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EO 12866 Review Draft 1 2 BILLING CODE 6560

– 50

– P 3 4 5 6 ENVIRONMENTAL PROTECTION AGENCY 7

40 CFR Parts 704, 710, and 711 8

[ EPA

– HQ

– OPPT

– 2009

– 0187; FRL

– 8833

– 5] 9

RIN 2070

– AJ43 10

TSCA Inventory Update Reporting Modi fications 11

12

AGENCY: Environmental Protection Agency (EPA). 13

ACTION: Final rule. 14

SUMMARY: EPA is amending t he Toxic Substances Control Act (TSCA) section 8(a) 15 Inventory Update Reporting (IUR) rule. The IUR enables EPA to collect and publish 16 information on t he manufacturing, processing, and use of commercial chemical substances and 17 mixtures (referred to hereafter as chemical substances) on the TSCA Chemical Substance 18 Inventory (TSCA Inventory). This includes current information on chemical production volumes, 19 manufacturing sites, and how the chemicals are used. This information helps the Agency 20 determine whether people or the environment are potentially exposed to reported chemicals. 21 EPA publishes submitted IUR data that is not Confidential Business Informati on (CBI). EPA is 22 amending the IUR rule to require submission of information that will better address Agency and 23 public information needs, improve the usability and reliability of the reported data, and ensure 24 that data are available in a timely manner. EPA is requiring electronic reporting of IUR 25 information and modifying IUR reporting requirements, including certain circumstances that 26 trigger reporting, the specific data to be reported, the reporting standard for processing and use 27 information, and CBI rep orting procedures. 28

DATES: This final rule is effective [ insert date 30 days after date of publication in the Federal 29 Register ]. 30 31 ADDRESSES: EPA has established a docket for this action under docket identification (ID) 32 number EPA

– HQ

– OPPT

– 20 09

- 0187. All documents in the docket are listed in the docket index 33 available at http://www.regulations.gov . Although listed in the index, some information is not 34 publicly available, e.g., Confidential Business In formation (CBI) or other information whose 35 disclosure is restricted by statute. Certain other material, such as copyrighted material, is not 36 placed on the Internet and will be publicly available only in hard copy form. Publicly available 37 docket materials a re available in the electronic docket at http://www.regulations.gov , or, if only 38*** Interagency EO 12866 Review Draft

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2 available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 39 Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, 40 DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 41 through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 42 Room is (202) 566

– 1744, and the telephone number for the OPPT Docket is (2 02) 566

– 0280. 43 Docket visitors are required to show photographic identification, pass through a metal detector

, 44 and sign the EPA visitor log. All visitor bags are processed through an X

- ray machine and 45 subject to search. Visitors will be provided an EPA/ DC badge that must be visible at all times in 46 the building and returned upon departure. 47 48 FOR FURTHER INFORMATION CONTACT: For technical information contact : Chenise 49 Farquharson, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, 50 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 51 0001; telephone number: 202

- 564

- 7768; e

- mail address: farquharson.chenise @epa.gov

. 52 For general information contact : Th e TSCA

- Hotline

, ABVI

- Goodwill, 422 South 53 Clinton Ave., Rochester, NY 14620 ; telephone number: (202) 554

– 1404; e

- mail address: TSCA

54 Hotline@epa.gov

. 55 56 SUPPLEMENTARY INFORMATION: 57 58 I. Does this Action Apply to Me? 59 60 You may be potentially affected by this acti on if you manufacture (including manufacture 61 as a byproduct) or import chemical substances listed on the TSCA Inventory (under TSCA 62 section 3, ―import‖ is included in the definition of manufacture). Potentially affected entities 63 may include, but are not l imited to: 64

• Chemical manufacturers and importers (NAICS codes 325 and 324110; e.g., chemical 65 manufacturing and processing and petroleum refineries). 66

• Chemical users and processors who, in addition to manufacturers described above, may 67 manufacture a b yproduct chemical substance (NAICS codes 22, 322, 331, and 3344; e.g., 68 utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other 69 electronic component manufacturing). 70

This listing is not intended to be exhaustive, but rather provides a guide for readers 71 regarding entities likely to be affected by this action. Other types of entities not listed in this unit 72 could also be affected. The North American Industrial Classification System (NAICS) codes 73 have been provided to assist y ou and others in determining whether this action might apply to 74 certain entities. If you have any questions regarding the applicability of this action to a particular 75 entity, consult the technical person listed under FOR FURTHER INFORMATION 76 CONTACT

. 77

II. Ba ckground 78 79 A. What Action is the Agency Taking? 80*** Interagency EO 12866 Review Draft

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3 In this action, EPA is promulgating several amendments to the IUR rule, taking into 81 consideration comments received on the proposal. The amendments were proposed on August 82 13, 2010 (75 FR 49656)(FRL

- 8833

- 5). The amendments contained in this final rule, as well as 83 the Inventory update provisions of 40 CFR part 710 subpart C unchanged by these amendments, 84 appear in a new part, 40 CFR part 711. The following is a brief listing of the primary 85 amendments to the I UR. These amendments are described in more detail in Unit II.E. 86

1. EPA is amending 40 CFR 710.59, which appears in the new part 711 as §711.35, to 87 require electronic reporting of the IUR data, using an Agency

- provided, web

- based reporting 88 software (e

- IUR web) to submit IUR reports through the Internet to EPA‘s Central Data 89 Exchange (CDX). After the final rule‘s effective date [see DATES ] , paper submissions will no 90 longer be accepted. 91

2. EPA is adding a new definition section, which appears in the new part 711 as §711.3; 92 revising the definition for manufacture and site ; and making other needed definitional 93 modifications and additions. 94

3. EPA is amending 40 CFR 710.53, which appears in the new part 711 as §711.20, to 95 change the reporting frequency from every 5 years to every 4 years. 96

4. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as §711.8(a), 97 to modify the method used to determine whether a manufacturer (including importer) is subject 98 to IUR reporting. The method would be effective aft er the 2011 IUR submission period. 99 Subsequent to 2011, reporting is required if the production volume of a chemical substance met 100 or exceeded the 25,000 pound (lb.) threshold in any calendar year since the last principal 101 reporting year (e.g., 2010). 102

5. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as §711.15(c), 103 to eliminate the 300,000 lb. threshold for processing and use information, thereby requiring all 104 submitters of non

- excluded chemical substances to report information in all par ts of the IUR 105 reporting form (Form U). 106

6. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as §711.8(a), 107 to eliminate the 25,000 lb. threshold for certain chemical substances that are the subject of 108 particular TSCA rules and/or orders, thereby requiring manufacturers (including importers) of 109 such chemical substances to report under the IUR rule, regardless of the production volume. 110

7. EPA is amending 40 CFR 710.46, which appears in the new part 711 as §711.6, to 111 make chemical substance s for which an enforceable consent agreement (ECA) to conduct testing 112 has been made under 40 CFR part 790 ineligible for exemptions, to provide a full exemption 113 from IUR requirements for water, and to remove polymers, which are already fully exempt from 114 th e partially exempt list of chemical substances at 40 CFR 710.46(b)(2)(iv), which appears in the 115 new part 711 as §711.6(b)(2)(iv). 116

8. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as §711.15(c), 117 to modify the reporting requirements fo r certain manufacturing data elements. Specifically, 118 manufacturers (including importers) are required to report: 119*** Interagency EO 12866 Review Draft

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4 i. The name and address belonging to the parent company. 120

ii. The current Chemical Abstracts (CA) Index Name, as used to list the chemical 121 subs tance on the TSCA Inventory, as part of the chemical identity. 122

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

iv. The volume of a manufactured (including imported) chemical substance used at the 124 reporting site. 125

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

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

vii. When a manufactured chemical substance, such as a byproduct, is being recycled, 128 remanufa ctured, reprocessed, or reused. 129

9. EPA is replacing the ―readily obtainable‖ reporting standard used for the reporting of 130 processing and use information required by 40 CFR 710.52(c)(4), which appears in the new part 131 711 as §711.15(b)(4), with the ―known to or reasonably ascertainable by‖ reporting standard. 132

10. EPA is amending 40 CFR 710.58, which appears in the new part 711 as §711.30, to 133 require upfront substantiation when processing and use information required by 40 CFR 134 710.52(c)(4), which appears in t he new part 711 as §711.15(b)(4), is claimed as CBI. 135

11. EPA will disallow confidentiality claims for processing and use data elements 136 identified as not ―known to or reasonably ascertainable by‖ (40 CFR 710.52(c)(4)), which 137 appears in the new part 711 as § 711.15(b)(4). 138

12. EPA is revising the list of industrial function categories for the reporting of 139 processing and use information. EPA is also amending 40 CFR 710.52(c)(4)(i)(C), which 140 appears in the new part 711 as §711.15(b)(4)(i)(B), to replace the 5

- dig it NAICS codes with 48 141 Industrial Sectors (IS). 142

13. EPA is amending 40 CFR 710.52(c)(4)(ii), which appears in the new part 711 as 143 §711.15(b)(4)(ii), to revise the list of consumer and commercial product categories for the 144 reporting of consumer and commerci al use information. EPA is also requiring the separate 145 reporting for consumer or commercial categories and the reporting of the number of commercial 146 workers reasonably likely to be exposed to the subject chemical substance. 147

14. EPA is eliminating the gaps in the ranges used to report concentration in 40 CFR 148 710.52(c)(3) and (c)(4), which appear in the new part 711 as §§711.15(b)(3) and (b)(4). 149

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

EPA is required under TSCA section 8(b), 15 U.S.C. 2607( b), to compile and keep 151 current an inventory of chemical substances manufactured or processed in the United States. This 152 inventory is known as the TSCA Chemical Substance Inventory (TSCA Inventory). The Agency 153*** Interagency EO 12866 Review Draft

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5 maintains the Master Inventory File as the aut horitative list of all the chemical substances 154 reported to EPA for inclusion on the TSCA Inventory. In 1977, EPA promulgated a rule 155 published in the Federal Register issue of December 23, 1977 (Ref. 1) under TSCA section 156 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that 157 time. In 1986, EPA promulgated the initial IUR rule under TSCA section 8(a) at 40 CFR part 158 710 published in the Federal Register issue of June 12, 1986 (Ref. 2) to facilitate the periodic 159 updating of information on chemical substances listed on the TSCA Inventory and to support 160 activities associated with the implementation of TSCA. In 2003, EPA promulgated extensive 161 amendments to the IUR rule, published in the Federal Register issue of January 7, 200 3 (2003 162 Amendments) (Ref. 3) to collect exposure

- related information associated with the 163 manufacturing, processing, and use of eligible chemical substances and to make certain other 164 changes. 165

Section 8(a)(1) of TSCA authorizes the EPA Administrator to prom ulgate rules under 166 which manufacturers and processors of chemical substances must maintain such records and 167 submit such information as the EPA Administrator may reasonably require. Section 8(a) of 168 TSCA generally excludes small manufacturers and processors of chemical substances from the 169 reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA 170 section 8(a)(3) to require TSCA section 8(a) reporting from small manufacturers and processors 171 with respect to any chemical substa nce that is the subject of a rule proposed or promulgated 172 under TSCA section 4, 5(b)(4), or 6, or that is the subject of an order in effect under TSCA 173 section 5(e), or that is the subject of relief granted pursuant to a civil action under TSCA section 174 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer for 175 purposes of 40 CFR part 710, which appears in the new part, 40 CFR part 711, is found at 40 176 CFR 704.3. Processors are not currently subject to the rules at 40 CFR par t 710, which appears 177 in the new part 40 CFR part 711. 178

This document promulgates the IUR as 40 CFR part 711, which includes provisions 179 copied from the existing IUR regulations in 40 CFR part 710 subpart C that are not substantively 180 changed as a part of this rulemaking, and the new IUR provisions in this final rule. Failure to 181 comply fully with any provision of this final rule will be a violation of TSCA section 15 and will 182 subject the violator to the penalties of TSCA sections 16 and 17. 183 184

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

The IUR rule, as modified by the 2003 Amendments, required U.S. manufacturers 186 (including importers) of chemical substances listed on the TSCA Inventory to report the identity 187 of chemi cal substances manufactured (including imported) during the reporting year in quantities 188 of 25,000 lb. or greater at any single site they own or control to EPA every five years. IUR data 189 were collected five times prior to the 2003 Amendments: 1986, 1990, 1994, 1998, and 2002, and 190 one time after the 2003 Amendments, in 2006. EPA uses the TSCA Inventory and data reported 191 under the IUR rule to support many TSCA

- related activities and to support a number of EPA and 192 other Federal health, safety, and environmen tal protection activities. The Agency also makes the 193 data available to the public, to the extent possible given CBI claims. 194*** Interagency EO 12866 Review Draft

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6 Persons manufacturing (including importing) chemical substances were required to report 195 information such as company name, site lo cation and other identifying information, production 196 volume of the reportable chemical substance, and exposure

- related information associated with 197 the manufacture of each reportable chemical substance. This exposure

- related information 198 included the physic al form and maximum concentration of the chemical substance and the 199 number of potentially exposed workers. Several groups of chemical substances were and will 200 continue to be generally excluded from IUR reporting requirements: e.g., polymers, 201 microorganism s, naturally occurring chemical substances, and certain natural gas substances. 202

Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lb. or 203 greater manufactured (including imported) during the reporting year at any single site ) were 204 required also to report certain processing and use information for the 2006 submission. This 205 information includes process or use category; NAICS code; industrial function category; percent 206 production volume associated with each process or use catego ry; number of use sites; number of 207 potentially exposed workers; and consumer/commercial information such as use category, use in 208 or on products intended for use by children, and maximum concentration. 209

The 2006 submission was the first instance where manuf acturers (including importers) of 210 inorganic chemical substances were required to report under the IUR rule. For the 2006 211 submission only, inorganic chemical substances were partially exempted from the IUR rule, and 212 manufacturers of such chemicals were requ ired to report the manufacturing information and not 213 the processing and use information, regardless of production volume. Under the previous rule, 214 for future collections (i.e., for 2011 or 2016 IUR collections, etc.), the partial exemption for 215 inorganic ch emicals would have no longer been applicable and submitters would have reported 216 in the same manner as was required for organic chemicals, including processing and use 217 information. In addition, starting with the 2006 collection and for future collections, specifically 218 listed petroleum process streams and other specifically listed chemical substances were partially 219 exempt, and manufacturers of such chemical substances were not required to report processing 220 and use information. These partial exemptions will continue in subsequent submission periods 221 under the IUR as revised today (including 2011), for as long as the chemical substances remain 222 on these partial exemption lists §§711.6(b)(1) and (b)(2). 223

Non

- confidential data, including both searchable and separa tely downloadable databases, 224 and the 2006 IUR data summary report are available to the public on the IUR website 225 ( http://www.epa.gov/iur ). 226

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

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

1. To tailor t he information collected to better meet the Agency‘s overall information 229 needs. 230

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

3. To obtain new and updated information relating to potential exposures to a subset of 232 chem ical substances listed on the TSCA Inventory. 233*** Interagency EO 12866 Review Draft

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7 4. To improve the usefulness of the information reported. 234

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

- depth 235 processing and use information is to be reported and adjusting the specific reported information, 236 the method and frequency of collecting the information, and CBI requirements will accomplish 237 these goals. 238

These goals are supported by a policy outlined in TSCA section 2, which is that 239 ―adequate data should be developed wit h respect to the effect of chemical substances and 240 mixtures on health and the environment and that the development of such data should be the 241 responsibility of those who manufacture and those who process such chemical substances and 242 mixtures‖ (TSCA section 2(b)(1)). Modifications to the IUR requirements by the 2003 243 Amendments provided many improvements to the data collected through that rule, and EPA‘s 244 efforts to use the 2006 IUR data identified areas where further improvements are needed. The 245 modificatio ns described in this final rule change some of the reporting requirements in an effort 246 by EPA to ensure the required information is properly reported and that the information in the 247 Agency‘s database reflects the information provided in the IUR reports; in crease the usability of 248 the collected information; increase the availability of information for the public; and focus 249 reporting on information that is most needed by the Agency. 250

In addition, these changes will enable EPA and other Federal agencies to impro ve their 251 risk screening capabilities, enabling them to better assess and manage risk, and improve public 252 awareness of basic information about a large number of chemical substances. 253

EPA provided reporting software for the 2006 IUR submission period and enc ouraged 254 electronic reporting through the Internet, using the Agency‘s CDX. EPA‘s experience with 255 populating the IUR database and with using the 2006 IUR data provided insight into how well 256 both the reporting software and submission methods worked. For in stance, because of 257 validations built into the reporting software, electronic submissions were able to be quickly 258 assimilated into the IUR database. Other forms of submission required the documents to be 259 scanned in or hand entered, and resulted in many int roduced errors during the data entry process. 260 Additionally, for the 2006 IUR, certain types of submissions (e.g., joint submissions) could not 261 be reported electronically. Other problems, such as incorrect chemical identities, delayed the 262 incorporation of the data into the database, resulting in the Agency‘s inability to begin using the 263 2006 IUR data and providing public access in a timely manner. The modifications in today‘s 264 rule associated with reporting methods and changes to the reporting software wil l better ensure 265 the information reported to the Agency is accurate and in compliance with the IUR requirements. 266

During the development of the 2003 Amendments, the Agency considered the data 267 accuracy and reliability needed for screening level exposure anal yses and took several steps to 268 ensure the IUR data met those needs. Screening level data need not be precise, but should be 269 accurate and reliable enough for the Agency to develop screening level assessments. The 2003 270 amendments to IUR rule supply exposure

- related information the Agency did not previously 271 possess, recognizing that industry has a greater knowledge than EPA about its own operations 272 and the uses of chemical substances it manufactures and sells. 273*** Interagency EO 12866 Review Draft

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8 EPA‘s extensive use of the 2006 IUR data in the A gency‘s Existing Chemicals Program 274 is consistent with how EPA envisioned the data would be used when the 2003 Amendments were 275 promulgated. In 2007, the Agency began to develop and post screening

- level hazard, exposure, 276 and risk characterizations for high production volume (HPV) chemicals, which are those 277 chemicals produced nationally at aggregated volumes of one million lb. or more per year. In 278 developing these characterizations, EPA identified areas where the IUR data collection can be 279 improved and enhan ced. Improvements would allow EPA to better identify and take follow

- up 280 action on chemical substances that may pose potential risks to human health or the environment. 281

During its review of the IUR data, EPA identified numerous examples of CBI claims 282 whe re the same or similar information to that claimed as CBI was already available to the public. 283 In several cases, information on production volume and uses for a chemical substance or group 284 of chemical substances was claimed CBI on Form U, while the same o r similar information was 285 submitted voluntarily by the company without such a claim under the HPV Challenge Program. 286 In those cases, EPA had previously made the information publicly available through the High 287 Production Volume Information System (HPVIS) o r on EPA‘s Existing Chemicals website. 288 More detailed CBI substantiation requirements will encourage the correct designation of non

289 confidential reported information, thereby facilitating reporting of this information to the public. 290

EPA Administrator Lisa P. Jackson has made it a priority to strengthen the Agency‘s 291 chemical management program, including the development of new regulatory risk management 292 actions, the development of Chemical Action Plans targeting the Agency‘s risk management 293 efforts, re quiring the reporting of information needed to understand chemical risks, and 294 increasing public access to information about chemical substances (Ref. 4). The IUR provides 295
exposure

- related data needed to understand chemical risks. The modifications to the IUR rule 296 will enhance the capabilities of the Agency to ensure risk management actions are taken on 297 chemical substances which may pose the greatest concern. More in

- depth reporting of the 298 processing and use data, more careful consideration of the need for confidentiality claims, and 299 adjustments to the specific data elements are important aspects of this action. By enhancing the 300 data supplied to the Agency, EPA expects to more effectively and expeditiously identify and 301 address potential risks posed by chem ical substances and provide improved access and 302 information to the public. 303

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

- CBI information, therefore increasing the transparency and public access ibility of 305 the chemical substance use, and exposure information and ensuring consistency with the 306 President‘s policy goals for government reliance on and public availability of scientific 307 information. 308

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

EPA is making a number of revisions to the IUR, as described in this unit. The 310 regulatory text of this document describes the full specific IUR reporting requirements and 311 includes both the modified and the unmodified portions of the regulatory text (see 40 CF R part 312 711). EPA has also developed guidance documents with specific reporting instructions, questions 313 and answers, and case studies, and intends to conduct a webinar to help potential IUR submitters 314 become familiar with the revised reporting form (Form U) and amended reporting requirements. 315*** Interagency EO 12866 Review Draft

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9 Guidance documents and information on the webinar are available on the IUR website, 316 www.epa.gov/iur. 317

A. What technical modifications have been made to the regulatory text? The Agency is 318 making several technical modif ication related to moving the regulatory text to its own section in 319 the CFR. The chemical substances that are covered by the IUR rule are on the Master Inventory 320 File, which includes chemical substances from the original TSCA Inventory compilation and 321 tho se added subsequently through the notice requirements of TSCA section 5. Because the IUR 322 rule applies to a list of chemical substances included on the original TSCA Inventory plus 323 additional chemical substances added subsequently, and because the Agency f rom time to time 324 has modified the IUR rule, the Agency believes the regulatory text associated with the IUR rule 325 should be in its own section in the CFR, distinct from both the original TSCA Inventory rules 326 and from the TSCA section 5 requirements. 327

1. Mov e the IUR regulatory text from 40 CFR part 710, subpart C, to 40 CFR part 711 328 and eliminate subpart divisions. Subpart C of 40 CFR part 710, 40 CFR 710.43 to 710.59, 329 contains the IUR regulatory text. EPA is moving all of the subpart C text from 40 CFR pa rt 710 330 to a new 40 CFR part 711 and adding a new scope and compliance section (40 CFR 711.1). 331

Table 1.

— Relocation of 40 CFR 710, Subpart C Provisions 332

Old CFR Citation New CFR Citation

40 CFR 710.43 40 CFR 711.3

40 CFR 710.45 40 CFR 711.5

40 CFR 710. 46 40 CFR 711.6

40 CFR 710.48 40 CFR 711.8

40 CFR 710.49 40 CFR 711.9

40 CFR 710.50 40 CFR 711.10

40 CFR 710.52 40 CFR 711.15

40 CFR 710.53 40 CFR 711.20

40 CFR 710.55 40 CFR 711.22

40 CFR 710.57 40 CFR 711.25

40 CFR 710.58 40 CFR 711.30

40 CFR 71 0.59 40 CFR 711.35

333*** Interagency EO 12866 Review Draft

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10 Because all of the text of subpart C was moved to 40 CFR part 711, 40 CFR part 710 no longer 334 has a subpart C. Neither 40 CFR part 710 nor 40 CFR part 711 have any subparts. 335

2. Consolidate definitions . As part of moving the regulatory text from 40 CFR part 710, 336 subpart C, to 40 CFR part 711, EPA is consolidating definitions copied from 40 CFR 710.3 and 337 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropriate definition is already in 338 place in TSCA section 3 or at 40 CFR 704.3 , and an additional definition of the term in 40 CFR 339 711.3 was therefore unnecessarily duplicative. The definitions in TSCA section 3 and at 40 CFR 340 704.3 are incorporated into 40 CFR 711.3, except insofar as 40 CFR 711.3 provides a modified 341 definition of a term also defined at 40 CFR 704.3. 342

The term mixture is defined in both 40 CFR 710.3 and TSCA section 3. For purposes of 343 the IUR rule, EPA is incorporating the definition of mixture from TSCA section 3. The TSCA 344 mixture definition differs from the defini tion in 40 CFR 710.3 and 40 CFR 720.3, the regulations 345 used to determine the chemical substances listed on the TSCA Inventory, in that it does not 346 specifically address hydrates. A hydrate is a mixture of water and an anhydrous chemical 347 substance. Because t hey are mixtures, hydrates are not listed as such on the TSCA Inventory. 348 For this reason, EPA believes it is superfluous to include a specific discussion of hydrates in the 349 IUR definition of mixture. Please see the instruction manual for additional discu ssion (Ref. 5). 350

Unit II.E.3 contains further discussions about changes to specific definitions, in relation 351 to the modifications included in this final rule. A summary of all IUR

- related definitions is 352 available in the docket (Ref. 6). 353

3. Delete non

- isola ted intermediate definition from 40 CFR 710.3 . EPA added a 354 definition to 40 CFR 710.43 for the term ―non

- isolated intermediate‖ as part of the 2003 355 Amendments. Subsequently, as part of the IUR Revisions Rule published in the Federal 356 Register issue of Dece mber 19, 2005 (Ref. 7), EPA erroneously moved the definition to 40 CFR 357 710.3 from 40 CFR 710.43. EPA is deleting the definition from 40 CFR 710.3 as this definition 358 was not associated with the original TSCA Inventory, and therefore does not belong in 40 C FR 359 710.3. A definition of this term, codified elsewhere at 40 CFR 704.3, is incorporated into the 360 IUR definitions at 40 CFR 711.3. 361

4. Delete subpart B text . EPA is deleting the regulatory text contained in 40 CFR part 362 710, 40 CFR 710.23 to 710.39 (subpart B). This text refers to IUR submission periods of 2002 363 and earlier and is obsolete. As noted in 40 CFR 710.1, the Agency expressed its intent to remove 364 subpart B once the 2002 update was complete. 365

5. Delete superfluous text associated with reporting prod uction volumes . EPA is deleting 366 the phrase ―provided that the reported figures are within ±10% of the actual volume‖ from the 367 production volume reporting requirements found in 40 CFR 710.52(c)(3)(iv), which appears in 368 the new 40 CFR part 711 as 40 CFR 711. 15(b)(3)(iv). The revised wording would be ―This 369 amount must be reported to two significant figures of accuracy.‖ The deleted phrase is 370 superfluous because any number reported accurately to two significant figures is within 10% of 371 the correct value. 372*** Interagency EO 12866 Review Draft

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11 6. C orrect text associated with reporting number of sites and number of workers . EPA is 373 replacing the phrase ―less than‖ with the phrase ―fewer than‖ in the ranges used to report the 374 number of workers found in the table in 40 CFR 710.52(c)(3)(v), which appears in the new 40 375 CFR part 711 as 40 CFR 711.15(b)(3)(vii) and the number of sites found in the table in 40 CFR 376 710.52(c)(4)(i)(E), which appears in the new 40 CFR part 711 as 40 CFR 711.15(b)(4)(i)(E). 377 This change makes the phrases describing the ranges gra mmatically correct. 378

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

- provided, web

- based reporting software (e

- IURweb) and CDX to submit the 380 completed Form U to the Agency. After the final rule‘s effective date, EPA will no longer 381 accept paper submissions or electronic media (i.e., as a file on a CD

- ROM) for any IUR 382 submission. 383

In order to submit electronically to EPA via CDX, individuals acting on behalf of the 384 submitter must first register with CDX. CDX registration is a requirement for all electronic 385 submissions using CDX; this requirement predates today‘s final rule. EPA has modified the 386 2006 electronic signature agreement (ESA) form to identify more clearly the individual(s) 387 required to sign the agre ement (Ref. 8). Each IUR submission must have an authorized official 388 associated with the submission, who is the person signing the certification statement and 389 submitting the IUR report via CDX. The authorized official must complete both an ESA and the 390 CD X registration process. Companies can access the reporting software upon completion of their 391 CDX registration. The instruction manual and other guidance materials are available on EPA‘s 392 website at www.epa.gov/iur

. 393

C. What definitions have been modified or added to clarify the reporting requirements? 394 As part of developing the definition section for 40 CFR part 711, EPA is modifying six 395 definitions associated with the IUR rule and adding four new definitions. In 40 CFR 704.3 and 396 40 CFR 710.3, EPA is also modifying the definition of importer by removing the citation to 19 397 CFR 1.11. 398

1. Manufacture and manufacturer

. To improve the information submitted through the 399 IUR rule, EPA is modifying the definition of manufactu re by incorporating elements from the 40 400 CFR 720.3 definition for manufacturer. The Agency is also adding a simple definition for the 401
term manufacturer to 40 CFR 711.3. In addition to the change to the definition of manufacture

, 402 EPA is adding a paragraph ( c) to the regulation at 40 CFR 711.22 to clarify the reporting 403 relationship between the contracting company and the toll manufacturer. The contracting 404 company and the toll manufacturer should confer with each other to avoid duplicate reporting, 405 and both th e contracting company and the toll manufacturer are liable if no report is made. EPA 406 agreed with comments that the "primarily responsible" language that was proposed was 407 confusing and needed to be revised. As a result, EPA modified paragraph (c) to clarify that the 408 contracting company and the toll manufacturer should determine among themselves who should 409 submit the required report for the site. EPA also added ―per site‖ in two places in paragraph (c) 410 to specify that there is supposed to be one report per ch emical, per site. See Unit III.3.b. for 411 further discussion of the site for contract manufacturing situations. 412

This final rule defines the term manufacture under the IUR to mean ―to manufacture, 413 produce, or import, for commercial purposes. Manufacture inc ludes the extraction, for 414*** Interagency EO 12866 Review Draft

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12 commercial purposes, of a component chemical substance from a previously existing chemical 415 substance or a complex combination of substances. When a chemical substance, manufactured 416 other than by import, is: 417

(1) Produced exclusive ly for another person who contracts for such production, and (2) 418 that other person specifies the identity of the chemical substance and controls the total amount 419 produced and the basic technology for the plant process, that chemical substance is 420 comanufact ured by the producing manufacturer and the person contracting for such production.‖ 421

This final rule defines the term manufacturer under the IUR to mean ―a person who 422 manufactures a chemical substance.‖ 423

2. Site . EPA is amending the definition of site to cla rify that the importer‘s site must be a 424 U.S. address; accommodate manufacturing under contract; and accommodate portable 425 manufacturing units. See Unit III10. for a further discussion of this final rule as it relates to 426 importers. 427

This final rule defines the term site under the IUR to mean ―a contiguous property unit. 428 Property divided only by a public right

- of

- way shall be considered one site. More than one plant 429 may be located on a single site. 430

(1) For chemical substances manufactured under contract, i.e ., by a toll manufacturer, the 431 site is the location where the chemical substance is physically manufactured. 432

(2) The site for an importer who imports a chemical substance described in 40 CFR 711.5 433 is the U.S. site of the operating unit within the person's organization that is directly responsible 434 for importing the chemical substance. The import site, in some cases, may be the organization's 435 headquarters in the United States. If there is no such operating unit or headquarters in the United 436 States, the site address for the importer is the U.S. address of an agent acting on behalf of the 437 importer who is authorized to accept service of process for the importer. 438

(3) For portable manufacturing units sent out to different locations from a single 439 distribution cente r, the distribution center shall be considered the site.‖ 440

3. Electronic

- reporting related definitions . EPA is adding two new terms, Central Data 441 Exchange (CDX) and e

- IURweb . The Agency is adding these terms to provide clarity to the 442 requirement for electro nic reporting of IUR data. The term CDX means ―EPA‘s centralized 443 electronic document receiving system, or its successors.‖ The term e

- IURweb means the 444 ―electronic, web

- based IUR software provided by EPA for the completion and submission of the 445 IUR data.‖ 446

4. Processing and use

- related definitions . EPA is amending the definitions of the terms 447 commercial use and consumer use in order to make them more consistent with the definitions 448 developed collaboratively by the United States and Canada. See Unit II.E.6.h . for further 449 information. While the definitions for these two terms differ in their precise wording from the 450 Canadian version (to preserve the use of terminology defined in IUR and related regulations), 451 EPA does not expect the basic application of these t wo terms to differ from the basic application 452 of the Canadian definitions (Ref. 9). The term commercial use means ―the use of a chemical 453*** Interagency EO 12866 Review Draft

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13 substance or a mixture containing a chemical substance (including as part of an article) in a 454 commercial enterprise pr oviding saleable goods or services.‖ Examples included in the 40 CFR 455 710.43 definition have been eliminated. The slightly modified definition of consumer use is ―the 456 use of a chemical substance or a mixture containing a chemical substance (including as part of an 457 article) when sold to or made available to consumers for their use.‖ The restrictions associated 458 with where a consumer would use the product have been removed. 459

EPA is adding a definition for the term industrial function . For the 2006 IUR, EPA 460 defined industrial use and did not define industrial function . The inclusion of both definitions 461 provides clarity for the industrial processing and use reporting requirements and makes the 462 Agency‘s requirements consistent with those collaboratively develo ped with Canada (Ref. 9). 463 Additional discussion of those requirements is in Unit III.E.6.g. With this final rule, industrial 464 function means ―the intended physical or chemical characteristic for which a chemical substance 465 or mixture is consumed as a reacta nt; incorporated into a formulation, mixture, reaction product, 466 or article; repackaged; or used.‖ 467

5. Principal reporting year and submission period . As described in Unit II.A., EPA is 468 changing the reporting cycle from every 5 years to every 4 years and req uiring the reporting of 469 production volumes for each calendar year since the last principal reporting year. EPA is 470 modifying the terms reporting year and submission period to reflect these changes. 471

The term reporting year is modified to add the term ―prin cipal‖ and to replace the word 472 ―information‖ with ―manufacturing, processing and use data.‖ These changes are to indicate 473 that the principal reporting year is the year in which most of the reported data are based. Under 474 the final rule, the principal rep orting year is the latest complete calendar year preceding the 475 submission period. Additionally, EPA is removing the reference to ―the calendar year at 5

– year 476 intervals thereafter‖ and removing the reference to ―calendar year 2005.‖ With these changes, 477 th e term principal reporting year is defined as ―the latest complete calendar year preceding the 478 submission period.‖ 479

The term submission period is modified by deleting the phrase ―generated during the 480 reporting year.‖ With this change, the definition of su bmission period reflects that data for years 481 in addition to the principal reporting year would be reported. With this change, the definition of 482 submission period means ―the period in which manufacturing, processing, and use data are 483 submitted to EPA.‖ 484

D. Has the reporting frequency been changed? As proposed, EPA has changed the 485 reporting frequency to every 4 years. The Agency has determined that reporting every 5 years is 486 too infrequent and believes that returning reporting to every 4 years will provide da ta sufficiently 487 current to meet Agency and public needs. After the 2011 reporting cycle, the next reporting 488 under the IUR rule will occur in 2015. The submission period will continue to occur in the year 489 following the principal reporting year. 490

E. How have the reporting thresholds changed ? Reporting thresholds are used to 491 determine when IUR reporting is required for a subject chemical substance at a manufacturing 492 (including importing) site. EPA has made three changes related to the reporting thresholds: 493*** Interagency EO 12866 Review Draft

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14 D etermination of whether you meet the 25,000 lb. threshold. 494

Elimination of the 300,000 lb. threshold for reporting information in Part III of 495 Form U. 496

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

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

. 498 For the 2011 submission period, manufacturers (including importers) are required to report under 499 the IUR rule if they manufacture (including import) a chemical substance listed on the TSCA 500 Inventory duri ng the principal reporting year (i.e., 2010 for the 2011 submission period); the 501 chemical substance is not otherwise exempt; and the associated production volume (domestically 502 manufactured plus imported volumes) at a site met or exceeded 25,000 lb. during the principal 503 reporting year (i.e.., 2010 for the 2011 submission period). 504

For submission periods subsequent to the 2011 submission period, the determination of 505 the need to report is based on whether, for any calendar year since the last principal reportin g 506 year, a chemical substance was manufactured (including imported) at a site in production 507 volumes of 25,000 lb. or greater. For example, for the 2015 submission period, it would be 508 necessary to examine the annual production volumes for the calendar years 2011 to 2014 for the 509 site. If the production volume for a reportable chemical substance were 25,000 lb. or greater for 510 any calendar year during that four year period, then it would be necessary to report the chemical 511 substance, unless it were otherwise ex empt. For instance, a subject chemical substance with 512 production volumes of 5,000 lb. in 2014 and 35,000 lb. in 2012 would be reported for the 2015 513 IUR. Regardless of the 2014 production volume, in this example scenario the 2015 IUR 514 submission would cont ain detailed information based on the production volume during the 2014 515 calendar year and production volume information only for the years 2011 through 2013. See Unit 516 III.D.1 of the proposed rule preamble for further discussion. 517

EPA is finalizing this c hange because of the mounting evidence that many chemical 518 substances, even larger production volume chemical substances, often experience wide 519 fluctuations in production volume from year to year. (See Unit III.D.1 in proposed rule.) This 520 can result in the production volume of a chemical substance exceeding the threshold for several 521 years, then falling below the threshold during the IUR principal reporting year. EPA believes 522 that using production volume reporting for all years since the last principal repor ting year to 523 determine reporting obligations will yield a much more accurate picture of the chemical 524 substances currently in commerce, ensuring proper review under EPA‘s risk screening, 525 assessment, and management activities and providing better information to the public. This issue 526 is addressing further in Unit V.C. of this preamble as well as the response to public comments 527 (Ref. 13). 528

2. Elimination of the 300,000 lb. threshold for processing and use information . EPA is 529 eliminating the 300,000 lb. thres hold for processing and use information, thereby requiring all 530 submitters of non

- excluded chemical substances to report information in all parts of Form U. 531 EPA is eliminating this reporting threshold in order to collect information necessary to complete 532

s creening

- level exposure characterizations for IUR reportable chemical substances. The 533 exposure information is an essential part of developing risk evaluations and, based on its 534*** Interagency EO 12866 Review Draft

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15 experience in using this information, the Agency believes that collecting this exposure 535 information is critical to its mission of characterizing exposure, identifying potential risks, and 536 noting uncertainties for these lower production volume chemical substances. In addition, this 537 change will provide the public with information on a greater number of chemical substances. 538

3. Elimination of the 25,000 lb. threshold for certain regulated chemical substances . EPA 539 is eliminating the 25,000 lb. reporting threshold for certain chemical substances that are the 540 subject of particular TSCA rule s and/or orders and requiring manufacturers (including importers) 541 of such chemical substances to report under the IUR rule, regardless of the production volume. 542 EPA is eliminating the 25,000 lb. threshold for those chemical substances that are: 543

• The subj ect of a rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 544 6, 545

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

• The subject of relief that has been granted under a civil action under TSCA section 5 or 547 7. 548

Chemical sub stances that are the subject of these particular TSCA actions are of 549 demonstrated high interest to the Agency. EPA is promulgating this change to ensure the 550 availability of current information when the Agency has expressed a concern in the form of 551 regulat ory action on those chemical substances, regardless of the production volume. EPA will 552 use the IUR data associated with these regulated chemical substances to monitor chemical 553 substance production and compliance with the rules. 554

Under this final rule, for the 2011 submission period, a manufacturer (including importer) 555 of such chemical substances is required to report information on the manufacturing, processing, 556 and use of the chemical substances if that person manufactured (including imported) any 557 quantity of these chemical substances during the principal reporting year (i.e., 2010) and must 558 report the production volumes for each year from 2006 to 2010 and the full manufacturing, 559 processing, and use information for 2010. 560

For subsequent IUR reporting cycle s, a manufacturer (including importer) of such 561 chemical substances is required to report information on the manufacturing, processing, and use 562 of the chemical substances if that person manufactured (including imported) any quantity of 563 these chemical subst ances during any of the years since the last principal reporting year, 564 including quantities under 25,000 lb. For 2015 reporting, the manufacturer must consider the 565 manufacture or import during the years 2011 through 2014; must report the production volume s 566 for each year from 2011 to 2014; and must report the full manufacturing, processing, and use 567 information for 2014. 568

In the IUR proposal, EPA specifically sought comment on whether circumstances 569 triggering an exception to the 25,000 lb. reporting thresho ld for a chemical substance should 570 include the proposal of certain rules for the chemical, under TSCA section 5(a)(2), 5(b)(4), or 6. 571 EPA explained that such an approach would more closely parallel the exception language in the 572 introductory paragraph to 4 0 CFR 711.6 and in 40 CFR 711.9. (See Unit III.D.3 of the preamble 573 of the proposal, at 75 FR 49664). Including these types of proposed rules in the list of triggering 574*** Interagency EO 12866 Review Draft

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16 circumstances is also more consistent with reporting obligations under other parts of TSC A, such 575 as 12(b). Among other situations, reporting under TSCA 12(b) is required when any rule under 576 section 5 or 6 is proposed or promulgated. In response to the comments received, EPA has 577 determined that chemical substances subject to a rule proposed un der TSCA section 5(a)(2), 578 5(b)(4), or 6 will be excepted from the 25,000 lb. reporting threshold, and thus will be reportable 579 at any production volume. See Unit V.C.2. of this preamble for further discussion. 580

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

1. Water . EPA is fully exempting all (both naturally occurring and manufactured) water 582 (CASRN 7732

– 18

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

2. Fully exempt polymers removed from partially exempt list . Polymers a re a class of 584 chemical substances for which IUR reporting is not required (40 CFR 711.6(a)(1)). However, 585 three polymers were previously listed in the partially exempt list of chemical substances at 40 586 CFR 710.46(b)(2)(iv): Starch (CASRN 9005

– 25

– 8), Dextri n (CASRN 9004

– 53

– 9), and 587 Maltodextrin (CASRN 9050

– 36

– 6). EPA has removed from the partially exempt list of 588 chemical substances at 40 CFR 711.6(b)(2)(iv) these three chemical substances which, as 589 polymers, are fully exempt from reporting. 590

3. C hemical subst ances that are the subject of an Enforceable Consent Agreement (ECA) 591 are ineligible for exemptions . EPA may enter into an ECA, pursuant to procedures at 40 CFR 592 part 790, with a manufacturer of a chemical substance to obtain testing where a consensus exists 593 among EPA, affected manufacturers and/or processors, and interested members of the public 594 concerning the need for and scope of testing. Chemical substances that are the subject of an 595 ECA are now included in the list of chemical substances that are inelig ible for an IUR 596 exemption, in the introductory paragraph of 40 CFR 711.6, along with the other chemical 597 substances that are likewise not eligible for an IUR exemption. The paragraph states that a 598 chemical substance ―is not exempted from any of the reporti ng requirements of this part if that 599 substance is the subject of a rule proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 600 of the Act, or is the subject of a consent agreement developed under the procedures of 40 CFR 601 part 790, or is the subjec t of an order issued under section 5(e) or 5(f) of the Act, or is the subject 602 of relief that has been granted under a civil action under section 5 or 7 of the Act.‖ 603

G. What changes have been made to reportable data elements? 1. Parent company and 604 site iden tity . Manufacturers (including importers) are required to report the company name and 605 Dun & Bradstreet D

- U

- N

- S® (D&B) number to identify the company associated with the plant 606 site, and also to report the site name, address, and D&B number. If the company associated with 607 the plant site does not have a D&B number, the manufacturer (including importer) must obtain 608 one for the company. Likewise, if the plant site does not have a D&B number, the manufacturer 609 (including importer) must obtain one for the site. EPA received a variety of questions 610 concerning the correct company name to report during the 2006 IUR submission period. EPA is 611 now clarifying what is meant by company name, by requiring at 40 CFR 711.15(b)(2)(ii) that the 612 company name provided be the pa rent company name. EPA believes this change will reduce 613 confusion by making this reporting requirement consistent with the Toxic Release Inventory 614 (TRI) requirements for parent company name. For further clarification regarding the correct 615 parent company name and the distinction between domestic (U.S.) and foreign parent company, 616*** Interagency EO 12866 Review Draft

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17 in particular for the small business determination, please refer to the ―Instructions for 2011 617 Inventory Update Reporting‖ (Ref. 5). The 2006 IUR submissions from different report ing sites 618 contained varying D&B numbers for parent companies that appeared to be the same company. 619 In order to better identify when reporting sites are under the same parent company, EPA is 620 requiring the address as well as the D&B number of the parent com pany. 621

2. Technical contact . Manufacturers (including importers) are required to provide a 622 technical contact for their IUR submission. The technical contact does not have to be a person 623 located at the manufacturing (including importing) site, but must be a person who can answer 624 questions EPA may have about the reported chemical substance. In the proposed rule, EPA had 625 stated that the technical contact should be a person located at the manufacturing (including 626 importing) site. EPA has decided, however, to n ot impose limitations on where the technical 627 contact can be located. Therefore, companies may use their discretion in selecting a technical 628 contact or multiple technical contacts, as provided by the new e

- IURweb software. Submitters 629 should consider, in sel ecting the technical contact, that EPA may have follow

- up questions about 630 an IUR submission, one or more years after the submission date. 631

3. Manufacturers (including importers) are required to submit the correct chemical 632 identity for each subject chemi cal substance. 633

a. Chemical name . EPA is requiring the reporting of the Chemical Abstracts ( CA) Index 634 Name currently used to list the chemical substance on the TSCA Inventory as the chemical name 635 reported for IUR. The reporting software will be directly linked to the nonconfidential portion of 636 the TSCA Inventory through the Agency‘s Substance Registry Services (SRS) database, which 637 lists all chemical substances on the TSCA Inventory. This link will enable submitters to select 638 the correct CA Index Name for their reportable chemical(s) from SRS. EPA believes that using 639 SRS to select the chemical name as currently listed on the TSCA Inventory will greatly reduce 640 the number of incorrectly identified chemical substances and allow the data to be released more 641
qu ickly to the public. See the discussion in unit 3.a. regarding identifying confidential chemical 642 substances. Manufacturers (including importers) are allowed to supply, as part of a joint 643 submission, an alternate chemical name, and in the case of importers, a trade name, in those 644 instances where a supplier will not disclose to the submitter the specific chemical name of the 645 imported TSCA Inventory chemical substance or a reactant used to manufacture the TSCA 646 Inventory chemical substance. In these cases, the manufacturer (including importer) and the 647 supplier may report the information required in this part in a joint submission. In order to clarify 648 this requirement, EPA is amending 40 CFR part 711.15(b)(3)(i), to state that the importer must 649 ask the supplier of the confidential chemical substance to directly provide EPA with the correct 650 chemical identity, in a joint submission with the manufacturer. Similarly, in the event a 651 manufacturer submitting a Form U cannot provide the whole chemical identity because the 652 reportable chemical substance is manufactured using a reactant having an unknown specific 653 chemical identity claimed as confidential by its supplier, the manufacturer must ask that the 654 supplier directly provide to EPA the correct chemical identity of t he confidential reactant in a 655 joint submission. Nothing in 40 CFR Part 711.15(b)(3)(i) relieves a manufacturer (including an 656 importer) of its obligation to report information that it actually knows or can reasonably 657 ascertain. See Unit III.10 for additio nal information regarding joint submissions. Detailed 658 instructions regarding joint submissions are included in the instructions manual included in the 659 docket (Ref. 5). 660*** Interagency EO 12866 Review Draft

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18 b. Chemical identifying number . As part of the chemical identity, submitters provide a 661 chemical identifying number associated with the correct CA Index Name, as described in Unit 662 II.E.7.c.i. EPA is requiring that submitters report only the CASRN as a chemical identifying 663 number, except in the case of confidential chemical substances. In the case of confidential 664 chemical substances, EPA is requiring that submitters report only the TSCA Accession Number 665 as a chemical identifying number. EPA is removing the Pre

- manufacture Notification (PMN) 666 number as an allowed chemical identifying number because each TSCA Inventory chemical 667 substance has either (or both) a CASRN or a TSCA Accession Number, which are likely to be 668 already known to the submitter. Submitters who, in the past, have reported using the PMN 669 number of a confidential substance can identify the TSCA Accession Number from SRS by 670 searching on the PMN number. Those submitters who are not able to identify the TSCA 671 Accession Number by searching SRS may contact EPA in writing, if necessary, to learn the 672 TSCA Accession Number assigned when the Notice of Commencement (NOC) was submitted to 673 the Agency. Specific information is included in the Instructions for Reporting manual. 674

c. Chemical identity for substances listed on the confidential portion of the TSCA 675 Inventory. In cases where a chemic al is listed on the confidential portion of the TSCA Inventory, 676 submitters are to report the chemical‘s Accession Number and generic name, which are listed on 677 the non

- confidential portion of the TSCA Inventory and are included in SRS. In order to 678 continue to protect the confidentiality of the underlying specific chemical identification 679 information (i.e., the CASRN and specific chemical name), the submitter must claim the 680 chemical identity as CBI and complete the upfront substantiation. Doing so will maint ain a 681 confidentiality claim for the underlying CASRN and specific chemical name on the confidential 682 portion of the TSCA Inventory (the Accession Number and generic chemical name remain non

683 confidential). Failure to identify the chemical identity as CBI an d complete the upfront 684 substantiation will waive any CBI claim to the chemical identity and will result in the transfer of 685 the chemical from the confidential portion of the TSCA Inventory to the non

- confidential, 686 publicly releasable, portion of the TSCA In ventory. 687 688 4. Production volume . Manufacturers (including importers) are required to report 689 production volume information for each chemical substance for which they submit an IUR 690 report. EPA has made a number of changes to the reporting of production volum e and associated 691 information. 692

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

. 693 EPA is requiring reporting of production volume for each year since the last IUR principal 694 reporting year. Thus, for the 2011submis sion period, manufacturers (including importers) of a 695 chemical at or above the 25,000 lb. threshold during the principal reporting year will report the 696 production volume of that chemical substance for each of the following calendar years: 2010, 697 2009, 2008, 2007, and 2006. Collecting the production volume for multiple years will provide 698 greater detail than the current once

- every

- reporting cycle snapshot. 699

For the principal reporting year, e.g., 2010, the domestic manufacture and the import 700 production volume will continue to be reported separately on the same report. EPA review and 701 analysis of the 2006 IUR data has revealed that some submitters are erroneously submitting 702 multiple reports for the same chemical substance, at times reporting the information ass ociated 703*** Interagency EO 12866 Review Draft

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19 with domestic manufacturing and importing in different reports. Submitters should complete 704 only one report for each chemical substance. 705

b. Volume of chemical substance used on

- site . EPA is requiring that submitters report the 706 volume of a manufact ured (including imported) chemical substance used at the reporting site. 707 The requirement to report the volume used on

- site is replacing the requirement to indicate that 708 the chemical substance is site

- limited. Under this final rule, either domestically ma nufactured or 709 imported chemical substances can be reported as used at the reporting site. 710

c. Indicate whether imported chemical substances are physically at reporting site . EPA is 711 adding a requirement to indicate whether an imported chemical substance is physically at the 712 reporting site. Often, the site reporting an imported chemical substance never physically 713 receives the chemical substance, but instead ships it directly to another location such as a 714 warehouse, a processing or use site, or a customer‘s s ite. 715

d. Report volume exported . EPA is adding a requirement to report the production volume 716 directly exported and not domestically processed or used. This will allow EPA to better identify 717 the proportion of the production volume accounted for by the pro cessing and use reporting, given 718 that such downstream reporting is not required for directly exported chemical substances. 719

5. Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, 720 or reused . In the proposed rule, EPA sought comment on adding a checkbox indicating whether 721 a manufactured chemical substance was recycled, remanufactured, reprocessed, reused, or 722 reworked. In response to the comments received, EPA has determined that the term ―reworked‖ 723 may be interpreted and appli ed too broadly to provide the type of information that EPA needs to 724 collect and has removed ―reworked‖ from the list of recycling synonyms, but has chosen to 725 otherwise finalize this reporting requirement as proposed. Consequently, EPA is adding a 726 requirem ent to indicate whether a manufactured chemical substance, such as a byproduct, is to be 727 recycled, remanufactured, reprocessed, or reused. Submitters should indicate whether their 728 manufactured chemical substance, which otherwise would be disposed of as a waste, is being 729 removed from the waste stream and has a commercial purpose (i.e., it is being recycled, 730 remanufactured, reprocessed, or reused). Indicating that a manufactured chemical, such as a 731 byproduct, is to be recycled, remanufactured, reprocessed, or reused does not affect the reporting 732 requirements associated with any chemical substance manufactured from the byproduct. See 733 Unit II.F.2. for detailed information on byproduct reporting. 734

6. Concentration ranges . EPA is eliminating gaps in the ranges u sed to report 735 concentration in 40 CFR 711.15(b)(3) and (4)). The ranges are now: 736

• Less than 1% by weight. 737

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

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

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

• At least 90% by weight. 741*** Interagency EO 12866 Review Draft

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20 7. Industrial processing and use information reporting . EPA is revising the list of 742 industrial function categories and replacing the NAICS codes with industrial sector categories, as 743 described in sections i. and ii. 744

a. Industrial function categori es . EPA is revising the list of industrial function categories 745 by combining categories that lead to common exposure scenarios and adding categories where 746 the Agency believes the existing categories do not adequately describe potential uses. EPA 747 worked wit h Environment Canada and Health Canada to develop the set of categories, which 748 will be used by both the United States and Canada for inventory reporting (Ref. 9). 749

EPA is adding eight new industrial function categories and deleting six existing 750 categories from the previous list; the total number of industrial function categories has increased 751 to 35. Also, EPA is renaming several of the industrial function categories to provide a more 752 informative description of the function of chemical substances that shoul d be reported in that 753 category. Lastly, EPA is requiring that if a submitter selects the category ―Other,‖ the submitter 754 must provide its own description of the industrial function of the chemical substance. EPA is 755 using the industrial function categorie s listed in Table 1 of this unit: 756

Table 1.

— Codes for Reporting Industrial Function Categories 757

Code Category U001 Abrasives U002 Adhesives and sealant chemicals U003 Adsorbents and absorbents U004 Agricultural chemicals (non

- pesticidal) U005 Anti

- adhes ive 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 (ope n 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 a gents U024 Process regulators U025 Processing aids, specific to petroleum production*** Interagency EO 12866 Review Draft

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21 U026 Processing aids, not otherwise listed U027 Propellants and blowing agents U028 Solids separation agents U029 Solvents (for cleaning or degreasing) U030 Solven ts (which become part of product formulation or mixture) U031 Surface active agents U032 Viscosity adjustors U033 Laboratory chemicals U034 Paint additives and coating additives not described by other

categories U999 Other (specify) 758 b. Industrial se ctors . EPA is replacing the 5

– digit NAICS codes with 48 IS codes (Ref. 759 10). The sectors were adapted from the European Union‘s (EU‘s) ―Guidance on Information 760 Requirements and Chemical Safety Assessment.‖ The IS codes divide the entire range of 761 NAICS cod es into sectors so that there is a sector corresponding to any NAICS code (see the 762 Instructions for Reporting ). The use of the sectors will reduce the number of unique 763 combinations, thereby increasing the usability of the data, and also reducing the IUR r eporting 764 burden. 765

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

Table 2.

— Industrial Sectors 767

Code Sector Description IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (exc ept Oil and Gas) and support activities IS4 Utilities IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Re lated 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 Ma nufacturing IS16 Industrial Gas Manufacturing IS17 Synthetic Dye and Pigment Manufacturing IS18 Carbon Black Manufacturing IS19 All Other Basic Inorganic Chemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Org anic Chemical Manufacturing*** Interagency EO 12866 Review Draft

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22 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 Resin s IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Non

- metallic Mineral Product Manufacturing (inc ludes clay, glass, cement,

concrete, lime, gypsum, and other non

- metallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manu facturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing IS46 Wholesale and Retail Trade IS47 Services IS48 Other (requires additional information) 768 When the category reported for the IS code is ―Other,‖ the submitter is required to 769 provide a written description of the use of the chemical substance, which may include the 770 NAICS code. 771

8. Consumer and commer cial use reporting. EPA is making four changes to the 772 consumer and commercial information required to be reported: 773

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

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

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

• Reporting the number of commercial workers reasonably likely to be exposed while 777 using the reported chemical substance. 778*** Interagency EO 12866 Review Draft

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23 Reporting associated with chi ldren‘s use, the maximum concentration, and the percent 779 production volume remains unchanged. 780

a. Consumer and commercial product categories . EPA is revising the list of consumer 781 and commercial product categories by combining categories that lead to common e xposure 782 scenarios and adding categories that were not adequately described in the initial set of categories. 783 EPA worked with Environment Canada and Health Canada to develop the categories. 784 Harmonized categories will facilitate consistent reporting of che mical substance use information 785 by industry in the United States and Canada (Ref. 9). 786

The list includes 33 product categories, including ―Other.‖ Examples of new categories 787 which have been added include explosive materials, building/construction products not covered 788 elsewhere, and air care products. The glass and ceramic products category had relatively few 789 IUR submissions in 2006 and overlaps with the new categories, and so has been eliminated. 790 Also, several of the consumer and commercial product categ ories have been renamed to better 791 describe the products that should be reported in those categories. In addition to revising the 792 overall product categories, narrower definitions and expanded lists of examples of products in 793 which the chemical substance wou ld be used will be added to each category descriptor. The 794 examples were selected to include items that could have fit into other categories in order to 795 address the overlap inherent in any product category list. The product categories were then 796 placed int o several broader groupings, e.g., ―Chemicals with Agriculture and Outdoor Uses‖ 797 based on the similarities of products. EPA believes that the user will find the current groupings 798 easier to use than the alphabetical listing used for the 2006 IUR. EPA is a lso requiring that if a 799 submitter chooses the product category ―Other,‖ the submitter must include a text description for 800 the consumer and commercial product containing the chemical substance. 801

EPA is using the consumer and commercial product categories listed in Table 3 of this 802 unit: 803

Table 3.

— Codes for Reporting Consumer and Commercial Product Categories 804

Code Category

Chemical Substances in Furnishing, Cleaning, Treatment Care Products C101 Floor Coverings C102 Foam Seating and Bedding Products C103 Furniture and Furnishings not covered elsewhere C104 Fabric, Textile, and Leather Products not covered elsewhere C105 Cleaning and Furnishing Care Products C106 Laundry and Dishwashing Products C107 Water Treatment Products C108 Personal Care Products C109 Air Care Products C110 Apparel and Footwear Care Products Chemical Substances in Construction, Paint, Electrical, and Metal Products C201 Adhesives and Sealants C202 Paints and Coatings*** Interagency EO 12866 Review Draft

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24 C203 Building/Construction Materials

- Wood and Engineered Wood Products C204 Building/Construc tion Materials not covered elsewhere C205 Electrical and Electronic Products C206 Metal Products not covered elsewhere C207 Batteries Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products C301 Food Packaging C302 Paper Products C303 Plastic and Rubber Products not covered elsewhere C304 Toys, Playground, and Spo rting Equipment C305 Arts, Crafts, and Hobby Materials C306 Ink, Toner, and Colorant Products C307 Photographic Supplies, Film, and Photochemicals Chemical Substances in Automotive, Fuel, A griculture, Outdoor Use Products C401 Automotive Care Products C402 Lubricants and Greases C403 Anti

- Freeze and De

- icing Products C404 Fuels and Related Products C405 Explosive Materials C406 Agricultural Products (non

- pesticidal) C407 Lawn and Garden Care Products Chemical Substances in Products not Described by Other Codes C980 Non

- TSCA Use C909 Other (specify) 805 b. Designation of consumer or commercial use . EPA is requiring submitters to designate, 806 via a checkbox, whether the indicated product category is a consumer or a commercial use, or 807 both. 808

c. Number of commercial workers reasonably likely to be exposed

. EPA is requiring that 809 submitters report the total number of commercial workers, including those at sites not under the 810 submitter‘s control, that are reasonably likely to be exposed while using the reportable chemical 811 substance, with respect to each commer cial use. The approximate number of workers should be 812 reported using the same definitions and ranges used for manufacturing and industrial processing 813 and use workers required by 40 CFR 711.15(b)(3)(vii) and (4)(i)(F), respectively. The ranges 814

are: 815

• Few er than 10 workers. 816

• At least 10 but fewer than 25 workers. 817

• At least 25 but fewer than 50 workers. 818

• At least 50 but fewer than 100 workers. 819

• At least 100 but fewer than 500 workers. 820*** Interagency EO 12866 Review Draft

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

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

• At least 10,000 workers. 823

H. What changes have been made to the standard for the reporting of processing and use 824 information? In order to collect more complete information regarding industrial processing and 825 use, and commercial and consumer use of chemicals, EPA is, in 40 CFR 711.15(b)(4), replacing 826 the ―readily obtainable‖ reporting standard used for reporting under 40 CFR 710.52(c)(4) with 827 the ―known to or reasonably ascertainable by‖ reporting standard set forth under TSCA sectio n 828 8(a)(2). This is the same standard that applied to the reporting of information described in the 829 regulations at 40 CFR 710.52(c)(1), (c)(2), and (c)(3) for the 2006 IUR submission, and this 830 standard continues to apply to the reporting of such informatio n under 40 CFR 711.15(b)(1), 831 (b)(2), and (b)(3). This standard covers all information in a person‘s possession or control, plus 832 all information that a reasonable person similarly situated might be expected to possess, control, 833 or know. EPA would like to clarify that submitters are not required to conduct customer surveys 834 under this standard, but to the extent that reasonable efforts to analyze or synthesize already

835 available customer surveys may inform processing and use information that is reported, the 836 information is generally ―reasonably ascertainable.‖ EPA‘s reporting software permits submitters 837 to enter ―NKRA‖ on Form U to address circumstances where the information is not known to or 838 reasonably ascertainable by the submitter. 839

I. What changes have b een made to requirements for making CBI claims ? EPA is making 840 several changes to the requirements for claiming information as confidential. Submitters may 841 claim certain information reported under the IUR as CBI in accordance with 40 CFR part 2 and 842 IUR rul es at 40 CFR 711.30. Claims of confidentiality may be made for chemical identity, site 843 identity, and processing and use information, and submitters must substantiate these claims at the 844 time information is submitted to EPA. EPA‘s procedures for handling information claimed as 845 confidential are set forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to 846 review confidentiality claims carefully to ensure that the information in question falls within the 847 parameters of TSCA section 14. EPA ca utions submitters that they may be subject to criminal 848 penalties under 18 U.S.C. § 1001 if they knowingly and willfully make a false statement in 849 connection with the assertion of a CBI claim. CBI claims should be limited to only those data 850 elements the re lease of which would likely cause substantial harm to the business‘ competitive 851 position. Interested persons are reminded that with regard to chemical substance use 852 information, EPA is interested in aggregated, general uses, not detailed uses associated w ith 853 specific customers. 854

To claim information as confidential, a submitter must indicate its claim by both 855 checking the appropriate box and signing the certification statement on the reporting form, and 856 may also be required (depending on the data element) to provide substantiation of the claim at 857 the time it is made. A submitter must indicate its claims at the time the information is submitted. 858 If a submitter fails to follow these procedures, EPA may release the information to the public 859 without further n otice to the submitter. By signing the certification statement the submitter 860 attests to the secrecy and value of the information for which confidentiality claims have been 861 asserted. 862*** Interagency EO 12866 Review Draft

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26 1. Chemical identity CBI claims . There is no substantive change to submi tters' ability to 863 make confidentiality claims for chemical identity in the IUR. As in the past, a submitter may 864 assert a claim of confidentiality for the identity of the reported chemical substance only when the 865 chemical is listed on the confidential port ion of the TSCA Inventory. Submitters who assert a 866 confidentiality claim for chemical identity must also provide substantiation for the claim at time 867 of filing. See 40 CFR 711.30(b). 868 869 However, in response to comment, this final rule incorporates some chang es to the 870 process that must be used to in making this type of CBI claim. The proposed rule, at 40 CFR 871 711.15(a)(3)(i), provided that ―[a] submitter under this part may use an EPA

- designated TSCA 872 Accession Number for a confidential chemical substance in li eu of a CASRN when a CASRN is 873 not known to or reasonably ascertainable by the submitter.‖ In the proposed rule, EPA also 874 noted that up to 5% of the reports submitted under the 2006 IUR contained chemical identity 875 problems. EPA therefore proposed to requi re that submitters report using the CA Index Name 876 currently used to list the chemical substance on the TSCA inventory. EPA further indicated that 877 it would incorporate CASRNs and CA Index Names into the e

- IURweb software, to the extent 878 possible without jeo pardizing confidentiality claims. EPA believes that selecting chemical 879 identity from a pre

- populated list, rather than keying in the chemical identity information, will 880 significantly improve the accuracy and consistency of submitted reports. 881 882 EPA received several comments from industry groups requesting that the e

- IURweb 883 software incorporate security safeguards to adequately protect CBI. In light of the security 884 concerns expressed in public comments, EPA has decided not to incorporate CASRNs and CA 885 Index Names for chemicals on the confidential portion of the TSCA Inventory into the portions 886 of the e

- IURweb software that will be publicly accessible. However, EPA still believes it is 887 important to require that all chemical identities be selected from a pre

- p opulated list, to avoid 888 repeating the chemical identity problems experienced with the 2006 IUR. Therefore, 40 CFR 889 711.15(a)(3)(i) has been revised in this final rule to require that submitters who wish to report 890 chemical substances listed on the confident ial portion of the TSCA Inventory use the chemical‘s 891 TSCA Accession Number and generic name. Requiring the use of accession numbers and 892 generic names will allow EPA to adequately protect confidential CASRNs and CA Index Names 893 (by omitting them from the pr e

- populated selection list) while still obtaining the improvements 894 in reporting accuracy it sought in the proposed rule. 895 896 In SRS, a submitter can readily find a cross

- reference list that displays the Accession 897 Number, generic chemical name, and the PMN cas e number (or for an initial Inventory 898 substance, the Inventory reporting form number) for any confidential chemical substance listed 899 on the Inventory. Submitters who wish to retain the CBI claim for the chemical substance 900 identified by the Accession number must assert and substantiate the claim at time of filing. 901 Submitters who do not wish to retain the CBI claim for the chemical substance identity, and who 902 wish the substance to be listed on the public portion of the TSCA Inventory, should not assert a 903 CBI claim or provide substantiation. Submitters who fail to follow the required procedures for 904 asserting CBI claims for chemical identity will waive the claims, and EPA may release the 905 information without further notice to the submitter. See the regulatory t ext at 40 CFR 711.30(e). 906 907*** Interagency EO 12866 Review Draft

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27 2. Upfront substantiation for processing and use information CBI claims . Under the IUR, 908 a submitter may assert a claim of confidentiality for data associated with the processing and use 909 of its chemical substance if the submitte r has reason to believe that release of the information 910 would reveal trade secrets, or confidential commercial or financial information, as provided by 911 TSCA section 14 and 40 CFR part 2. Under this final rule, EPA is requiring upfront 912 substantiation for C BI claims for processing and use information. 913

In order to submit a claim of confidentiality for processing and use information data 914 elements, the submitter is required (in addition to signing the certification statement) to both 915 check the appropriate box on the reporting form and substantiate the claim in writing, within the 916 reporting software, by answering certain questions provided in 40 CFR 711.30(d). EPA revised 917 the substantiation question at 40 CFR 711.30(d)(1)(ii), respecting competitive harm, to in clude 918 harmful effect ―to your customer‘s competitive position.‖ Where a submitter fails to submit 919 substantiation of the processing and use CBI claim in accordance with the applicable rules (i.e., 920 the submitter does not provide an answer to all the required questions associated with the claim 921 on the Form U it submits via e

- IURweb), EPA will consider the information not subject to a 922 confidentiality claim and may make the information available to the public without further notice 923 to the submitter. 924

3. Prohibiti on of confidentiality claims for data elements identified as “not known or 925 reasonably ascertainable.” EPA is prohibiting claims of confidentiality pertaining to the 926 designation that information is ―not known or reasonably ascertainable.‖ As described in Un it 927 II.A., for the 2011 and future IUR collections, submitters will be required to report processing 928 and use information to the extent that it is known to or reasonably ascertainable by them. 929

For the 2006 IUR collection, EPA observed that, on occasion, pr ocessing and use 930 information was claimed as confidential when a submitter determined that the information was 931 not readily obtainable. Section 14 of TSCA limits the disclosure of information entitled to 932 confidential treatment under Exemption 4 of the Freedo m of Information Act (FOIA). EPA has 933 considered the NKRA designation and its relationship to a potential CBI or trade secret claim. 934 Given that a NKRA assertion is an assertion that no information is available, the Agency does 935 not believe that the designa tion conveys trade secret or confidential commercial or financial 936 information. 937

J. What changes specifically affect importers? 938

1. Importer site address. Submitters report IUR data on chemical substances that they 939 manufacture domestically and that they im port into the United States. Previously, the 940 regulations defining the site for importer reporting were found in both the definition for site in 40 941 CFR 710.3 and in paragraph 40 CFR 710.48(b). EPA is eliminating unnecessary duplication in 942 the IUR regulati on by moving the additional information regarding the importer site from 40 943 CFR 710.48(b) into a revised definition for site at 40 CFR 711.3, as described in Unit II.F.3.b., 944 and eliminating 40 CFR 710.48(b). 945

In addition, EPA has observed that submitters occasionally use a foreign address as the 946 site address for the importer. EPA now is requiring that submitters report a U.S. site address, by 947 modifying the definition for site to state specifically that the site must be a U.S. site. The U.S. 948*** Interagency EO 12866 Review Draft

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28 address of an agent acting on behalf of the importer, and authorized to accept service of process 949 for the importer, may be reported as the importer‘s site address if the operating unit that is 950 directly responsible for importing the chemical substance and that controls the import transaction 951 has no U.S. address. The Agency expects that all importers will have a U.S. site, as defined in 952 the 40 CFR 711.3 definition for site, because, under Customs regulations at 19 CFR 141.18, a 953

non

- resident corporation is not permitted t o enter merchandise for consumption unless it has a 954 resident agent in the State where the port of entry is located, who is authorized to accept service 955 of process against the corporation. 956

2. Joint submissions. For purposes of IUR, submitters are allowed to report the IUR 957 information jointly with the foreign supplier of a reportable chemical substance whose chemical 958 identity is unknown to the importer. Previously, joint submissions could not be made 959 electronically. EPA is now requiring that submitters use CD X and e

- IURweb for preparation and 960 submission of joint submissions. See 40 CFR 711.15(b)(3)(i)(C). Therefore, the authorized 961 officials of the jointly submitting companies will need to register with CDX in order to submit a 962 joint report to EPA. 963

Importers may not know the specific chemical identity of a chemical substance because 964 the foreign supplier chooses to keep it confidential. In such a situation, the importer must use e

965 IURweb to ask the foreign supplier to submit the chemical identity information d irectly to EPA 966 through a joint report. To submit a joint report, the importer completes the majority of the 967 required information, and supplies a trade name or other designation to identify the chemical 968 substance, and provides contact information for the f oreign supplier. The importer then uses e

969 IURweb to contact the foreign supplier and request that the foreign supplier report the specific 970 chemical identity information directly to EPA. The importer must submit a copy of such request 971 to EPA, along with th e rest of its IUR submission for the chemical substance. As a general 972 matter, EPA expects that importers will supply the information described at 40 CFR 973 711.15(b)(3)(i)(A), rather than an ―NKRA‖ designation, when importers do not know the 974 confidential che mical identity of a chemical substance they import. EPA believes that an NKRA 975 designation would generally only be appropriate in the unlikely event that an importer did not 976 know, and could not reasonably ascertain, the information needed to link its submi ssion with a 977 secondary report from the supplier. 978

In an acceptable joint submission, the secondary submitter supplies the chemical identity, 979 as well as its technical contact and company information, and provides the primary submitter‘s 980 site information. EP A will not accept joint submissions that are not submitted electronically 981 using e

- IURweb and CDX. All information will be saved by the reporting software and both 982 submissions will be matched based upon company and chemical information. Once the forms are 983 linked, EPA will process the joint submission as one report for the reported chemical substance. 984 See the guidance manual, available on EPA‘s website at www.epa.gov/iur , for detailed 985 instructions on submitting a joint r eport. 986

IV. What clarifications have been made to reporting requirements? 987

1. Clarification of the Relationship Between Company Name and Site Identity CBI 988 Claims. Under the IUR, submitters are able to separately claim as CBI the company name and 989 site ident ity associated with a chemical substance for which they are reporting under the IUR. 990*** Interagency EO 12866 Review Draft

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29 The submitter is required to provide an upfront substantiation for CBI claims for the site identity. 991 EPA believes there is some confusion as to what is considered confid ential when such claims are 992 made, and is taking this opportunity to provide clarification. 993

The CBI claim protects the link between the company and/or site identity and the 994 particular chemical substance. If the company or site identity associated with a par ticular 995 chemical substance is not claimed as CBI, EPA may make that information available to the 996 public without further notice to the submitter. EPA will not impute the existence of a CBI claim 997 for company identity or for site identity from a CBI claim as sociated with a different chemical 998 substance. 999

Company and site identity CBI claims are separate claims, and in some cases one type of 1000 claim may be justified while the other is not. Therefore, a submitter is permitted to assert its CBI 1001 claim for the compa ny identity, the site identity, or both the company and site identity. Such 1002 claims must be made for each chemical substance for which such claims are being made. 1003 Because the circumstances for each chemical substance can vary, the IUR rule does not allow for 1004 blanket claims covering all chemicals in a site‘s IUR report. 1005

Likewise, the submitter must provide separately the required upfront substantiation for 1006 the site identity CBI claims associated with each chemical substance. For instance, if the 1007 submitte r is reporting for five chemical substances and wishes to claim its site information 1008 confidential for three of the five chemical substances, it must assert the claim and provide 1009 separate upfront substantiation three times, once for each of the three chemic al substances. 1010

EPA has also observed that submitters sometimes claim only their company identity, and 1011 not their site identity, as confidential. If the site identity for a particular chemical substance is 1012 not claimed as CBI, or is claimed but not substa ntiated pursuant to 40 CFR 711.30(c), EPA may 1013 make that information available to the public without further notice to the submitter. EPA will 1014 not impute the existence of a CBI claim for site identity from a CBI claim for company identity, 1015 even if the comp any name appears within the site identity information. To help ensure that 1016 submitters consider this issue, the e

- IURweb reporting software provides a warning whenever 1017 the company identity is claimed as CBI for a particular chemical substance and the site identity is 1018 not also claimed as CBI for that chemical substance. 1019

2. Explanation of Byproduct Reporting. During the 2006 submission period, EPA 1020 received questions about the requirements for reporting byproducts. The questions included 1021 whether byproduct m anufacturers (including importers) were required to report the byproducts 1022 under the IUR rule. Based on those and subsequent inquiries, and from the public comments 1023 from the proposed rule, it is apparent that scope of the IUR obligation to report byproduct s is not 1024 well understood by industry. The scope of byproduct reporting has become a particularly 1025 pertinent issue because (by the terms of the 2003 Amendments to the IUR) inorganic chemicals 1026 are now no longer exempt from reporting under IUR, including (beg inning with the 2011 IUR) 1027 the information collection requirements for processing and use information. Inorganic chemicals 1028 are often recycled, thereby triggering the need to report a byproduct substance that is recycled. 1029 In an effort to further clarify re porting obligations, EPA is providing additional information on 1030 byproduct reporting, including circumstances under which reporting is not required, in the 1031 instruction manual and in other guidance materials included in the docket for this final rule 1032*** Interagency EO 12866 Review Draft

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30 (Refs. 5, 11, and 12) and on EPA‘s website at www.epa.gov/iur

. For purposes of IUR, a 1033 byproduct is a chemical substance produced without a separate commercial intent during the 1034 manufacture, processing, use or disposal of an other chemical substance or mixture (40 CFR 1035 704.3). Thus, for example, when a chemical substance or mixture is used for the purpose of 1036 manufacturing an article, and that manufacture results in the production of a different chemical 1037 substance, that differe nt chemical substance is a byproduct for purposes of the IUR. Chemical 1038 substances that are byproducts of the manufacture, processing, use, or disposal of another 1039 chemical substance or mixture, like any other manufactured chemical substances, are subject t o 1040 IUR reporting if they are listed in the TSCA Inventory, are not otherwise excluded from 1041 reporting, and their manufacturer is not specifically exempted from IUR reporting requirements. 1042

The 40 CFR 704.3 definition of manufacture for commercial purposes st ates that 1043 ―[m]anufacture for commercial purposes also applies to substances that are produced 1044 coincidentally during the manufacture, processing, use, or disposal of another substance or 1045 mixture, including both byproducts that are separated from that other substance or mixture and 1046 impurities that remain in that substance or mixture. Such byproducts and impurities may, or may 1047 not, in themselves have commercial value. They are nonetheless produced for the purpose of 1048 obtaining a commercial advantage since they are part of the manufacture of a chemical product 1049 for a commercial purpose.‖ Thus, byproducts of the manufacture, processing, use, or disposal of 1050 another chemical substance or mixture for a commercial purpose are themselves both 1051 ―manufactured‖ and ―manufa ctured for commercial purposes.‖ Also, considering the overall 1052 context of this definition, EPA interprets ―chemical product‖ broadly to include any product of 1053 the manufacturing, processing, use, or disposal of another chemical substance or mixture, other 1054 than a byproduct. 1055

1056

Byproducts that are manufactured (including imported) in volumes of 25,000 lb. or more 1057 at a single site are potentially subject to IUR requirements. However, 40 CFR 711.10(c) 1058 excludes from reporting those chemical substances meeting th e requirements of 40 CFR 1059 720.30(g) or (h). Manufacturers (including importers) of byproducts are not required to report 1060 the manufacture (including import) of a byproduct if the byproduct is not used for commercial 1061 purposes. See 40 CFR 720.30(h)(2). Thus, even where a byproduct is manufactured (including 1062 imported) for a commercial purpose, if the byproduct is not subsequently put to use for another 1063 commercial purpose, the byproduct is excluded from IUR reporting. Furthermore, if the 1064 byproduct‘s ―only comm ercial purpose is for use by public or private organizations that: (1) burn 1065 it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract 1066 component chemical substances from it for commercial purposes,‖ 40 CFR 720 .30(g), that 1067 byproduct is also excluded from IUR reporting. This exclusion applies only to the byproduct; it 1068 does not apply to the component chemical substances extracted from the byproduct. 1069

Some manufacturers (including importers) of byproducts have exp ressed a belief that a 1070 chemical substance that is regulated by another EPA program, such as under the Resource 1071 Conservation and Recovery Act (RCRA), or that is exempt from certain requirements by the 1072 other program based on certain treatments or disposals, should not be required to be reported for 1073 IUR purposes. However, under this rule, when such chemical substances have a commercial 1074 purpose not exempted by 40 CFR 720.30(g), the manufacturer (including importer) of such a 1075*** Interagency EO 12866 Review Draft

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31 chemical substance may have IUR rep orting obligations, and is not relieved of those obligations 1076 based on exemptions under other laws. 1077

V. Public Comments 1078 EPA carefully considered the comments it received on the proposed IUR modifications. 1079 Major comments are discussed below. Additional commen t summaries and more detailed 1080 responses, including responses to most of the additional issues that EPA requested comment on, 1081 are contained in the  ̳ ̳Summary of EPA‘s Responses to Public Comments Submitted in Response 1082 to Proposed TSCA Inventory Update Report ing Modifications‘‘ (Ref. 13). 1083 1084 A. General Comments 1085 1086 1 . Justification for Proposed Modifications. Several commenters supported many of 1087 EPA‘s proposed reporting changes, stating that the changes will facilitate EPA‘s ability to track 1088 chemicals used and made i n the United States, which would strengthen EPA‘s ability to identify 1089 chemicals for further assessment. They also noted that the IUR data not only supports activities 1090 under EPA authorities, but is also used by other Federal agencies, the states, and other interested 1091 stakeholders to identify potential chemicals of concern. Other commenters expressed the view 1092 that EPA has not provided adequate justification supporting the Agency‘s need for the IUR data 1093 and has not sufficiently tailored the requested informa tion to meet EPA‘s goals. One commenter 1094 did not agree that the modifications will increase the ―usability of collected information‖ or 1095 ―focus reporting‖ on what is ―most needed‖ by EPA. Another commenter mentioned that the 1096 Agency does not explain how the e xisting IUR fails to meet these goals or why an IUR 1097 expansion is needed to carry out its Congressionally

- mandated TSCA duties. Additionally, 1098 commenters suggested that EPA should clearly indicate how the IUR data will be utilized in 1099 programs that systematic ally review hazard and exposure of existing chemicals. 1100 1101 EPA has an obligation under TSCA to protect human health and the environment from 1102 unreasonable risks associated with chemicals under its jurisdiction. EPA is amending the IUR 1103 rule to improve and enha nce data reporting requirements under IUR reporting beyond that 1104 required during the 2006 reporting cycle. There were problems associated with many 2006 IUR 1105 data submissions that severely limited EPA‘s ability to screen chemicals for exposure and risks 1106 and to make data available to the public. These problems included the fact that many 1107 submissions were incomplete or improperly completed, contained invalid chemical identities, 1108 and/or inappropriately or incorrectly claimed certain data elements as CBI. EPA a nticipates that 1109 today‘s amendments will (1) ensure the required information is properly reported and that the 1110 information in the Agency‘s database reflects the information provided in the IUR reports; (2) 1111 increase the usability of the collected information ; (3) increase the availability of information for 1112 the public; and (4) focus reporting on information that is most needed by the Agency. 1113 Additionally, EPA believes that the modifications to the rule will supply manufacturing and 1114 processing and use informat ion the Agency did not previously possess and should be accurate 1115 and reliable enough to develop screening level assessments. 1116 1117 Data collected under the IUR will be used in a wide variety of programs fundamental to 1118 fulfilling the Agency‘s TSCA statutory man date. EPA believes that the IUR data is the most 1119 basic data set that will give EPA and the public an understanding of the volume of chemicals 1120 produced or imported into the United States, how the chemicals are or may be used, and the 1121*** Interagency EO 12866 Review Draft

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32 types of exposures (o ccupational, consumer, environmental, etc.) potentially associated with the 1122 chemicals. Many chemicals are exempted from reporting under the IUR rule, which further 1123 tailors IUR requirements to EPA‘s information needs. Data about production volume, 1124
exposur es, and/or environmental releases are required to make some of the findings necessary to 1125 require testing under section 4, and helps EPA to prioritize chemicals for further data gathering 1126 or risk management action. The Agency‘s Existing Chemicals program w ill use the IUR data to 1127 assess whether the Agency needs additional data about the hazards or exposures to a particular 1128 chemical under sections 4 or 8 of TSCA, and may use IUR data to inform risk management 1129 actions such as those identified in TSCA Sections 5 and 6. EPA‘s extensive use of the 2006 IUR 1130 data in the Agency‘s Existing Chemicals Program is consistent with how EPA envisioned the 1131 data would be used when the 2003 Amendments were promulgated. For example, in 2007, the 1132 Agency began to develop and pos t screening

- level hazard, exposure, and risk characterizations 1133 for HPV chemicals, which are those chemicals produced nationally at aggregated volumes of one 1134 million lb. or more per year. In developing these characterizations, EPA identified areas where 1135 th e IUR data could be improved and enhanced. The amendments in today‘s final rule will allow 1136 EPA to better identify and take follow

- up action on chemical substances that may pose potential 1137 risks to human health or the environment. More detailed discussions are in the Responses to 1138 Comments document (Ref. 13). 1139 1140 2 . Transitioning to 2011. Commenters stated the new requirements are overly 1141 burdensome and unrealistic considering the time constraints. Another commenter stated there 1142 would be insufficient time for c ollecting and verifying data, conducting quality checks, or 1143 completing the necessary paperwork for the report. Many commenters suggested that EPA 1144 should extend the IUR submission deadline by several months and make the changes that are 1145 finalized effective in the next reporting period. 1146 1147 EPA disagrees that transitioning into the new 2011 requirements is overly burdensome 1148 and unrealistic. EPA believes that the four month submission period provides sufficient time to 1149 collect and submit the required data, and t hat steps taken by the Agency provided the opportunity 1150 for companies to gain an understanding of the submission process and to prepare their internal 1151 electronic systems as needed. For example, EPA was asked by several companies and trade 1152 organizations to provide an overview of the reporting software. Acknowledging that companies 1153 were concerned about the time needed to develop their internal databases to collect the required 1154 information, on November 30, 2010, the Agency held an informational workshop and we binar to 1155 help companies develop a better understanding of the CDX registration process and the e

1156 IURweb electronic reporting tool

. A recording of the workshop and a summary of the questions 1157 and answers is available on the IUR website ( www.epa.gov/iur ). EPA used stakeholders‘ 1158 comments from the workshop and additional comments obtained during the tool‘s beta

- test to 1159 help ensure the tool would address the needs of the submitters. The Agency plans to conduct a 1160 training webinar shortly after the publication of this final rule to provide detailed instructions on 1161 the reporting requirements and on using the reporting software, e

- IURweb, to complete and 1162 submit Form U. Finally, to the extent that the timing of the next submis sion period actually 1163 presents a substantial obstacle to the submission of any particular data element, notwithstanding 1164 EPA‘s efforts to familiarize submitters with the draft and final reporting software, and EPA‘s 1165 post

- promulgation efforts to familiarize s ubmitters with the reporting requirements, the IUR 1166*** Interagency EO 12866 Review Draft

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33 reporting standard of ―known to or reasonably ascertainable‖ addresses such circumstances 1167 without the need for a delay in implementation (see Unit V.E.1.). 1168 1169 One commenter suggested that EPA continue un der the old IUR rule for this submission 1170 period. The Agency does not agree that it should revert to the existing 2006 IUR rule because the 1171 enhancements addressed in the proposal will significantly increase the amount of exposure 1172 information available to th e public and Agency. The new and updated information collected 1173 under this final rule will increase the Agency‘s ability to understand exposure concerns. EPA 1174 will be better able to identify steps needed to manage risks associated with chemical substances. 1175 I n addition, requiring the use of electronic reporting will help ensure that data are available in a 1176 timely manner and it will reduce data entry errors, thereby increasing the usability and reliability 1177 of the data for EPA and other federal agencies as well as help fulfill the Administrator‘s 1178 commitment to increase public access to information on chemicals. 1179 1180 3 . EPA’s use of IUR data. The Agency received comments related to how IUR data can 1181 best be used to assist in assessing, prioritizing, and taking action on chemicals that pose 1182 unreasonable risks. Commenters stated that the current IUR was sufficient for EPA to use as a 1183 screening tool for the prioritization of chemicals in commerce, and that EPA should use the 1184 Agency‘s wide variety of regulatory tools and authorities to collect more detailed information. 1185 Commenters also expressed interest in providing input on using the IUR and the Agency‘s 1186 prioritization process. 1187 1188 EPA disagrees that the current IUR is sufficient for its purposes. B etween August 2007 1189

a nd mid

- 2009, EPA developed screening

- level hazard, exposure, and risk characterizations for 1190 some chemicals produced or imported in quantities of 25,000 pounds or greater a year. Based on 1191 those characterizations, EPA developed either a risk

- based prioritiza tion (RBP) or a hazard

1192 based prioritization (HBP) for individual chemicals or a group of chemicals that were similar in 1193 some way, e.g., structure, properties, toxicity. Those prioritizations did not constitute definitive 1194 determinations regarding hazard, r isk, or the sufficiency of available information for any 1195 regulatory purpose, but were rather initial evaluations of data and understanding currently 1196 available to EPA. EPA‘s experience using the IUR information to develop the prioritizations 1197 was that the 2 006 IUR data were not sufficient to provide the needed exposure

- related 1198 information. When EPA was developing RBPs for its HPV chemicals, it needed both hazard and 1199 exposure screening

- level information. Lacking sufficient exposure information, EPA found it 1200 necessary in many cases to make assumptions about exposure and the resulting prioritization 1201 decision was primarily hazard

- based, as opposed to risk

- based, as evidenced by statements in 1202 many of the RBP as well as HBP documents that EPA developed (available at 1203 http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML) that further 1204 information on exposure was needed to confirm the prioritization. Thus the exposure 1205 information provided in the 2006 IUR reporting did not provide EPA with sufficient information 1206 to prioritize chemicals for which it generally possessed a base set of hazard data. Therefore, for 1207 some of the RBPs the next steps indicated that additional exposure information would be 1208 necessary to validate the prioritizations before deter mining whether any further action was 1209 needed. In developing these characterizations, EPA identified areas where the IUR data 1210 collection should be improved and enhanced. These improvements, which are reflected in the 1211 modifications to the reporting require ments in the current rule, will allow EPA to better prioritize 1212*** Interagency EO 12866 Review Draft

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34 chemicals for further assessment as well as make appropriate risk management decisions for 1213 follow

- up action on chemical substances that may pose potential risks to human health or the 1214 environme nt. 1215 1216 EPA is considering using other regulatory tools and authorities to collect more in

- depth 1217 information, but believes the IUR is the correct mechanism for the data collection finalized in 1218 this notice. EPA also is considering ways to obtain public input on its use of the IUR data and its 1219 chemical prioritization process, as suggested by the commenters. 1220 1221 4. Canada’s prioritization approach. Some commenters recommended that EPA adopt 1222 Canada‘s prioritization approach. EPA assumes that the commenters were ref erring to the 1223 Domestic Substances List Categorization that Canada completed in 2006. The DSL 1224 Categorization was a statutorily mandated risk

- based prioritization which required review of 1225 both hazard and exposure information for 23,000 chemicals in a very s hort period of time. 1226 Health Canada was required to identify chemicals presenting human health hazards as well as the 1227 greatest potential for exposure to Canadians. Even though categorization was a legally mandated 1228 process with a deadline for consideration of all chemicals on the DSL, Health Canada felt that 1229 production volume alone was not a sufficient surrogate for exposure and developed a complex 1230 process for the exposure portion that required extensive literature review, input of information 1231 from industry , and used some of the types of data that EPA is requesting for the 2011 IUR 1232 reporting period ( Ref. 14 ). 1233 1234 Based on its review of hazard and IUR data collected on HPV and medium production 1235 volume (MPV) chemicals, EPA also believes that using large producti on volume as the sole 1236 surrogate for exposure is not sufficient to identify chemicals of highest concern. Some of the 1237 risk

- based prioritizations of HPV chemicals resulted in low priority decisions for the HPV 1238 chemicals that were low hazard, used in closed systems and consumed as intermediates. On the 1239 other hand, some of the MPV chemicals were identified as potentially high or medium priority, 1240 because they had high or medium hazard and would present high or medium risk concerns if they 1241 had widespread exposu re or dispersive uses. The only way for the Agency to move from 1242 prioritizations based primarily on hazard to truly risk

- based prioritization is for it to receive 1243 regularly updated information on exposure and use for chemical substances being made and used 1244 in the United States. The chemical manufacturing industry has indicated in several ways, 1245 including in comments on the proposed rule, that it supports risk

- based as opposed to hazard

1246 based prioritization. A commenter also noted that industry strongly sup ports risk

- based 1247 decisions and for that reason needs to provide robust production, processing and use data. 1248 1249 B. Comments on Electronic Reporting 1250 1251 EPA received various comments on the proposed requirement to use the reporting 1252 software, e

- IURweb, to submit all IUR submissions. In general, comments were submitted on the 1253 reporting software, phasing

- in electronic reporting registering with CDX, and electronic 1254 signatures. See Section B. in the Responses to Comments document (Ref. 13) for further 1255 discussion on electronic reporting. 1256 1257*** Interagency EO 12866 Review Draft

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35 1. Comments on the reporting software and phasing

- in electronic reporting. In general, 1258 commenters supported electronic reporting. Some commenters suggested that the Agency 1259 develop a phased

- in process for electronic reporting, in order to provide more time for 1260 companies to become familiar with the new format and to develop their own data systems. Some 1261 commenters wanted to be able to upload data via an XML file into the web

- based tool. The 1262 requirement to use electronic submissions over the internet was a concern for some commenters. 1263 1264 EPA, based on its experience collecting and managing the 2006 IUR reports, has 1265 concluded that mandatory electronic reporting is a critical next step for collection of the 2011 1266 data. Optional electroni c reporting for the 2006 IUR provided the Agency with experience 1267 relating to both industry and Agency needs, and the Agency has applied this experience in the 1268 course of developing of the 2011 electronic reporting tool (e

- IURweb). For example, t he use of 1269

a web

- based solution for the 2011 IUR will eliminate many of the software compatibility and 1270 firewall setting issues that were encountered during the 2006 submission period. In addition, the 1271 2011 e

- IURweb utilizes other Agency systems, such as SRS, enabling the submitter to readily 1272 select the chemical identity in the correct format, thereby eliminating problems relating to the 1273 previous need to type or write in the chemical name. With these enhancements, EPA believes 1274 the use of e

- IURweb will substantially re duce error rates and burden; consequently, EPA does 1275 not believe it is necessary to have another optional electronic reporting period. 1276 1277 In addition, the Agency‘s CDX service is increasingly being used by a variety of 1278 programs, as the Agency moves toward com prehensive electronic reporting. EPA is continually 1279 looking for ways to improve CDX, to better address submitter and Agency needs. For example, 1280 the EPA has developed an eTSCA registration for CDX which, when fully implemented, will 1281 eliminate the need to register separately for eIUR and ePMN. For the 2011 eIUR, ePMN 1282 registrations using the current eTSCA are acceptable eIUR registrations. 1283 1284 The Agency believes that commenters‘ concerns regarding mandatory use of the new 1285 electronic reporting tool reflect a lack of understanding of the tool‘s capabilities and 1286 enhancements. The reporting tool provides the ability to submit data in an XML format and 1287 includes enhancements to CDX that are designed to allow for multi

- user capabilities and 1288 otherwise facilitate ele ctronic reporting. EPA has provided training opportunities and guidance 1289 materials to facilitate electronic reporting, as well as product testing opportunities, to alleviate 1290 particular commenters‘ concerns. 1291 1292 For example, the Agency held an informational wo rkshop and webinar in November 1293 2010. The workshop was designed help companies develop a better understanding of the CDX 1294 registration process and the e

- IURweb electronic reporting tool. In early January, 2011, EPA 1295 provided a draft XML schema, allowing com panies to ensure their internal systems will be able 1296 to directly upload data to the e

- IURweb. In addition, EPA invited several companies to test e

1297 IURweb. EPA invited each company to identify areas where it believed the reporting tool could 1298 be improved. A recording of the workshop, summary questions and answers, the final schema, 1299 and additional webinar training that provides detailed instructions of using the reporting tool are 1300 available on the IUR website, www.epa. gov/IUR . In 2011, EPA intends to hold further training 1301 and outreach sessions at which industry representatives may express remaining questions and 1302 concerns regarding the operation of e

- IURweb software, which EPA will address. 1303*** Interagency EO 12866 Review Draft

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36 1304 Electronic reporting was fi rst offered as an option for the 2006 IUR. As explained in the 1305 preamble to the proposed rule and the Responses to Comments document, there were many 1306 problems, errors, and delays associated with paper submissions of the 2006 IUR data, which 1307 make the contin ued use of paper reporting highly inefficient and therefore undesirable. In light 1308 of the substantial disadvantages associated with allowing paper submissions, and the reporting 1309 tool improvements and training opportunities outlined in this unit (and explai ned in greater detail 1310 in the proposed rule and the Responses to Comments document) EPA does not believe it is 1311 reasonable to phase in electronic reporting over another reporting period and is confident that 1312 submitters will be able to successfully use the e

- IURweb tool to electronically report under the 1313 IUR rule in 2011. 1314 1315 2. Comments on registering with CDX and providing electronic signatures. Commenters 1316 thought the modified Electronic Signature Authority Form, in particular the need for multiple 1317 notarized signatures, was burdensome and unnecessary. Commenters stated that there should be 1318 more than one individual with an electronic signature and that multiple persons may need to be 1319 able to input and submit IUR data for a company‘s U.S. sites. The commenters noted that the 1320 actual preparer/drafter would rarely be the signatory. Another respondent noted that companies 1321 should be allowed, but not required, to have the same authorized official for the PMN and IUR 1322 submission. 1323 1324 As with PMN electronic submissions, m ultiple people from the same site or company are 1325 able to register with CDX and participate in completing the site‘s Form U. Although one 1326 individual will be designated as an authorized official who will sign and submit the completed 1327 Form U, the e

- IURweb to ol allows for more than one individual to edit a submission. 1328 Ultimately, EPA‘s goal is to provide one electronic signature agreement across all TSCA 1329 programs and is exploring the reuse of e

- signatures issued under the e

- PMN program as well as 1330 other EPA pr ograms. Regarding notarized signatures, EPA has determined that requiring a 1331 notarized signature as part of the electronic signature agreement is no longer necessary. 1332 1333 C. Comments on Reporting Thresholds 1334 1335 1. Method for determining whether you must report

. EPA proposed to modify the method 1336 used to determine whether a person is subject to IUR reporting. The new method requires 1337 persons to report under the IUR if they manufactured (including imported) 25,000 lb. or more of 1338 a chemical substance at any single s ite in any calendar year since the last principal reporting 1339 year, (note: there is no production volume threshold for certain chemicals, see 40 CFR 711.8(b)). 1340 This method becomes effective after the 2011 IUR submission period. 1341 1342 Several commenters believed the change is appropriate and should be implemented for 1343 the 2015 reporting cycle. They noted that the new requirement is essential to effectively capture 1344 the substantial year

- to

– year fluctuation in production/import volumes that was missed in past 1345 IUR rep orting cycles, thereby skewing the picture of how many and which chemicals are 1346 actually in commerce at a given time and what levels of production or import. One commenter 1347 went further to say that the modification would eliminate gaps and uncertainties in t he 1348 information collected under the current IUR that result from infrequent collections and reporting 1349*** Interagency EO 12866 Review Draft

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37 of data. Another said that this will keep manufacturers from disguising their actual output by 1350 producing certain specialty chemicals only in years that are not currently subject to IUR 1351 reporting. Two commenters supported the change but opposed the proposal to delay 1352 implementation until the 2015 reporting cycle, because it further delay the ability to obtain 1353 accurate annual production information. 1354 1355 In contras t, others had mixed opinions or did not think the change was needed. Some 1356 commenters felt that unless the value of collecting and analyzing retroactive data could be 1357 clearly demonstrated such that the resource for the Agency and regulatory community can be 1358 justified, EPA should retain the single reporting year and current threshold. Some commenters 1359 stated that EPA had not shown special utility for the information generated. Another commenter 1360 believes that there is no significant incremental benefit to requi re reporting from companies that 1361 produce or import less than 25,000 lb. of a reportable chemical substance for four out of five 1362
years. 1363 1364 The Agency realizes that the new multi

- year consideration of production volume will 1365 increase reporting burden on indust ry, but believes that there is sufficient evidence that wide 1366 fluctuations in production volumes from year to year indicate the past IUR reporting was not 1367 accurately characterizing the chemical production. As EPA noted in the proposed rule preamble, 1368 product ion volumes of chemical substances vacillating above and below reporting thresholds in 1369 different IUR reporting periods resulted in a change of approximately 30% in the composition of 1370 the chemicals being reported from one IUR reporting period to the next. For example, EPA 1371 prepared a prioritization document for the Butenedioic Acid Dialkyl Esters Cluster, which 1372 consists of 10 butenedioic acid dialkyl esters, seven of which were MPVs and three HPVs in 1373 2006 (Ref. 15 ). Three of the chemicals have had fluctuati ng production volumes above and 1374 below one million pounds. In 1990 and 1994 when the HPV Challenge program was being 1375 developed, the CASRNs 68921

- 51

- 7, 141

- 05

- 9, and 624

- 48

- 6 had production volumes below 1376 one million pounds and so were not included in the H PV Challenge for completion of SIDS 1377 datasets. In 1998 and 2006, CASRN 68921

- 51

- 7‘s production volumes have been above one 1378 million pounds, making it an HPV in those years. In 2002, CASRNs 141

- 05

- 9 and 624

- 48

- 6 had 1379 production volumes above one million poun ds. In part because of their fluctuating production 1380 volumes, neither SIDS datasets nor consistent exposure and use information were available for 1381 these chemicals and so they were included in a cluster for an HBP as opposed to an RBP. One 1382 commenter also su bmitted an analysis of the degree of fluctuation of chemicals and production 1383 volumes in the 2002 and 2006 IUR reporting years. This analysis found that about 32% of the 1384 organic chemicals reported in 2002, including 400 HPVs, were not reported for 2006 and that 1385 about 26% of the chemicals reported in 2006, including more than 200 organic HPVs, were not 1386 reported in 2002. 1387 1388 In addition, in comments submitted to the Agency in response to other programs, industry 1389 representatives expressed concern that short repor ting determination periods would drastically 1390 misrepresent the chemical substances that currently are in commerce. They stated they 1391 manufactured or imported some chemical substances only occasionally, and that these chemical 1392 substances would not be capture d if the reporting covered too short a period. The proposed rule 1393 preamble provides a more detailed discussion of these comments (see 75 FR 49664). 1394 1395*** Interagency EO 12866 Review Draft

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38 EPA believes that most sites will be able to gather production volume information 1396 without a substantial ef fort. In many instances, production volumes for recent past years are 1397 tracked under standard business practices. For example, EPA believes it is standard business 1398 practice for a company to furnish records of recent operations in the case of a proposed s ale or 1399 merger, and that companies therefore typically retain such records so as to be prepared for such 1400 eventualities. EPA also notes that in the case that prior years‘ production volume information is 1401 not known to or reasonably ascertainable by the submi tter (EPA expects that such cases would 1402 be extremely rare), those data would not be subject to reporting under the IUR and therefore 1403 would not trigger an obligation to report Furthermore, persons who have submitted a PMN to 1404 the Agency‘s New Chemicals prog ram are required to maintain records of production volume for 1405 the first 3 years of production or import, including but not limited to the names, addresses of any 1406 person to whom the substance is distributed ( info includes any distributed) . They must be 1407

ma intained for 5 years from the date of commencement of manufacture or import (See 720.78). 1408 EPA expects that many companies would also track production volumes for planning, marketing, 1409 and sales projection purposes. Several TSCA regulations, such as 5(a)(2) SNURs and 5(e) 1410 orders also require that production volume records be kept for five years for certain chemicals, 1411 and several commenters indicated that they archived these records. 1412 1413 2. Elimination of the 300,000 lb. threshold. The Agency received a subst antial number of 1414 comments on the elimination of the 300,000 lb. threshold for reporting processing and use 1415 information. Comments submitted on various topics are described in this unit. 1416 1417

a. Increased numbers of covered chemical substances. Commenters asse rted that the 1418 influx of inorganic chemicals, coupled with the threshold change for processing and use 1419 information, will result in a substantial increase in the amount of data being submitted to the 1420 Agency. Commenters felt that EPA staff will need significa nt time to compile, review, and 1421 analyze the data submitted. One commenter suggested the Agency use a phased

- in approach to 1422 adequately collect and process the increased information. 1423 1424 While it is true that the amount of data in the IUR reports is expected to increase 1425 substantially in the 2011 and subsequent reporting years, EPA is better prepared now than it was 1426 for the 2006 IUR to compile, review, and analyze the anticipated increase of data. With the new 1427

e

- IURweb electronic tool, large amounts of data wi ll be able to be submitted with less difficulty 1428 on the part of the submitter, and will be more readily organized, analyzed, and made available to 1429 the public by the Agency. In addition, the use of SRS for identifying chemical substances and 1430 validation proc ess built into the e

- IURweb tool will eliminate most or all of the problems EPA 1431 had with missing information (which necessitated phone calls and emails to submitters), and 1432 manual entry of data, which was time

- consuming and resulted in many mistakes. Given the 1433 requirement for mandatory electronic submissions and the corresponding improvements to the e

1434 IURweb tool, the Agency is confident that the increase in data submissions will be easily 1435 managed for this reporting period, and both EPA and the public will quickly have a useable set 1436 of exposure

- related IUR data. 1437 1438 b. Reporting Burden. Numerous commenters were concerned about the increased 1439 reporting burden, particularly for smaller companies, and the complexity of IUR Form U Part III. 1440 One commenter stated tha t EPA should assess the benefits of the additional reporting 1441*** Interagency EO 12866 Review Draft

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39 requirements to establish a cost justification of the proposal. Other commenters were concerned 1442 that the lowered threshold would increase the number of imported mixtures and that it would be 1443 dif

ficult to calculate and aggregate across products for lower volume chemicals. 1444 1445 EPA analyzed the potential impacts of this requirement to all submitters, including 1446 potential burden to small businesses, in the Economic Analysis (Ref. 19). EPA recognizes tha t 1447 reducing the reporting threshold for processing and use information increases the reporting 1448 burden for this reporting cycle, but the cost to industry will decrease in all future reporting 1449 cycles. 1450 1451 EPA disagrees with comments suggesting that the requirem ent may have a 1452 disproportionate effect on smaller companies (commenters suggested that smaller companies are 1453 more likely to manufacture below the 300,000 lb. threshold that is being eliminated.) The 1454 quantity of a chemical that is manufactured (including im ported) at a site is not necessarily 1455 dependent on the number of employees, which is the criteria by which a company is considered 1456 to be small. For example, a highly automated facility could produce large volumes of a chemical 1457 substance with a relatively sm all number of employees . Additionally, as noted in the Economic 1458 Analysis, the Agency determined that because the small businesses affected by today‘s final rule 1459 actually have average sales of more than $11 million, and because any potentially affected 1460
comp anies with sales of $1.02 million or less (the level at which the cost

- to

- sales ratio of the 1461 final rule would exceed 1%) would generally be exempt from reporting obligations under the 1462 IUR, small entities will not be significantly affected by today‘s final amendments to the IUR 1463 rule. 1464 1465 EPA recognizes that, with the elimination of the 300,000 lb. threshold, importers may 1466 face an increase in burden to identify more component chemicals contained within more 1467 imported mixtures. However, ,EPA disagrees that importe rs are unprepared to conduct a 1468 reasonable inquiry as to the specific chemicals they import in mixtures. Importers have long been 1469 responsible for certifying that their imported chemical substances, including those chemical 1470 substances present as part of mixt ures, are in compliance with TSCA (See 19 CFR 12.119). 1471 Furthermore, importers have long been required to provide chemical specific information as to 1472 the constituents of imported mixtures under the IUR (see the definition of ―importer‖ at 40 CFR 1473 704.3 and the note at 40 CFR 710.4(c)(2)) and under the PMN program (40 CFR 720.30(b). 1474 Furthermore, importers are often required to report chemical specific information regarding 1475 imported mixtures under other EPA

- administered statutes, such as the Emergency Plannin g and 1476 Community Right

- To

- Know Act (EPCRA) and the Resource Conservation and Recovery Act 1477 (RCRA). While reporting under the IUR differs in many significant respects from reporting 1478 under the EPCRA and RCRA programs, in all cases the importer is required to k now the identify 1479 of the chemical substances they import. EPA notes that one commenter described, in detail, its 1480 practice of accounting for component chemical substances in imported mixtures. The 1481 commenter stated that ―[w]ith the advent of REACH we recentl y implemented an application 1482 that is capable of tracking volumes of individual substances in mixtures and summing them up 1483 over a period of time. The system automatically looks at the current formulation of any product 1484 that is crossing a border and adds the volume of each component to the cumulative total for that 1485 substance‖ (Ref. 18). EPA expects that the burden associated with reporting these chemicals will 1486 decline in reporting periods subsequent to 2011, as additional recordkeeping procedures are put 1487*** Interagency EO 12866 Review Draft

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40 into practice. Finally, EPA notes that a chemical substance that is imported solely in small 1488 quantities for research and development, as an impurity, as part of an article, or in certain other 1489 forms, see 40 CFR 720.30(g) and (h), is not subject to the IUR repo rting requirements. See 40 1490 CFR 711.10. 1491 1492

c. Justification for data. Several commenters strongly supported EPA‘s proposed change, 1493 stating that the information is essential for the completion of prioritizations for IUR reportable 1494 chemical substances; is cri tical for evaluating the potential for release of and exposure to 1495 chemicals in commerce; and that the information requested is basic, screening

- level data that 1496 should be required for all reported chemicals. Additional commenters generally supported the 1497 cha nges, but wanted the change to take effect after the 2011 reporting cycle. Other commenters 1498 had concerns about the value of the information that is reported in Part III. One commenter 1499 stated that EPA has not made public documentation of the past use of thi s information to address 1500 screening and prioritization of chemicals. Another commenter believes that EPA should provide 1501 more specificity on its needs and explain why other, more tailored, options do not provide the 1502 necessary data. 1503 1504 EPA‘s information needs have changed since the last major amendment of the IUR rule 1505 in 2003. Production volume changes from year to year, so chemicals can easily fluctuate above 1506 and below a relatively high reporting threshold, such as the previous 300,000 lb. threshold for 1507
repor ting processing and use, making it difficult for EPA to collect regular exposure information 1508 on many chemicals. Requiring the reporting of processing and use information on an expanded 1509 list of chemicals will assist the Agency and others in screening poten tial exposures and risks 1510 resulting from industrial chemical operations and commercial and consumer uses of chemical 1511 substances. The information will also help to provide an accurate and readily available source of, 1512 as noted in Unit V.A.1, basic exposure

- re lated information for a subset of chemicals listed on the 1513 TSCA Inventory. Furthermore, collection of this data is consistent with the Administrator‘s 1514 strong commitment to provide the public with more information on a greater number of 1515 chemicals. 1516 1517 As mentio ned in the preamble of the proposed rule and as explained in Units V.A.3 and 1518 V.A.4 herein, the data reported in 2006 did not provide an adequate amount of exposure

- related 1519 information, especially for HPV chemicals. When attempting to use the 2006 IUR data for its 1520 screening level exposure assessments, EPA found that numerous chemicals previously identified 1521 as HPVs were reported in amounts classifying them as MPV chemicals, below the 300,000 lb. 1522 cut off, and thus processing and use information was not provide d for chemicals for which EPA 1523 had a relatively complete hazard data set from the HPV Challenge. For example, an RBP was 1524 prepared for the Chlorobenzenes Category, which consisted of four chlorobenzenes sponsored 1525 under the HPV Challenge ( Ref. 18 )

. Only one o f the four substances, 1,3

- dichloro benzene 1526 (CASRN 541

- 73

- 1), was considered high priority; however, because it was an MPV chemical in 1527 2006, no exposure and use data was available from the IUR reporting, so the high priority 1528 determination was based on high human health hazard and assumptions made about exposure. 1529 1530 The 2006 IUR data did not provide sufficient information on moderate production 1531 volume (MPV) chemicals for use by the Agency‘s Existing Chemicals Program. Screening 1532 chemical risks generally requi res a combination of both hazard and exposure information. 1533*** Interagency EO 12866 Review Draft

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41 Because most MPV chemicals were produced below the 300,000 lb. reporting threshold, EPA 1534 did not have exposure information available from the 2006 IUR and therefore, developed hazard 1535 based prioritiz ations which were supported by a screening level hazard characterization and 1536 consideration of very limited exposure and use data. The lack of information on exposure and 1537 use was especially problematic in those instances where the screening level hazard 1538 cha racterization identified either a medium or high hazard. Basic hazard data is easier to find in 1539 existing databases; however, specific exposure data is needed to make a priority determination 1540 risk

- based. EPA believes that the lower reporting threshold w ill provide more exposure

- related 1541 information on a greater number of MPV chemicals. 1542 1543 EPA disagrees with the comment that it has not made public documentation of the past 1544 use of processing and use information to address screening and prioritization of chemi cals. As 1545 discussed above in Unit V.A.3, EPA used 2006 IUR data starting in 2007 in its development of 1546 RBPs and HBPs which it has made available on its website. More recently, the Existing 1547 Chemicals Program used the IUR database when developing the Chemica l Action Plans. For 1548 some Action Plan chemicals, the 2006 IUR data were not sufficiently complete to be useful. An 1549 example is the Action Plan for Dyes Derived from Benzidine and Its Congeners, where the 1550 substances of concern are known or reasonably antic ipated human carcinogens; however, those 1551 listed were produced in amounts below the 300,000 lb. threshold and so little exposure data was 1552 reported. Based on IUR data from prior reporting periods, some of the other dyes had been 1553 reported in the 10,000 to 25,000 lb. range, but there was no 2006 IUR data available to determine 1554 whether these chemicals were still being used in amounts beyond the small amounts used as 1555 analytical reagents. The Action Plans are available on EPA‘s web site at 1556 http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html

. 1557 1558 By lowering the reporting threshold for processing and use information, EPA is 1559 increasing consistency for the IUR with re porting requirements of the TRI program. Under the 1560 TRI program, chemicals that are not chemicals of special concern listed at 40 CFR section 1561 372.28 (e.g., mercury, lead) are required to be reported if they are manufactured or processed in 1562 volumes of 25,000 lb. or more annually or otherwise used in volumes of 10,000 lb. or more 1563 annually. Though the chemicals on the TRI toxic chemical list may be different from those 1564 reported under the IUR, an analysis showed that over 80 percent of the sites that reported un der 1565 the 2006 IUR also reported under TRI in 2006. Given that there is some overlap in the 1566 companies that report and the information collected on activities and uses of chemicals under 1567 both programs, EPA believes that many companies are already accustomed t o reporting on lower 1568 volume chemicals. 1569 1570 d. Lack of data for chemical substances. Several commenters noted that the 2010 1571 reporting year will be over by the time the rule is finalized, and companies would not have had 1572 the opportunity to establish systems fo r collecting the information for chemicals in the 25,000 to 1573 300,000 lb. range. Other commenters asserted that EPA was seeking data that are limited or 1574 unavailable because manufacturers do not know how their chemicals are used by their customers 1575 downstream from the manufacturing. Another commenter asserted that the lowered threshold 1576 will not enhance the quality or integrity of the resulting IUR data due to uncertainties in making 1577 estimates. 1578 1579*** Interagency EO 12866 Review Draft

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42 EPA recognizes that submitters may not always have detailed inform ation about how the 1580 chemical(s) they manufacture (including import) are used. As a result, submitters will be 1581 required only to report this information to the extent that it is known or can be reasonably 1582 ascertained. Based on its experience with the New Che micals Program, discussions with industry 1583 about voluntary risk management programs, and industry‘s various self

- regulation initiatives, the 1584 Agency believes that most submitters have at least some basic information about downstream 1585 uses, such as the informa tion that is required by the IUR rule. 1586 1587 EPA acknowledges that the final rule will be published shortly before the start of the 1588 submission period. EPA does not anticipate that the quality of the data collected in 2011 will 1589 significantly decrease due to th e timing of the amendment to the reporting threshold. Many of the 1590 reporting elements are the same as in past IUR reporting periods, and EPA notes that the rule 1591 affords sufficient flexibility to account for those circumstances in which information is truly 1592 unknown and not reasonably ascertainable. The Agency believes that the data will be of 1593 sufficient reliability for use by the Agency and others for purposes such as screening

- level risk 1594 assessments and prioritization. 1595 1596 3 . Eliminate 25,000 lb. threshold fo r selected substances. EPA proposed to eliminate the 1597 25,000 lb. reporting threshold for certain chemical substances subject to particular TSCA rules 1598 and/or orders and to require manufacturers (including importers) of such chemical substances to 1599 report unde r the IUR, regardless of the production volume. Comments submitted on various 1600 topics are described in this unit. 1601 1602

a. Burden. One commenter stated that companies not expecting this significant change 1603 will be unprepared to gather required information. Sever al commenters expressed the view that 1604 the requirement will increase the burden upon industry without any real benefit to the 1605 environment and will create a situation where manufacturers are responsible for knowing all 1606 byproducts of their process, no matter how small. Others felt that enacting this requirement 1607 without a de minimis concentration threshold would add an unnecessary additional layer of 1608 complexity to IUR analysis and would result in each reporting entity responsible for a far greater 1609 number of For m U submittals. 1610 1611 The Agency believes it is unlikely that recordkeeping practices were not already in place 1612 for companies to track the volumes of the chemicals they are manufacturing. EPA analyzed the 1613 potential impacts of this requirement to submitters a nd recognizes that eliminating the 25,000 lb 1614 threshold for these substances increases the reporting burden (see the Economic Analysis). 1615 However, the burden of reporting will be ameliorated by the use of electronic reporting. 1616 1617 EPA disagrees that the incr eased burden will not yield any real benefit and agrees with 1618 the commenters who supported eliminating the 25,000 pound threshold for certain TSCA

- subject 1619 chemicals so that more useful information would be received

. Chemical substances that are the 1620 subject of particular TSCA rules and/or orders are of demonstrated high interest to the Agency. 1621 Receipt of up

- to

- date exposure and use information on these chemicals, regardless of production 1622 volume, will help EPA as it develops risk management strategies for th ose chemicals subject to 1623 proposed rules. Additionally, EPA will use the IUR data as it monitors chemical substance 1624 production and compliance with the rules. The new requirement will also contribute to the 1625*** Interagency EO 12866 Review Draft

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43 Administrator‘s commitment to increase the availa bility of chemical information to the public. 1626 EPA expects instances when the required information is not known or reasonably ascertainable 1627 will decline substantially in reporting cycles subsequent to 2011, as additional recordkeeping 1628 procedures are put int o practice. 1629 1630 b. Imports and Mixtures. Commenters thought this requirement will be difficult to meet 1631 in practice, particularly for imported chemicals or mixtures. One commenter felt the requirement 1632 would create a needle

- in

- a

- haystack situation in which a c ompany would need to examine all 1633 chemicals and/or mixtures imported, regardless of the concentration of the chemical or volume 1634 of the import. Other commenters believed that importers would have great difficulty knowing 1635 that low

- concentration ingredients ar e present in formulated mixtures, especially when they are 1636 not subject to inclusion on a label or Material Safety Data Sheets (MSDS). 1637 1638 EPA recognizes that eliminating the 25,000 lb. reporting threshold may, in some 1639 instances, make it more difficult for imp orters to determine the production information for 1640 component chemical substances in imported products. However, the IUR incorporates a number 1641 of exemptions that address the ―needle

- in

- a

- haystack‖ concern expressed by the commenter. 1642 IUR reporting is not re quired for a chemical substance that is imported solely in small quantities 1643 for research and development, as an impurity, as part of an article, or in certain other forms. See 1644 40 CFR 711.10, 40 CFR 720.30(g) and (h). Furthermore, for the reasons discussed in Unit 1645 II.D.5., companies should be accustomed to reporting chemical specific information to EPA 1646 because the Agency has always sought information on individual chemical substances in 1647 mixtures under the IUR and PMN programs. Similar to the requirement to report processing and 1648 use information for lower volume chemicals (see Unit E.5.b), EPA believes that instances where 1649 this information is not known or reasonably ascertainable will decline substantially for reporting 1650 periods subsequent to 2011 as additiona l recordkeeping procedures are established. 1651 1652

c. List of subject chemical substances. Commenters suggested that EPA provide an up

1653
to

- date list of the chemical substances impacted at the beginning of the information collection 1654 year to ensure more accurate a nd complete reporting. EPA provides just such a list. It is titled 1655 ―Chemical Substances that are the Subject of Certain TSCA Orders, Proposed or Final TSCA 1656 Rules, or Relief Granted under Civil Actions.‖ It can be found in Appendix C of the Instructions 1657 f or Reporting Guidance Document. The pertinent chemicals are listed both by CASRNs (for 1658

non

- confidential chemical substances) or by Accession Numbers (for confidential substances) 1659 that are the subject of a rule. This document, which will be updated for the 2011 IUR reporting, 1660 is available in the docket for this final rule and on EPA‘s IUR website at www.epa.gov/iur. This 1661 list is intended to be a helpful information resource, but it is not legally determinative of the 1662 status of any particular chemical substa nce. 1663 1664 d. Reporting for chemicals subject to a proposed rule. Some commenters supported 1665 EPA‘s suggestion to eliminate the 25,000 lb. threshold for certain chemical substances that are 1666 the subject of a rule proposed under TSCA section 5(a)(2), 5(b)(4), or 6. Another commenter 1667 believed it was inappropriate to impose expanded reporting requirements on substances subject 1668 to proposed rules which might not be finalized. 1669 1670*** Interagency EO 12866 Review Draft

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44 The Agency agrees with the commenters who stated that if chemicals that would 1671 typically be exempted from reporting are subject of a rule proposed under TSCA Section 5(a)(2), 1672 5(b)(4) or 6, the reporting threshold should be eliminated and the chemicals should be reported 1673 despite the lower volumes produced. The Agency disagrees with the commenter w ho argued that 1674 the elimination of the reporting threshold should not be triggered by the mere issuance of a 1675 proposed rule for a chemical. The latter commenter suggested that it would be inappropriate to 1676 collect more detailed information on such a chemical until the proposed rule had been fully 1677 vetted and analyzed, noting that finalization can often take a number of years. However, EPA 1678 believes that the issuance of one of the proposed rules described above represents an appropriate 1679 circumstance to trigger en hanced information collection under the IUR. EPA issues a proposed 1680 rule under TSCA sections 5, or 6 only after making findings that a chemical substance or some 1681 specified use of a chemical substance presents some level of concern. Precisely because the 1682 regulatory status of the chemical would be under analysis and because there might be an 1683 opportunity for a fuller IUR dataset to help inform that analysis and the development of risk 1684 management actions, EPA believes it is appropriate for the elimination of the reporting threshold 1685 to be triggered at rule proposal. Furthermore, those chemicals that are the subject of a rule 1686 proposed under sections 5(a)(2), 5(b)(4), or 6 are of demonstrated high interest to the Agency. In 1687 an effort to better understand the ex tent of manufacture, use, and potential exposure to such 1688 chemicals, EPA believes it is appropriate to eliminate the 25,000 lb. threshold for reporting on 1689 their manufacture. 1690 1691

e. De minimis threshold volume. EPA asked for comment on whether a de minimis 1692
pro duction volume threshold should be set for these chemical substances. Some commenters 1693 opposed setting a new de minimis threshold. Other commenters suggested a variety of methods 1694 for establishing a de minimis threshold. Specifically, one commenter recomme nded that EPA set 1695

a de minimis threshold of 2,500 lb., similar to the European REACH regulation‘s registration 1696 threshold of 2,200 lb. One commenter thought a de minimis volume should be set on a chemical

1697 by

- chemical basis for chemicals for which EPA needs specific information. Another commenter 1698 felt that there should be no threshold level for persistent, bioaccumulative, or toxic chemicals 1699 (PBTs). Other commenters thought the reporting threshold volume should be kept at 25,000 lb. 1700 1701 The Agency agrees with the commenters who opposed setting a de minimis level. While 1702 a 2,500 lb. de minimis threshold level would harmonize more closely with the European REACH 1703 regulations‘ reporting threshold, the two programs are not completely analogous, e.g., REACH 1704 does not require periodic reporting. EPA also believes that setting a de minimis threshold on a 1705 chemical

- by

- chemical basis or special thresholds for PBTs or carcinogens would require more 1706 time and resources than are presently available. Chemicals regulated or propo sed for regulation 1707 under the rules listed in 40 CFR 711.8(b) are of demonstrated high interest to the Agency, and 1708 may present unreasonable risks at even relatively low concentrations. At this time, EPA does not 1709 have an informed basis to set a uniform de m inimis concentration (such as the 1% or 0.1% 1710 concentrations suggested by the commenter) for these chemicals. However, if an importer does 1711 not know, or can‘t reasonably ascertain that a particular chemical is present in a mixture, they are 1712 not required to report it. 1713 1714 D. Comments on Specific Data Elements 1715 1716*** Interagency EO 12866 Review Draft

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45 1 . Parent company and site identity. During the 2006 submission period, submitters 1717 indicated that further clarification was needed to identify the correct company name for reporting 1718 purposes. Based on these previous comments, EPA has determined that the parent company‘s 1719 name, address, and Dun and Bradstreet Number is necessary to provide clarity as to which 1720 company name to use for reporting under the IUR. This reporting requirement, at 40 CFR 1721 711.15(b)( 2)(ii), is consistent with the Toxic Release Inventory (TRI) requirements for parent 1722 company name and it will help to better identify reporting sites that are under the same parent 1723 company. EPA provides further clarification regarding the correct domestic (U.S.) parent 1724 company name in the ―Instructions for 2011 Inventory Update Reporting (Ref. 5). 1725 1726 2 . Technical contact. EPA requested comment on requiring that the technical contact be 1727 a person knowledgeable about the reported chemical substance and be lo cated at the 1728 manufacturing (including importing) site. Several commenters stated that companies should be 1729 able to use their discretion in identifying the most appropriate contact or contacts. They believe 1730 that the technical contact need not be physically l ocated at the reporting site, and that information 1731 may be more reasonably generated by a corporate contact rather than a technical contact at the 1732 production site. Some commenters said that the technical contact should be an employee of the 1733 submitting compa ny. 1734 1735 EPA agrees with commenters who stated that companies should use their discretion in 1736 selecting a technical contact or multiple technical contacts, as permitted by the new e

- IURweb 1737 software. However, EPA believes that a technical contact must be someo ne who can answer 1738 detailed follow

- up questions that EPA may have regarding the submission. EPA has found that 1739 technical contacts not at the reporting site generally are less knowledgeable about the submission 1740 or chemical and therefore may not be able to d iscuss follow

- up questions. Also, it has been 1741 EPA's general experience that short

- term contractors have not been suitable technical contacts, 1742 because they may no longer be under contract with the submitting company when EPA contacts 1743 them a year or more aft er the submission is made. 1744 1745 3 . Correct chemical name. 1746 1747

a. Comments on imported chemicals and joint submissions. EPA received several 1748 comments regarding its proposal to require that importers ensure that their supplier completes the 1749 joint reporting of th e CA Index Name currently used to list the chemical substance on the TSCA 1750 Inventory. The comments indicated that it would be difficult for an importer to require that 1751 another party complete a joint submission because foreign suppliers are not subject to th e same 1752 Federal regulations as U.S. companies, compliance with U.S. regulations is not their top priority, 1753 and in some cases they are slow to comply. 1754 1755 EPA agrees with the commenters that its proposed joint submission procedures for 1756 importers, which requir ed the importer to ensure that a foreign supplier prepared a secondary 1757 submission on its behalf, presented implementation difficulties. This is because, as the 1758 commenters suggested, the foreign supplier may not be subject to any direct legal obligation to 1759 provide the information to EPA. The Agency also notes that this issue extends to the regulations 1760 at 40 CFR 711.15(b)(3)(i)(B), as there may be circumstances in which the manufacture of a 1761 chemical substance is reportable under the IUR, yet the supplier of a reactant used in 1762*** Interagency EO 12866 Review Draft

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46 manufacturing that chemical substance would not have an independent legal obligation to report 1763 the chemical identity of the reactant under the IUR. 1764 1765 Therefore, the Agency has modified the regulatory requirements at 40 CFR 1766 711.15(b)(3)( i) to reflect the primary submitter‘s underlying obligation to provide what it knows 1767 or can reasonably ascertain respecting the identity of a chemical substance subject to reporting. 1768 The joint submission requirement is no longer to ensure that suppliers p rovide secondary 1769 submissions to EPA, but to properly ask that they do so. Consistent with 40 CFR 1770 711.15(b)(3)(i), a request for a secondary submission to EPA must be prepared using e

- IURweb, 1771 include instructions for electronically submitting the informati on to EPA, and explain how to 1772 provide a clear reference to the primary submission. Documentation of the request to the 1773 supplier must be submitted to EPA along with the rest of the primary submission. 1774 1775 Finally, EPA has also modified the regulatory requir ements to more clearly reflect, see 1776 proposal at 75 FR 49666, that they only apply in cases where a supplier will not reveal the 1777 pertinent chemical identity information to the submitter. In the event that a manufacturer 1778 (including importer) actually knows the chemical identity of a chemical substance subject to IUR 1779 reporting, the manufacturer must provide that information irrespective of a supplier‘s 1780 confidentiality claims. EPA has modified the substantiation question at 40 CFR 711.30(b)(1)(i) 1781 to include i nformation about harm to the submitter‘s competitive position ―or to your supplier‘s 1782 competitive position.‖ 1783 1784 b. Comments on reporting ( International Union of Pure and Applied Chemistry) IUPAC 1785 names as an alternate . A commenter recommended allowing I UPAC names as a substitute for 1786 CA Index Names for discrete chemicals, because the IUPAC nomenclature provides the exact 1787 chemical structure and because the commenter was concerned that submitters would be required 1788 to go through a particular fee

- based servic e to obtain CA Index Names for chemicals. 1789 1790 T he Agency disagrees that IUPAC names should be allowed as a substitute for CA Index 1791 Names in reporting discrete chemicals for the IUR. Chemicals are listed on the TSCA Inventory 1792 using CA Index Names, and only c hemicals listed on the TSCA Inventory are to be reported for 1793 IUR. The requirement for using CA Index names is directly related to positively identifying the 1794 listed TSCA Inventory substance. Using a different nomenclature for the purposes of reporting 1795 for IUR could create confusion, both for Industry and for EPA. 1796 1797 Additionally, there will generally be no need for submitters to use a fee

- based service to 1798 obtain the CA Index Name and corresponding CASRN for IUR reporting purposes. As part of 1799 the electron ic reporting process for the IUR, submitters will be able to easily connect 1800 electronically from the IUR reporting software directly to the Agency's SRS database in order to 1801 obtain CA Index Names and corresponding CASRNs for all of their non

- confidential ch emical 1802 substances on the TSCA Inventory. These data can then be electronically copied back to the 1803 IUR reporting tool. 1804 1805 4 . Chemical Identifying Number . Some commenters were opposed to removing the PMN 1806 number as an allowed identifying number, suggesting that the Agency might be inundated with 1807 requests for Accession Numbers, and that for historical products, this may pose an extra burden 1808*** Interagency EO 12866 Review Draft

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47 for both industry and EPA. It was suggested that the Agency provide a cross

- reference list of 1809 PMN numbers to Accession Numbers so that the information can be easily obtained without 1810 additional burden on industry and the Agency. 1811 1812 The Agency has added PMN numbers to the SRS listing to provide a cross

- reference list, 1813 as suggested by the commenters. The e

- IURweb reporting too l allows the user to search SRS 1814 using the PMN number in order to populate the IUR report with the pertinent chemical 1815 identification information for confidential chemical substances listed on the Inventory. 1816 1817 There are certain circumstances where a submitte r occasionally may not be sure of the 1818 particular PMN case number and Accession Number the Agency has assigned to one of its 1819 confidential substances, such that the submitter would not be able to definitely determine this 1820 solely from searching in the SRS. T his could happen, for example, if the substance were 1821 originally reported as part of a consolidated PMN and the submitter did not learn from EPA 1822 which particular case number in the consolidated PMN number sequence corresponds to which 1823 of the several reporte d confidential substances. This could also happen if a certain PMN 1824 represented a mixture of two or more confidential substances, such that multiple Accession 1825 Numbers were assigned to the different substances reported in that single PMN, and the 1826 submitter didn't already request the particular Accession Numbers from EPA for the individual 1827 chemical substances comprising that multi

- component type of PMN. In such circumstances, a 1828 submitter should contact EPA in writing, well before initiating IUR reporting, to obtain the 1829 required Accession Numbers from the Agency. The Agency will respond to such inquiries in as 1830 timely a manner as possible. It is the responsibility of the submitter to contact the EPA for such 1831 information in sufficient time to allow for the Age ncy to respond. 1832 1833 5 . Production volume 1834 1835

a . Report production volume for each year. EPA requested comment on the requirement 1836 to report production volume for each of the five years since the last IUR principal reporting year. 1837 Comments submitted on variou s topics are described in this unit. 1838 1839 i. Insufficient time to collect data . Most commenters stated that companies were prepared 1840 to compile and report the required information for the 2010 reporting year; some companies 1841 indicated, however, that they had no t established systems to collect and compile information for 1842 2006

- 2009. One commenter was concerned that the short period of time given by EPA to collect 1843 the information will result in significantly decreased data quality and reliability. Another 1844
commente r said that most companies archive data after 18

- 24 months. Some found it confusing 1845 that the threshold to determine the need to report in the 2015 cycle would change to include 1846 production data from previous years, but that the reporting of production data from previous 1847 years would take effect in the 2011 cycle. 1848 1849 EPA acknowledges that there will be submitters for whom certain information for 2006 1850 to 2009 will not be known or reasonably ascertainable. However, EPA believes it is unlikely that 1851 normal business practices would not include tracking the volumes of the chemicals a company 1852 was manufacturing, at least for a few years. In many instances, production volumes for recent 1853 past months and years are tracked under standard business practices. For example, seve ral TSCA 1854*** Interagency EO 12866 Review Draft

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48 regulations, such as 5(a)(2) SNURs and 5(e) orders, require that production volume records be 1855 kept for five years for certain chemicals, and several commenters indicated that they archived 1856 these records. EPA does not anticipate that the quality o f the data reported will decrease because 1857 of the new reporting requirement, particularly for the data elements that are not new. EPA 1858 believes that the data will be of sufficient reliability for use by the Agency and others for 1859 purposes such as screening

- le vel risk assessments and prioritization. To the extent that required 1860 information is indeed not known or reasonably ascertainable, EPA expects such circumstances to 1861 be less frequent in reporting periods subsequent to 2011, as additional recordkeeping proce dures 1862 are put into practice. 1863 1864 ii. Reporting burden . Several commenters stated that the requirement is overly 1865 burdensome, especially for chemical importers and manufacturers who (according to the 1866 commenters) will need to analyze all products to track the vo lumes of all component chemicals. 1867 Another commenter acknowledges that, while the burden of reporting the data for each principal 1868 reporting year was minor, the information would be of little value to the Agency. On the other 1869 hand, one commenter stated that this requirement could increase the burden by at least three fold. 1870 Another commenter said that in some cases, businesses have no need to capture past production 1871 volumes. One commenter asserted that many companies will consider the production volume in 1872

eve ry year to be CBI and will take the necessary steps to request CBI coverage of this 1873 information. The commenter acknowledged that the information will still be available to EPA for 1874 consideration, but was concerned that the burden on EPA of keeping the infor mation confidential 1875 will increase substantially due to the potential number of CBI claims. 1876 1877 EPA‘s burden estimates represent the average burden across all sites for providing 1878 production volumes. As such, commenters should be aware that their particular circumstance 1879 may not be average and therefore the estimate may not accurately reflect their own, individual, 1880 circumstance. However, because the estimate represents an average across all sites, EPA is 1881 confident that the estimate does reflect the average b urden and, when taken as a whole 1882 encompasses the range of burdens faced by submitters. 1883 1884 In addition, some comments identified a misunderstanding of the reporting requirements. 1885 For example, one commenter stated that many electronics manufacturers have nev er considered 1886 themselves to be engaged in chemical manufacturing when they recycle their spent chemicals, 1887 and therefore have not been collecting and tracking the production volume of each component 1888 chemical substance comprising their byproducts. As descri bed elsewhere in this Unit, 1889 accounting for the manufacture of a byproduct does not necessarily entail accounting for each 1890 individual component chemical substance in the byproduct. Therefore, EPA believes the 1891 commenter is overestimating the burden associat ed with developing production volume 1892 information

. In any event, it is not a new requirement that byproduct manufacturers are subject 1893 to the IUR

— that is an established feature of the IUR that predates the amendments being 1894 finalized in this rule. The Agency does expect that the reporting burden will decrease in reporting 1895 cycles beyond 2011, as submitters put additional recordkeeping procedures into practice. While 1896 more CBI claims may increase EPA‘s burden slightly, the Economic Analysis estimates the 1897 amend ments will save EPA approximately $180,000 in the first reporting year through 1898 efficiencies from electronic reporting. CBI claims on production volumes are unlikely to create 1899 any significant burden beyond what is estimated in the Economic Analysis. Inappro priate CBI 1900*** Interagency EO 12866 Review Draft

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49 claims will, however, prevent valuable information about chemical manufacture (including 1901 import) from becoming publicly available. 1902 1903 iii. Retroactive reporting . Several commenters expressed concerns asserting that EPA 1904 retroactively is requiring historical data and that the requirement for past production information 1905 was beyond the scope of EPA‘s TSCA authority for IUR reporting. Another commenter said it 1906 was not feasible to accurately produce this historical data for the many byproducts that 1907

co mpanies produce and send for recycling, primarily because manufacturers did not know they 1908 needed to have such data gathering mechanisms in place. 1909 1910 EPA disagrees with commenters‘ suggestion that reporting information on past 1911 production constitutes an impos ition of retroactive reporting requirements. While the rule 1912 establishes new requirements to report production volumes from several previous years prior to 1913 the finalization of the rule, it does not alter the reporting requirements for the 2006 reporting 1914
cyc le, or any other prior reporting cycles. Neither does the final rule establish a new legal 1915 requirement to have taken some particular recordkeeping action in the past. Instead, it holds 1916 submitters to a prospective standard of reasonableness. EPA acknowle dges that for the 2011 1917 reporting period, some companies may neither know nor be able to reasonably ascertain all of the 1918 newly requested information. However, EPA does not expect such circumstances to be prevalent 1919 in 2011, and it would expects such circums tances will further decline in reporting periods 1920 subsequent to 2011, as additional recordkeeping procedures are put into practice. 1921 1922 iv. Alternate approaches . Several commenters recommended that EPA delay the 1923 implementation of the reporting requirement unti l the next reporting cycle to allow companies 1924 sufficient time to prepare for the additional data collection effort. A few commenters suggested 1925 that burden would be reduced if companies reported in ranges or provided best estimates. Other 1926 commenters sugge sted that reporting be limited to a subset of industries or chemicals, based on 1927 criteria to focus on data collection and evaluation activities that are more valuable to the Agency. 1928 Examples of criteria include substances with a history of fluctuations in chemical manufacture 1929 and import practices or substances that are considered hazardous. With the advent of REACH, 1930 one commenter said they recently implemented an application that is capable of tracking 1931 volumes of individual substances in mixtures and summi ng them up over a period of time. 1932 1933 EPA disagrees that a delay is needed to allow submitters time to gather the information. 1934 As discussed in Unit V.B, production volumes can vary significantly over a five year reporting 1935 cycle and it is not uncommon for ch emicals to rise above or fall below the reporting threshold 1936 each reporting cycle. As some commenters pointed out, the requirement is essential to effectively 1937 capture the substantial year

- to

- year fluctuations that occur in manufactured volumes that were 1938 fou nd to be missing in past IUR reporting cycles (Ref EDF comments). EPA does not believe it 1939 practicable to provide a definitive list of chemicals with a ―known history of fluctuations.‖ The 1940 Agency does not have such a list, and believes that because year t o year fluctuation could be 1941 caused by such a wide variety of circumstances, including circumstances such as economic 1942 changes and manufacturing practices, that developing and maintaining such a list is not only not 1943 practicable, but confining that list to su bstances with a ―history‖ of fluctuations would not 1944 capture the industry variability that EPA is seeking. 1945 1946*** Interagency EO 12866 Review Draft

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50 EPA also disagrees that reporting production volume in ranges or estimates would 1947 provide data of comparable value. Though EPA requires some of the IUR information to be 1948 reported in specified ranges, EPA sees little value in allowing submitters to report the production 1949 volumes in ranges or estimates, or requiring the information for only chemicals that are 1950 hazardous. EPA believes that a higher level of confidence in data accuracy will be achieved by 1951 requiring specific numeric data. It is important to note that EPA is interested in exposure and use 1952 data on all chemicals that are not exempted from IUR reporting. Especially since there is a 1953 multi

- year g ap between IUR submission periods, t he mere fact that a chemical is not known to 1954 be hazardous at this time does not mean that EPA is not interested in exposures and uses of that 1955 chemical. Under a contrary policy, EPA would potentially need to wait several years before 1956 obtaining the basic exposure information necessary to determine whether a hazardous chemical 1957 may present an unreasonable risk (since the collection of screening

- level exposure information 1958 would not be triggered until hazard data had been asses sed). In summary, after considering the 1959 suggestions, EPA believes its decision to collect multi

- year production volume under the 2011 1960 IUR is still sound. 1961 1962 b. Volume of chemical substances used on site. One commenter stated that this data 1963 element was essen tial to improving accuracy and utility of the reported production volume and 1964 two commenters stated they thought there was no value in this data element and that the Agency 1965 should retain the site

- limited check box because, the commenters stated, it was more informative 1966 for screening

- level risk assessment. Five commenters expressed confusion about the 1967 requirements of reporting this data element. Specific concerns included a concern about 1968 duplicative reporting for this data element and the industrial process ing and use information for 1969 chemicals used on

- site; whether this applied to chemicals used in synthesis or also to chemicals 1970 that were repackaged; and the need to identify the amount of a chemical present on site during a 1971 specific time period. 1972 1973 Some of th e commenters have misunderstood this data element, which provides more 1974 detailed and clearer information than did the previous site

- limited check box. Previously, 1975 submitters checked a box to indicate that a reported chemical substance was site limited

– in 1976 other words, that it was both manufactured and used on the site. Some submitters misreported, 1977 identifying an imported chemical as site

- limited (a situation that is not possible because the 1978 imported chemical, by definition, is brought onto the site from o utside of the U.S., and therefore 1979 is not physically manufactured and used at the reporting site) or reporting the same substance 1980 twice, once for the volume that is site limited and once for the volume that is sent off site. 1981 Because of this confusion, EPA replaced the site

- limited check box with reporting the volume of 1982 the chemical production volume reported on the form that is used on the site. For example, if 1983 50,000 lb. of a substance was manufactured and used on the same site, the submitter would 1984 report 50,000 lb. for domestically manufactured and 50,000 lb. for the volume used on

- site. If 1985 70,000 lb. of a substance was manufactured, 25,000 lb. was used on

- site and 45,000 lb. was 1986 shipped to a different site, the submitter would report 70,000 lb. for dome stically manufactured 1987 and 25,000 lb. for the volume used on

- site. If a site imported 30,000 lb. and used it at the import 1988 site, the submitter would report 30,000 lb. for imported production volume and 30,000 lb. for the 1989 volume used on

- site. If a site imp orted 100,000 lb. and shipped it to an alternate site, the 1990 submitter would report 100,000 lb. for imported production volume and 0 lb. for the volume used 1991

on

- site. As these examples illustrate, the submitter is not identifying the amount of a chemical 1992*** Interagency EO 12866 Review Draft

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51 on

- site during a particular time period, but rather that amount of a chemical that is manufactured 1993 (including imported) and used at the same site. 1994 1995 Commenters also asked for clarification regarding the activities considered to be ―used at 1996 the reporting site.‖ For a domestically manufactured substance, if the volume would have been 1997 considered to be site

- limited, then the substance is used on site. If the substance is domestically 1998 manufactured, temporarily stored, and then packaged for shipment off of the site , that volume 1999 would not be considered ―used at the reporting site.‖ For an imported substance, any use at the 2000 importing site (e.g. consumed in a reaction or crosslinked or cured in an article) would be 2001 considered ―used at the reporting site.‖ 2002 2003 EPA does no t believe reporting the portion of the production volume that is both 2004 manufactured and used on site will result in duplicative reporting. Even with the previous site

2005 limited check box, submitters provided information about the use of a chemical in both th e 2006 manufacturing and industrial processing and use sections of the IUR Form U. The information 2007 reported under the manufacturing section identifies that this substance is processed or used at 2008 that particular site and reports the number of workers associated with the manufacture of that 2009 substance. In the same report, the information reported under the industrial processing and use 2010 section provides more details about how the chemical is processed or use and, in the event that a 2011 substance has a use identified by the same combination of use, function, and NAICS code by 2012 another site, the production volumes, sites, and workers would be combined with the information 2013 describing the other sites‘ processing or uses. 2014 2015 c. Report volume exported. The majority of the comm ents against reporting the volume 2016 directly exported stated that capturing the volumes for each chemical in each exported product 2017 was difficult and burdensome. These comments indicated a misunderstanding of the reporting 2018 requirement, and EPA believes that a better understanding will eliminate those concerns. For the 2019 chemical substance that was manufactured and is being reported, the submitter is to report the 2020 volume of that chemical substance that is directly exported. If the chemical is processed in any 2021

w ay (e.g., combined with other substances to form a mixture), the chemical is not directly 2022 exported. Also, if a chemical is sent to a distributor who then exports it, the chemical is not 2023 directly exported. In both of these examples, the manufacturer would instead report either the 2024 processing to form a mixture or the transfer to a distributor under the processing and use portion 2025 of the IUR reporting form. ―Directly Exported‖ and ―Domestically Processed or Used‖ are 2026 mutually exclusive designations; only one designation applies to any particular portion of the 2027 production volume. 2028 2029 6 . Identify whether a chemical substance is to be recycled, remanufactured, reprocessed, 2030 reused or reworked. EPA received several comments on the proposal to add a checkbox 2031 indicatin g whether a manufactured chemical substance was or is expected to be recycled, 2032 including remanufactured, reprocessed, reused, or reworked. Some commenters were supportive 2033 of adding this reporting element, but several of the commenters were concerned that the term 2034 ―recycle‖ has been difficult to define in other programs, indicated confusion about EPA‘s 2035 purpose in including the checkbox, and expressed doubt that this data element would yield useful 2036 information. 2037 2038*** Interagency EO 12866 Review Draft

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52 EPA intends that this checkbox would be used by manufacturers to indicate whether a 2039 chemical substance they manufactured, such as a byproduct, which might otherwise be disposed 2040 of as waste, was or is expected to be recycled. EPA also included the terms remanufactured, 2041 reprocessed, reused, or rework ed, intending to capture a broad array of similar, and perhaps 2042 synonymous, activities by which a substance (that would otherwise be disposed of as waste) may 2043 be put to use. EPA is interested in the exposures from these activities, and believes that having 2044 more information about which chemicals are being recycled will help the Agency to refine future 2045 IUR reporting requirements (i.e., if EPA knows enough about exposures to a chemical from an 2046

on

- site recycling use, EPA could consider an exemption in the future ). 2047 2048 EPA also believes that this information would help the Agency to identify where this 2049 activity is already occurring, and could be used to recognize companies, industries, and sectors 2050 that are using ―green‖ practices. This information would also help to identify sectors where 2051 recycling is not occurring, providing useful data to measure the effectiveness of various EPA 2052 programs, such as the Resource Conservation Challenge (RCC) Program, and informing other 2053 Agency efforts to encourage practices that redu ce waste. EPA disagrees that a precise definition 2054 of ―recycle‖ is needed to make this data element useful for the purposes that EPA has identified. 2055 Submitters should simply indicate, to the extent that they know or can reasonably ascertain, 2056 whether the r eported volume of the substance that they manufactured, which would otherwise be 2057 disposed of as waste, was or is expected to be recycled, remanufactured, reprocessed, or reused, 2058 as those terms are understood by the submitter. 2059 2060 One commenter indicated tha t many chemicals are ―reworked‖ in many industrial 2061 processes, at least at some point, so this box would be checked so often that it would provide 2062 little meaningful data. EPA agrees that the term may be interpreted and applied too broadly to 2063 provide the ty pe of information that EPA is trying to collect, so has removed ―reworked‖ from 2064 the list of recycling synonyms. Two commenters expressed concern that revealing whether a 2065 substance they manufactured was recycled would reveal confidential business informati on. In 2066 such a situation, the submitter will be able to claim the information as confidential. Another 2067 commenter suggested that EPA collect information about recycling under a separate rule. EPA 2068 disagrees that this would be an efficient way to collect th e desired information. A separate 2069 rulemaking for one ―yes or no‖ data element would be extremely inefficient and needlessly time

2070 consuming for both the Agency and industry, particularly when the IUR rule already provides a 2071 suitable vehicle to collect chem ical manufacturing, processing, and use information. 2072 2073 7 . Industrial processing and use information 2074 2075

a . Industrial function categories. The Agency received several comments regarding 2076 revising the list of industrial function categories for processing and us e information. Some 2077 commenters were in favor of the changes and supported EPA‘s efforts to work collaboratively 2078 with Canada to align the categories. Other commenters said that this would require additional 2079 effort by the regulated community to assign the n ew codes, and a clear explanation of the 2080 changes with the reporting instructions, e.g., a ―read across‖ of old and new codes, including 2081 additional definitions to ensure that activities are consistently coded across companies. 2082 Commenters stated that provid ing a description for ―other‖ will be challenging, may not provide 2083 useful information (e.g., due to lack of information from the downstream customers), and would 2084*** Interagency EO 12866 Review Draft

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53 require additional burden to report. One commenter felt that the list of industrial function 2085 category codes is too limited for inorganic chemicals, and suggested that the Agency add an IFC 2086 code for ―Solid Manufacturing Materials.‖ The comment stated that such a code would alleviate 2087 the need to address many industrial uses in the "other" category

, thereby reducing reporting 2088 burden

. 2089 2090 EPA agrees with the commenters that a table indicating the relationship between the 2006 2091 IFC codes and the new 2011 IFC codes would be useful, along with clear definitions for each 2092 code. Such information is contained i n the 2011 IUR Instructions for Reporting. 2093 2094 EPA also recognizes that the requirement to report a description when the submitter 2095 selects the IFC code ―Other‖ may be more burdensome than for the other IFC codes, but expects 2096 any increase to be minor. The descriptive information is essential to enable users of the data to 2097 estimate potential exposures associated with the overall processing or use of the chemical, of 2098 which the function is an important component. The Agency‘s experience with the 2006 IUR 2099 dat a was that the category of ―other,‖ with no further description, was insufficient for the data to 2100 be of much use. 2101 2102 EPA disagrees with the suggestion to include a ―Solid Manufacturing Materials‖ IFC 2103 code and believes such a code will not accurately descri be the industrial function of the chemical 2104 substance. In addition, EPA believes the proposed list of IFC codes covers the majority of the 2105 industrial functions. This belief is based on the past experience of both the U.S. 2006 IUR and 2106 Canadian reporting. However, EPA does recognize that it did not collect such information for 2107 inorganic chemicals in the past, and therefore will use the written description for ―Other‖ to help 2108 evaluate and improve the inclusiveness of future IFC codes, including those applica ble to 2109 inorganic chemicals. 2110 2111 b . Industrial sectors. EPA proposed to replace the five digit NAICS code with a new 2112 code, Industrial Sector (IS), to describe the industrial setting. Some commenters were in favor of 2113 this change, noting that using code harmoni zed with Canadian codes would be helpful to both 2114 industry and data users. Other commenters stated that many companies have already begun the 2115 process of data collection based on the former system, which has precedent. The commenters 2116 believe NAICS codes ar e the classification system with which industry and regulators are most 2117 familiar, and in some cases, the IS codes are less descriptive than the NAICS codes. Commenters 2118 also asserted that the Agency should recognize that these changes will result in increas ed 2119 reporting burden and time. 2120 2121 EPA disagrees with the commenters that the use of IS codes in place of the NAICS codes 2122 will present increased burden on industry. The IS codes simply group together similar NAICS 2123 codes while still providing the sufficient di fferentiation needed to differentiate overall industrial 2124 processing and use scenarios. The IS codes span the entire range of NAICS codes and can be 2125 translated from known NAICS codes. Both the e

- IURweb reporting tool and the 2011 IUR 2126 Instructions for Repo rting contain cross

- walk tables for submitters to use to determine the proper 2127 IS code, based on the NAICS code information they may already have collected. 2128 2129*** Interagency EO 12866 Review Draft

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54 Information on the Agency‘s development of the IS codes is described in the technical 2130 support doc ument ―Inventory Update Reporting (IUR) Technical Support Document 2131 Replacement of 5

- digit NAICS Codes with Industrial Sector (IS) Codes‖ (EPA

- HQ

- OPPT

- 2009

- 2132 0187

- 0005). In developing the IS codes, EPA considered the level of detail required for 2133 developing u se and exposure scenarios, the number of 2006 IUR submissions using the code, the 2134 code definition, and the level of difficulty required in reporting more detailed codes. 2135 Submissions to the 2006 IUR reported over 340 unique five

- digit NAICS codes. In the 2006 2136 IUR, the three

- code combination of processing and use (P/U) code, NAICS code, and IFC codes 2137 resulted in a large number of possible exposure scenarios that could be reported. Although not all 2138 of the NAICS codes are applicable to chemical manufacturing and processing, the 2006 IUR 2139 database has over 2,300 unique combinations of P/U, NAICS, and IFC. Many of the NAICS 2140 codes reported are from similar industries that would have similar exposure scenarios. 2141 2142 EPA agrees that the new IS codes are less descripti ve than NAICS codes, but believes the 2143 reduction in specificity will not adversely affect, and will actually improve, the Agency‘s ability 2144 to use the processing and use data for screening

- level purposes. The large number of unique 2145 combinations increases th e difficulty and time required to sort and classify chemicals since EPA 2146 would either need to develop exposure scenarios for each unique combination or determine 2147 which three

- code combinations have similar exposure scenarios and can be grouped together. 2148 By replacing the NAICS codes with the IS code, the number of potential three

- code 2149 combinations is reduced from in excess of 100,000 possible combinations to 7,920 combinations. 2150 Based on information collected from the last reporting cycle the number of combina tions 2151 actually reported would be significantly less. Additionally, the IS codes will more closely align 2152 to the EU Sector of Use codes which will allow EPA to compare U.S. data with that collected by 2153 the European Union. 2154 2155 8 . Consumer and commercial use 2156 2157

a . C onsumer and commercial product categories. Many commenters supported revising 2158 the list of consumer and commercial product categories for consumer and commercial use 2159 information. Those commenters stated that harmonizing codes with Canada, revising the prod uct 2160 categories, and requiring descriptive information when the ―other‖ category is reported are 2161 essential to improving the consumer and commercial data. The commenters stated also that 2162 these changes will provide a better understanding of how chemicals are used in downstream 2163 products and will help facilitate consistent reporting of chemical use information in the United 2164 States and Canada. Other commenters wanted more explanation as to why the categories are 2165 being revised and requested that the Agency provi de more descriptive information for each 2166 product category, including a table identifying how the new categories relate to the previous 2167 categories. Some commenters stated that providing a description for the category ―other‖ will be 2168 challenging and may not provide useful information. One commenter stated that the Agency 2169 should not further complicated downstream reporting, noting that was already challenging to 2170 choose the top ten categories for substances with a large number of uses. 2171 2172 EPA appreciates the s upport for the harmonized consumer and commercial product 2173 categories , and agrees that the changes finalized in this rule will improve the IUR data . As 2174 described in Unit III.G.8.a., information from data collected during the 2006 IUR and from 2175*** Interagency EO 12866 Review Draft

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55 Canada was us ed to develop a more useable listing of product categories. EPA eliminated 2176 categories for which few chemicals were reported, added categories identified as needed, and 2177 eliminated overlap in categories. In addition, some categories were renamed to better match 2178 their definitions, other categories descriptors were improved, and categories were grouped to 2179 allow for easier identification. EPA believes these changes will make reporting easier for the 2180 submitter, and does not agree that these changes result in m ore complicated reporting. The 2181 Agency is providing more detailed descriptive information in the 2011 IUR Instructions for 2182 Reporting and other guidance materials. 2183

EPA recognizes that the requirement to report a description when the submitter selects 2184 the product code ―Other‖ may be more burdensome than for the other product codes, but expects 2185 any increase to be minor. The descriptive information is essential to enable users of the data to 2186 estimate potential exposures associated with the consumer or commer cial use of the chemical. 2187 The Agency‘s experience with the 2006 IUR data was that the category of ―other,‖ with no 2188 further description, was insufficient for the data to be of much use. 2189 2190 b . Designation of consumer or commercial use. Commenters had mixed vi ewpoints 2191 regarding the need to designate whether the indicated product category is consumer use, 2192 commercial use, or both. One commenter strongly in support of making this designation stated 2193 that such distinctions are critical to EPA‘s ability to assess exp osure at even the most basic level. 2194 Others didn‘t oppose the added designation, but did ask for further clarification between 2195 consumer and commercial uses. Commenters opposing the added designation stated that they 2196 were too removed from the consumer and co mmercial uses to have a clear understanding of the 2197 uses at that level of distinction, especially for commodity chemicals with a large number of uses. 2198 One commenter said suppliers to formulated products were less likely to know the distinction 2199 because of t he confidentiality of the downstream user formulations. 2200 2201 The intent of the consumer and commercial use data element is to clearly identify the 2202 exposed populations. These two populations (i.e., consumers and commercial workers) are very 2203 different from eac h other, and the ability to distinguish uses between the two enables better 2204
exposure

- based screening of chemicals. EPA recognizes that submitters may not always have 2205 detailed information about how the chemical(s) they make are used and to what extent they are 2206 used. However, EPA believes a manufacturer generally has a certain awareness of the 2207 downstream uses of chemicals it manufactures and sells, even if it does not control its customers‘ 2208 sites, and can report this information, based on what is known to or reasonably ascertainable by 2209 the submitter. 2210 2211

c . Number of commercial workers. Commenters strongly opposed EPA‘s proposal to 2212 require that submitters report the number of commercial workers reasonably likely to be exposed 2213 while using a product containing a reportable substance. Most commenters indicated that they 2214 do not have sufficient information about the work practices of eventual commercial users to 2215 estimate this number, that such information is not typically shared upstream, and that any such 2216 data EPA received would be, at best, an educated guess. It was suggested that the Agency rely on 2217 worker statistics from the Bureau of Labor as it conducts risk assessments, or gather additional 2218 data under a separate TSCA Section 8(a) rule. 2219 2220*** Interagency EO 12866 Review Draft

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56 EPA is requiring this in formation to better assess the size of the commercial population in 2221 screening risk assessments. In the past, the Agency has used the Bureau of Labor Statistics for 2222 general workers statistics to conduct chemical

- specific risk assessments; however, these wor ker 2223 statistics, which are industry

- specific, overestimate the exposures associated with a chemical 2224 because a chemical is likely to be used by only a portion of the industry. Identifying chemical

2225 specific worker populations for downstream activities will f ill this gap for the Agency. The 2226 knowledge of a chemical‘s uses in industry and the respective commercial population potentially 2227 affected by their uses provides the Agency a more complete picture of the potential risks 2228 associated with a chemical. 2229 2230 EPA reco gnizes that submitters may not always have detailed information about how the 2231 chemical(s) they manufacture are used and to what extent they are used in commercial 2232 enterprises. However, EPA believes that a manufacturer generally has a certain awareness of 2233 d ownstream uses of chemicals it manufactures and sells, even if it does not control its customers‘ 2234 sites. Based on its experience with the PMN program, many stakeholder meetings, discussions 2235 about voluntary risk management programs, and industry‘s various self

- regulation initiatives, the 2236 Agency believes that most submitters can report on downstream uses, including the information 2237 that would be reported under IUR, based on what is known to or reasonably ascertainable by the 2238 submitter. To reduce the burden i n reporting, the IUR provides that the number of commercial 2239 workers need only be reported in ranges, and the ranges are the same as for manufacturing and 2240 industrial workers. Reporting in ranges will lessen the reporting burden when the precise 2241 number of w orkers for multiple end uses is not known. Although this may result in some 2242 uncertainty in the data reported, the chemical manufacturer or importer has fulfilled his 2243 obligation by providing information to the extent it is known or reasonably ascertainable. EPA 2244 believes that the data will be sufficiently reliable for the Agency and others to use for screening

2245 level risk assessments and prioritization. 2246 2247 E. Definitions and Clarification Requests 2248 2249 1 . Changing the reporting standard for processing and use info rmation to “known to or 2250 reasonably ascertainable.” A number of commenters requested further clarification (beyond that 2251 offered in Section 4.0 of the Reporting Instructions) of the scope of pre

- reporting inquiry that 2252 would be required under the ―known to or reasonably ascertainable by‖ reporting standard. 2253 Specifically, the commenters requested further clarification of how this reporting standard would 2254 apply in the case of information reported under 40 CFR 711.15(b)(4) (―specific information 2255 related to proce ssing and use‖). The commenters also expressed some confusion about how this 2256 standard would differ from the ―not readily obtainable standard,‖ previously applicable to such 2257 reporting, and whether the change of standard indicates that ―extensive file searc hes and 2258 customer surveys‖ would now be expected of submitters. Other commenters from the chemical 2259 industry expressed their understanding that the change in reporting standard only altered the 2260 level of diligence with which submitters must search for informa tion within their own 2261 organization. They requested confirmation that, as under the ―not readily obtainable‖ standard, 2262 submitters would not be required to conduct customer surveys in order to assemble data for 2263 purposes of inventory update reporting. 2264 2265*** Interagency EO 12866 Review Draft

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57 The term ―known to or reasonably ascertainable by‖ is defined at 40 CFR 704.3. It 2266 means ―all information in a person‘s possession or control, plus all information that a reasonable 2267 person similarly situated might be expected to possess, control, or know.‖ B y contrast, ―readily 2268 obtainable‖ information does not even cover all the information in a submitter‘s possession or 2269 control. As defined for the 2006 IUR, it was limited to what was known by certain 2270 ―management and supervisory employees of the submitter.‖ See 68 FR 879 (2003). Under the 2271 ―known to or reasonably ascertainable by‖ standard, a submitter must therefore ascertain what it 2272 knows about the processing and use of a chemical substance it manufactures, without confining 2273 its inquiry to what is known to managerial and supervisory employees. The inquiry must be as 2274 extensive as a reasonable person, similarly situated, might be expected to perform. Information 2275 derived from customer surveys or other customer contacts, like any other information, would be 2276

― known to or reasonably ascertainable by‖ to the submitter if it is available after a reasonably 2277 extensive inquiry. 2278 2279 EPA agrees that further clarification would be useful regarding what is ―reasonably 2280 ascertainable‖ to submitters about processing and use in formation because this component of the 2281 reporting standard potentially may require submitters to obtain information previously unknown 2282 to them, for the purposes of reporting. This would occur if a submitter knows less than that what 2283 is reasonably ascertain able to it. EPA is therefore offering the following further guidance 2284 regarding the interpretation of this term. 2285 2286 For many of the reasons identified by industry commenters (e.g., the expense and burden 2287 of surveying customers, and uncertainty as to the exte nt to which customers will respond to such 2288 surveys), EPA agrees that if particular information cannot be developed or reasonably estimated 2289 without conducting further customer surveys, it is generally not ―reasonably ascertainable‖ to the 2290 submitter for purp oses of the IUR. However, to the extent that customer surveys are already in 2291 the submitter‘s possession or control, and to the extent that reasonable efforts to locate or analyze 2292 those surveys may result in additional processing and use information (or re asonable estimates of 2293 such information), the information is generally ―reasonably ascertainable.‖ 2294 2295 A number of commenters requested that EPA specify the precise degree of effort required 2296 of manufacturers if they must survey their customers to generate data for the IUR; e.g., how far 2297 down the chain of commerce must such inquiries go? How persistent must the manufacturer be 2298 in seeking such information? As described earlier, EPA does not anticipate that the IUR will 2299 generally require any degree of effort to s urvey customers. However, where surveys have 2300 already been performed, and the results are already in the submitters‘ possession or control, EPA 2301 expects that submissions will be informed by the submitters‘ reasonable efforts to identify and 2302 interpret the re sults. 2303 2304 A number of commenters objected to the ―known to or reasonably ascertainable by‖ 2305 standard on the grounds that it was subjective or too vague to be appropriately applied to the 2306 collection of processing and use information outside of the submitter‘s direct control. Other 2307 commenters objected to the standard‘s reference to what a reasonable person similarly situated 2308 ―might‖ be expected to possess, control, or know. They suggested that the standard be amended 2309 to what a reasonable person ―should‖ be exp ected to know. 2310 2311*** Interagency EO 12866 Review Draft

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58 EPA does not agree that the ―known to or reasonably ascertainable‖ standard is 2312 subjective or excessively vague. The standard is set forth in EPA‘s statutory authority to collect 2313 information under Section 8(a) of TSCA, and EPA‘s definitio n is consistent with Congressional 2314 intent to establish an objective standard: ―The conferees intend that the  ̳reasonably 2315 ascertainable‘ standard be an objective rather than a subjective one. Thus, the manufacturer or 2316 processor must provide information of which a reasonable person similarly situated might be 2317 expected to have knowledge.‖ H.R. Rep. 94

- 1679 at 80 (1976). Thus, whether a particular level 2318 of diligence meets this standard does not depend on the submitter‘s subjective view of what 2319

seems a reasona

ble person ―should‖ be expected to know. It turns on an objective question: the 2320 level of diligence that a reasonable person, similarly situated, might expect to undertake. EPA 2321 believes it is appropriate to define the standard consistently for all persons reporting under 2322 Section 8(a) of TSCA, and that the existing definition appropriately reflects Congressional intent. 2323 Finally, EPA does not think the standard of objective reasonableness will be unfamiliar to 2324 submitters. It is incorporated into a wide var iety of legal standards under state and federal law, 2325 and in the 2006 IUR it applied to all aspects of the information collection other than processing 2326 and use information. 2327 2328 2 . Clarifications to byproduct reporting. a. Concern that new byproduct report ing 2329 requirements are being added. In general, some commenters asserted that EPA‘s explanation of 2330 the IUR byproduct

- related reporting requirements reflect new requirements, inconsistent with 2331 current byproduct exemptions. 2332 2333 EPA is clarifying, not enlarging, the reporting requirements for byproducts, which have 2334 been in place for decades. Byproducts are defined at 40 CFR 704.3, under an existing definition 2335 that has been in place since 1988. The reporting exemptions for byproducts at 720.30(g) and (h) ) 2336 (cross referenced at 40 CFR 711.10) have been in place since 1983. While this final rule is 2337 modifying the applicable definition of ―manufacture,‖ the pertinent language (providing that 2338 manufacture includes ―the extraction, for commercial purposes, of a componen t chemical 2339 substance from a previously existing chemical substance or complex combination of chemical 2340 substances‖) is identical in all material respects to language found in the definition of 2341 ―manufacturer‖ at 40 CFR 704.3 That language has been in force, and applicable to the IUR, 2342 since 1988. 2343 2344 In 1983, EPA promulgated a rule that made clear (for subsequent IUR and PMN 2345 purposes) that the reporting exemption for the manufacture of byproducts is only potentially 2346 applicable to the manufacture of the byproduct and would in no case apply to the manufacture of 2347 component substances extracted from the byproduct. 40 CFR 720.30(g)(3). Furthermore, it has 2348 been the Agency‘s position since at least 1991 that, in order for byproduct manufacture to qualify 2349 for the 720.3 0(g)(3) exemption, ―the component to be extracted must be already existing as a 2350 distinct chemical substance in the waste stream.‖ (Ref.20). When the chemical substance present 2351 in the byproduct and the chemical substance extracted from the byproduct are di stinct chemical 2352 substances, neither the manufacture of the byproduct nor the manufacture of the extracted 2353 chemical substance qualify for the 720.30(g)(3) exemption. 2354 2355 The guidance docketed with today‘s notice, which explains existing byproducts reporting 2356

re quirements under the IUR, is consistent with past guidance issued in connection with the IUR 2357*** Interagency EO 12866 Review Draft

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59 and TSCA new chemicals program. For example: In a 2002 response to public comments on a 2358 previous proposed amendment to the TSCA Inventory Update Rule (see 2003 fi nal rule 2359 published at 68 FR 848, Ref. 18), EPA explained that ―distillation, extraction, refining, and 2360 similar activities may result in the manufacture of a chemical substance.‖ In a 2006 letter to the 2361 Aluminum Association, EPA described a circumstance in which the extraction of aluminum 2362 from aluminum dross byproduct constituted the reportable manufacture of aluminum, while 2363 cautioning that if the aluminum is ―chemically changed during the extraction process,‖ then not 2364 only the extracted aluminum but also t he dross byproduct would be reportable under the IUR 2365 (Ref. 21). In 2008, EPA provided similar guidance by letter to IPC, another trade group (Ref. 2366 22). 2367 2368 Due to the 2003 expansion of the IUR reporting requirements to inorganic chemicals, 2369 many companies ha ve recently become aware of their status as chemical manufacturers when 2370 they recycle their waste materials. Instead of disposing of those waste materials, the 2371 manufacturers return them to commerce by recycling the materials

– either themselves or 2372 through a third party. Recycling may be beneficial for many reasons: it conserves resources, 2373 may reduce the expense of purchasing new raw or starting materials, may reduce the reliance of 2374 the United States on foreign suppliers of raw materials, reduces the need for landfill or other 2375 disposal sites, and returns a waste to commerce. However, many recycling activities fit the 2376 TSCA and IUR rule definition of manufacture, and are likely to be considered ―manufacture for 2377 a commercial purpose.‖ EPA has finalized the d raft IUR guidance documents that were 2378 published with the proposed rule. These documents include examples of many common 2379 manufacturing scenarios to assist individuals in determining whether their company is 2380 manufacturing a chemical that needs to be reported under the IUR (Refs. 11 and 12). 2381 2382 b. Concerns about the IUR byproduct reporting requirements, in relation to RCRA and 2383 the Toxics Release Inventory. Some commenters asserted that byproducts should be regulated, if 2384 at all, under RCRA and/or reported unde r TRI, and should not subject to IUR reporting 2385 requirements. One commenter suggested that EPA revisit the entire issue of the management of 2386 recycled materials to determine the appropriate roles for the TSCA and RCRA programs. Some 2387 commenters also asserte d that reporting under IUR presents a disincentive for recycling. 2388 2389 In broad terms, the purpose of TSCA sections 8 (governing the IUR) and 5 (governing 2390 PMN reporting) is to understand the universe of chemicals in commerce in the United States. 2391 (Section 5 al so provides EPA with the ability to control for risks of new chemicals before they 2392 are placed into commerce.) The IUR requires reporting of manufacture, processing, and use 2393 information for chemicals in commerce, and exemptions exist for those substances o r 2394 manufacturing activities for which EPA has a low current interest. With limited exception, such 2395 as those included in 40 CFR 720.30, all chemical substances in commerce in the United States 2396 are to be listed on the TSCA Inventory; companies can trigger th e addition of a chemical 2397 substance to the Inventory by filing a PMN and meeting certain other requirements. 2398 2399 RCRA is focused on waste

– it is concerned with the generation, transportation, 2400 treatment, storage, and disposal of hazardous wastes and the mana gement of non

- hazardous solid 2401 wastes. RCRA is also focused on waste minimization, phasing out land disposal of hazardous 2402 waste, corrective action for releases, and recycling. EPA notes that while RCRA or other 2403*** Interagency EO 12866 Review Draft

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60 statutes may exempt a certain chemical from reporting requirements based on certain treatments 2404 or disposals, RCRA exemptions do not apply to TSCA reporting obligations, and, given the 2405 different purposes of RCRA reporting and the TSCA IUR rule, are not necessarily relevant to 2406 IUR reporting. It is im portant to note that finding a commercial use for a substance previously 2407 treated as a waste under RCRA can relieve the manufacturer of that substance from some RCRA 2408 requirements, but may then subject that manufacturer to TSCA reporting requirements. EPA i s 2409 aware that, in certain circumstances, reporting under both RCRA and TSCA may be required. It 2410 is the Agency‘s intention to identify and address such circumstances, retaining reporting under 2411 the rule that best fits Agency needs. However, it is important to note that the TSCA program is 2412 working with the RCRA program

-- the application of RCRA regulations varies state

- by

- state, 2413 and recent changes to RCRA regulations have not been adopted by all states. Therefore the 2414 overlap between RCRA reporting and IUR r eporting may vary depending upon the state in which 2415 a submitter‘s site is located. 2416 2417 A similar situation exists for some sites that meet the requirements to report under both 2418 TRI and IUR. The TRI program goal is to provide communities with information about toxic 2419 chemical releases and waste management, and the TRI reporting requirements are designed to 2420 address that goal. Because the IUR program goals differ, the specific information collected 2421 under each program is not the same. Where a person must rep ort for both for the same site, EPA 2422 and the public will have a broader picture of the exposure scenarios at that site, including 2423 environmental releases from that site; while the two information collections may be 2424 complementary, neither is an adequate subst itute for the other. A more in

- depth discussion is 2425 provided in the Responses to Comments document (Ref. 13). 2426 2427 EPA believes that commenters‘ concern that reporting under IUR would be a disincentive 2428 to recycle reflects certain misunderstandings of the I UR requirements. The Agency expects that 2429 revised byproduct guidance materials, as well as EPA‘s responses to the comments concerning, 2430 for instance, byproduct chemical identification requirements, will help to alleviate the majority 2431 of those concerns. EPA believes that many factors play into whether a company chooses to 2432 recycle, including the value of the recovered materials, the expense of disposal, desire to 2433 maintain or build a ―green‖ reputation, technical limitations or flexibility, state and local 2434
req uirements or incentives, and the incentives offered or requirements imposed by other federal 2435 laws (such as RCRA). EPA strongly believes that the benefits of recycling usually outweigh the 2436 burden associated with IUR reporting for these materials, and, just as with any other chemical 2437 whose manufacture must be reported under the IUR, production volume, worker exposure and 2438 other IUR data collected on byproduct chemicals supports the Agency‘s mandate to protect 2439 human health and the environment. 2440 2441 c. Concerns about how to identify the byproduct chemical and with reporting both the 2442 byproduct and a substance extracted from the byproduct. 2443 Commenters stated that it is very difficult to identify the chemicals in a byproduct mixture, and 2444 that the mixture can vary ov er time, depending upon the specific manufacturing situation. 2445 Commenters also argued that there would be duplicative reporting by the byproduct 2446 manufacturer and the recycler/processor who extracted a component chemical substance from 2447 the byproduct mixture. 2448 2449*** Interagency EO 12866 Review Draft

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61 The comments reflect a misperception that characterizing the identity of complex 2450 chemical substances, as are found in or comprise many byproducts, necessarily involves a 2451 detailed analysis of the ―individual components of the chemical substance.‖ In reali ty, a 2452 byproduct may be listed in the Inventory as a single chemical substance that represents, for 2453 TSCA purposes, what may be a complex composition of chemicals. In this way, the chemical 2454 identity of a byproduct may represent a chemical process stream. C omplex chemical substances 2455 are listed (or can be listed) on the Inventory as chemical substances of Unknown or Variable 2456 composition, Complex reaction products and Biological materials (―UVCB‖ substances). As 2457 described by the commenters, the byproduct ―mixt ure‖ is often complex and varies over time, 2458 making the identification of the individual components a very difficult task. This description 2459 itself indicates that the proper identification of such a reaction product is as a UVCB substance. 2460 As stated in EPA ‘s on

- line guidance, ―Each combination of substances resulting from a reaction 2461 is considered by the Agency to be either (1) a mixture, composed of two or more well

- defined 2462 chemical substances to be named and listed separately, or (2) a reaction product, to be listed as a 2463 single chemical substance, using one name that collectively describes the products, or, failing 2464 that, the reactants used to make the products. ― (see 2465 http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt ) Situations may exist where the 2466 byp roduct substance is actually a mixture, but as further described in the aforementioned 2467 guidance, ―A combination of products resulting from a chemical reaction is considered a mixture 2468 provided that all of the component product substances are unambiguously i dentified and are 2469 represented as forming each time the reaction is run.‖ 2470 2471 UVCB substances in some cases include an Inventory definition to further describe the 2472 substance. Here is one example from EPA‘s on

- line guidance (see 2473 http://www.epa.gov/oppt/newch ems/pubs/uvcb.txt): 2474 2475 Dust, iron

- ore, sinter 2476 CASRN 69012

- 53

- 9 2477 Definition: Dust generated during the making, breaking and handling of sinter which is 2478 recovered through the use of pollution abatement equipment. 2479 2480 A byproduct manufacturer, therefore, would potentially report the UVCB name for the 2481 byproduct composition, while the subsequent recycler of the byproduct would potentially report 2482 the specific chemical identity of the substance they chemically manufacture from the byproduct. 2483 EPA does not agree that such reporting is duplicative, because reporting will fall into one of 2484 following two scenarios. If the chemical substance manufactured from the UVCB byproduct is 2485 already present as a constituent of the UVCB byproduct, then the byproduct manufacturer need 2486 not report the byproduct that is sent for such processing/recycling. If the chemical substance 2487 manufactured from the UVCB byproduct is distinct from any chemical substance present in the 2488 UVCB byproduct as a constituent, then the separate reporting by the byproduct manufacturer and 2489 the processor/recycler reflects a change in chemical composition. Either way, there is no 2490 duplication of reporting between the manufacturer of the UVCB byproduct and the 2491 processor/recycler. As a general matter, if there is to be appropriate stewardship of potential 2492 chemicals risks, EPA believes that chemical manufacturers, processors, and users should know 2493 and understand the identities of chemicals they handle. 2494 2495*** Interagency EO 12866 Review Draft

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62 Some commenters stated that many byproduct mixtures in the metals industry are 2496 processed to recover the metal values and indicated that the metal value should be considered a 2497 component chemical substance (i.e., that if Nickel (II) hydroxide (Ni(OH) 2 ) is present in a 2498 byproduct mixture, then the elemental substance Nickel (Ni) should be considered the 2499 component chemical substance). EPA disagrees with this statement. (See Ref. 20 for a 2500 precedent from a 1991 prenotice communication.) Under TSCA, Ni(OH) 2 and elemental Ni are 2501 two different chemical substances, with separate listings on the TSCA Inventory. If the 2502 byproduct contains Ni(OH) 2 but not elemental Ni, only Ni(OH) 2 is considered a component 2503 chemical substance of the byproduct. The manufacture of elemental Ni from either the Ni(OH) 2 2504

– bearing byproduct (or Ni(OH) 2 its elf) results in a potential need to report under IUR. That is, if 2505 the extracted component substance is an oxide and used as an intermediate to form an elemental 2506 metal, then both the oxide and elemental metal are subject to reporting by their manufacturer( s). 2507 Note that information pertaining to manufacture of a chemical substance need only be reported to 2508 the extent that the information is known to or reasonably ascertainable by the submitter. 2509 2510 A second example of a metal

- containing byproduct is: 2511 2512 Electro lytes, copper

- manufg., spent 2513 CASRN 69012

- 54

- 0 2514 Definition: Spent copper sulfate electrolyte consisting of copper sulfate and sulfuric acid 2515 resulting from the electrolytic refining of copper. 2516 2517 This spent material is a UVCB substance that is likely to be recycled. If the only 2518 commercial purpose for this spent material is to extract the component chemical substance 2519 copper sulfate, then the manufacture of the spent material is exempted from reporting (but the 2520 manufacture of the copper sulfate [via extracti on from the byproduct] is subject to reporting). 2521 On the other hand, if the spent material is used directly to manufacture elemental copper, then 2522 both the spent material and the elemental copper are subject to reporting under the IUR by their 2523 respective ma nufacturers, because elemental copper is not a component chemical substance in 2524 the spent material byproduct. 2525 2526 d. Concerns regarding determining when a byproduct is manufactured. 2527 Commenters stated that clarification is needed regarding purification and extr action and when a 2528 chemical is considered manufactured versus purified. Commenters asserted that where there is 2529 no change in chemical identity, only a change in purity, a chemical should not be considered 2530 manufactured, regardless of the method of purifica tion. 2531 2532 Much of the commenters‘ confusion regarding the differences between purification and 2533 extraction appears to concern whether extraction or purification involves a change in chemical 2534 identity; the potential for a change in chemical identity is closel y linked with the proper 2535 identification of the manufactured substance, as described in the previous comment response. 2536 Where there is no change in chemical identity but rather just a change in purity (an impure 2537 chemical substance correctly identified for T SCA purposes as ―substance A,‖ for example, 2538 undergoing purification to a more pure form of ―substance A‖), the Agency agrees with the 2539 commenter that, for purposes of IUR, the chemical is not being manufactured. The substance 2540 that appears on the Inventory may actually represent a category consisting of the same chemical 2541*** Interagency EO 12866 Review Draft

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63 substance in various degrees of purity. For example, if a company manufactures a specific, 2542 discrete chemical substance at 90% purity and it is correctly identified as that discrete substanc e 2543 (not having a UVCB name), then increasing the purity of the substance (such that it retains its 2544 chemical identity) is considered purification and, for purposes of IUR, such purification is not 2545 considered manufacture. 2546 2547 Note, however, that the extract ion of component chemical substances from certain 2548 complex byproduct mixtures or process streams (i.e., UVCB substances), is not considered 2549 purification, because the complex byproduct mixture and the extracted substance do not have the 2550 same chemical identit y. For example, a manufacturing process involving the use of solvent A 2551 results in the manufacture of a spent solvent. As a variable, complex mixture of solvent A, 2552 finished product, unreacted reactants, individual byproduct substances, and other impuritie s, the 2553 spent solvent is considered to be a UVCB substance. It is not unusual for the manufacture to 2554 extract solvent A from this UVCB substance. In such a case, the extracted solvent A is 2555 considered to be manufactured, and therefore is reportable for purp oses of IUR. When the spent 2556 solvent is a byproduct whose only commercial purpose is the extraction of a component chemical 2557 substance, solvent A, the byproduct exemption at 40 CFR 720(g)(3) can be applied and the spent 2558 solvent byproduct does not need to be reported. The extracted solvent A is nevertheless 2559 reportable for purposes of IUR. 2560 2561 3 . Definitions of Manufacture and manufacturer. EPA received several comments on the 2562 definition of ―manufacture,‖ asserting that the definition of manufacture included i n the proposed 2563 rule was inconsistent with past definitions, over

- broad, and confusing. 2564 2565 EPA disagrees, except with respect to minor typographical errors noted below. EPA 2566 consolidated existing definitions into a single ―manufacture‖ definition to reduce confusion. 2567 EPA also added a very short clarifying definition that ―a manufacturer is a person who 2568 manufactures a chemical substance,‖ to direct the reader to the relevant language in the 2569 definition of ―manufacture,‖ and to avoid confusion with an existing definition of 2570 ―manufacturer‖ in 704.3. The definition of ―manufacture‖ is consistent with established 2571 regulatory and statutory definitions, and is sufficiently flexible to accommodate the actual 2572 allocation of knowledge between toll manufacturers and cont racting companies. EPA has 2573 separately addressed the comments received relating to the extraction of component chemical 2574 substances. (See the discussion on reporting byproducts and recycling elsewhere in this Unit.) 2575 2576 The first part of the definition of ma nufacture in today‘s final rule is as follows: 2577 ―Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture 2578 includes the extraction, for commercial purposes, of a component chemical substance from a 2579 previously existing chemi cal substance or complex combination of substances.‖ It is similar to 2580 the definitions of ―manufacture‖ and ―manufacturer‖ used for past IUR reporting. For example, 2581 the definition of manufacturer in effect for the 2006 IUR reporting period is in 40 CFR 70 4.3: 2582 ―Manufacturer means a person who imports, produces, or manufactures a chemical substance. A 2583 person who extracts a component chemical substance from a previously existing chemical 2584 substance or a complex combination of substances is a manufacturer of t hat component chemical 2585 substance.‖ The two similar definitions of ―manufacture‖ in effect for the 2006 IUR reporting 2586 period were found in 40 CFR 710.3 (―to manufacture, produce, or import for commercial 2587*** Interagency EO 12866 Review Draft

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64 purposes,‖ and 40 CFR 704.3 (―to manufacture for com mercial purposes‖). The Part 711 2588 definition of ―manufacture‖ is also consistent with the established definition of ―manufacturer‖ 2589 used for purposes of PMN reporting, at 40 CFR 720.3. Existing Part 704.3, which was not 2590 modified in today‘s final rule, also includes a definition of manufacture: ―Manufacture means to 2591 manufacture for commercial purposes,‖ and a definition of ―manufacture for commercial 2592 purposes‖ that makes clear that byproducts produced during manufacturer are also 2593 ―manufactured for a commerci al purpose.‖ 2594 2595 The definition of ―manufacture‖ in today‘s final rule is also similar to and consistent with 2596 TSCA‘s definition of ―manufacture‖ at Section 3: ―‘manufacture‘ means to import in the 2597 customs territory of the United States, produce, or manufact ure,‖ and Section 8: (―For purposes 2598 of this section, the term ―manufacture‖ . . . mean[s] manufacture . . . for commercial purposes.‖) 2599 2600 The second part of the definition, as noted in the preamble to the proposed rule, adds an 2601 explanation, derived from t he definition of ―manufacturer‖ in Part 720, of the conditions under 2602 which a contract manufacturer would be considered to ―manufacture,‖ and therefore be 2603 responsible for IUR reporting. Persons contracting with a toll manufacturer and toll 2604 manufacturers ar e now considered to be co

- joint manufacturers of what is produced at the toll 2605 manufacturer‘s site. Consistent with 40 CFR 711.22(c), such parties should coordinate amongst 2606 themselves to submit a single report, rather than duplicative individual reports, r especting what 2607 they have co

- manufactured. The joint submission mechanism, under 40 CFR 711.15(b)(3)(i), is 2608

not available to co

- joint manufacturers. The joint submission mechanism addresses distinct 2609 circumstances: those in which one party is the manufactu rer/importer, and a second party (not a 2610 manufacturer of the chemical substance in question) possesses confidential information needed 2611 to determine the chemical identity of what the first party has manufactured/imported. In the final 2612 rule, EPA uses the ter m ―co

- manufactured‖ rather than the proposed term ―jointly 2613 manufactured.‖ This change of terminology is intended to avoid confusion between the 2614 reporting provisions at 40 CFR 711.22(c) and those at 40 CFR 711.15(b)(3)(i). 2615 2616 EPA notes that one change to the definition of ―manufacture‖ was made to correct a 2617 typographical error in the definition as proposed and to address a comment that the definition 2618 used confusing syntax. The word ―and‖ should have been included between the paragraphs 2619 numbered (1) and (2), and the text should have been formatted differently, to make clear that the 2620 conditions in paragraph (1), and the conditions in paragraph (2) (up to the comma), must both be 2621 satisfied before a chemical substance will be considered ―co

- manufactured‖ by the p roducing 2622 manufacturer (i.e., the toll manufacturer) and the person contracting for such production (i.e., the 2623 contracting company). 2624 2625 Several commenters suggested that the toll manufacturer should be primarily or solely 2626 responsible for IUR reporting, or exp ressed concern that the rule would compel contracting 2627 companies to submit information on behalf of toll manufacturers. Another commenter supported 2628 the assignment of responsibility as proposed. Some commenters also suggested that EPA should 2629 ―acknowledge t he complexity of contractual mechanisms and not offer a blanket,  ̳one size fits 2630 all‘ requirement for reporting responsibilities.‖ 2631 2632*** Interagency EO 12866 Review Draft

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65 EPA agrees that a diversity of contractual arrangements may exist, and notes that there 2633 was nothing in the proposed IUR rul e to prevent toll and contracting manufacturers from sharing 2634 information and agreeing between themselves that one or the other will undertake all or a portion 2635 of the work associated with IUR reporting for a given chemical, though comments indicated that 2636 th ere was some confusion caused by EPA‘s assignment of ―primary‖ responsibility for reporting 2637 to the contracting manufacturer (see 40 CFR 711.22(c)). EPA expects that in most instances, a 2638 person that contracts with a toll manufacturer will generally know mo re about the particular 2639 chemical substances, and will usually be a better position to report on industrial processing and 2640 use of a substance, and on commercial and consumer uses of products containing the substance. 2641 Similarly, EPA expects that the toll ma nufacturer will generally be in a better position to report 2642 on the number of workers and other information about their plant. In light of the contracting 2643 company‘s control over the ―total amount produced and the basic technology for the plant 2644 process,‖ an d based on EPA‘s expectations of the relative knowledge of the contracting 2645 company, EPA initially indicated, in proposed section 711.22(c), that the contracting company 2646 would be ―primarily responsible‖ for IUR reporting. However, given the confusion intro duced 2647 by indicating that one party or the other is ―primarily‖ responsible for reporting, and not wishing 2648 to interfere in contractual agreements to the contrary, EPA has decided not to allocate ―primary‖ 2649 responsibility to either party in the final rule. C onforming changes have been made to section 2650 711.22(c) in this final rule. However, the enforceability of the rule requires EPA to specify the 2651 persons who are legally responsible for reporting. In fairness, EPA has chosen to make both 2652 parties responsible for reporting on the chemical substances they have co

- manufactured, as 2653 specified in the proposed rule. 2654 2655 4 . Definition of Site. Several commenters asserted that the proposed revision to the 2656 definition of ―site‖ would force different companies that are a t the same site to report together. 2657 EPA disagrees with this assertion. In the proposal, EPA added explanations to accommodate 2658 manufacturing under contract and for portable manufacturing units, and clarified that an 2659 importer‘s site must be a US address. The definition of site used in the past, at 40 CFR 710.3, 2660 was not otherwise significantly changed. The old definition states that ―Site means a contiguous 2661 property unit. Property divided only by a public right

- of

- way will be considered one site. There 2662

m ay be more than one manufacturing plant on a single site. ...‖ This portion of the definition 2663 was retained, with slight wording change (―More than one plant may be located on a single 2664 site.‖), in the proposed rule. 2665 2666 The statement ―More than one plant m ay be located on a single site‖ is meant to guide 2667 companies that have multiple plants at one site to sum production volumes and other IUR

2668 reportable data across all of their plants at one site and produce one report for each reportable 2669 substance at each si te (not at each plant). The definition does not require different companies 2670 located at the same site to report together. 2671 2672 5 . Processing and use

- related definitions. EPA received comments in favor of the 2673 amended definitions for commercial and consumer use . However, a commenter indicated that the 2674 definitions of "industrial," "commercial," "function," and "use," were unclear and referred to 2675 problems in reporting both product

- and substance

- level information. EPA appreciates the 2676 support for the amending the t erms commercial and consumer use to harmonize the definitions 2677 developed by the U.S. and Canada. 2678*** Interagency EO 12866 Review Draft

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66 2679 EPA feels the terms industrial and commercial are adequately defined. To clarify, EPA 2680 defines industrial function as ―the intended physical or chemical charac teristic for which a 2681 chemical substance or mixture is consumed as a reactant; incorporated into a formulation, 2682 mixture, reaction product, or article; repackaged; or used.‖ This definition can be found in the 2683 document ―IUR Modifications Rule: Development of Definitions for 40 CFR 711.3‖, which is 2684 located in EPA IUR docket (EPA

- HQ

- OPPT

- 2009

- 0187

- 0032) and will be part of the proposed 2685 regulation changes. EPA also notes that the terms ―use‖, ―industrial use,‖ ―consumer use,‖ and 2686 ―commercial use‖ have already b een in use for IUR and were previously defined in 40 CFR Part 2687 710.43 (relocated in today‘s final rule to 711.3). 2688 2689 F. Confidential Business Information 2690 2691 1 . Release of information not validly claimed as CBI. The Agency received comments 2692 about the proposed ch ange to make information claimed as CBI available to the public without 2693 further notice to the submitter, in the circumstance that the required substantiation is not 2694 submitted with the claim. Opponents of the change are concerned that a reporting error cou ld 2695 result in public release of legitimate CBI. They suggested notifying the submitter if further 2696 substantiation is needed prior to releasing data to the public. The commenters are in favor of a 2697 warning system that would allow submitters time to provide ad ditional substantiation on CBI 2698 claims before the Agency determines the data is non

- CBI and releases it as public information. 2699 2700 There are three situations during which the Agency will release IUR information claimed 2701 as CBI without further notice to the subm itter. First is the circumstance that a CBI claim is made 2702 for the identity of a chemical already listed on the non

- confidential portion of the Master 2703 Inventory File. Any such CBI claims were invalid under the previous IUR regulations 2704 (applicable to the 2 006 and earlier submission periods). 2705 2706 The second is the circumstance that a submission lacks the certification required under 40 2707 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a certification stating that the submitted 2708 information has been completed in c ompliance with the requirements of this part and that the 2709 confidentiality claims made on the Form U are true and correct. The certification must be signed 2710 and dated by the authorized official for the submitter company, and provide that person‘s name, 2711 offi cial title, and e

- mail address. Consistent with this regulatory provision, the e

- IUR software is 2712 designed to entirely block the submission of a Form U lacking an appropriate certification. 2713 2714 The third is the circumstance that a particular CBI claim is not accompanied by upfront 2715 substantiation required under 40 CFR 711.30(b),(c),or (d) (e.g., upfront substantiation of 2716 processing and use information). The e

- IURweb reporting tool is designed to protect against a 2717 company not providing an upfront substantiatio n. When a CBI claim is made and substantiation 2718 is required, the reporting tool will open the substantiation question page. Should the submitter 2719 choose not to complete the substantiation at that time, or to only partially complete it, the 2720 validation porti on of the tool will again alert the submitter to the need for substantiation. The 2721 tool also includes warnings that information with unsubstantiated CBI claims will be released 2722 without further notice to the submitter. EPA believes these reminders provide sufficient notice 2723 to the submitter of the need to substantiate these claims. 2724*** Interagency EO 12866 Review Draft

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67 2725 2 . Upfront substantiation for processing and use information. The Agency received 2726 comments both for and against the proposed upfront substantiation requirement when processin g 2727 and use information is claimed as confidential. Commenters opposing the proposed change 2728 explained that processing and use information is often considered confidential by customers to 2729 protect their competitive positions in the market. Commenters voiced c oncern that the proposed 2730 change will impact their ability to remain competitive or will reduce innovation. These 2731 commenters were concerned that the manufacturers of the chemical substances would not 2732 correctly identify CBI associated with downstream uses, a nd that confidentiality agreements 2733 between the chemical manufacturer and the downstream users would not provide sufficient 2734 substantiation for the processing and use information. The Agency believes that the processing 2735 and use information in the publicly

- r eleased IUR reports is sufficiently agglomerated to address 2736 these concerns. However, the Agency also recognizes that there are circumstances when the 2737 release of information about a particular use could harm the competitive position of the 2738 submitter‘s cust omer. Therefore, EPA has modified the substantiation question at proposed 40 2739 CFR 711.30(d)(1)(ii) to include information about harm to the submitter‘s competitive position 2740 ―or to your customer‘s competitive position.‖ EPA also notes that under its confide ntiality 2741 regulations, the Agency normally solicits input from all affected businesses when making a final 2742 confidentiality determination respecting information claimed as CBI. 2743 2744 Some commenters stated that providing written explanations for multiple scenario s would 2745 be burdensome. Another commenter argued, however, that requiring such explanations will help 2746 to limit CBI claims to information that in fact warrants protection as a legitimate trade secret. 2747 The commenter asserted that the frequency with which sit e information was claimed as CBI 2748 dropped from 28% to 7% after EPA added an upfront substantiation requirement for that data 2749 element, and suggested that the drop represented an elimination of ―excessive‖ trade secrecy 2750 claims. 2751 2752 The Agency recognizes that the re is a burden associated with providing written 2753 explanations. However, based on the significant number of CBI claims for processing and use 2754 information in the last information collection, EPA believes that allowing submitters to assert 2755 CBI claims merely by checking a box encourages submitters to assert such claims without 2756 sufficiently considering whether there is a basis for the claim. While EPA believes that such 2757 claims are appropriate under certain circumstances, the Agency wants to ensure that all suc h 2758 claims are carefully considered and only information that is truly confidential, the release of 2759 which would substantially injure the competitive position of the submitter, is claimed as CBI. A 2760 substantiation requirement for such claims helps ensure that this consideration takes place. 2761 2762 3. Prohibition of confidentiality claims for data elements designated as “not known or 2763 reasonably ascertainable.” Commenters agreed with prohibiting CBI claims for processing and 2764 use information when designated as ―not k nown o r reasonably ascertainable

. " The primary 2765 reason cited by supporters was that the proposed change will reduce the potential for 2766 unwarranted CBI claims. 2767 2768 G. Administrative Comments 2769 2770*** Interagency EO 12866 Review Draft

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68 1 . Changes to reporting frequency. The Agency received comments regard ing the 2771 proposed change to increase the IUR reporting frequency from every 5 years to every 4 years. 2772 Some commenters suggested a change to the reporting frequency would still present a burden to 2773 industry and that EPA has not provided adequate justification to warrant or support any increase 2774 in the reporting frequency. Other commenters expressed support for the return to the reporting 2775 frequency of every 4 years but some felt that to increase the frequency further would be 2776 problematic. Additional commenters suggesting even more frequent reporting cycles and these 2777 comments are addressed in more detail in the  ̳ ̳Summary of EPA‘s Responses to Public 2778 Comments Submitted in Response to Proposed TSCA Inventory Update Reporting 2779 Modifications‘‘ (Ref. 13). 2780 2781 In the 2003 IUR Amendments, EPA changed its reporting requirement from every 4 2782 years to every 5 years to lessen the burden associated with complying with the amendments. 2783 However, EPA has decided to return to the reporting frequency of every 4 years, in order to 2784 better meet Agency needs. EPA has determined that reporting every 5 years is too infrequent, 2785 and does not provide enough data to sufficiently cover the Agency's and public's needs. As 2786 discussed in Unit III.D.1 of the proposed rule, many chemical substances, eve n larger volume 2787 chemical substances, often experience wide fluctuations in manufacturing volume from year to 2788 year. This can result in the production volume of a chemical substance exceeding the threshold 2789 for several years, then falling below the threshold during the IUR principal reporting year. A 2790 review of the previous reporting under the IUR indicates an approximately 30% change in the 2791 chemicals that are reported from one reporting period to the next. Therefore, the 1

– year snapshot 2792 of production volume do es not provide an accurate picture of the chemical substances in 2793 commerce, and may provide an erroneous view of the exposure scenarios associated with a 2794 particular chemical substance. In addition, EPA has been criticized for using outdated 2795 information, w hich will be remedied with more frequent reporting. As such, EPA has determined 2796 that the value gained through obtaining more current and useful data is essential to fulfilling the 2797 Agency‘s statutory obligations under TSCA, and outweighs the incremental bur den to 2798 submitters. 2799 2800 2 . Delete superfluous text regarding production volume. The Agency received comments 2801 on the proposal to delete superfluous text associated with reporting production volumes, in 2802 particular the +/

- 10 percent standard of precision. All commenters opposed changing the 2803 current language. Several commenters indicated that reporting accurately to two significant 2804 figures is not equivalent to reporting to a precision of +/

- 10%. One commenter indicated that, if 2805 reporting to two significant fi gures, at higher production volumes there would be a narrower 2806 allowable range of variation. 2807 2808 EPA is replacing ―provided that the reported figures are within +/

- 10% of the actual 2809 volume‖ currently found in 40 CFR 710.52(c)(3)(iv) with ―This amount must be r eported to two 2810 significant figures of accuracy.‖ The deleted phrase is superfluous because any number reported 2811 accurately to two significant figures is within 10% of the correct value. EPA recognizes some 2812 commenters‘ concern that this will result in a slid ing precision scale between 1% and 10% that is 2813 solely based on the reported digits. However, EPA believes that reporting to two significant 2814 figures will maintain a balance between data needs for exposure screening and the industry 2815 burden associated with d ata collection. In the 2006 IUR data collection, nearly all manufacturers 2816 reported production volumes in greater precision (i.e., more significant figures) than is required 2817*** Interagency EO 12866 Review Draft

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69 for 2011 reporting. Based on years of experience assessing chemical risks through programs 2818 such as the New Chemicals Program, the Agency believes requiring reporting to two or more 2819 significant figures is appropriate to facilitate the Agency‘s initial exposure screens of chemicals, 2820 and to prioritize and make basic risk management decisio ns about those chemicals of greatest 2821 concern. Those decisions then can prompt more detailed assessments as necessary. 2822 2823 H. Economic Impact Estimates 2824 2825 1 . General burden comments. The Agency received a number of comments expressing 2826 concerns about the Econ omic Analysis (Ref. 19); the majority of which suggest that the Agency 2827 has significantly underestimated t he effort required to collect, organize, verify and report IUR 2828 data . Commenters disagreed with EPA‘s burden estimates for several proposed modification s to 2829 the rule, including the retroactive reporting of production volumes, reporting on imported 2830 mixtures, mandatory electronic submission, the lowering of the threshold for downstream 2831 processing and use information, the change in the standard of reporting from ―readily obtainable‖ 2832 to ―known to or reasonably ascertainable by‖, and the change in the reporting cycle from every 2833 five to every four years. Several commenters asserted that the reporting burden will increase to 2834 between two and six times the burden f or reporting in 2006. However, few commenters provided 2835 specific reasons for why they believe that the Agency‘s estimates were low, and no commenters 2836 provided any analytical basis for revising EPA‘s estimates or substantiated their alternative 2837 estimates. Th e Agency has used the best available data to estimate the burden associated with the 2838 modifications to the IUR rule, and disagrees with the commenters. The burden estimates 2839 presented in the economic analysis are reasonable estimates for the average IUR subm itter. 2840 2841

a. Identification of affected entities. In general, commenters stated that the Economic 2842 Analysis does not identify all affected entities, and EPA has inaccurately assumed that the 2843 proposed rule will affect only chemical manufacturers. Another com menter noted that a wide 2844 range of industries manufacture byproducts, so to accurately estimate the burden of the proposed 2845 rule, EPA must identify all affected industries and facilities. The commenter further stated that 2846 byproducts sent for recycling are n ew chemicals reportable under the IUR rule and the Economic 2847 Analysis fails to identify these manufacturers. 2848 2849 The Economic Analysis assumes that all companies manufacturing or importing 2850 chemicals annually in amounts of 25,000 lb. or greater that are listed on the TSCA Inventory will 2851 report under this rule. Chemical users and processors who may manufacture a byproduct 2852 chemical substance for a commercial purpose, e.g., utilities, paper manufacturers, primary metal 2853 manufacturers, and semiconductor and other el ectronic component manufacturers (NAICS codes 2854 22, 322, 331, and 3344), are considered to be chemical manufacturers for the purposes of the 2855 IUR rule. Sites that manufactured a byproduct in a volume above the 25,000 lb. threshold during 2856 the 2006 reporting cy cle were required to report under IUR, and therefore are included in the 2857 2006 baseline estimates. 2858 2859 b . Total industry compliance determination burden. Commenters made a number of 2860 specific points regarding the compliance determination burden. According to o ne commenter, 2861 provisions requiring reporting of more data for many chemicals, replacing NAICS codes with 2862 European IS codes, and requiring upfront substantiation for CBI claims for Part III information 2863 will contribute to the increased effort required to rep ort. 2864*** Interagency EO 12866 Review Draft

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70 2865 EPA disagrees that the Economic Analysis underestimates the reporting costs and 2866 burdens of today‘s IUR amendments as asserted by the commenters. EPA does agree that many 2867 of the amended rule requirements, including provisions requiring reporting of m ore data for 2868 many chemicals, replacing NAICS codes with Industrial Sector codes, and requiring upfront 2869 substantiation for CBI claims for Part III information, will cause an increase in burden and cost. 2870 While EPA does state throughout the EA that the burden s and costs may be overestimated, the 2871 analysis also says that they may be underestimated. The statements regarding limitations of the 2872 study serve to make the analysis more transparent. EPA does not have the ability to take into 2873 account the effects of indiv idual company circumstances concerning downsizing, growth, 2874 mergers and acquisitions, on estimates of reporting burden and cost, as mentioned by one 2875
commenter. 2876 2877 Several commenters assert that EPA has underestimated the burden associated with IUR 2878 complian ce determination by estimating the burden on a per

- report basis. According to the 2879 comments, this methodology does not capture the burden associated with tracking, screening, 2880 and keeping records for chemicals that ultimately are not required to be reported to IUR because 2881 they are manufactured or imported in quantities below the reporting threshold. 2882 2883 Compliance determination occurs on a per

- site basis and is based on a manufacturer 2884 (including importer) determining that it manufactures at least one chemical at or above the 2885 threshold, thus necessitating that the site complete and submit a Form U. The Economic Analysis 2886 assumes all sites that report to the IUR incur the same average cost for compliance determination 2887 regardless of the number of chemicals reported . EPA expects that it is standard company practice 2888 to track and maintain records of production volumes for all chemicals manufactured at a given 2889 site. Therefore, EPA expects that the burden associated with compliance determination should 2890 not be substantial . The commenters appear to have misinterpreted EPA‘s compliance 2891 determination burden to include the burden of actually reporting for the chemicals subject to the 2892 IUR, but this is not the case. See Section 4.2.2 of Ref. 19 for further clarification. 2893 2894 Final ly, EPA notes that the IUR does not require submitters to retain documentation 2895 showing that particular chemicals did not need to be included in a given year‘s report. In 2896 addition, once a submitter has made a compliance determination that it has reporting obligations 2897 under the IUR, it can rely on production volume information already reasonably available, in the 2898 ordinary course of business, to determine that particular chemicals do not need to be reported 2899 under the IUR. For this reason, EPA believes it is unreasonable to attribute to the rule the costs 2900 of tracking, screening, and keeping records of the various production volumes of chemicals that 2901 ultimately are not required to be reported to IUR because they are below the reporting threshold. 2902 2903

c . Underlyin g assumptions and data: baseline costs. Commenters question the baseline 2904 number of reports EPA used in calculating baseline costs. One commenter questions whether 2905 EPA‘s estimate included inorganic substances. Another commenter questions whether EPA has 2906 adj usted the baseline estimates to account for new manufacturing facilities that never previously 2907 reported under the IUR rule, the elimination the 300,000 lb. threshold for processing and use 2908 data, and the change in the method of determining the eligibility t o report. 2909 2910*** Interagency EO 12866 Review Draft

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71 The 2006 IUR submission data provide the best estimate for the number of reports that 2911 would be submitted under the baseline scenario. The baseline scenario in the Economic Analysis 2912 assumes no changes have been made to the 2006 reporting requi rements. This cost is used as a 2913 basis on which to calculate the incremental cost of the rule. Therefore, in the baseline, the 2914 number of reports should not be adjusted to account for any proposed modifications. The 2915 Economic Analysis does estimate the additi onal number of Part III reports that will be submitted 2916 as a result of today‘s final rule amendments, including the elimination of the 300,000 lb. 2917 threshold (see Section 4.4.4 of Ref. 19 ), as well as the additional number of reports submitted as 2918 a result of the change in the method of determining the eligibility to report (see Section 4.4.3 of 2919 Ref. 19 ). In addition, the Economic Analysis accounts for rule familiarization costs for any new 2920 companies submitting data (see Section 4.2.2 of Ref. 19 ). The 2006 dat a do include reports for 2921 inorganic chemicals, because while inorganic chemical manufacturers were exempt from 2922 submitting downstream processing and use information in the 2006 reporting cycle, they were 2923 required to submit Parts I and II of Form U, and there fore are included in the baseline number of 2924 reports. 2925 2926 G. Request for Comment on Additional Issues. EPA requested comment on several 2927 additional topics in Unit V of the preamble to the proposal, at p. 49676. The comment summaries 2928 and responses to these is sues are contained in the ―Summary of EPA‘s Responses to Public 2929 Comments Submitted in Response to Proposed TSCA Inventory Update Reporting Modifications 2930 Rule‖ (Ref 13). 2931 2932 IV. References 2933

As indicated under ADDRESSES , a docket has been established for this rulemaking 2934 under docket ID number EPA

– HQ

– OPPT

– 2009

– 0187. The following is a listing of the 2935 documents that are specifically referenced in this document. The docket includes these 2936 documents and other information considered by EPA in developing this final r ule, including 2937 documents that are referenced within the documents that are included in the docket, even if the 2938 referenced document is not physically located in the docket. For assistance in locating these 2939 other documents, please consult the technical pers on listed under FOR FURTHER 2940 INFORMATION CONTACT

. 2941

1. EPA. Inventory Reporting Regulations; Final rule. Federal Register (42 FR 64572, 2942 December 23, 1977) (FRL

– 817

– 1). 2943

2. EPA. Partial Updating of TSCA Inventory Data Base; Production and Site Reports; 2944 Final ru le. Federal Register (51 FR 21438, June 12, 1986) (FRL

– 2973

– 3). 2945

3. EPA. TSCA Inventory Update Rule Amendments; Final rule. Federal Register (68 FR 2946 848, January 7, 2003) (FRL

– 6767

– 4). 2947

4. EPA. OPPT. Enhancing EPA's Chemical Management Program. Available on

- l ine at: 2948 http//www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html

. 2949

5. EPA. Instructions for 2011 Inventory Update Reporting, July 2010. 2950*** Interagency EO 12866 Review Draft

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72 6. EPA. OPPT. IUR Modifications Rule: Development of Definitions for Proposed 40 2951 CFR 711.3. July 8, 2010. 2952

7. EPA. TSCA Inventory Update Reporting Revisions; Final rule. Federal Register (70 2953 FR 75059, December 19, 2005) (FRL

– 7743

– 9). 2954

8. EPA. OPPT. Electronic Signature Agreement. August 2009. 2955

9. EPA/Environment Canada/Health Canada, Overview of Harmonized U.S.

- Canada 2956 Industrial Function and Consumer and Commercial Product Codes for Chemical Inventory 2957 Reporting. June 2009, Revised November 2009. 2958

10. EPA. OPPT. Summary of EPA‘s Responses to Public Comments Submitted in 2959 Response to Proposed TSCA Inventory Update Reporting Modifications Rule. Federal Register 2960 (75 FR 49656, August 13, 2010) (FRL

- 8833

- 5). 2961

11. EPA. OPPT. EETD. Inventory Update Reporting (IUR) Technical Support Document 2962

— Replacement of 5

– digit NAICS Codes with Industrial Sector (IS) Codes. October 2009. 2963

12. E PA. OPPT. Fact Sheet: Recycling and the TSCA Inventory of Chemical Substances 2964 Premanufacture Notification and Inventory Update Reporting Requirements. July 2010. 2965

13. EPA. OPPT. Q&A Document: Recycling and the TSCA Inventory of Chemical 2966 Substances Premanufa cture Notification and Inventory Update Reporting Requirements. July 2967 2010. 2968

14. Proposal for Priority Setting for Existing Substances on the Domestic Substances List 2969 under the Canadian Environmental Protection Act, 1999. Greatest Potential for Human 2970 Exposur e, Canada, 2003. 2971

15. EPA. OPPT. Screening

- Level Hazard Characterization and Prioritization Document. 2972 March 2009. Available on

- line at: 2973 http://ww w.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP_Marc 2974 h%202009.pdf

. 2975

16. EPA. OPPT. Economics, Exposure and Technology Division (EETD). Economic 2976 Analysis for the Proposed Inventory Update Reporting (IUR) Modifications Rule. July 20, 201 0. 2977

17. NOVA Chemicals, Letter to Docket ID No. EPA

- HQ

- OPPT

- 2009

- 0187, from Linda 2978 Santry. October 7, 2010. 2979

18. EPA. OPPT. Initial Risk

- Based Prioritization of High Production Volume (HPV) 2980 Chemicals. April 2009. Available on

- line at : 2981 http://www.epa.gov/chem rtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.pdf. 2982

19. Environmental Defense Fund, Letter to Docket # EPA

- HQ

- OPPT

- 2009

- 0187 (on 2983 behalf of 32 organizations), from Richard Denison, PhD, October 12, 2010. 2984*** Interagency EO 12866 Review Draft

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73 20. Prenotice Communication Letter from Mary E. Cushmac, EPA, July 29, 1991. 2985

21. Letter from Susan Sharkey, EPA, to Robert P. Strieter, The Aluminum Association, 2986 October 24, 2006. 2987

22. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC, August 27, 2008. 2988

V. Statutory and Executive Order Reviews 2989 2990 A. Executive Order 12866 2991

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 2992 October 4, 1993), this action has been designated a ―significant regulatory action‖ by the Office 2993 of Management and Budget (OMB). Accordingly, EPA s ubmitted this action to OMB for review 2994 under Executive Order 12866 and any changes made in response to OMB recommendations have 2995 been documented in the docket for this action. 2996

In addition, EPA has prepared an economic analysis of the potential impacts asso ciated 2997 with this action. A copy of this economic analysis, entitled, Economic Analysis for the Inventory 2998 Update Reporting (IUR) Modifications Rule (Ref. 19), is available in the docket and is briefly 2999 summarized in this unit. The Agency, in promulgating t his rule, is required under TSCA to 3000 consider the potential costs and benefits associated with IUR. The analysis was therefore used by 3001 the decision

- makers to help in the selection of the final rule requirements presented in this 3002 document. 3003 3004

The amendments in this rule affect the number of reports submitted during a submission 3005 period, the burden to prepare a report, and the reporting frequency. EPA estimates that the 3006 combined impact of all the amendments will increase the total burden and cost to industry 3007 associated with IUR reporting. 3008

In its Economic Analysis, EPA estimated industry cost and burden on a per

- report and a 3009
per

- site basis and at the industry level. Industry cost and burden are incurred by performing 3010 activities to comply with the amendments, including compliance determination, rule 3011 familiarization, preparation and submission of reports, and recordkeeping. 3012

On a per

- report basis, EPA estimated incremental increases of 4.28 hours and $350 for a 3013 site to complete a partial report for one chemical s ubstance and 17.38 hours and $1,408 to 3014 complete a full report for one chemical substance, in the first reporting cycle after the effective 3015 date of the rule amendments. A partial report includes Parts I and II of Form U. A full report 3016 includes Parts I, II , and III of Form U. For future reporting cycles, EPA estimated incremental 3017 increases of 3.28 hours and $275 for a site to complete a partial report for one chemical 3018 substance and 12.98 hours and $1,075 to complete a full report for one chemical substance

. 3019

As a result of the amendments, EPA estimates that the average site will submit 3020 approximately 2.01 fewer partial reports and 2.98 additional full reports in a submission period. 3021 For the average site, this will increase the burden by 341 hours during the first reporting cycle 3022 and 264 hours for all subsequent reporting cycles. EPA estimates that the average site will incur 3023*** Interagency EO 12866 Review Draft

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74 a net cost increase of $22,493 during the first reporting cycle and $17,517 during all future 3024 reporting cycles. 3025

At the industry level f or all sites submitting a Form U, EPA estimates a net total burden 3026 increase of 1.39 million hours in the first reporting cycle, and 1.21 million hours for all 3027 subsequent reporting cycles. EPA estimates a net cost increase of $91.87 million in the first 3028

re porting cycle of the rule, and $79.29 million in all subsequent reporting cycles. When the 3029 reporting cycle costs are averaged over the four

– year reporting cycle, the average annualized 3030 increase in industry cost attributable to the amendments is approximate ly $21.61 million over a 3031 25

– year period (at a 3% discount rate). 3032

EPA estimates that the Agency will experience a reduction in both burden and cost to 3033 administer the IUR rule as a result of the amendments. Specifically, EPA expects to experience a 3034 net burde n reduction of 1,721 hours in the first reporting cycle and all subsequent reporting 3035 cycles. The Agency estimates it will experience a net savings of $179,600 during each reporting 3036 cycle. This information will be reflected in the ICR that is submitted eve ry three years to OMB 3037 under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq

. 3038

EPA believes that this final rule represents an appropriate balance between the burden 3039 placed on industry to provide information and the Agency‘s need for that informati on to fill its 3040 statutory obligations and fulfill its mission under TSCA and, as part of that mission, to provide 3041 information needed by other agencies (OSHA, NIOSH, CPSC, etc.). 3042 3043 B. Paperwork Reduction Act 3044

The information collection requirements in 40 CF R part 710 related to the submission of 3045 Form Us are already approved by OMB under PRA. That ICR has been assigned EPA ICR No. 3046 1884 and OMB control no. 2070

– 0162. Because this final rule involves new or revised 3047 information collection activities that requi re additional OMB approval, EPA has prepared an 3048 addendum to the currently approved ICR (Ref. 20). An agency may not conduct or sponsor, and 3049 a person is not required to respond to an information collection request subject to PRA, unless it 3050 displays a curre ntly valid OMB control number. The OMB control numbers for EPA‘s 3051 regulations are listed in 40 CFR part 9 and included on any related collection instrument (e.g., on 3052 the form or survey). 3053

Under PRA, the term ―burden‖ is interpreted as the total time, effor t, or financial 3054 resources expended by people to generate, maintain, retain, disclose, or provide information to or 3055 for a Federal agency. This includes the time needed by regulated entities to review instructions 3056 and to develop, acquire, install, and use te chnology and systems to collect, validate, verify, and 3057 disclose information. Time taken to adjust existing ways to comply with any previously 3058 applicable instructions and requirements and to train personnel to respond to the information 3059 collection task is a lso included. In this analysis, total industry burden hours represent the sum of 3060 time spent on reporting and on other administrative activities. Industry respondents will spend 3061 time on the following activities associated with the IUR rule: Compliance det ermination, rule 3062 familiarization, preparation and submission of reports, and recordkeeping. 3063*** Interagency EO 12866 Review Draft

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75 As presented in the Economic Analysis (Ref. 19) and the addendum ICR, EPA estimates 3064 that the final rule would generate a total incremental industry burden of 1. 39 million hours in the 3065 first reporting cycle. The burden for a site to complete a full IUR report for one chemical 3066 substance is estimated to be 140.38 hours, which includes an incremental burden increase of 3067 17.38 hours over the current estimated burden. The burden for a site to complete a partial IUR 3068 report for one chemical substance is estimated to be 57.36 hours, which includes an incremental 3069 burden increase of 5.28 hours over the current estimated burden. For future reporting cycles, 3070 EPA estimates th at the final rule would create a total incremental industry burden of 1.21 million 3071 hours. The burden to complete a full report is estimated to be 95.03 hours, which is an 3072 incremental increase of 12.98 hours over the current estimated future burden. The b urden for a 3073 partial report is estimated to be 29.40 hours, which is an incremental increase of 3.28 hours over 3074 the current estimate. 3075

C. Regulatory Flexibility Act 3076

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), 3077 the Agency hereby certifies that this action will not have a significant adverse economic impact 3078 on a substantial number of small entities. The Agency‘s basis is briefly summarized here and is 3079 detailed in the Economic Analysis (Ref. 19). 3080

Under RFA, small entities include small businesses, small organizations, and small 3081 governmental jurisdictions. For purposes of assessing the impacts of this rule on small entities, 3082 small entity is defined as: 3083

1. A small business, as defined by the SBA's regulations at 13 CFR 121.201. The SBA 3084 definitions typically are based upon either a sales or an employment level, depending on the 3085 nature of the industry. Companies engaged in chemical manufacturing (NAICS Code 325) or 3086 petroleum refining (NAICS Code 324110) are the most l ikely to report under the IUR rule. These 3087 employee size standards range from 500 employees to 1,500 employees for NAICS Codes 325 3088 and 324110. 3089

2. A small governmental jurisdiction that is a government of a city, county, town, school 3090 district, or special dis trict with a population of less than 50,000. 3091

3. A small organization that is any not

- for

- profit enterprise which is independently owned 3092 and operated and is not dominant in its field. 3093

Since the regulated community does not include small governmental juri sdictions or small not

3094 for

- profit organizations, the analysis focuses on small businesses. 3095

The existing IUR rule, at 40 CFR 710.59, generally exempts from reporting small 3096 businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 m illion and 3097 less than 100,000 lb. production of any given chemical substance at a site; or annual sales of less 3098 than $4 million. This exemption is maintained in today‘s final amendments. A small business 3099 would be required to report under the final rule, how ever, if it produces any chemical substance 3100 that is the subject of a regulation proposed or promulgated under TSCA section 4, 5(b)(4), or 6, 3101 or that is the subject of an order under TSCA section 5(e), or that is the subject of relief that has 3102*** Interagency EO 12866 Review Draft

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76 been granted pursuant to a civil action under TSCA section 5 or 7. A small business may also 3103 report voluntarily. 3104

EPA analyzed potential small business impacts from this final rule using both the SBA 3105 employee size standards and the TSCA sales

- based definition of small business. EPA estimates 3106 that 466 small firms potentially would be affected by this final rule using the employment

- based 3107 definition, and 280 small firms potentially would be affected using the sales

- based definition. 3108 Based on costs annualized over a four

– year period and average sales data for the parent 3109 companies, EPA estimated that the cost

- to

- sales ratio of the final rule would be less than 0.1% 3110 for an average small company subject to the rule. For a company to have a cost

- to

- sales ratio 3111 larger than 1%, company sales would have to be less than $1.02 million. Because the small 3112 businesses affected by the final rule have average sales of more than $412.7 million under the 3113 employment

- based definition, and $11.8 million under the sales

- based definition, small entities 3114 will not be affected by the amendments to the IUR rule at a cost

- to

- sales ratio of greater than 1% 3115 (Ref. 19). 3116

D. Unfunded Mandates Reform Act 3117

This action does not contain any Federal mandates for State, local, or tribal governments 3118 or the privat e sector under the provisions of Title II of the Unfunded Mandates Reform Act 3119 (UMRA), 2 U.S.C. 1531

– 1538. EPA has determined that this regulatory action will not result in 3120 annual expenditures of $100 million or more for State, local, and tribal government s, in the 3121 aggregate, or for the private sector. The costs associated with this action are briefly described in 3122 Unit V.A., and is contained in the Economic Analysis (Ref. 19). 3123

Based on EPA's past experience, State, local, and tribal governments have not b een 3124 affected by this reporting requirement, and EPA does not have any reason to believe that any 3125 State, local, or tribal government will be affected by this final rule. As such, EPA has determined 3126 that this final rule does not impose any enforceable duty, contain any unfunded mandate, or 3127 otherwise have any effect on small governments. Accordingly, this final rule is not subject to the 3128 requirements of sections 202, 203, or 205 of UMRA. 3129

E. Executive Order 13132 3130

Pursuant to Executive Order 13132, entitled F ederalism (64 FR 43255, August 10, 1999), 3131 EPA has determined that this final rule does not have federalism implications because it will not 3132 have substantial direct effects on the States, on the relationship between the national government 3133 and the States, o r on the distribution of power and responsibilities among the various levels of 3134 government, as specified in the Executive Order. This final rule simply amends the IUR rule in 3135 several ways to provide information to better address Agency and public informati on needs, 3136 improve the usability and reliability of the reported data, and ensure that data are available in a 3137 timely manner. Because EPA has no information to indicate that any State or local government 3138 manufactures or processes the chemical substances cov ered by this action, the final rule does not 3139 apply directly to States and localities and will not affect State and local governments. Thus, 3140 Executive Order 13132 does not apply to the final rule. 3141

F. Executive Order 13175 3142*** Interagency EO 12866 Review Draft

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77 As required by Executive Order 13 175, entitled Consultation and Coordination with 3143 Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this 3144 final rule does not have tribal implications because it will not have any effect on tribal 3145 governments, on the relation ship between the Federal Government and the Indian tribes, or on 3146 the distribution of power and responsibilities between the Federal Government and Indian tribes, 3147 as specified in the Order. Thus, Executive Order 13175 does not apply to this final rule. 3148

G. Executive Order 13045 3149

EPA interprets Executive Order 13045, entitled Protection of Children from 3150 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to 3151 those regulatory actions that concern health or safety risks, such that the analysis required under 3152 section 5

– 501 of Executive Order 13045 has the potential to influence the regulation. This 3153 action is not subject to Executive Order 13045 because it does not establish an environmental 3154 standard intended to mitigate he alth or safety risks. Nevertheless, the information obtained by 3155 the reporting required by this final rule will be used to inform the Agency‘s decision making 3156 process regarding chemical substances to which children may be disproportionately exposed. 3157 This i nformation will also assist the Agency and others in determining whether the chemical 3158 substances in this final rule present potential risks, allowing the Agency and others to take 3159 appropriate action to investigate and mitigate those risks. 3160

H. Executive Or der 13211 3161

This action is not a ―significant energy action‖ as defined in Executive Order 13211, 3162 entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or 3163 Use (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on 3164 the supply, distribution, or use of energy as described in the Executive Order. 3165

I. National Technology Transfer and Advancement Act 3166

Since this action does not involve any technical standards, section 12(d) of the Nati onal 3167 Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104

– 113, section 3168 12(d) (15 U.S.C. 272 note), does not apply to this action. 3169

J. Executive Order 12898 3170

The final rule does not have an adverse impact on the environmental and health 3171

c onditions in low

- income and minority communities that require special consideration by the 3172 Agency under Executive Order 12898, entitled Federal Actions to Address Environmental 3173 Justice in Minority Populations and Low

- Income Populations (59 FR 7629, Februar y 16, 1994). 3174 The Agency believes that the information collected under this final rule will assist EPA and 3175 others in determining the potential hazards and risks associated with the chemical substances 3176 covered by the rule. Because the IUR rule is an informat ion collection requirement, the 3177 information that will become available through the rule will enable the Agency to target 3178 educational, regulatory, or enforcement activities towards industries or chemical substances that 3179 pose the greatest risks and/or to tar get programs for geographic areas that are at the highest risk. 3180 Thus, the information to be gathered under the rule will help EPA make decisions that will 3181 benefit potentially at

- risk communities, some of which may be disadvantaged. 3182*** Interagency EO 12866 Review Draft

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78 The final rule is direc ted at manufacturers (including importers) of chemical substances. 3183 All consumers of these chemical products and all workers who come into contact with these 3184 chemical substances could benefit if data regarding the chemical substances‘ health and 3185 environment al effects were developed. Therefore, it does not appear that the costs and the 3186 benefits of the final rule will be disproportionately distributed across different geographic 3187 regions or among different categories of individuals. 3188

IV. Congressional Review Act 3189 3190 The Congressional Review Act, 5 U.S.C. 801 et seq ., generally provides that before a rule 3191 may take effect, the agency promulgating the rule must submit a rule report to each House of the 3192 Congress and the Comptroller General of the United States. EPA wi ll submit a report containing 3193 this rule and other required information to the U.S. Senate, the U.S. House of Representatives, 3194 and the Comptroller General of the United States prior to publication of the rule in the Federal 3195 Register . This rule is not a ―ma jor rule‖ as defined by 5 U.S.C. 804(2). 3196 3197 List of Subjects in 40 CFR Parts 704, 710, and 711 3198

Environmental protection, Chemicals, Confidential Business Information (CBI), 3199 Hazardous materials, Imports, Reporting and recordkeeping requirements. 3200

Dated: _____

_________________ 3201

________________________________________________ 3202

Assistant Administrator, Office of Chemical Safety and Pollution Prevention. 3203

3204

Therefore, 40 CFR chapter I is amended as follows: 3205

PART 704

— [AMENDED] 3206

1. The authority citation for part 704 c ontinues to read as follows: 3207

Authority: 15 U.S.C. 2607(a). 3208

§ 704.3 [Amended] 3209

2. In § 704.3, remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (1)(ii) of the 3210 definition importer

. 3211

PART 710

— COMPILATION OF THE TSCA CHEMICAL INVENTORY 3212

3. The authori ty citation for part 710 continues to read as follows: 3213

Authority: 15 U.S.C. 2607(a). 3214*** Interagency EO 12866 Review Draft

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79 4. Revise the heading for part 710 to read as set forth above. 3215

5. Remove the heading ―Subpart A

— General Provisions.‖ 3216

6. Revise paragraph (b) of § 710.1 to read as foll ows: 3217

§ 710.1 Scope and compliance. 3218

* * * * * 3219 (b) This part applies to the activities associated with the compilation of the TSCA Chemical 3220 Substance Inventory (TSCA Inventory) and the update of information on a subset of the 3221

c hemical substances included on the TSCA Inventory. 3222

* * * * * 3223 7. Section 710.3 is amended as follows: 3224

i. Remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (2) of the definition importer

. 3225

ii. Remove the definition no n

- isolated intermediate

. 3226

iii. Revise the introductory text of the section to read as follows: 3227

§ 710.3 Definitions. 3228

For purposes of this part: 3229

* * * * * 3230 Subpart B §§ 710.23

– 710.39 [Removed] 3231

8. Remove subpart B, consisting of §§ 710.23

– 710.39. 3232

Subpart C §§ 710.43

– 710.59 [Removed] 3233

9. Remove subpart C, consisting of §§ 710.43

– 710.59. 3234

10. Add new part 711 to subchapter R to read as follows: 3235

PART 711

— TSCA INVENTORY UPDATE REPORTING REQUIREMENTS 3236

Sec. 3237 3238 711.1 Scope and compliance. 3239 711.3 Definitions. 3240 711.5 Chemical substances for which information must be reported. 3241 711.6 Chemi cal substances for which information is not required. 3242 711.8 Persons who must report. 3243 711.9 Persons not subject to this part. 3244 711.10 Activities for which reporting is not required. 3245 711.15 Reporting information to EPA. 3246*** Interagency EO 12866 Review Draft

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80 711.20 When to report. 3247 711.22 Duplicati ve reporting. 3248 711.25 Recordkeeping requirements. 3249 711.30 Confidentiality claims. 3250 711.35 Electronic filing. 3251 3252 Authority: 15 U.S.C. 2607(a). 3253 3254 § 711.1 Scope and compliance. 3255

(a) This part specifies reporting and recordkeeping procedures under section 8(a) of the 3256 Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain manufacturers (including 3257 importers) of chemical substances. Section 8(a) of TSCA authorizes the EPA Administrator to 3258 require reporting of information necessary for administration of T SCA, including issuing 3259 regulations for the purpose of compiling and keeping current the TSCA Chemical Substance 3260 Inventory (TSCA Inventory) manufactured or processed in the United States as required by 3261 TSCA section 8(b). In accordance with TSCA section 8(b) , EPA amends the TSCA Inventory to 3262 include new chemical substances manufactured (including imported) in the United States and 3263 reported under TSCA section 5(a)(1). EPA also revises the categories of chemical substances 3264 and makes other amendments as appropr iate. 3265

(b) This part applies to the activities associated with the periodic update of information 3266 on a subset of the chemical substances included on the TSCA Inventory. 3267

(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to submit 3268 information required under this part. In addition, TSCA section 15(3) makes it unlawful for any 3269 person to fail to keep, and permit access to, records required by this part. Section 16 of TSCA 3270 provides that any person who violates a provision of TSCA secti on 15 is liable to the United 3271 States for a civil penalty and may be criminally prosecuted. Pursuant to TSCA section 17, the 3272 Federal Government may seek judicial relief to compel submission of TSCA section 8(a) 3273 information and to otherwise restrain any viol ation of TSCA section 15. (EPA does not intend to 3274 concentrate its enforcement efforts on insignificant clerical errors in reporting.) 3275

(d) Each person who reports under this part must maintain records that document 3276 information reported under this part and, in accordance with TSCA, permit access to, and the 3277 copying of, such records by EPA officials. 3278

§ 711.3 Definitions

. 3279

The definitions in this section and the definitions in TSCA section 3 apply to this part. In 3280 addition, the definitions in 40 CFR 704.3 also apply to this part, except the definitions 3281 manufacture and manufacturer in 40 CFR 704.3. 3282

CDX or Central Data Exchange means EPA's centralized electronic document receiving 3283 system, or its successors. 3284*** Interagency EO 12866 Review Draft

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81 Commercial use means the use of a chemical substance or a mixture containing a 3285 chemical substance (including as part of an article) in a commercial enterprise providing saleable 3286 goods or services. 3287

Consumer use means the use of a chemical substance or a mixture containing a chemical 3288 substance (including as part of an article) when sold to or made available to consumers for their 3289

use. 3290

e

- IURweb means the electronic, web

- based IUR software provided by EPA for the 3291 completion and submission of the IUR data. 3292

Industrial function means the intended physical or chemical c haracteristic for which a 3293 chemical substance or mixture is consumed as a reactant; incorporated into a formulation, 3294 mixture, reaction product, or article; repackaged; or used. 3295

Industrial use means use at a site at which one or more chemical substances or m ixtures 3296 are manufactured (including imported) or processed. 3297

Intended for use by children means the chemical substance or mixture is used in or on a 3298 product that is specifically intended for use by children age 14 or younger. A chemical substance 3299 or mixture is intended for use by children when the submitter answers ―yes‖ to at least one of the 3300 following questions for the product into which the submitter's chemical substance or mixture is 3301 incorporated: 3302

(1) Is the product commonly recognized (i.e., by a reaso nable person) as being intended 3303 for children age 14 or younger? 3304

(2) Does the manufacturer of the product state through product labeling or other written 3305 materials that the product is intended for or will be used by children age 14 or younger? 3306

(3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or 3307 younger? 3308

Manufacture means to manufacture, produce, or import, for commercial purposes. 3309 Manufacture includes the extraction, for commercial purposes, of a component chemical 3310

s ubstance from a previously existing chemical substance or complex combination of chemical 3311 substances. When a chemical substance, manufactured other than by import, is: 3312

(1) Produced exclusively for another person who contracts for such production, and 3313

(2) that other person specifies the identity of the chemical substance and controls the total 3314 amount produced and the basic technology for the plant process, that chemical substance is co

3315 manufactured by the producing manufacturer and the person contracting f or such production. 3316

Manufacturer means a person who manufactures a chemical substance. 3317

Master Inventory File means EPA's comprehensive list of chemical substances which 3318 constitutes the TSCA Inventory compiled under TSCA section 8(b). It includes chemical 3319*** Interagency EO 12866 Review Draft

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82 s ubstances reported under 40 CFR part 710 and substances reported under 40 CFR part 720 for 3320 which a Notice of Commencement of Manufacture or Import has been received under 40 CFR 3321 720.120. 3322

Principal reporting year means the latest complete calendar year pre ceding the 3323 submission period. 3324

Reasonably likely to be exposed means an exposure to a chemical substance which, under 3325 foreseeable conditions of manufacture (including import), processing, distribution in commerce, 3326 or use of the chemical substance, is more l ikely to occur than not to occur. Such exposures would 3327 normally include, but would not be limited to, activities such as charging reactor vessels, 3328 drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and 3329 transfers, and ana lytical operations. Covered exposures include exposures through any route of 3330 entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical 3331
exposures. 3332

Repackaging means the physical transfer of a chemical substance or mixture, as is, from 3333 one container to another container or containers in preparation for distribution of the chemical 3334 substance or mixture in commerce. 3335

Reportable chemical substance means a chemical substance described in § 711.5. 3336

Site means a contiguous property unit. Property divided only by a public right

- of

- way 3337 shall be considered one site. More than one manufacturing plant may be located on a single site. 3338

(1) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the 3339 site is the location where the chemical substance is physically manufactured. 3340

(2) The site for an importer who imports a chemical substance described in § 711.5 is the 3341 U.S. site of the operating unit within the person's organization that is directly responsible for 3342 importing the chemical substance. The import site, in some cases, may be the organization's 3343 headquarters in the United States. If there is no s uch operating unit or headquarters in the United 3344 States, the site address for the importer is the U.S. address of an agent acting on behalf of the 3345 importer who is authorized to accept service of process for the importer. 3346

(3) For portable manufacturing uni ts sent to different locations from a single distribution 3347 center, the distribution center shall be considered the site. 3348

Site

- limited means a chemical substance is manufactured and processed only within a site 3349 and is not distributed for commercial purposes as a chemical substance or as part of a mixture or 3350 article outside the site. Imported chemical substances are never site

- limited. Although a site

3351 limited chemical substance is not distributed for commercial purposes outside the site at which it 3352 is manufact ured and processed, the chemical substance is considered to have been manufactured 3353 and processed for commercial purposes. 3354

Submission period means the period in which the manufacturing, processing, and use data 3355 are submitted to EPA. 3356*** Interagency EO 12866 Review Draft

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83 Use means any utilizatio n of a chemical substance or mixture that is not otherwise 3357 covered by the terms manufacture or process. Relabeling or redistributing a container holding a 3358 chemical substance or mixture where no repackaging of the chemical substance or mixture 3359 occurs does n ot constitute use or processing of the chemical substance or mixture. 3360

§ 711.5 Chemical substances for which information must be reported. 3361

Any chemical substance that is in the Master Inventory File at the beginning of a 3362 submission period described in § 711.20, unless the chemical substance is specifically excluded 3363 by § 711.6. 3364

§ 711.6 Chemical substances for which information is not required. 3365

The following groups or categories of chemical substances are exempted from some or 3366 all of the reporting require ments of this part, with the following exception: A chemical substance 3367 described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of 3368 the reporting requirements of this part if that chemical substance is the subject of a rule proposed 3369 or promulgated under TSCA section 4, 5(a)(2), 5(b)(4), or 6, or is the subject of a consent 3370 agreement developed under the procedures of 40 CFR part 790, or is the subject of an order 3371 issued under TSCA section 5(e) or 5(f), or is the subjec t of relief that has been granted under a 3372 civil action under TSCA section 5 or 7. 3373

(a) Full exemptions . The following categories of chemical substances are exempted from 3374 the reporting requirements of this part. 3375

(1) Polymers

— (i) Any chemical substance desc ribed with the word fragments ―*polym,‖ 3376 ―*alkyd,‖ or ―*oxylated‖ in the Chemical Abstracts (CA) Index Name in the Master Inventory 3377 File, where the asterisk (*) in the listed word fragments indicates that any sets of characters may 3378 precede, or follow, the c haracter string defined. 3379

(ii) Any chemical substance that is identified in the Master Inventory File as siloxane and 3380 silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a 3381 polysaccharide (starch, cellulose, gum), rubber, or lignin. 3382

(iii) This exclusion does not apply to a polymeric substance that has been hydrolyzed, 3383 depolymerized, or otherwise chemically modified, except in cases where the intended product of 3384 this reaction is totally polymeric in structure. 3385

(2) Microorganisms . Any combination of chemical substances that is a living organism, 3386 and that meets the definition of ―microorganism‖ at 40 CFR 725.3. Any chemical substance 3387 produced from a living microorganism is reportable under this part unless otherwise e xcluded. 3388

(3) Naturally occurring chemical substances . Any naturally occurring chemical 3389 substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is determined in 3390 each case by the specific activities of the person who manufactures the chemical substance in 3391 question. Some chemical substances can be manufactured both as described in 40 CFR 710.4(b) 3392 and by means other than those described in 40 CFR 710.4(b). If a person described in § 711.8 3393 manufactures a chemical substance by means other than those described in 40 CFR 710.4(b), the 3394*** Interagency EO 12866 Review Draft

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84 person must report regardless of whether the chemical substance also could have been produced 3395 as described in 40 CFR 710.4(b). Any chemical substance that is produced from such a naturally 3396 occurring chemical su bstance described in 40 CFR 710.4(b) is reportable unless otherwise 3397 excluded. 3398

(4) Certain forms of natural gas and water . Chemical substances with the following 3399 CASRN: CASRN 64741

– 48

– 6, natural gas (petroleum), raw liq. mix; CASRN 68919

– 39

– 1, 3400 natural gas condensates; CASRN 8006

– 61

– 9, gasoline, natural; CASRN 68425

– 31

– 0, gasoline 3401 (natural gas), natural; CASRN 8006

– 14

– 2, natural gas; CASRN 68410

– 63

– 9, natural gas, dried; 3402 and CASRN 7732

– 18

– 5, water. 3403

(b) Partial exemptions . The following groups of chemical su bstances are partially 3404 exempted from the reporting requirements of this part (i.e., the information described in § 3405 711.15(b)(4) need not be reported for these chemical substances). Such chemical substances are 3406 not excluded from the other reporting requirements under this part. 3407

(1) Petroleum process streams . EPA has designated the chemical substances listed in 3408 Table 1 of this paragraph by CASRN, as partially exempt from reporting under the IUR. 3409

Table 1.

— CAS Registry Numbers of Partially Exempt Chemical Substances Termed 3410 ―Petroleum Process Streams‖ for Purposes of Inventory Update Reporting 3411

CASRN Product 8002

– 05

– 9 Petr oleum 8002

– 74

– 2 Paraffin waxes and hydrocarbon waxes 8006

– 20

– 0 Fuel gases, low and medium B.T.U. 8008

– 20

– 6 Kerosine (petroleum) 8009

– 03

– 8 Petrolatum 8012

– 95

– 1 Paraffin oils 8030

– 30

– 6 Naphtha 8032

– 32

– 4 Ligroine 8042

– 47

– 5 White mineral oil (petroleum ) 8052

– 41

– 3 Stoddard solvent 8052

– 42

– 4 Asphalt 61789

– 60

– 4 Pitch 63231

– 60

– 7 Paraffin waxes and hydrocarbon waxes, microcryst. 64741

– 41

– 9 Naphtha (petroleum), heavy straight

- run 64741

– 42

– 0 Naphtha (petroleum), full

- range straight

- run 64741

– 43

– 1 Gas oi ls (petroleum), straight

- run 64741

– 44

– 2 Distillates (petroleum), straight

- run middle 64741

– 45

– 3 Residues (petroleum), atm. tower 64741

– 46

– 4 Naphtha (petroleum), light straight

- run 64741

– 47

– 5 Natural gas condensates (petroleum) 64741

– 49

– 7 Condensates ( petroleum), vacuum tower 64741

– 50

– 0 Distillates (petroleum), light paraffinic 64741

– 51

– 1 Distillates (petroleum), heavy paraffinic*** Interagency EO 12866 Review Draft

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85 64741

– 52

– 2 Distillates (petroleum), light naphthenic 64741

– 53

– 3 Distillates (petroleum), heavy naphthenic 64741

– 54

– 4 Nap htha (petroleum), heavy catalytic cracked 64741

– 55

– 5 Naphtha (petroleum), light catalytic cracked 64741

– 56

– 6 Residues (petroleum), vacuum 64741

– 57

– 7 Gas oils (petroleum), heavy vacuum 64741

– 58

– 8 Gas oils (petroleum), light vacuum 64741

– 59

– 9 Distillate s (petroleum), light catalytic cracked 64741

– 60

– 2 Distillates (petroleum), intermediate catalytic cracked 64741

– 61

– 3 Distillates (petroleum), heavy catalytic cracked 64741

– 62

– 4 Clarified oils (petroleum), catalytic cracked 64741

– 63

– 5 Naphtha (petroleum ), light catalytic reformed 64741

– 64

– 6 Naphtha (petroleum), full

- range alkylate 64741

– 65

– 7 Naphtha (petroleum), heavy alkylate 64741

– 66

– 8 Naphtha (petroleum), light alkylate 64741

– 67

– 9 Residues (petroleum), catalytic reformer fractionator 64741

– 68

– 0 N aphtha (petroleum), heavy catalytic reformed 64741

– 69

– 1 Naphtha (petroleum), light hydrocracked 64741

– 70

– 4 Naphtha (petroleum), isomerization 64741

– 73

– 7 Distillates (petroleum), alkylate 64741

– 74

– 8 Naphtha (petroleum), light thermal cracked 64741

– 75

– 9 Residues (petroleum), hydrocracked 64741

– 76

– 0 Distillates (petroleum), heavy hydrocracked 64741

– 77

– 1 Distillates (petroleum), light hydrocracked 64741

– 78

– 2 Naphtha (petroleum), heavy hydrocracked 64741

– 79

– 3 Coke (petroleum) 64741

– 80

– 6 Residues (petro leum), thermal cracked 64741

– 81

– 7 Distillates (petroleum), heavy thermal cracked 64741

– 82

– 8 Distillates (petroleum), light thermal cracked 64741

– 83

– 9 Naphtha (petroleum), heavy thermal cracked 64741

– 84

– 0 Naphtha (petroleum), solvent

- refined light 6474 1

– 85

– 1 Raffinates (petroleum), sorption process 64741

– 86

– 2 Distillates (petroleum), sweetened middle 64741

– 87

– 3 Naphtha (petroleum), sweetened 64741

– 88

– 4 Distillates (petroleum), solvent

- refined heavy paraffinic 64741

– 89

– 5 Distillates (petroleum), solv ent

- refined light paraffinic 64741

– 90

– 8 Gas oils (petroleum), solvent

- refined 64741

– 91

– 9 Distillates (petroleum), solvent

- refined middle 64741

– 92

– 0 Naphtha (petroleum), solvent

- refined heavy 64741

– 95

– 3 Residual oils (petroleum), solvent deasphalted 64 741

– 96

– 4 Distillates (petroleum), solvent

- refined heavy naphthenic 64741

– 97

– 5 Distillates (petroleum), solvent

- refined light naphthenic 64741

– 98

– 6 Extracts (petroleum), heavy naphtha solvent 64741

– 99

– 7 Extracts (petroleum), light naphtha solvent 64742

– 01

– 4 Residual oils (petroleum), solvent

- refined*** Interagency EO 12866 Review Draft

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86 64742

– 03

– 6 Extracts (petroleum), light naphthenic distillate solvent 64742

– 04

– 7 Extracts (petroleum), heavy paraffinic distillate solvent 64742

– 05

– 8 Extracts (petroleum), light paraffinic distillate solven t 64742

– 06

– 9 Extracts (petroleum), middle distillate solvent 64742

– 07

– 0 Raffinates (petroleum), residual oil decarbonization 64742

– 08

– 1 Raffinates (petroleum), heavy naphthenic distillate decarbonization 64742

– 09

– 2 Raffinates (petroleum), heavy paraffi nic distillate decarbonization 64742

– 10

– 5 Extracts (petroleum), residual oil solvent 64742

– 11

– 6 Extracts (petroleum), heavy naphthenic distillate solvent 64742

– 12

– 7 Gas oils (petroleum), acid

- treated 64742

– 13

– 8 Distillates (petroleum), acid

- treated mid dle 64742

– 14

– 9 Distillates (petroleum), acid

- treated light 64742

– 15

– 0 Naphtha (petroleum), acid

- treated 64742

– 16

– 1 Petroleum resins 64742

– 18

– 3 Distillates (petroleum), acid

- treated heavy naphthenic 64742

– 19

– 4 Distillates (petroleum), acid

- treated ligh t naphthenic 64742

– 20

– 7 Distillates (petroleum), acid

- treated heavy paraffinic 64742

– 21

– 8 Distillates (petroleum), acid

- treated light paraffinic 64742

– 22

– 9 Naphtha (petroleum), chemically neutralized heavy 64742

– 23

– 0 Naphtha (petroleum), chemically neu tralized light 64742

– 24

– 1 Sludges (petroleum), acid 64742

– 25

– 2 Lubricating oils (petroleum), acid

- treated spent 64742

– 26

– 3 Hydrocarbon waxes (petroleum), acid

- treated 64742

– 27

– 4 Distillates (petroleum), chemically neutralized heavy paraffinic 64742

– 28

– 5 Distillates (petroleum), chemically neutralized light paraffinic 64742

– 29

– 6 Gas oils (petroleum), chemically neutralized 64742

– 30

– 9 Distillates (petroleum), chemically neutralized middle 64742

– 31

– 0 Distillates (petroleum), chemically neutralized ligh t 64742

– 32

– 1 Lubricating oils (petroleum), chemically neutralized spent 64742

– 33

– 2 Hydrocarbon waxes (petroleum), chemically neutralized 64742

– 34

– 3 Distillates (petroleum), chemically neutralized heavy naphthenic 64742

– 35

– 4 Distillates (petroleum), che mically neutralized light naphthenic 64742

– 36

– 5 Distillates (petroleum), clay

- treated heavy paraffinic 64742

– 37

– 6 Distillates (petroleum), clay

- treated light paraffinic 64742

– 38

– 7 Distillates (petroleum), clay

- treated middle 64742

– 39

– 8 Neutralizing age nts (petroleum), spent sodium carbonate 64742

– 40

– 1 Neutralizing agents (petroleum), spent sodium hydroxide 64742

– 41

– 2 Residual oils (petroleum), clay

- treated 64742

– 42

– 3 Hydrocarbon waxes (petroleum), clay

- treated microcryst. 64742

– 43

– 4 Paraffin waxes ( petroleum), clay

- treated 64742

– 44

– 5 Distillates (petroleum), clay

- treated heavy naphthenic 64742

– 45

– 6 Distillates (petroleum), clay

- treated light naphthenic 64742

– 46

– 7 Distillates (petroleum), hydrotreated middle 64742

– 47

– 8 Distillates (petroleum), hyd rotreated light 64742

– 48

– 9 Naphtha (petroleum), hydrotreated heavy*** Interagency EO 12866 Review Draft

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87 64742

– 49

– 0 Naphtha (petroleum), hydrotreated light 64742

– 50

– 3 Lubricating oils (petroleum), clay

- treated spent 64742

– 51

– 4 Paraffin waxes (petroleum), hydrotreated 64742

– 52

– 5 Distillate s (petroleum), hydrotreated heavy naphthenic 64742

– 53

– 6 Distillates (petroleum), hydrotreated light naphthenic 64742

– 54

– 7 Distillates (petroleum), hydrotreated heavy paraffinic 64742

– 55

– 8 Distillates (petroleum), hydrotreated light paraffinic 64742

– 56

– 9 Distillates (petroleum), solvent

- dewaxed light paraffinic 64742

– 57

– 0 Residual oils (petroleum), hydrotreated 64742

– 58

– 1 Lubricating oils (petroleum), hydrotreated spent 64742

– 59

– 2 Gas oils (petroleum), hydrotreated vacuum 64742

– 60

– 5 Hydrocarbon waxes (petroleum), hydrotreated microcryst. 64742

– 61

– 6 Slack wax (petroleum) 64742

– 62

– 7 Residual oils (petroleum), solvent

- dewaxed 64742

– 63

– 8 Distillates (petroleum), solvent

- dewaxed heavy naphthenic 64742

– 64

– 9 Distillates (petroleum), solvent

- dewaxed light naphthenic 64742

– 65

– 0 Distillates (petroleum), solvent

- dewaxed heavy paraffinic 64742

– 67

– 2 Foots oil (petroleum) 64742

– 68

– 3 Naphthenic oils (petroleum), catalytic dewaxed heavy 64742

– 69

– 4 Naphthenic oils (petroleum), catalytic dewaxed light 64742

– 70

– 7 Paraffin oils (petroleum), catalytic dewaxed heavy 64742

– 71

– 8 Paraffin oils (petroleum), catalytic dewaxed light 64742

– 72

– 9 Distillates (petroleum), catalytic dewaxed middle 64742

– 73

– 0 Naphtha (petroleum), hydrodesulfurized light 64742

– 75

– 2 Naphtheni c oils (petroleum), complex dewaxed heavy 64742

– 76

– 3 Naphthenic oils (petroleum), complex dewaxed light 64742

– 78

– 5 Residues (petroleum), hydrodesulfurized atmospheric tower 64742

– 79

– 6 Gas oils (petroleum), hydrodesulfurized 64742

– 80

– 9 Distillates (petr oleum), hydrodesulfurized middle 64742

– 81

– 0 Kerosine (petroleum), hydrodesulfurized 64742

– 82

– 1 Naphtha (petroleum), hydrodesulfurized heavy 64742

– 83

– 2 Naphtha (petroleum), light steam

- cracked 64742

– 85

– 4 Residues (petroleum), hydrodesulfurized vacuum 6 4742

– 86

– 5 Gas oils (petroleum), hydrodesulfurized heavy vacuum 64742

– 87

– 6 Gas oils (petroleum), hydrodesulfurized light vacuum 64742

– 88

– 7 Solvent naphtha (petroleum), medium aliph. 64742

– 89

– 8 Solvent naphtha (petroleum), light aliph. 64742

– 90

– 1 Residue s (petroleum), steam

- cracked 64742

– 91

– 2 Distillates (petroleum), steam

- cracked 64742

– 92

– 3 Petroleum resins, oxidized 64742

– 93

– 4 Asphalt, oxidized 64742

– 94

– 5 Solvent naphtha (petroleum), heavy arom. 64742

– 95

– 6 Solvent naphtha (petroleum), light arom. 64742

– 96

– 7 Solvent naphtha (petroleum), heavy aliph. 64742

– 97

– 8 Distillates (petroleum), oxidized heavy*** Interagency EO 12866 Review Draft

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88 64742

– 98

– 9 Distillates (petroleum), oxidized light 64742

– 99

– 0 Residual oils (petroleum), oxidized 64743

– 00

– 6 Hydrocarbon waxes (petroleum), oxidized 64743

– 01

– 7 Petrolatum (petroleum), oxidized 64743

– 02

– 8 Alkenes, C>10 .alpha.

- 64743

– 03

– 9 Phenols (petroleum) 64743

– 04

– 0 Coke (petroleum), recovery 64743

– 05

– 1 Coke (petroleum), calcined 64743

– 06

– 2 Extracts (petroleum), gas oil solvent 64743

– 07

– 3 Slu dges (petroleum), chemically neutralized 64754

– 89

– 8 Naphthenic acids (petroleum), crude 64771

– 71

– 7 Paraffins (petroleum), normal C>10 64771

– 72

– 8 Paraffins (petroleum), normal C5

- 20 67254

– 74

– 4 Naphthenic oils 67674

– 12

– 8 Residual oils (petroleum), oxidi zed, compounds with triethanolamine 67674

– 13

– 9 Petrolatum (petroleum), oxidized, partially deacidified 67674

– 15

– 1 Petrolatum (petroleum), oxidized, Me ester 67674

– 16

– 2 Hydrocarbon waxes (petroleum), oxidized, partially deacidified 67674

– 17

– 3 Distillate s (petroleum), oxidized light, compounds with triethanolamine 67674

– 18

– 4 Distillates (petroleum), oxidized light, Bu esters 67891

– 79

– 6 Distillates (petroleum), heavy arom. 67891

– 80

– 9 Distillates (petroleum), light arom. 67891

– 81

– 0 Distillates (petroleu m), oxidized light, potassium salts 67891

– 82

– 1 Hydrocarbon waxes (petroleum), oxidized, compounds with

ethanolamine 67891

– 83

– 2 Hydrocarbon waxes (petroleum), oxidized, compounds with

isopropanolamine 67891

– 85

– 4 Hydrocarbon waxes (petroleum), oxidized, c ompounds with

triisopropanolamine 67891

– 86

– 5 Hydrocarbon waxes (petroleum), oxidized, compds. with

diisopropanolamine 68131

– 05

– 5 Hydrocarbon oils, process blends 68131

– 49

– 7 Aromatic hydrocarbons, C6

- 10, acid

- treated, neutralized 68131

– 75

– 9 Gases (petro leum), C3

- 4 68153

– 22

– 0 Paraffin waxes and Hydrocarbon waxes, oxidized 68187

– 57

– 5 Pitch, coal tar

- petroleum 68187

– 58

– 6 Pitch, petroleum, arom. 68187

– 60

– 0 Hydrocarbons, C4, ethane

- propane

- cracked 68307

– 98

– 2 Tail gas (petroleum), catalytic cracked distil late and catalytic cracked

naphtha fractionation absorber 68307

– 99

– 3 Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer 68308

– 00

– 9 Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer,

hydrogen sulfide

- free 683 08

– 01

– 0 Tail gas (petroleum), cracked distillate hydrotreater stripper 68308

– 02

– 1 Tail gas (petroleum), distn., hydrogen sulfide

- free*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review ***

89 68308

– 03

– 2 Tail gas (petroleum), gas oil catalytic cracking absorber 68308

– 04

– 3 Tail gas (petroleum), gas recovery plan t 68308

– 05

– 4 Tail gas (petroleum), gas recovery plant deethanizer 68308

– 06

– 5 Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized

naphtha fractionator, acid

- free 68308

– 07

– 6 Tail gas (petroleum), hydrodesulfurized vacuum gas oil strip per,

hydrogen sulfide

- free 68308

– 08

– 7 Tail gas (petroleum), isomerized naphtha fractionation stabilizer 68308

– 09

– 8 Tail gas (petroleum), light straight

- run naphtha stabilizer, hydrogen

sulfide

- free 68308

– 10

– 1 Tail gas (petroleum), straight

- run distillat e hydrodesulfurizer, hydrogen

sulfide

- free 68308

– 11

– 2 Tail gas (petroleum), propane

- propylene alkylation feed prep deethanizer 68308

– 12

– 3 Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen

sulfide

- free 68308

– 27

– 0 Fuel gases, refinery 6833 3

– 22

– 2 Residues (petroleum), atmospheric 68333

– 23

– 3 Naphtha (petroleum), heavy coker 68333

– 24

– 4 Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine 68333

– 25

– 5 Distillates (petroleum), hydrodesulfurized light catalytic cracked 68333

– 26

– 6 Clarified oils (petroleum), hydrodesulfurized catalytic cracked 68333

– 27

– 7 Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked 68333

– 28

– 8 Distillates (petroleum), hydrodesulfurized heavy catalytic cracked 68333

– 29

– 9 Residues (pe troleum), light naphtha solvent extracts 68333

– 30

– 2 Distillates (petroleum), oxidized heavy thermal cracked 68333

– 81

– 3 Alkanes, C4

- 12 68333

– 88

– 0 Aromatic hydrocarbons, C9

- 17 68334

– 30

– 5 Fuels, diesel 68409

– 99

– 4 Gases (petroleum), catalytic cracked over heads 68410

– 00

– 4 Distillates (petroleum), crude oil 68410

– 05

– 9 Distillates (petroleum), straight

- run light 68410

– 12

– 8 Distillates (petroleum), steam

- cracked, C5

- 10 fraction, high

- temp.

stripping products with light steam

- cracked petroleum naphtha C5 fra ction polymers 68410

– 71

– 9 Raffinates (petroleum), catalytic reformer ethylene glycol

- water

countercurrent exts. 68410

– 96

– 8 Distillates (petroleum), hydrotreated middle, intermediate boiling 68410

– 97

– 9 Distillates (petroleum), light distillate hydrotreat ing process, low

- boiling 68410

– 98

– 0 Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer

overheads 68411

– 00

– 7 Alkenes, C>8 68425

– 29

– 6 Distillates (petroleum), naphtha

- raffinate pyrolyzate

- derived, gasoline

blending 68425

– 33

– 2 Petrolatum (petroleum), oxidized, barium salt 68425

– 34

– 3 Petrolatum (petroleum), oxidized, calcium salt*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

90 68425

– 35

– 4 Raffinates (petroleum), reformer, Lurgi unit

- sepd. 68425

– 39

– 8 Alkenes, C>10 .alpha.

- , oxidized 68441

– 09

– 8 Hydrocarbon waxes (petroleum), clay

- treate d microcryst., contg.

polyethylene, oxidized 68459

– 78

– 9 Alkenes, C18

- 24 .alpha.

- , dimers 68475

– 57

– 0 Alkanes, C1

- 2 68475

– 58

– 1 Alkanes, C2

- 3 68475

– 59

– 2 Alkanes, C3

- 4 68475

– 60

– 5 Alkanes, C4

- 5 68475

– 61

– 6 Alkenes, C5, naphtha

- raffinate pyrolyzate

- derived 68475

– 70

– 7 Aromatic hydrocarbons, C6

- 8, naphtha

- raffinate pyrolyzate

- derived 68475

– 79

– 6 Distillates (petroleum), catalytic reformed depentanizer 68475

– 80

– 9 Distillates (petroleum), light steam

- cracked naphtha 68476

– 26

– 6 Fuel gases 68476

– 27

– 7 Fuel gase s, amine system residues 68476

– 28

– 8 Fuel gases, C6

- 8 catalytic reformer 68476

– 29

– 9 Fuel gases, crude oil distillates 68476

– 30

– 2 Fuel oil, no. 2 68476

– 31

– 3 Fuel oil, no. 4 68476

– 32

– 4 Fuel oil, residues

- straight

- run gas oils, high

- sulfur 68476

– 33

– 5 Fue l oil, residual 68476

– 34

– 6 Fuels, diesel, no. 2 68476

– 39

– 1 Hydrocarbons, aliph.

- arom.

- C4

- 5

- olefinic 68476

– 40

– 4 Hydrocarbons, C3

- 4 68476

– 42

– 6 Hydrocarbons, C4

- 5 68476

– 43

– 7 Hydrocarbons, C4

- 6, C5

- rich 68476

– 44

– 8 Hydrocarbons, C>3 68476

– 45

– 9 Hydrocarbo ns, C5

- 10 arom. conc., ethylene

- manuf.

- by

- product 68476

– 46

– 0 Hydrocarbons, C3

- 11, catalytic cracker distillates 68476

– 47

– 1 Hydrocarbons, C2

- 6, C6

- 8 catalytic reformer 68476

– 49

– 3 Hydrocarbons, C2

- 4, C3

- rich 68476

– 50

– 6 Hydrocarbons, C≥5, C5

- 6

- rich 68476

– 52

– 8 Hydrocarbons, C4, ethylene

- manuf.

- by

- product 68476

– 53

– 9 Hydrocarbons, C≥20, petroleum wastes 68476

– 54

– 0 Hydrocarbons, C3

- 5, polymn. unit feed 68476

– 55

– 1 Hydrocarbons, C5

- rich 68476

– 56

– 2 Hydrocarbons, cyclic C5 a nd C6 68476

– 77

– 7 Lubricating oils, refined used 68476

– 81

– 3 Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts 68476

– 84

– 6 Petroleum products, gases, inorg. 68476

– 85

– 7 Petroleum gases, liquefied 68476

– 86

– 8 Petroleum gases, liquefied, sweetene d 68477

– 25

– 8 Waste gases, vent gas, C1

- 6 68477

– 26

– 9 Wastes, petroleum 68477

– 29

– 2 Distillates (petroleum), catalytic reformer fractionator residue, high

-*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

91 boiling 68477

– 30

– 5 Distillates (petroleum), catalytic reformer fractionator residue,

intermediate

- bo iling 68477

– 31

– 6 Distillates (petroleum), catalytic reformer fractionator residue, low

boiling 68477

– 33

– 8 Gases (petroleum), C3

- 4, isobutane

- rich 68477

– 34

– 9 Distillates (petroleum), C3

- 5, 2

- methyl

- 2

- butene

- rich 68477

– 35

– 0 Distillates (petroleum), C3

- 6, piperylene

- rich 68477

– 36

– 1 Distillates (petroleum), cracked steam

- cracked, C5

- 18 fraction 68477

– 38

– 3 Distillates (petroleum), cracked steam

- cracked petroleum distillates 68477

– 39

– 4 Distillates (petroleum), cracked stripped steam

- cracked petroleum

disti llates, C8

- 10 fraction 68477

– 40

– 7 Distillates (petroleum), cracked stripped steam

- cracked petroleum

distillates, C10

- 12 fraction 68477

– 41

– 8 Gases (petroleum), extractive, C3

- 5, butadiene

- butene

- rich 68477

– 42

– 9 Gases (petroleum), extractive, C3

- 5, butene

- isobutylene

- rich 68477

– 44

– 1 Distillates (petroleum), heavy naphthenic, mixed with steam

- cracked

petroleum distillates C5

- 12 fraction 68477

– 47

– 4 Distillates (petroleum), mixed heavy olefin vacuum, heart

- cut 68477

– 48

– 5 Distillates (petroleum), mixed heav y olefin vacuum, low

- boiling 68477

– 53

– 2 Distillates (petroleum), steam

- cracked, C5

- 12 fraction 68477

– 54

– 3 Distillates (petroleum), steam

- cracked, C8

- 12 fraction 68477

– 55

– 4 Distillates (petroleum), steam

- cracked, C5

- 10 fraction, mixed with light

steam

- cr acked petroleum naphtha C5 fraction 68477

– 58

– 7 Distillates (petroleum), steam

- cracked petroleum distillates, C5

- 18

fraction 68477

– 59

– 8 Distillates (petroleum), steam

- cracked petroleum distillates

cyclopentadiene conc. 68477

– 60

– 1 Extracts (petroleum), co ld

- acid 68477

– 61

– 2 Extracts (petroleum), cold

- acid, C4

- 6 68477

– 62

– 3 Extracts (petroleum), cold

- acid, C3

- 5, butene

- rich 68477

– 63

– 4 Extracts (petroleum), reformer recycle 68477

– 64

– 5 Gases (petroleum), acetylene manuf. off 68477

– 65

– 6 Gases (petroleum), a mine system feed 68477

– 66

– 7 Gases (petroleum), benzene unit hydrodesulfurizer off 68477

– 67

– 8 Gases (petroleum), benzene unit recycle, hydrogen

- rich 68477

– 68

– 9 Gases (petroleum), blend oil, hydrogen

- nitrogen

- rich 68477

– 69

– 0 Gases (petroleum), butane spl itter overheads 68477

– 70

– 3 Gases (petroleum), C2

- 3 68477

– 71

– 4 Gases (petroleum), catalytic

- cracked gas oil depropanizer bottoms, C4

-

rich acid

- free 68477

– 72

– 5 Gases (petroleum), catalytic

- cracked naphtha debutanizer bottoms, C3

- 5

-

rich 68477

– 73

– 6 Gases ( petroleum), catalytic cracked naphtha depropanizer overhead, C3

-

rich acid

- free*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

92 68477

– 74

– 7 Gases (petroleum), catalytic cracker 68477

– 75

– 8 Gases (petroleum), catalytic cracker, C1

- 5

- rich 68477

– 76

– 9 Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2

- 4

-

rich 68477

– 77

– 0 Gases (petroleum), catalytic reformed naphtha stripper overheads 68477

– 79

– 2 Gases (petroleum), catalytic reformer, C1

- 4

- rich 68477

– 80

– 5 Gases (petroleum), C6

- 8 catalytic reformer recycle 68477

– 81

– 6 Gases (petroleum), C6

- 8 catalytic reformer 68477

– 82

– 7 Gases (petroleum), C6

- 8 catalytic reformer recycle, hydrogen

- rich 68477

– 83

– 8 Gases (petroleum), C3

- 5 olefinic

- paraffinic alkylation feed 68477

– 84

– 9 Gases (petroleum), C2

- return stream 68477

– 85

– 0 Gases (petroleum), C4

- rich 68477

– 86

– 1 Gases (petroleum), deethanizer overheads 68477

– 87

– 2 Gases (petroleum), deisobutanizer tower overheads 68477

– 88

– 3 Gases (petroleum), deethanizer overheads, C3

- rich 68477

– 89

– 4 Distillates (petroleum), depentanizer overheads 68477

– 90

– 7 Gases (petroleum), depropanizer dry, propene

- rich 68477

– 91

– 8 Gases (petroleum), depropanizer overheads 68477

– 92

– 9 Gases (petroleum), dry sour, gas

- concn.

- unit

- off 68477

– 93

– 0 Gases (petroleum), gas concn. reabsorber distn. 68477

– 94

– 1 Gases (petroleum), gas re covery plant depropanizer overheads 68477

– 95

– 2 Gases (petroleum), Girbatol unit feed 68477

– 96

– 3 Gases (petroleum), hydrogen absorber off 68477

– 97

– 4 Gases (petroleum), hydrogen

- rich 68477

– 98

– 5 Gases (petroleum), hydrotreater blend oil recycle, hydrogen

- nitrogen rich 68477

– 99

– 6 Gases (petroleum), isomerized naphtha fractionater, C4

- rich, hydrogen

sulfide

- free 68478

– 00

– 2 Gases (petroleum), recycle, hydrogen

- rich 68478

– 01

– 3 Gases (petroleum), reformer make

- up, hydrogen

- rich 68478

– 02

– 4 Gases (petroleum) , reforming hydrotreater 68478

– 03

– 5 Gases (petroleum), reforming hydrotreater, hydrogen

- methane

- rich 68478

– 04

– 6 Gases (petroleum), reforming hydrotreater make

- up, hydrogen

- rich 68478

– 05

– 7 Gases (petroleum), thermal cracking distn. 68478

– 08

– 0 Naphtha (p etroleum), light steam

- cracked, C5

- fraction, oligomer conc. 68478

– 10

– 4 Naphtha (petroleum), light steam

- cracked, debenzenized, C8

- 16

-

cycloalkadiene conc. 68478

– 12

– 6 Residues (petroleum), butane splitter bottoms 68478

– 13

– 7 Residues (petroleum), catalytic reformer fractionator residue distn. 68478

– 15

– 9 Residues (petroleum), C6

- 8 catalytic reformer 68478

– 16

– 0 Residual oils (petroleum), deisobutanizer tower 68478

– 17

– 1 Residues (petroleum), heavy coker gas oil and vacuum gas oil 68478

– 18

– 2 Residues (petro leum), heavy olefin vacuum 68478

– 19

– 3 Residual oils (petroleum), propene purifn. splitter 68478

– 20

– 6 Residues (petroleum), steam

- cracked petroleum distillates

cyclopentadiene conc., C4

- cyclopentadiene

- free*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

93 68478

– 22

– 8 Tail gas (petroleum), catalytic crac ked naphtha stabilization absorber 68478

– 24

– 0 Tail gas (petroleum), catalytic cracker, catalytic reformer and

hydrodesulfurizer combined fractionater 68478

– 25

– 1 Tail gas (petroleum), catalytic cracker refractionation absorber 68478

– 26

– 2 Tail gas (petrol eum), catalytic reformed naphtha fractionation stabilizer 68478

– 27

– 3 Tail gas (petroleum), catalytic reformed naphtha separator 68478

– 28

– 4 Tail gas (petroleum), catalytic reformed naphtha stabilizer 68478

– 29

– 5 Tail gas (petroleum), cracked distillate hy drotreater separator 68478

– 30

– 8 Tail gas (petroleum), hydrodesulfurized straight

- run naphtha separator 68478

– 31

– 9 Tail gas (petroleum), isomerized naphtha fractionates, hydrogen sulfide

free 68478

– 32

– 0 Tail gas (petroleum), saturate gas plant mixed stre am, C4

- rich 68478

– 33

– 1 Tail gas (petroleum), saturate gas recovery plant, C1

- 2

- rich 68478

– 34

– 2 Tail gas (petroleum), vacuum residues thermal cracker 68512

– 61

– 8 Residues (petroleum), heavy coker and light vacuum 68512

– 62

– 9 Residues (petroleum), light va cuum 68512

– 78

– 7 Solvent naphtha (petroleum), light arom., hydrotreated 68512

– 91

– 4 Hydrocarbons, C3

- 4

- rich, petroleum distillates 68513

– 02

– 0 Naphtha (petroleum), full

- range coker 68513

– 03

– 1 Naphtha (petroleum), light catalytic reformed, arom.

- free 6851 3

– 11

– 1 Fuel gases, hydrotreater fractionation, scrubbed 68513

– 12

– 2 Fuel gases, saturate gas unit fractionater

- absorber overheads 68513

– 13

– 3 Fuel gases, thermal cracked catalytic cracking residue 68513

– 14

– 4 Gases (petroleum), catalytic reformed straight

- run naphtha stabilizer

overheads 68513

– 15

– 5 Gases (petroleum), full

- range straight

- run naphtha dehexanizer off 68513

– 16

– 6 Gases (petroleum), hydrocracking depropanizer off, hydrocarbon

- rich 68513

– 17

– 7 Gases (petroleum), light straight

- run naphtha stabil izer off 68513

– 18

– 8 Gases (petroleum), reformer effluent high

- pressure flash drum off 68513

– 19

– 9 Gases (petroleum), reformer effluent low

- pressure flash drum off 68513

– 62

– 2 Disulfides, C5

- 12

- alkyl 68513

– 63

– 3 Distillates (petroleum), catalytic reformed straight

- run naphtha overheads 68513

– 65

– 5 Butane, branched and linear 68513

– 66

– 6 Residues (petroleum), alkylation splitter, C4

- rich 68513

– 67

– 7 Residues (petroleum), cyclooctadiene bottoms 68513

– 68

– 8 Residues (petroleum), deethanizer tower 68513

– 69

– 9 R esidues (petroleum), steam

- cracked light 68513

– 74

– 6 Waste gases, ethylene oxide absorber

- reactor 68514

– 15

– 8 Gasoline, vapor

- recovery 68514

– 29

– 4 Hydrocarbons, amylene feed debutanizer overheads non

- extractable

raffinates 68514

– 31

– 8 Hydrocarbons, C1

- 4 6 8514

– 32

– 9 Hydrocarbons, C10 and C12, olefin

- rich 68514

– 33

– 0 Hydrocarbons, C12 and C14, olefin

- rich 68514

– 34

– 1 Hydrocarbons, C9

- 14, ethylene

- manuf.

- by

- product*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

94 68514

– 35

– 2 Hydrocarbons, C14

- 30, olefin

- rich 68514

– 36

– 3 Hydrocarbons, C1

- 4, sweetened 68514

– 3 7

– 4 Hydrocarbons, C4

- 5

- unsatd. 68514

– 38

– 5 Hydrocarbons, C4

- 10

- unsatd. 68514

– 39

– 6 Naphtha (petroleum), light steam

- cracked, isoprene

- rich 68514

– 79

– 4 Petroleum products, hydrofiner

- powerformer reformates 68515

– 25

– 3 Benzene, C1

- 9

- alkyl derivs. 68515

– 26

– 4 Benzene, di

- C12

- 14

- alkyl derivs. 68515

– 27

– 5 Benzene, di

- C10

- 14

- alkyl derivs., fractionation overheads, heavy ends 68515

– 28

– 6 Benzene, di

- C10

- 14

- alkyl derivs., fractionation overheads, light ends 68515

– 29

– 7 Benzene, di

- C10

- 14

- alkyl derivs., fractionatio n overheads, middle cut 68515

– 30

– 0 Benzene, mono

- C20

- 48

- alkyl derivs. 68515

– 32

– 2 Benzene, mono

- C12

- 14

- alkyl derivs., fractionation bottoms 68515

– 33

– 3 Benzene, mono

- C10

- 12

- alkyl derivs., fractionation bottoms, heavy ends 68515

– 34

– 4 Benzene, mono

- C12

- 14

- alkyl derivs., fractionation bottoms, heavy ends 68515

– 35

– 5 Benzene, mono

- C10

- 12

- alkyl derivs., fractionation bottoms, light ends 68515

– 36

– 6 Benzene, mono

- C12

- 14

- alkyl derivs., fractionation bottoms, light ends 68516

– 20

– 1 Naphtha (petroleum), steam

- crac ked middle arom. 68526

– 52

– 3 Alkenes, C6 68526

– 53

– 4 Alkenes, C6

- 8, C7

- rich 68526

– 54

– 5 Alkenes, C7

- 9, C8

- rich 68526

– 55

– 6 Alkenes, C8

- 10, C9

- rich 68526

– 56

– 7 Alkenes, C9

- 11, C10

- rich 68526

– 57

– 8 Alkenes, C10

- 12, C11

- rich 68526

– 58

– 9 Alkenes, C11

- 13, C12

- r ich 68526

– 77

– 2 Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum 68526

– 99

– 8 Alkenes, C6

- 9 .alpha.

- 68527

– 00

– 4 Alkenes, C8

- 9 .alpha.

- 68527

– 11

– 7 Alkenes, C5 68527

– 13

– 9 Gases (petroleum), acid, ethanolamine scrubber 68527

– 14

– 0 Gas es (petroleum), methane

- rich off 68527

– 15

– 1 Gases (petroleum), oil refinery gas distn. off 68527

– 16

– 2 Hydrocarbons, C1

- 3 68527

– 18

– 4 Gas oils (petroleum), steam

- cracked 68527

– 19

– 5 Hydrocarbons, C1

- 4, debutanizer fraction 68527

– 21

– 9 Naphtha (petroleum), clay

- treated full

- range straight

- run 68527

– 22

– 0 Naphtha (petroleum), clay

- treated light straight

- run 68527

– 23

– 1 Naphtha (petroleum), light steam

- cracked arom. 68527

– 26

– 4 Naphtha (petroleum), light steam

- cracked, debenzenized 68527

– 27

– 5 Naphtha (petrol eum), full

- range alkylate, butane

- contg. 68553

– 00

– 4 Fuel oil, no. 6 68553

– 14

– 0 Hydrocarbons, C8

- 11 68602

– 79

– 9 Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads 68602

– 81

– 3 Distillates, hydrocarbon resin prodn. higher boiling 686 02

– 82

– 4 Gases (petroleum), benzene unit hydrotreater depentenizer overheads*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

95 68602

– 83

– 5 Gases (petroleum), C1

- 5, wet 68602

– 84

– 6 Gases (petroleum), secondary absorber off, fluidized catalytic cracker

overheads fractionater 68602

– 96

– 0 Distillates (petroleu m), oxidized light, strong acid components, compds.

with diethanolamine 68602

– 97

– 1 Distillates (petroleum), oxidized light, strong acid components, sodium

salts 68602

– 98

– 2 Distillates (petroleum), oxidized light, strong acid components 68602

– 99

– 3 Distil lates (petroleum), oxidized light, strong acid

- free 68603

– 00

– 9 Distillates (petroleum), thermal cracked naphtha and gas oil 68603

– 01

– 0 Distillates (petroleum), thermal cracked naphtha and gas oil, C5

- dimer

contg. 68603

– 02

– 1 Distillates (petroleum), ther mal cracked naphtha and gas oil, dimerized 68603

– 03

– 2 Distillates (petroleum), thermal cracked naphtha and gas oil, extractive 68603

– 08

– 7 Naphtha (petroleum), arom.

- contg. 68603

– 09

– 8 Hydrocarbon waxes (petroleum), oxidized, calcium salts 68603

– 10

– 1 Hyd rocarbon waxes (petroleum), oxidized, Me esters, barium salts 68603

– 11

– 2 Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts 68603

– 12

– 3 Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts 68603

– 13

– 4 Petrolatum (petroleum), oxi dized, ester with sorbitol 68603

– 14

– 5 Residual oils (petroleum), oxidized, calcium salts 68603

– 31

– 6 Alkenes, C10, tert

- amylene concentrator by

- product 68603

– 32

– 7 Alkenes, C15

- 20 .alpha.

- , isomerized 68606

– 09

– 7 Fuel gases, expander off 68606

– 10

– 0 Gasol ine, pyrolysis, debutanizer bottoms 68606

– 11

– 1 Gasoline, straight

- run, topping

- plant 68606

– 24

– 6 Hydrocarbons, C4, butene concentrator by

- product 68606

– 25

– 7 Hydrocarbons, C2

- 4 68606

– 26

– 8 Hydrocarbons, C3 68606

– 27

– 9 Gases (petroleum), alkylation feed 6 8606

– 28

– 0 Hydrocarbons, C5 and C10

- aliph. and C6

- 8

- arom. 68606

– 31

– 5 Hydrocarbons, C3

- 5, butadiene purifn. by

- product 68606

– 34

– 8 Gases (petroleum), depropanizer bottoms fractionation off 68606

– 36

– 0 Hydrocarbons, C5

- unsatd. rich, isoprene purifn. by

- produ ct 68607

– 11

– 4 Petroleum products, refinery gases 68607

– 30

– 7 Residues (petroleum), topping plant, low

- sulfur 68608

– 56

– 0 Waste gases, from carbon black manuf. 68647

– 60

– 9 Hydrocarbons, C>4 68647

– 61

– 0 Hydrocarbons, C4

- 5, tert

- amylene concentrator by

- produ ct 68647

– 62

– 1 Hydrocarbons, C4

- 5, butene concentrator by

- product, sour 68650

– 36

– 2 Aromatic hydrocarbons, C8, o

- xylene

- lean 68650

– 37

– 3 Paraffin waxes (petroleum), oxidized, sodium salts 68782

– 97

– 8 Distillates (petroleum), hydrofined lubricating

- oil 68 782

– 98

– 9 Extracts (petroleum), clarified oil solvent, condensed

- ring

- arom.

- contg. 68782

– 99

– 0 Extracts (petroleum), heavy clarified oil solvent, condensed

- ring

- arom.

-*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

96 contg. 68783

– 00

– 6 Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. 68783

– 01

– 7 Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc. 68783

– 02

– 8 Extracts (petroleum), intermediate clarified oil solvent, condensed

- ring

arom.

- contg. 68783

– 04

– 0 Extracts (petroleum), solvent

- refined heavy paraffinic dis tillate solvent 68783

– 05

– 1 Gases (petroleum), ammonia

- hydrogen sulfide, water

- satd. 68783

– 06

– 2 Gases (petroleum), hydrocracking low

- pressure separator 68783

– 07

– 3 Gases (petroleum), refinery blend 68783

– 08

– 4 Gas oils (petroleum), heavy atmospheric 6878 3

– 09

– 5 Naphtha (petroleum), catalytic cracked light distd. 68783

– 12

– 0 Naphtha (petroleum), unsweetened 68783

– 13

– 1 Residues (petroleum), coker scrubber, condensed

- ring

- arom.

- contg. 68783

– 15

– 3 Alkenes, C6

- 7 .alpha.

- 68783

– 61

– 9 Fuel gases, refinery, sweet ened 68783

– 62

– 0 Fuel gases, refinery, unsweetened 68783

– 64

– 2 Gases (petroleum), catalytic cracking 68783

– 65

– 3 Gases (petroleum), C2

- 4, sweetened 68783

– 66

– 4 Naphtha (petroleum), light, sweetened 68814

– 47

– 1 Waste gases, refinery vent 68814

– 67

– 5 Gases ( petroleum), refinery 68814

– 87

– 9 Distillates (petroleum), full

- range straight

- run middle 68814

– 89

– 1 Extracts (petroleum), heavy paraffinic distillates, solvent

- deasphalted 68814

– 90

– 4 Gases (petroleum), platformer products separator off 68814

– 91

– 5 Alkene s, C5

- 9 .alpha.

- 68855

– 57

– 2 Alkenes, C6

- 12 .alpha.

- 68855

– 58

– 3 Alkenes, C10

- 16 .alpha.

- 68855

– 59

– 4 Alkenes, C14

- 18 .alpha.

- 68855

– 60

– 7 Alkenes, C14

- 20 .alpha.

- 68911

– 58

– 0 Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off 68911

– 59

– 1 Gases (petroleum), hydrotreated sour kerosine flash drum 68915

– 96

– 8 Distillates (petroleum), heavy straight

- run 68915

– 97

– 9 Gas oils (petroleum), straight

- run, high

- boiling 68918

– 69

– 4 Petrolatum (petroleum), oxidized, zinc salt 68918

– 73

– 0 Residues (petroleum), clay

- treating filter wash 68918

– 93

– 4 Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts 68918

– 98

– 9 Fuel gases, refinery, hydrogen sulfide

- free 68918

– 99

– 0 Gases (petroleum), crude oil fractionation off 68919

– 00

– 6 Gases (pet roleum), dehexanizer off 68919

– 01

– 7 Gases (petroleum), distillate unifiner desulfurization stripper off 68919

– 02

– 8 Gases (petroleum), fluidized catalytic cracker fractionation off 68919

– 03

– 9 Gases (petroleum), fluidized catalytic cracker scrubbing secon dary

absorber off 68919

– 04

– 0 Gases (petroleum), heavy distillate hydrotreater desulfurization stripper

off*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review ***

97 68919

– 05

– 1 Gases (petroleum), light straight run gasoline fractionation stabilizer off 68919

– 06

– 2 Gases (petroleum), naphtha unifiner desulfurizat ion stripper off 68919

– 07

– 3 Gases (petroleum), platformer stabilizer off, light ends fractionation 68919

– 08

– 4 Gases (petroleum), preflash tower off, crude distn. 68919

– 09

– 5 Gases (petroleum), straight

- run naphtha catalytic reforming off 68919

– 10

– 8 Gase s (petroleum), straight

- run stabilizer off 68919

– 11

– 9 Gases (petroleum), tar stripper off 68919

– 12

– 0 Gases (petroleum), unifiner stripper off 68919

– 15

– 3 Hydrocarbons, C6

- 12, benzene

- recovery 68919

– 16

– 4 Hydrocarbons, catalytic alkylation, by

- products, C 3

- 6 68919

– 17

– 5 Hydrocarbons, C12

- 20, catalytic alkylation by

- products 68919

– 19

– 7 Gases (petroleum), fluidized catalytic cracker splitter residues 68919

– 20

– 0 Gases (petroleum), fluidized catalytic cracker splitter overheads 68919

– 37

– 9 Naphtha (petroleum ), full

- range reformed 68920

– 06

– 9 Hydrocarbons, C7

- 9 68920

– 07

– 0 Hydrocarbons, C`10

- linear 68920

– 64

– 9 Disulfides, di

- C1

- 2

- alkyl 68921

– 07

– 3 Distillates (petroleum), hydrotreated light catalytic cracked 68921

– 08

– 4 Distillates (petroleum), light straight

- run gasoline fractionation stabilizer

overheads 68921

– 09

– 5 Distillates (petroleum), naphtha unifiner stripper 68921

– 67

– 5 Hydrocarbons, ethylene

- manuf.

- by

- product distn. residues 68952

– 76

– 1 Gases (petroleum), catalytic cracked naphtha debutanizer 68952

– 77

– 2 Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer 68952

– 78

– 3 Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation

stabilizer, hydrogen sulfide

- free 68952

– 79

– 4 Tail gas (petroleum), catalytic hydrodesulfu rized naphtha separator 68952

– 80

– 7 Tail gas (petroleum), straight

- run naphtha hydrodesulfurizer 68952

– 81

– 8 Tail gas (petroleum), thermal

- cracked distillate, gas oil and naphtha

absorber 68952

– 82

– 9 Tail gas (petroleum), thermal cracked hydrocarbon fracti onation

stabilizer, petroleum coking 68953

– 80

– 0 Benzene, mixed with toluene, dealkylation product 68955

– 27

– 1 Distillates (petroleum), petroleum residues vacuum 68955

– 28

– 2 Gases (petroleum), light steam

- cracked, butadiene conc. 68955

– 31

– 7 Gases (petrole um), butadiene process, inorg. 68955

– 32

– 8 Natural gas, substitute, steam

- reformed desulfurized naphtha 68955

– 33

– 9 Gases (petroleum), sponge absorber off, fluidized catalytic cracker and

gas oil desulfurizer overhead fractionation 68955

– 34

– 0 Gases (petro leum), straight

- run naphtha catalytic reformer stabilizer

overhead 68955

– 35

– 1 Naphtha (petroleum), catalytic reformed 68955

– 36

– 2 Residues (petroleum), steam

- cracked, resinous 68955

– 76

– 0 Aromatic hydrocarbons, C9

- 16, biphenyl deriv.

- rich 68955

– 96

– 4 Disu lfides, dialkyl and di

- Ph, naphtha sweetening*** Interagency EO 12866 Review Draft

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98 68956

– 47

– 8 Fuel oil, isoprene reject absorption 68956

– 48

– 9 Fuel oil, residual, wastewater skimmings 68956

– 52

– 5 Hydrocarbons, C4

- 8 68956

– 54

– 7 Hydrocarbons, C4

- unsatd. 68956

– 55

– 8 Hydrocarbons, C5

- unsatd. 68 956

– 70

– 7 Petroleum products, C5

- 12, reclaimed, wastewater treatment 68988

– 79

– 4 Benzene, C10

- 12

- alkyl derivs., distn. residues 68988

– 99

– 8 Phenols, sodium salts, mixed with sulfur compounds, gasoline alk.

scrubber residues 68989

– 88

– 8 Gases (petroleum), cr ude distn. and catalytic cracking 68990

– 35

– 2 Distillates (petroleum), arom., hydrotreated, dicyclopentadiene

- rich 68991

– 49

– 1 Alkanes, C10

- 13, arom.

- free desulfurized 68991

– 50

– 4 Alkanes, C14

- 17, arom.

- free desulfurized 68991

– 51

– 5 Alkanes, C10

- 13, desulf urized 68991

– 52

– 6 Alkenes, C10

- 16 69013

– 21

– 4 Fuel oil, pyrolysis 69029

– 75

– 0 Oils, reclaimed 69430

– 33

– 7 Hydrocarbons, C6

- 30 70024

– 88

– 3 Ethene, thermal cracking products 70528

– 71

– 1 Distillates (petroleum), heavy distillate solvent ext. heart

- cut 70528

– 72

– 2 Distillates (petroleum), heavy distillate solvent ext. vacuum overheads 70528

– 73

– 3 Residues (petroleum), heavy distillate solvent ext. vacuum 70592

– 76

– 6 Distillates (petroleum), intermediate vacuum 70592

– 77

– 7 Distillates (petroleum), light vacuum 70592

– 78

– 8 Distillates (petroleum), vacuum 70592

– 79

– 9 Residues (petroleum), atm. tower, light 70693

– 00

– 4 Hydrocarbon waxes (petroleum), oxidized, sodium salts 70693

– 06

– 0 Aromatic hydrocarbons, C9

- 11 70913

– 85

– 8 Residues (petroleum), solvent

- extd. vacuu m distilled atm. residuum 70913

– 86

– 9 Alkanes, C18

- 70 70955

– 08

– 7 Alkanes, C4

- 6 70955

– 09

– 8 Alkenes, C13

- 14 .alpha.

- 70955

– 10

– 1 Alkenes, C15

- 18 .alpha.

- 70955

– 17

– 8 Aromatic hydrocarbons, C12

- 20 71243

– 66

– 8 Hydrocarbon waxes (petroleum), clay

- treated, mic rocryst., oxidized,

potassium salts 71302

– 82

– 4 Hydrocarbons, C5

- 8, Houdry butadiene manuf. by

- product 71329

– 37

– 8 Residues (petroleum), catalytic cracking depropanizer, C4

- rich 71808

– 30

– 5 Tail gas (petroleum), thermal cracking absorber 72230

– 71

– 8 Distil lates (petroleum), cracked steam

- cracked, C5

- 17 fraction 72623

– 83

– 7 Lubricating oils (petroleum), C>25, hydrotreated bright stock

- based 72623

– 84

– 8 Lubricating oils (petroleum), C15

- 30, hydrotreated neutral oil

- based,

contg. solvent deasphalted residual o il 72623

– 85

– 9 Lubricating oils (petroleum), C20

- 50, hydrotreated neutral oil

- based,

high

- viscosity*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review ***

99 72623

– 86

– 0 Lubricating oils (petroleum), C15

- 30, hydrotreated neutral oil

- based 72623

– 87

– 1 Lubricating oils (petroleum), C20

- 50, hydrotreated neutral oil

- based 73138

– 65

– 5 Hydrocarbon waxes (petroleum), oxidized, magnesium salts 92045

– 43

– 7 Lubricating oils (petroleum), hydrocracked non

- arom. solvent

deparaffined 92045

– 58

– 4 Naphtha (petroleum), isomerization, C6

- fraction 92062

– 09

– 4 Slack wax (petroleum), hydrotreated 93762

– 80

– 2 Alkenes, C15

- 18 98859

– 55

– 3 Distillates (petroleum), oxidized heavy, compds. with diethanolamine 98859

– 56

– 4 Distillates (petroleum), oxidized heavy, sodium salts 101316

– 73

– 8 Lubricating oils (petroleum), used, non

- catalytically r efined 164907

– 78

– 2 Extracts (petroleum), asphaltene

- low vacuum residue solvent 164907

– 79

– 3 Residues (petroleum), vacuum, asphaltene

- low 178603

– 63

– 9 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized,

hydrogenated, C10

- 25 178603

– 64

– 0 Gas oils ( petroleum), vacuum, hydrocracked, hydroisomerized,

hydrogenated, C15

- 30, branched and cyclic 178603

– 65

– 1 Gas oils (petroleum), vacuum, hydrocracked, hydroisomerized,

hydrogenated, C20

- 40, branched and cyclic 178603

– 66

– 2 Gas oils (petroleum), vacuum, hydr ocracked, hydroisomerized,

hydrogenated, C25

- 55, branched and cyclic 212210

– 93

– 0 Solvent naphtha (petroleum), heavy arom., distn. residues 221120

– 39

– 4 Distillates (petroleum), cracked steam

- cracked, C5

- 12 fraction 445411

– 73

– 4 Gas oils (petroleum), vacuu m, hydrocracked, hydroisomerized,

hydrogenated, C10

- 25, branched and cyclic 3412 (2) Specific exempted chemical substances

— (i) Exemption . EPA has determined that, at 3413 this time, the information in § 711.15(b)(4) associated with the chemical substances listed in 3414 paragraph (b)(2)(iv) of this section is of low current interest. 3415

(ii) Considerations . In making its determination of whether this partial exemption should 3416 apply to a particular chemical substance, EPA will consider the totality of information available 3417 for the chemical substance in question, including but not limited to, one or more of the following 3418 considerations: 3419

(A) Whether the chemical substance qualifies or has qualified in past IUR collections for 3420 the reporting of the information described in § 711.15(b)(4) (i.e., at least one site manufactures 3421 300,000 pounds (lb.) or more of the chemical substance). 3422

(B) The chemical substance's chemical and physical properties or potential for 3423 persistence, bioaccumulation, health effects, or environmental effe cts (considered independently 3424 or together). 3425

(C) The information needs of EPA, other Federal agencies, tribes, States, and local 3426 governments, as well as members of the public. 3427*** Interagency EO 12866 Review Draft

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100 (D) The availability of other complementary risk screening information. 3428

(E) Th e availability of comparable processing and use information. 3429

(F) Whether the potential risks of the chemical substance are adequately managed. 3430

(iii) Amendments . EPA may amend the chemical substance list in paragraph (b)(2)(iv) of 3431 this section on its own initiative or in response to a request from the public based on EPA's 3432 determination of whether the information in § 711.15(b)(4) is of low interest. 3433

(A) Any person may request that EPA amend the chemical substance list in Table 2 in 3434 paragraph (b)(2)(iv) o f this section. Your request must be in writing and must be submitted to the 3435 following address: OPPT IUR Submission Coordinator (Mail Code 7407M), Attention: 3436 Inventory Update Reporting, Office of Pollution Prevention and Toxics, Environmental 3437 Protection A gency, 1200 Pennsylvania Ave., NW., Washington, DC 20460

– 0001. Requests must 3438 identify the chemical substance in question, as well as its CASRN or other chemical 3439 identification number as identified in § 711.15(b)(3)(i), and must contain a written rationale for 3440 the request that provides sufficient specific information, addressing the considerations listed in § 3441 711.6(b)(2)(ii), including cites and relevant documents, to demonstrate to EPA that the collecti on 3442 of the information in § 711.15(b)(4) for the chemical substance in question either is or is not of 3443 low current interest. If a request related to a particular chemical substance is resubmitted, any 3444 subsequent request must clearly identify new information contained in the request. EPA may 3445 request other information that it believes necessary to evaluate the request. EPA will issue a 3446 written response to each request within 120 days of receipt of the request, and will maintain 3447 copies of these responses in a d ocket that will be established for each reporting cycle. 3448

(B) As needed, the Agency will initiate rulemaking to make revisions to Table 2 in 3449 paragraph (b)(2)(iv) of this section. 3450

(C) To assist EPA in reaching a decision regarding a particular request prio r to a given 3451 principal reporting year, requests must be submitted to EPA no later than 12 months prior to the 3452 start of the next principal reporting year. 3453

(iv) List of chemical substances . EPA has designated the chemical substances listed in 3454 Table 2 of thi s paragraph by CASRN, as partially exempt from reporting under the IUR. 3455

Table 2.

— CASRN of Partially Exempt Chemical Substances 3456

CASRN Chemical 50

– 70

– 4 D

- Glucitol 50

– 81

– 7 L

- Ascorbic acid 50

– 99

– 7 D

- Glucose 56

– 81

– 5 1,2,3

- Propanetriol 56

– 87

– 1 L

- Lysine 57

– 50

– 1 .alpha.

- D

- Glucopyranoside, .beta.

- D

- fructofuranosyl 58

– 95

– 7 2H

- 1

- Benzopyran

- 6

- ol, 3,4

- dihydro

- 2,5,7,8

- tetramethyl

- 2

- [(4R,8R)

-

4,8,12

- trimethyltridecyl]

- , acetate, (2R)

-*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review ***

101 59

– 02

– 9 2H

- 1

- Benzopyran

- 6

- ol, 3,4

- dihydro

- 2,5,7,8

- tetramethyl

- 2

- [(4R,8R)

-

4,8,12

- trimethyltridecyl]

- , (2R)

- 59

– 51

– 8 Methionine 69

– 65

– 8 D

- Mannitol 87

– 79

– 6 L

- Sorbose 87

– 99

– 0 Xylitol 96

– 10

– 6 Aluminum, chlorodiethyl

97

– 93

– 8 Aluminum, triethyl

100

– 99

– 2 Aluminum, tris(2

- methylpropyl)

- 123

– 94

– 4 Octadecanoic acid, 2,3

- dihydroxyprop yl ester 124

– 38

– 9 Carbon dioxide 137

– 08

– 6 .beta.

- Alanine, N

- [(2R)

- 2,4

- dihydroxy

- 3,3

- dimethyl

- 1

- oxobutyl]

- ,

calcium alt (2:1) 142

– 47

– 2 L

- Glutamic acid, monosodium salt 150

– 30

– 1 Phenylalanine 563

– 43

– 9 Aluminum, dichloroethyl

1070

– 00

– 4 Aluminum, trioct yl

1116

– 70

– 7 Aluminum, tributyl

1116

– 73

– 0 Aluminum, trihexyl

1191

– 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 778 2

– 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*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review ***

102 8029

– 43

– 4 Syrups, hydrolyzed starch 11103

– 57

– 4 Vitamin A 12075

– 68

– 2 Aluminum, di

- .mu.

- chlorochlorotriethyldi

12542

– 85

– 7 Aluminum, trichlorotrimethyldi

16291

– 96

– 6 Charcoal 26836

– 47

– 5 D

- Glucitol, monooctadecanoate 61789

– 44

– 4 Fatty acids, castor

- oil 61789

– 97

– 7 Tallow 61789

– 99

– 9 Lard 64147

– 40

– 6 Castor oil, dehydrate d 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 684 24

– 45

– 3 Fatty acids, linseed

- oil 68424

– 61

– 3 Glycerides, C16

- 18 and C18

- unsatd. mono

- and di

68425

– 17

– 2 Syrups, hydrolyzed starch, hydrogenated 68439

– 86

– 1 Bone, ash 68442

– 69

– 3 Benzene, mono

- C10

- 14

- alkyl derivs. 68476

– 78

– 8 Molasses 68514

– 27

– 2 Grease, catch basin 68514

– 74

– 9 Palm oil, hydrogenated 68525

– 87

– 1 Corn oil, hydrogenated 68648

– 87

– 3 Benzene, C10

- 16

- alkyl derivs. 68918

– 42

– 3 Soaps, stocks, soya 68952

– 94

– 3 Soaps, stocks, vegetable

- oil 68956

– 68

– 3 Fats and glyceridic oils, vegetable 68989

– 98

– 0 Fats and glyceridic oils, vegetable, residues 73138

– 67

– 7 Lard, hydrogenated 120962

– 03

– 0 Canola oil 129813

– 58

– 7 Benzene, mono

- C10

- 13

- alkyl derivs. 129813

– 59

– 8 Benzene, mono

- C12

- 14

- alkyl derivs. 129813

– 60

– 1 Benzene, mono

- C14

- 16

- alkyl derivs. 3457 § 711.8 Persons who must report. 3458*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review ***

103 Except as provided in § 711.9 and § 711.10, the following persons are subject to the 3459 requirements of this part. Persons must determine whether they must report under this section for 3460 each chemical substance that they manuf acture (including import) at an individual site. 3461

(a) Persons subject to recurring reporting

— (1) For the 2011 submission period, any 3462 person who manufactured (including imported) for commercial purposes 25,000 lb. (11,340 3463 kilogram (kg)) or more of a chemica l substance described in § 711.5 at any single site owned or 3464 controlled by that person during the principal reporting year (i.e., calendar year 2010) is subject 3465 to reporting. 3466

(2) For the submission periods subsequent to the 2011 submission period, any person 3467 who manufactured (in cluding imported) for commercial purposes 25,000 lb. (11,340 kg) or more 3468 of a chemical substance described in § 711.5 at any single site owned or controlled by that 3469 person during any calendar year since the last principal reporting year (e.g., for the 2015 3470 submission period, consider calendar years 2011, 2012, 2013, and 2014, given that 2010 was the 3471 last principal reporting year). 3472

(b) Exceptions . Any person who manufactured (including imported) for commercial 3473 purposes any chemical substance that is the su bject of a rule proposed or promulgated under 3474 TSCA section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 3475 5(e), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 3476 7 is subject to reporting for that chemical substance, regardless of the production volume. 3477

§ 711.9 Persons not subject to this part. 3478

A person described in § 711.8 is not subject to the requirements of this part if that person 3479 qualifies as a small manufacturer as tha t term is defined in 40 CFR 704.3. Notwithstanding this 3480 exclusion, a person who qualifies as a small manufacturer is subject to this part with respect to 3481 any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 3482 4, 5(b )(4), or 6, or is the subject of an order in effect under TSCA section 5(e), or is the subject 3483 of relief that has been granted under a civil action under TSCA section 5 or 7. 3484

§ 711.10 Activities for which reporting is not required. 3485

A person described in § 711.8 is not subject to the requirements of this part with respect 3486 to any chemical substance described in § 711.5 that the person solely manufactured or imported 3487 under the fo llowing circumstances: 3488

(a) The person manufactured or imported the chemical substance described in § 711.5 3489 solely in small quantities for research and development. 3490

(b) The person imported the chemical substance described in § 711.5 as part of an article. 3491

(c) The person manufactured the chemical substance described in § 711.5 in a manner 3492 described in 40 CFR 720.30(g) or (h). 3493

§ 711.15 Reporting information to EPA. 3494*** Interagency EO 12866 Review Draft

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104 For the 2011 submission period, any person who must report under this part, as described 3495 in § 711.8, must submit the information described in this section for each chemical substance 3496 described in § 711.5 that the person manufactured (including imported) for commercial purposes 3497 in an amount of 25,000 lb. (11,340 kg) or more (or lower volume for ch emical substances subject 3498 to the rules, orders, or actions described in § 711.8(b)) at any one site during the principal 3499 reporting year (i.e., calendar year 2010). For the submission periods subsequent to the 2011 3500 submission period, any person who must re port under this part, as described in § 711.8(b), must 3501 submit the information described in this section for each chemical substance described in § 711.5 3502 that the person manufactured (including imported) for commercial purposes in an amount of 3503 25,000 lb. (1 1,340 kg) or more (or lower volume for chemical substances subject to the rules, 3504 orders, or actions described in § 711.8(b)) at any one site during any calendar year since the last 3505 principal reporting year (e.g., for the 2015 submission period, consider c alendar years 2011, 3506 2012, 2013, and 2014, since 2010 was the last principal reporting year). The principal reporting 3507 year for each submission period is the previous calendar year (e.g., the principal reporting year 3508 for the 2015 submission period is calenda r year 2014). For all submission periods, a separate 3509 report must be submitted for each chemical substance at each site for which the submitter is 3510 required to report. A submitter of information under this part must report information as 3511 described in this se ction to the extent that such information is known to or reasonably 3512 ascertainable by that person. 3513

(a) Reporting information to EPA . Any person who reports information to EPA must do 3514 so using the e

- IURweb reporting software provided by EPA at the address s et forth in § 711.35. 3515 The submission must include all information described in paragraph (b) of this section. Persons 3516 must submit a separate Form U for each site for which the person is required to report. The e

3517 IURweb reporting software is described in the instruction s available from EPA at the website set 3518 forth in § 711.35. 3519

(b) Information to be reported . Manufacturers (including importers) of a reportable 3520 chemical substance in an amount of 25,000 lb. (11,340 kg) or more at a site during any calendar 3521 year since the l ast principal reporting year must report the information described in this section. 3522 As described in § 711.6(b)(1) and (b)(2), manufacturers of certain chemical substances are not 3523 required to report the information described in paragraph (b)(4) of this sect ion. 3524

(1) A certification statement signed and dated by an authorized official of the submitter 3525
company . Persons reporting must submit this information using e

- IURweb as described in § 3526 711.35. The authorized official must certify that the submitted inform ation has been completed 3527 in compliance with the requirements of this part and that the confidentiality claims made on the 3528 Form U are true and correct. The certification must be signed and dated by the authorized 3529 official for the submitter company, and pro vide that person‘s name, official title, and e

- mail 3530 address. 3531

(2) Company and plant site information . The following currently correct company and 3532 plant site information must be reported for each site at which at least 25,000 lb. (11,340 kg) of a 3533 reportable chemical substance is manufactured (including imported) during any calendar year 3534 since the last principal reporting year (see § 711.3 for the ―site‖ for importers): 3535*** Interagency EO 12866 Review Draft

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105 (i) The parent company name, address, and Dun and Bradstreet Number. A submitter 3536 under t his part must obtain a Dun and Bradstreet Number for the parent company if none exists. 3537

(ii) The name of a person who will serve as technical contact for the submitter company, 3538 and who will be able to answer questions about the information submitted by th e company to 3539 EPA, the contact person's full mailing address, telephone number, and e

- mail address. 3540

(iii) The name and full street address of each site. A submitter under this part must 3541 include the appropriate Dun and Bradstreet Number for each plant site reported, and the county 3542 or parish (or other jurisdictional indicator) in which the plant site is located. A submitter under 3543 this part must obtain a Dun and Bradstreet Number for the site reported if none exists. 3544

(3) Specific information for chemical subs tances manufactured in amounts of 25,000 lb. 3545

or more . The following chemical

- specific information must be reported for each reportable 3546 chemical substance manufactured (including imported) at each site in amounts of 25,000 lb. 3547 (11,340 kg) or more during any calendar year since the last principal reporting year: 3548

(i) The specific, currently correct Chemical Abstracts ( CA) Index name as used to list the 3549 chemical substance on the TSCA Inventory and the correct corresponding Chemical Abstracts 3550 Service (CAS) Regi stry Number ( CASRN) for each reportable chemical substance at each site. A 3551 submitter under this part may use an EPA

- designated TSCA Accession Number for a chemical 3552 substance in lieu of a CASRN when a CASRN is not known to or reasonably ascertainable by 3553 the submitter. Submitters who wish to report chemical substances listed on the confidential 3554 portion of the TSCA Inventory will need to report the substance using a TSCA Accession 3555 Number. 3556 In addition to reporting the number itself, submitters must specify th e type of number they are 3557 reporting by selecting from among the codes in Table 3 of this paragraph. 3558

Table 3.

— Codes to Specify Type of Chemical Identifying Number 3559

Code Number Type A Accession Number C Chemical Abstracts Service Registry Number (CASRN) 3560 3561

(A) If an importer submitting a report cannot provide the information specified in § 3562 711.15(b)(3)(i) of this section because it is unknown to the importer and claimed as confidential 3563 by the supplier of the chemical substance or mixture, the importer must use e

- IURweb to ask the 3564 supplier to provide the correct chemical identity information directly to EPA in a joint 3565 submission. Such request must include instructions for submitting chemical identity information 3566 electronically, using e

- IURweb and CDX (see § 711.35), and for clearly referencing the 3567 importer's submission. Contact information for the supplier, a trade name or other designation 3568 for the chemical substance or mixture, and a copy of the request to the supplier must be included 3569 with the importer‘s submission respecting the chemical substance. 3570*** Interagency EO 12866 Review Draft

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106 (B) If a manufacturer submitting a report cannot provide the information specified in § 3571 711.15(b)(3)(i) of this section because the reportable chemical substance is manufactured using a 3572 reactant having a specific chemical identity that is unknown to the manufacturer and claimed as 3573 confidential by its supplier, the manufacturer must use e

- IUR web to ask the supplier of the 3574 confidential reactant to provide the correct chemical identity of the confidential reactant directly 3575 to EPA in a joint submission. Such request must include instructions for submitting chemical 3576 identity information electroni cally using e

- IURweb and CDX (see § 711.35), and for clearly 3577 referencing the manufacturer's submission. Contact information for the supplier, a trade name or 3578 other designation for the chemical substance, and a copy of the request to the supplier must be 3579 included with the importer‘s submiss ion respecting the chemical substance. 3580

(C) EPA will only accept joint submissions that are submitted electronically using e

3581 IURweb and CDX (see § 711.35) and that clearly reference the primary submission to which 3582 they refer. 3583

(ii) For the principal report ing year only, a statement indicating, for each reportable 3584 chemical substance at each site, whether the chemical substance is manufactured in the United 3585 States, imported into the United States, or both manufactured in the United States and imported 3586 into th e United States. 3587

(iii) For the principal reporting year, the total annual volume (in pounds) of each 3588 reportable chemical substance domestically manufactured and imported at each site. The total 3589 annual domestically manufactured volume (not including import ed volume) and the total annual 3590 imported volume must be separately reported. This amount must be reported to two significant 3591 figures of accuracy. For each complete calendar year since the last principal reporting year, the 3592 total annual volume (domestically manufactured and imported volumes in pounds) of each 3593 reportable chemical substance at each site. 3594

(iv) For the principal reporting year only, the volume used on site and the volume 3595 exported of each reportable chemical substance domestically manufactured a nd imported at each 3596 site. This amount must be reported to two significant figures of accuracy. 3597

(v) For the principal reporting year only, a designation indicating, for each imported 3598 reportable chemical substance at each site, whether the imported chemical substance is 3599 physically present at the reporting site. 3600

(vi) For the principal reporting year only, a designation indicating, for each reportable 3601 chemical substance at each site, whether the chemical substance is being recycled, 3602 remanufactured, reprocesse d, reused, or otherwise used for a commercial purpose instead of 3603 being disposed of as a waste or included in a waste stream. 3604

(vii) For the principal reporting year only, the total number of workers reasonably likely 3605 to be exposed to each reportable chemic al substance at each site. For each reportable chemical 3606 substance at each site, the submitter must select from among the ranges of workers listed in 3607 Table 4 of this paragraph and report the corresponding code (i.e., W1 through W8): 3608

Table 4.

— Codes for Repor ting Number of Workers Reasonably Likely To Be Exposed 3609*** Interagency EO 12866 Review Draft

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107 Code Range W1 Fewer than 10 workers W2 At least 10 but fewer than 25 workers W3 At least 25 but fewer than 50 workers W4 At least 50 but fewer than 100 workers W5 At least 100 but fewer than 500 w orkers W6 At least 500 but fewer than 1,000 workers W7 At least 1,000 but fewer than 10,000 workers W8 At least 10,000 workers 3610 (viii) For the principal reporting year only, the maximum concentration, measured by 3611 percentage of weight, of each reportab le chemical substance at the time it is sent off

- site from 3612 each site. If the chemical substance is site

- limited, you must report the maximum concentration, 3613 measured by percentage of weight of the reportable chemical substance at the time it is reacted 3614

on

- s ite to produce a different chemical substance. This information must be reported regardless 3615 of the physical form(s) in which the chemical substance is sent off

- site/reacted on

- site. For each 3616 chemical substance at each site, select the maximum concentration of the chemical substance 3617 from among the ranges listed in Table 5 of this paragraph and report the corresponding code (i.e., 3618 M1 through M5): 3619

Table 5.

— Codes for Reporting Maximum Concentration of Chemical Substance 3620

Code Concentration Range (% weight) M1 L ess than 1% by weight M2 At least 1 but less than 30% by weight M3 At least 30 but less than 60% by weight M4 At least 60 but less than 90% by weight M5 At least 90% by weight 3621 (ix) For the principal reporting year only, the physical form(s) of the r eportable chemical 3622 substance as it is sent off

- site from each site. If the chemical substance is site

- limited, you must 3623 report the physical form(s) of the reportable chemical substance at the time it is reacted on

- site to 3624 produce a different chemical subst ance. For each chemical substance at each site, the submitter 3625 must report as many physical forms as applicable from among the physical forms listed in this 3626 unit: 3627

(A) Dry powder. 3628

(B) Pellets or large crystals. 3629

(C) Water

- or solvent

- wet solid. 3630

(D) Other solid. 3631

(E) Gas or vapor. 3632

(F) Liquid. 3633*** Interagency EO 12866 Review Draft

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108 (x) For the principal reporting year only, submitters must report the percentage, rounded 3634 off to the closest 10%, of total production volume of the reportable chemical substance, reported 3635 in response to paragraph (b )(3)(iii) of this section, that is associated with each physical form 3636 reported under paragraph (b)(3)(ix) of this section. 3637

(4) Specific information related to processing and use . Persons subject to paragraph 3638 (b)(3) of this section must report the informa tion described in paragraphs (b)(4)(i) and (b)(4)(ii) 3639 of this section for each reportable chemical substance at sites under their control and at sites that 3640 receive a reportable chemical substance from the submitter directly or indirectly (including 3641 through a broker/distributor, from a customer of the submitter, etc.). Information reported in 3642 response to this paragraph must be reported for the principal reporting year only and only to the 3643 extent that it is known to or reasonably ascertainable by the submitte r. Information required to be 3644 reported under this paragraph is limited to domestic (i.e., within the customs territory of the 3645 United States) processing and use activities. If information responsive to a given data 3646 requirement under this paragraph, includin g information in the form of an estimate, is not known 3647 or reasonably ascertainable, the submitter is not required to respond to the requirement. 3648

(i) Industrial processing and use information

— (A) A designation indicating the type of 3649 industrial processing o r use operation(s) at each site that receives a reportable chemical 3650 substance from the submitter site directly or indirectly (whether the recipient site(s) are 3651 controlled by the submitter site or not). For each chemical substance, report the letters which 3652 correspond to the appropriate processing or use operation(s) listed in Table 6 of this paragraph. A 3653 particular designation may need to be reported more than once, to the extent that a submitter 3654 reports more than one sector (under paragraph (b)(4)(i)(B) of this section) that applies to a given 3655 designation under this paragraph. 3656

Table 6.

— Codes for Reporting Type of Industrial Processing or Use Operation 3657

Designation Operation PC Processing as a reactant PF Processing

— incorporation into formulation, mixture or reaction

product PA Processing

— incorporation into article PK Processing

— repackaging U Use

— non

- incorporative activities 3658 (B) A code indicating the sector(s) that best describe the industrial activities associated 3659 with each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this 3660 section. For each chemical substance, report the code that corresponds to the appropriate 3661 sector(s) listed in Table 7 of this paragraph. A particular sector code may need to be reported 3662 more than onc e, to the extent that a submitter reports more than one industrial function code 3663 (under paragraph (b)(4)(i)(C) of this section) that applies to a given sector code under this 3664 paragraph. 3665

Table 7.

— Codes for Reporting Industrial Sectors 3666

Code Sector Descriptio n*** Interagency EO 12866 Review Draft

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109 IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (except Oil and Gas) and support activities IS4 Utilities IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Related Support Activities IS11 Petroleum Refineries IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing IS13 Pet roleum 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 I S19 All Other Basic Inorganic Chemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Organic Chemical Manufacturing IS22 Plastics Material and Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic F iber 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 Prepa ration 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 Manufacturi ng IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Non

- metallic Mineral Product Manufacturing (includes clay, glass,

cement, concrete, lime, gypsum, and other non

- metallic mineral product manufacturing) IS38 Primary Metal Man ufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing*** Interagency EO 12866 Review Draft

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110 IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturing IS46 Wholesale and Retail Trade IS47 Services IS48 Other (requires additional information) 3667 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s ) from 3668 Table 8 of this paragraph must be selected to designate the industrial function category(ies) that 3669 best represents the specific manner in which the chemical substance is used. A particular 3670 industrial function category may need to be reported more th an once, to the extent that a 3671 submitter reports more than one industrial processing or use operation/sector combination (under 3672 paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given industrial function 3673 category under this paragra ph. If more than 10 unique combinations of industrial processing or 3674 use operations/sector/industrial function categories apply to a chemical substance, submitters 3675 need only report the 10 unique combinations for the chemical substance that cumulatively 3676
repr esent the largest percentage of the submitter's production volume for that chemical 3677 substance, measured by weight. If none of the listed industrial function categories accurately 3678 describes a use of a chemical substance, the category ―Other‖ may be used, an d must include a 3679 description of the use. 3680

Table 8.

— Codes for Reporting Industrial Function Categories 3681

Code Category U001 Abrasives U002 Adhesives and sealant chemicals U003 Adsorbents and absorbents U004 Agricultural chemicals (non

- pesticidal) U005 Ant i

- 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 flui ds (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*** Interagency EO 12866 Review Draft

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111 U023 Plating agents and surface tre ating agents U024 Process regulators U025 Processing aids, specific to petroleum production U026 Processing aids, not otherwise listed U027 Propellants and blowing agents U028 Solids separation agents U029 Solvents (for cleaning or degreasing) U030 Solvents (which become part of product formulation or

mixture) U031 Surface active agents U032 Viscosity adjustors U033 Laboratory chemicals U034 Paint additives and coating additives not described by other

categories U999 Other (specify) 3682 (D) The e stimated percentage, rounded off to the closest 10%, of total production volume 3683 of the reportable chemical substance associated with each combination of industrial processing 3684 or use operation, sector, and industrial function category. Where a particular co mbination of 3685 industrial processing or use operation, sector, and industrial function category accounts for less 3686 than 5% of the submitter's site's total production volume of a reportable chemical substance, the 3687 percentage must not be rounded off to 0% if th e production volume attributable to that industrial 3688 processing or use operation, sector, and industrial function category combination is 25,000 lb. 3689 (11,340 kg) or more during the reporting year. Instead, in such a case, submitters must report the 3690 percentag e, rounded off to the closest 1%, of the submitter's site's total production volume of the 3691 reportable chemical substance associated with the particular combination of industrial processing 3692 or use operation, sector, and industrial function category. 3693

(E) Fo r each combination of industrial processing or use operation, sector, and industrial 3694 function category, the submitter must estimate the number of sites at which each reportable 3695 chemical substance is processed or used. For each combination associated with e ach chemical 3696 substance, the submitter must select from among the ranges of sites listed in Table 9 of this 3697 paragraph and report the corresponding code (i.e., S1 through S7): 3698

Table 9.

— Codes for Reporting Numbers of Sites 3699

Code Range S1 Fewer than 10 sites S2 at least 10 but fewer than 25 sites S3 at least 25 but fewer than 100 sites S4 at least 100 but fewer than 250 sites S5 at least 250 but fewer than 1,000 sites S6 at least 1,000 but fewer than 10,000 sites S7 at least 10,000 sites 3700*** Interagency EO 12866 Review Draft

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112 (F) For each c ombination of industrial processing or use operation, sector, and industrial 3701 function category, the submitter must estimate the number of workers reasonably likely to be 3702 exposed to each reportable chemical substance. For each combination associated with ea ch 3703 chemical substance, the submitter must select from among the worker ranges listed in paragraph 3704 (b)(3)(ii) of this section and report the corresponding code (i.e., W1 though W8). 3705

(ii) Consumer and commercial use information

— (A) Using the codes listed in Table 10 3706 of this paragraph, submitters must designate the consumer and commercial product category or 3707 categories that best describe the consumer and commercial products in which each reportable 3708 chemical substance is used (whether the recipient site(s) are controlled by the submitter site or 3709 not). If more than 10 codes apply to a chemical substance, submitters need only report the 10 3710 codes for the chemical substance that cumulatively represent the largest percentage of the 3711 submitter's production volume for that chemical, measured by weight. If none of the listed 3712 consumer and commercial product categories accurately describes the consumer and commercial 3713 products in which each reportable chemical substance is used, the category ―Other‖ may be used, 3714 and must in clude a description of the use. 3715

Table 10.

— Codes for Reporting Consumer and Commercial Product Categories 3716

Code Category

Chemical Substances in Furnishing, Cleaning, Treatment Care Products C101 Floor Coverings C102 Foam Seating and Bedding Products C1 03 Furniture and Furnishings not covered elsewhere C104 Fabric, Textile, and Leather Products not covered elsewhere C105 Cleaning and Furnishing Care Products C106 Laundry and Dishwashing Products C107 Water Treatment Products C108 Personal Care Pr oducts C109 Air Care Products C110 Apparel and Footwear Care Products Chemical Substances in Construction, Paint, Electrical, and Metal Products C201 Adhesives and Sealants C202 Paints and Coatings C203 Building/Construction Materials

- Wood and En gineered Wood Products C204 Building/Construction Materials not covered elsewhere C205 Electrical and Electronic Products C206 Metal Products not covered elsewhere C207 Batteries Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products C301 Food Packaging C302 Paper Products C303 Plastic and Rubber Products not covered elsewhere C304 Toys, Playground, and Sporting Equipment C305 Arts, Crafts, and Hobby Materials C306 Ink, Toner, and Colorant Products*** Interagency EO 12866 Review Draft

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113 C307 Photographic Supplies, Fi lm, 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 Material s C406 Agricultural Products (non

- pesticidal) C407 Lawn and Garden Care Products

Chemical Substances in Products not Described by Other Codes C980 Non

- TSCA Use C909 Other (specify) 3717 (B) An indication, within each consumer and commercial product cat egory reported 3718 under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use. 3719

(C) Submitters must determine, within each consumer and commercial product category 3720 reported under paragraph (b)(4)(ii)(A) of this section, wh ether any amount of each reportable 3721 chemical substance manufactured (including imported) by the submitter is present in (for 3722 example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a 3723 component in the paint on a toy) any con sumer products intended for use by children age 14 or 3724 younger, regardless of the concentration of the chemical substance remaining in or on the 3725 product. Submitters must select from the following options: The chemical substance is used in or 3726
on any consumer products intended for use by children, the chemical substance is not used in or 3727 on any consumer products intended for use by children, or information as to whether the 3728 chemical substance is used in or on any consumer products intended for use by children is not 3729 known to or reasonably ascertainable by the submitter. 3730

(D) The estimated percentage, rounded off to the closest 10%, of the submitter's site's 3731 total production volume of the reportable chemical substance associated with each consumer and 3732 commercial product category. Where a particular consumer and commercial product category 3733 accounts for less than 5% of the total production volume of a reportable chemical substance, the 3734 percentage must not be rounded off to 0% if the production volume attributable t o that 3735 commercial and consumer product category is 25,000 lb. (11,340 kg) or more during the 3736 reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the 3737 closest 1%, of the submitter's site's total production volume of the reportable chemical substance 3738 associated with the particular consumer and commercial product category. 3739

(E) Where the reportable chemical substance is used in consumer or commercial 3740 products, the estimated typical maximum concentration, measured by we ight, of the chemical 3741 substance in each consumer and commercial product category reported under paragraph 3742 (b)(4)(ii)(A) of this section. For each chemical substance in each commercial and consumer 3743 product category reported under paragraph (b)(4)(ii)(A) of this section, submitters must select 3744 from among the ranges of concentrations listed in Table 5 in paragraph (b)(3)(viii) of this section 3745 and report the corresponding code (i.e., M1 through M5). 3746*** Interagency EO 12866 Review Draft

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114 (F) Where the reportable chemical substance is used in a comm ercial product, the 3747 submitter must estimate the number of commercial workers reasonably likely to be exposed to 3748 each reportable chemical substance. For each combination associated with each substance, the 3749 submitter must select from among the worker ranges listed in Table 4 in paragraph (b)(3)(vii) of 3750 this section and report the corresponding code (i.e., W1 though W8). 3751

§ 711.20 When to report. 3752

All information reported to EPA in response to the requirements of this part must be 3753 submitted during an applicable submission period from June 1 to September 30 at 4

– year 3754 intervals, beginning in 2011. Any person described in § 71 1.8(a) must report during each 3755 submission period for each chemical substance described in § 711.5 that the person 3756 manufactured (including imported) during any calendar year since the last principal reporting 3757 year (e.g., for the 2011 submission period, cons ider calendar years 2006, 2007, 2008, 2009, and 3758 2010, since 2005 was the last principal reporting year). 3759

§ 711.22 Duplicative reporting. 3760

(a) With regard to TSCA section 8(a) rules . Any person subject to the requirements of 3761 this part who previously has co mplied with reporting requirements of a rule under TSCA section 3762 8(a) by submitting the information described in § 711.15 for a chemical substance described in § 3763 711.5 to EPA, and has done so within 1 year of the start of a submission period described in § 3764 711.20, is not required to report again on the manufacture of that chemical substance at that site 3765 during that submission period. 3766

(b) With regard to importers . This part requires that only one report be submitted on each 3767 import transaction involving a che mical substance described in § 711.5. When two or more 3768 persons are involved in a particular import transaction and each person meets the Agency's 3769 definition of ―importer‖ as set forth in 40 CFR 704.3, they may determine among themselves 3770 who should submit the required report; if no repo rt is submitted as required under this part, EPA 3771 will hold each such person liable for failure to report. 3772

(c) Toll manufacturers and persons contracting with a toll manufacturer . This part 3773 requires that only one report per site be submitted on each chemic al substance described in § 3774 711.5. When a company contracts with a toll manufacturer to manufacture a chemical substance, 3775 and each party meets the Agency's definition of ―manufacturer‖ as set forth in § 711.3, they may 3776 determine among themselves who should submit the required report for that site. However, both 3777 the contracting company and the toll manufacturer are liable if no report is made. 3778

§ 711.25 Recordkeeping requirements. 3779

Each person who is subject to the reporting requirements of this part must retain records 3780 that document any information reported to EPA. Records relevant to reporting during a 3781 submission period must be retained for a period of 5 years beginning on the last day of the 3782 submission period. Submitters are encouraged to retain their records longer than 5 years to 3783 ensure that past records are available as a reference when new submissions are being generated. 3784

§ 711.30 Confidentiality claims. 3785*** Interagency EO 12866 Review Draft

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115 (a) Confidentiality claims . Any person submitting information under this part may assert 3786 a business confidentiality claim for the information at the time it is submitted. Any such 3787 confidentiality claims must be made at the time the information is submitted. Confidentiality 3788 claims cannot be made when a response is left blank or designated as not known or reasonably 3789 ascertainable. These claims will apply only to the information submitted with the claim. New 3790 confidentiality claims, if appropriate, must be asserted with regard to information submitted 3791 during a different submission period. Guidance for asserting confidentiality claims is provided in 3792 the instructions identified in § 711.35. Information claimed as confidential in accordance with 3793 this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2. 3794

(b) Chemical identity . A person may assert a claim of confidentiality for the chemical 3795 identity of a specific chemical substance only if the identity of that chemical substance is treated 3796 as confidential in the Master Inventory File as of the time the report is submitted for that 3797 chemical substance under this part. The following steps must be taken t o assert a claim of 3798 confidentiality for the identity of a reportable chemical substance: 3799

(1) The submitter must submit with the report detailed written answers to the following 3800 questions signed and dated by an authorized official. 3801

(i) What harmful effect s to your competitive position, if any, or to your supplier‘s 3802 competitive position, do you think would result from the identity of the chemical substance being 3803 disclosed in connection with reporting under this part? How could a competitor use such 3804 informat ion? Would the effects of disclosure be substantial? What is the causal relationship 3805 between the disclosure and the harmful effects? 3806

(ii) How long should confidential treatment be given? Until a specific date, the 3807 occurrence of a specific event, or perman ently? Why? 3808

(iii) Has the chemical substance been patented? If so, have you granted licenses to others 3809 with respect to the patent as it applies to the chemical substance? If the chemical substance has 3810 been patented and therefore disclosed through the pate nt, why should it be treated as 3811 confidential? 3812

(iv) Has the identity of the chemical substance been kept confidential to the extent that 3813 your competitors do not know it is being manufactured or imported for a commercial purpose by 3814 anyone? 3815

(v) Is the fact that the chemical substance is being manufactured (including imported) for 3816 a commercial purpose available to the public, for example in technical journals, libraries, or 3817 State, local, or Federal agency public files? 3818

(vi) What measures have been taken to p revent undesired disclosure of the fact that the 3819 chemical substance is being manufactured (including imported) for a commercial purpose? 3820

(vii) To what extent has the fact that this chemical substance is manufactured (including 3821 imported) for commercial pur poses been revealed to others? What precautions have been taken 3822 regarding these disclosures? Have there been public disclosures or disclosures to competitors? 3823*** Interagency EO 12866 Review Draft

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116 (viii) Does this particular chemical substance leave the site of manufacture (including 3824 import) in any form, e.g., as product, effluent, emission? If so, what measures have been taken to 3825 guard against the discovery of its identity? 3826

(ix) If the chemical substance leaves the site in a product that is available to the public or 3827 your competitors, can th e chemical substance be identified by analysis of the product? 3828

(x) For what purpose do you manufacture (including import) the substance? 3829

(xi) Has EPA, another Federal agency, or any Federal court made any pertinent 3830 confidentiality determinations regardin g this chemical substance? If so, please attach copies of 3831 such determinations. 3832

(2) If any of the information contained in the answers to the questions listed in paragraph 3833 (b)(1) of this section is asserted to contain confidential business information (CBI ), the submitter 3834 must clearly identify the information that is claimed confidential by marking the specific 3835 information on each page with a label such as ―confidential business information,‖ ―proprietary,‖ 3836 or ―trade secret.‖ 3837

(c) Site identity . A submitter may assert a claim of confidentiality for a site only if the 3838 linkage of the site with a reportable chemical substance is confidential and not publicly available. 3839 The following steps must be taken to assert a claim of confidentiality for a site identity: 3840

(1) The submitter must submit with the report detailed written answers to the following 3841 questions signed and dated by an authorized official: 3842

(i) Has site information been linked with a chemical identity in any other Federal, State, 3843 or local reporting sch eme? For example, is the chemical identity linked to a facility in a filing 3844 under the Emergency Planning and Community Right

- to

- Know Act (EPCRA) section 311, 3845 namely through a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the 3846 link age claimed as confidential in any of these instances? 3847

(ii) What harmful effect, if any, to your competitive position do you think would result 3848 from the identity of the site and the chemical substance being disclosed in connection with 3849 reporting under thi s part? How could a competitor use such information? Would the effects of 3850 disclosure be substantial? What is the causal relationship between the disclosure and the harmful 3851 effects? 3852

(2) If any of the information contained in the answers to the questions li sted in paragraph 3853 (c)(1) of this section is asserted to contain CBI, the submitter must clearly identify the 3854 information that is claimed confidential by marking the specific information on each page with a 3855 label such as ―confidential business information,‖ ―proprietary,‖ or ―trade secret.‖ 3856

(d) Processing and use information . A submitter may assert a claim of confidentiality for 3857 each data element required by § 711.15(b)(4) only if the linkage of the information with a 3858 reportable chemical substance is confidential and not publicly available. The following steps 3859 must be taken to assert a claim of confidentiality for each data element, individually, required by 3860 § 711.15(b)(4): 3861*** Interagency EO 12866 Review Draft

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117 (1) The submitter must submit with the report detailed written answers to the following 3862 questions signed and dated by an authorized official: 3863

(i) Is the identified use of this chemical substance publicly known? For example, is 3864 information on the use available in advertisements or other marketing materials, professional 3865 journals or other similar materials, or in non

- confidential mandatory or voluntary government 3866 filings or publications? Has your company ever provided use information on the c hemical 3867 substance that was not claimed as confidential? 3868

(ii) What harmful effect, if any, to your competitive position or to your customer‘s 3869 competitive position do you think would result from the information reported as required by § 3870 711.15(b)(4) and the chemical substance being disclosed in connection with reporting under this 3871 part? How could a competitor use such information? Would the effects of disclosure be 3872 substantial? What is the causal relationship between the disclosure and the substantial harmfu l 3873 effects? 3874

(2) If any of the information contained in the answers to the questions listed in paragraph 3875 (d)(1) of this section is asserted to contain CBI, the submitter must clearly identify the 3876 information that is claimed confidential by marking the speci fic information on each page with a 3877 label such as ―confidential business information,‖ ―proprietary,‖ or ―trade secret.‖ 3878

(e) No claim of confidentiality . If no claim of confidentiality is indicated on Form U 3879 submitted to EPA under this part; if Form U lac ks the certification required by § 3880 711.15(b)(1); if confidentiality claim substantiation required under paragraphs (b), (c), and (d) of 3881 this section is not submitted with Form U; or if the identity of a chemical substance listed on the 3882

non

- confidential portion of the Ma ster Inventory File is claimed as confidential, EPA may make 3883 the information available to the public without further notice to the submitter. 3884

§ 711.35 Electronic filing. 3885

(a) You must use e

- IURweb to complete and submit Form U; EPA Form 7740

– 8. 3886 Submissio ns may only be made as set forth in this section. 3887

(b) Submissions must be sent electronically to EPA via CDX. 3888

(c) Access e

- IURweb and instructions, as follows: 3889

(1) By website . Go to the EPA Inventory Update Reporting Internet homepage at 3890 http://www.epa .gov/iur and follow the appropriate links. 3891

(2) By phone or e

- mail . Contact the EPA TSCA Hotline at (202) 554

– 1404 or TSCA

3892 Hotline@epa.gov for a CD

- ROM containing the instructions. 3893