*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

1 of 78 EO12866_IUR ModificationNPRM_2010-01-28.doc 1
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ENVIRONMENTAL PR OTECTION 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

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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, ther eby providing improved information for EPA to better identify 18 and, where appropriate, take step s 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 Ch emical 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 th at trigger reporting, the specific data to be 25 reported, the reporting standard for processing and use information, a nd 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 ar e available in a timely manner. 29

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

ADDRESSES: Submit your comments, identified by doc ket 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), Offi ce 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. Atte ntion: 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 78 accepted during the DCO’s normal hours of operati on, and special arrangements should be made 44
for deliveries of boxed information. 45

Instructions : Direct your comments to docke t 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 include s information claimed to be Confidential 49 Business Information (CBI) or other information whos e disclosure is restrict ed by statute. Do not 50 submit information that you consider to be CBI or otherwise protec ted 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 inform ation 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 automati cally 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 recomme nds 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 fr ee of any defects or viruses. Fo r 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 list ed in the docket index available at 64 http://www.regulations.gov . Although listed in the index, so me information is not publicly 65 available, e.g., CBI or other information whose disc losure 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 ar e available elect ronically at http://www.regulations.gov , or, if only 68 available in hard copy, at the OPPT Docket. Th e 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 Federa l holidays. The telephone numb er 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 requi red to show photographic iden tification, pass through a metal 74 detector, and sign the EPA visitor log. All vis itor bags are processed through an X-ray machine 75 and subject to search. Visitors will be provide d 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, Environmen tal Assistance Divisi on (7408M), Office of 79 Pollution Prevention and Toxics, Environmenta l Protection Agency, 1200 Pennsylvania Ave., 80 NW., Washington, DC 20460–0001; telephone nu mber: (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 78 88
I. General Information 89

A. Does this Action Apply to Me? 90

You may be potentially affected by this ac tion 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., utiliti es, paper manufacturing, primary metal 97 manufacturing, and semiconductor and other electronic component manufacturing) 98

This listing is not intended to be exhaustiv e, but rather provides a guide for readers 99 regarding entities likely to be aff ected 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 whet her this action might apply to 102 certain entities. If you have any que stions regarding the applicability of this action to a particular 103 entity, consult the tech nical 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 th e part or all of the in formation that you claim 108
to be CBI. For CBI information in a disk or CD -ROM that you mail to EP A, mark the outside of 109 the disk or CD-ROM as CBI and then identify electronically within th e 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 c opy 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 a ny 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 78 sufficient detail to allow for it to be reproduced. 125

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

vii. Explain your views as cl early 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 appli cable, the current regu latory text reference is followed by a 134 parenthetical containing the propos ed new reference. These amendments are described in more 135
detail in Unit III. 136

137 First, EPA is proposing to amend 40 CF R 710.59 (proposed 40 CF R 711.19) to require 138 electronic reporting of th e IUR data, using Agency-provided e-IUR reporting software to submit 139 IUR reports through the Internet to EPA’s Central Data Exchange (CDX). After the final rule’s 140 effective date, paper submissi ons would no longer be accepted. 141

142 Second, EPA is proposing to enhance the manuf acturing data and the processing and use 143 data reported. 144

145 Third, EPA is proposing a new definition section in proposed 40 CFR 711.3, revisions to 146
the definition for manufacture and site, and other needed definitional modifications and 147
additions. 148
149 Fourth, EPA is proposing to amend 40 CFR 710.53 (proposed 40 CFR 711.13) to change 150 the reporting frequency from every five years to every four years. 151

152 Fifth, EPA is proposing to amend 40 CF R 710.48(a) (proposed 40 CFR 711.8(a)) to 153 modify the method used to determine whether a manufacture or importe r is subject to IUR 154 reporting. Reporting would be required if the pro duction volume of a chem ical substance met or 155 exceeded the 25,000 lb. threshold in any calendar y ear since the last principal reporting year 156 (e.g., 2005). 157

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

162 Seventh, EPA is proposing to amend 40 CF R 710.48(a) (proposed 40 CFR 711.8(a)) to 163 eliminate the 25,000 lb. threshold for certain chem ical substances that are the subject of 164 particular TSCA rules and/or orders and to re quire manufacturers (incl uding importers) of such 165 chemicals to report under the IUR rule, regardless of the production volume. 166

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5 of 78 Eighth, EPA is proposing to amend 40 CFR 710.46 (proposed 40 CFR 711.6) to make 168
chemical substances for which an enforceable consent agreement (ECA) to conduct testing has 169 been made under 40 CFR part 790 ineligible for exemptions, to provide a full exemption from 170 IUR requirements for water, and to remove polymers that are already fully exempt from the 171 partially exempt list of chemicals at 40 CFR 710 .46(b)(2)(iv) (proposed 40 CFR 711.6(b)(2)(iv)). 172

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

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

2. The current Chemical Abstracts (CA) Index Na me, as used to list the substance in the 178 Inventory, as part of the chemical identity. 179

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

4. The production volume of a manufactured (i ncluding imported) chemical substance 181 used at the reporting site. 182

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

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

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

186 Tenth, EPA is proposing to replace the “readily obtainable” reporting standard used for 187 the reporting of processing and use informa tion required by 40 CFR 710.52(c)(4) (proposed 40 188 CFR 711.12(c)(4)) with the “known to or reasonably ascertaina ble by” reporting standard. 189
190 Eleventh, EPA is proposing to amend 40 CFR 710.58 (proposed 40 CFR 711.18) to 191 require upfront substantiation when proces sing and use information required by 40 CFR 192 710.52(c)(4) (proposed 40 CFR 711. 12(c)(4)) is claimed as conf idential business information 193 (CBI). 194
195 Twelfth, EPA is proposing to disallow confiden tiality claims for processing and use data 196
elements identified as not “known to or r easonably ascertainable by” (40 CFR 710.52(c)(4) 197 (proposed 40 CFR 711.12(c)(4))). 198
199 Thirteenth, EPA is proposing to revise the lis t of industrial function categories for the 200 reporting of processing and use information. EPA is also propos ing to amend 40 CFR 201 710.52(c)(4)(i)(C) (proposed 40 CFR 711.12(c)(4 )(i)(C)) to replace the five-digit North 202 American Industrial Classification System (NAI CS) codes with 48 Industrial Sectors (IS). 203

204 Fourteenth, EPA is proposing to amend 40 CFR 710.52(c)(4)(ii) (p roposed 40 CFR 711. 205 12(c)(4)(ii)) to revise th e list of consumer and commercial pr oduct categories for the reporting of 206
consumer and commercial use information. EPA is also proposing to require the separate 207 reporting for consumer or commercial categorie s and reporting of the number of commercial 208 workers reasonably likely to be e xposed to the subject chemical. 209

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

213 B. What is the Agency's Aut hority for Taking this Action? 214

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep 215*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

6 of 78 current an inventory of chemical substances manuf actured or processed in the United States. This 216 inventory is known as the TSCA Chemical Subs tance Inventory (the TSCA Inventory). In 1977, 217 EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 218 2607(a), to compile an inventory of chemical substances in co mmerce at that time. In 1986, EPA 219 promulgated the initial IUR rule under TSCA section 8(a) at 40 CFR part 710 (51 FR 21438, 220 June 12, 1986) to facilitate the periodic updating of information on chemicals listed on the TSCA 221 Inventory and to support activitie s associated with the implemen tation of TSCA. In 2003, EPA 222 promulgated extensive amendments to the IUR rule (68 FR 848, January 7, 2003) (2003 223 Amendments) to collect exposur e-related information associat ed with the manufacturing, 224 processing, and use of eligible chemical subs tances and to make certain other changes. 225

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

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C. What is the Current Invento ry Update Reporti ng (IUR) Rule? 241

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

253 Persons manufacturing or importing chem ical substances are required to report 254 information such as company name, site loca tion and other identifying information, production 255 volume of the reportable chemical substance, an d exposure-related inform ation associated with 256 the manufacture of each reportable chemical s ubstance. This exposure-related information 257 includes the physical form and maximum concen tration of the chemical substance and the 258 number of potentially exposed workers (40 CFR 710.52). Several groups of chemical substances 259 are generally excluded from IUR reporting re quirements: e.g., polymers, microorganisms, 260 naturally occurring chemical substances, and certain natural gas substances (40 CFR 710.46). 261

262 Manufacturers (including importers) of chem icals in larger volumes (i.e., 300,000 lb. or 263*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

7 of 78 greater manufactured (including imported) during the reporting year at any single site) are 264 required also to report certain processing a nd use information (40 CFR 710.52(c)(4)). This 265 information includes process or use category; NAI CS code; industrial func tion category; percent 266 production volume associated with each process or use category; number of use sites; number of 267 potentially exposed workers; a nd consumer/commercial informati on such as use category, use in 268 or on products intended for use by children, and maximum concentration. 269

270
The 2006 submission was the first instance where manufacturers (including importers) 271 of inorganic chemical substances were requ ired to report under th e IUR rule. For the 2006 272 submission only, inorganic chemical substances were partially exempted from the IUR rule, and 273 manufacturers of such chemicals were required to report the manufactur ing information and not 274 the processing and use information, regardless of production volume. A partial exemption means 275 that a submitter is exempt from the processi ng and use reporting requirements described in 40 276 CFR 710.52(c)(4). Under the current rule, for fu ture collections (i.e., for 2011 or 2016 IUR 277 collections, etc.), the pa rtial exemption for inorganic chemical s will no longer be applicable and 278 submitters will report in the same manner as is required for organic chemicals, including 279 processing and use information (40 CFR 710.46(b )(3)). In addition, starting with the 2006 280 collection and for future collections, specifica lly listed petroleum process streams and other 281 specifically listed chemical substances are partially exempt, and manufacturers of such 282 substances are not required to re port processing and use informa tion. These partial exemptions 283 will continue in subsequent submission periods (including 2011), for as long as the chemical 284 substances remain on these partial exemption lists (40 CFR 710.46(b)(1) and (b)(2) (proposed 40 285 CFR 711.6(b)(1) and (b)(2))). 286

287 Non-confidential data, in cluding both searchable a nd separately downloadable 288 databases, and a 2006 IUR data summary report ar e available for public use on the IUR website 289 (http://www.epa.gov/iur). 290
291 D. Why is the Agency Proposing Changes in the IUR Rule? 292
293 EPA is proposing to modify the IUR rule to meet four primary goals : (1) to tailor the 294
information collected to better m eet the Agency’s overall information needs; (2) to increase its 295 ability to effectively provide public access to the information; (3) to obtain new and updated 296 information relating to potential exposures to a subs et of chemical substances listed on the TSCA 297 Inventory; and (4) to improve the usefulness of the information reported. EPA believes that 298 expanding the range of chemicals for which compre hensive information is to be reported and 299 adjusting the specific reporte d information, the method and frequency of collecting the 300 information, and CBI requirements will accomplish these goals. 301

302 These goals are supported by a policy outlined in section 2 of TSCA, which is that 303 “adequate data should be developed with respec t to the effect of ch emical substances and 304
mixtures on health and the environment and that the development of such data should be the 305 responsibility of those who manuf acture and those who process such chemical substances and 306 mixtures” (TSCA section 2(b)(1)). Modifi cations to the IUR re quirements by the 2003 307 Amendments (68 FR 848, January 7, 2003) provide d many improvements to the data collected 308 through this rule, and EPA’s efforts to use the 20 06 IUR data have identif ied areas where further 309 improvements are needed. The modifications de scribed in this proposed rule would change 310 some of the reporting requirements in an effort by EPA to (1) ensure the required information is 311*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

8 of 78 properly reported and that the information in the Agency’s database reflects the information 312 provided in the IUR reports, (2) increase the usab ility of the collected information, (3) increase 313 the availability of information for the public, and (4) focus reporting on information that is most 314 needed by the Agency. In addition, these propos ed changes will enable EPA and other Federal 315 agencies to improve their risk screening capabil ities, enabling them to be tter assess and manage 316 risk, and improving public awarenes s of basic information about a large number of chemical 317
substances. 318
319 EPA provided reporting software for the 2006 IUR submission period and encouraged 320 electronic reporting through the Internet, using the Agency’s Central Data Exchange (CDX). 321 EPA’s experience with populating the IUR databa se and with using the 2006 IUR data provided 322 insight into how well both the re porting software and submission methods worked. For instance, 323 because of validations built into the reporting soft ware, electronic submissions were able to be 324 quickly assimilated into the IUR database. Othe r forms of submission re quired the documents to 325 be scanned in or hand entered, and resulted in many introduced errors during the data entry 326 process. Additionally, for 2006 IUR, certain types of submissions (e.g., joint submissions) could 327 not be reported electroni cally. Other problems, such as incorr ect chemical identities, delayed the 328 incorporation of the data into th e database, resulting in the Agency’s inability to begin using the 329 2006 IUR data and providing public access. Th e proposed modifications associated with 330 reporting methods and changes to the reporting software will better ensure the information 331 reported to the Agency is accurate and in compliance with the IUR requirements. 332

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

EPA’s extensive use of the 2006 IUR data in the Agency’s Existing Chemicals Program 341 is representative of how EPA envisioned the da ta would be used when the 2003 Amendments 342 were promulgated. In 2007, the Agency began to develop and post screening-level hazard, 343 exposure, and risk characterizations for high production volume (HPV) chemicals, which are 344 those chemicals produced nationally at aggregated volumes of one million lb. or more per year. 345 In developing these characterizations, EPA identified areas where the IUR data collection can be 346 improved and enhanced. Improvements would allo w EPA to better identify and take follow-up 347 action on chemicals that may pose potential risks to human health or the environment. 348

During its review of the IUR data, EPA iden tified numerous examples of CBI claims on 349
the IUR form where the same or similar informati on to that claimed as CBI was already available 350 to the public. In several cases, information on production volume and uses for a chemical or 351 group of chemicals was claimed CBI on the IUR fo rm, while the same or similar information 352 was submitted voluntarily by the company without such a claim under the HPV Challenge 353 Program. In those cases, EPA had previously made the information publicly available through 354 the High Production Volume Information Syst em (HPVIS) or on EPA’s Existing Chemicals 355 website. Correct designation of reported info rmation as non-confidentia l will facilitate reporting 356 of this information to the public. 357*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

9 of 78 358 These proposed modifications to the IUR ru le would enhance the capabilities of the 359 Agency to ensure risk management actions are taken on chemicals posing the greatest concern. 360 More in-depth reporting of the processing and use data, more careful consideration of the need 361 for confidentiality claims, and adjustments to the specific data elements are important aspects of 362 this action. By enhancing the data supplied to the Agency, EPA expects to more effectively and 363 expeditiously identify and address potential risks posed by chemicals and provide improved 364 access and information to the public. 365

366 An important and anticipated result of th is action is that EPA would receive more 367 publicly available, non-CBI information, theref ore increasing the transparency and public 368 accessibility of the chemical use and exposure in formation and ensuring consistency with the 369 President’s policy goals for government relian ce on and public availability of scientific 370
information. 371

372 III. Modifications Affecting All Ma nufacturers (Including Importers) 373

374
As discussed in detail in Unit III.C. of this preamble, unde r this proposal, sites that 375 manufactured (including imported) a reportable chemical substan ce in quantities of 25,000 lb. or 376 more in any calendar year si nce the last IUR principal re porting year (e.g., 2005) would be 377 required to complete all manu facturing (including production volume), processing, and use 378 information for the principal reporting year (e .g., 2010), plus production volume information for 379 all the preceding years since the last IUR pr incipal reporting year (e.g., 2006 through 2009, for 380 the principal reporting year 2010). Draft de tailed instructions fo r completing the IUR 381
submission are available in the docket establ ished for this rulemaking. (Ref. 2) 382

383 Persons making an IUR submission would be required to use e-IUR, the Agency384 provided software designed to complete Form U (the IUR reporting form) and submit the 385 information electronically over th e Internet, through EPA’s Centra l Data Exchange (CDX). The 386
2011 e-IUR will be similar in format to the 2006 e-IUR, and will include changes associated 387 with the proposed amendments that are fina lized and improved valida tion checks. A more 388 detailed description of e-IUR a nd the electronic submission proce ss is provided in Unit III.B. 389
390 The following discussion describes the proposed changes to the IUR rule contained in this 391
action. 392

393
A. Technical Modifications to the Regulatory Text 394
395 Currently, 40 CFR part 710 contains three subp arts. Subpart A cont ains regulatory text 396 associated with the original compilation of the TSCA Inventory; Subpart B contains regulatory 397
text associated with the IUR ru le covering the update reporting in 2002; and Subpart C contains 398 the regulatory text associated with the IUR rule for 2006 and beyond. The chemicals that are 399 covered by the IUR rule are on th e Master Inventory File, whic h includes chemicals from the 400 original Inventory compilation and those added subsequently through the notice requirements of 401 section 5 of TSCA. Because the IUR rule applies to a list of chemicals included in the original 402 Inventory plus additional chemicals added subse quently, and because the Agency from time to 403 time has modified the IUR rule, the Agency believes the regulatory text associated with the IUR 404
rule should be in its own secti on in the Code of Federal Regulations (CFR), distinct from both 405*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

10 of 78 the original TSCA Inventor y rules and from the TSCA section 5 requirements. 406

407
1. Moving the IUR regulatory text from Part 710 subpart C to Part 711 and 408 eliminating subpart divisions. 409
410 Subpart C of 40 CFR part 710, §§ 710.43 to 710.59, cont ains the IUR regulatory text. EPA 411 is proposing to move all of the Subpart C text from 40 CFR part 710 to a new 40 CFR part 711 412 and would add a new Scope and Compliance sec tion (40 CFR 711.1). Specific sections would 413 be moved as follows: § 710.43 would become § 711.3; § 710.45 would become § 711.5; § 414 710.46 would become § 711.6; § 710.48 would become § 711.8; § 710.49 would become § 415 711.9; § 710.50 would become § 711.10; § 710.52 would become § 711.12; § 710.53 would 416 become § 711.13; § 710.55 would become § 711.15; § 710.57 would become § 711.17; § 710.58 417 would become § 711.18; and § 710.59 would become § 711.19. Because a ll of the text of 418 Subpart C would be moved to 40 CFR part 711, 40 CFR part 710 would no longer have a 419 Subpart C. Neither part 710 or part 711 would have any subparts. 420

421
2. Consolidation of definitions. 422

423 As part of moving the regulatory text from 40 CFR part 710, subpart C to 40 CFR part 711, 424 EPA is proposing to consolidate definitions c opied from 40 CFR 710.3 and those currently found 425 at 40 CFR 710.43 into the new 40 CFR 711.3, except wh ere an appropriate definition is already 426 in place in section 3 of TSCA or at 40 CFR 704 .3, and an additional definition of the term in 40 427 CFR 711.3 would therefore be unnecessarily duplicativ e. The definitions in section 3 of TSCA 428 and at 40 CFR 704.3 would be incorporated by refe rence into 40 CFR 711.3, except insofar as 40 429 CFR 711.3 provides a modified definition of a term also defined at 40 CFR 704.3. 430

431
The term mixture is defined in both 40 CFR 710.3 and s ection 3 of TSCA. For purposes of 432 the IUR rule, EPA is proposing to incorporate the definition of mixture from section 3 of TSCA. 433
The TSCA mixture definition differs from th e definition in 40 CFR 710.3 and 40 CFR 720.3, the 434 regulations used to determine the chemicals listed on the Inventory, in that it does not 435 specifically address hydrates. While hydrates are not addressed specificall y in the definition, a 436 hydrate is a mixture of water and an anhydrous ch emical substance. As with mixtures in 437 general, the individual component s of the mixture may be separate ly reportable at the time of 438 their manufacture or import. EPA believes, for purposes of the IUR rule, it is not necessary to 439 include hydrates separately in th e definition of mixture. The Ag ency would continue to include 440
such a discussion in the Instructions. (Ref. 2) 441

442 Unit III.C. contains further discussions about change s to specific definitions, in relation to the 443 modifications included in this proposal. A summary of all IUR-related definitions is available in 444 the docket. (Ref. 3) 445

446
3. Delete non-isolated intermed iate definition from 710.3. 447
448
EPA added a definition to 40 CFR 710.43 for the te rm “non-isolated intermediate” as part of 449 the 2003 Amendments (68 FR 848, January 7, 2003) . Subsequently, as part of the IUR 450 Revisions Rule (70 FR 75059, December 19, 2005), EP A erroneously moved the definition to 40 451 CFR 710.3 from 40 CFR 710.43. EPA is proposing to delete the definition from 40 CFR 710.3 452
as this definition was not associated with the or iginal Inventory, and ther efore does not belong in 453*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

11 of 78 40 CFR 710.3. A definition of this term, codi fied elsewhere at 40 CFR 704.3, would be 454 incorporated by reference into the IU R definitions at proposed 40 CFR 711.3. 455

456
4. Deleting Subpart B text. 457
458 EPA is proposing to delete the regulatory text contained in 40 CFR part 710, §§ 710.23 to 459 710.39 (subpart B). This text refers to IU R submission periods of 2002 and earlier and is 460 obsolete. As noted in § 710.1, the Agency expre ssed its intent to remove subpart B once the 461 2002 update was complete. 462

463
5. Deleting superfluous text associated with reporting production volumes. 464
465 EPA is proposing to delete the phrase “provided that the reported figures are within ±10% of 466
the actual volume” from the production volume reporting requirements currently found in 40 467 CFR 710.52(c)(3)(iv) (proposed 40 CFR711.12(b)(3)(iv)). The revi sed wording would be “This 468 amount must be reported to two significant figures of accuracy.” The deleted phrase is 469 superfluous because any number reported accura tely to two significant figures is within ten 470 percent of the correct value. 471

472
6. Correcting text associated with reporting number of sites and number of workers. 473

474 EPA is proposing to replace the phrase “less than ” with the phrase “fewer than” in the ranges 475 used to report the number of workers curre ntly found in the table in 40 CFR 710.52(c)(3)(v) 476 (proposed 40 CFR 711.12(c)(3)(vii)) and the number of sites currently found in the table in 40 477 CFR 710.52(c)(4)(i)(E) (proposed 40 CFR 711.12(). This proposed change would make the 478 phrases describing the range s grammatically correct. 479

480

B. Method of submission

. 481
482 The upcoming IUR submission period, during which submitters will be required to report the 483 IUR information to EPA, will be June 1 to September 30, 2011. The Agency will make e-IUR 484 and associated guidance materials available to submitters prior to the start of the submission 485 period. Draft instructions ar e included in the docket for this proposed rule. 486

487 EPA is proposing to require the mandatory use of Agency-provided reporting software (e488 IUR) to complete the IUR Form U and the Central Data Exchange (CDX) to submit the 489 completed Form U to the Agency. Users of CD X are required to register and to submit an 490 authorized signature agreement. 491
492 EPA accepted 2006 IUR submissions in several wa ys. Submissions could be completed and 493 delivered electronically via the Internet and CDX, or submissions could be completed on paper 494 or electronic media (i.e., as a file on a CD) and delivered by mail or a delivery service. 495 Approximately one-third of the submissions we re made electronically, and EPA was able to 496 immediately process and quickly begin to use the information from those electronic submissions. 497 Submissions sent as a file on a CD were printe d and, along with paper submissions, scanned into 498 an electronic system. 499

500 Due mostly to the time and resources needed to review and correct submitter- and 501*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

12 of 78 scanning-related errors associated with non-electronic submissions, EPA required over two years 502 to validate and process the data from the 2006 IUR. The Agency had to take extra steps in order 503 to correct the data during that period, such as accessing the or iginal submission instead of the 504 information in the IUR database. In addition, EPA released the public database in December 505 2008 without information on approximately five pe rcent of the reported chemicals due to the 506 high error rate experienced with the 2006 IUR data colle ction and receipt. A large number of 507 errors were created through th e scanning process and require d correction by hand, which was 508 very labor intensive. The introduced errors included incorrectly scanned chemical identities and 509
indications of whether a data element was claimed CBI. An in correctly recorded CBI claim 510
could lead to the inadvertent di sclosure of confidential informa tion or to the non-release of non511
confidential information. 512

513 EPA also detected significant errors not re lated to scanning on a substantial number of 514 reporting forms and faced difficulties resolving issu es pertaining to submissions with incorrect 515
chemical identification information. Some of th e errors included submitters not specifically 516 identifying a chemical substance, providing chem ical names and CAS Registry Numbers that did 517 not match, or providing a CAS Regist ry Number that did not exist. Often, the submitted data did 518 not conform to the reporting requirements desc ribed and explained in the IUR rule and 2006 519 guidance documents. 520

521 The 2006 IUR reporting software provided by th e Agency contained a validation program 522 designed to identify certain errors prior to submission. Sometim es a submitter used the software 523 to prepare a submission, but printed the reporting form prior to completing the validation check 524 because it was not able to pass the valida tion. Such reports typically contained incomplete or 525 incorrect information, and EPA needed to contact th e submitter or take othe r steps to correct the 526 data prior to entering it into the database. 527

528 EPA believes the proposed requirement to us e e-IUR to report el ectronically would 529 eliminate problems related to the scanning of pape r documents, incorrect chemical identities, and 530 other errors introduced by the submitter. These e rrors substantially delayed the availability of 531 the IUR information to both internal EPA progr ams, such as the Existing Chemicals Program, 532 and the public. 533

534
1. Updated e-IUR reporting software 535

536 EPA developed e-IUR reporting software for use in preparing and submitting reports 537 electronically during the 2006 IUR submission period (see www.epa.gov/iur). The 2011 e-IUR 538
would feature several enhancements over the 2006 e-IUR. These improvements include a 539 sophisticated validation system, which would aler t users when a required field on the form is 540 either missing information or contains certain kinds of potentially inco rrect information. Other 541 updates are expected to include automated chem ical identity checks, automated company and 542 site identity checks, and the facilitation of joint submissions and amendments. For the 2011 e543 IUR, EPA is also considering a free web-based application in pl ace of, or in addition to, free 544
downloadable software. 545

546
2. Require electronic submissions over the Internet 547
548 EPA is proposing to require that manufactur ers (including importers) submit their IUR 549*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

13 of 78 reports to the Agency through CDX via the Internet. EPA would re quire that all submissions be 550 generated using e-IUR, as described in Unit III.B.1. Electronic submissions would ensure that 551 IUR data will have completed a basic validation check, could be quickly incorporated into a 552 database and ready for immediate Agency use, and would not be subject to subsequent data entry 553

errors. Furthermore, EPA believes the require d use of e-IUR and CDX would reduce the 554 reporting burden on industry by re ducing both the cost and the time required to review, edit and 555 transmit data to the Agency. After the final ru le’s effective date, EP A would no longer accept 556 paper submissions or electronic media (i.e., as a file on a CD) for any IUR submission. 557

558 EPA is proposing that submission of IUR data through CDX become EPA’s required 559 submission method for several reasons. Electronic submission enables EPA to notify the 560 submitter that the Agency has received its submission, it reduces reporting errors, and it enables 561 data to be available for Agency and public us e more quickly. During the comment period for the 562 renewal of the Information Collection Reque st (ICR) (73 FR 51805, September 5, 2008), EPA 563 received positive comments regarding the use of CDX, the encrypted Internet submission 564 process, and the ability to use a secure elect ronic signature method to submit IUR reports. 565

566
3. Electronic Signature process 567
568 In order to submit electronically to EPA vi a CDX, individuals acting on behalf of the 569 submitter must first register with CDX. CDX registration is a requirement for all electronic 570 submissions using CDX and is not being introduced with this proposal. During the 2006 IUR, 571 submitters were required to complete an electronic signature agreement (ESA) and to submit the 572 agreement in hard copy with a wet ink signatu re to EPA in order to complete the CDX 573 registration. (Ref. 4) There was confusion among some submitters regarding the correct identity 574 of the individual eligible to register for C DX and the individual required to sign the ESA. 575

576 EPA is making changes to the registration pro cess in order to addre ss problems identified 577 during the 2006 IUR electronic reporting. Fo r 2011 IUR reports, EPA is modifying the 2006 578 ESA to identify more clearly the individual(s) requ ired to sign the agreement. The Agency is 579 developing an ESA process similar to that planned for New Chemical Program electronic 580 submissions. (Ref. 5) Each IUR submission must ha ve an authorized official associated with the 581 submission, who is the person signing the certif ication statement and submitting the IUR report 582
via CDX. The authorized official would need to complete both an ESA and the CDX 583 registration process. 584

585 EPA is requesting comment on whether some re porting sites may need or desire to have 586 more than one individual complete an electronic signature agreement, so that other individuals 587
could add information to the IUR submission. Th e other individual may be a paid employee of 588 the company, an outside consultant for the compa ny, or an authorized representative agent for 589 the company. While this individual would not be ab le to sign the certific ation statement required 590 for the initial IUR submission, he or she would be able to provide additional information, if 591 needed, using CDX. For 2006 and prior IUR submissions, submitters were not able to provide 592 additional information electronically. 593
594 EPA is considering developing a single Electronic Signature Agreement and CDX 595 registration process that would be applicable to all TSCA program s. EPA believes a company or 596 site may want to use the same authorized official for both Premanufacture Notice (PMN) 597*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

14 of 78 submissions and IUR submissions. EPA is inte rested in obtaining comme nts on this approach. 598 For example, would the authorized official re sponsible for signing both an IUR submission and a 599 PMN submission be the same person? 600

601
C. Modifications to Selected Definitions 602
603 As part of developing the definition section for 40 CFR part 711, EPA is proposing to 604 modify six definitions associated with the IUR rule and to add four new definitions. In 40 CFR 605 704.3 and 40 CFR 710.3, EPA is also propos ing to modify th e definition of importer by 606 removing the citation to 19 CFR 1.11. The citati on, which would correctly read 19 CFR 101.1, is 607
not needed for this definition because it does not add additional information to the definition of 608 importer

. 609

610
1. Manufacture and Manufacturer 611
612 In order to improve the information submitted through the IUR rule, EPA is proposing to 613 modify the definition of manufacture by incorporating elements from the 40 CFR 720.3 614
definition for manufacturer . The proposed 40 CFR 711.3 definition of manufacture would allow 615 persons contracting with a toll manufacturer to report the chemical phys ically manufactured at 616
the toll manufacturer’s site. U nder the proposed definition of site , the site information would be 617 the toll manufacturer’s site (see Unit III.C.2.). Adopting this definition would allow the person 618 contracting for the manufacture of a chemical substance to report the information on the 619 industrial processing and use of a chemical substance and on the consumer and commercial uses 620 of a product containing the chemical substance. Information on the uses of a chemical substance 621
is often unavailable to a toll manufacturer w ho produces a chemical substance for another 622 person. EPA is proposing to include a modified definition of manufacture in 40 CFR part 711 623 instead of adopting the definition of manufacturer from 40 CFR 720.3 because the IUR rule does 624
not use the term manufacturer . In order to avoid any confusion with the definitions of these 625 terms found at 40 CFR 704.3, the Agency is also proposing to add a simple definition for the 626

term manufacturer to 40 CFR 711.3. In addition to the pr oposed change to the definition of 627 manufacture , EPA is proposing to add a paragraph (c ) to the proposed regulation at 40 CFR 628 711.15 to clarify the reporting relationship be tween the contracting company and the toll 629 manufacturer. The contracting company is prim arily responsible for the IUR reporting, but in 630 the event the contracting company does not report, the toll manufact urer must report. Both the 631 contracting company and the toll manufacturer are liable if no re port is made. Note that the 632 contracting company and the toll manufacturer s hould confer with each other to avoid duplicate 633 reporting. 634

635 With this proposal, the term manufacture therefore would be defined under the IUR rule 636 to mean “to manufacture, produce, or import fo r commercial purposes. Manufacture includes the 637 extraction, for commercial purposes, of a com ponent chemical substance from a previously 638 existing chemical substance or a complex comb ination of substances. When a substance, 639 manufactured other than by import, is (1) produ ced exclusively for another person who contracts 640 for such production, and (2) that other person specifi es the identity of the substance and controls 641 the total amount produced and the basic technology for the plant process, that substance is jointly 642 manufactured by the producing ma nufacturer and the person cont racting for such production.” 643 Also with this proposal, the term manufacturer would be defined under the IUR rule to mean “a 644 person who manufactures a chemical substance.” 645*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

15 of 78 646
2. Site 647

648 EPA is proposing to amend the definition of site to: (1) clarify that the importer’s site must 649 be a U.S. address, (2) accommodate manuf acturing under contract, and (3) accommodate 650 portable manufacturing units. See Unit III.I for a fu rther discussion of this proposal as it relates 651 to importers. As described in Unit II I.C.1., the proposed 40 CFR 711.3 definition of 652 manufacture would allow persons contracting with a toll manufacturer to report the chemical 653 physically manufactured at the to ll manufacturer’s site and the site identification information 654 pertaining to the toll ma nufacturer’s site. 655

656 EPA identified the need to accommodate porta ble manufacturing units during the 2006 IUR 657 submission period. Two examples of portable manu facturing units are tanks used to manufacture 658 calcium hydroxide slurry for us e in building construction and ro ad and highway projects, and 659 tanks used to mix anhydrous ammonia and wate r to manufacture ammonium hydroxide prior to 660 application to agricultural lands. EPA is interest ed in including chemical manufacturing that is, 661 for instance, performed by road crews or is occu rring at construction sites at which chemicals are 662
mixed on site in such a manner to create a different chemical substance, e.g., asphalt emulsifiers. 663 The site of physical manufacturing could cha nge on a frequent basis. Manufacturers would 664 report the aggregated production volume for all of th e portable manufacturing units sent out to 665 different locations from a single distribution center. The address of the distributi on center would 666 be reported as the site locati on. EPA is interested in comments on whether the proposed 667 definition addressing portable manufacturing units would result in reporting, under the IUR rule, 668 for situations similar to those presented as examples. 669
670 With this proposal, the term site would be defined under the IUR rule to mean “a contiguous 671 property unit. Property di vided only by a public right-of-way sh all be considered one site. More 672 than one plant may be located on a single site. 673

674 (a) For substances manufactured under contract, i.e., by a toll manufact urer, the site is the 675
location where the chemical substa nce is physically manufactured. 676

677 (b) The site for an importer who imports a chem ical substance described in §711.5 is the U.S. 678 site of the operating unit within the person's organization that is directly responsible for 679 importing the substance. The import site, in some cases, may be the organization's 680 headquarters in the United Stat es. If there is no such opera ting unit or headquarters in the 681 United States, the site address for the importer is the U.S. address of an agent acting on 682 behalf of the importer who is authorized to accept service of process for the importer. 683

684 (c) For portable manufacturing un its sent out to different loca tions from a single distribution 685 center, the distribution center sh all be considered the site.” 686

687
3. Electronic-Reporting Related Definitions 688
689 EPA is proposing to add two new terms, Central Data Exchange (CDX) and electronic 690 IUR (e-IUR). The Agency is adding these terms to pr ovide clarity to the proposed requirement 691 for electronic reporting of IUR data. The term CDX means “EPA’s centralized electronic 692 document receiving system, or its successors, includi ng associated instructions for registering to 693*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

16 of 78 submit electronic documents.” The new definition would make the term consistent with the new 694
PMN definition. The term e-IUR means the “electronic-IUR software provided by EPA for the 695 completion and submission of the IUR Form U report.” 696

697
4. Processing and Use-Related Definitions 698

699 EPA is proposing to amend the definitions of the terms c ommercial use and consumer use 700
in order to make them more consistent with the definitions developed collaboratively by the 701
United States and Canada. See Unit III.F.8 for fu rther information. The proposed definitions for 702 these two terms differ in wording from the Cana dian version to ensure the use of terminology 703 defined in IUR and related regulations, and EP A believes the basic application of these two 704 terms would not differ from the basic applic ation of the Canadian definitions. (Ref. 13) The term 705

c ommercial use would mean “the use of a chemical subs tance or a mixture containing a chemical 706 substance (including as part of an article) in a commerc ial enterprise providing saleable goods or 707 services.” Examples included in the § 710.43 de finition would be eliminated. The slightly 708
modified definition of consumer use would be “the use of a chemical substance or a mixture 709 containing a chemical substance (inc luding as part of an article) when sold to or made available 710
to consumers for their use.” The restrictions associated with where a consumer would use the 711 product would be removed. 712

713 EPA is proposing to add a definition for the term industrial function. For the 2006 IUR, 714
EPA defined industrial use and did not define industrial function . The inclusion of both 715 definitions provides clarity for the industrial processing and use reporting requirements and 716 would make the Agency’s requirements consiste nt with those collabor atively developed with 717 Canada. (Ref. 13) Additional discussion of those requirements is in Unit III.F.7

. With this 718 proposal, industrial function would mean “the intended physical or chemical characteristic for 719
which a chemical substance or mixture is co nsumed as a reactant; incorporated into a 720 formulation, mixture, reaction product, or article; repackaged; or used.” 721

722
5. Principal Reporting Year and Submission Period 723

724 As described in Unit II.A, EPA is proposing to change the reporting cycle from every 725 five years to every four year s and to require the reporting of production volumes for each 726 calendar year since the last pr incipal reporting year. EPA is proposing to modify the terms 727 reporting year and submission period to reflect these changes. 728
729
The term reporting year would be modified to add the te rm “principal” and to replace 730 the word “information” with “manufacturing, pro cessing and use data.” These changes are to 731 indicate that the principal reporti ng year is the year in which most of the reported data are based. 732 Under the current proposal, the pr incipal reporting year is the latest complete calendar year 733 proceeding the submission period. Additionally, EP A is proposing to remove the reference to 734 “the calendar year at 5-year intervals thereafter ” and to remove the reference to “calendar year 735
2005.” With these ch anges, the term principal reporting year would be defined as “the calendar 736 year in which manufacturing, processing, and use activ ities associated with the data reported to 737 EPA during an IUR submission period occur. Pr oduction volume for manuf acturing activities in 738 other years of the reporting cycle may also be reportable during the s ubmission period, but full 739 manufacturing, processing, and use data are reported only for activities during the principal 740 reporting year.” 741*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

17 of 78 742
The term submission period would be modified by deleting the phrase “generated during the 743 reporting year.” With this change, the definition of submission period would reflect that data for 744 years in addition to the principal reporting year would be reported. With this change, the 745
definition of submission period would mean “the period in wh ich manufacturing, processing, and 746
use data are submitted to EPA.” 747

748

D. Modifications to Reporting Thresholds 749
750 Reporting thresholds are used to determine wh en IUR reporting is re quired for a subject 751 chemical at a manufacturing (i ncluding importing) site. Ever y person manufacturing (including 752 importing) a non-excluded substance at or abov e the 25,000 lb. threshold is required to report 753
information in Parts I. and II. of the IUR Fo rm U. Beginning with the 2006 IUR submission 754 period, every person manufacturing (including importing) a non-exclud ed substance at or above 755 the 300,000 lb. threshold was required to report inform ation in Part III. of Form U, unless the 756 substance was partially exempt. EPA is pr oposing three changes related to the reporting 757 thresholds: (1) determination of whether you m eet the 25,000 lb. threshold, (2) elimination of 758 the 300,000 lb. threshold for reporting information in Part III, and (3) elimination of the 25,000 759 lb. reporting threshold for certain chemicals. 760

761

1. Method for determining whether a person is subject to IUR reporting 762 requirements. 763
764 Currently, a one-year snap shot of manufacturing (including impor ting) is used to determine 765 the need to report for the IUR rule. The me thod used to make the reporting determination 766 involves identifying that a person manufactured (inc luding imported) a chemical substance listed 767 on the TSCA Inventory during the principa l reporting year (e .g., 2005 for the 2006 IUR 768 submission period); that the chemical substa nce was not otherwise exempt; and that the 769 associated production volume (domestically manufactured plus imported volumes) met or 770 exceeded 25,000 lb. for the principal reporti ng year (e.g., 2005 for the 2006 IUR submission 771 period). 772

773 EPA is proposing to modify the method used to determine whether a person is subject to IUR 774 reporting. The proposed method would be to determ ine whether, for any calendar year since the 775 last principal reporting year, a chemical was ma nufactured (including impor ted) at a site in 776 production volumes of 25,000 lb. or greater. For the 2011 subm ission period, it would be 777 necessary to examine the annual production volumes for the year s 2006 to 2010 for the site. If 778 the production volume for a report able chemical substance was 25,000 lb. or greater for any 779 calendar year during that five-year period, then it would be necessary to report the chemical 780 substance, unless it is otherwise exempt. Fo r instance, a subject ch emical with production 781 volumes of 5,000 lb. in 2010 and 35,000 lb. in 2 007 would be reported for the 2011 IUR. 782 Regardless of the 2010 production volume, in this example scenario the 2011 IUR submission 783
would contain detailed information based on ma nufacturing during the 2 010 calendar year and 784 production volume information only for the years 2006 through 2009, as described in Unit 785 III.F.4.i., due to the 2007 production volume. 786

787 EPA is proposing this change because of the mounting evidence that many chemicals, even 788 larger volume chemicals, often experience wide fluctuations in manufacturing volume from year 789*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

18 of 78 to year. This can result in the production volume of a chemical exceeding the threshold for 790 several years, then falling below the thresh old during the IUR prin cipal reporting year. 791 Consequently, previous IUR repor ting has resulted in a change of approximately 30 percent in 792 the composition of the chemicals being reporte d from one submission period to the next. 793 Therefore, the one-year snapshot of production vo lume does not provide an accurate picture of 794 the chemicals in commerce, and may provide an erroneous view of the exposure scenarios 795 associated with a particular chemical substance. 796

797 An example of the wide fluctuations in ma nufacturing volume is found in the Agency’s HPV 798 Challenge Program (described in Unit III.D.1). In this program, IUR data were used to 799 determine the HPV chemicals, or the chemicals with nationally aggregated production volumes 800
of one million lb. or more. As the HPV Challe nge Program progressed, the Agency chose not to 801 pursue certain chemicals because new IUR reporti ng indicated that the nationally aggregated 802 production volume had dropped below one million lb. However, based on the latest IUR, the 803 production volume for some of the chemicals th e Agency was no longer pursuing had risen again 804
to exceed one million lb. 805

806 Industry representatives have pr ovided further evidence that ca pturing producti on volume for 807 only the principal reporting year is resulting in the omission of information on chemicals in 808 current production. In comments submitted to th e Agency in response to other programs, the 809 industry representatives expressed concern that short reporting determ ination periods would 810 drastically misrepresent the chemicals that curr ently are in commerce. Industry representatives 811 stated they manufactured or imported some chemicals only occasionally, and that these 812 chemicals would not be captured if the reporting covered too short a peri od. Comments included 813 statements such as “A longer time frame is necessary to capture the sporadically produced 814 chemicals... As such, a ‘snapshot’ in time may not adequately identify the complete inventory 815 requirements...” (Ref. 6). Another commenter ag reed “a longer timeframe to report chemicals 816 would capture those chemicals that undergo pe riodic manufacture based upon customer-driven 817 demand or other factors (e.g., variation in availability or cost of raw materials, cost of substitute 818 materials, etc.)” (Ref. 7) or chemicals that ar e used infrequently and upon request when working 819 with suppliers (Ref. 8). 820

821 In light of these comments and EPA’s own experiences, the Agency believes that using 822 production volume reporting for all years since the last principal reportin g year to determine 823 reporting obligations would yield a much more accu rate picture of the ch emicals currently in 824 commerce, ensuring proper review under EPA’s risk screening, assessment, and management 825 activities and providi ng better information to the public. 826

827
2. Eliminate 300,000 lb. threshold for pr ocessing and use information. 828
829 EPA is proposing to eliminate the 300,000 lb. threshold for processing and use 830 information, thereby requiring all reporters of non- excluded substances to report information in 831 all parts of the IUR Form U. EPA is proposing to eliminate this reporting threshold in order to 832 collect information necessary to complete screen ing-level exposure characterizations for all IUR 833 reportable chemicals. The exposure informati on is an essential part of developing risk 834 evaluations and, based on its experience in usi ng this information, the Agency believes that 835 collecting this exposure informa tion is critical to its missi on of characterizing exposure, 836 identifying potential risks, and noting uncertainties for these lower production volume chemicals. 837*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

19 of 78 In addition, this change will provide the publ ic with information on a greater number of 838
chemicals. In the 2003 Amendments fina l rule (68 FR 848, January 7, 2003), EPA 839 acknowledged the value of inform ation for chemical substances manufactured in lower volumes 840 and stated that if the Agency were to find it n ecessary in the future, it would collect information 841 on chemical substances at reporting thresholds belo w the thresholds that we re introduced in that 842 action (i.e., 25,000 lb. and 300,000 lb.). 843

844 The current 300,000 lb. threshold applies to each reportable chemical manufactured 845 (including imported) at each individual reporting site and was selected w ith the intention that 846 exposure-related processing and use information would be collected for HPV chemicals (HPV 847 being defined as a national aggregate pr oduction volume, potentially from a number of 848 manufacturing sites, of great er than 1,000,000 lb. per year). When EPA promulgated the 2003 849 Amendments, the Agency believed a 300,000 lb. per ye ar site-specific repo rting threshold would 850 capture sufficient exposure-related information fo r substantially all HPV chemicals. However, 851 based on the 2006 data, approximately 23% of the reports submitted for known HPV chemicals 852 had reported production volumes below the 300,000 lb. threshold, and consequently did not 853 contain exposure-related processing and use information. Therefore, EPA believes that the 854 300,000 lb. threshold was too high to provide sufficient processi ng and use data for the HPV 855 chemicals. The Agency explored setting th e threshold for reporting processing and use 856
information to an alternate level between the basic reporting thre shold of 25,000 lb. and 300,000 857 lb. for this action. However, the need to comple te characterizations for chemicals manufactured 858 (including imported) in volumes of 25,000 lb. to 300,000 lb. led the Agency to believe that it 859 would be best to eliminate the upper threshol d and collect full information for all reported 860
chemicals. 861

862
3. Elimination of the 25,000 lb . threshold for certain regulated chemicals. 863

864 EPA is proposing to eliminate the 25,000 lb. re porting threshold fo r certain chemical 865 substances that are the subject of particular TSCA rules and/or orders and to require 866 manufacturers (including importers) of such chem icals to report under the IUR rule, regardless of 867 the production volume. This provision will ensure the availability of cu rrent information when 868 EPA has expressed a concern in the form of regulatory action on those chemical substances, 869 regardless of the production volume. EPA is pr oposing to eliminate the 25,000 lb. threshold for 870 those chemicals that are: (1) th e subject of a rule proposed or promulgated under section 5(a)(2), 871 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 872 (3) the subject of relief that ha s been granted under a civil action under section 5 or 7 of TSCA. 873

874 Under this proposal, a manufacturer, including importer, of such chemical substances 875 would be required to report information on th e manufacturing, processing, and use of the 876
chemical substances if it ma nufactured (including imported) any quantity of these chemical 877 substances during any of the years since the last principal reporting y ear, including quantities 878 under 25,000 lb. For 2011 reporting, the manufactu rer would need to consider the manufacture 879 or import during the years 2006 through 2010; would report the production volumes for each 880 year from 2006 to 2010; and would report the full manufacturing, processing, and use 881
information for 2010. 882

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

20 of 78 Chemicals that are the subject of particular TS CA rules and/or orders are of demonstrated 884 high interest to the Agency. EPA will use the IUR data associated with these regulated 885 chemicals to monitor chemical producti on and compliance with the rules. 886

887

E. Changes to Substances Covered by IUR 888
889
1. Water 890
891 Naturally occurring water is excluded from reporting under the IUR rule, but 892 manufactured water, which is not naturally o ccurring, is a reportable substance. EPA is 893 proposing to fully exempt all (both naturally occurring and manufactured) water (CASRN 7732- 894 18-5) and to remove water from the petroleum streams partial exemption (40 CFR 710.46(b)(1)). 895
896 EPA received approximately 43 IUR reports for water during the 2006 submission 897 period. Therefore, this proposed exemption w ould likely result in a burden reduction for IUR 898
submitters. 899
900
2. Remove fully exempt polymers from partially exempt list 901
902 Polymers are a class of chemical substances for which IUR reporting is not required (40 903 CFR 710.46(a)(1)) (proposed 40 CFR 711.6(a)(1)). Ho wever, three polymers are listed in the 904 partially exempt list of chemicals at 40 CF R 710.46(b)(2)(iv): Starch (CASRN 9005-25-8), 905 Dextrin (CASRN 9004-53-9), and Maltodextri n (CASRN 9050-36-6). Improperly including 906 substances that meet the IUR definition of a pol ymer in the partially exempt list of chemicals 907 may be confusing to submitters and may lead to unnecessary reporting for these substances. 908 EPA is proposing to amend the partially exempt list of chemicals at 40 CFR 710.46(b)(2)(iv) 909 (proposed 40 CFR 711.6(b)(2)) to remove these th ree chemical substances which, as polymers, 910 are fully exempt from reporting. 911
912
3. Making chemicals that are the subject of an Enforceable Consent Agreement 913 ineligible for exemptions 914
915 EPA may enter into an enforceable consent ag reement (ECA), pursuant to procedures at 916 40 CFR part 790, with a manufacturer of a ch emical substance to obtain testing where a 917 consensus exists among EPA, affected manufacturer s and/or processors, a nd interested members 918 of the public concerning the need for and scope of testing. Chemicals covered by ECAs are of 919 demonstrated high interest to EPA. The Agency has an interest in identifying the manufacturing, 920 processing, and use of substances under such ag reements, and therefore is proposing to require 921 that such substances be reporte d for IUR purposes, regardless of whether the substance otherwise 922 meets the requirements listed in 40 CFR 710.46 (proposed 40 CFR 711.6) as an exempt or 923 partially exempt chemical substance. This pr ovision will ensure the availability of current 924 information if EPA has expressed a concern in the form of an ECA on any substance otherwise 925 excluded from the IUR rule. EPA is therefore pr oposing to make chemical substances that are 926 the subject of an ECA ineligible for IUR exemptions. 927
928 With this proposal, chemicals that are the subj ect of an ECA would be included in the list 929 of chemicals that are ineligible for an IUR ex emption, in the introductory paragraph of 40 CFR 930 710.46 (proposed 40 CFR 711.6) listing the other chemi cals that are likewise not eligible for an 931*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

21 of 78 IUR exemption. The paragraph would state that a chemical “is not exempted from any of the 932 reporting requirements of this part if that s ubstance is the subject of a rule proposed or 933 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 934 agreement developed under the procedures of 40 CFR part 790, or is the subject of an order 935 issued under section 5(e) or 5(f) of the Act, or is the subject of relief th at has been granted under 936
a civil action under section 5 or 7 of the Act.” 937
938

F. Modifications to Reportable Data Elements 939
940
1. Parent Company and Site Identity 941
942 Manufacturers (including importers) are requ ired to report the company name and Dun 943 and Bradstreet (D&B) number to identify the compa ny associated with the pl ant site, and also to 944 report the site name, address, and D&B number. If the company associated with the plant site 945 does not have a D&B number, the manufacturer must obtain a D&B numb er for the company. 946 Likewise, if the plant site doe s not have a D&B number, the ma nufacturer must obtain a D&B 947
number for the site. EPA recei ved a variety of questions con cerning the correct company name 948 to report during the 2006 IUR submission period. EPA is now clarifying what is meant by 949 company name, by proposing to require that the company name provided be the ultimate 950 domestic parent company name. EPA believes th is change will reduce confusion by making this 951 reporting requirement consistent with the Toxic Release Inventory (TRI) requirements for parent 952 company name. The requirement that the ultim ate domestic parent company name be reported 953
does not affect the determinati on of small business status, which is not limited to domestic 954 companies. Persons covered by the IUR rule should continue to base small business 955 determinations on the ultimate parent company, re gardless of whether that company is domestic 956 or foreign. 957
958
The 2006 IUR submissions from different reporting sites cont ained varying D&B 959 numbers for parent companies that appeared to be the same compa ny. In order to better identify 960 when reporting sites are under the same parent company, EPA is proposing to include the 961 address as well as the D&B number of the parent company. 962
963
2. Technical Contact 964
965 Manufacturers (including importers) are required to provide a techni cal contact for their 966
IUR submission. The technical contact must be a person who can answer questions EPA may 967 have about the reported chemical substance and should be a person located at the manufacturing 968 site. Based on EPA’s experience with contacting the reported t echnical contact with follow-up 969 questions concerning 2006 IUR submissions, reporte rs often provide the names of individuals 970 who are not directly connected to the reporting site, and theref ore, are not knowledgeable about 971
either the chemical or the submission. EPA has al so seen situations wher e the technical contact 972 is a contracted employee who is able to address subsequent concerns only if he or she remains 973 under contract. Note that EPA may raise follo w-up questions about an IUR submission, possibly 974 years after the submission date. EPA is intere sted in any comments or suggestions regarding 975 how to better identify the technical contact. 976

977 EPA is considering allowing multiple techni cal contacts on a chemical-by-chemical 978 basis. The e-IUR reporting software would allow the identification of several names associated 979*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

22 of 78 with a submission. EPA is interested in any comment or suggestions regarding this 980
consideration. 981
982
3. Chemical Identity 983
984 Manufacturers, including importers, are required to submit the correct chemical identity 985 for each subject chemical substance. For the 200 6 IUR, the correct chemical identity included a 986 specific chemical name and a corresponding iden tifying number. The identifying number could 987 be the Chemical Abstracts Service Registry Nu mber (CASRN), the TSCA Accession Number, or 988
the PMN number. 989
990
i. Chemical Name 991
992 EPA is proposing to require the reporting of the Chemical Abstracts (CA) Index Name 993 currently used to list the substance in the Inve ntory as the chemical name reported for IUR. 994 Currently submitters are required to report a speci fic chemical name, with no further elaboration 995 in the regulatory text. The Instructions for Re porting presently state th at manufacturers should 996 use CA Index Names or, if CA Index Names are not available, manufacturers should use 997 nomenclature that completely and accurate ly describes the chemical substance. 998

999 EPA has found, however, that submitters so metimes supply a name that is somewhat 1000 generic or excludes parts of the specific chemical identity that distinguishes one substance from 1001 another. EPA’s experience from the 2006 IUR wa s that up to five percent of the reports 1002 submitted contained chemical identity problems serious enough that the Agency was unable to 1003 precisely identify the substance. These problem s resulted in the temporary exclusion of the 1004 information associated with the poorly or errone ously identified chemical from the IUR database 1005 until the Agency was able to obtain correct and specific chemical identity information from the 1006 submitter. EPA believes the requirement to use the substance name as currently listed on the 1007 Inventory will greatly reduce the number of poorly identified substances. EPA intends to include 1008 the CASRN and CA Index Names as part of e-IU R, to the extent possi ble without jeopardizing 1009 confidentiality claims. 1010

1011 Manufacturers (including importers) will be allowed to supply an alternate chemical 1012 name, and in the case of importers, a trade name , in those instances where a supplier will not 1013 disclose to the submitter the specific chemical name of the imported Inventory substance or a 1014 reactant used to manufacture the Inventory substance. In these cases, the manufacturer 1015 (including importer) and th e supplier report the information re quired in this part in a joint 1016 submission. In order to clarify this require ment, EPA is proposing an amendment to 40 CFR 1017 710.52(c)(3)(i) (proposed 40 CFR 7 11.12(b)(3)(i)) to stat e that the importer must have the 1018 supplier of the confidential chemical substance directly provide EPA with the correct chemical 1019 identity, in a joint submission with the manufactur er. Furthermore, in the event the manufacturer 1020 submitting a report cannot provide the whole chemi cal identity because the reportable chemical 1021 substance is manufactured using a reactant ha ving a specific chemical identity claimed as 1022 confidential by its supplier, the manufacturer must submit a report directly to EPA containing all 1023 other information known to or reasonably ascert ainable by the manufacturer about the chemical 1024 identity of the reported substan ce and must ensure that the supp lier directly provides to EPA the 1025 correct chemical identity of the confidential reactant in a joint subm ission. See Unit 3.I for 1026 additional information regarding jo int submissions. Detailed draf t instructions regarding joint 1027*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

23 of 78 submissions are included in the dr aft Instructions included in the docket. (Ref. 2) EPA is 1028 interested in any comments regardin g the procedure under consideration. 1029

1030
ii. Chemical Identifying Number 1031
1032 As part of the chemical identity, submitters provide a chemical identifying number 1033 associated with the correct CA Index Name, as de scribed in Unit III.E.3. For most chemicals, 1034 the chemical identifying number is the CASR N correctly corresponding to the reported CA 1035
Index Name. If the CASRN number is not availa ble because the chemical substance is listed on 1036 the confidential portion of the Inventory and a CASRN does not already exist for that substance, 1037 the submitter could report either the associated TSCA Accession or PMN number. 1038
1039 EPA is proposing to allow submitters to report only the CASRN as a chemical identifying 1040 number or, in the case of confidential chemical substances, the accession number. Note that in 1041
cases where a CASRN exists for a confidential chemical, it can be reported instead of the 1042 accession number and claimed as confidential for purposes of the IUR submission. EPA is 1043 proposing to remove the PMN number as an allo wed chemical identifying number because each 1044 Inventory substance has either (or both) a CASRN or a TSCA Accession Number, which are 1045 likely to be already known to the submitter. Furthermore, the Agency has to spend considerably 1046 more time and effort to access and review reported information that has been identified only by a 1047
PMN case number. 1048
1049 Submitters who, in the past, have reported using the PMN number of a confidential 1050 substance may contact EPA, if necessary, to le arn the TSCA Accession Number assigned when 1051 the Notice of Commencement (NOC) was submitted to the Agency. 1052

1053
4. Production Volume 1054
1055 Manufacturers, including importers, are requir ed to report production volume information 1056 for each chemical substance for which they submit an IUR report. For the 2006 IUR, 1057 production volume information consisted of the manufactured production volume; the imported 1058 production volume; an indication of whether the substance was manufactured, imported, or both; 1059
and an indication of whether the substance was site -limited. In instances wh ere a single site both 1060 manufactures and imports the same chemical subs tance, the site was to report the manufactured 1061 and imported production volumes separately on one report. The combined total production 1062
volume was then used as the basis for determini ng the percentage of prod uction volume in other 1063 areas of the report, such as for the physical form, the industrial process or us e, or the consumer 1064
or commercial use. 1065

1066 EPA is proposing a number of changes to the reporting of pr oduction volume and 1067 associated information. The Agency believes th ese changes would improve the usefulness of the 1068 information for EPA and others, and would provide clarity for the reporti ng obligations of the 1069
submitter. 1070

1071
i. Report production volume for each of the years since the last principal 1072 reporting year. 1073
1074 EPA is proposing to require reporting of production volume for each of the five years 1075*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

24 of 78 since the last IUR principal reporting year. Thus, for the 2011 IUR submission period, 1076 manufacturers (including importers) of a chem ical at or above the 25,000 lb. threshold would 1077 report the production volume of that chemical for each of the following calendar years: 2010, 1078 2009, 2008, 2007, and 2006. This change would provide information EPA and others need as 1079 stated in Unit III.D. Collecting the producti on volume for multiple years would provide greater 1080 detail than the current once-every-five-years snapshot. 1081

1082 For the principal reporting year, e.g., 2010, the domestic manufacture and the import 1083 production volume would continue to be reported separately on the same report. EPA review 1084 and analysis of the 2006 IUR data has revealed that some submitters are erroneously submitting 1085 multiple reports for the same chemical, at tim es reporting the information associated with 1086 manufacturing and importing in different reports. The submitter should complete only one report 1087
for each chemical substance. 1088
1089 EPA uses production volume data in several im portant ways. The data help the Agency 1090
to establish trends in chemical manufacturing; to determine the effectiveness of various Agency 1091 and other programs; to estimate the magnitude of consumer, worker, and environmental 1092 exposures; and to determine the costs (and financia l impacts) of potential control strategies in 1093 economic analyses. As discussed in Unit II I.D.2., the collection of annual production volume 1094 data would allow EPA to identify more cons istently the HPV chemicals. Voluntary EPA 1095 programs such as Design for the Environment (DfE) and other pollution prevention programs 1096 would use the annual production vo lume data to identify trends and program performance. 1097 Relying on a single snapshot of annual production volume in each reporting determination period 1098 hampers EPA’s ability to identify the programs a nd techniques that are most effective, using 1099 measurable, readily identifi able production trend data. 1100

1101 Unit V of this Preamble contains a series of requests for comments on additional ideas 1102 under consideration by the Agency. One of the ideas concerns the collection of more than just 1103 the production volume since the last reporting year. The Agency is interested in comments on 1104
this matter. Please see Un it V for additional discussion. 1105

1106
ii. Volume of chemical substance used on-site. 1107
1108 EPA is proposing to require that submitters report the volumes of a manufactured 1109 (including imported) chemical substance used at th e reporting site. The re quirement to report the 1110 volume used on-site is replacing th e requirement to indicate that the chemical is site-limited. 1111 Under this proposal, either domes tically manufactured or imported chemicals could be reported 1112 as used at the reporting site, whereas, unde r the current reporting requirements, only 1113 domestically manufactured chemical s, consumed entirely at the site of manufacture, should be 1114 reported as site-limited. 1115

1116 EPA is proposing this change to simplify repor ting and to collect information that better 1117 addresses the Agency’s needs. In the past, submitters sometimes incorrectly reported their 1118 production volume separately to identify the portion of their chemical that was consumed at the 1119 site of manufacture. For the 2006 IUR, many su bmitters continued this practice and erroneously 1120 filed separate reports to identify that a por tion of their production vol ume was site-limited. 1121 Filing separate reports resulted in the need to report processing and use information separately 1122 when the combined producti on volume was 300,000 lb. or great er. Reporting all production 1123*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

25 of 78 volumes on one report simplifies reporting for such submitters and results in a less complicated 1124 database, thereby making the data easier to use. In addition, reporting the volume used on-site 1125 provides valuable information related to potential exposures associated with the on-site volumes, 1126 providing the Agency with better information for exposure assessments and other data analyses. 1127

1128
iii. Indicate whether imported chemicals are physically at reporting site. 1129

1130 EPA is proposing to add a requirement to indicate whether an imported chemical is 1131 physically at the reportin g site. Often, the site reporting an imported chemical never physically 1132 receives the chemical, but instead ships it direc tly to another location su ch as a warehouse, a 1133 processing or use site, or a customer’s site. Iden tifying whether the chemical is physically at the 1134 reporting site provides more accurate information fo r screening-level analyses and other uses of 1135
the IUR data. 1136

1137
iv. Report volume exported. 1138
1139 EPA is proposing to add a requirement to re port the production volum e directly exported 1140 and not domestically processed or used. This would allow EPA to better identify the proportion 1141 of the production volume accounted for by the use reporting, given that downstream reporting is 1142 not required for expor ted substances. 1143

1144
5. Identify whether a chemical is to be recycled, remanufactured, reprocessed, 1145 reused, or reworked. 1146

1147 EPA is proposing to add a requirement to indicate (via a check-box) whether a 1148 manufactured chemical, such as a byproduct, is to be recycled, remanufactured, reprocessed, 1149 reused, or reworked. Submitters would iden tify that their manufactured chemical, which 1150 otherwise would be disposed of as a waste, is being removed from the waste stream and has a 1151 commercial purpose (i.e., it is being recycle d, remanufactured, reprocessed, reused, or 1152 reworked). EPA believes that such informati on will help the Agency to identify where these 1153 activities are already occurring, and can be used to encourage such activities. Collecting 1154 information on whether a chemical is being re cycled, remanufactured, reprocessed or reused and 1155 is not entering the waste stream provides valuab le information to EPA and others regarding 1156 trends in chemical manufacturing. This informa tion also can be used to help determine the 1157 effectiveness of various programs, such as EPA’s Resource Conserva tion Challenge (RCC) 1158 Program. EPA launched the RCC in 2002, implem enting Congress’ instruction to prevent 1159 pollution and conserve natural resources and en ergy by managing materials more efficiently. 1160 The RCC Program’s goals include promoting reus e and recycling and reducing chemicals of 1161 national concern in products and waste. Indicating that a manufactured chemical, such as a 1162 byproduct, is to be recycled, re manufactured, reprocessed, reused, or reworked does not affect 1163 the reporting requirements associated with any substance manufactured from the byproduct. See 1164 Unit IV.2 for detailed information on byproduct reporting. 1165

1166
6. Concentration ranges. 1167
1168 EPA is proposing to eliminate gaps in the ranges used to report concen tration in § 710.52(C)(3) 1169 and (4). The current ranges result in gaps between 30 and 31 percent and 60 and 61 percent. 1170 The proposed ranges would be: 1171*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

26 of 78 1172 Less than 1% by weight 1173
At least 1% but less than 30% by weight 1174 At least 30% but less than 60% by weight 1175 At least 60% but less than 90% by weight 1176 At least 90% by weight 1177

1178

7. Industrial processing and use information reporting. 1179

1180 In 2003, EPA added industrial processing and use data to the information collected 1181 through the IUR rule for chemical substances manufactured in quantities of 300,000 lb. or 1182 greater during the principal re porting year. The industrial processing and use information 1183 included industrial function categories and Nort h American Industrial Classification System 1184 (NAICS) codes. EPA found that knowing these two data elements for a chemical substance was 1185 useful in selecting a scenario th at characterizes the frequency, r oute, and duration of exposure to 1186 a chemical substance during manufacture, processi ng, and use of the substance. These data are 1187
also useful when EPA characte rizes the quantity of the chemi cal substance in wastes and 1188 emissions entering the environment and for antic ipating the environmental media into which 1189
wastes will be released. The Agency is proposing to revise the list of industrial function 1190 categories and to replace the NAI CS codes with industrial sector categories, as described in 1191
sections i. and ii. 1192
1193
i. Industrial function categories. 1194
1195 EPA is proposing to revise the list of i ndustrial function categories by combining 1196 categories that lead to common exposure scen arios and adding categories where the Agency 1197 believes the existing categories do not adequately describe potential uses. EPA worked with 1198
Environment Canada and Health Canada to devel op the proposed set of categories, which would 1199 be used by both the United States and Canada for Inventory reporting. Harmonization of the 1200 categories for reporting the industr ial functions of chemical subs tances would facilitate the 1201 exchange of information between EPA and Canadian agencies and could serve as a model to be 1202 used by Mexico in developing an inventory of chemical substan ces. In addition, the harmonized 1203 categories would facilitate cons istent reporting of chemical use information by industry in the 1204 United States and Canada. (Ref. 13) 1205

1206 EPA is proposing to add eight new industria l function categories and to delete six 1207 existing categories from the curren t list; the total number of industrial fu nction categories would 1208 increase to 35. Also, EPA is proposing to rename several of the industria l function categories to 1209 provide a more informative description of the fu nction of chemical substances that should be 1210 reported in that category. Lastly, EPA is propos ing to require that if a submitter selects the 1211 category “Other,” the submitter must provide its ow n description of the industrial function of the 1212 chemical substance. EPA is proposing th e following industrial function categories: 1213

Table 1: Codes for Reporting Industrial Function Categories. 1214
Code Category

U001 Abrasives
U002 Adhesives and sealant chemicals
U003 Adsorbents and absorbents U004 Agricultural chemicals (non-pesticidal)*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

27 of 78 U005 Anti-adhesive agents U006 Bleaching agents U007 Corrosion inhibitors and anti-scaling agents U008 Dyes
U009 Fillers U010 Finishing agents
U011 Flame retardants
U012 Fuels and fuel additives U013 Functional fluids (closed systems) U014 Functional fluids (open systems)
U015 Intermediates U016 Ion exchange agents
U017 Lubricants and lubricant additives U018 Odor agents U019 Oxidizing/reducing agents
U020 Photosensitive chemicals U021 Pigments
U022 Plasticizers U023 Plating agents and surface treating agents U024 Process regulators U025 Processing aids, specific to petroleum production U026 Processing aids, not otherwise listed U027 Propellants and blowing agents U028 Solids separation agents U029 Solvents (for cleaning or degreasing) U030 Solvents (which become part of product formulation or mixture) U031 Surface active agents U032 Viscosity adjustors U033 Laboratory chemicals U034 Paint additives and coating additives not described by other categories U999 Other (specify)
1215
ii. Industrial Sectors 1216

1217 EPA is proposing to replace the five-digit North American Industrial Classification 1218 System (NAICS) codes with 48 I ndustrial Sectors (IS). The s ectors were adapted from the 1219 European Union’s (EU’s) “Guidance on info rmation requirements and chemical safety 1220
assessment.” The Industrial Sectors chosen divide the entire range of NAICS codes into sectors 1221
so that there is a sector corre sponding to any NAICS code. Th e Agency believes this change 1222 would provide several benefits. First, the sectors would reduce re porting burden because 1223 submitters would not have to look up the NAI CS code. Second, it would encourage more 1224 complete reporting by using terms that are alrea dy familiar to industry. Third, the sectors would 1225
reduce the likelihood of errors that result from th e selection of miscellaneous or inappropriate 1226 NAICS codes. Fourth, it would reduce the number of codes that could apply to one substance. 1227 Table 2 lists the proposed sectors. The rationale for selecting the sectors and the link between 1228 the sectors and the NAICS system is further de scribed in Inventory U pdate Reporting (IUR) 1229 Technical Support Document – Replacement of 5- digit NAICS Codes with Industrial Sector 1230 Codes (Ref. 9). 1231

1232 One of the primary purposes of the IUR data collection is to group t ogether similar data 1233 for priority setting exercises and activities. Respondents to the 2006 IUR submitted 342 unique 1234*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

28 of 78 five-digit NAICS codes, which made it difficult for EPA to group chemicals based on industrial 1235 processing and use scenarios. The 2006 IUR database has 2,330 unique combinations of 1236 processing or use code, NAICS co de, and industrial function categor y, in all. This large number 1237 of unique combinations increases the difficulty and time required by EPA to sort and classify 1238 chemicals because EPA either would need to develop exposure scenarios for each unique 1239 combination, or determine which three-code comb inations have similar exposure scenarios and 1240 can be grouped. The use of the sectors woul d reduce the number of unique combinations, 1241 thereby increasing the usability of the data, a nd also reducing the IUR reporting burden. 1242

1243 EPA is proposing the following 48 sectors: 1244

1245
Table 2: Industrial Sectors. 1246
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 to bacco 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 In termediate 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 Produc t Manufacturing (includes clay, glass, cement, concrete, lime, gypsum, and other nonmetallic mineral product manufacturing) IS38 Primary Metal Manufacturing*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

29 of 78 IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing
IS46 Wholesale and Retail Trade
IS47 Services IS48 Other (requires additional information)
1247 When the category chosen for the Industrial Se ctor Code is “Other,” a written description 1248 of the use of the chemical substance, which may include the NAICS code, would also need to be 1249 provided. 1250

1251
8. Consumer and commercial use reporting 1252
1253 In the 2003 Amendments, EPA added a reportin g requirement for submitters to include 1254
information about the consumer and commercial us es of chemicals they reported under the IUR 1255 rule. For the 2006 IUR, manufacturers (including importers) of subject chemicals manufactured 1256 in quantities of 300,000 lb. or more during calendar year 2005 were required to select up to ten 1257 consumer and commercial product categories from a list of 20 categories that correspond to the 1258 actual use of the chemical substance they are repo rting. For each category, submitters also were 1259 required to indicate whether the chemical was us ed in a product intende d for use by children, to 1260 report the maximum concentration of the chemical in the product categor y, and to report the 1261 percentage of total production volume a ssociated with the product category. 1262

1263 EPA is using the information provided by the 2006 IUR reports in the Existing Chemicals 1264 Program. While the Agency found that the in formation was useful in identifying when 1265
consumers and commercial users and children ar e potentially exposed populations, EPA also 1266 found that the data had signi ficant limitations concerni ng the product categories and 1267 identification of potentially expos ed populations. The Agency believes the limitations stem from 1268
two characteristics of the data: (1) the lack of specificity in the product categor ies and (2) the 1269 inability to distinguish between consumer and commercial uses. In addition, because 29 percent 1270 of the reported categories were for the category “O ther,” EPA was constrained in its ability to 1271 characterize use and exposure scenarios. Als o, consumer and commercial uses affect very 1272 different populations. The reported informa tion was not useful in differentiating these 1273 populations when characteri zing potential exposures. 1274

1275 To address these issues, EPA is proposing thr ee changes to the consumer and commercial 1276 information required to be reported: (1) a revised and expanded list of consumer and 1277 commercial product categories, (2) the additional re quirement to provide a description when the 1278 product category “Other” is selected, and (3) the id entification of whether the use is a consumer 1279 or a commercial use, or both. Reporting a ssociated with children’s use, the maximum 1280 concentration, and the percent production volume would remain unchanged. 1281

1282
i. Consumer and Commercial Product Categories 1283
1284 EPA is proposing to revise the list of c onsumer and commercial product categories by 1285*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

30 of 78 combining categories that lead to common exposure scenarios and adding categories that were 1286 not adequately described in the initial set of cat egories. EPA worked with Environment Canada 1287 and Health Canada to develop the proposed cate gories. Harmonized categories for reporting the 1288
consumer and commercial uses of chemical s ubstances would facilitate the exchange of 1289 information between EPA and Canadian agencies and would serve as a model to be used by 1290 Mexico in developing an inve ntory of chemical substances . In addition, the harmonized 1291 categories would facilitate cons istent reporting of chemical use information by industry in the 1292 United States and Canada. (Ref. 13) 1293
1294 During the development of the revised product category list, EPA and Canada considered 1295 existing product category schemes, such as th e NAICS and REACH categories, but found them 1296
to be either too detailed or not right for the task at hand. Th e NAICS categories are defined for 1297 manufacturing processes, not for consumer a nd commercial products, and therefore did not 1298
address the situations of intere st. The REACH program collects detailed information on the use 1299 of chemicals in consumer and commercial product s sold in the EU: all of the codes used by 1300 REACH are represented in the harmonized indu strial function and consumer and commercial 1301
codes. 1302

1303 The proposed list includes 33 product categories, including “Other.” Examples of new 1304 categories which have been added include expl osive materials, building/construction products 1305 not covered elsewhere, and air care products. The glass and ceramic products category had 1306 relatively few IUR submissions in 2006 and overlaps with proposed new categories, and so has 1307 been proposed for elimination. Also, several of the consumer and commercial product categories 1308
would be renamed to better descri be the products that should be reported in those categories. 1309

1310 EPA believes that expanding the list of consumer and co mmercial product categories 1311 would provide persons submitting IUR information with a greater opportunity to characterize the 1312 product in which chemical substances they ma nufacture are used and would reduce the number 1313 of uses reported as “Other.” 1314

1315 In addition to revising the overall product ca tegories, narrower de finitions and expanded 1316 lists of examples of products in which the chem ical substance would be used would be added to 1317 each category descriptor. The examples were select ed to include items that could have fit into 1318 other categories in order to address the overlap in herent in any product category list. The 1319 product categories were then placed into se veral broader groupings, e.g., “Chemicals with 1320 Agriculture and Outdoor Uses’ based on the similari ties of products. EPA believes that the user 1321 would find the proposed groupings ea sier to use than the alphab etical listing used for the 2006 1322

IUR. 1323

1324 EPA is also proposing to require that if a submitter chooses the product category “Other,” 1325 the submitter must include a text description for the consumer and commercial product 1326 containing the chemical substance. In the 2006 IUR reports, the category “Other” was reported 1327 with the greatest frequency, with 1,206 out of a total number of 4,157 reports containing 1328 consumer and commercial use information, resulti ng in a reporting rate of 29 percent for the 1329 category. Although one of EPA’s objectives in revising the co nsumer and commercial product 1330 categories was to reduce the repo rting frequency of “Other,” EP A believes that in many cases 1331 where “Other” was reported, submitters may not ha ve selected the correct categories for their 1332 situation. By requiring the submitters to supply a written description for “Other,” EPA would be 1333*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

31 of 78 able to evaluate and improve the inclusiveness of future consumer and commercial category lists 1334 or descriptions. In addition, th e descriptor information would be more useful than simply the 1335
selection of “Other” for EPA’s Exis ting Chemicals and other programs. 1336

1337 EPA is proposing the following consum er and commercial product categories: 1338
1339 Table 3: Codes for Reporting Consum er and Commercial Product Categories. 1340
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 Produc ts 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, Pa int, Electrical, and Metal Products

C201 Adhesives and Sealants

C202 Paints and Coatings

C203 Building/Construction Materials - Wood and Engineered Wood Pr oducts

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
Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)
1341
ii. Designation of Consumer or Commercial Use 1342
1343*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

32 of 78 EPA is proposing to require submitters to designate, via a checkbox, whether the 1344 indicated product category is a cons umer or a commercial use, or both

. The Agency’s 1345 experience using the 2006 IUR data identified a n eed to distinguish between potentially exposed 1346 consumer and commercial populations. The desi gnation of consumer or commercial use, or 1347 both, would allow EPA to complete a better characterization of the potentially exposed 1348 populations. 1349

1350
iii. Number of Commercial Workers Reas onably Likely to be Exposed 1351
1352 EPA is proposing to require that submitters report the total number of commercial 1353 workers, including those at sites not under the subm itter’s control, that are reasonably likely to 1354 be exposed while using the reportab le chemical substance, with respect to each commercial use. 1355 The approximate number of workers would be reported using the same definitions and ranges 1356 used for manufacturing and industrial proc essing and use workers required by 40 CFR 1357 710.52(c)(3)(v) and (4)(i )(F) (proposed 40 CFR 7 11.12(c)(3)(vii) and (4)(i)(F)), respectively. 1358 The ranges are: 1359

1360
Fewer than 10 workers 1361
At least 10 but fewer than 25 workers 1362
At least 25 but fewer than 50 workers 1363
At least 50 but fewer than 100 workers 1364
At least 100 but fewer than 500 workers 1365 At least 500 but fewer than 1,000 workers 1366 At least 1,000 but fewer than 10,000 workers 1367 At least 10,000 workers 1368
1369
Information on the number of commercial work ers reasonably likely to be exposed to the 1370 reportable chemical substance would be used to characterize the commercial population 1371 reasonably likely to be exposed to the s ubject chemical substance. The population 1372 characterization is important to the developmen t of the overall exposur e characterization. 1373

1374
G. Changes to standard for the reporting of processing and use information 1375
1376 In order to collect more complete inform ation regarding the industrial processing and 1377 industrial, commercial, and cons umer use of chemicals, EPA is proposing in § 711.12(c)(4) to 1378 replace the “readily obtainable” reporting standard used for re porting under 40 CFR 710.52(c)(4) 1379 in 2006 with the “known to or reasonably asce rtainable by” reporting st andard set forth under 1380 TSCA for this type of TSCA reporting. TSCA s ection 8(a)(2) authorizes EPA to require persons 1381 to report information that is “known to or reasonab ly ascertainable by” the submitter. This is the 1382 same standard that currently applies to the repor ting of information described in the regulations 1383 at §§ 710.52(c)(1), (c)(2), and (c)(3) , and this standard would con tinue to apply to the reporting 1384 of such information under proposed §§ 711.12(c)(1), (c )(2), and (c)(3). It covers all information 1385 in a person’s possession or cont rol, plus all information that a reasonable person similarly 1386 situated might be expected to possess, control, or know. The “known to or reasonably 1387 ascertainable by” reporting sta ndard was the only standard used for IUR reporting purposes prior 1388 to the 2006 IUR submission period. 1389
1390*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

33 of 78 EPA is proposing this change because reporting under the “readily obtainable” 1391 reporting standard did not generate sufficiently complete processing and use information. EPA 1392 believes the “readily obtainable” reporting stan dard limited the usefulness of the 2006 IUR 1393 processing and use data for screening level review s. In addition, the 2006 IUR response rate for 1394 the processing and use information did not capture a sufficiently large portion of the production 1395 volume that the Agency believes actually was us ed for either industrial processing and use or 1396 consumer and commercial use. Thirty percent of the reports submitted for the 2006 IUR met the 1397 requirements (based on type of chemical and production volume) to trigger reporting of 1398 processing and use information. Of those, al most thirteen percent contained no industrial 1399 processing and use information and almost half contained no commercial or consumer use 1400 information. For the reports that did contain so me processing and use information, the portion of 1401 the production volume for which some information was reported is detailed in Table 4. Note that 1402
an IUR Form U submission contains one or more re ports; each report is for a single chemical at a 1403 single site. 1404

1405 Table 4: Percentage of reports providing production volume information related to 1406 processing and use of chemicals reported for the 2006 IUR. 1407

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 inform ation 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 fraction of the total numbe r of reports that triggered the need to report processing 1408

and use information. 1409
1410 The Agency believes the percentage of mi ssing processing and use information actually 1411 is larger than indicated by this analysis. As described in the 2003 Amendments final rule (68 FR 1412 861), EPA anticipated that, on an individual repo rt basis, the total percentages of production 1413
volumes associated with the indus trial processing or use information may add up to more than 1414 100 percent of the reported production volume. This could happen because the submitter 1415 reported on the distribution of a chem ical to sites in its control as well as downstream sites, some 1416 of which were not immediate purchasers from the original manufacturin g site. For example, 1417
consider the scenario where a ce rtain volume of a reported chemical is reported as processed by a 1418 repackager, sent to another site that adds the chemical to a mixture, and then sent to a 1419
combination of industrial and commercial users. If the repackaged vol ume were 100 percent of 1420 the production volume, the total volume reported fo r the different processing and use scenarios 1421 could equal 300 percent of the production volume. EPA expected and anticipated this type of 1422*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

34 of 78 reporting, as each instance of processing or usin g the chemical created a different exposure 1423 scenario. As indicated in Table 4, only 12 per cent of the reports contained processing and use 1424 information that equaled or exceeded the produc tion volume for their chemical. EPA expected 1425 this percentage to be significantly larger. 1426

1427 Focusing on the industrial processing and us e information, a complete use scenario is 1428 comprised of three of the IUR data elements: th e type of process or us e, the NAICS codes, and 1429
the industrial function code. A re port could contain up to ten unique combinations of these three 1430 data elements (i.e., use scenarios). For the reports required to incl ude processing and use 1431 information in 2006, submitters reported an average of slightly more than two use scenarios. For 1432 each unique combination of these three data el ements, the manufacturer reports the percent 1433 production volume, the number of sites, and the number of reasonably likely to be exposed 1434
workers associated with the use scenario. In 2006, only about half of th e reported use scenarios 1435
also included information for the number of s ites, the number of workers, and a production 1436 volume that was greater than zero. 1437

1438 Reports for consumer and commercial use information included a product category, 1439 and, for that category, whether the chemical is used in products in tended for children, the percent 1440 production volume, and the maximum concentrati on. A report could contain up to ten product 1441 categories. For the reports that were required to include processing and use information in 2006, 1442 submitters reported an average of slightly less than one product category. Much of the consumer 1443
and commercial information contained data el ements reported as not readily obtainable 1444 (NRO) or were left blank. Specifically, 14 pe rcent of product category information, 24 percent 1445 of children’s information, and 40 percent of the maximum concentration were either reported as 1446 NRO or left blank. Overall, fewer than half of the consumer and commercial records (i.e., the 1447 individually reported product ca tegories and associated informa tion) contained complete data 1448 (e.g., where none of the data elements contained in formation reported as zer o, NRO, or were left 1449 blank). 1450

1451 This low reporting rate also occurred on an individual chemical basis; 2006 IUR 1452 submitters did not report processing and use info rmation even though they were required to 1453 report such information. This happened for 20 per cent of the chemicals for which the criteria for 1454 reporting processing and use information were met. For those chemicals, EPA has no processing 1455 or use information reported through the IUR rule. 1456

1457 For over 30 years, the Agency’s New Chem icals Program has successfully applied the 1458 “known to or reasonably ascerta inable by” reporting standard. (See 40 CFR 720.45) Companies 1459 have used this standard to report to EPA info rmation about how their chemicals are processed 1460 and used by submitting more than 30,000 TSCA section 5 Premanufactur e Notices (PMNs). 1461 Because of this experience, EPA believes that companies routinely have more information about 1462 how their chemicals are processe d and used than is reflecte d in the 2006 IUR data. PMNs 1463 routinely include extensive, detailed informa tion on how a company’s customers and others 1464 outside the company’s control will process and use its chemicals. EPA believes that the 1465 reporting under the Agency’s New Chemical pr ogram indicates that companies generally do 1466 know the intended ultimate uses, as well as the intervening proces sing steps, for their products. 1467 In addition, EPA’s experience in the New Chemi cals Program indicates that this reporting 1468 standard generates information sufficient for scr eening-level reviews. Therefore, the Agency 1469 believes that using this standard for reporting of IUR industrial processing and industrial, 1470*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

35 of 78 consumer, and commercial use information will impr ove reporting rates and assist EPA’s efforts 1471 to characterize chemical uses and to pred ict potential exposure to these chemicals. 1472

1473 The Agency’s experience using the 2006 IUR data to develop exposure 1474 characterizations, coupled with th e limited data EPA was able to publicly release, highlighted the 1475 incompleteness of the data and lead the Agency to determine that the data are insufficient, even 1476 for screening level purp oses. Effective risk screeni ng by EPA depends on the ability to 1477 accurately characterize chemical uses and to pred ict potential exposures. As described in Unit 1478 II.D, these data are used by EPA to prioritize wo rk on existing chemicals. If the information 1479 provided does not include thes e data, EPA must make assump tions about the use of the 1480 unreported production volume. Incorrect assu mptions may lead EPA to designate an 1481 inappropriately high or low priority level for th e chemical, resulting in unnecessary effort and 1482 resource expenditures for both regulated parties and EPA in cases where more complete data 1483 would have led the Agency to act differently. 1484

1485 For the foregoing reasons, EPA believes that using the reporting standard “known to or 1486 reasonably ascertainable by” woul d result in companies reporting more consistent and complete 1487 processing and use information in their IUR repo rts, and that the information reported would 1488 better enable EPA to develop the exposure charac terizations needed for the Agency’s screening 1489 of existing chemicals. 1490
1491

H. Amendments to Requirements Concerning Confidential Business Information claims 1492
1493 Submitters may currently claim certain inform ation reported under the IUR as confidential 1494 business information (CBI) in accordance with 40 CFR part 2 and IUR rules at 40 CFR 710.38 1495 (proposed 40 CFR 711.18). Submitters must asse rt claims of confidentiality at the time 1496 information is submitted to EPA. EPA’s procedures for handling information claimed as 1497
confidential are set forth at 40 CF R part 2, subpart B. EPA str ongly encourages submitters to 1498 review confidentiality claims caref ully to ensure that the informa tion in question falls within the 1499 parameters of TSCA section 14. CBI claims shoul d be limited to only those data elements the 1500 release of which would likely cause substantia l harm to the business’ competitive position. 1501 Interested persons are reminded that with regard to chemical use information, EPA is interested 1502 in aggregated, general uses, not detailed uses associated with specific customers. 1503

1504 To claim information as confidential, a submitter must both indicate its claim by both 1505 checking the appropriate box and signing the certification statement on the reporting form. A 1506
submitter must indicate its claims at the time the information is submitted. If a submitter fails to 1507 follow these procedures, EPA may release the info rmation to the public w ithout further notice to 1508 the submitter. By signing the certification stat ement the submitter attests to the secrecy and 1509 value of the information for which confidentiality claims have been asserted. 1510

1511 EPA expects that reducing the number of CBI claims would increase the amount of 1512 information available to the public and improve th e timeliness of its public availability. As a 1513 result, the Agency would be able to publicly disc uss and explain its risk management actions and 1514 decisions more clearly. Currently, much of the factual and data support fo r Agency decisions is 1515 claimed as CBI, which complicates the creati on of publicly available documents. The public 1516
would be better informed and better able to understand and provide meaningful comment on 1517 Agency actions if less information were unnecess arily or inappropriately claimed as CBI. The 1518*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

36 of 78 Agency would also be able to provide other public and private organizations and individuals with 1519 better information for making their own deci sions. Thus, EPA is proposing the changes 1520 described in sections H.1., H.2., and H.3. with th e belief that the proposed changes would reduce 1521 the number of unjustifiable CBI claims. 1522

1523 1. Chemical identity CBI claims 1524
1525 Under the IUR, a submitter may assert a clai m of confidentiality for data associated with 1526 the identity of the reported chemical substance when the chemical is listed on the confidential 1527 portion of the Master Inventory File and when the submitter provides the required substantiation 1528
at the time the submitter makes the confidentia lity assertion. See 40 CFR 710.58(b) (proposed 1529 40 CFR 711.18(b)). At times a submitter will asse rt a claim of confiden tiality for the chemical 1530 identity of a substance that is listed on the public portion of the Master Inventory File. EPA is 1531 proposing that, when this occurs , the Agency may make the info rmation available to the public 1532
without further notice to the submitter. See the proposed regulatory text at 40 CFR 711.18(e). 1533

1534 2. Upfront substantiation for processing and use information CBI claims 1535

1536 Under the IUR, a submitter may assert a claim of confidentiality for data associated with 1537 the processing and use of its chemical if the subm itter has reason to believe that release of the 1538 information would reveal trade secrets, or conf idential commercial or financial information, as 1539 provided by section 14 of TSCA and 40 CFR part 2. During the 2006 IUR, submitters made 1540 confidentiality claims ranging fr om 25 percent (when considering individual data elements) to 50 1541 percent (when considering data elements combined into use scenarios) of the reported processing 1542 and use information. While the Agency does not question that confidentiality claims are 1543 sometimes necessary, it encourages submitters to consider carefully whether such claims are in 1544 fact necessary before asserting them. The Agency has identified instances in which submitters 1545 have claimed the processing and us e data as confidential, yet similar if not identical information 1546 was found in publicly available sources, such as company websites, published Material Safety 1547 Data Sheets (MSDSs), or information submitted to the Agency and posted on the Agency’s 1548 HPVIS website (see Unit II.D for more discussion). Note that EPA can take steps to challenge or 1549 verify confidentiality claims. The Agency beli eves companies should limit their CBI claims to 1550 those that they are capable of adequately substantiating. 1551

1552 For the 2006 IUR reports, submitters were not required to provide upfront substantiation 1553 of CBI claims for processing and use data. In these proposed modifications to the IUR rule, EPA 1554 would require upfront substantiation fo r CBI claims for this information. 1555

1556 EPA believes that many of the CBI claims fo r processing and use da ta are inappropriate 1557 and that the new substantiation requirement w ould reduce the occurrence of unnecessary claims. 1558 The high number of confidentiality claims asserted for the reported 2006 IUR reports on 1559 industrial processing and use info rmation impeded the release of important data. This included 1560 the number of processing sites, the number of potentially exposed indus trial workers, and the 1561 percent production volume for each industrial pro cessing or use scenario. (Ref. 10) A decrease 1562 in the number of inappropriate CBI claims under the new substantiation requirement would 1563 improve EPA’s ability to make current plant site information available to other Federal agencies 1564 and the public because more information submit ted under IUR could be released publicly. 1565

1566*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

37 of 78 Under this proposed rule, in order to submit a claim of confidentiality for processing and 1567 use information data elements, the submitter would be required to both check the appropriate box 1568 on the reporting form and substantiate the cl aim in writing by answering certain questions 1569 provided in § 711.18(d) of the proposed rule. Where a submitter fails to substantiate the 1570 processing and use CBI claim in accordance with the applicable rules, EPA would consider the 1571 information not subject to a confidentiality claim and may make the information available to the 1572 public without further notice to the submitter. 1573

1574 3. Limitation on confidentiality claims fo r data elements identified as “not known 1575 or reasonably ascertainable” 1576

1577 Under the IUR rule, submitters provide information on the industrial processing and use 1578
and consumer and commercial use of the IUR re portable chemicals they manufacture (including 1579 import). As described in Unit II.A, for the 2011 and future IUR collections, EPA is proposing 1580 that submitters be required to report this info rmation to the extent that it is known to or 1581 reasonably ascertainable by them. For the 2006 IUR collection, submitters reported the 1582 processing and use information to the extent that it was readily obtainable, and were permitted to 1583 identify when such information was not read ily obtainable by entering “NRO.” EPA has 1584 observed that, on occasion, processing and use information has been claimed as confidential 1585 when a submitter determined that the information was not readily obtainable. 1586

1587
TSCA section 14 limits the disclosure of information entitled to confidential treatment 1588 under Exemption 4 of FOIA. EPA has considered the NRO designation and its relationship to a 1589 potential CBI or trade secret cl aim. Given that a NRO asser tion is an assertion that no 1590 information is available, the Agency does not beli eve that the designation c onveys trade secret or 1591
confidential commercial or financial informati on. For this reason, EPA is proposing to prohibit 1592 claims of confidentiality pertaining to the desi gnation that information is not “known to or 1593 reasonably ascertainable by” the submitter. EPA solicits comment on this issue. 1594
1595

I. Modifications Specifically Affecting Importers 1596
1597 Submitters report IUR data on chemicals that they manufacture domestically and that 1598 they import into the United States. Current IUR regulations provide that the site responsible for 1599 reporting for imported chemicals is the site of th e operating unit that is di rectly responsible for 1600 importing the substance and that co ntrols the import transaction. In some cases, the import site 1601 may be the organization’s headquarters in the United States. The regulations defining the site for 1602 importer reporting is found in both the definition for site in 40 CFR 710.3 and in paragraph 40 1603 CFR 710.48(b). 1604

1605 EPA is proposing to eliminate unnecessary duplication in the IUR regulation by moving 1606 the additional information regarding the importer site from § 710.48(b) into a revised definition 1607
for site , as described in Unit III.C.2. of this preamble, and eliminating § 710.48(b). 1608
1609 In addition, EPA has observed that submitters occasionally use a foreign address as the 1610 site address for the importer. EP A now is proposing to require that submitters report a U.S. site 1611 address, by modifying the definition for site to state specifically that the site must be a U. S. site. 1612 The U.S. address of an agent acting on behalf of the importer, and authorized to accept service of 1613 process for the importer, may be reported as the importer’s site address if the operating unit that 1614*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

38 of 78 is directly responsible for importing the substan ce and that controls the import transaction has no 1615 U.S. address. The Agency expects that all importers will have a U.S. site, as defined in the 1616 proposed 40 CFR 711.3 definition for site becau se, under Customs regulations at 19 CFR 141.18, 1617 a non-resident corporation is not permitted to enter merchandise for consumption unless it has a 1618 resident agent in the State where the port of entr y is located, who is authorized to accept service 1619 of process against the corporation. 1620

1621 For purposes of IUR, submitters are currently allowed to report the IUR information 1622 jointly with the foreign manuf acturer of the chemical. Impo rters may not know the specific 1623 chemical identity of a substance because the forei gn supplier chooses to keep it confidential. In 1624 such a situation, the importer is still responsible for ensuri ng that the IUR information is 1625 submitted to EPA and may do so by submitting a joint report. To do so, the U.S. importer, as the 1626 primary submitter, completes the majority of th e required information, but supplies a trade name 1627 or other designation to identify the chemical substance. In addition, the primary submitter 1628 provides technical contact information for the foreign supplier. The primary submitter then 1629 contacts the foreign supplier, as the secondary submitter, to notify it of the need to report the 1630 specific chemical identity information to EPA. In addition to the chemical identity, the 1631 secondary submitter supplies its technical cont act and company information but provides the 1632 primary submitter’s site information. The seco ndary submitter should also provide the upfront 1633 substantiation required for any confidentiali ty claims for chemical identity. 1634

1635 Under this proposed rule, the process woul d be the same, except that submitters would 1636 be required to use CDX and e-IUR for prepara tion and submission of joint submissions. See 1637 proposed 40 CFR 711.12(b)(3)(i). Previousl y, joint submissions could not be made 1638 electronically. In order to submit electronically to EPA via CDX, individuals must first register 1639 with CDX. Therefore, the authorized officials of the jointly submitting companies would need to 1640 register in order to submit their reports to EP A. The secondary submitter (e.g., a foreign supplier 1641 or manufacturer) would have to register as someone authorized by the primary submitter’s (e.g., 1642 the importer’s) authorized official to send joint submissi ons to EPA. 1643

1644 For joint submissions to be submitted elec tronically, the primary submitter would use e1645 IUR to identify the need to submit a joint report and would identify itself as a primary submitter. 1646 The primary submitter would then complete his or her portion of the report and provide the 1647 secondary submitter's company information, along with select information on the chemical 1648 substance(s) that are manufactured using a chemical substance made by the secondary submitter. 1649 The primary submitter reports only the volume that it used. A secondary submitter would also 1650 need to use e-IUR to identify the need to subm it a joint report and would identify itself as a 1651 secondary submitter. It would pr ovide the primary submitter’s company information and its own 1652 technical contact information, and would identify the chemical substa nce(s) that is in its product, 1653 including the percentages. This information would be saved by the reporting tool and both 1654 submissions would be matched based upon company and chemical information. Once the forms 1655 are matched, the joint submission would be ready to be processed by EPA. The Agency is 1656 currently developing the proce ss to submit joint reports electronically and welcomes any 1657 comments concerning this process. 1658
1659 For the 2006 IUR submission period, EPA set asid e joint submissions un til both reports were 1660 received and matched. Oftentimes, EPA had no way to determine whether a submission was a 1661 “joint” submission, which increased the time re quired for manual processing of the data. EPA 1662*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

39 of 78 anticipates that the use of the reporting tool wi ll help to make joint IUR reporting easier for 1663 industry and streamline EPA processing of the IUR information submitted in the 2011 1664 submission period. 1665

1666

J. Change to Reporting Frequency 1667

1668 Prior to the 2003 Amendments, th e IUR collection occurred ever y four years. EPA reduced 1669 the reporting frequency from ever y four years to every five year s starting with the 2006 IUR to 1670
reduce the burden associated with the amended IUR rule. For the reasons described in this 1671 section, the Agency has determined that reporting every five year s is too infrequent, and now is 1672 proposing to return to repor ting every four years. 1673

1674 As described in Unit III.D.1, a review of the previous reporting under IUR has revealed an 1675 approximately 30 percent change in the chemical s that are reported from one submission period 1676 to the next. While the less frequent repor ting does reduce burden, EPA now believes that 1677 reporting every five years does not provide data sufficiently current to meet Agency and public 1678 needs. As described in Unit V.2.a, the Agen cy has been criticized for using outdated 1679 information. EPA, therefore, also is consider ing increasing the frequenc y of reporting to every 1680 three years, or possibly to annua l reporting. The Agency believes that efficiencies are gained 1681 with more frequent reporting, both for the submitter and for EPA. With more frequent reporting, 1682 companies would be able to establish standard systems and practices to collect the required 1683 information. For instance, for annual reporting the Agency estimates that submitters would 1684 reduce the burden for each repor ting cycle by approximately 20 percent. (See Chapter 4 of the 1685 Economic Analysis, Ref. 11). EPA invites co mment on the proposed return to four-year 1686 reporting intervals, and also on mo re frequent reporting (i.e., ev ery three years, biennial, or 1687 annual reporting). Further information is provide d in Question 2.a under Unit V, and the various 1688 reporting frequency alternatives are analyzed in the Economic Analysis. (See Chapter 4 and 1689 Appendix G of the Economic Analysis, Ref. 11) 1690
1691 IV. Clarifications to Reporting Requirements 1692
1693
A. Clarification of the relatio nship between company name and site ID CBI claims 1694
1695 Under the IUR, submitters are able to claim as CBI both the company name and site 1696 identity associated with a chemical for which th ey are reporting under the IUR. The submitter is 1697 required to provide an upfront substantiation fo r CBI claims for the s ite identification. EPA 1698
believes there is some confusion as to what is considered confidential when such claims are 1699 made, and is taking this opportunity to provide clarification. 1700

1701 The e-IUR reporting software does not allow for blanket CBI claims for company and 1702 site identification information, si nce those are separate claims a nd in some cases one type of 1703 claim may be justified while the other is not. Rather, a submitter is permitted to assert its CBI 1704 claim for the company identity, the site identity, or both the company and s ite identity associated 1705 with each chemical for which they are submitting an IUR report. In addition, the submitter must 1706 provide separately the required upf ront substantiation for the site identity CBI claims associated 1707 with each chemical. For instance, if the submitter is reporting for five chemicals and wishes to 1708
claim its site information confidential for three of the five chemicals, it must assert the claim and 1709 provide separate upfront substant iation three times, once for each of the three chemicals. The 1710*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

40 of 78 CBI claim protects the link between the company and/or site identification and the particular 1711 chemical substance. If the company or site identi ty associated with a particular chemical is not 1712 claimed as CBI, EPA may make that information av ailable to the public w ithout further notice to 1713 the submitter. EPA will not impute the existence of a CBI claim for company identity or for site 1714 identity from a CBI claim associ ated with a different chemical. 1715

1716 EPA has also observed that submitters sometimes claim only their company identity, and 1717 not their site identity, as confidential. If the site identity for a particular chemical is not claimed 1718 as CBI, or is claimed but not substantiated pursuant to 40 CFR 710.58(c) (proposed 40 CFR 1719 711.18(c)), EPA may make that information availabl e to the public without further notice to the 1720 submitter. EPA will not impute the existence of a CBI claim for site identity from a CBI claim 1721 for company identity, even if the company name a ppears within the site id entity information. To 1722 help ensure that submitters consider this issue, EPA plans to modify the e-IUR reporting 1723 software so that it will provide a warning whenev er the company identity is claimed as CBI for a 1724 particular chemical and the site ID is not al so claimed as CBI for that chemical. 1725

1726

B. Explanation of byproduct reporting. 1727
1728 During the 2006 submission period, EPA receive d questions about the requirements for 1729 reporting byproducts, including wh ether byproduct manufacturers were required to report the 1730 byproducts under the IUR rule. These included some questions involving a manufacturer that uses 1731 a chemical in the production of an article. Such manufacturing may produce a byproduct 1732 substance that is chemically different from th e starting substance; the manufacturer therefore 1733 may incur reporting obligations und er the IUR rule for that bypr oduct. In light of these and 1734 similar questions, EPA is providing detailed information on byproduct reporting, including 1735 circumstances under which reporting is not require d, in the draft instruct ion manual included in 1736 the docket for this rule. (Ref. 2) 1737

1738 For purposes of IUR, a byproduct is a chemi cal substance produced without a separate 1739 commercial intent during the manufacture, proce ssing, use or disposal of another chemical 1740 substance or mixture (40 CFR 704.3). Thus, for ex ample, when a chemical substance or mixture 1741 is used for the purpose of manufacturing an ar ticle, and that manuf acture results in the 1742 production of a different chemical substance, that different chemical substance is a byproduct for 1743 purposes of the IUR. Chemical substances th at are byproducts of the manufacture, processing, 1744 use, or disposal of another chemical substance or mixture, like any other manufactured chemical 1745 substances, are subject to IUR reporting if they are manufactured, are listed in EPA’s Master 1746 Inventory File, are not otherwise excluded fr om reporting, and their manufacturer is not 1747 specifically exempted from IUR reporting requirements. 1748
1749 For purposes of IUR, a byproduct is “manuf actured” only if it is “manufactured for 1750 commercial purposes.” See TSCA secti on 8(f). The 40 CFR 704.3 definition of manufacture for 1751 commercial purposes states that “[m]anufacture for co mmercial purposes also applies to 1752 substances that are produced coincidentally dur ing the manufacture, proce ssing, use, or disposal 1753 of another substance or mixture, including both byproducts that are sepa rated from that other 1754 substance or mixture and impurities that remain in that substance or mixture. Such byproducts 1755 and impurities may, or may not, in themselves have commercial value. They are nonetheless 1756 produced for the purpose of obtaining a commer cial advantage since they are part of the 1757 manufacture of a chemical product for a comm ercial purpose.” Thus, byproducts of the 1758*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

41 of 78 manufacture, processing, use, or disposal of another substanc e or mixture for a commercial 1759 purpose are themselves both "manufactured" an d "manufactured for commercial purposes." 1760

1761 Byproducts that are manufactured in volumes of 25,000 lb. or more at a single site are 1762 potentially subject to IUR requirements. However, 40 CFR 710.50(c) (proposed 40 CFR 1763 711.10(c)) excludes from reporting t hose substances meeting the re quirements of §§ 720.30(g) or 1764 (h). Manufacturers (including importers) of byproducts are not required to report the 1765 manufacture of a byproduct if the byproduct is no t used for commercial purposes. See 40 CFR 1766 720.30(h)(2). Thus, even where a byproduct is manufactured for a commercial purpose, if the 1767 byproduct is not subsequently put to use for a nother commercial purpose, the byproduct is 1768 excluded from IUR reporting. Furthermore, if the byproduct’s “only commercial purpose is for 1769 use by public or private organizatio ns that (1) burn it as a fuel, (2) dispose of it as a waste, 1770 including in a landfill or for enri ching soil, or (3) extract compone nt chemical substances from it 1771 for commercial purposes,” 40 CFR 720.30(g), that byproduct is also excluded from IUR 1772 reporting. This exclusion applies only to th e byproduct; it does not a pply to the component 1773 substances extracted from the byproduct. 1774

1775 V. Request for Comment 1776

1777 The following is a list of issues on which the Agency is specifically requesting public 1778 comment, in addition to those noted in Unit III of this preamble. EPA encourages all interested 1779 persons to submit comments on these issues, and to identify any other releva nt issues as well. 1780 This input will assist the Agency in devel oping a final rule that successfully addresses 1781 information needs while minimizing potential repo rting burdens associated with the rule. EPA 1782 requests that commenters making specific recomm endations include supporting documentation 1783 where appropriate. 1784

1785 1) As discussed in Unit II.E, EPA is increas ing its emphasis on asse ssing, prioritizing, and 1786 taking action on existing chemicals that pose unr easonable risks, with particular emphasis on 1787 protecting children. EPA is interested in re ceiving comments regardi ng how to utilize IUR 1788 data, including how to amend the rule, to best assist in this effort. 1789
1790 2) The proposals discussed in Unit III.D.3 would result in a site reporting data on subject 1791 chemical substances exceeding the 25,000 lb. threshold for any calendar year since the last 1792 principal reporting year. The site wo uld report manufacturing (including production 1793 volume), processing, and use information for th e principal reporting y ear (e.g., 2010), as well 1794 as production volume information for all the year s since the last IUR pr incipal reporting year 1795 (i.e., 2006 through 2009, for principal reporting ye ar 2010). In developing this proposal, 1796 EPA considered several other reporting options and is seeking comme nt on these options, 1797 which are described in paragraph (2 )(i) and (2)(ii) of this section. 1798
1799 i) EPA is proposing to return the reporting fre quency to four years and is considering 1800 further increasing the frequency to every th ree years, biennially, or annually. (See 1801 Ref. 11 for burden and cost information.) More frequent repo rting provides more 1802 current data. Eliminating the five-year wait for current information would address 1803
concerns that IUR data is outdated and th erefore less useful than if it were more 1804 current. EPA is particularly interested in the annual reporting option for several 1805 reasons. Annual reporting would enable EPA to better analy ze trends, including 1806*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

42 of 78 ascertaining which chemicals are manufact ured on a consistent basis, which 1807
chemicals have wide variations from year to year, and which chemicals are 1808 increasing or decreasing in volume. Tr end analyses measure the success of 1809 programs and can be used to proactively identify developing i ssues and generally 1810 provide a greater insight into the chemi cal industry. Obtaining this information 1811 annually, instead of the proposed option of reporting four years of production 1812 volume at one time, would allow for clos er monitoring of trends and the more 1813 timely feedback on the success of program s than would be possible under the 1814 proposed option. In addition, annual reporti ng would provide the opportunity to tie1815 in more closely or actually integrate IU R reporting with the already-required annual 1816 Toxic Release Inventory (TRI) reporting. 1817

1818 ii) EPA is also interested in comments rega rding changing the repor ting threshold from 1819 25,000 lb. to 10,000 lb., but is not including this change in the regulatory text 1820 accompanying this proposal. (See Ref. 11 for burden and cost information.) Prior 1821 to the 2006 IUR, the threshold for determining the need to report was 10,000 lb., 1822 therefore this change in the reporting thre shold would be a return to the status quo 1823 for the IUR. The Agency is interested in collecting information on chemicals with 1824 nationally aggregated production volume s of 25,000 lb. or higher. Because 1825
chemicals are often manufactured at more th at one site, chemicals with site-specific 1826 production volumes that fall below the 25,000 lb. reporting threshold and therefore 1827 would not be reported for IUR may have aggregated production volumes of 25,000 1828 lb. or greater. 1829

1830 3) EPA is considering collecting additional expos ure-related data, similar to those collected 1831 under TSCA section 5 (new chemicals program), to enhance the Agen cy’s capabilities in 1832 conducting screening-level exposure assessments of chemical substances reported to the 1833 TSCA Inventory Update. 1834

1835 EPA, through its experience in using the IU R exposure-related and use information, has 1836
learned that the current IUR da ta are not sufficient for determ ining quantitative estimates of 1837 releases of and exposures to chemical substan ces. As a result of the available 2006 IUR data, 1838 EPA could develop only qualitati ve exposure characterizations with relative ranking of low, 1839 medium or high for characterizing potential exposures to various populations. While the 1840
usefulness of these data was limited because data we re only partially reported (see Unit III.G.), it 1841 was also limited because the specific data el ements, as included in the 2006 IUR, were not 1842 detailed and comprehensive enough to enable EPA to generate a more robust estimate. For 1843 instance, the function and use categories used for processing and use information were broad, 1844 and the reported production volume information was insufficient to identify the volumes of 1845 chemical used at the manufacturing s ite or domestically processed or used . The Agency believes 1846 the proposed rule text changes will improve its ability to identify and ma nage risks associated 1847 with existing chemicals, but also believes that supplementary, more in-depth exposure-related 1848 information (i.e., beyond the elements under the ru le text currently accompanying this proposal) 1849 would substantially improve EPA’s ability to quantify chemical ri sks. The ability to quantify 1850 chemical risks would further improve the Agency’s ability to identify and manage those risks. 1851 EPA therefore believes that, while the changes included in the proposed regulatory text address 1852 the limitations associated with qualitative charac terizations, further changes would be needed to 1853 enable the more quantitative estimates. 1854*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

43 of 78 1855 If additional data identified below were to be reported, EPA could use currently available 1856 assessment tools and methodologies to devel op screening-level estimates of chemical 1857
environmental releases and concen trations to various environmenta l media (including air, water, 1858 and land) and exposures to the potentially exposed populations (such as workers, consumers, 1859 children, and the general population). Examples of the tool s and methodologies include the 1860 Agency's Chemical Screening Tool For Expos ures & Environmental Releases (ChemSTEER) 1861 (Ref. 14) and Exposure and Fate Assessment Scr eening Tool (EFAST) (Ref. 15). The Agency 1862 anticipates that the improved scre ening-level exposure assessments would be similar to what is 1863 developed for new chemical substances submitted to the Agency for review to identify chemicals 1864 of concern and potential risk management. The Pre-Manufacturing Notice (PMN) Program 1865 Form 7710-25 (available at: http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm) was 1866 used to develop the following list of additional pote ntial exposure-related data elements and their 1867 brief descriptions: 1868
1869 Manufacturing Process: 1870 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 tr ansferred 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 substa nce will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the substance. Continuous or batch process Indicate whether the chemical substance is manufactured in discrete batches or is produced by continuously adding reactants and removing the reaction product. Amount of substance produced per day or per batch If the chemical substance is produced in discrete batches, indicate the amount of the substance in pounds produced in each batch; if the substance is produced in a continuous process, indicate the amount of substance in pounds manufactured each day. Batch or daily run time If the chemical substance is produced in discrete batches, indicate the batch time (hours/ batch); if the substance is produced in a continuous process, indicate the daily run time (hours/day). Days of operation per year or number of batches per year If the chemical substance is produced in discrete batches, indicate the number of batches per year necessary to produce the reported production volume; if the chemical substance is produced in a continuous process, indicate the number of days of operation per year needed to produce the reported production volume. Unit operations List the unit operations needed to produce the chemical substance. Unit operation means a functional step in manufacturing, processing, or use operation where substances*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

44 of 78 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 bo ttles, 5-gallon pails, 55-gallon drums, 200-pound totes, 5000-gallon tank trucks, and 20,000- gallon railcars.
1871 Manufacturing Worker Exposures: 1872 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 subs tances from one container to another, changing filters, filli ng drums, loading and loading tank cars or trucks, etc. Activities must be described even when workers wear protective equipment. Duration and frequency of worker exposure For each worker activity, enter the maximum duration in hours per day and number of days per year that any one worker will engage in the activity during a normal work day based on the reported production volume. Physical form For each worker activity , indicate the physical form of the substance at the time of exposure. Maximum concentration For each worker activity, indicate the maximum concentration of the substance in the product at the time of

exposure. Personal protective equipment and engineering controls used by
workers For each worker activity, iden tify the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substance, e.g., gloves, goggles, protective garment, local ventilation, respirator, etc. Worker monitoring data
available Indicate whether monitoring data on occupational exposure of
workers is available. Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure.
1873 Manufacturing Releases to the Environment: 1874 Release source (or release point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g . releases due to spillage, residues, separation losses, and other sources from each batch or each day). Media and type of release For each release, indicate the media (air, liquid or aqueous solution, solid) and type of release [stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW or other (specify)] of a release stream containing the chemical

substance. Quantity of substance released a) For each release, provide the quantity (in pounds) of chemical*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

45 of 78 directly to the environment or b) into control technology to the
environment substance released a) directly to the environment or b) into control technology to the environment in pounds per day for continuous operation or pounds per batch for batch operations. Control technology For each release, describe the type of technology used to
control the release of the substance to the environment. Examples of control technologies include carbon filter, scrubber and biological treatment (primary, secondary, etc.). Efficiency of control technology Indicate the established efficien cy of the control technology in removing or destroying the chemical substance. Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway, a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, indicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

Additional release related

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

attached.
1875 Industrial Processing or Use Activities: 1876 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 tr ansferred 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 substa nce will be released to the environment or to control equipment, including small or intermittent releases (e.g. some cleaning releases, drum residues, etc.) and trace amounts of the substance. Processing or use at sites controlled by manufacturer Indicate whether the sites at which the chemical is processed or used are owned by the manufacturer or others. Continuous or batch process Indicate whether the industrial process in which the chemical is processed or used in a batch or continuous process. Amount of substance processed per day or per batch Provide the amount of the substance in pounds processed or used per batch for batch operation or processed or used per day for continuous operation, respectively. Batch or daily run time If the chemical substance is processed in discrete batches, indicate the batch time (hours/ batch); if the substance is processed in a continuous process, indicate the daily run time (hours/day). Days of operation per year or number of batches per year If the chemical substance is processed in discrete batches, indicate the number of batches per year necessary to process the reported production volume; if the chemical substance is*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

46 of 78 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 bo ttles, 5-gallon pails, 55-gallon drums, 5,000-gallon tank trucks, and 20,000-gallon railcars.
1877 Industrial Processing or Us e Occupational Exposures: 1878 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 subs tances from one container to another, changing filters, filli ng drums, loading and loading tank cars or trucks, etc. Activities must be described even when workers wear protective equipment. Duration and frequency of worker exposure For each worker activity, provide the maximum duration in hours per day and the number of days per year during which any one worker will engage in the activity during a normal work day during in processing or use. Physical form For each worker activity , indicate the physical form of the substance at the time of exposure. Maximum concentration For each worker activity, indicate the maximum concentration of the substance in the product at the time of

exposure. Personal protective equipment and engineering controls used by
workers For each worker activity, iden tify the specific types of protective equipment and engineering controls that will be employed to protect the worker from potential exposure to the chemical substance, e.g., gloves, goggles, protective garment, local ventilation, respirator, etc. Worker monitoring data
available Indicate whether monitoring data on occupational exposure of
workers is available. Summary of occupational exposure monitoring included Indicate whether a summary of occupational exposure monitoring data is included. Summary should include information on the # of workers involved, # of samples taken, types of samples (area or personal), average and standard deviations of exposure.
1879 Industrial Processing or Use Releases to the Environment: 1880 Release source (or point) For each point of release containing the chemical substance, identify and describe the point in the process description at which the release occurs (e.g . releases due to spillage, residues, separation losses, and other sources from each batch or each day). Media and type of release For each release, indicate the media (air, liquid or aqueous*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

47 of 78 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 efficien cy of the control technology in removing or destroying the chemical substance. Destination of release For aqueous releases containing the chemical substance, indicate whether release enters a navigable waterway, a publicly-owned treatment works (POTW), or other. Identify the name of the POTW and/or NPDES # as appropriate. For other releases, indicate whether the release goes to a municipal or hazardous waste landfill, a commercial incinerator, enters the atmosphere, or is otherwise disposed (specify).

Additional release related

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

attached.
1881 Commercial Use Occupational Exposure: 1882 Description of commercial use Describe the commercial use(s) of products containing the

chemical substance.

Function of chemical in commercial product Describe the function of the chemical in the commercial product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc. Number of potentially exposed
commercial workers Indicate the number of workers in commercial establishments who are reasonably likely to be exposed to the chemical

substance. Physical form of commercial product Indicate the physical form of the product containing the
chemical substance. Method of commercial product application Describe the application method (e.g. sprayed applied via pump sprayer or aerosols, poured or applied manually) of the product containing the chemical substance and whether the commercial use is destructive, contained, dispersive, etc. Duration and frequency of commercial product use Indicate the duration of use, e.g. 5 minutes or less, 30 minutes or less, 1 hour or less, etc. and frequency of commercial use, e.g. used more than once a day, used once a day, used several times a week, etc.
1883 Consumer Use and Exposure: 1884 Description of consumer use Describe the consumer use(s) of products containing the

chemical substance.

Function of chemical in Describe the f unction of the chemical in the consumer*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

48 of 78 consumer product product, e.g., dispersive dye, solvent, stabilizer, hardener, plasticizer, filler, etc. Number of potentially exposed

consumers Indicate the number of consumers reasonably likely to be exposed to the chemical substance. Physical form of consumer product(s) containing the
chemical substance Indicate the physical form, e.g., gel, foam, powder, etc. of the consumer product containing the chemical substance.

Method of consumer product application Describe the application of the consumer product containing the chemical substance, for example, chemicals in products that will be sprayed via pump sprayer or aerosols; products that are poured, mixed, applied by hand/mechanical device; chemicals that can be released via diffusion, evaporation, abrasion, etc., from articles; or chemicals that are incorporated into articles with no potential for release, etc. Duration and frequency of consumer product use Indicate the duration of consumer use, e.g., used for 5 minutes or less, 30 minutes or less, less than 1 hour, etc. and frequency of consumer use, e.g. used more than once a day, used once a day, used sever al times a week, etc.
1885 EPA is soliciting comment on the data elements identified above. Collecting these data 1886 would enable the Agency to develop more comp rehensive and complete screening assessments 1887 of the exposures that may be encountered dur ing the manufacture, processing, and use of 1888 chemicals. The Agency also is interested in whether any additional data elements should be 1889 collected, and in any other considerations relating to the collection of additional data. Because 1890
these data elements are based on the data elem ents included in a PMN submission, EPA believes 1891 the burden a site would incur to provide these da ta would be similar to the burden incurred for a 1892 site to develop a PMN submission. (Ref. 11) 1893
1894 EPA is also soliciting comment on the best me thod to collect these data. The Agency is 1895 considering three approaches to collect these data from known manufacturers (including 1896 importers). These approaches ar e: integrating these data elements into the IUR, promulgating a 1897 new reporting mechanism under TSCA section 8( a), or using TSCA s ection 11(c) subpoena 1898 authority. Integrating these data elements into the IUR would provide a more complete set of 1899 data, enabling the Agency to identify proactiv ely potential exposure-based chemical risk 1900 management issues and to provide the public acce ss to an enhanced database. The Agency is 1901 also soliciting comment on the appropriate scope of an IUR requirement to report these data 1902 elements. For instance, the scope could be ba sed on chemical identity, and the Agency could 1903 provide a list of chemicals for which these data would be repo rted. Alternatively, the scope 1904 could be based on production volume, and the Agency could identify the production volume 1905 range for which these data would be reported. 1906
1907 As a second option, the Agency is consid ering promulgating a new reporting mechanism 1908 under TSCA section 8(a) that would enable the collection of enhanced exposure-related data, 1909 described in this section, for about 100 chemical substances per year. For instance, EPA could 1910 notify manufacturers (including impo rters) of the need to submit additional information, e.g., via 1911 a Federal Register notice or individually via U.S. mail, with details on the data to report and the 1912 reporting criteria. (See Ref. 11 for burden and co st information.) This approach would enable 1913 the Agency to target the collection to those ch emicals of current priority for screening-level 1914 assessment. The Agency also solicits commen t on the need to establish a complementing 1915 recordkeeping requirement. Such a recordkeepi ng requirement would ensure that the additional 1916*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

49 of 78 data subject to the new reporting mechanism would be more quickly available at the time that 1917 EPA requested them. However, without advanc e notice regarding the specific chemicals for 1918 which information would be required, manufactur ers (including importers) of all chemicals 1919 subject to the IUR would be requi red to maintain the records. 1920
1921 As a third option, EPA considering the use of TSCA section 11(c) subpoena authority to 1922 collect enhanced exposure-related data. TSCA sec tion 11(c) gives the Agency broad authority to 1923 collect information for regulatory purposes a nd would, therefore, allow EPA to require, by 1924 subpoena, the submission of the enhanced exposur e-related data. Among the circumstances in 1925 which the Agency is considering exercising th is subpoena authority are those in which the 1926
enhanced data elements are not available thr ough other means and are necessary for a more 1927 effective screening level review of chemi cal substances on a case by case basis. 1928
1929 4) EPA is considering collecting exposure-related information from processors in addition to 1930 collecting the data from manufacturers. 1931
1932 Currently, only manufacturers (including importers) are responsible for providing 1933 information required by the IUR rule. TSCA sec tion 8(a) enables the Agency also to collect 1934 information from processors. EPA seeks comm ent on also requiring processors to report 1935 processing and use data under the three data co llection approaches described above (i.e., by 1936 modification of the IUR rule, via notification is sued under a new data reporting mechanism, or 1937 using existing subpoena authority). (See Ref. 11 for burden and cost information.) The Agency 1938 believes that processors may be more familiar wi th the processing and use of the chemicals than 1939 manufacturers, and therefore may be able to provide more complete and accurate exposure1940
related data. 1941

1942
VI. References 1943
1944
As indicated under ADDRESSES , a docket has been established for this rulemaking 1945 under docket ID number EPA-HQ-OPPT-2009-0187. The following is a listing of the 1946 documents that are specifically referenced in this document. Th e docket includes these 1947 documents and other information considered by EP A in developing this proposed rule, including 1948
documents that are referenced within the documents that are included in the docket, even if the 1949 referenced document is not physically located in the docket. For assi stance in locating these 1950 other documents, please consult th e technical contact listed under FOR FURTHER 1951
INFORMATION CONTACT

. 1952
1953

1. U.S. EPA, Memorandum to EPA Employees from Lisa P. Jackson, Administrator, 1954 January 23, 2009, Located at: 1955 http://www.epa.gov/administrator/memotoemployees.html

. 1956
1957

2. U.S. EPA, “Draft Instructions for 2011 Inventory Update Reporting,” October 2009. 1958
1959

3. U.S. EPA, “IUR Modifications Rule: Devel opment of Definitions for proposed 40 CFR 1960 711.3,” OPPT, August 2009. 1961
1962

4. U.S. EPA, “Electronic Signature Agreement,” OPPT, August 2009. 1963
1964*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

50 of 78 5. U.S. EPA, “Development of CDX Workflow for Electronic Toxic Substances Control 1965 Act (eTSCA) Submissions: Draft User Gu ide” (Version 1.0), CDX, November13, 2008. 1966
1967

6. American Petroleum Institute, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785; 1968 EPA-HQ-OPPT-2008-0807 from Howard J. Feldman, December 8, 2008. 1969
1970

7. Proctor & Gamble, Letter to Docket ID No. EPA-HQ-OPPT-2008-0785, from Julie 1971 Froelicher, January 23, 2009. 1972
1973

8. Synthetic Organic Chemical Manufacturers A ssociation, Comments submitted to Docket 1974 ID No. EPA-HQ-OPPT-2008-0785 from Daniel Newton, January 23, 2009. 1975
1976

9. U.S. EPA, “Inventory Update Reporti ng (IUR) Technical Support Document – 1977 Replacement of 5-digit NAICS Codes with Industrial Sectors.” OPPT/EETD, August 1978
2009. 1979
1980

10. U.S. EPA, “2006 Inventory Update Reportin g: Data Summary,” OPPT, EPA report 1981 number 740S08001, December 2008. Located at: 1982 http://www.epa.gov/opptintr/i ur/pubs/2006_data_summary.pdf

. 1983
1984

11. U.S. EPA, “Draft Economic Analysis for the Proposed IUR Modifications Rule,” 1985 OPPT/EETD, January 2010. 1986
1987

12. U.S. EPA, “Addendum to Information Collection Request 1884.04,” OMB control 1988 number 2070-0162, OPPT, September 2009. 1989
1990

13. U.S. EPA/Environment Canada/Health Cana da, “Overview of Harmonized U.S.-Canada 1991
Industrial Function and Consumer and Commercial Product Codes for Chemical 1992 Inventory Reporting,” September 2009. 1993
1994

14. U.S. EPA, “Chemical Screening Tool For Exposures & Environmental Releases.” 1995
Located at: http://www.epa.gov/oppt/exposure/pubs/chemsteer.htm , September 2009. 1996
1997

15. U.S. EPA, “Exposure and Fate Assess ment Screening Tool.” Located at: 1998 http://www.epa.gov/oppt/exposure/pubs/efast.htm , September 2009. 1999

2000 VII. Statutory and Executive Order Reviews 2001

A. Regulatory Review 2002

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 2003 October 4, 1993), this action has be en designated a “significant re gulatory action” by the Office 2004 of Management and Budget (OMB). Accordingl y, EPA submitted this action to OMB for review 2005 under Executive Order 12866 and any changes made in response to OMB recommendations have 2006
been documented in the docket for this action. 2007

2008 In addition, EPA has prepared an economic an alysis of the potentia l impacts associated 2009 with this action. A copy of th is economic analysis, entitled, Draft Economic Analysis for the 2010 Proposed Inventory Update Reporting (IUR) Modifications Rule (Ref. 11), is available in the 2011*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

51 of 78 docket and is briefly summarized in this Unit of the preamble. The amendments in this proposal 2012 affect the number of reports submitted duri ng a submission period, the burden to prepare a 2013 report, and the reporting frequency. EPA estimates that the combin ed impact of all the proposed 2014
amendments will increase the total burden and co st to industry associated with IUR reporting. 2015

2016 In its economic analysis, EPA estimated indu stry cost and burden on a per-report and a 2017 per-site basis and at the industry level. I ndustry cost and burden are incurred by performing 2018 activities to comply with the proposed amendments, including compliance determination, rule 2019 familiarization, preparation and submissi on of reports, and recordkeeping. 2020

2021 On a per-report basis, EPA estimated incremental increases of 5.2 hours and $410 for a 2022 site to complete a partial report for one ch emical and 18.3 hours and $1,468 to complete a full 2023 report for one chemical, in the first submission cycl e after the effective date of the proposed rule 2024 amendments. A partial report incl udes Parts I and II of Form U. A full report includes Parts I, II 2025 and III of Form U. For future submission cycl es, EPA estimated incremental increases of 3.4 2026 hours and $284 for a site to complete a par tial report for one chemical and 13.1 hours and $1,084 2027 to complete a full report for one chemical. 2028
2029 As a result of the proposed amendments, EPA estimates that the average site will submit 2030 approximately 2.01 fewer partial reports and 2.98 more full reports in a submission period. For 2031 the average site, this will increase the burde n by 342 hours during the first submission cycle and 2032 264 hours for all subsequent submission cycles. EP A estimates that the av erage site will incur a 2033 net cost increase of $22,553 during the first submission cycle and $17,526 during all future 2034 submission cycles. 2035

2036 At the industry level for all sites submitting a Form U, EPA estimates a net total burden 2037
increase of 1.56 million hours in the first submission year, and 1.21 million hours for all 2038 subsequent submission years. EPA estimates a net cost increase of $103.70 million in the first 2039 submission cycle of the rule, and $79.31 million in all subsequent submission cycles. When the 2040 submission cycle costs, which would be incurred once every four years under the proposed rule, 2041 are spread over the proposed four-year reporti ng cycle, the average annualized increase in 2042 industry cost attributable to the proposed amendments is approximately $26.27 million over a 2043 20-year period (at a 3% discount rate). 2044

2045 EPA estimates that the Agency will experi ence a reduction in both burden and cost to 2046 administer the IUR rule as a result of the pr oposed amendments. Specifically, EPA expects to 2047 experience a net burden reduction of 1,704 hours in the first submi ssion cycle and all subsequent 2048 submission cycles. The Agency estimates it will experience a net savings of $177,683 during 2049 each submission cycle. This information will be reflected in the Information Collection Request 2050 (ICR) that is submitted every three years to OMB under the Paperwork Reduction Act (PRA), 44 2051

U.S.C. 3501 et seq

. 2052

B. Paperwork Reduction Act 2053

2054 The information collection requirements in 40 CFR part 710 related to the submission of 2055 Form Us are already approved by OMB under the PRA. That ICR has been assigned EPA ICR 2056
No. 1884 and OMB control No. 2070-0162. Becaus e this rule involve s new or revised 2057 information collection activities that require additional OMB approval, EPA has prepared an 2058*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

52 of 78 addendum to the currently approved ICR (Ref. 12). An agency may not conduct or sponsor, and 2059 a person is not required to respond to an inform ation collection request su bject to the PRA unless 2060 it displays a currently valid OMB control number. The OMB control numbers for EPA’s 2061 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 2062 the form or survey). 2063

2064 Under the PRA, the term “burden” is interpreted as the total time, effort, or financial 2065 resources expended by people to generate, maintain, retain, disclose, or provi de information to or 2066 for a federal agency. This includes the time needed by regulated entities to review instructions 2067 and to develop, acquire, install, and use technology and systems to collect, validate, verify, and 2068 disclose information. Time taken to adjust ex isting ways to comply with any previously 2069 applicable instructions and requi rements and to train personnel to respond to the information 2070
collection task is also included. In this analysis, total indus try burden hours represent the sum of 2071 time spent on reporting and on other administrativ e activities. Industry respondents will spend 2072 time on the following activities associated with the IUR rule: compliance determination, rule 2073 familiarization, preparation and submissi on of reports, and recordkeeping. 2074

As presented in the economic analysis (R ef. 11) and the addendum ICR (Ref. 12), EPA 2075 estimates that the proposed rule would create a total incremental industry burden of 1.56 million 2076 hours, if all proposed amendments are finalized as proposed. The bur den for a site to complete a 2077 full report for IUR for one chemical is estimated to be 141.33 hours, which is an incremental 2078
burden increase of 18.33 hours over the current es timated burden. The burden for a site to 2079 complete a partial report for IUR for one chemical is estimated to be 58.31 hours, which is an 2080
incremental burden increase of 5.23 hours over the current estimated burden. For future 2081 reporting cycles, the burden for a full report is estimated to be 95.17 hours, which is an 2082
incremental increase of 13.11 hours over the curr ent estimated future burden and for a partial 2083 report is estimated to be 29.54 hours, which is an incremental increase of 3.41 hours over the 2084
current estimate. 2085

2086 To comment on the Agency's need for this information, the accuracy of the provided 2087 burden estimates, and any suggested methods for minimizing respondent burden, EPA has 2088 established a docket for this pr oposed rule, which in cludes this ICR, under docket ID number 2089 EPA-HQ-OPPT-2009-0187. Submit any comments related to the ICR to EPA and OMB. See 2090
ADDRESSES for where to submit comments to EPA. Send comments to OMB at the Office of 2091 Information and Regulatory Affairs, Office of Management and Budget, 725 17th St, N.W., 2092 Washington, DC 20503, Attention: Desk Office fo r EPA. Since OMB is required to make a 2093 decision concerning the ICR between 30 and 60 days after [ insert date of publication in the 2094 Federal Register ], a comment to OMB is best assured of having its full effect if OMB receives 2095 it by [ Insert date 30 days after publication in the Federal Register ]. The final rule will respond 2096 to any OMB or public comments on the informati on collection requirements contained in this 2097 proposed rule. 2098
2099 C. Small Entity Impacts 2100
2101 Pursuant to section 605(b) of the Regul atory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), 2102 the Agency hereby certifies that this action will not have a sign ificant adverse economic impact 2103 on a substantial number of small entities. The Agen cy’s basis is briefly summarized here and is 2104 detailed in the economic analysis (Ref. 11). 2105

2106*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

53 of 78 Under the RFA, small entities include sma ll businesses, small organizations, and small 2107 governmental jurisdictions. For purposes of assessing the impacts of today's rule on small 2108 entities, small entity is defined as: (1) a sm all business, as defined by the Small Business 2109 Administration’s (SBA) regula tions at 13 CFR 121.201; (2) a sm all governmental jurisdiction 2110 that is a government of a city, c ounty, town, school distri ct or special district with a population of 2111 less than 50,000; and (3) a small organization that is any not-fo r-profit enterprise which is 2112 independently owned and operated and is not do minant in its field. Since the regulated 2113 community does not include small government al jurisdictions or small not-for-profit 2114 organizations, the analysis focuses on small businesses. 2115

2116 The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 2117 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and 2118 less than 100,000 lb. production of a ny given chemical at a site; or annual sales of less than $4 2119 million. This exemption is maintained in the proposed amendments. A small business would be 2120 required to report under the proposed rule, however, if it produces any chemical substance that is 2121 the subject of a regulation proposed or promulgate d under TSCA section 4, 5(b)(4), or 6, or that 2122 is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been 2123 granted pursuant to a ci vil action under TSCA section 5 or 7. A small business may also report 2124 voluntarily. 2125

2126 EPA analyzed potential small business imp acts from this rule using both the SBA 2127 employee size standards and the TSCA sales-based definition of small business. EPA estimates 2128 that 503 small firms potentially would be affected by this proposed rule using the employment2129 based definition, and 280 small firms potentially would be affected using the sales-based 2130
definition. Based on costs annualized over a four -year period and averag e sales data for the 2131 parent companies, EPA estimated that the cost-to-sale s ratio of the proposed rule would be less 2132 than 0.1 percent for an average small company subj ect to the rule. For a company to have a cost2133 to-sales ratio larger than one percent, compa ny sales would have to be less than $1.25 million. 2134 Because the small businesses affected by the prop osed rule have average sales of more than 2135 $412.7 million under the employment-based defin ition, and $11.8 million under the sales-based 2136 definition, small entities will not be affected by the proposed amendments to the IUR rule at a 2137 cost-to-sales ratio of greate r than one percent (Ref. 11). 2138

EPA continues to be interested in the pot ential impacts of this proposed rule on small 2139
entities and welcomes comments on i ssues related to such impacts. 2140

2141 D. Unfunded Mandates 2142
2143 This action does not contain any Federal manda tes for State, local, or tribal governments 2144 or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act 2145 (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory ac tion will not result in 2146 annual expenditures of $100 million or more for St ate, local, and tribal governments, in the 2147 aggregate, or for the private sector. The analys is of the costs associated with this action are 2148 briefly described in Unit VII. A., and is contained in the economic analysis (Ref. 11). 2149

2150 Based on EPA's past experience, State, lo cal, and tribal govern ments have not been 2151 affected by this reporting requirement, and EPA does not have any reason to believe that any 2152 State, local, or tribal governm ent will be affected by this rulemaking. As such, EPA has 2153 determined that this regulatory action doe s not impose any enforceable duty, contain any 2154*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

54 of 78 unfunded mandate, or otherwise have any affect on small governments. Accordingly, this rule is 2155 not subject to the requirements of sections 202, 203 or 205 of UMRA. 2156

E. Federalism 2157
2158 Pursuant to Executive Order 13132, entitle d “Federalism” (64 FR 43255, August 10, 2159 1999), EPA has determined that this proposed ru le does not have federalism implications 2160
because it will not have substantial direct eff ects on the states, on the relationship between the 2161 national government and the states, or on the di stribution of power and responsibilities among 2162 the various levels of government, as specified in the Order. This rule simply amends the 2163 Inventory Update Reporting rule in several ways to provide inform ation to better address Agency 2164 and public information needs, improve the usabili ty and reliability of the reported data, and 2165 ensure that data are available in a timely manne r. Because EPA has no information to indicate 2166 that any state or local governme nt manufactures or processes the chemical substances covered by 2167 this action, the proposed rule does not apply direc tly to states and localit ies and will not affect 2168 state and local governments. Thus, Executive Orde r 13132 does not apply to the proposed rule. 2169

2170 F. Tribal Implications 2171

2172 As required by Executive Order 13175, entitled Consultation and Coordination with 2173
Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 2174 proposed rule does not have tribal implications because it will not have any affect on tribal 2175 governments, on the relationship between the Federa l government and the Indian tribes, or on the 2176 distribution of power and respons ibilities betwee n the Federal government and Indian tribes, as 2177 specified in the Order. Thus, Executive Order 13175 does not apply to this rule. 2178
2179
G. Children’s Health 2180
2181 EPA interprets Executive Order 13045, entitled Protection of Children from 2182
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 2183 those regulatory actions that con cern health or safety risks, such that the analysis required under 2184
section 5-501 of Executive Order 13045 has the potential to influe nce the regulation. This action 2185 is not subject to Executive Order 13045 because it does not establish an environmental standard 2186 intended to mitigate health or safety risks. Nevertheless, the information obtained by the 2187 reporting required by this rule will be used to inform the Agency’s decision-making process 2188 regarding chemicals to which children may be disproportionately exposed. This information will 2189 also assist the Agency and others in determin ing whether the chemicals in this proposed rule 2190 present potential risks, allowing the Agency and others to take appropriate action to investigate 2191 and mitigate those risks. 2192

H. Energy Effects 2193

2194 This action is not a “significant energy action” as defined in Executive Order 13211, 2195
entitled Actions Concerning Regulations that Signific antly Affect Energy Supply, Distribution, or 2196

Use (66 FR 28355, May 22, 2001), because it is not likel y to have a significant adverse effect on 2197 the supply, distribution, or use of en ergy as described in the Order. 2198
2199*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

55 of 78 I. Technical Standards 2200
2201
Since this action does not invol ve any technical standards, section 12(d) of the National 2202 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 2203 12(d) (15 U.S.C. 272 note), doe s not apply to this action. 2204

J. Environmental Justice 2205
2206 The proposed rule does not have an advers e impact on the envir onmental and health 2207 conditions in low-income and minority communiti es that require specia l consideration by the 2208 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 2209 Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 2210 The Agency believes that the information collect ed under this proposed rule, if finalized, will 2211 assist EPA and others in determining the pot ential hazards and risks associated with the 2212 chemicals covered by the rule. Because the IUR ru le is an information collection requirement, 2213 the information that will become available throug h the rule will enable the Agency to target 2214 educational, regulatory, or enforcement activities towards industries or chemicals that pose the 2215 greatest risks and/or to target pr ograms for geographic areas that ar e at the highest risk. Thus, the 2216 information to be gathered under the rule will help EPA make decisions that will benefit 2217 potentially at-risk communities, some of which may be disadvantaged. 2218

The proposed rule is directed at manufacturer s or importers of chemicals. All consumers 2219 of these chemical products and all workers who come into contact with these chemicals could 2220 benefit if data regarding the chemicals’ heal th and environmental effects were developed. 2221 Therefore, it does not appear that the costs a nd the benefits of the proposed rule will be 2222 disproportionately distributed ac ross different geographic regions or among different categories 2223
of individuals. 2224

List of Subjects in 40 CFR part 704 2225
2226 Environmental protection, Chemicals, Ch emical Substance, Confidential business 2227 information, Hazardous substances, Imports, Reporting and recordkeeping requirements. 2228

List of Subjects in 40 CFR part 710 2229
2230 Environmental protection, Chemicals, Chem ical Substance, Hazardous materials, 2231 Reporting and recordkeeping requirements. 2232

List of Subjects in 40 CFR part 711 2233
2234 Environmental protection, Chemicals, Chem ical Substance, Hazardous materials, 2235 Reporting and recordkeeping requirements. 2236

Dated: ________ 2237

2238

________________ 2239
Assistant Administrator for Preventi on, Pesticides and Toxic Substances. 2240*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

56 of 78 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 2241

PART 704--[AMENDED] 2242

 1. Part 704 is amended as follows: 2243

 a. The authority citation for part 704 would continue to read as follows: 2244

Authority: 15 U.S.C. 2607(a) 2245

2246

 b. Section 704.3 is amended by removing the phrase “(as defined in 19 CFR 1.11)” in the 2247
definition for importer. 2248

PART 710--[AMENDED] 2249

 2. Part 710 is amended as follows: 2250

 a. The authority citation for part 710 would continue to read as follows: 2251

Authority: 15 U.S.C. 2607(a) 2252

2253

 b. By revising the heading for part 710 to read: 2254

2255 “Part 710—Compilation of th e TSCA Chemical Inventory” 2256

2257

 c. By removing the heading for “Subpart A”. 2258
2259

 d. By removing the term “subpart” and in its place add the term “part” everywhere it appears 2260 in §§ 710.1, 710.3 and 710.4. 2261

2262

 e. In § 710.1(b), by removing the text “The Inventory Update regulations were amended in 2263 2002...The Agency intends to remove subpart B from the CFR once the 2002 update is 2264 complete.” 2265

2266

 f. Section 710.3 is amended as follows: 2267

2268 (i) By replacing the introductory text with the phrase “For purposes of this part:” 2269

(ii) By removing the phrase “(as defi ned in 19 CFR 1.11)” in the definition for importer. 2270

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

. 2271

 g. By removing Subpart B, consisting of §§ 710.23 - 710.39 and Subpart C, consisting of §§ 2272
710.43 - 710.59. 2273

2274

 3. A new part 711 is added to read as follows: 2275

2276
PART 711 – TSCA INVENTORY UPDA TE REPORTING REQUIREMENTS 2277
2278

Sec. 2279*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

57 of 78 § 711.1 Scope and compliance. 2280 § 711.3 Definitions. 2281 § 711.5 Chemical substances for whic h information must be reported. 2282 § 711.6 Chemical substances for which information is not required. 2283 § 711.8 Persons who must report. 2284 § 711.9 Persons not subject to this part. 2285 § 711.10 Activities for which re porting is not required. 2286 § 711.12 Reporting information to EPA. 2287 § 711.13 When to report. 2288 § 711.15 Duplicative reporting. 2289 § 711.17 Recordkeeping requirements. 2290 § 711.18 Confidentiality. 2291 § 711.19 General. 2292
2293 Authority: 15 U.S.C. 2607(a). 2294
2295 § 711.1 Scope and compliance. 2296

(a) This part specifies reporti ng and recordkeeping procedures under section 8(a) of the Toxic 2297 Substances Control Act (15 U.S.C. 2607(a)) (TSCA) for certain manufacturers (including 2298 importers) of chemical substances. Section 8(a) authorizes the Administra tor to require reporting 2299 of information necessary for administration of the Act, including issu ing regulations for the 2300 purpose of compiling and keeping cu rrent the Inventory of chemical substances manufactured or 2301 processed in the United States as required by sect ion 8(b) of the Act. In accordance with section 2302 8(b), EPA amends the Inventory to include ne w chemical substances manufactured (including 2303 imported) in the United States a nd reported under section 5(a)(1) of the Act. EPA also revises 2304 the categories of chemical substances a nd makes other amendments as appropriate. 2305

(b) The regulations in this part apply to the ac tivities associated with the periodic update of 2306
information on a subset of the chemical substances included on the Inventory. 2307

(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit 2308 information required under thes e reporting regulations. In ad dition, section 15(3) makes it 2309 unlawful for any person to fail to keep, a nd permit access to, records required by these 2310 regulations. Section 16 provides that any person who violates a provi sion of section 15 is liable 2311 to the United States for a civil penalty and may be criminally prosecuted. Pursuant to section 17, 2312 the Government may seek judicial relief to compel submission of section 8(a) information and to 2313 otherwise restrain any violat ion of section 15. (EPA does not intend to concentrate its 2314 enforcement efforts on insignificant clerical errors in reporting.) 2315

(d) Each person who reports unde r these regulations must main tain records that document 2316 information reported under these regulations and, in accordance with the Act, permit access to, 2317 and the copying of, such records by EPA officials. 2318

§ 711.3 Definitions. 2319

2320
All definitions as set forth in section 3 of TSCA apply in this part. In addition, the following 2321 definitions and the definitions found in § 704.3 of this chapter (except as modified by the 2322*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

58 of 78 following definitions) ap ply to this part: 2323

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

. 2324

CDX or Central Data Exchange means EPA's centralized electronic document receiving system, 2325 or its successors, including associated instruct ions for registering to submit electronic 2326
documents. 2327

Commercial use means the use of a chemical substan ce or a mixture containing a chemical 2328 substance (including as part of an article) in a commerc ial enterprise providing saleable goods or 2329
services. 2330

Consumer use means the use of a chemical substance or a mixture containing a chemical 2331 substance (including as part of an article) when sold to or made available to consumers for their 2332

use. 2333

e-IUR means the electronic-IUR software provide d by EPA for the completion and submission 2334 of the IUR Form U report. 2335

2336 Industrial function means the intended physical or chemical characteristic for which a chemical 2337
substance or mixture is consum ed as a reactant; incorporated into a formulation, mixture, 2338 reaction product, or articl e; repackaged; or used. 2339

2340
Industrial use means use at a site at which one or mo re chemical substances or mixtures are 2341 manufactured (including imported) or processed. 2342

2343 Intended for use by children means the chemical substance or mixture is used in or on a product 2344 that is specifically intended for use by child ren age 14 or younger. A chemical substance or 2345 mixture is intended for use by children when the submitter answers “yes” to at least one of the 2346 following questions for the product into which the submitter's chemical substance or mixture is 2347 incorporated: 2348
2349 (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended 2350 for children age 14 or younger? 2351

2352 (2) Does the manufacturer of the product st ate through product labe ling or other written 2353 materials that the product is intended for or will be used by children age 14 or younger? 2354

2355 (3) Is the advertising, promoti on, or marketing of the product aimed at children age 14 or 2356 younger? 2357

Manufacture means to manufacture, produce, or impor t for commercial purposes. Manufacture 2358 includes the extraction, for commercial purposes, of a component chemical substance from an 2359 already existing chemical substance or complex co mbination of substances. The manufacture of 2360 a chemical substance by a manufacturer is also the manufacture of a chemical substance by a 2361 person who contracts for such manufacturing, wh ere (1) the manufactur er manufactures or 2362 produces the substance exclusively for that perso n, and (2) that person speci fies the identity of 2363*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

59 of 78 the substance and controls th e total amount produced and the basic technology for the plant 2364

process. 2365

Manufacturer means a person who manufactures a chemical substance. 2366

2367 Master Inventory File means EPA's comprehensive list of ch emical substances which constitute 2368 the Chemical Substances Inventory compiled und er section 8(b) of the Act. It includes 2369 substances reported under part 710 of this chapte r and substances reported under part 720 of this 2370 chapter for which a Notice of Commencement of Manufacture or Import has been received under 2371 §720.120 of this chapter. 2372

Principal reporting year means the calendar year in which manufacturing, processing, and use 2373 activities associated with the data reported to EPA during an IUR submission period occur. 2374 Production volume for manufacturing activities in other y ears of the reporting cycle may also be 2375 reportable during the submission period, but fu ll manufacturing, processing, and use data are 2376 reported only for activities during the principal reporting year. 2377

Reasonably likely to be exposed means an exposure to a chem ical substance which, under 2378 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 2379 or use of the chemical substance, is more likely to occur than not to occur. Such exposures would 2380 normally include, but would not be limited to, activities such as ch arging reactor vessels, 2381 drumming, bulk loading, cleaning equipment, maintena nce operations, materials handling and 2382 transfers, and analytical opera tions. Covered exposures include exposures through any route of 2383 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes acci dental or theoretical 2384

exposures. 2385

2386 Repackaging means the physical transfer of a chemical substance or mixture, as is, from one 2387
container to another container or containers in preparation fo r distribution of the chemical 2388
substance or mixture in commerce. 2389
2390 Reportable chemical substance means a chemical substance described in §711.5. 2391

Site means a contiguous property unit . Property divided only by a public right-of-way shall be 2392 considered one site. More than one plant may be located on a single site. 2393

(a) For substances manufactured under contract, i.e., by a toll manufact urer, the site is the 2394
location where the chemical substa nce is physically manufactured. 2395
2396 (b)The site for an importer who imports a chemical substance described in §711.5 is the 2397 U.S. site of the operating unit within the person's organization that is directly responsible 2398 for importing the substance. The import site, in some cases, may be the organization's 2399 headquarters in the United Stat es. If there is no such opera ting unit or headquarters in the 2400 United States, the site address for the importer is the U.S. address of an agent acting on 2401 behalf of the importer who is authorized to accept service of process for the importer. 2402

(c) For portable manufacturing units sent out to different locations from a single 2403 distribution center, the di stribution center shall be considered the site. 2404*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

60 of 78 Site-limited means a chemical substance is manufactured and processed only within a site and is 2405 not distributed for commercial purpo ses as a substance or as part of a mixture or article outside 2406 the site. Imported substances ar e never site-limited. Although a site -limited chemical substance is 2407 not distributed for commercial purposes outside the site at which it is manufactured and 2408 processed, the substance is considered to have been manufactured and pr ocessed for commercial 2409

purposes. 2410

Submission period means the period in which the manufact uring, processing, and use data are 2411
submitted to EPA. 2412

Use means any utilization of a chemical substance or mixtur e that is not otherwise covered by 2413 the terms manufacture or process. Relabeling or redistributing a container holding a chemical 2414 substance or mixture where no repa ckaging of the chemical substance or mixture occurs does not 2415 constitute use or processing of th e chemical substance or mixture. 2416

§ 711.5 Chemical substances for whic h information must be reported. 2417

2418 Any chemical substance which is in the Master Inventory File at the beginning of a submission 2419 period described in §711.13, unless the chemical substance is specifically excluded by §711.6. 2420

§ 711.6 Chemical substances for wh ich information is not required. 2421

The following groups or categories of chemical subs tances are exempted from some or all of the 2422 reporting requirements of this part, with th e following exception: A chemical substance 2423 described in paragraph (a)(1), (a)(2) , or (a)(4), or (b) of this sec tion is not exempted from any of 2424 the reporting requirements of this part if that substance is th e subject of a rule proposed or 2425 promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of a consent 2426 agreement developed under the procedures of 40 CFR Part 790, or is the subject of an order 2427 issued under section 5(e) or 5(f) of the Act, or is the subject of relief th at has been granted under 2428
a civil action under section 5 or 7 of the Act. 2429

(a) Full exemptions. The following categories of chemical substances are exempted from the 2430 reporting requirements of this subpart. 2431

(1) Polymers. (i) Any chemical substance described with the word fragments “*polym*”, 2432 “*alkyd”, or “*oxylated” in the Chemical Abstract s (CA) Index Name in the Master Inventory 2433 File, where the asterisk (*) in th e listed word fragments indicates that any sets of characters may 2434 precede, or follow, the character string defined. 2435

(ii) Any chemical substance which is identified in the Master Inventory File as siloxane and 2436 silicone, silsesquioxane, a protei n (albumin, casein, gelatin, glut en, hemoglobin), an enzyme, a 2437 polysaccharide (starch, cellulose, gum), rubber, or lignin. 2438
2439 (iii) This exclusion does not apply to a polymeric substa nce that has been hydrolyzed, 2440 depolymerized, or otherwise chemically modifie d, except in cases where the intended product of 2441 this reaction is totally polymeric in structure. 2442

2443 (2) Microorganisms. Any combination of chemical substances that is a living organism, and that 2444*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

61 of 78 meets the definition of “microorganism” at §725.3 of this chapter. Any chemical substance 2445 produced from a living microorganism is repor table under this subpart unless otherwise 2446
excluded. 2447

2448 (3) Naturally occurring chemical substances . Any naturally occurring chemical substance, as 2449 described in §710.4(b). The applicability of this exclusion is determined in each case by the 2450 specific activities of the pers on who manufactures the substan ce in question. Some chemical 2451
substances can be manufactured both as descri bed in §710.4(b) and by means other than those 2452 described in §710.4(b). If a person described in §711.8 manufactures a chemical substance by 2453 means other than those described in §710.4(b), the person must report regardless of whether the 2454 substance also could have been produced as de scribed in §710.4(b). Any ch emical substance that 2455 is produced from such a naturally occurring chemical substance described in §710.4(b) is 2456 reportable unless otherwise excluded. 2457

(4) Certain forms of natural gas and water. Chemical substances with the following Chemical 2458 Abstract Service (CAS) Registry Numbers: CASRN 64741–48–6, Natural gas (petroleum), raw 2459 liq. mix; CASRN 68919–39–1, Natural gas conden sates; CASRN 8006–61–9, Gasoline, natural; 2460 CASRN 68425–31–0, Gasoline (natural gas), na tural; CASRN 8006–14–2, Natural gas; CASRN 2461 68410–63–9, Natural gas, dried; a nd CASRN 7732-18-5, Water. 2462

(b) Partial exemptions. The following groups of chemical s ubstances are partially exempted 2463 from the reporting requirements of this part (i .e., the information described in §711.12(c)(4) need 2464 not be reported for these substances). Such chem ical substances are not excluded from the other 2465 reporting requirements under this part. 2466

2467 (1) Petroleum process streams. EPA has designated the following chemical substances, listed by 2468 CAS Number, as partially exempt from reporting under the IUR. 2469

2470 CAS Numbers of Partially Exempt Chemical Substances Termed “Petroleum Process 2471 Streams” for Purposes of In ventory Update Reporting 2472

The table currently in § 710.46(b)(1) will be moved to this location its entirety, excluding only the line directly after the heading, which reads:
“7732–18–5 Water” This is a very long table and, to avoid confusing reviewers, has not been replicated
in the draft document.

2473 (2) Specific exempted chemical substances —(i) Exemption. EPA has determined that, at this 2474 time, the information in §711.12(c)(4) associated with the chemicals listed in paragraph 2475 (b)(2)(iv) of this section is of low current interest. 2476

2477 (ii) Considerations. In making its determination of whethe r this partial exemption should apply 2478 to a particular chemical substance, EPA will consid er the totality of information available for the 2479 chemical substance in question, including but not limited to, one or more of the following 2480
considerations: 2481

2482 (A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of 2483 the information described in §711.12(c)(4) (i.e., at least one site manufactures 300,000 pounds or 2484*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

62 of 78 more of the chemical). 2485

2486 (B) The chemical substance's chemical and physi cal properties or potential for persistence, 2487 bioaccumulation, health effects, or environmental effects (considered indepe ndently or together). 2488
2489 (C) The information needs of EPA, other federal agencies, tribes, states, and local governments, 2490 as well as members of the public. 2491
2492 (D) The availability of other comple mentary risk screening information. 2493
2494 (E) The availability of comparable processing and use information. 2495
2496 (F) Whether the potential risks of the chem ical substance are adequately managed. 2497
2498 (iii) Amendments. EPA may amend the chemical list in para graph (b)(2)(iv) of this section on its 2499 own initiative or in response to a request fr om the public based on EPA's determination of 2500 whether the information in §711.12( c)(4) is of low interest. 2501

2502 (A) Any person may request that EPA amend the ch emical list in paragraph (b)(2)(iv) of this 2503 section. Your request must be in writing and must be submitted to the address provided in 2504 §711.19(d). Requests must identify the chemical in question, as well as its CAS number or other 2505
chemical identification number as identified in §711.12(c)(3)(i), and mu st contain a written 2506 rationale for the request that provides su fficient specific information, addressing the 2507 considerations listed in §711.6(b )(2)(ii), includin g cites and relevant documents, to demonstrate 2508
to EPA that the collection of th e information in §711.12(c)(4) for the chemical in question either 2509 is or is not of low current interest. If a request related to a particular chemical is resubmitted, any 2510 subsequent request must clearl y identify new information cont ained in the request. EPA may 2511 request other information that it believes nece ssary to evaluate the request. EPA will issue a 2512 written response to each request within 120 days of receipt of the request, and will maintain 2513 copies of these responses in a public docket th at will be established for each reporting cycle. 2514

2515 (B) As needed, the Agency will initiate rulemaki ng to make revisions to the list in paragraph 2516 (b)(2)(iv) of this section. 2517

2518 (C) To assist EPA in reaching a decision regarding a particular request prio r to a given principal 2519 reporting year, requests must be submitted to EPA no later than 12 months prior to the start of 2520 the next principal reporting year. 2521

2522 (iv ) List of chemical substances. EPA has designated the followi ng chemical substances, listed 2523 by CAS Number, as partially exem pt from reporting under the IUR. 2524

2525 CAS Numbers of Partially Exempt Chemical Substances Under §711.6(b)(2) 2526

CAS No. Chemical

50–70–4 D-Glucitol

50–81–7 L-Ascorbic acid

50–99–7 D-Glucose 56–81–5 1,2,3-Propanetriol 56–87–1 L-Lysine 57–50–1 .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

63 of 78 CAS No. Chemical
58–95–7 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, acetate, (2R)- 59–02–9 2H-1-Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, (2R)-

59–51–8 Methionine

69–65–8 D-Mannitol

87–79–6 L-Sorbose 87–99–0 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 61789–44–4 Fatty acids, castor-oil

61789–97–7 Tallow

61789–99–9 Lard*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

64 of 78 CAS No. Chemical
64147–40–6 Castor oil, dehydrated 64755–01–7 Fatty acids, tallow, calcium salts 65996–63–6 Starch, acid-hydrolyzed 65996–64–7 Starch, enzyme-hydrolyzed 67701–01–3 Fatty acids, C12-18 68002–85–7 Fatty acids, C14-22 and C16-22-unsatd. 68131–37–3 Syrups, hydrolyzed starch, dehydrated 68188–81–8 Grease, poultry 68308–36–1 Soybean meal 68308–54–3 Glycerides, tallow mono-, di- and tri-, hydrogenated 68334–00–9 Cottonseed oil, hydrogenated 68334–28–1 Fats and glyceridic oils, vegetable, hydrogenated 68409–76–7 Bone meal, steamed 68424–45–3 Fatty acids, linseed-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.
2527 § 711.8 Persons who must report. 2528
2529 Except as provided in §§711.9 and 711.10, the followi ng persons are subject to the requirements 2530 of this subpart. Persons must determine whethe r they must report under this section for each 2531 chemical substance that they manufacture (including import) at an individual site. 2532

2533 (a) Persons subject to recurring reporting. Any person who manufactur ed (including imported) 2534 for commercial purposes 25,000 lb. (11,340 kg) or more of a chemical substance described in 2535 §711.5 at any single site owned or controlled by that person at a ny time during any calendar year 2536 since the last principa l reporting year (e.g., for the 2011 subm ission period, consider calendar 2537 years 2006, 2007, 2008, 2009, and 2010). 2538
2539 (b) Exceptions. Any person who manufactured (includi ng imported) for commercial purposes 2540 any chemical substance that is the subject of a rule proposed or promulgated under section 2541 5(a)(2), 5(b)(4), or 6 of the Act, or is the subj ect of an order in effect under section 5(e) of the 2542 Act, or is the subject of relief that has been granted under a civ il action under sec tion 5 or 7 of 2543 the Act is subject to repor ting for that chemical, regard less of the production volume. 2544

2545*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

65 of 78 § 711.9 Persons not subject to this part. 2546
2547 A person described in §711.8 is not subject to the requirements of this subpart if that person 2548 qualifies as a small manufacturer as that te rm is defined in §704.3 of this chapter. 2549 Notwithstanding this exclusion, a person who qualifie s as a small manufacturer is subject to this 2550 subpart with respect to any chemical substan ce that is the subject of a rule proposed or 2551 promulgated under section 4, 5(b)(4), or 6 of the Act, or is the subj ect of an order in effect under 2552 section 5(e) of the Act, or is the subject of relief that has be en granted under a civil action under 2553
section 5 or 7 of the Act. 2554

2555 § 711.10 Activities for which reporting is not required. 2556
2557 A person described in §711.8 is not subject to the requirements of this subpart with respect to 2558 any chemical substance described in §711.5 that the person solely manufactured or imported 2559 under the following circumstances: 2560

2561 (a) The person manufactured or im ported the chemical substance described in §711.5 solely in 2562 small quantities for research and development. 2563
2564 (b) The person imported the chemical substance described in §711.5 as part of an article. 2565

2566 (c) The person manufactured the chemical subs tance described in §711.5 in a manner described 2567 in §720.30(g) or (h) of this chapter. 2568
2569 § 711.12 Reporting information to EPA. 2570

Any person who must report under this part, as described in §711.8, must submit the information 2571
described in this section for each chemical substance described in §711.5 that the person 2572 manufactured (including importe d) for commercial purposes in an amount of 25,000 lb. (11,340 2573 kg) or more (or lower volume for chemicals subject to the rules, orders, or actions described in 2574 711.8(c)) at any one site during any calendar year since the last pr incipal reporting year (i.e., for 2575 the 2011 submission period, consider calendar years 2006, 2007, 2008, 2009, and 2010). A 2576 separate report must be submitted for each chemical substance at each site for which the 2577 submitter is required to report. A submitter of information under this part must report 2578
information as described in this section to the extent that such information is known to or 2579 reasonably ascertainable by that person. 2580

(a) Reporting information to EPA. Any person who reports informati on to EPA must do so using 2581 the e-IUR reporting software provided by EP A at the address set forth in §711.19. The 2582
submission must include all information described in paragraph (b) of this section. Persons must 2583 submit a separate form for each site for whic h the person is required to report. The e-IUR 2584 reporting software is described in the instruction booklet availabl e from EPA at the address set 2585 forth in §711.19. 2586

(b) Information to be reported. Manufacturers (including import ers) of a reportable chemical 2587 substance in an amount of 25,000 lbs. (11,340 kg) or more at a site any calendar year since the 2588 last principal reporting year must report the inform ation described in this section. As described in 2589 §711.6(b)(1) and (b)(2), manufactur ers of certain chemicals are not required to report the 2590*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

66 of 78 information described in para graph (b)(4) of this section. 2591
2592 (1) A certification statement signed and dated by an authorized official of the submitter 2593 company. Persons reporting must submit this in formation using e-IUR as described in §711.19. 2594 The authorized official must certify that the submitted information has been completed in 2595 compliance with the requirements of the rule and that the confidentiality claims made on the 2596
form are true and correct. The certification must be signed and dated by the authorized official 2597 for the submitter company, and provide that pers on’s name, official title, and e-mail address. 2598
2599 (2) Company and plant site information. The following company and plant site information must 2600 be reported for each site at which at least 25,000 lbs. (11,340 kg) of a reportable chemical 2601 substance is manufactured (incl uding imported) during any calendar year since the last principal 2602 reporting year (see §711.3 for the “site” for importers): 2603

2604 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter under this 2605 part must obtain a Dun and Bradstreet Numb er for the parent company if none exists. 2606

2607 (ii) The name of a person who will serve as technical contact for the submitter company, and 2608 who will be able to answer que stions about the information submitted by the company to EPA, 2609 the contact person's full mailing address, telephone number and e-mail address. 2610

2611 (iii) The name and full street address of each si te. A submitter under this subpart must include 2612 the appropriate Dun and Bradstreet Number for each plant site reported, and the county or parish 2613 (or other jurisdictional indicator) in which the plant site is located. A submitter under this part 2614
must obtain a Dun and Bradstreet Number for the site reported if none exists. 2615

2616 (3) Specific information for chemicals manuf actured in amounts of 25,000 lbs. or more. The 2617 following chemical-specific information must be re ported for each reportable chemical substance 2618 manufactured at (including imported into) each site in amounts of 25,000 lbs. (11,340 kg) or 2619 more during any calendar year since the last principa l reporting year: 2620

(i) The specific, currently correct Chemical Abst racts (CA) Index name as used to list the 2621 chemical substance in the TSCA Inventory and the correct corresponding CAS Registry Number 2622 (CASRN) for each reportable chemical substance at each site. A submitter under this part may 2623 use an EPA-designated TSCA Accession Number fo r a confidential substance in lieu of a 2624
CASRN when a CASRN is not known to or re asonably ascertainable by the submitter. In 2625 addition to reporting the number itself, submitters must specify the type of number they are 2626 reporting by selecting from among the following codes 2627

Codes to Specify Type of Chemical Identifying Number 2628

Codes Number Type

A Accession Number

C CAS Registry Number

2629 (a) If an importer submitting a report cannot provide all the information specified in 2630 §711.12(b) of this section because it is claimed as confidential by the supplier of the chemical 2631 substance, the importer must have the supplier pr ovide the correct chemical identity information 2632*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

67 of 78 directly to EPA in a joint submission, electr onically using e-IUR and via CDX (see §711.19 of 2633 this part), and which clearly refe rences the importer's submission. 2634

2635 (b) If a manufacturer submitting a report canno t provide all the information specified in 2636 §711.12(b) of this section because the reportable chemical subs tance is manufactured using a 2637 reactant having a specific chemical identity claimed as confidential by its supplier, the 2638 manufacturer must submit a repor t directly to EPA containing all the information known to or 2639 reasonably ascertainable by the manufacturer ab out the chemical identity of the reported 2640 substance. In addition, the manufact urer must ensure that the supplie r of the confidential reactant 2641 provide the correct chemical identity of the conf idential reactant directly to EPA in a joint 2642 submission, electronically using e-IUR and vi a CDX (see §711.19 of this part), and which 2643 clearly references the manufacture's submission. 2644

(ii) A statement indicating, for each reportable chemical substance at each site, whether the 2645
substance is manufactured in the United Stat es, imported into the United States, or both 2646
manufactured in the United States and imported into the United States. 2647

(iii) For each calendar year since the last principal reporti ng year, the total annual volume (in 2648 pounds) of each reportable chemical substance dome stically manufactured and imported at each 2649
site. The total annual domesti cally manufactured volume (not including imported volume) and 2650 the total annual imported volume must be separate ly reported. This amount must be reported to 2651 two significant figures of accuracy. 2652

(iv) For the principal reporting year only, the volume used on s ite and the volume exported of 2653 each reportable chemical substance domestically manufactured and imported at each site. This 2654 amount must be reported to two significant figures of accuracy. 2655

(v) A designation indicating, for each imported re portable chemical substance at each site, 2656 whether the imported chemical substance is physically present at the reporting site. 2657

(vi) A designation indicating, for each reportabl e chemical substance at each site, whether the 2658 substance is being recycled, reused, remanufact ured, reprocessed, reworked, or otherwise used 2659 for a commercial purpose instead of being disposed of as a waste or included in a waste stream. 2660

(vii) The total number of workers reasonably likely to be exposed to each reportable chemical 2661 substance at each site. For each reportable substance at each site, the submitter must select from 2662 among the ranges of workers listed in the followi ng table and report the corresponding code (i.e., 2663 W1 through W8): 2664

2665 Codes for Reporting Number of Workers Reasonably Likely To Be Exposed 2666

Codes Range

W1 Less than 10 workers

W2 At least 10 but fewer than 25 workers

W3 At least 25 but fewer than 50 workers

W4 At least 50 but fewer than 100 workers

W5 At least 100 but fewer than 500 workers W6 At least 500 but fewer than 1,000 workers W7 At least 1,000 but fewer than 10,000 workers W8 At least 10,000 workers*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

68 of 78 2667 (viii) The maximum concentration, measured by percentage of weight, of each reportable 2668 chemical substance at the time it is sent off-site from each site. If the chemical is site-limited, 2669 you must report the maximum concentration, m easured by percentage of weight, of the 2670 reportable chemical substance at the time it is reacted on-site to produce a different chemical 2671 substance. This information must be reported regardless of the physical form(s) in which the 2672
substance is sent off-site/reacted on-site. For each substance at each site, select the maximum 2673 concentration of the substance from among the ra nges listed in the following table and report the 2674 corresponding code (i.e., M1 through M5): 2675

2676 Codes for Reporting Maximum Con centration of Chemical Substance 2677

Codes Concentration Range (% weight) M1 Less than 1% by weight

M2 At least 1 but le ss than 30% by weight M3 At least 30 but less than 60% by weight M4 At least 60 but less than 90% by weight M5 At least 90% by weight

2678 (ix) The physical form(s) of the reportable chemical substance as it is sent off-site from each site. 2679 If the chemical is site-limited, you must report the physical form(s) of the reportable chemical 2680
substance at the time it is reac ted on-site to produce a different chemical substance. For each 2681 substance at each site, the submitter must repor t as many physical forms as apply from among 2682 the physical forms listed below: 2683

2684 (A) Dry powder. 2685

2686 (B) Pellets or large crystals. 2687

2688 (C) Water- or solvent-wet solid. 2689
2690 (D) Other solid. 2691
2692 (E) Gas or vapor. 2693
2694 (F) Liquid. 2695
2696 (x) Submitters must report the percentage, rounded off to the closest 10%, of total production 2697 volume of the reportable chemical substance, fo r the principal reporting year only, reported in 2698 response to paragraph (c)(3) (iii) of this section, that is associ ated with each physical form 2699 reported under paragraph (c)(3) (ix) of this section. 2700

2701 (4) Specific information related to processing and use. Persons subject to paragraph (b)(4) of this 2702 section must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this section 2703 for each reportable chemical substance at sites under their control and at sites that receive a 2704 reportable chemical substance from the submitte r directly or indirect ly (including through a 2705 broker/distributor, from a customer of the submitte r, etc.). Information reported in response to 2706 this paragraph must be reported on ly to the extent that it is know n to or reasonably ascertainable 2707 by the submitter. Information require d to be reported under this pa ragraph is limited to domestic 2708*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

69 of 78 (i.e., within the customs territory of the Un ited States) processing and use activities. If 2709 information responsive to a given data requir ement under this paragraph, including information 2710 in the form of an estimate, is not known or reasonably ascertainable, the submitter is not required 2711 to respond to the requirement. 2712

2713 (i) Industrial processing and use information. (A) A designation indicating the type of industrial 2714 processing or use operation(s) at each site that receives a reportable substance from the submitter 2715 site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not). 2716 For each chemical substance, report the letters which correspond to the appropriate processing or 2717 use operation(s). A particular designation may need to be reported more than once, to the extent 2718 that a submitter reports more than one sector (u nder paragraph (b)(4)(i)(B) of this section) that 2719 applies to a given design ation under this paragraph. 2720

2721 Codes for Reporting Type of Industrial Processing or Use Operation 2722 Designation Operation PC Processing as a reactant PF Processing - incorporation into fo rmulation, mixture or reaction product PA Processing - incorporation into article PK Processing - repackaging U Use - non-incorpor ative activities

(B) A code indicating the sector(s ) which best describe the industr ial activities associated with 2723 each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this section. 2724 For each chemical substance, report the code th at corresponds to the appropriate sector(s). A 2725 particular sector code may need to be reported more than once, to the extent that a submitter 2726 reports more than one industrial function code (under paragraph (b)(4 )(i)(C) of this section) that 2727 applies to a given sector code under this paragraph. 2728

Codes for Reporting Industrial Sectors 2729

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

70 of 78 Code Sector Description IS20 Cyclic Crude and In termediate 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 Manufact uring (includes clay, glass, cement, concrete, lime, gypsum, and other nonm etallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing

IS46 Wholesale and Retail Trade

IS47 Services IS48 Other (requires additional information)
2730 (C) For each sector reported under paragraph (b )(4)(i)(B) of this sec tion, code(s) from the 2731 following list must be selected to designate th e industrial function category(ies) that best 2732 represents the specific manner in which the chemi cal substance is used. A particular industrial 2733 function category may need to be reported more than once, to the extent th at a submitter reports 2734 more than one industrial processing or use ope ration/sector combina tion (under paragraphs 2735 (b)(4)(i)(A) and (b)(4 )(i)(B) of this section) that applies to a given industrial function category 2736 under this paragraph. If more than 10 unique combinations of industr ial processing or use 2737 operations/sector/industrial function categories appl y to a chemical substance, submitters need 2738 only report the 10 unique combinations for the ch emical substance that cumulatively represent 2739 the largest percentage of th e submitter's production volume for that chemical, measured by 2740 weight. If none of the listed industrial func tion categories accurately describes a use of a 2741 chemical substance, the category “Other” may be us ed, and must include a de scription of the use. 2742 Codes for Reporting Industrial Function Categories 2743

Codes Category

U001 Abrasives

U002 Adhesives and sealant chemicals*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

71 of 78 Codes Category

U003 Adsorbents and absorbents

U004 Agricultural chemicals (non-pesticidal)

U005 Anti-adhesive agents

U006 Bleaching agents

U007 Corrosion inhibitors and anti-scaling agents

U008 Dyes

U009 Fillers

U010 Finishing agents

U011 Flame retardants

U012 Fuels and fuel additives

U013 Functional fluids (closed systems)

U014 Functional fluids (open systems)

U015 Intermediates

U016 Ion exchange agents

U017 Lubricants and lubricant additives

U018 Odor agents

U019 Oxidizing/reducing agents

U020 Photosensitive chemicals

U021 Pigments

U022 Plasticizers

U023 Plating agents and surface treating agents

U024 Process regulators

U025 Processing aids, specific to petroleum production

U026 Processing aids, not otherwise listed

U027 Propellants and blowing agents

U028 Solids separation agents

U029 Solvents (for cleaning or degreasing)

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

U031 Surface active agents

U032 Viscosity adjustors*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

72 of 78 Codes Category

U033 Laboratory chemicals

U034 Paint additives and coating additives not described by other categories

U999 Other (specify)

2744 (D) The estimated percentage, rounded off to th e closest 10%, of total pr oduction volume of the 2745 reportable chemical substance associated with ea ch combination of industrial processing or use 2746 operation, sector and industrial function category. Where a partic ular combination of industrial 2747 processing or use operation, sector and industrial function category accounts for 5% or less of the 2748 submitter's site's total production volume of a repor table chemical substance, the percentage must 2749 not be rounded off to zero percent if the produc tion volume attributable to that industrial 2750 processing or use operation, sect or and industrial function cate gory combination is 25,000 lb. 2751 (11,340 kg.) or more during the reporting year. Instea d, in such a case, submitters must report the 2752 percentage, rounded off to the closest 1%, of the submitter's site's total production volume of the 2753 reportable chemical substance associated with th e particular combination of industrial processing 2754 or use operation, sector and industrial function category. 2755

2756 (E) For each combination of industrial processing or use operation, sector and industrial function 2757 category, the submitter must estimate the number of sites at which each reportable chemical 2758 substance is processed or used. For each comb ination associated with each substance, the 2759 submitter must select from among the ranges of s ites listed in the following table and report the 2760 corresponding code (i.e., S1 through S7): 2761

2762 Codes for Reporting Numbers of Sites 2763

Codes Range

S1 less than 10 sites

S2 at least 10 but fewer than 25 sites

S3 at least 25 but fewer than 100 sites

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

2764 (F) For each combination of industrial processing or use operation, sector and industrial function 2765 category, the submitter must estimate the number of workers reasonably likely to be exposed to 2766 each reportable chemical substance. For each co mbination associated with each substance, the 2767 submitter must select from among the worker ranges listed in paragraph (b)(3)(v) of this section 2768 and report the corresponding code (i.e., W1 though W8). 2769

2770 (ii) Consumer and commercial use information. (A) Using the codes listed in this paragraph, 2771 submitters must designate the consumer and comme rcial product category or categories that best 2772 describe the consumer and commercial products in which each reportable chemical substance is 2773 used (whether the recipi ent site(s) are controlled by the submitt er site or not). If more than 10 2774 codes apply to a chemical substance, submitters need only report the 10 codes for the chemical 2775 substance that cumulatively represent the larges t percentage of the submitter's production volume 2776 for that chemical, measured by weight. If none of the listed consumer and commercial product 2777*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

73 of 78 categories accurately describes the consumer and commercial produc ts in which each reportable 2778 chemical substance is used, the category “Other” may be used, and must include a description of 2779
the use. 2780

2781 Codes for Reporting Consumer and Commercial Product Categories 2782

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 Produc ts 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 Foot wear 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 elsew here

C207 Batteries

Chemical Substances in Packaging, Paper, Plastic, Hobby Products

C301 Food Packaging

C302 Paper Products

C303 Plastic and Rubber Prod ucts not covered elsewhere

C304 Toys, Playground, and Sporting Equipment

C305 Arts, Crafts, and Hobby Materials

C306 Ink, Toner, and Colorant Products*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

74 of 78 Codes Category

C307 Photographic Supplies, Film, and Photochemicals

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

C401 Automotive Care Products

C402 Lubricants and Greases

C403 Anti-Freeze and De-icing Products

C404 Fuels and Related Products

C405 Explosive Materials

C406 Agricultural Products (non-pesticidal)

C407 Lawn and Garden Care Products

Chemical Substances in Products not Described by Other Codes

C980 Non-TSCA Use

C909 Other (specify)

2783 (B) An indication, within each consumer a nd commercial product category reported under 2784 paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use. 2785

2786 (C) Submitters must determine, within each co nsumer and commercial product category reported 2787 under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical 2788 substance manufactured (including imported) by the submitter is present in (for example, a 2789 plasticizer chemical used to make pacifiers) or on (for example, as a co mponent in the paint on a 2790 toy) any consumer products intended for use by ch ildren up to the age of 14, regardless of the 2791 concentration of the substance remaining in or on the product. Submitters must select from the 2792 following options: the chemical substance is used in or on any consumer products intended for 2793 use by children, the chemical substance is not us ed in or on any consumer products intended for 2794 use by children, or information as to whether the chemical substance is used in or on any 2795 consumer products intended for use by children is not known to or reasonably ascertainable by 2796
the submitter. 2797
2798 (D) The estimated percentage, rounded off to th e closest 10%, of the submitter's site's total 2799 production volume of the reportable chemical s ubstance associated with each consumer and 2800 commercial product category. Where a particular consumer and commercial product category 2801
accounts for 5% or less of the to tal production volume of a reportable chemical substance, the 2802 percentage must not be rounded o ff to zero percent if the production volume attributable to that 2803 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 2804 reporting year. Instead, in such a case, submitters must report the percen tage, rounded off to the 2805 closest 1%, of the submitter's site's total produc tion volume of the reportable chemical substance 2806 associated with the particular cons umer and commercial product category. 2807

2808 (E) Where the reportable chemical substance is us ed in consumer or commercial products, the 2809 estimated typical maximum concentration, measur ed by weight, of the chemical substance in 2810*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

75 of 78 each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this 2811
section. For each substance in each commercial and consumer product category reported under 2812 paragraph (b)(4)(ii)(A) of this section, subm itters must select from among the ranges of 2813 concentrations listed in the table in paragra ph (b)(3)(viii) of this section and report the 2814 corresponding code (i.e., M1 through M5). 2815

2816 (F) Where the reportable chemical substance is used in a commercial product, the submitter must 2817
estimate the number of commercial workers reasonably likely to be exposed to each reportable 2818 chemical substance. For each combination associated with each substance, the submitter must 2819 select from among the worker rang es listed in paragraph (b)(3)(vii) of this secti on and report the 2820 corresponding code (i.e., W1 though W8). 2821

2822 § 711.13 When to report. 2823
2824 All information reported to EPA in response to the requirements of this subpart must be 2825 submitted during an applicable submission period from June 1 to September 30 at 4–year 2826 intervals, beginning in 2011. Any person desc ribed in §711.8(a) must report during each 2827 submission period for each chemical substance described in §711.5 that the person manufactured 2828 (including imported) during any calendar year since the last principal repo rting year (e.g., for the 2829 2011 submission period, consider cale ndar years 2006, 2007, 2008, 2009, and 2010, since 2005 2830 was the last principal reporting year). 2831

2832 § 711.15 Duplicative reporting. 2833
2834 (a) With regard to section 8(a) rules. Any person subject to the re quirements of this part who 2835 previously has complied with reporting requirement s of a rule under section 8(a) of the Act by 2836 submitting the information described in §711.12 for a chemical substance described in §711.5 to 2837 EPA, and has done so within 1 year of the st art of a submission period described in §711.13, is 2838 not required to report again on the manufacture of that substance at th at site during that 2839 submission period. 2840

2841 (b) With regard to importers. This part requires that only one report be submitted on each import 2842 transaction involving a chemical substance desc ribed in §711.5. When two or more persons are 2843 involved in a particular import transaction and each person meet s the Agency's definition of 2844 “importer” as set forth in §704.3 of this chapte r, they may determine among themselves who 2845 should submit the required report; if no report is submitted as required under this part, EPA will 2846 hold each such person liable for failure to report. 2847

2848 (c) Toll manufacturers and persons cont racting with a toll manufacturer. This part requires that 2849 only one report be submitted on each chemical substance described in §711.5. When a company 2850
contracts with a toll manufacturer to manufacture a chemical subs tance, and each party meets the 2851 Agency's definition of “manufacturer” as se t forth in §711.3, the contracting company is 2852 primarily responsible for the IU R submission. In the event the contracting company does not 2853 report, the toll manufacturer must report. Both the contracting company and the toll 2854
manufacturer are liable if no report is made. 2855

2856 § 711.17 Recordkeeping requirements. 2857
2858*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

76 of 78 Each person who is subject to th e reporting requirements of this s ubpart must retain records that 2859 document any information reported to EPA. Reco rds relevant to reporting during a submission 2860 period must be retained for a period of 5 y ears beginning on the last day of the submission 2861 period. Submitters are encouraged to retain their r ecords longer than 5 years to ensure that past 2862
records are available as a reference wh en new submissions are being generated. 2863

2864 § 711.18 Confidentiality. 2865
2866 (a) Any person submitting information under this s ubpart may assert a business confidentiality 2867
claim for the information at the time it is subm itted. Any such confidentiality claims must be 2868 made at the time the information is submitted. Confidentiality claims cannot be made when a 2869 response is left blank or an i ndication of not known to or reasona bly ascertainable by is provided. 2870 These claims will apply only to the information submitted with the claim. New confidentiality 2871 claims, if appropriate, must be asserted with re gard to information submitted during a different 2872 submission period. Guidance for asserting confidentia lity claims is provided in the instructions 2873 identified in §711.19. Information claimed as confiden tial in accordance with this section will be 2874
treated and disclosed in accordance with the procedures in part 2 of this chapter. 2875

2876 (b) Chemical identity. A person may assert a claim of confidentiality for the chemical identity of 2877 a specific chemical substance only if the identity of that substance is treated as confidential in the 2878 Master Inventory File as of the time the report is submitted for that substance under this subpart. 2879 The following steps must be taken to assert a cl aim of confidentiality for the identity of a 2880 reportable chemical substance: 2881

2882 (1) The submitter must submit with the report deta iled written answers to the following questions 2883 signed and dated by an authorized official. 2884

2885 (i) What harmful effects to your competitive pos ition, if any, do you think would result from the 2886 identity of the chemical substance being disc losed in connection with reporting under this 2887 subpart? How could a competitor use such information? Would the effects of disclosure be 2888 substantial? What is the causal relationship be tween the disclosure and the harmful effects? 2889
2890 (ii) How long should confidential treatment be gi ven? Until a specific da te, the occurrence of a 2891 specific event, or permanently? Why? 2892
2893 (iii) Has the chemical substance been patented? If so, have you granted licenses to others with 2894 respect to the patent as it applies to the chemi cal substance? If the chemical substance has been 2895 patented and therefore disclosed through the pate nt, why should it be trea ted as confidential? 2896
2897 (iv) Has the identity of the chemical substance been kept confidential to the extent that your 2898 competitors do not know it is being manufactur ed or imported for a commercial purpose by 2899 anyone? 2900
2901 (v) Is the fact that the chemical substance is being manufactured (including imported) for a 2902 commercial purpose available to the public, for exampl e in technical journals, libraries, or State, 2903 local, or Federal agency public files? 2904
2905 (vi) What measures have been taken to prevent un desired disclosure of the fact that the chemical 2906*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

77 of 78 substance is being manufactured (includi ng imported) for a commercial purpose? 2907
2908 (vii) To what extent has the fact that this chemical substance is manufactured (including 2909 imported) for commercial purposes been revealed to others? What precautions have been taken 2910 regarding these disclosures? Have there been public disclosures or disclosures to competitors? 2911
2912 (viii) Does this particular chemical substance le ave the site of manufacture (including import) in 2913 any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard 2914 against the discovery of its identity? 2915
2916 (ix) If the chemical substance leaves the site in a product that is availa ble to the public or your 2917 competitors, can the substance be identified by analysis of the product? 2918
2919 (x) For what purpose do you manufacture (including import) the substance? 2920
2921 (xi) Has EPA, another Federal agency, or any Fe deral court made any pe rtinent confidentiality 2922 determinations regarding this chemical substa nce? If so, please attach copies of such 2923
determinations. 2924
2925 (2) If any of the information contained in the an swers to the questions li sted in paragraph (b)(1) 2926
of this section is asserted to contain confidential business info rmation, the submitter must clearly 2927 identify the information that is claimed confid ential by marking the specific information on each 2928 page with a label such as “confid ential business information,” “pr oprietary,” or “trade secret.” 2929
2930 (c) Site identity. A submitter may assert a claim of confidentiality for a site only if the linkage of 2931 the site with a reportable chemi cal is confidential and not publicly available. The following steps 2932 must be taken to assert a claim of confidentiality for a site identity: 2933
2934 (1) The submitter must submit with the report deta iled written answers to the following questions 2935 signed and dated by an authorized official: 2936
2937 (i) Has site information been linked with a chemical identity in any other Federal, state or local 2938 reporting scheme? For example, is the chemical iden tity linked to a facili ty in a filing under the 2939 Emergency Planning and Community Right-to-K now Act (EPCRA) section 311, namely through 2940 a Material Safety Data Sheet (MSDS)? If so, id entify all such schemes. Was the linkage claimed 2941 as confidential in any of these instances? 2942
2943 (ii) What harmful effect, if any, to your comp etitive position do you think would result from the 2944 identity of the site and the chemical substance being disclosed in connect ion with reporting under 2945 this subpart? How could a competitor use such info rmation? Would the effects of disclosure be 2946 substantial? What is the causal relationship be tween the disclosure and the harmful effects? 2947
2948 (2) If any of the information contained in the answ ers to the questions list ed in paragraph (c)(1) 2949
of this section is asserted to contain confidential business info rmation, the submitter must clearly 2950 identify the information that is claimed confid ential by marking the specific information on each 2951 page with a label such as “confid ential business information,” “pr oprietary,” or “trade secret.” 2952

(d) Processing and Use information . A submitter may assert a clai m of confidentiality for each 2953 data element required by 711.12(b)(4) only if the li nkage of the information with a reportable 2954*** Interagency EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During Review ***

78 of 78 chemical is confidential and not publicly available. The following st eps must be taken to assert a 2955 claim of confidentiality for each data element, individually, required by 711.12(b)(4): 2956

(1) The submitter must submit with the report deta iled written answers to the following questions 2957 signed and dated by an authorized official: 2958

(i) Is the identified use of this chemical publicly known? For example, is information on the use 2959 available in advertisements or other marketing ma terials, professional journals or other similar 2960 materials, or in non-confidential mandatory or voluntary government filings or publications? Has 2961 your company ever provided use information on the chemical that was not claimed as 2962
confidential? 2963

(ii) What harmful effect, if any, to your comp etitive position do you think would result from the 2964 information reported as required by 711.12(b)(4) a nd the chemical substance being disclosed in 2965 connection with reporting under this part? How could a competitor use such information? Would 2966
the effects of disclosure be s ubstantial? What is the causal relationship between the disclosure 2967
and the substantial harmful effects? 2968

(2) If any of the information contained in the an swers to the questions li sted in paragraph (d)(1) 2969
of this section is asserted to contain confidential business info rmation, the submitter must clearly 2970 identify the information that is claimed confid ential by marking the specific information on each 2971 page with a label such as “confid ential business information,” “pr oprietary,” or “trade secret.” 2972

(e) If no claim of confidentiality is indicated on the reporting form submitted to EPA under this 2973 subpart; if the reporting form l acks the certification required by 711.12(b)(1); if confidentiality 2974 claim substantiation required under paragraphs (b), (c), and (d) of this section is not submitted 2975 with the reporting form; or if the identity of a chemical substance listed on the public portion of 2976 the Master Inventory File was cl aimed as confidential, EPA may make the information available 2977 to the public without furthe r notice to the submitter. 2978
2979 § 711.19 General. 2980
2981 (a) You must use e-IUR to complete and subm it the form identified as “Form U,” EPA Form 2982 7740-8. Submissions may only be made as set forth in this section. 2983

(b) Submissions must be sent el ectronically to EPA via CDX. 2984

(c) Obtain e-IUR and instructions, as follows: 2985
2986 (1) By website. Go to the EPA Inventory Update Reporting Internet home page at 2987 http://www.epa.gov/iur and follo w the appropriate links. 2988
2989 (2) By phone or e-mail. Contact th e EPA TSCA Hotline at (202) 554–1404 or TSCA2990 Hotline@epa.gov for a CD-ROM containing the software and instructions. 2991
2992 [FR Doc. 09–????? Filed ??–??–09; 8:45 am] 2993
BILLING CODE 6560–50–S 2994
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2997