.S.C. 2607(a). 2511

2512 § 711.1 Scope and compliance. 2513

(a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic 2514 Substances Control Act (15 U.S.C. 2607(a)) (TSCA) for certain manufacturers (including 2515 importers) of chemical substances. Section 8(a) authorizes the Administrator to require reporting 2516 of information necessary for administration of the Act, including issuing regulations for the 2517 purpose of compiling and keeping current the Inventory of chemical substances manufactured or 2518 processed in the United States as required by section 8(b) of the Act. In accordance with section 2519 8(b), EPA amends the Inventory to include new chemical substances manufactured (including 2520 imported) in the United States and reported under section 5(a)(1) of the Act. EPA also revises 2521 the categories of chemical substances and makes other amendments as appropriate. 2522

(b) The regulations in this part apply to the activities associated with the periodic update of 2523 information on a subset of the chemical substances included on the Inventory. 2524

(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit 2525 information required under these reporting regulations. In addition, section 15(3) makes it 2526 unlawful for any person to fail to keep, and permit access to, records required by these 2527 regulations. Section 16 provides that any person who violates a provision of section 15 is liable 2528 to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, 2529 the Government may seek judicial relief to compel submission of section 8(a) information and to 2530 otherwise restrain any violation of section 15. (EPA does not intend to concentrate its 2531 enforcement efforts on insignificant clerical errors in reporting.) 2532

(d) Each person who reports under these regulations must maintain records that document 2533 information reported under these regulations and, in accordance with the Act, permit access to, 2534 and the copying of, such records by EPA officials. 2535

§ 711.3 Definitions. 2536

2537 All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following 2538 definitions and the definitions found in § 704.3 of this chapter (except as modified by the 2539*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

63 of 84 following definitions) apply to this part: 2540

Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq

. 2541

CDX or Central Data Exchange means EPA's centralized electronic document receiving system, 2542 or its successors, including associated instructions for registering to submit electronic 2543

documents. 2544

Commercial use means the use of a chemical substance or a mixture containing a chemical 2545 substance (including as part of an article) in a commercial enterprise providing saleable goods or 2546

services. 2547

Consumer use means the use of a chemical substance or a mixture containing a chemical 2548 substance (including as part of an article) when sold to or made available to consumers for their 2549

use. 2550

e-IUR web means the electronic , web-based

- IUR software provided by EPA for the completion 2551 and submission of the IUR Form U report. 2552

2553 Industrial function means the intended physical or chemical characteristic for which a chemical 2554 substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, 2555 reaction product, or article; repackaged; or used. 2556

2557

Industrial use means use at a site at which one or more chemical substances or mixtures are 2558 manufactured (including imported) or processed. 2559

2560 Intended for use by children means the chemical substance or mixture is used in or on a product 2561 that is specifically intended for use by children age 14 or younger. A chemical substance or 2562 mixture is intended for use by children when the submitter answers “yes” to at least one of the 2563 following questions for the product into which the submitter's chemical substance or mixture is 2564 incorporated: 2565

2566 (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended 2567 for children age 14 or younger? 2568

2569 (2) Does the manufacturer of the product state through product labeling or other written 2570 materials that the product is intended for or will be used by children age 14 or younger? 2571

2572 (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 2573 younger? 2574

Manufacture means to manufacture, produce, or import for commercial purposes. Manufacture 2575 includes the extraction, for commercial purposes, of a component chemical substance from an 2576 already a previously existing chemical substance or complex combination of substances. When a 2577 substance, manufactured other than by import, is (1) produced exclusively for another person 2578 who contracts for such production, and (2) that other person specifies the identity of the 2579 substance and controls the total amount produced and the basic technology for the plant process, 2580 that substance is jointly manufactured by the producing manufacturer and the person contracting 2581*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

64 of 84 for such production. The manufacture of a chemical substance by a manufacturer is also the 2582 manufacture of a chemical substance by a person who contracts for such manufactur ing, where 2583 (1) the manufacturer manufactures or produces the substance exclusively for that person, and (2) 2584 that person specifies the identity of the substance and controls the total amount produced and the 2585 basic technology for the plant process. 2586

Manufacturer means a person who manufactures a chemical substance. 2587

2588 Master Inventory File means EPA's comprehensive list of chemical substances which constitute 2589 the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes 2590 substances reported under part 710 of this chapter and substances reported under part 720 of this 2591 chapter for which a Notice of Commencement of Manufacture or Import has been received under 2592 §720.120 of this chapter. 2593

Principal reporting year means the latest complete calendar year in which manufacturing, 2594 processing, and use activities associated with the data reported to EPA during an IUR submission 2595 period occur. Production volume for manufacturing activities in other years of the reporting 2596 cycle may also be reportable dur ing the submission period, but full manufacturing, processing, 2597 and use data are reported only for acti vities during the principal reporting year preceding the 2598 submission period

. 2599

Reasonably likely to be exposed means an exposure to a chemical substance which, under 2600 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 2601 or use of the chemical substance, is more likely to occur than not to occur. Such exposures would 2602 normally include, but would not be limited to, activities such as charging reactor vessels, 2603 drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and 2604 transfers, and analytical operations. Covered exposures include exposures through any route of 2605 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical 2606

exposures. 2607

2608 Repackaging means the physical transfer of a chemical substance or mixture, as is, from one 2609 container to another container or containers in preparation for distribution of the chemical 2610

substance or mixture in commerce. 2611

2612 Reportable chemical substance means a chemical substance described in §711.5. 2613

Site means a contiguous property unit. Property divided only by a public right-of-way shall be 2614 considered one site. More than one plant may be located on a single site. 2615

(a) For substances manufactured under contract, i.e., by a toll manufacturer, the site is the 2616 location where the chemical substance is physically manufactured. 2617

2618 (b)The site for an importer who imports a chemical substance described in §711.5 is the 2619 U.S. site of the operating unit within the person's organization that is directly responsible 2620 for importing the substance. The import site, in some cases, may be the organization's 2621 headquarters in the United States. If there is no such operating unit or headquarters in the 2622 United States, the site address for the importer is the U.S. address of an agent acting on 2623 behalf of the importer who is authorized to accept service of process for the importer. 2624*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

65 of 84 (c) For portable manufacturing units sent out to different locations from a single 2625 distribution center, the distribution center shall be considered the site. 2626

Site-limited means a chemical substance is manufactured and processed only within a site and is 2627 not distributed for commercial purposes as a substance or as part of a mixture or article outside 2628 the site. Imported substances are never site-limited. Although a site-limited chemical substance is 2629 not distributed for commercial purposes outside the site at which it is manufactured and 2630 processed, the substance is considered to have been manufactured and processed for commercial 2631

purposes. 2632

Submission period means the period in which the manufacturing, processing, and use data are 2633

submitted to EPA. 2634

Use means any utilization of a chemical substance or mixture that is not otherwise covered by 2635 the terms manufacture or process. Relabeling or redistributing a container holding a chemical 2636 substance or mixture where no repackaging of the chemical substance or mixture occurs does not 2637 constitute use or processing of the chemical substance or mixture. 2638

§ 711.5 Chemical substances for which information must be reported. 2639

2640 Any chemical substance which is in the Master Inventory File at the beginning of a submission 2641 period described in §711.13, unless the chemical substance is specifically excluded by §711.6. 2642

§ 711.6 Chemical substances for which information is not required. 2643

The following groups or categories of chemical substances are exempted from some or all of the 2644 reporting requirements of this part, with the following exception: A chemical substance 2645 described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of 2646 the reporting requirements of this part if that substance is the subject of a rule proposed or 2647 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 2648 agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order 2649 issued under section 5(e) or 5(f) of the Act, or is the subject of relief that has been granted under 2650

a civil action under section 5 or 7 of the Act. 2651

(a) Full exemptions. The following categories of chemical substances are exempted from the 2652 reporting requirements of this subpart. 2653

(1) Polymers. (i) Any chemical substance described with the word fragments “*polym*”, 2654 “*alkyd”, or “*oxylated” in the Chemical Abstracts (CA) Index Name in the Master Inventory 2655 File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may 2656 precede, or follow, the character string defined. 2657

(ii) Any chemical substance which is identified in the Master Inventory File as siloxane and 2658 silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a 2659 polysaccharide (starch, cellulose, gum), rubber, or lignin. 2660

2661 (iii) This exclusion does not apply to a polym eric substance that has been hydrolyzed, 2662 depolymerized, or otherwise chemically modified, except in cases where the intended product of 2663*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

66 of 84 this reaction is totally polymeric in structure. 2664

2665 (2) Microorganisms. Any combination of chemical substances that is a living organism, and that 2666 meets the definition of “microorganism” at §725.3 of this chapter. Any chemical substance 2667 produced from a living microorganism is reportable under this subpart unless otherwise 2668

excluded. 2669

2670 (3) Naturally occurring chemical substances . Any naturally occurring chemical substance, as 2671 described in §710.4(b). The applicability of this exclusion is determined in each case by the 2672 specific activities of the person who manufactures the substance in question. Some chemical 2673 substances can be manufactured both as described in §710.4(b) and by means other than those 2674 described in §710.4(b). If a person described in §711.8 manufactures a chemical substance by 2675 means other than those described in §710.4(b), the person must report regardless of whether the 2676 substance also could have been produced as described in §710.4(b). Any chemical substance that 2677 is produced from such a naturally occurring chemical substance described in §710.4(b) is 2678 reportable unless otherwise excluded. 2679

(4) Certain forms of natural gas and water. Chemical substances with the following Chemical 2680 Abstract Service (CAS) Registry Numbers: CASRN 64741–48–6, Natural gas (petroleum), raw 2681 liq. mix; CASRN 68919–39–1, Natural gas condensates; CASRN 8006–61–9, Gasoline, natural; 2682 CASRN 68425–31–0, Gasoline (natural gas), natural; CASRN 8006–14–2, Natural gas; CASRN 2683 68410–63–9, Natural gas, dried; and CASRN 7732-18-5, Water. 2684

(b) Partial exemptions. The following groups of chemical substances are partially exempted 2685 from the reporting requirements of this part (i.e., the information described in §711.12(c)(4) need 2686 not be reported for these substances). Such chemical substances are not excluded from the other 2687 reporting requirements under this part. 2688

2689 (1) Petroleum process streams. EPA has designated the following chemical substances, listed by 2690 CAS Number, as partially exempt from reporting under the IUR. 2691

2692 CAS Numbers of Partially Exempt Chemical Substances Termed “Petroleum Process 2693 Streams” for Purposes of Inventory Update Reporting 2694

The table currently in § 710.46(b)(1) will be moved to this location its entirety, excluding only the line directly after the heading, which reads:

“7732–18–5 Water” This is a very long table and, to avoid confusing reviewers, has not been replicated

in the draft document.

2695 (2) Specific exempted chemical substances —(i) Exemption. EPA has determined that, at this 2696 time, the information in §711.12(c)(4) associated with the chemicals listed in paragraph 2697 (b)(2)(iv) of this section is of low current interest. 2698

2699 (ii) Considerations. In making its determination of whether this partial exemption should apply 2700 to a particular chemical substance, EPA will cons ider the totality of information available for the 2701 chemical substance in question, including but not limited to, one or more of the following 2702

considerations: 2703*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

67 of 84 2704 (A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of 2705 the information described in §711.12(c)(4) (i.e., at least one site manufactures 300,000 pounds or 2706 more of the chemical). 2707

2708 (B) The chemical substance's chemical and physical properties or potential for persistence, 2709 bioaccumulation, health effects, or environmental effects (considered independently or together). 2710

2711 (C) The information needs of EPA, other federal agencies, tribes, states, and local governments, 2712 as well as members of the public. 2713

2714 (D) The availability of other complementary risk screening information. 2715

2716 (E) The availability of comparable processing and use information. 2717

2718 (F) Whether the potential risks of the chemical substance are adequately managed. 2719

2720 (iii) Amendments. EPA may amend the chemical list in paragraph (b)(2)(iv) of this section on its 2721 own initiative or in response to a request from the public based on EPA's determination of 2722 whether the information in §711.12(c)(4) is of low interest. 2723

2724 (A) Any person may request that EPA amend the chemical list in paragraph (b)(2)(iv) of this 2725 section. Your request must be in writing and must be submitted to the address provided in 2726 §711.19(d). Requests must identify the chemical in question, as well as its CAS number or other 2727 chemical identification number as identified in §711.12(c)(3)(i), and must contain a written 2728 rationale for the request that provides sufficient specific information, addressing the 2729 considerations listed in §711.6(b)(2)(ii), includin g cites and relevant documents, to demonstrate 2730

to EPA that the collection of th e information in §711.12(c)(4) for the chemical in question either 2731 is or is not of low current interest. If a request re lated to a particular chemical is resubmitted, any 2732 subsequent request must clearly identify new information contained in the request. EPA may 2733 request other information that it believes necessary to evaluate the request. EPA will issue a 2734 written response to each request within 120 days of receipt of the request, and will maintain 2735 copies of these responses in a public docket that will be established for each reporting cycle. 2736

2737 (B) As needed, the Agency will initiate rulemaking to make revisions to the list in paragraph 2738 (b)(2)(iv) of this section. 2739

2740 (C) To assist EPA in reaching a decision regarding a particular request prior to a given principal 2741 reporting year, requests must be submitted to EPA no later than 12 months prior to the start of 2742 the next principal reporting year. 2743

2744 (iv ) List of chemical substances. EPA has designated the following chemical substances, listed 2745 by CAS Number, as partially exempt from reporting under the IUR. 2746

2747 CAS Numbers of Partially Exempt Chemical Substances Under §711.6(b)(2) 2748

CAS No. Chemical

50–70–4 D-Glucitol

50–81–7 L-Ascorbic acid

50–99–7 D-Glucose*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

68 of 84 CAS No. Chemical
56–81–5 1,2,3-Propanetriol 56–87–1 L-Lysine 57–50–1 .alpha.-D-Glucopyranosi de, .beta.-D-fru ctofuranosyl 58–95–7 2H-1-Benzopyran-6-ol, 3,4-dihydr o-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, acetate, (2R)- 59–02–9 2H-1-Benzopyran-6-ol, 3,4-dihydr o-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 Xylitol96–10–6 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 Phenylalanine563–43–9 Aluminum, dichloroethyl1070–00–4 Aluminum, trioctyl1116–70–7 Aluminum, tributyl1116–73–0 Aluminum, trihexyl1191–15–7 Aluminum, hydrobis(2-methylpropyl)-

1317–65–3 Limestone 1333–74–0 Hydrogen
1592–23–0 Octadecanoic acid, calcium salt 7440–37–1 Argon

7440–44–0 Carbon 7727–37–9 Nitrogen 7782–42–5 Graphite 7782–44–7 Oxygen

8001–21–6 Sunflower oil 8001–22–7 Soybean oil

8001–23–8 Safflower oil

8001–26–1 Linseed oil

8001–29–4 Cottonseed oil

8001–30–7 Corn oil

8001–31–8 Coconut oil 8001–78–3 Castor oil, hydrogenated

8001–79–4 Castor oil

8002–03–7 Peanut oil 8002–13–9 Rape oil

8002–43–5 Lecithins

8002–75–3 Palm oil

8006–54–0 Lanolin
8016–28–2 Lard, oil 8016–70–4 Soybean oil, hydrogenated
8021–99–6 Charcoal, bone 8029–43–4 Syrups, hydrolyzed starch

11103–57–4 Vitamin A12075–68–2 Aluminum, di-.mu.-chlorochlorotriethyldi12542–85–7 Aluminum, trichlorotrimethyldi16291–96–6 Charcoal
26836–47–5 D-Glucitol, monooctadecanoate*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

69 of 84 CAS No. Chemical
61789–44–4 Fatty acids, castor-oil

61789–97–7 Tallow

61789–99–9 Lard 64147–40–6 Castor oil, dehydrated 64755–01–7 Fatty acids, tallow, calcium salts 65996–63–6 Starch, acid-hydrolyzed 65996–64–7 Starch, enzyme-hydrolyzed 67701–01–3 Fatty acids, C12-18 68002–85–7 Fatty acids, C14-22 and C16-22-unsatd. 68131–37–3 Syrups, hydrolyzed starch, dehydrated 68188–81–8 Grease, poultry 68308–36–1 Soybean meal 68308–54–3 Glycerides, tallow mono-, di- and tri-, hydrogenated 68334–00–9 Cottonseed oil, hydrogenated 68334–28–1 Fats and glyceridic oils, vegetable, hydrogenated
68409–76–7 Bone meal, steamed 68424–45–3 Fatty acids, linseed-oil68424–61–3 Glycerides, C16-18 and C18-unsatd. mono- and di68425–17–2 Syrups, hydrolyzed starch, hydrogenated
68439–86–1 Bone, ash 68442–69–3 Benzene, mono-C10-14-alkyl derivs.

68476–78–8 Molasses
68514–27–2 Grease, catch basin 68514–74–9 Palm oil, hydrogenated 68525–87–1 Corn oil, hydrogenated 68648–87–3 Benzene, C10-16-alkyl derivs. 68918–42–3 Soaps, stocks, soya 68952–94–3 Soaps, stocks, vegetable-oil 68956–68–3 Fats and glyceridic oils, vegetable 68989–98–0 Fats and glyceridic oils, vegetable, residues 73138–67–7 Lard, hydrogenated

120962–03–0 Canola oil 129813–58–7 Benzene, mono-C10-13-alkyl derivs. 129813–59–8 Benzene, mono-C12-14-alkyl derivs. 129813–60–1 Benzene, mono-C14-16-alkyl derivs.
2749 § 711.8 Persons who must report. 2750

2751 Except as provided in §§711.9 and 711.10, the following persons are subject to the requirements 2752 of this subpart. Persons must determine whether they must report under this section for each 2753 chemical substance that they manufacture (including import) at an individual site. 2754

2755 (a) Persons subject to recurring reporting. (i) For the 2011 submission period , any person who 2756 manufactured (including imported) for commercial purposes 25,000 lb. (11,340 kg) or more of a 2757 chemical substance described in §711.5 at any single site owned or controlled by that person at 2758 any time during the principal reporting year (i.e., calendar year 2010) is subject to reporting. (ii) 2759 For the submission periods subsequent to the 2011 submission period , a A ny person who 2760 manufactured (including imported) for commercial purposes 25,000 lb. (11,340 kg) or more of a 2761 chemical substance described in §711.5 at any single site owned or controlled by that person at 2762 any time during any calendar year since the last principal reporting year (e.g., for the 201 5 1 2763 submission period, consider calendar years 2006 2011

, 2007 2012

, 2008 2013

, 200 9, and 201 4 0

, 2764 given that 2010 was the last principal reporting year ). 2765*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

70 of 84 2766 (b) Exceptions. Any person who manufactured (including imported) for commercial purposes 2767 any chemical substance that is the subject of a rule proposed or promulgated under section 2768 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order in effect under section 5(e) of the 2769 Act, or is the subject of relief that has been granted under a civil action under section 5 or 7 of 2770 the Act is subject to reporting for that ch emical, regardless of the production volume. 2771

2772 § 711.9 Persons not subject to this part. 2773

2774 A person described in §711.8 is not subject to the requirements of this subpart if that person 2775 qualifies as a small manufacturer as that term is defined in §704.3 of this chapter. 2776 Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this 2777 subpart with respect to any chemical substance that is the subject of a rule proposed or 2778 promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in effect under 2779 section 5(e) of the Act, or is the subject of relief that has been granted under a civil action under 2780

section 5 or 7 of the Act. 2781

2782 § 711.10 Activities for which reporting is not required. 2783

2784 A person described in §711.8 is not subject to the requirements of this subpart with respect to 2785 any chemical substance described in §711.5 that the person solely manufactured or imported 2786 under the following circumstances: 2787

2788 (a) The person manufactured or imported the chemical substance described in §711.5 solely in 2789 small quantities for research and development. 2790

2791 (b) The person imported the chemical substance described in §711.5 as part of an article. 2792

2793 (c) The person manufactured the chemical substance described in §711.5 in a manner described 2794 in §720.30(g) or (h) of this chapter. 2795

2796 § 711.12 Reporting information to EPA. 2797

For the 2011 submission period , any person who must report under this part, as described in 2798 §711.8, must submit the information described in this section for each chemical substance 2799 described in §711.5 that the person manufactured (including imported) for commercial purposes 2800 in an amount of 25,000 lb. (11,340 kg) or more (or lower volume for chemicals subject to the 2801 rules, orders, or actions described in 711.8(c)) during the principal reporting year (i.e., calendar 2802 year 2010). For the submission periods subsequent to the 2011 submission period, any Any 2803 person who must report under this part, as described in §711.8, must submit the information 2804 described in this section for each chemical substance described in §711.5 that the person 2805 manufactured (including imported) for commercial purposes in an amount of 25,000 lb. (11,340 2806 kg) or more (or lower volume for chemicals subject to the rules, orders, or actions described in 2807 711.8(c)) at any one site during any calendar year since the last principal reporting year ( i.e e.g
., 2808

for the 201 5 1 submission period, consider calendar years 2006 2011

, 2007 2012

, 2008 2013

, 2009, 2809

and 201 4 0 , since 20 0 105 was the last principal reporting year). The principal reporting year for 2810 each submission period is the previous calendar year (e.g., the principal reporting year for the 2811

201 51 submission period is calendar year 201 0 4 ). A For all submission periods, a separate report 2812

must be submitted for each chemical substance at each site for which the submitter is required to 2813*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

71 of 84 report. A submitter of information under this part must report information as described in this 2814

section to the extent that such information is known to or reasonably ascertainable by that 2815

person. 2816

(a) Reporting information to EPA. Any person who reports information to EPA must do so using 2817

the e-IUR web reporting software provided by EPA at the address set forth in §711.19. The 2818 submission must include all information described in paragraph (b) of this section. Persons must 2819 submit a separate form for each site for which the person is required to report. The e-IUR web 2820 reporting software is described in the instruction booklet available from EPA at the address set 2821 forth in §711.19. 2822

(b) Information to be reported. Manufacturers (including importers) of a reportable chemical 2823 substance in an amount of 25,000 lbs. (11,340 kg) or more at a site any calendar year since the 2824 last principal reporting year must report the information described in this section. As described in 2825 §711.6(b)(1) and (b)(2), manufacturers of certain chemicals are not required to report the 2826 information described in paragraph (b)(4) of this section. 2827

2828 (1) A certification statement signed and dated by an authorized official of the submitter 2829 company. Persons reporting must submit this information using e-IUR web as described in 2830 §711.19. The authorized official must certify that the submitted information has been completed 2831 in compliance with the requirements of the rule and that the confidentiality claims made on the 2832 form are true and correct. The certification must be signed and dated by the authorized official 2833 for the submitter company, and provide that person’s name, official title, and e-mail address. 2834

2835 (2) Company and plant site information. The following currently correct company and plant site 2836 information must be reported for each site at which at least 25,000 lbs. (11,340 kg) of a 2837 reportable chemical substance is manufactured (including imported) during any calendar year 2838 since the last principal reporting year (see §711.3 for the “site” for importers): 2839

2840 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter under this 2841 part must obtain a Dun and Bradstreet Number for the parent company if none exists. 2842

2843 (ii) The name of a person who will serve as technical contact for the submitter company, and 2844 who will be able to answer questions about the information submitted by the company to EPA, 2845 the contact person's full mailing address, telephone number and e-mail address. 2846

2847 (iii) The name and full street address of each site. A submitter under this subpart must include 2848 the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish 2849 (or other jurisdictional indicator) in which the plant site is located. A submitter under this part 2850 must obtain a Dun and Bradstreet Number for the site reported if none exists. 2851

2852 (3) Specific information for chemicals manufactur ed in amounts of 25,000 lbs. or more. The 2853 following chemical-specific information must be reported for each reportable chemical substance 2854 manufactured at (including imported into) each site in amounts of 25,000 lbs. (11,340 kg) or 2855 more during any calendar year since the last principal reporting year: 2856

(i) The specific, currently correct Chemical Abstracts (CA) Index name as used to list the 2857 chemical substance in the TSCA Inventory and the correct corresponding CAS Registry Number 2858*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

72 of 84 (CASRN) for each reportable chemical substance at each site. A submitter under this part may 2859 use an EPA-designated TSCA Accession Number for a confidential substance in lieu of a 2860 CASRN when a CASRN is not known to or reasonably ascertainable by the submitter. In 2861 addition to reporting the number itself, submitters must specify the type of number they are 2862 reporting by selecting from among the following codes 2863

Codes to Specify Type of Chemical Identifying Number 2864

Codes Number Type

A Accession Number

C CAS Registry Number

2865 ( A a ) If an importer submitting a report cannot provide all the information specified in 2866 §711.12(b) of this section because it is claimed as confidential by the supplier of the chemical 2867 substance, the importer must have the supplier provide the correct chemical identity information 2868 directly to EPA in a joint submission, electronically using e-IUR and via CDX (see §711.19 of 2869 this part), and which clearly references the importer's submission. 2870

2871 ( B b ) If a manufacturer submitting a report cannot provide all the information specified in 2872 §711.12(b) of this section because the reportable chemical substance is manufactured using a 2873 reactant having a specific chemical identity claimed as confidential by its supplier, the 2874 manufacturer must submit a report directly to EPA containing all the information known to or 2875 reasonably ascertainable by the manufacturer about the chemical identity of the reported 2876 substance. In addition, the manufacturer must ensure that the supplier of the confidential reactant 2877 provide the correct chemical identity of the confidential reactant directly to EPA in a joint 2878 submission, electronically using e-IUR web and via CDX (see §711.19 of this part), and which 2879 clearly references the manufacture's submission. 2880

(ii) For the principal reporting year only, a A statement indicating, for each reportable chemical 2881 substance at each site, whether the substance is manufactured in the United States, imported into 2882 the United States, or both manufactured in the United States and imported into the United States. 2883

(iii) For each complete calendar year since the last principal reporting year, the total annual 2884 volume (in pounds) of each reportable chemical substance domestically manufactured and 2885 imported at each site. The total annual domestically manufactured volume (not including 2886 imported volume) and the total annual imported volume must be separately reported. This 2887 amount must be reported to two significant figures of accuracy. 2888

(iv) For the principal reporting year only, the volume used on site and the volume exported of 2889 each reportable chemical substance domestically manufactured and imported at each site. This 2890 amount must be reported to two significant figures of accuracy. 2891

(v) For the principal reporting year only, a A designation indicating, for each imported reportable 2892 chemical substance at each site, whether the imported chemical substance is physically present at 2893 the reporting site. 2894

(vi) For the principal reporting year only, a A designation indicating, for each reportable chemical 2895 substance at each site, whether the substance is being recycled, reused, remanufactured, 2896*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

73 of 84 reprocessed, reworked, or otherwise used for a commercial purpose instead of being disposed of 2897

as a waste or included in a waste stream. 2898

(vii) For the principal reporting year only, t T he total number of workers reasonably likely to be 2899 exposed to each reportable chemical substance at each site. For each reportable substance at each 2900 site, the submitter must select from among the ranges of workers listed in the following table and 2901 report the corresponding code (i.e., W1 through W8): 2902

2903 Codes for Reporting Number of Workers Reasonably Likely To Be Exposed 2904

Codes Range

W1 Less Fewer than 10 workers

W2 At least 10 but fewer than 25 workers

W3 At least 25 but fewer than 50 workers

W4 At least 50 but fewer than 100 workers

W5 At least 100 but fewer than 500 workers
W6 At least 500 but fewer than 1,000 workers
W7 At least 1,000 but fewer than 10,000 workers
W8 At least 10,000 workers

2905 (viii) For the principal reporting year only, t T he maximum concentration, measured by 2906 percentage of weight, of each reportable chemical substance at the time it is sent off-site from 2907 each site. If the chemical is site-limited, you must report the maximum concentration, measured 2908 by percentage of weight, of the reportable chemical substance at the time it is reacted on-site to 2909 produce a different chemical substance. This information must be reported regardless of the 2910 physical form(s) in which the substance is sent off-site/reacted on-site. For each substance at 2911 each site, select the maximum concentration of the substance from among the ranges listed in the 2912 following table and report the corresponding code (i.e., M1 through M5): 2913

2914 Codes for Reporting Maximum Concentration of Chemical Substance 2915

Codes Concentration Range (% weight) M1 Less than 1% by weight M2 At least 1 but less than 30% by weight M3 At least 30 but less than 60% by weight M4 At least 60 but less than 90% by weight M5 At least 90% by weight

2916 (ix) For the principal reporting year only, t T he physical form(s) of the reportable chemical 2917

substance as it is sent off-site from each site. If the chemical is site-limited, you must report the 2918 physical form(s) of the reportable chemical substance at the time it is reacted on-site to produce a 2919 different chemical substance. For each substance at each site, the submitter must report as many 2920 physical forms as apply from among the physical forms listed below: 2921

2922 (A) Dry powder. 2923

2924 (B) Pellets or large crystals. 2925

2926 (C) Water- or solvent-wet solid. 2927

2928*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

74 of 84 (D) Other solid. 2929

2930 (E) Gas or vapor. 2931

2932 (F) Liquid. 2933

2934 (x) For the principal reporting year only, s S ubmitters must report the percentage, rounded off to 2935 the closest 10%, of total production volume of the reportable chemical substance, for the 2936 principal reporting year only, reported in response to paragraph (c)(3) (iii) of this section, that is 2937 associated with each physical form reported under paragraph (c)(3) (ix) of this section. 2938

2939 (4) Specific information related to processing and use. Persons subject to paragraph (b)( 4 3 ) of 2940 this section must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this 2941 section for each reportable chemical substance at sites under their control and at sites that receive 2942 a reportable chemical substance from the submitter directly or indirectly (including through a 2943 broker/distributor, from a customer of the submitter, etc.). Information reported in response to 2944 this paragraph must be reported for the principal reporting year only and only to the extent that it 2945 is known to or reasonably ascertainable by the submitter. Information required to be reported 2946 under this paragraph is limited to domestic (i.e., within the customs territory of the United States) 2947 processing and use activities. If information responsive to a given data requirement under this 2948 paragraph, including information in the form of an estimate, is not known or reasonably 2949 ascertainable, the submitter is not required to respond to the requirement. 2950

2951 (i) Industrial processing and use information. (A) A designation indicating the type of industrial 2952 processing or use operation(s) at each site that receives a reportable substance from the submitter 2953 site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). 2954 For each chemical substance, report the letters which correspond to the appropriate processing or 2955 use operation(s). A particular designation may need to be reported more than once, to the extent 2956 that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that 2957 applies to a given designation under this paragraph. 2958

2959 Codes for Reporting Type of Industrial Processing or Use Operation 2960 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

(B) A code indicating the sector(s) which best describe the industrial activities associated with 2961 each industrial processing or use operation reported u nder paragraph (b)(4)(i)(A) of this section. 2962 For each chemical substance, report the code that corresponds to the appropriate sector(s). A 2963 particular sector code may need to be reported more than once, to the extent that a submitter 2964 reports more than one industrial function code (under paragraph (b)(4)(i)(C) of this section) that 2965 applies to a given sector code under this paragraph. 2966

Codes for Reporting Industrial Sectors 2967

Code Sector Description*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

75 of 84 Code Sector Description IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (except Oil and Gas) and support activities

IS4 Utilities

IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Related Support Activities

IS11 Petroleum Refineries IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing IS13 Petroleum Lubricating Oil and Grease Manufacturing IS14 All other Petroleum and Coal Products Manufacturing IS15 Petrochemical Manufacturing IS16 Industrial Gas Manufacturing IS17 Synthetic Dye and Pigment Manufacturing IS18 Carbon Black Manufacturing IS19 All Other Basic Inorganic Chemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Organic Chemical Manufacturing IS22 Plastics Material and Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic Fiber Manufacturing
IS25 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing IS26 Pharmaceutical and Medicine Manufacturing IS27 Paint and Coating Manufacturing IS28 Adhesive Manufacturing IS29 Soap, Cleaning Compound, and Toilet Preparation Manufacturing IS30 Printing Ink Manufacturing IS31 Explosives Manufacturing IS32 Custom Compounding of Purchased Resins IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Nonmetallic Mineral Product Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other nonmetallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade

IS47 Services IS48 Other (requires additional information)

2968*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

76 of 84 (C) For each sector reported under paragraph (b )(4)(i)(B) of this section, code(s) from the 2969 following list must be selected to designate the industrial function category(ies) that best 2970 represents the specific manner in which the chemical substance is used. A particular industrial 2971 function category may need to be reported more than once, to the extent that a submitter reports 2972 more than one industrial processing or use operation/sector combination (under paragraphs 2973 (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given industrial function category 2974 under this paragraph. If more than 10 unique combinations of industrial processing or use 2975 operations/sector/industrial function categories apply to a chemical substance, submitters need 2976 only report the 10 unique combinations for the chemical substance that cumulatively represent 2977 the largest percentage of the submitter's production volume for that chemical, measured by 2978 weight. If none of the listed industrial function categories accurately describes a use of a 2979 chemical substance, the category “Other” may be used, and must include a description of the use. 2980

2981 Codes for Reporting Industrial Function Categories 2982

Codes Category

U001 Abrasives

U002 Adhesives and sealant chemicals

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents

U008 Dyes

U009 Fillers

U010 Finishing agents

U011 Flame retardants

U012 Fuels and fuel additives

U013 Functional fluids (closed systems)

U014 Functional fluids (open systems)

U015 Intermediates

U016 Ion exchange agents

U017 Lubricants and lubricant additives

U018 Odor agents

U019 Oxidizing/reducing agents

U020 Photosensitive chemicals

U021 Pigments*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

77 of 84 Codes Category

U022 Plasticizers

U023 Plating agents and surface treating agents

U024 Process regulators

U025 Processing aids, specific to petroleum production

U026 Processing aids, not otherwise listed

U027 Propellants and blowing agents

U028 Solids separation agents

U029 Solvents (for cleaning or degreasing)

U030 Solvents (which become part of product formulation or mixture)

U031 Surface active agents

U032 Viscosity adjustors

U033 Laboratory chemicals

U034 Paint additives and coating additives not described by other categories

U999 Other (specify)

2983 (D) The estimated percentage, rounded off to the closest 10%, of total production volume of the 2984 reportable chemical substance associated with each combination of industrial processing or use 2985 operation, sector and industrial function category. Where a particular combination of industrial 2986 processing or use operation, sector and industrial function category accounts for 5% or less of the 2987 submitter's site's total production volume of a reportable chemical substance, the percentage must 2988 not be rounded off to zero percent if the production volume attributable to that industrial 2989 processing or use operation, sector and industr ial function category combination is 25,000 lb. 2990 (11,340 kg.) or more during the reporting year. Instead, in such a case, submitters must report the 2991 percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the 2992 reportable chemical substance associated with the particular combination of industrial processing 2993 or use operation, sector and industrial function category. 2994

2995 (E) For each combination of industrial processing or use operation, sector and industrial function 2996 category, the submitter must estimate the number of sites at which each reportable chemical 2997 substance is processed or used. For each combination associated with each substance, the 2998 submitter must select from among the ranges of sites listed in the following table and report the 2999 corresponding code (i.e., S1 through S7): 3000

3001 Codes for Reporting Numbers of Sites 3002

Codes Range

S1 less than 10 sites

S2 at least 10 but fewer than 25 sites

S3 at least 25 but fewer than 100 sites*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

78 of 84 S4 at least 100 but fewer than 250 sites
S5 at least 250 but fewer than 1,000 sites
S6 at least 1,000 but fewer than 10,000 sites
S7 at least 10,000 sites

3003 (F) For each combination of industrial processing or use operation, sector and industrial function 3004 category, the submitter must estimate the number of workers reasonably likely to be exposed to 3005 each reportable chemical substance. For each combination associated with each substance, the 3006 submitter must select from among the worker ranges listed in paragraph (b)(3)(v) of this section 3007 and report the corresponding code (i.e., W1 though W8). 3008

3009 (ii) Consumer and commercial use information. (A) Using the codes listed in this paragraph, 3010 submitters must designate the consumer and commercial product category or categories that best 3011 describe the consumer and commercial products in which each reportable chemical substance is 3012 used (whether the recipient site(s) are controlled by the submitter site or not). If more than 10 3013 codes apply to a chemical substance, submitters need only report the 10 codes for the chemical 3014 substance that cumulatively represent the largest percentage of the submitter's production volume 3015 for that chemical, measured by weight. If none of the listed consumer and commercial product 3016 categories accurately describes the consumer and commercial products in which each reportable 3017 chemical substance is used, the category “Other” may be used, and must include a description of 3018

the use. 3019

3020 Codes for Reporting Consumer and Commercial Product Categories 3021

Codes Category

Chemical Substances in Furnishing, Cleaning, Treatment/Care Products

C101 Floor Coverings

C102 Foam Seating and Bedding Products

C103 Furniture and Furnishings not covered elsewhere

C104 Fabric, Textile, and Leather Products not covered elsewhere

C105 Cleaning and Furnishing Care Products

C106 Laundry and Dishwashing Products

C107 Water Treatment Products

C108 Personal Care Products

C109 Air Care Products

C110 Apparel and Footwear Care Products

Chemical Substances in Construction, Paint, Electrical, and Metal Products

C201 Adhesives and Sealants

C202 Paints and Coatings

C203 Building/Construction Materials - Wood and Engineered Wood Products*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

79 of 84 Codes Category

C204 Building/Construction Materials not covered elsewhere

C205 Electrical and Electronic Products

C206 Metal Products not covered elsewhere

C207 Batteries

Chemical Substances in Packaging, Paper, Plastic, Hobby Products

C301 Food Packaging

C302 Paper Products

C303 Plastic and Rubber Products not covered elsewhere

C304 Toys, Playground, and Sporting Equipment

C305 Arts, Crafts, and Hobby Materials

C306 Ink, Toner, and Colorant Products

C307 Photographic Supplies, Film, and Photochemicals

Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products

C401 Automotive Care Products

C402 Lubricants and Greases

C403 Anti-Freeze and De-icing Products

C404 Fuels and Related Products

C405 Explosive Materials

C406 Agricultural Products (non-pesticidal)

C407 Lawn and Garden Care Products

Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)

3022 (B) An indication, within each consumer and commercial product category reported under 3023 paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use. 3024

3025 (C) Submitters must determine, within each consumer and commercial product category reported 3026 under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical 3027 substance manufactured (including imported) by the submitter is present in (for example, a 3028 plasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on a 3029 toy) any consumer products intended for use by children up to the age of 14, regardless of the 3030 concentration of the substance remaining in or on the product. Submitters must select from the 3031*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

80 of 84 following options: the chemical substance is used in or on any consumer products intended for 3032 use by children, the chemical substance is not used in or on any consumer products intended for 3033 use by children, or information as to whether the chemical substance is used in or on any 3034 consumer products intended for use by children is not known to or reasonably ascertainable by 3035

the submitter. 3036

3037 (D) The estimated percentage, rounded off to the closest 10%, of the submitter's site's total 3038 production volume of the reportable chemical substance associated with each consumer and 3039 commercial product category. Where a particular consumer and commercial product category 3040 accounts for 5% or less of the total production volume of a reportable chemical substance, the 3041 percentage must not be rounded off to zero percent if the production volume attributable to that 3042 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 3043 reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the 3044 closest 1%, of the submitter's site's total production volume of the reportable chemical substance 3045 associated with the particular consumer and commercial product category. 3046

3047 (E) Where the reportable chemical substance is used in consumer or commercial products, the 3048 estimated typical maximum concentration, measured by weight, of the chemical substance in 3049 each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this 3050 section. For each substance in each commercial and consumer product category reported under 3051 paragraph (b)(4)(ii)(A) of this section, subm itters must select from among the ranges of 3052 concentrations listed in the table in paragraph (b)(3)(viii) of this section and report the 3053 corresponding code (i.e., M1 through M5). 3054

3055 (F) Where the reportable chemical substance is used in a commercial product, the submitter must 3056 estimate the number of commercial workers reasonably likely to be exposed to each reportable 3057 chemical substance. For each combination associated with each substance, the submitter must 3058 select from among the worker ranges listed in paragraph (b)(3)(vii) of this section and report the 3059 corresponding code (i.e., W1 though W8). 3060

3061 § 711.13 When to report. 3062

3063 All information reported to EPA in response to the requirements of this subpart must be 3064 submitted during an applicable submission period from June 1 to September 30 at 4–year 3065 intervals, beginning in 2011. Any person described in §711.8(a) must report during each 3066 submission period for each chemical substance described in §711.5 that the person manufactured 3067 (including imported) during any calendar year since the last principal reporting year (e.g., for the 3068 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 2010, since 2005 3069 was the last principal reporting year). 3070

3071 § 711.15 Duplicative reporting. 3072

3073 (a) With regard to section 8(a) rules. Any person subject to the requirements of this part who 3074 previously has complied with reporting requirements of a rule under section 8(a) of the Act by 3075 submitting the information described in §711.12 for a chemical substance described in §711.5 to 3076 EPA, and has done so within 1 year of the start of a submission period described in §711.13, is 3077 not required to report again on the manufacture of that substance at that site during that 3078 submission period. 3079*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

81 of 84 3080 (b) With regard to importers. This part requires that only one report be submitted on each import 3081 transaction involving a chemical substance described in §711.5. When two or more persons are 3082 involved in a particular import transaction and each person meets the Agency's definition of 3083 “importer” as set forth in §704.3 of this chapter, they may determine among themselves who 3084 should submit the required report; if no report is submitted as required under this part, EPA will 3085 hold each such person liable for failure to report. 3086

3087 (c) Toll manufacturers and persons contracting with a toll manufacturer. This part requires that 3088 only one report be submitted on each chemical substance described in §711.5. When a company 3089 contracts with a toll manufacturer to manufacture a chemical substance, and each party meets the 3090 Agency's definition of “manufacturer” as set forth in §711.3, the contracting company is 3091 primarily responsible for the IUR submission. In the event the contracting company does not 3092 report, the toll manufacturer must report. Both the contracting company and the toll 3093 manufacturer are liable if no report is made. 3094

3095 § 711.17 Recordkeeping requirements. 3096

3097 Each person who is subject to the reporting requirements of this subpart must retain records that 3098 document any information reported to EPA. Records relevant to reporting during a submission 3099 period must be retained for a period of 5 years beginning on the last day of the submission 3100 period. Submitters are encouraged to retain their records longer than 5 years to ensure that past 3101 records are available as a reference when new submissions are being generated. 3102

3103 § 711.18 Confidentiality. 3104

3105 (a) Any person submitting information under this subpart may assert a business confidentiality 3106

claim for the information at the time it is subm itted. Any such confidentiality claims must be 3107 made at the time the information is submitted. Confidentiality claims cannot be made when a 3108 response is left blank or an indication of not known to or reasonably ascertainable by is provided. 3109 These claims will apply only to the information submitted with the claim. New confidentiality 3110 claims, if appropriate, must be asserted with regard to information submitted during a different 3111 submission period. Guidance for asserting confidentiality claims is provided in the instructions 3112 identified in §711.19. Information claimed as confidential in accordance with this section will be 3113 treated and disclosed in accordance with the procedures in part 2 of this chapter. 3114

3115 (b) Chemical identity. A person may assert a claim of confidentiality for the chemical identity of 3116 a specific chemical substance only if the identity of that substance is treated as confidential in the 3117 Master Inventory File as of the time the report is submitted for that substance under this subpart. 3118 The following steps must be taken to assert a claim of confidentiality for the identity of a 3119 reportable chemical substance: 3120

3121 (1) The submitter must submit with the report deta iled written answers to the following questions 3122 signed and dated by an authorized official. 3123

3124 (i) What harmful effects to your competitive position, if any, do you think would result from the 3125 identity of the chemical substance being disclosed in connection with reporting under this 3126 subpart? How could a competitor use such information? Would the effects of disclosure be 3127*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

82 of 84 substantial? What is the causal relationship between the disclosure and the harmful effects? 3128

3129 (ii) How long should confidential treatment be given? Until a specific date, the occurrence of a 3130 specific event, or permanently? Why? 3131

3132 (iii) Has the chemical su bstance been patented? If so, have you granted licenses to others with 3133 respect to the patent as it applies to the chemi cal substance? If the chemical substance has been 3134 patented and therefore disclosed through the patent, why should it be treated as confidential? 3135

3136 (iv) Has the identity of the chemical substance been kept confidential to the extent that your 3137 competitors do not know it is being manufactured or imported for a commercial purpose by 3138 anyone? 3139

3140 (v) Is the fact that the chemical substance is being manufactured (including imported) for a 3141 commercial purpose available to the public, for example in technical journals, libraries, or State, 3142 local, or Federal agency public files? 3143

3144 (vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical 3145 substance is being manufactured (including imported) for a commercial purpose? 3146

3147 (vii) To what extent has the fact that this chemical substance is manufactured (including 3148 imported) for commercial purposes been revealed to others? What precautions have been taken 3149 regarding these disclosures? Have there been public disclosures or disclosures to competitors? 3150

3151 (viii) Does this particular chemical substance leave the site of manufacture (including import) in 3152 any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard 3153 against the discovery of its identity? 3154

3155 (ix) If the chemical substance leaves the site in a product that is available to the public or your 3156 competitors, can the substance be identified by analysis of the product? 3157

3158 (x) For what purpose do you manufacture (including import) the substance? 3159

3160 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality 3161 determinations regarding this chemical substance? If so, please attach copies of such 3162

determinations. 3163

3164 (2) If any of the information contained in the answers to the questions listed in paragraph (b)(1) 3165

of this section is asserted to contain confidenti al business information, th e submitter must clearly 3166 identify the information that is claimed confidential by marking the specific information on each 3167 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 3168

3169 (c) Site identity. A submitter may assert a claim of confiden tiality for a site only if the linkage of 3170 the site with a reportabl e chemical is confidential and not publicly available. The following steps 3171 must be taken to assert a claim of confidentiality for a site identity: 3172

3173 (1) The submitter must submit with the report deta iled written answers to the following questions 3174 signed and dated by an authorized official: 3175*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

83 of 84 3176 (i) Has site information been linked with a chemical identity in any other Federal, state or local 3177 reporting scheme? For example, is the chemical identity linked to a facility in a filing under the 3178 Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through 3179 a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed 3180 as confidential in any of these instances? 3181

3182 (ii) What harmful effect, if any, to your competitive position do you think would result from the 3183 identity of the site and the chemical substance being disclosed in connection with reporting under 3184 this subpart? How could a competitor use such information? Would the effects of disclosure be 3185 substantial? What is the causal relationship between the disclosure and the harmful effects? 3186

3187 (2) If any of the information contained in the answers to the questions listed in paragraph (c)(1) 3188

of this section is asserted to contain confidenti al business information, th e submitter must clearly 3189 identify the information that is claimed confidential by marking the specific information on each 3190 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 3191

(d) Processing and Use information . A submitter may assert a claim of confidentiality for each 3192 data element required by 711.12(b)(4) only if the linkage of the information with a reportable 3193 chemical is confidential and not publicly available. The following steps must be taken to assert a 3194 claim of confidentiality for each data element, individually, required by 711.12(b)(4): 3195

(1) The submitter must submit with the report deta iled written answers to the following questions 3196 signed and dated by an authorized official: 3197

(i) Is the identified use of this chemical publicly known? For example, is information on the use 3198 available in advertisements or other marketing materials, professional journals or other similar 3199 materials, or in non-confidential mandatory or voluntary government filings or publications? Has 3200 your company ever provided use information on the chemical that was not claimed as 3201

confidential? 3202

(ii) What harmful effect, if any, to your competitive position do you think would result from the 3203 information reported as required by 711.12(b)(4) and the chemical substance being disclosed in 3204 connection with reporting under this part? How could a competitor use such information? Would 3205

the effects of disclosure be substantial? What is the causal relationshi p between the disclosure 3206

and the substantial harmful effects? 3207

(2) If any of the information contained in the answers to the questions listed in paragraph (d)(1) 3208

of this section is asserted to contain confidenti al business information, th e submitter must clearly 3209 identify the information that is claimed confidential by marking the specific information on each 3210 page with a label such as “confidential business information,” “proprietary,” or “trade secret.” 3211

(e) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this 3212 subpart; if the reporting form lacks the certification required by 711.12(b)(1); if confidentiality 3213 claim substantiation required under paragraphs (b), (c), and (d) of this section is not submitted 3214 with the reporting form; or if the identity of a chemical substance listed on the public portion of 3215 the Master Inventory File was claimed as confidential, EPA may make the information available 3216 to the public without further notice to the submitter. 3217

3218 § 711.19 General Electronic Filing

. 3219

3220 (a) You must use e-IUR to complete and submit the form identified as “Form U,” EPA Form 3221*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

84 of 84 7740-8. Submissions may only be made as set forth in this section. 3222

(b) Submissions must be sent electronically to EPA via CDX. 3223

(c) Obtain e-IUR and instructions, as follows: 3224

3225 (1) By website. Go to the EPA Inventory Update Reporting Internet home page at 3226 http://www.epa.gov/iur and follow the appropriate links. 3227

3228 (2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554–1404 or TSCA3229 Hotline@epa.gov for a CD-ROM containing the software and instructions. 3230

3231 [FR Doc. 09–????? Filed ??–??–09; 8:45 am] 3232

BILLING CODE 6560–50–S 3233

3234

3235

3236