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DRAFT_EO12866_IUR Mods_FRM_2010

- 12

- 30.doc 1 2 Revised to address Interagency Comments received under EO 12866 Review. 3 4 BILLING CODE 6560

– - 50

– - P 5 6 7 8 ENVIRONMENTAL PROTECTION AGENCY 9

40 CFR Parts 704, 710, and 711 10

[ EPA

– - HQ

– - OPPT

– - 20 09

– - 0187 ; FRL

– 8833

– 5

- XXXX

- X ] 11

RIN 2070

– - AJ43 12
TSCA Inventory Update Reporting Modif ications 13

14

AGENCY: Environmental Protection Agency (EPA). 15

ACTION: Final rule. 16

SUMMARY: EPA is amending the Toxic Substances Control Act (TSCA) section 8(a) 17
Inventory Update Reporting (IUR) rule. The IUR enables EPA to collect and publish 18

information on the manufacturing, processing, and use of commercial chemical 19

substances and mixtures (referred to hereafter as chemical substances) on the TSCA 20
Chemical Substance Inventory (TSCA Inventory). This includes current information on 21

chemical substance production v olumes, manufacturing sites, and how the 22

chemicals chemical s ubstance s are used. This information helps the Agency determine 23
whether people or the environment are potentially exposed to reported 24

chemicals. chemical s ubstance s. EPA publishes submitted IUR data that is not 25

Conf

idential Business Information (CBI). EPA is amending the IUR rule to require 26
submission of information that will better address Agency and public information needs, 27
improve the usability and reliability of the reported data, and ensure that data are 28*** Interagency EO 12866 Review Draft

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2 availa ble in a timely manner. EPA is requiring electronic reporting of IUR information 29
and modifying IUR reporting requirements, including certain circumstances that trigger 30
reporting, the specific data to be reported, the reporting standard for processing and u se 31
information, and CBI reporting procedures. 32

DATES: This final rule is effective [ insert date 30 days after date of publication in the 33
Federal Register ]. 34

35 ADDRESSES: EPA has established a docket for this action under docket identification 36

(ID) number EPA

– - HQ

– - OPPT

– 20 09

- 20 09

- 0187

. . All documents in the docket are 37

listed in the docket index available at http://www.regulations.gov . Although listed in the 38
index, some information is not publicly available, e.g., Confidential Business Information 39
(CBI) or other information whose disclosure is restricted by statute. Certain other 40
material, such as copyrighted material, is not placed on the Internet and will be publicly 41
available only in hard copy form. Publicly ava ilable docket materials are available in the 42

electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the 43

OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 44
3334, EPA West Bldg., 1301 Constituti on Ave., NW., Washington, DC. The EPA/DC 45
Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through 46
Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading 47

Room is (202) 566

– 1744, and the telephone number for the OPPT Docket is (202) 566

– 48
0280. Docket visitors are required to show photographic identification, pass through a 49

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

50
ray machine and subject to search. Visitors will be provided an EPA/DC badge that must 51
be visible at all times in the building and returned upon departure. 52*** Interagency EO 12866 Review Draft

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3 53 FOR FURTHER INFORMATION CONTACT: For technical information contact : 54
Chenise Farquharson, Chemical Control Division (7405M), Office of Pollution 55
Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 56
NW., Washington, DC 20460

– - 0001; telephone number: 202

- 564

- 7768; e

- mail address: 57
farquharson.chenise @epa.gov

. Farquharson.chenise @epa.gov

. 58
For general information contact : The TSCA

- Hotline, ABVI

- Goodwil l, 422 South 59

Clinton Ave., Rochester, NY 14620 ; telephone number: (202) 554

– - 1404; e

- mail address: 60

TSCA

- Hotline@epa.gov

. 61

62 SUPPLEMENTARY INFORMATION: 63

64 I. Does this Action Apply to Me? 65

66 You may be potentially affected by this action if you manufacture (includin g 67
manufacture as a byproduct) or import , for commercial purposes, chemical substances 68
listed on the TSCA Inventory (under TSCA section 3, ―import‖ is included in the 69
definition of manufacture). Potentially affected entities may include, but are not limite d 70

to: 71

• Chemical substance manufacturers and importers (NAICS codes 325 and 72
324110; e.g., chemical substance manufacturing and processing and petroleum 73

refineries). 74

• Chemical substance users and processors who, in addition to manufacturers 75

described above in this section , may manufacture a byproduct chemical substance 76*** Interagency EO 12866 Review Draft

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4 (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal 77
manufacturing, and semiconductor and other electronic component manufacturing). 78
This listing is not inte nded to be exhaustive, but rather provides a guide for 79
readers regarding entities likely to be affected by this action. Other types of entities not 80

listed in this unit could also be affected. The North American Industrial Classification 81
System (NAICS) co des have been provided to assist you and others in determining 82
whether this action might apply to certain entities. If you have any questions regarding 83
the applicability of this action to a particular entity, consult the technical person listed 84

under FOR F URTHER INFORMATION CONTACT

. 85

II. Background 86

87 A. What Action is the Agency Taking? 88
In this action, EPA is promulgating several amendments to the IUR rule, taking 89

into consideration comments received on the proposal. propos ed rule

. The amendments 90
were proposed on Augu st 13, 2010 (75 FR 49656)(FRL

- 8833

- 5 ) (Ref. 1 ) . The 91

amendments contained in this final rule, as well as the TSCA Inventory update provisions 92
of 40 CFR part 710 subpart C unchanged by these amendments, appear in a new part, 40 93
CFR part 711. The following i s a brief listing of the primary amendments to the IUR. 94

These amendments are described in more detail in Unit II.E II I

. 95
1. EPA is amending 40 CFR 710.59, which appears in the new part 711 as 96
§711.35, to require electronic reporting of the IUR data, using an A gency

- provided, web

97
based reporting software tool (e

- IURweb) to submit IUR reports through the Internet to 98
EPA‘s Central Data Exchange (CDX). After the final rule‘s effective date [see DATES ], 99
paper submissions will no longer be accepted. 100*** Interagency EO 12866 Review Draft

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5 2. EPA is adding a new def inition section, which appears in the new part 711 as 101
§711.3; revising the definition for manufacture and site ; and making other needed 102

definitional modifications and additions. 103
3. EPA is amending 40 CFR 710.53, which appears in the new part 711 as 104

§711.20 , to change the reporting frequency from every 5 years to every 4 years. 105
4. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as 106
§711.8(a), to modify the method used to determine whether a manufacturer (including 107
importer) is subject to I UR reporting. The method would w ill be effective after the 108

2011 201 2 IUR submission period. Subsequent to 2011 201 2 , reporting is required if the 109
production volume of a chemical substance met or exceeded the 25,000 pound (lb .) ) 110
threshold in any calendar year since the last principal reporting year (e.g., 2010 201 1 ). 111
5. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as 112

§711.15( c b ), to eliminate replace the 300,000 lb

. reporting threshold for processing and 113

use information , thereby requiring all submitters of non

- excluded chemical substances to 114

report by phasing in a lower threshold

. Fo r the 2012 subm ission period, the threshold for 115
reporting processing and use information in all par ts of is 100,000 lb . In subsequent 116
submission periods, the IUR reporting form (Form U). threshold will be 25,000 lb

. 117
6. EPA is amending 40 CFR 710.48(a), which appears in the new part 711 as 118

§711.8( a b ), to eliminate replace the 25,000 lb

. threshold for certain specific chemical 119
substances that are the subject of particular TSCA rules and/or orders
, thereby requiring 120
manufacturers (including importers) of such . The new reporting threshold for these 121

chemical substances to report under is 2,500 lb , which is effective for the IUR rule, 122*** Interagency EO 12866 Review Draft

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6 regardless of the production volume 2016 submission period and subs equent submission 123
periods

. 124
7. EPA is amending 40 CFR 710.46, which appears in the new part 711 as §711.6, 125
to make chemical substances for which an enforceable consent agreement (ECA) to 126
conduct testing has been made under 40 CFR part 790 ineligible for ex emptions, to 127
provide a full exemption from IUR requirements for water, and to remove polymers, 128
which are already fully exempt from the partially exempt list of chemical substances at 129
40 CFR 710.46(b)(2)(iv), which appears in the new part 711 as §711.6(b)(2 )(iv). 130
8. EPA is amending 40 CFR 710.52(c), which appears in the new part 711 as 131

§711.15( c b ), to modify the reporting requirements for certain manufacturing data 132
elements. Specifically, manufacturers (including importers) are required to report: 133

i a

. The nam e and address belonging to the parent company. 134

ii b

. The current Chemical Abstracts (CA) Index Name, as used to list the 135
chemical substance on the TSCA Inventory, as part of the chemical identity. 136

iii c

. For the 2012 submission period only, t he production volum e for calendar 137
year 2010. 138

d

. The production volume for each of the years since the last principal reporting 139

year. This requirement will be effective after the 201 2 reporting cycle (i.e., for the 2016 140
submission period and subsequent submission periods)

. 141

iv e

. The volume of a manufactured (including imported) chemical substance used 142
at the reporting site. 143

v f

. Whether an imported chemical substance is physically present at the reporting 144

site. 145*** Interagency EO 12866 Review Draft

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7 vi g

. The volume directly exported and not domestically processed or used. 146

vii h

. When a manufactured chemical substance, such as a byproduct, is being 147
recycled, remanufactured, reprocessed, or reused. 148
9. EPA is replacing the ―readily obtainable‖ reporting standard used for the 149
reporting of processing and use information requi red by 40 CFR 710.52(c)(4), which 150
appears in the new part 711 as §711.15(b)(4), with the ―known to or reasonably 151
ascertainable by‖ reporting standard. 152
10. EPA is amending 40 CFR 710.58, which appears in the new part 711 as 153
§711.30, to require upfront subs tantiation when processing and use information required 154
by 40 CFR 710.52(c)(4), which appears in the new part 711 as §711.15(b)(4), is claimed 155

as CBI. 156
11. EPA will disallow confidentiality claims for processing and use data elements 157

identified as not ―know n to or reasonably ascertainable by‖ (40 CFR 710.52(c)(4)), which 158
appears in the new part 711 as §711.15(b)(4). 159
12. EPA is revising the list of industrial function categories for the reporting of 160
processing and use information. EPA is also amending 40 CFR 710.52(c)(4)(i)(C), which 161
appears in the new part 711 as §711.15(b)(4)(i)(B), to replace the 5

- digit NAICS codes 162

with 48 Industrial Sectors (IS). 163
13. EPA is amending 40 CFR 710.52(c)(4)(ii), which appears in the new part 711 164

as §711.15(b)(4)(ii), to revise the list of consumer and commercial product categories for 165
the reporting of consumer and commercial use information. EPA is also requiring the 166
separate reporting for consumer or commercial categories and the reporting of the 167*** Interagency EO 12866 Review Draft

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8 number of commercial workers r easonably likely to be exposed to the subject chemical 168

substance. 169
14. EPA is eliminating the gaps in the ranges used to report concentration in 40 170
CFR 710.52(c)(3) and (c)(4), which appear in the new part 711 as §§711.15(b)(3) and 171

(b)(4). 172

B. What is the A gency's Authority for Taking this Action? 173
EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and 174
keep current an inventory of chemical substances manufactured or processed in the 175
United States. This inventory is known as the TSCA Chemic al Substance Inventory 176
(TSCA Inventory). The Agency maintains the Master Inventory File as the authoritative 177
list of all the chemical substances reported to EPA for inclusion on the TSCA Inventory. 178
In 1977, EPA promulgated a rule published in the Federal R egister issue of December 179

23, 1977 (Ref. 1 2 ) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory 180
of chemical substances in commerce at that time. In 1986, EPA promulgated the initial 181
IUR rule under TSCA section 8(a) at 40 CFR part 710 publis hed in the Federal Register 182

issue of June 12, 1986 (Ref. 2 3 ) to facilitate the periodic updating of information on 183
chemical substances listed on the TSCA Inventory and to support activities associated 184
with the implementation of TSCA. In 2003, EPA promulgat ed extensive amendments to 185
the IUR rule, published in the Federal Register issue of January 7, 2003 (2003 IUR 186

Amendments) (Ref. 3 4 ) to collect exposure

- related information associated with the 187
manufacturing, processing, and use of eligible chemical substanc es and to make certain 188
other changes. 189*** Interagency EO 12866 Review Draft

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9 Section 8(a)(1) of TSCA authorizes the EPA Administrator to promulgate rules 190
under which manufacturers and processors of chemical substances must maintain such 191

records and submit such information as the EPA Administra tor may reasonably require. 192
Section 8(a) of TSCA generally excludes small manufacturers and processors of chemical 193
substances from the reporting requirements established in TSCA section 8(a). However, 194
EPA is authorized by TSCA section 8(a)(3 ) (A)(ii ) to r equire TSCA section 8(a) reporting 195
from small manufacturers and processors with respect to any chemical substance that is 196
the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that 197
is the subject of an order in effect under TSCA section 5(e), or that is the subject of relief 198
granted pursuant to a civil action under TSCA section 5 or 7. The standard for 199
determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR 200
part 710, which appears in the new par t, 40 CFR part 711, is found at 40 CFR 704.3. 201
Processors are not currently subject to the rules at 40 CFR part 710, which appears in the 202
new part 40 CFR part 711. 203
This document promulgates the IUR as 40 CFR part 711, which includes 204
provisions copied from the existing IUR regulations in 40 CFR part 710 subpart C that 205
are not substantively changed as a part of this rulemaking, and the new IUR provisions in 206
this final rule. Failure to comply fully with any provision of this final rule will be a 207

violation of TSCA section 15 and will subject the violator to the penalties of TSCA 208

sections 16 and 17. 209

210
C. What Was the TSCA Inventory Update Reporting (IUR) Rule Prior to These 211
Modifications? 212*** Interagency EO 12866 Review Draft

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10 The IUR rule, as modified by the 2003 Amendments, required U.S. manufactur ers 213
(including importers) of chemical substances listed on the TSCA Inventory to report the 214
identity of chemical substances manufactured (including imported) during the reporting 215
year in quantities of 25,000 lb

. or greater at any single site they own or con trol to EPA 216
every five years. IUR data were collected five times prior to the 2003 Amendments: 217

1986, 1990, 1994, 1998, and 2002, and one time after the 2003 Amendments, in 2006. 218
EPA uses the TSCA Inventory and data reported under the IUR rule to support many 219

TSCA

- related activities and to support a number of EPA and other Federal health, safety, 220
and environmental protection activities. The Agency also makes the data available to the 221
public, to the extent possible given CBI claims. 222
Persons manufacturing (including importing) chemical substances were required 223
to report information such as company name, site location and other identifying 224
information, production volume of the reportable chemical substance, and exposure

225

related information associated with t he manufacture of each reportable chemical 226
substance. This exposure

- related information included the physical form and maximum 227
concentration of the chemical substance and the number of potentially exposed workers. 228
Several groups of chemical substances we re and will continue to be generally excluded 229
from IUR reporting requirements: e.g., polymers, microorganisms, naturally occurring 230
chemical substances, and certain natural gas substances. 231
Manufacturers (including importers) of chemicals chemical s ubstance s in large r 232

volumes (i.e., 300,000 lb

. or greater manufactured (including imported) during the 233
reporting year at any single site) were required also to report certain processing and use 234
information for the 2006 submission. This information includes process or use cat egory; 235*** Interagency EO 12866 Review Draft

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11 NAICS code; industrial function category; percent production volume associated with 236
each process or use category; number of use sites; number of potentially exposed 237
workers; and consumer/commercial information such as use category, use in or on 238
prod ucts intended for use by children, and maximum concentration. 239
The 2006 submission was the first instance where manufacturers (including 240
importers) of inorganic chemical substances were required to report under the IUR rule. 241
For the 2006 submission only, i norganic chemical substances were partially exempted 242

from the IUR rule, and manufacturers of such chemicals chemical s ubstance s were 243
required to report the manufacturing information and not the processing and use 244
information, regardless of production volume. Under t he previous rule, for future 245
collections (i.e., for 2011 or 2016 IUR collections, etc.), the partial exemption for 246
inorganic ch emicals chemical s ubstance s would have no longer been applicable and 247
submitters would have reported in the same manner as was required for organic 248

chemicals chemical s ubstance s , including processing and use information. In addition, 249
starting with the 2006 collection and for future collections, specifically listed petroleum 250
process streams and other specifically listed chemical substances were partiall y exempt, 251
and manufacturers of such chemical substances were not required to report processing 252
and use information. These partial exemptions will continue in subsequent submission 253
periods under the IUR as revised today in this final rule (including 2011 the 201 2 IUR 254

collection ), for as long as the chemical substances remain on these partial exemption lists 255

§§711.6(b)(1) and (b)(2). 256*** Interagency EO 12866 Review Draft

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12 Non

- confidential data, including both searchable and separately downloadable 257
databases, and the 2006 IUR data summary report are availab le to the public on the IUR 258

website ( http://www.epa.gov/iur ). 259
D. Why is the Agency Amending the IUR Rule? 260
EPA has modified the IUR rule to meet four primary goals: 261
1. To tailor the information collected to better meet the Agency‘s overall 262

information ne eds. 263
2. To increase its ability to effectively provide public access to the information. 264
3. To obtain new and updated information relating to potential exposures to a 265
subset of chemical substances listed on the TSCA Inventory. 266
4. To improve the usefulness of the information reported. 267
EPA believes that expanding the range of chemical substances for which more in

- depth 268
processing and use information is to be reported and adjusting the specific reported 269
information, the method and frequency of collecting the i nformation, and CBI 270
requirements will accomplish these goals. 271
These goals are supported by a policy outlined in TSCA section 2, which is that 272
―adequate data should be developed with respect to the effect of chemical substances and 273

mixtures on health and t he environment and that the development of such data should be 274
the responsibility of those who manufacture and those who process such chemical 275
substances and mixtures‖ (TSCA section 2(b)(1)). Modifications to the IUR 276
requirements by the 2003 Amendments pr ovided many improvements to the data 277
collected through that rule, and EPA‘s efforts to use the 2006 IUR data identified areas 278
where further improvements are needed. The modifications described in this final rule 279*** Interagency EO 12866 Review Draft

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13 change some of the reporting requirements i n an effort by EPA to ensure the required 280
information is properly reported and that the information in the Agency‘s database 281
reflects the information provided in the IUR reports; increase the usability of the 282

collected information; increase the availabilit y of information for the public; and focus 283
reporting on information that is most needed by the Agency. 284
In addition, these changes will enable EPA and other Federal agencies to improve 285
their risk screening capabilities, enabling them to better assess and ma nage risk, and 286
improve public awareness of basic information about a large number of chemical 287

substances. 288
EPA provided reporting software for the 2006 IUR submission period and 289
encouraged electronic reporting through the Internet, using the Agency‘s CDX. EPA‘s 290
experience with populating the IUR database and with using the 2006 IUR data provided 291
insight into how well both the reporting software and submission methods worked. For 292
instance, because of validations built into the reporting software, electroni c submissions 293
were able to be quickly assimilated into the IUR database. Other forms of submission 294
required the documents to be scanned in or hand entered, and resulted in many introduced 295
errors during the data entry process. Additionally, for the 2006 I UR, certain types of 296
submissions (e.g., joint submissions) could not be reported electronically. Other 297
problems, such as incorrect chemical identities, delayed the incorporation inc lusion of the 298
data into the database, resulting in the Agency‘s inability to begin using the 2006 IUR 299
data and providing public access in a timely manner. The modifications in today‘s this 300

final rule associated with reporting methods and changes to the reporting software will 301*** Interagency EO 12866 Review Draft

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14 better ensure the information reported to the Agency is accurate and in co mpliance with 302
the IUR requirements. 303
During the development of the 2003 Amendments, the Agency considered the 304
data accuracy and reliability needed for screening level exposure analyses and took 305
several steps to ensure the IUR data met those needs. Screenin g level data need not be 306
precise, but should be accurate and reliable enough for the Agency to develop screening 307

level assessments. The 2003 amendments to the IUR rule supply suppl ie d exposure

308
related information the Agency did not previously possess, recognizin g that industry has 309
a greater knowledge than EPA about its own operations and the uses of chemical 310

substances it manufactures and sells. 311
EPA‘s extensive use of the 2006 IUR data in the Agency‘s Existing Chemicals 312
Program is consistent with how EPA envision ed the data would be used when the 2003 313
Amendments were promulgated. In 2007, the Agency began to develop and post 314
screening

- level hazard, exposure, and risk characterizations for high production volume 315

(HPV) chemicals chemical s ubstance s , which are those chemicals chemical s ubstance s 316
produced nationally at aggregated volumes of one million lb

. or more per year. In 317
developing these characterizations, EPA identified areas where the IUR data collection 318
can be improved and enhanced. Improvements would allow EPA to better identi fy and 319

take follow

- up action on chemical substances that may pose potential risks to human 320

health or the environment. 321
During its review of the IUR data, EPA identified numerous examples of CBI 322

claims where the same or similar information to that claimed as CBI was already 323
available to the public. In several cases, information on production volume and uses for a 324*** Interagency EO 12866 Review Draft

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15 chemical substance or group of chemical substances was claimed CBI on Form U, while 325
the same or similar information was submitted voluntarily by the company without such a 326
claim under the HPV Challenge Program. In those cases, EPA had previously made the 327
information publicly available through the High Production Volume Information System 328
(HPVIS) or on EPA‘s Existing Chemicals website. More detail ed CBI substantiation 329
requirements will encourage the correct designation of non

- confidential reported 330
information, thereby facilitating reporting of this information to the public. 331
EPA Administrator Lisa P. Jackson has made it a priority to strengthe n the 332
Agency‘s chemical management program, including the development of new regulatory 333
risk management actions, the development of Chemical Action Plans targeting the 334
Agency‘s risk management efforts, requiring the reporting of information needed to 335

under stand chemical substance risks, and increasing public access to information about 336

chemical substances (Ref. 4 5 ). The IUR provides exposure

- related data needed to 337

understand chemical substance risks. The modifications to the IUR rule will enhance the 338
capabi lities of the Agency to ensure risk management actions are taken on chemical 339
substances which may pose the greatest concern. More in

- depth reporting of the 340
processing and use data, more careful consideration of the need for confidentiality claims, 341
and adj ustments to the specific data elements are important aspects of this action. By 342
enhancing the data supplied to the Agency, EPA expects to more effectively and 343
expeditiously identify and address potential risks posed by chemical substances and 344
provide impr oved access and information to the public. 345
An important and anticipated result of this action is that EPA will receive more 346
publicly available, non

- CBI information, therefore increasing the transparency and public 347*** Interagency EO 12866 Review Draft

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16 accessibility of the chemical substanc e use, and exposure information and ensuring 348
consistency with the President‘s policy goals for government reliance on and public 349
availability of scientific information. 350
E. When is Reporting Required? 351
EPA promulgated a final rule, published in the Federal Register issue of May 11
, 352

2011, ( 76 FR 27271 ) (FRL

- 8874

- 2 ) (Ref. 6 ) to suspend the 2011 IUR submission period

. 353
EPA suspended the submission period to allow additional time to finalize the proposed 354

modifications
, and to provide sufficient time for companies to comply with the amended 355

IUR reporting requirement s

. This action supersedes the suspension of the 2011 IUR 356
submission period by establishing a new sequence of submission periods, beginning with 357

an IUR submission period in 2012

. For the 2012 IUR, all inf ormation reported to EPA in 358
response to 40 CFR part 711 must be submitted between February 1, 20 12 and June 30, 359

2012

. Beginning in 2016 and for each subsequent submission period, the submission 360
period will begin June 1 and end September 30 (40 CFR 711.20). 361
III. What Are the Revised Requirements of the IUR? 362
EPA is making a number of revisions to the IUR, as described in this unit. The 363
regulatory text of this document describes the full specific IUR reporting requirements 364

and includes both the modified and the unmodified portions of the regulatory text (see 40 365
CFR part 711). EPA has also developed guidance documents with specific reporting 366
instructions, questions and answers, and case studies, and intends to conduct a webinar to 367
help potential IUR submitters become familiar with the revised reporting form (Form U) 368
and amended reporting requirements. Guidance documents and information on the 369

webinar are available on the IUR website
, ( http:// www.epa.gov/iur

. )

. 370*** Interagency EO 12866 Review Draft

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17 A. What technical modifications have been made to t he regulatory text? The 371
Agency is making several technical modification related to moving the regulatory text to 372
its own section in the CFR. The chemical substances that are covered by the IUR rule are 373
on the Master Inventory File, which includes chemica l substances from the original 374
TSCA Inventory compilation and those added subsequently through the notice 375
requirements of TSCA section 5. Because the IUR rule applies to a list of chemical 376
substances included on the original TSCA Inventory plus additional chemical substances 377
added subsequently, and because the Agency from time to time has modified the IUR 378
rule, the Agency believes the regulatory text associated with the IUR rule should be in its 379
own section in the CFR, distinct from both the original TSCA Inventory rules and from 380
the TSCA section 5 requirements. 381

1. Move the IUR regulatory text from 40 CFR part 710, subpart C, to 40 CFR 382
part 711 and eliminate subpart divisions. Subpart C of 40 CFR part 710, 40 CFR 710.43 383
to 710.59, contains the IUR regulato ry text. EPA is moving all of the subpart C text 384
from 40 CFR part 710 to a new 40 CFR part 711 and adding a new scope and compliance 385

section (40 CFR 711.1). 386

Table 1.

— Relocation of 40 CFR 710, Subpart C Provisions Regulatory Text 387 Old CFR Citation New CFR Citatio n 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 711.2 2 40 CFR 710.57 40 CFR 711.25 40 CFR 710.58 40 CFR 711.30 40 CFR 710.59 40 CFR 711.35*** Interagency EO 12866 Review Draft

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18 388 Because all of the text of subpart C was moved to 40 CFR part 711, 40 CFR part 389
710 no longer has a subpart C. Neither 40 CFR part 710 nor 40 CFR part 711 have any 390
subparts. 391

2. Consolidate definitions . As part of moving the regulatory text from 40 CFR 392
part 710, subpart C, to 40 CFR part 711, EPA is consolidating definitions copied from 40 393
CFR 710.3 and 40 CFR 710.43 into the new 40 CFR 711.3, except where an appropri ate 394
definition is already in place in TSCA section 3 or at 40 CFR 704.3, and an additional 395
definition of the term in 40 CFR 711.3 was therefore unnecessarily duplicative. The 396

definitions in TSCA section 3 and at 40 CFR 704.3 are incorporated into in cluded in 40 397

CFR 711.3, e xcept insofar as 40 CFR 711.3 provides a modified definition of a term also 398

defined at 40 CFR 704.3. 399

The term mixture is defined in both 40 CFR 710.3 and TSCA section 3. For 400
purposes of the IUR rule, EPA is incorporating including the definition of mixture from 401

TSCA se ction 3

. with the definitions at 40 CFR 711.3

. The TSCA mixture definition 402
differs from the definition in 40 CFR 710.3 and 40 CFR 720.3, the regulations used to 403
determine the chemical substances listed on the TSCA Inventory, in that it does not 404
specificall y address hydrates. A hydrate is a mixture of water and an anhydrous chemical 405
substance. Because they are mixtures, hydrates are not listed as such on the TSCA 406
Inventory. For this reason, EPA believes it is superfluous to include a specific discussion 407

of hydrates in the IUR definition of mixture. Please see the instruction 408

manual I nstruction s for the 2012 Inventory Update Reporting (Instructions document) for 409

additional discussion (Ref. 5 7 ). 410*** Interagency EO 12866 Review Draft

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19 Unit II.E.3 contains further discussions about changes to specific definitions, in 411

r elation to the modifications included in this final rule. A summary of all IUR

- related 412

definitions is available in the docket (Ref. 6 8 ). 413

3. Delete Remove “ non

- isolated intermediate ” definition from 40 CFR 710.3

. 414

EPA added a definition to 40 CFR 710.43 for the ter m ―non

- isolated intermediate‖ as part 415
of the 2003 Amendments. Subsequently, as part of the IUR Revisions Rule published in 416

the Federal Register issue of December 19, 2005 (Ref. 7 9 ), EPA erroneously moved the 417

definition to 40 CFR 710.3 from 40 CFR 710.43. EPA is deleting remov ing the definition 418
from 40 CFR 710.3 as this definition was not associated with the original TSCA 419
Inventory, and therefore does not belong in 40 CFR 710.3. A definition of this term, 420

codified elsewhere at 40 CFR 704.3, is incorporated into inc luded with the IUR 421

definitions at 40 CFR 711.3. 422

4. Delete Remove 40 CFR part 710, subpart B text . EPA is deleting remov ing the 423
regulatory text contained in 40 CFR part 710, 40 CFR 710.23 to 710.39 (subpart B). This 424
text refers to IUR submission periods of 2002 and earlier and is obsolete. As noted in 40 425
CFR 710.1, the Agency expressed its intent to remove subpart B once the 2002 update 426
was complete. 427

5. Delete Remove superfluous text associated with reporting production volumes

. 428

EPA is deleting remov ing the phrase ―provided that the reported figures are wi thin ±10% 429
of the actual volume‖ from the production volume reporting requirements found in 40 430
CFR 710.52(c)(3)(iv), which appears in the new 40 CFR part 711 as 40 CFR 431
711.15(b)(3)(iv). The revised wording would be ―This amount must be reported to two 432
sign ificant figures of accuracy.‖ The deleted phrase that was removed is superfluous 433*** Interagency EO 12866 Review Draft

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20 because any number reported accurately to two significant figures is within 10% of the 434

correct value. 435

6. Correct text associated with reporting number of sites and number of workers

. 436
EPA is replacing the phrase ―less than‖ with the phrase ―fewer than‖ in the ranges used to 437
report the number of workers found in the table in 40 CFR 710.52(c)(3)(v), which 438
appears in the new 40 CFR part 711 as 40 CFR 711.15(b)(3)(vii) and the number of si tes 439
found in the table in 40 CFR 710.52(c)(4)(i)(E), which appears in the new 40 CFR part 440
711 as 40 CFR 711.15(b)(4)(i)(E). This change makes the phrases describing the ranges 441
grammatically correct. 442

B. What are the changes to the method of submission? EPA is requiring the 443
mandatory use of Agency

- provided, web

- based reporting software tool (e

- IURweb) and 444
CDX to submit the completed Form U to the Agency. After the final rule‘s effective 445
date, EPA will no longer accept paper submissions or electronic media (i.e., as a file on a 446

CD

- ROM) for any IUR submission. 447
In order to submit electronically to EPA via CDX, individuals acting on behalf of 448
the submitter must first register with CDX. CDX registration is a requirement for all 449
electronic submissions using CDX; this re quirement predates today‘s this final rule. EPA 450
has modified the 2006 electronic signature agreement (ESA) form to identify more 451
clearly the individual(s) required to sign the agre ement ESA (Ref. 8 10 ). Each IUR 452

submission must have an authorized official associated with th e submission, who is the 453
person signing the certification statement and submitting the IUR report via CDX. The 454
authorized official must complete both an ESA and the CDX registration process. 455
Companies can access the reporting software tool upon completion of their CDX 456*** Interagency EO 12866 Review Draft

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21 registration. The instruction manual and other guidance materials are available on EPA‘s 457

website at www.epa.gov/iur

. http://www.epa.gov/iur

. 458

C. What definitions have been modified or added to clarify the reporting 459

requirements? As part of developing the definition section for 40 CFR part 711, EPA is 460
modifying six definitions associated with the IUR rule and adding four new definitions. 461
In 40 CFR 704.3 and 40 CFR 710.3, EPA is also modifying the definition of importer by 462
removing the citation to 19 CFR 1.11. 463

1. Man ufacture and manufacturer

. To improve the information submitted 464
through the IUR rule, EPA is modifying the definition of manufacture by 465
incorporating inc lud ing elements from the 40 CFR 720.3 definition for manufacturer. The 466
Agency is also adding a simple definition for the term manufacturer to 40 CFR 711.3. In 467
addition to the change to the definition of manufacture , EPA is adding a paragraph (c) to 468
the regulation at 40 CFR 711.22 to clarify the reporting relationship between the 469
contracting company and the toll manufact urer. The contracting company and the toll 470
manufacturer should confer with each other to avoid duplicate reporting, and both the 471
contracting company and the toll manufacturer are liable if no report is made. EPA 472
agreed with comments that the "primarily res ponsible" language that was proposed was 473
confusing and needed to be revised. As a result, EPA modified paragraph (c) to clarify 474
that the contracting company and the toll manufacturer should determine among 475
themselves who should submit the required report f or the site. EPA also added ―per site‖ 476
in two places in paragraph (c) to specify that there is supposed to be one report per 477

chemical substance , per site. See Unit III. 3.b C

. 2 . for further discussion of the site for 478
contract manufacturing situations. 479*** Interagency EO 12866 Review Draft

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22 This fin al rule defines the term manufacture under the IUR to mean ―to 480
manufacture, produce, or import, for commercial purposes. Manufacture includes the 481
extraction, for commercial purposes, of a component chemical substance from a 482
previously existing chemical su bstance or a complex combination of substances. When a 483
chemical substance, manufactured other than by import, is: 484
(1) Produced exclusively for another person who contracts for such production, 485

and 486
(2) that other person specifies the identity of the chemi cal substance and controls 487
the total amount produced and the basic technology for the plant process, then that 488

chemical substance is comanufact ured co

- manufactured by the producing manufacturer 489
and the person contracting for such production.‖ 490

This final rule defines the term manufacturer under the IUR to mean ―a person 491

who manufactures a chemical substance.‖ 492

2. Site . EPA is amending the definition of site to clarify that the importer‘s site 493
must be a U.S. address; accommodate manufacturing under contract; and accommodate 494
portable manufacturing units. See Unit III10 III .J . for a further discussion of this final rule 495
as it relates to importers. 496

This final rule defines the term site under the IUR to mean ―a contiguous property 497
unit. Property divided only by a public right

- of

- way shall be considered one site. More 498
than one plant may be located on a single site. 499
(1) For chemical substances manufactured under contract, i.e., by a toll 500
manufacturer, the site is the location where the chemical substance is physically 501

manufactured. 502*** Interagency EO 12866 Review Draft

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23 (2) The site for an importer who imports a chemical substance described in 40 503
CFR 711.5 is the U.S. site of the operating unit within the person's organization that is 504
directly responsible for importing the chemical substance. The import site, in some cases, 505
may be the organization's headquarters in the United States. If there is no such operating 506
unit or headquarters in the United States, the site address for the importer is the U.S. 507
address of an agent acting on behalf of the importer who is authorized to a ccept service of 508
process for the importer. 509
(3) For portable manufacturing units sent out to different locations from a single 510

distribution center, the distribution center shall be considered the site.‖ 511

3. Electronic

- reporting related definitions . EPA is ad ding two new terms, Central 512
Data Exchange (CDX) and e

- IURweb . The Agency is adding these terms to provide 513
clarity to the requirement for electronic reporting of IUR data. The term CDX means 514
―EPA‘s centralized electronic document receiving system, or its s uccessors.‖ The term e

515

IURweb means the ―electronic, web

- based IUR software tool provided by EPA for the 516
completion and submission of the IUR data.‖ 517

4. Processing and use

- related definitions . EPA is amending the definitions of the 518

terms commercial use and consumer use in order to make them more consistent with the 519
definitions developed collaboratively by the United States and Canada. See Unit II.E.6.h. 520
for further information. While the definitions for these two terms differ in their precise 521
wording from the Canadi an version (to preserve the use of terminology defined in IUR 522
and related regulations), EPA does not expect the basic application of these two terms to 523
differ from the basic application of the Canadian definitions (Ref. 9 1 1 ). The term 524

commercial use means ―the use of a chemical substance or a mixture containing a 525*** Interagency EO 12866 Review Draft

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24 chemical substance (including as part of an article) in a commercial enterprise providing 526
saleable goods or services.‖ Examples included in the 40 CFR 710.43 definition have 527

been eliminated. The slightly modified definition of consumer use is ―the use of a 528
chemical substance or a mixture containing a chemical substance (including as part of an 529
article) when sold to or made available to consumers for their use.‖ The restrictions 530

associated with w here a consumer would use the product have been removed. 531
EPA is adding a definition for the term industrial function . For the 2006 IUR, 532

EPA defined industrial use and did not define industrial function . The inclusion of both 533
definitions provides clarity for the industrial processing and use reporting requirements 534
and makes the Agency‘s requirements consistent with those collaboratively developed 535

with Canada (Ref. 9 11 ). Additional discussion of those requirements is in Unit III.E.6.g. 536

With this final rule, industrial function means ―the intended physical or chemical 537

characteristic for which a chemical substance or mixture is consumed as a reactant; 538
incorporated into a formulation, mixture, reaction product, or article; repackaged; or 539

used.‖ 540

5. Principal rep orting year and submission period . As described in Unit II.A., 541
EPA is changing the reporting cycle from every 5 years to every 4 years and requiring the 542
reporting of production volumes for each calendar year since the last principal reporting 543
year. EPA is modifying the terms reporting year and submission period to reflect these 544
changes. 545

The term reporting year is modified to add the term ―principal‖ and to replace the 546
word ―information‖ with ―manufacturing, processing and use data.‖ These changes are 547

to indicate that the principal reporting year is the year in which most of the reported data 548*** Interagency EO 12866 Review Draft

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25 are based. Under the final rule, the principal reporting year is the latest complete 549
calendar year preceding the submission period. Additionally, EPA is removing t he 550
reference to ―the calendar year at 5

– year intervals thereafter‖ and removing the reference 551
to ―calendar year 2005.‖ With these changes, the term principal reporting year is defined 552
as ―the latest complete calendar year preceding the submission period.‖ 553

The term submission period is modified by deleting remov ing the phrase 554
―generated during the reporting year.‖ With this change, the definition of submission 555
period reflects that data for years in addition to the principal reporting year would be 556
reported. With this change, the definition of submission period means ―the period in 557
which manufacturing, processing, and use data are submitted to EPA.‖ 558

D. Has the reporting frequency been changed? As proposed, EPA has changed 559
the reporting frequency to every 4 years. T he Agency has determined that reporting every 560
5 years is too infrequent and believes that returning reporting to every 4 years will 561
provide data sufficiently current to meet Agency and public needs. After the 2011 562
reporting cycle 201 2 submission period , the next reporting submission per iod under the 563

IUR rule will occur in 2015 201 6 . The submission period will continue to occur in the 564
year following the principal reporting year. 565

E. How have the reporting thresholds changed ? Reporting thresholds are used to 566
determine when IUR reporting is req uired for a subject chemical substance at a 567
manufacturing (including importing) site. EPA has made three changes related to the 568
reporting thresholds: 569

Determination of whether you meet the 25,000 lb

. threshold. 570*** Interagency EO 12866 Review Draft

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26 Elimination Replacement of the 300,000 lb

. threshold for re porting 571

information in Part III of Form U. 572

Elimination Reduction of the 25,000 lb

. threshold for certain chemical 573

substances. 574

1. Method for determining whether a person is subject to IUR reporting 575

requirements . For the 2011 201 2 submission period, manufacturers (including importers) 576
are required to report under the IUR rule if they manufacture (including import) a 577
chemical substance listed on the TSCA Inventory during the principal reporting year (i.e., 578

2010 201 1 for the 2011 201 2 submission period); the chemical substance is not ot herwise 579
exempt; and the associated production volume (domestically manufactured plus imported 580

volumes) at a site met or exceeded 25,000 lb

. during the principal reporting year (i.e.., 581

2010 201 1 for the 2011 201 2 submission period). 582
For submission periods subsequent t o the 2011 201 2 submission period, the 583
determination of the need to report is based on whether, for any calendar year since the 584
last principal reporting year, a chemical substance was manufactured (including 585
imported) at a site in production volumes of 25,000 l b

. or greater. For example, for the 586

2015 201 6 submission period, it would be necessary to examine the annual production 587
volumes for the calendar years 2011 201 2 to 2014 201 5 for the site. If the production 588
volume for a reportable chemical substance were 25,000 lb

. or grea ter for any calendar 589
year during that four year period, then it would be necessary to report the chemical 590
substance, unless it were otherwise exempt. For instance, a subject chemical substance 591
with production volumes of 5,000 lb

. in 2014 201 5 and 35,000 lb

. in 2 012 would be 592
reported for the 2015 201 6 IUR. Regardless of the 2014 201 5 production volume, in this 593*** Interagency EO 12866 Review Draft

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27 example scenario the 2015 201 6 IUR submission would contain detailed information 594
based on the production volume during the 2014 201 5 calendar year and production 595

volume inform ation only for the years 2011 201 2 through 2013 201 4 . See Unit III.D.1 of 596
the proposed rule preamble (Ref. 1) for further discussion. 597
EPA is finalizing this change because of the mounting evidence that many 598
chemical substances, even larger production volume chemical subst ances, often 599
experience wide fluctuations in production volume from year to year. (See Unit III.D.1 600

in of the proposed rule .) (Ref. 1) .) This can result in the production volume of a chemical 601
substance exceeding the threshold for several years, then falling bel ow the threshold 602
during the IUR principal reporting year. EPA believes that using production volume 603
reporting for all years since the last principal reporting year to determine reporting 604
obligations will yield a much more accurate picture of the chemical substances currently 605
in commerce, ensuring proper review under EPA‘s risk screening, assessment, and 606
management activities and providing better information to the public. This issue is 607
addressing address ed further in Unit V.C. of this preamble as well as in the 608

response ―Sum mary of EPA‘s Responses to public comments Public Comments Submitted 609
in Response to Proposed TSCA Inventory Update Reporting Modifications Rule ‖ 610
(Responses to Comments document) (Ref. 13 12 ). 611

2. Elimination Replacement of the 300,000 lb

. threshold for processing and use 612

information . EP A is eliminating replacing the 300,000 lb

. threshold for processing and use 613

information , thereby requiring by phasing in a lower reporting threshold. For the 2012 614

IUR, all submitters of non

- excluded chemical substances are required to report 615
processing and use information in all parts if they manufac ture d (including import ed ) 616*** Interagency EO 12866 Review Draft

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28 100,000 lb or more of Form U. a chemical substance in 2011

. Subsequent to the 2012 617
submission period , the reporting threshold will be 25,000 lb (or 2,500 lb for chemical 618
substances subject to 711.8(b))

. EPA is eliminating this replacing th e 300,000 lb 619
reporting threshold in order to collect information necessary to complete screening

- level 620
exposure characterizations for IUR reportable chemical substances. EPA is phasing in 621
the lower threshold in order to give chemical manufacturers time to comply with t he 622
modified reporting requirements. 623
In order to select a threshold for processing and use reporting, EPA consider ed the 624
burden of reporting as well as the Agency‘s needs for processing and use information on 625

the maximum number of chemical substances. As discussed elsewhere in this preamble 626
and other supporting documents, EPA identified that the processing and use data received 627
from the 2006 IUR was not sufficient in part because it did not include information on 628
many HPV and most moderate production volu me ( MPV ) chemical substances that EPA 629
was trying to assess. Therefore, in its proposal, EPA proposed lowering the processing 630
and use reporting threshold from 300,0 00 lb to 25,000 lb in order to enable the Agency to 631
collect exposure

- related information nee ded to screen and prioritize the HPV and MPV 632

chemical substances

. EPA received comments suggest ing that the Agency adopt a 633
phased

- in approach for reducing the threshold, similar to the approach used for 634
introducing the requi rement for reporting informatio n for inorganic chemical s ubstances

. 635
Manufacturers reporting for inorganic chemical substances were provide d a one

- time 636
partial exemption for those substances for the 2006 IUR , thereby phasing in reporting. 637
Other commenters suggested that because report ing of processing and use information for 638
inorganic chemicals w as not required for the 2006 IUR , the industry sector is still 639*** Interagency EO 12866 Review Draft

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29 inexperienced with reporting such information and therefore should be given an 640
opportunity to report under the existing thresholds

. Another commenter suggested that 641

EPA lower the processing and use threshold to 100,000 lb, which is consistent with one 642
of the triggers for the small business exemption. 643
EPA agrees with a phased

- in approach because it provides submitters with an 644

opportu nity to become familiar with the reporting requirements, while at the same time 645
provid ing much needed and more complete processing and use information on chemical 646

substances of interest to the Agency

. Future reporting of the processing and use 647

information by all submitters will provide EPA and others with needed additional 648
information for those chemical substances with production volumes of 25,000 lb or more 649

at a site. In the future, EPA may find it necessary to collect information on chemical 650

substances a t reporting thresholds below the thresholds introduced in this action. 651
Using the 2006 IUR data, EPA looked at the effect of setting the processing and 652
use reporting threshold at various levels. Based on this information, lowering the 653

threshold to 25,000 l b would not have brought in a significant number of new reporters 654

for the 2012 submission period
, because about 89 % of companies and 86% of sites 655
reported at least one chemical substance with a production volume of 300,000 lb or more 656

in 2006 (Ref. 13). The refore, most companies would be expected to be generally aware of 657
the processing and use reporting requirements because the company would have reported 658

such information on at least one chemical substance

. 659

On a chemical

- by

- chemical basis, EPA ‘s examinatio n of the 2006 IUR data 660

revealed that approximately 66% of the individual reports were above the 300,000 lb 661
threshold, and that these reports covered approximately 60% of the chemical substances 662*** Interagency EO 12866 Review Draft

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30 reported for the 2006 IUR

. Lowering the threshold to 25,000 l b would result in 663
processing and use information on 40% more chemicals and would have greatly informed 664
EPA‘s existing chemical s program

. As discussed earlier, EPA recognized the need to 665
allow companies time to become familiar with reporting the processing and use 666
information, and therefore considered alternate reporting thresholds for the 2012 IUR

. 667
Lowering the threshold to 100,000 lb results in processing and use information on 668
approximately 23% more chemical substances than the 300,000 lb threshold, whi le 669
increasing the number o f reports by only approximately 1 8 %

. EPA believes that the 670

100,000 lb threshold , as an interim threshold, provides an appropriate balance between 671
increasing the number of chemicals with processing and use information and increasin g 672
the reporting burden on industry. Se e the Economic Analysis (Ref. 14 ) for further 673

discussion. 674
The exposure information is an essential part of developing risk evaluations and, 675
based on its experience in using this information, the Agency believes that collecting this 676
exposure information is critical to its mission of characterizing exposure, identifying 677
potential risks, and noting uncertainties for these lower production volume chemical 678

substances. In addition, this change the lower thresholds will provide the pub lic with 679
information on a greater number of chemical substances. This issue is addressed further 680

in Unit V.C. 2 of this preamble as well as in the Responses to Comments document (Ref. 681

12 ). 682

3. Elimination Reduction of the 25,000 lb

. threshold for certain specific regulated 683

ch emical substances

. For the 2012 IUR, EPA is eliminating maint ain ing the 25,000 lb

. 684
reporting threshold for certain chemical substances that are the subject of particular 685*** Interagency EO 12866 Review Draft

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31 TSCA rules and/or orders

. For future IUR collections, EPA is reducing the threshold 686
(including the threshol d for the collection of processing and requiring use information) to 687

2,500 lb for those chemical substances (40 CFR 711.8(b))

. 688
EPA proposed to eliminate the threshold, which would have requir ed 689
manufacturers (including importers) of such chemical substances to rep ort under the IUR 690
rule, regardless of the production volume. EPA is eliminating the 25,000 lb. threshold for 691

those chemical substances that are: A number of commenters supported the proposal to 692

elimina te the reporting threshold while o thers f elt the requirement would be overly 693

burdensome , especially for imported chemical substances or mi xtures

. In its proposal, 694
EPA specifically asked for comment on whether a de minimis production volume 695

threshold should be set for these chemical substances and how best to set such a de 696

minimis threshold

. Some c ommenters opposed setting a de minimis thresh old and o thers 697
suggested a variety of methods for establishing one

. 698
For many of the reasons identified by commenters (e.g., the expense and burden 699
of collecting the information, and difficulty in knowing whether low

- concentration 700

chemical substances are pr esent in formulated mixtures ), EPA has decided to set a de 701

minimis threshold and to delay its implementation. B eginning with the 2016 submission 702
period , the reporting threshold will be reduced to 2,500 lb for those chemical substances 703

that are: 704
• The subj ect of a rule proposed or promulgated under TSCA section 5(a)(2), 705

5(b)(4), or 6, 706
• The subject of an order issued under TSCA section 5(e ) or 5(f )
, or 707*** Interagency EO 12866 Review Draft

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32 • The subject of relief that has been granted under a civil action under TSCA 708

section 5 or 7. (40 CFR 711.8(b) ) 709

Fo r the 2016 submission period and submission periods thereafter, a manufacturer 710
(including importer) of such chemical substances is required to report manufacturing 711
information on the chemical substances if they are manufactured (including imported) in 712

volu mes of 2,500 lb or more during any of the years since the last principal reporting year 713
(e.g. , 2011). Information on the processing and use of the chemical substances must be 714
reported if they were manufactured (including imported) in volumes of 2
, 500 lb or more 715
during any of the years since the last principal reporting year. In addition to the 716
manufacturing, processing and use information for the principal reporting year (e.g., 717

2015 ) , the production volume s for each year since the last principal reporting y ear must 718
also be reported. F or the 201 6 submission period
, for example, a manufacturer (including 719
importer) must consider the manufacture d or import ed volume during the years 201 2 720
through 201 5 to determine the need to report ; must report the production vo lumes for 721
each year from 201 2 to 201 5 ; and must report the full manufacturing, processing, and use 722

information for 201 5

. 723
Chemical substances that are the subject of these particular TSCA actions are of 724
demonstrated high interest to the Agency. EPA is pr omulgating this change to help 725

reduce the reporting burden for submitters and to ensure the availability of current 726
information when the Agency has expressed a concern in the form of regulatory action on 727

those chemical substances , regardless of the production volume.

. EPA will use the IUR 728

dat a associated with these specific regulated chemical substances to monitor chemical 729
substance production and compliance with the rules. In the future, EPA may find it 730*** Interagency EO 12866 Review Draft

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33 necessary to collect information on chemical s ubstances at a reporting threshold below 731

the 2,500 lb threshold introduced in this action. Although the 2,500 lb threshold is higher 732
than the proposed threshold of zero , the enhanced information that will be gathered 733
during the 2016 submission period will enable the Agency and others to more efficie ntly 734
identify those chemical substances warranting further, more in

- depth review, as well as 735

chemical s ubstances of lesser concern. See Unit V.C.3. of this preamble for further 736

discussion. 737

Under this final rule, for the 2011 submission period, a manufacturer (including 738 importer) of such chemical substances is required to report information on the 739 manufacturing, processing, and use of the chemical substances if that person 740 manufactured (including imported) any quantity of these chemical substances during the 741 principal reporting year (i.e., 2010) and must report the production volumes for each year 742 from 2006 to 2010 and the full manufacturing, processing, and use information for 2010. 743
For subsequent IUR reporting cycle s, a manufacturer (including importer) of such 744 chemical substances is required to report information on the manufacturing, processing, 745 and use of the chemical substances if that person manufactured (including imported) any 746 quantity of these chemical subst ances during any of the years since the last principal 747 reporting year, including quantities under 25,000 lb. For 2015 reporting, the 748 manufacturer must consider the manufacture or import during the years 2011 through 749 2014; must report the production volume s for each year from 2011 to 2014; and must 750 report the full manufacturing, processing, and use information for 2014. 751
In the IUR proposal As under the 2006 IUR, if a manufacturer qualifies for the 752

small ma nufacturer exemption at 40 CFR 711.9, it is exempt from IUR reporting. 753
Nothing in this final rule affects the scope of this exemption at 40 CFR 711.9. However, 754
because the reduction in the reporting threshold to 2,500 lb is generally applicable to all 755

ma nufacturers of the subject chemical substances, for the 2016 submission period and 756
subsequent submission periods, it may affect small manufacturers to the extent they are 757

non

- exempt under 40 CFR 711.9. As under the 2006 IUR, small manufacturers are 758

genera lly exempt from IUR reporting but are specifically subject to reporting with respect 759
to any chemical substance that is the subject of a rule proposed or promulgated under 760*** Interagency EO 12866 Review Draft

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34 TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA sec tion 761
5(e), or is the subject of relief that has been granted under a civil action under TSCA 762

section 5 or 7 (40 CFR 711.9)

. With the exception of rules proposed or promulgated 763

under TSCA section 4, the same TSCA actions that make small manufacturers ineli gible 764
for an IUR exemption under 40 CFR 711.9 (with respect to the particular chemical 765
substance that is the subject of the action) will also make those small manufacturers 766
subject to the 2,500 lb reporting threshold in the 2016 submission period and subse quent 767
submission periods (40 CFR 711.8(b)). The proposal or promulgation of a rule under 768
TSCA section 4 affects the small manufacturer exemption but it does not affect the 769
applicable reporting threshold under IUR. 770

In the propos ed rule
, EPA specifically s ought comment on whether circumstances 771
triggering an exception to the 25,000 lb

. reporting threshold for a chemical substance 772
should include the proposal of certain rules for the chemical substance , under TSCA 773
section 5(a)(2), 5(b)(4), or 6. EPA explained that such an approach would more closely 774
parallel the exception language in the introductory paragraph to 40 CFR 711.6 and in 40 775

CFR 711.9. (See Unit III.D.3 of the preamble of the proposal, at 75 FR 49664). propos ed 776

rule (Ref. 1) ). Including these types of proposed rules in the list of triggering 777
circumstances is also more consistent with reporting obligations under other parts of 778
TSCA, such as 12(b). Among other situations, reporting under TSCA 12(b) is required 779
when any rule under section 5 or 6 is proposed or promulgated. In response to the 780

com ments received, EPA has determined that chemical substances subject to a rule 781
proposed under TSCA section 5(a)(2), 5(b)(4), or 6 will be excepted from the 25,000 lb

. 782*** Interagency EO 12866 Review Draft

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35 reporting threshold, and thus will be reportable at any production volume. 2,500 lb 783
beginning with the 2016 IUR. See Unit V.C. 2 3

. of this preamble for further discussion. 784

F. What are the changes to the chemical substances covered by IUR ? 785

1. Water . EPA is fully exempting all (both naturally occurring and manufactured) 786

water (CASRN 7732

– 18

– 5) (40 CFR 711.6(a)(4)) fro m reporting under the IUR rule. 787

2. Fully exempt polymers removed from partially exempt list . Polymers are a class 788
of chemical substances for which IUR reporting is not required (40 CFR 711.6(a)(1)). 789
However, three polymers were previously listed in the pa rtially exempt list of chemical 790

substances at 40 CFR 710.46(b)(2)(iv): Starch (CASRN 9005

– 25

– 8), Dextrin (CASRN 791

9004

– 53

– 9), and Maltodextrin (CASRN 9050

– 36

– 6). EPA has removed from the 792
partially exempt list of chemical substances at 40 CFR 711.6(b)(2)(iv) these three 793
chemical substances which, as polymers, are fully exempt from reporting. 794

3. C hemical substances that are the subject of an Enforceable Consent Agreement 795
(ECA) are ineligible for exemptions . EPA may enter into an ECA, pursuant to procedures 796

at 40 CFR part 790, with a manufacturer of a chemical substance to obtain testing where 797
a consensus exists among EPA, affected manufacturers and/or processors, and interested 798
members of the public concerning the need for and scope of testing. Chemical 799

substa nces that are the subject of an ECA are now included in the list of chemical 800
substances that are ineligible for an IUR exemption, in the introductory paragraph of 40 801
CFR 711.6, along with the other chemical substances that are likewise not eligible for an 802
IUR exemption. The paragraph states that a chemical substance ―is not exempted from 803
any of the reporting requirements of this part if that substance is the subject of a rule 804
proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the 805*** Interagency EO 12866 Review Draft

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36 subject of a consent agreement developed under the procedures of 40 CFR part 790, or is 806
the subject of an order issued under section 5(e) or 5(f) of the Act, or is the subject of 807
relief that has been granted under a civil action under section 5 or 7 o f the Act.‖ 808

G. What changes have been made to reportable data elements? 1. Parent 809
company and site identity . Manufacturers (including importers) are required to report the 810
company name and Dun & Bradstreet D

- U

- N

- S® (D&B) number to identify the 811

company ass ociated with the plant site, and also to report the site name, address, and 812
D&B number. If the company associated with the plant site does not have a D&B 813
number, the manufacturer (including importer) must obtain one for the company. 814
Likewise, if the plan t site does not have a D&B number, the manufacturer (including 815
importer) must obtain one for the site. EPA received a variety of questions concerning 816
the correct company name to report during the 2006 IUR submission period. EPA is now 817
clarifying what is meant by company name, by requiring at 40 CFR 711.15(b)(2)(ii) that 818
the company name provided be the pa rent company name. U.S. parent company name 819
and defining "U.S. parent company," at 40 CFR 711.3, to mean "the highest level 820
company, located in the United States, that direct ly owns at least 50 percent of the voting 821

stock of the man ufacturer." As noted in the proposed rule (Ref. 1), EPA believes this 822
change will reduce confusion by making this reporting requirement that using an approach 823

that is consistent with the TRI reporting requirement s would be most clear both for 824
reporters and users of the data. The IUR definition of "U.S. parent company name" is 825
consistent with the use of the term of "parent company" in Section 5 of the 2009 Toxic 826

Chemical Release Inventory (TRI) requirements for parent company name. For further 827
clarification regarding the correct parent company name and the distinction between 828*** Interagency EO 12866 Review Draft

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37 domestic (U.S.) and foreign parent company, in particular for the small business 829
determination, please refer to the ― Reporting Forms and Instructions for 2011 Inventory 830
Update Reporting‖ (Ref. 5 15 ). The 2006 IUR submissions from differe nt reporting sites 831
contained varying D&B numbers for parent companies that appeared to be the same 832
company. In order to better identify when reporting sites are under the same parent 833
company, EPA is requiring the address as well as the D&B number of the p arent 834

company. 835

2. Technical contact . Manufacturers (including importers) are required to provide 836

a technical contact for their IUR submission. The technical contact does not have to be a 837
person located at the manufacturing (including importing) site, but must be a person who 838
can answer questions EPA may have about the reported chemical substance. In the 839
proposed rule, EPA had stated that the technical contact should be a person located at the 840
manufacturing (including importing) site. EPA has decided, howe ver, to not impose 841
limitations on where the technical contact can be located. Therefore, companies may use 842
their discretion in selecting a technical contact or multiple technical contacts, as provided 843
by the new e

- IURweb software tool

. Submitters should consider, i n selecting the technical 844
contact, that EPA may have follow

- up questions about an IUR submission, one or more 845
years after the submission date. 846
3. Manufacturers (including importers) are required to submit the correct 847
chemical identity for each subject chemical substance. 848

a. Chemical name . EPA is requiring the reporting of the Chemical Abstracts ( CA) 849
Index Name currently used to list the chemical substance on the TSCA Inventory as the 850
chemical name reported for IUR. The reporting software tool will be directly linked to 851*** Interagency EO 12866 Review Draft

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38 the nonconfidential portion of the TSCA Inventory through the Agency‘s Substance 852
Registry Services (SRS) database, which lists all chemical substances on the TSCA 853
Inventory. This link will enable submitters to select the correct CA Index Name fo r their 854
reportable chemical substance (s) from SRS. EPA believes that using SRS to select the 855
chemical name as currently listed on the TSCA Inventory will greatly reduce the number 856
of incorrectly identified chemical substances and allow the data to be relea sed more 857
quickly to the public. See the discussion in unit 3.a. regarding identifying confidential 858
chemical substances. Manufacturers (including importers) are allowed to supply, as part 859
of a joint submission, an alternate chemical name, and in the case of importers, a trade 860
name, in those instances where a supplier will not disclose to the submitter the specific 861
chemical name of the imported TSCA Inventory chemical substance or a reactant used to 862
manufacture the TSCA Inventory chemical substance. In these cases, the manufacturer 863
(including importer) and the supplier may report the information required in this part in a 864
joint submission. In order to clarify this requirement, EPA is amending 40 CFR part 865
711.15(b)(3)(i), to state that the importer must ask t he supplier of the confidential 866
chemical substance to directly provide EPA with the correct chemical identity, in a joint 867
submission with the manufacturer. Similarly, in the event a manufacturer submitting a 868
Form U cannot provide the whole chemical identi ty because the reportable chemical 869
substance is manufactured using a reactant having an unknown specific chemical identity 870
claimed as confidential by its supplier, the manufacturer must ask that the supplier 871
directly provide to EPA the correct chemical ide ntity of the confidential reactant in a joint 872
submission. Nothing in 40 CFR Part 711.15(b)(3)(i) relieves a manufacturer (including 873
an importer) of its obligation to report information that it actually knows or can 874*** Interagency EO 12866 Review Draft

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39 reasonably ascertain. See Unit III.10 f or additional information regarding joint 875
submissions. Detailed instructions regarding joint submissions are included in the 876

instructions manual I nstructions document included in the docket (Ref. 5 7 ). 877

b. Chemical identifying number . As part of the chemical identity, submitt ers 878
provide a chemical identifying number associated with the correct CA Index Name, as 879
described in Unit II.E.7.c.i. EPA is requiring that submitters report only the CASRN as a 880
chemical identifying number, except in the case of confidential chemical subs tances. In 881
the case of confidential chemical substances, EPA is requiring that submitters report only 882
the TSCA Accession Number as a chemical identifying number. EPA is removing the 883

Pre

- manufacture Notification (PMN) number as an allowed chemical identif ying number 884
because each TSCA Inventory chemical substance has either (or both) a CASRN or a 885
TSCA Accession Number, which are likely to be already known to the submitter. 886
Submitters who, in the past, have reported using the PMN number of a confidential 887

su bstance can identify the TSCA Accession Number from SRS by searching on the PMN 888
number. Those submitters who are not able to identify the TSCA Accession Number by 889
searching SRS may contact EPA in writing, if necessary, to learn the TSCA Accession 890

Number a ssigned when the Notice of Commencement (NOC) was submitted to the 891
Agency. Specific information is included in the Instructions for Reporting 892

manual document

. 893

c. Chemical identity for chemical substances listed on the confidential portion of 894
the TSCA Inventory. In cases where a chemical substance is listed on the confidential 895
portion of the TSCA Inventory, submitters are to report the chemical‘s chemical 896

substance ‘s Accession Number and generic name, which are listed on the non

- 897*** Interagency EO 12866 Review Draft

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40 confidential portion of the TSCA Inventory and are included in SRS. In order to continue 898
to protect the confidentiality of the underlying specific chemical identification 899
information (i.e., the CASRN and specific chemical name), the submitter must claim the 900
chemical identity as CBI and complete the upfront substan tiation. Doing so will maintain 901
a confidentiality claim for the underlying CASRN and specific chemical name on the 902
confidential portion of the TSCA Inventory (the Accession Number and generic chemical 903

name remain non

- confidential). Failure to identify th e chemical identity as CBI and 904
complete the upfront substantiation will waive any CBI claim to the chemical identity 905

and will result in the transfer of the chemical substance from the confidential portion of 906
the TSCA Inventory to the non

- confidential, publ icly releasable, portion of the TSCA 907

Inventory. 908

909 4. Production volume . Manufacturers (including importers) are required to report 910
production volume information for each chemical substance for which they submit an 911
IUR report. EPA has made a number of change s to the reporting of production volume 912

and associated information. 913

a. Report production volume for each of the years since the last principal 914

reporting year

. In addition to the production volume for the principal reporting year, EPA 915
is requiring the re porting of production volume for 2010 for the 2012 submission period 916

and for each of the years since the last princi pal reporting year beginning with the 201 6 917
submission period. More specifically, f or the 2012 submission period, manufacture r s 918
(including i mporters) will be required to report the total annual volume (domestically 919
manufactured and imported volumes in pounds) of each reportable chemical substance at 920
each site during calendar year 2010. F or submission periods subseque nt to the 2012 921*** Interagency EO 12866 Review Draft

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41 submission p eriod
, manufacture r s (including importers) will be required to report the 922
total annual volume (domestically manufactured and imported volumes in pounds) of 923
each reportable chemical substance at each site for each complete calendar year since the 924
last IUR p rincipal reporting year. Thus For example
, for the 2011submis sion 2016 925

submission period, manufacturers (including importers) of a chemical at or above the 926
25,000 lb. threshold during the principal reporting year reportable chemical substance 927
will report the production volume of that chemical substance for each of the following 928
calendar years: 2010, 2009, 2008, 2007, and 2006. Collecting the production volume for 929
multiple years will provide greater detail than the current once

- every

- reporting cycle 930
snapshot. 2015, 2014, 2013, and 2012

. 931
EPA had proposed that this requirement begin in full starting with the 932
current submission period, which would have required submitters to report production 933
volumes for 2006 through 2010 for the 2012 submission period. Several commenters 934
supported the proposed change while others stated that the requirement would be overly 935

burdensome , especially for the submission period immediately following promulgation of 936

the rule . Some commenters recommended that EPA delay the implementation of the 937

re quirement until the next reporting cycle to allow companies sufficient time to prepare 938

for the additional data collection effort. In response to the comments received

. EPA 939

believes its decision to defer this requirement until the next reporting cycle is wa rranted 940
in light of other simultaneous changes to the IUR rule which increase reporting burden. 941
The Agency also believes the delay will give companies adequate time to establish 942
systems to collect and compile the required information

. 943*** Interagency EO 12866 Review Draft

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42 For the principal re porting year, e.g., 2010 201 1
, the domestic manufacture and the 944
import production volume will continue to be reported separately on the same report. 945
EPA review and analysis of the 2006 IUR data has revealed that some submitters are 946
erroneously submitting multi ple reports for the same chemical substance, at times 947
reporting the information associated with domestic manufacturing and importing in 948
different reports. Submitters should complete only one report for each chemical 949

substance. 950

b. Volume of chemical subst ance used on

- site . EPA is requiring that submitters 951
report the volume of a manufactured (including imported) chemical substance used at the 952
reporting site. The requirement to report the volume used on

- site is replacing the 953
requirement to indicate that the chemical substance is site

- limited. Under this final rule, 954
either domestically manufactured or imported chemical substances can be reported as 955
used at the reporting site. 956

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

. 957
EPA is adding a requirement to indicate whether an imported chemical substance is 958
physically at the reporting site. Often, the site reporting an imported chemical substance 959
never physically receives the chemical substance, but instead ships it directly t o another 960
location such as a warehouse, a processing or use site, or a customer‘s site. 961

d. Report volume exported . EPA is adding a requirement to report the production 962
volume directly exported and not domestically processed or used. This will allow EPA to 963
better identify the proportion of the production volume accounted for by the processing 964
and use reporting, given that such downstream reporting is not required for directly 965
exported chemical substances. 966*** Interagency EO 12866 Review Draft

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43 5. Identify whether a chemical substance is to be recycled, remanufactured, 967
reprocessed, or reused . In the proposed rule, EPA sought comment on adding a checkbox 968
indicating whether a manufactured chemical substance was recycled, remanufactured, 969
reprocessed, reused, or reworked. In response to the comments received, EPA has 970
determined that the term ―reworked‖ may be interpreted and applied too broadly to 971
provide the type of information that EPA needs to collect and has removed ―reworked‖ 972
from the list of recycling synonyms, but has chosen to otherwise final ize this reporting 973
requirement as proposed. Consequently, EPA is adding a requirement to indicate 974
whether a manufactured chemical substance, such as a byproduct, is to be recycled, 975
remanufactured, reprocessed, or reused. Submitters should indicate whethe r their 976
manufactured chemical substance, which otherwise would be disposed of as a waste, is 977
being removed from the waste stream and has a commercial purpose (i.e., it is being 978
recycled, remanufactured, reprocessed, or reused). Indicating that a manufactu red 979

chemical substance , such as a byproduct, is to be recycled, remanufactured, reprocessed, 980
or reused does not affect the reporting requirements associated with any chemical 981
substance manufactured from the byproduct. See Unit II.F.2. for detailed informa tion on 982
byproduct reporting. 983

6. Concentration ranges . EPA is eliminating gaps in the ranges used to report 984
concentration in 40 CFR 711.15(b)(3) and (4)). The ranges are now: 985
• Less than 1% by weight. 986
• At least 1% but less than 30% by weight. 987

• At least 3 0% but less than 60% by weight. 988
• At least 60% but less than 90% by weight. 989*** Interagency EO 12866 Review Draft

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44 • At least 90% by weight. 990

7. Industrial processing and use information reporting . EPA is revising the list of 991
industrial function categories and replacing the NAICS codes with indu strial sector 992
categories, as described in sections i. and ii. 993

a. Industrial function categories . EPA is revising the list of industrial function 994
categories by combining categories that lead to common exposure scenarios and adding 995
categories where the Agenc y believes the existing categories do not adequately describe 996
potential uses. EPA worked with Environment Canada and Health Canada to develop the 997
set of categories, which will be used by both the United States and Canada for inventory 998
reporting (Ref. 9 11 ). 999
EPA is adding eight new industrial function categories and deleting remov ing six 1000
existing categories from the previous list; the total number of industrial function 1001
categories has increased to 35. Also, EPA is renaming several of the industrial function 1002
categori es to provide a more informative description of the function of chemical 1003
substances that should be reported in that category. Lastly, EPA is requiring that if a 1004
submitter selects the category ―Other,‖ the submitter must provide its own description of 1005

the industrial function of the chemical substance. EPA is using the industrial function 1006
categories listed in Table 1 of this unit: 1007

Table 1.

— Codes for Reporting Industrial Function Categories 1008 Code Category U001 Abrasives U002 Adhesives and sealant chemicals U003 Adsorbents and absorbents U004 Agricultural chemicals (non

- pesticidal) U005 Anti

- adhesive agents U006 Bleaching agents U007 Corrosion inhibitors and anti

- scaling agents U008 Dyes*** Interagency EO 12866 Review Draft

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45 U009 Fillers U010 Finishing agents U011 Flame retardants U012 Fuels and fuel additives U013 Functional fluids (closed systems) U014 Functional fluids (open systems) U015 Intermediates U016 Ion exchange agents U017 Lubricants and lubricant additives U018 Odor agents U019 Oxidizing/reducing agents U020 Photosen sitive chemicals U021 Pigments U022 Plasticizers U023 Plating agents and surface treating agents U024 Process regulators U025 Processing aids, specific to petroleum production U026 Processing aids, not otherwise listed U027 Propellants and blowing agents U028 Solids separation agents U029 Solvents (for cleaning or degreasing) U030 Solvents (which become part of product formulation or mixture) U031 Surface active agents U032 Viscosity adjustors U033 Laboratory chemicals U034 Paint additives an d coating additives not described by other

categories U999 Other (specify) 1009

b. Industrial sectors . EPA is replacing the 5

– digit NAICS codes with 48 IS codes 1010

(Ref. 10 16 ). The sectors were adapted from the European Union‘s (EU‘s) ―Guidance on 1011

Information Re quirements and Chemical Safety Assessment.‖ The IS codes divide the 1012
entire range of NAICS codes into sectors so that there is a sector corresponding to any 1013

NAICS code (see the Instructions for Reporting document , Ref. 7 ). The use of the sectors 1014

will reduce the number of unique combinations, thereby increasing the usability of the 1015
data, and also reducing the IUR reporting burden. 1016
EPA is using the 48 sectors listed in Table 2 of this unit: 1017*** Interagency EO 12866 Review Draft

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46 Table 2.

— Industrial Sectors 1018 Code Sector Description IS1 Agriculture, Forestry, F ishing 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 lea ther manufacturing IS8 Wood Product Manufacturing IS9 Paper Manufacturing IS10 Printing and Related Support Activities IS11 Petroleum Refineries IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing IS13 Petroleum Lubricating Oil and Grea se Manufacturing IS14 All other Petroleum and Coal Products Manufacturing IS15 Petrochemical Manufacturing IS16 Industrial Gas Manufacturing IS17 Synthetic Dye and Pigment Manufacturing IS18 Carbon Black Manufacturing IS19 All Other Basic Inorganic C hemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Organic Chemical Manufacturing IS22 Plastics Material and Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic Fiber Manufacturing IS25 Pestic ide, 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 Prin ting Ink Manufacturing IS31 Explosives Manufacturing IS32 Custom Compounding of Purchased Resins IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manuf acturing IS36 Rubber Product Manufacturing IS37 Non

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

concrete, lime, gypsum, and other non

- metallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Met al Product Manufacturing IS40 Machinery Manufacturing IS41 Computer and Electronic Product Manufacturing*** Interagency EO 12866 Review Draft

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47 IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product M anufacturing IS45 Miscellaneous Manufacturing IS46 Wholesale and Retail Trade IS47 Services IS48 Other (requires additional information) 1019
When the category reported for the IS code is ―Other,‖ the submitter is required to 1020
provide a written descripti on of the use of the chemical substance, which may include the 1021

NAICS code. 1022

8. Consumer and commercial use reporting. EPA is making four changes to the 1023
consumer and commercial information required to be reported: 1024
• Revising and expanding the list of consum er and commercial product categories. 1025
• Requiring the provision of a description when the product category ―Other‖ is 1026
reported. 1027
• Identifying whether the use is a consumer or a commercial use, or both. 1028
• Reporting the number of commercial workers reasonabl y likely to be exposed 1029
while using the reported chemical substance. 1030
Reporting associated with children‘s use, the maximum concentration, and the percent 1031
production volume remains unchanged. 1032

a. Consumer and commercial product categories . EPA is revising the list of 1033
consumer and commercial product categories by combining categories that lead to 1034
common exposure scenarios and adding categories that were not adequately described in 1035
the initial set of categories. EPA worked with Environment Canada and Health Can ada 1036
to develop the categories. Harmonized categories will facilitate consistent reporting of 1037*** Interagency EO 12866 Review Draft

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48 chemical substance use information by industry in the United States and Canada (Ref. 1038

9 11 ). 1039
The list includes 33 product categories, including ―Other.‖ Examples o f new 1040
categories which have been added include explosive materials, building/construction 1041
products not covered elsewhere, and air care products. The glass and ceramic products 1042
category had relatively few IUR submissions in 2006 and overlaps with the new 1043

c ategories, and so has been eliminated. Also, several of the consumer and commercial 1044
product categories have been renamed to better describe the products that should be 1045
reported in those categories. In addition to revising the overall product categories, 1046

n arrower definitions and expanded lists of examples of products in which the chemical 1047
substance would be used will be added to each category descriptor. The examples were 1048
selected to include items that could have fit into other categories in order to addre ss the 1049
overlap inherent in any product category list. The product categories were then placed 1050
into several broader groupings, e.g., ―Chemicals with Agriculture and Outdoor Uses‖ 1051
based on the similarities of products. EPA believes that the user will find the current 1052
groupings easier to use than the alphabetical listing used for the 2006 IUR. EPA is also 1053
requiring that if a submitter chooses the product category ―Other,‖ the submitter must 1054
include a text description for the consumer and commercial product containing the 1055

chemical substance. 1056
EPA is using the consumer and commercial product categories listed in Table 3 of 1057

this unit: 1058

Table 3.

— Codes for Reporting Consumer and Commercial Product Categories 1059 Code Category

Chemical Substances in Furnishing , Cleaning, Treatment Care Products C101 Floor Coverings*** Interagency EO 12866 Review Draft

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49 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 Lau ndry and Dishwashing Products C107 Water Treatment Products C108 Personal Care Products C109 Air Care Products C110 Apparel and Footwear Care Products Chemical Substances in Construction, Paint, Electrical, and Metal Products C201 Adhesives and Sealants C202 Paints and Coatings C203 Building/Con struction Materials

- Wood and Engineered Wood Products C204 Building/Construction Materials not covered elsewhere C205 Electrical and Electronic Products C206 Metal Products not c overed 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 C3 07 Photographic Supplies, Film, and Photochemicals Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products C401 Automotive Care Products C402 Lubricants and Greases C403 Anti

- Freeze and De

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

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

- TSCA Use C909 Other (specify) 1060

b. Designation of consumer or commercial use . EPA is requiring submitters to 1061
designate, via a checkbox, whether the indicated produc t category is a consumer or a 1062

commercial use, or both. 1063*** Interagency EO 12866 Review Draft

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50 c. Number of commercial workers reasonably likely to be exposed . EPA is 1064
requiring that submitters report the total number of commercial workers, including those 1065

at sites not under the submitter‘s con trol, that are reasonably likely to be exposed while 1066
using the reportable chemical substance, with respect to each commercial use. The 1067
approximate number of workers should be reported using the same definitions and ranges 1068
used for manufacturing and indust rial processing and use workers required by 40 CFR 1069
711.15(b)(3)(vii) and (4)(i)(F), respectively. The ranges are: 1070

• Fewer than 10 workers. 1071

• At least 10 but fewer than 25 workers. 1072

• At least 25 but fewer than 50 workers. 1073

• At least 50 but fewer than 100 workers. 1074

• At least 100 but fewer than 500 workers. 1075

• At least 500 but fewer than 1,000 workers. 1076

• At least 1,000 but fewer than 10,000 workers. 1077

• At least 10,000 workers. 1078

H. What changes have been made to the standard for the reporting of processing 1079

and u se information? In order to collect more complete information regarding industrial 1080
processing and use, and commercial and consumer use of chemicals chemical s ubstance s , 1081
EPA is, in 40 CFR 711.15(b)(4), replacing the ―readily obtainable‖ reporting standard 1082

used for re porting under 40 CFR 710.52(c)(4) with the ―known to or reasonably 1083
ascertainable by‖ reporting standard set forth under TSCA section 8(a)(2). This is the 1084
same standard that applied to the reporting of information described in the regulations at 1085

40 CFR 710 .52(c)(1), (c)(2), and (c)(3) for the 2006 IUR submission, and this standard 1086*** Interagency EO 12866 Review Draft

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51 continues to apply to the reporting of such information under 40 CFR 711.15(b)(1), 1087
(b)(2), and (b)(3). This standard covers all information in a person‘s possession or 1088
control, p lus all information that a reasonable person similarly situated might be expected 1089
to possess, control, or know. 1090
Under the standard, a submitter would therefore prepare its report about the 1091
processing and use of a chemical substance it manufactures (inclu ding imports), without 1092
confining its inquiry solely to what is known to managerial and supervisory employees, 1093
but would also be expected to review information which the manufacturer (including 1094
importer) may have in their possession or control, plus all inf ormation that a reasonable 1095
person similarly situated might be expected to possess, control, or know. The inquiry 1096
would be as extensive as a reasonable person, similarly situated, might be expected to 1097
perform. The standard does not necessarily require tha t the manufacturer conduct an 1098
exhaustive survey of all employees. 1099
‖Known to or reasonably ascertainable‖ information includes, but is not limited 1100
to, information that may be possessed by employees or other agents of the company 1101
reporting under the IUR rul e, including persons involved in the research, development, 1102
manufacturing or marketing of a chemical substance and includes knowledge gained 1103
through discussions, symposia, and technical publications. Examples of types of 1104

information that are considered to be in a person‘s possession or control, or that a 1105
reasonable person similarly situated might be expected to posses, control, or know, 1106
include files maintained by the submitter, such as marketing studies, sales reports, or 1107
customer surveys; information con tained in standard references, such as MSDSs, that 1108*** Interagency EO 12866 Review Draft

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52 contain use information or concentrations of chemicals in mixtures; and information from 1109

the Chemical Abstracts Service (CAS) and from Dun & Bradstreet D

- U

- N

- S ®. 1110
The following hypothetical examples illust rate the anticipated application of the 1111
―known to or reasonably ascertainable standard,‖ in the specific context of the collection 1112
of processing and use data under the IUR. Because the standard applies on a case

- by

1113
case basis, however, these examples cann ot substitute for a complete analysis of a 1114
submitter‘s particular circumstances: 1115
Company XYZ discovers that it has no knowledge of how a particular reportable 1116
chemical substance (Substance #1) is processed or used by its customers. Company 1117
XYZ usually ma intains marketing data documenting customers‘ use of its chemicals, in 1118
line with the reasonable business practices typical of comparable manufacturers, but it 1119
irrevocably lost these data for Substance #1 due to an inadvertent computer malfunction. 1120
Company XYZ has many customers, but it expects that it could substantially reconstruct 1121
this missing information by briefly contacting its largest customer and asking that 1122
customer what Substance #1 is generally used for. Company XYZ contacts this 1123

customer, repor ts on the basis of the processing and use data that the customer was 1124
willing to provide. Company XYZ has likely fulfilled its duties under the reporting 1125
standard. Company XYZ would not have fulfilled its duties under the reporting standard 1126

if it had not endeavored to supplement the information it already knew. 1127
Company XYZ has never maintained information on how a particular reportable 1128
chemical substance (Substance #2) is processed or used by its customers. However, it is 1129
typical for comparable manufactur ers to collect such information as part of their 1130
reasonable business practices. Company XYZ has many customers but it expects that it 1131*** Interagency EO 12866 Review Draft

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53 could substantially fill this data gap by reviewing the public web site of its largest 1132
customer. Company XYZ reviews thi s web site, and reports on the basis of the 1133
information contained in the web site. Company XYZ has likely fulfilled its duties under 1134
the reporting standard. Company XYZ would not have fulfilled its duties under the 1135
reporting standard if it had not endeav ored to supplement the information it already 1136

knew. 1137
Company ABC maintains seasonal marketing data on changes in use patterns for 1138
a particular chemical substance (Substance #3). Comparable manufacturers typically 1139
only maintain such data on an annual basis, in line with reasonable business practices. 1140
Company ABC irrevocably loses its summer marketing data for Substance #3, due to an 1141
inadvertent computer malfunction. Company ABC expects that it could substantially 1142
reconstruct the missing summer marketing d ata by contacting its largest customer and 1143
asking the customer what it used or processed Substance #3 for in the past summer. 1144
Nevertheless, instead of attempting to reconstruct the summer data in this manner, 1145
Company ABC reports on the basis of the proces sing and use data that it already knows 1146
(regarding the winter, spring, and fall of the year). Company ABC has likely fulfilled its 1147
duties under the reporting standard. Company ABC would not have fulfilled its duties 1148
under the reporting standard if it des ignated the information as ―not known or reasonably 1149
ascertainable‖ simply because one of the seasonal marketing reports was missing. 1150
Company ABC has never maintained information on how a particular reportable 1151
chemical substance (Substance #4) is processed or used by its customers. However, it is 1152
typical for comparable manufacturers to collect such information as part of their 1153
reasonable business practices. Company ABC has one major customer and ten minor 1154*** Interagency EO 12866 Review Draft

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54 customers. Company ABC asks its major customer to supply information about how 1155
Substance #4 is processed and used, but that customer is unwilling to supply this 1156
information. Company ABC reasonably expects that the only remaining way to 1157
substantially fill this data gap would be to send a survey to its ten minor customers. 1158
Company ABC reports that the information is ―not known or reasonably ascertainable‖ to 1159
it. Company ABC has likely fulfilled its duties under the reporting standard. 1160

EPA would like furthermore to clarify that submitters are not required to conduct 1161
customer surveys under this standard, but a new or additional customer survey (i.e., to 1162
pose a comprehensive set of identical questions to multiple customers) under this 1163

standard. If particular information cannot be derived or reasonably estimated from the 1164

information available to the c ompany without conducting further customer surveys, it is 1165
not ―known to or reasonably ascertainable‖ to the submitter for purposes of the IUR. 1166

However, to the extent that customer surveys are already in the submitter‘s possession or 1167

control, and to the ex tent that reasonable efforts to analyze or synthesize derive 1168

information from already

- available customer surveys may inform processing and use 1169
information that is reported, the information is generally ― known to or reasonably 1170

ascertainable.‖ See Unit V.E.1. of this preamble and the Respon se s to Comments 1171

document (Ref. 12 ) for further discussion. EPA‘s reporting software tool permits 1172

submitters to enter or select ―NKRA‖ on Form U to address circumstances where the 1173
information is not known to or reasonably ascertainable by the submitter. 1174

I. What changes have been made to requirements for making CBI claims ? EPA is 1175
making several changes to the requirements for claiming information as confidential. 1176
Submitters may claim certain information reported under the IUR as CBI in accord ance 1177*** Interagency EO 12866 Review Draft

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55 with 40 CFR part 2 and IUR rules at 40 CFR 711.30. Claims of confidentiality may be 1178
made for chemical identity, site identity, and processing and use information, and 1179

submitters must substantiate these claims at the time information is submitted to E PA. 1180
EPA‘s procedures for handling information claimed as confidential are set forth at 40 1181
CFR part 2, subpart B. EPA strongly encourages submitters to review confidentiality 1182
claims carefully to ensure that the information in question falls within the par ameters of 1183
TSCA section 14. EPA cautions submitters that they may be subject to criminal penalties 1184
under 18 U.S.C. § 1001 if they knowingly and willfully make a false statement in 1185

connection with the assertion of a CBI claim. CBI claims should be limited to only those 1186
data elements the release of which would likely cause substantial harm to the business‘ 1187
competitive position. Interested persons are reminded that with regard to chemical 1188
substance use information, EPA is interested in aggregated, general u ses, not detailed 1189
uses associated with specific customers. 1190
To claim information as confidential, a submitter must indicate its claim by both 1191
checking the appropriate box and signing the certification statement on the reporting 1192
form, and may also be requir ed (depending on the data element) to provide substantiation 1193

of the claim at the time it is made. A submitter must indicate its claims at the time the 1194
information is submitted. If a submitter fails to follow these procedures, EPA may 1195

release the informat ion to the public without further notice to the submitter. By signing 1196
the certification statement the submitter attests to the secrecy and value of the 1197
information for which confidentiality claims have been asserted. 1198

1. Chemical identity CBI claims . Ther e is no substantive change to submitters' 1199
ability to make confidentiality claims for chemical identity in the IUR. As in the past, a 1200*** Interagency EO 12866 Review Draft

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56 submitter may assert a claim of confidentiality for the identity of the reported chemical 1201
substance only when the chemical substance is listed on the confidential portion of the 1202
TSCA Inventory. Submitters who assert a confidentiality claim for chemical identity 1203
must also provide substantiation for the claim at time of filing. See 40 CFR 711.30(b). 1204

1205 However, in response to comment comm ent s , this final rule incorporates includes 1206
some changes to the process that must be used to in making make this type of CBI claim. 1207
The proposed rule, at 40 CFR 711.15( a b )(3)(i), provided that ―[a] submitter under this 1208
part may use an EPA

- designated TSCA Accession Number for a c onfidential chemical 1209
substance in lieu of a CASRN when a CASRN is not known to or reasonably 1210
ascertainable by the submitter.‖ In the proposed rule, EPA also noted that up to 5% of 1211
the reports submitted under the 2006 IUR contained chemical identity proble ms. EPA 1212
therefore proposed to require that submitters report using the CA Index Name currently 1213
used to list the chemical substance on the TSCA inventory. EPA further indicated that it 1214

would incorporate inc lude CASRNs and CA Index Names into the e

- IURweb 1215

software tool
, to the extent possible without jeopardizing confidentiality claims. EPA 1216
believes that selecting chemical identity from a pre

- populated list, rather than keying in 1217
the chemical identity information, will significantly improve the accuracy and 1218
consistency of subm itted reports. 1219

1220 EPA received several comments from industry groups requesting that the e

1221

IURweb software incorporate tool inc lude security safeguards to adequately protect CBI. 1222
In light of the security concerns expressed in public comments, EPA has decided not to 1223
incorporate inc lude CASRN s and CA Index Names for chemicals chemical s ubstance s on 1224*** Interagency EO 12866 Review Draft

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57 the confidential portion of the TSCA Inventory into the portions of the e

- IURweb 1225

software tool that will be publicly accessible. However, EPA still believes it is important 1226
to require that all chemical identities be selected from a pre

- populated list, to avoid 1227
repeating the chemical identity problems experienced with the 2006 IUR. Therefore, 40 1228
CFR 711.15(a)(3)(i) has been revised in this final rule to require that submitters who wish 1229
to report chemical substances li sted on the confidential portion of the TSCA Inventory 1230

use the chemical‘s chemical substance ‘s TSCA Accession Number and generic name. 1231
Requiring the use of accession numbers and generic names will allow EPA to adequately 1232
protect confidential CASRNs and CA Index Name s (by omitting them from the pre

1233
populated selection list) while still obtaining the improvements in reporting accuracy it 1234
sought in the proposed rule. 1235

1236 In SRS, a submitter can readily find a cross

- reference list that displays the 1237
Accession Number, generic chemical name, and the PMN case number (or for an initial 1238

TSCA Inventory chemical substance, the TSCA Inventory reporting form number) for 1239
any confidential chemical substance listed on the TSCA Inventory. Submitters who wish 1240

to retain the CBI claim for the chemical substance identified by the Accession number 1241
must assert and substantiate the claim at time of filing. Submitters who do not wish to 1242
retain the CBI claim for the chemical substance identity, and who wish the chemical 1243

substance to be listed on th e public portion of the TSCA Inventory, should not assert a 1244
CBI claim or provide substantiation. Submitters who fail to follow the required 1245
procedures for asserting CBI claims for chemical identity will waive the claims, and EPA 1246
may release the information without further notice to the submitter. See the regulatory 1247

text at 40 CFR 711.30(e). 1248*** Interagency EO 12866 Review Draft

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58 1249 2. Upfront substantiation for processing and use information CBI claims . Under 1250
the IUR, a submitter may assert a claim of confidentiality for data associated with the 1251
processing and use of its chemical substance if the submitter has reason to believe that 1252

release of the information would reveal trade secrets, or confidential commercial or 1253
financial information, as provided by TSCA section 14 and 40 CFR part 2. Under th is 1254
final rule, EPA is requiring upfront substantiation for CBI claims for processing and use 1255

information. 1256
In order to submit a claim of confidentiality for processing and use information 1257
data elements, the submitter is required (in addition to signing the certification statement) 1258
to both check the appropriate box on the reporting form and substantiate the claim in 1259
writing, within the reporting software tool
, by answering certain questions provided in 40 1260
CFR 711.30(d). EPA revised the substantiation question at 40 CFR 711.30(d)(1)(ii), 1261
respecting competitive harm, to include harmful effect ―to your customer‘s competitive 1262
position.‖ Where a submitter fails to submit substantiation of the processing and use CBI 1263
claim in accordance with the applicable rules (i.e., the submitter does not provide an 1264
answer to all the required questions associated with the claim on the Form U it submits 1265

via e

- IURweb), EPA will consider the information not subject to a confidentiality claim 1266
and may make the information available to the publ ic without further notice to the 1267

submitter. 1268

3. Prohibition of confidentiality claims for data elements identified as “not known 1269
or reasonably ascertainable.” EPA is prohibiting claims of confidentiality pertaining to 1270
the designation that information is ―no t known or reasonably ascertainable.‖ As described 1271

in Unit II.A., for the 2011 201 2 and future IUR collections, submitters will be required to 1272*** Interagency EO 12866 Review Draft

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59 report processing and use information to the extent that it is known to or reasonably 1273
ascertainable by them. 1274

For the 2006 IUR collection, EPA observed that, on occasion, processing and use 1275

information was claimed as confidential when a submitter determined that the 1276
information was not readily obtainable. Section 14 of TSCA limits the disclosure of 1277

information entitled t o confidential treatment under Exemption 4 of the Freedom of 1278
Information Act (FOIA). EPA has considered the NKRA designation and its relationship 1279
to a potential CBI or trade secret claim. Given that a NKRA assertion is an assertion that 1280

no information is available, the Agency does not believe that the designation conveys 1281

trade secret or confidential commercial or financial information. 1282

J. What changes specifically affect importers? 1283

1. Importer site address. Submitters report IUR data on chemical substa nces that 1284
they manufacture domestically and that they import into the United States. Previously, 1285
the regulations defining the site for importer reporting were found in both the definition 1286
for site in 40 CFR 710.3 and in paragraph 40 CFR 710.48(b). EPA is eliminating 1287
unnecessary duplication in the IUR regulation by moving the additional information 1288
regarding the importer site from 40 CFR 710.48(b) into a revised definition for site at 40 1289
CFR 711.3, as described in Unit II.F.3.b., and eliminating 40 CFR 71 0.48(b). 1290
In addition, EPA has observed that submitters occasionally use a foreign address 1291
as the site address for the importer. EPA now is requiring that submitters report a U.S. 1292
site address, by modifying the definition for site to state specifically th at the site must be 1293
a U.S. site. The U.S. address of an agent acting on behalf of the importer, and authorized 1294
to accept service of process for the importer, may be reported as the importer‘s site 1295*** Interagency EO 12866 Review Draft

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60 address if the operating unit that is directly responsible for importing the chemical 1296
substance and that controls the import transaction has no U.S. address. The Agency 1297
expects that all importers will have a U.S. site, as defined in the 40 CFR 711.3 definition 1298
for site, because, under Customs regulations at 19 C FR 141.18, a non

- resident 1299
corporation is not permitted to enter merchandise for consumption unless it has a resident 1300
agent in the State where the port of entry is located, who is authorized to accept service of 1301
process against the corporation. 1302

2. Joint sub missions. For purposes of IUR, submitters are allowed to report the 1303
IUR information jointly with the foreign supplier of a reportable chemical substance 1304
whose chemical identity is unknown to the importer. Previously, joint submissions could 1305

not be made ele ctronically. EPA is now requiring that submitters use CDX and e

- IURweb 1306
for preparation and submission of joint submissions. See 40 CFR 711.15(b)(3)(i)(C). 1307
Therefore, the authorized officials of the jointly submitting companies will need to 1308
register with CDX in order to submit a joint report to EPA. 1309
Importers may not know the specific chemical identity of a chemical substance 1310
because the foreign supplier chooses to keep it confidential. In such a situation, the 1311
importer must use e

- IURweb to ask the foreig n supplier to submit the chemical identity 1312
information directly to EPA through a joint report. To submit a joint report, the importer 1313
completes the majority of the required information, and supplies a trade name or other 1314
designation to identify the chemic al substance, and provides contact information for the 1315
foreign supplier. The importer then uses e

- IURweb to contact the foreign supplier and 1316
request that the foreign supplier report the specific chemical identity information directly 1317
to EPA. The importer must submit a copy of such request to EPA, along with the rest of 1318*** Interagency EO 12866 Review Draft

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61 its IUR submission for the chemical substance. As a general matter, EPA expects that 1319
importers will supply the information described at 40 CFR 711.15(b)(3)(i)(A), rather than 1320

an ―NKRA‖ desi gnation, when importers do not know the confidential chemical identity 1321
of a chemical substance they import. EPA believes that an NKRA designation would 1322
generally only be appropriate in the unlikely event that an importer did not know, and 1323

could not reason ably ascertain, the information needed to link its submission with a 1324
secondary report from the supplier. 1325
In an acceptable joint submission, the secondary submitter supplies the chemical 1326
identity, as well as its technical contact and company information, an d provides the 1327
primary submitter‘s site information. EPA will not accept joint submissions that are not 1328
submitted electronically using e

- IURweb and CDX. All information will be saved by the 1329
reporting software tool and both submissions will be matched based upon c ompany and 1330

chemical substance information. Once the forms are linked, EPA will process the joint 1331
submission as one report for the reported chemical substance. See the guidance manual, 1332

available on EPA‘s website at www.epa.gov/iur
, http:// www.epa.gov/iur
, for detailed 1333

inst ructions on submitting a joint report. 1334

IV. What clarifications have been made to reporting requirements? 1335
1. Clarification of the Relationship Between Company Name and Site Identity CBI 1336

Claims. Under the IUR, submitters are able to separately claim as CBI the company 1337
name and site identity associated with a chemical substance for which they are reporting 1338
under the IUR. The submitter is required to provide an upfront substantiation for CBI 1339
claims for the site identity. EPA believes there is some confusion as to what is 1340*** Interagency EO 12866 Review Draft

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62 considered confidential when such claims are made, and is taking this opportunity to 1341
provide clarification. 1342
The CBI claim protects the link between the company and/or site identity and the 1343
particular chemical substance. If the company or site identity associated with a particular 1344
chemical substance is not claimed as CBI, EPA may make that information available to 1345
the public without further notice to the submitter. EPA will not impute the existence of a 1346
CBI claim for company identity or for si te identity from a CBI claim associated with a 1347

different chemical substance. 1348
Company and site identity CBI claims are separate claims, and in some cases one 1349
type of claim may be justified while the other is not. Therefore, a submitter is permitted 1350

to ass ert its CBI claim for the company identity, the site identity, or both the company 1351
and site identity. Such claims must be made for each chemical substance for which such 1352
claims are being made. Because the circumstances for each chemical substance can var y, 1353
the IUR rule does not allow for blanket claims covering all chemicals chemical s ubstance s 1354

in a site‘s IUR report. 1355
Likewise, the submitter must provide separately the required upfront 1356
substantiation for the site identity CBI claims associated with each chemical substance. 1357
For instance, if the submitter is reporting for five chemical substances and wishes to 1358

claim its site information confidential for three of the five chemical substances, it must 1359
assert the claim and provide separate upfront substantiation three times, once for each of 1360

the three chemical substances. 1361
EPA has also observed that submitters sometimes claim only their company 1362
identity, and not their site identity, as confidential. If the site identity for a particular 1363*** Interagency EO 12866 Review Draft

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63 chemical substance is not cla imed as CBI, or is claimed but not substantiated pursuant to 1364
40 CFR 711.30(c), EPA may make that information available to the public without 1365
further notice to the submitter. EPA will not impute the existence of a CBI claim for site 1366
identity from a CBI cla im for company identity, even if the company name appears 1367
within the site identity information. To help ensure that submitters consider this issue, 1368

the e

- IURweb reporting software tool provides a warning whenever the company identity 1369
is claimed as CBI for a partic ular chemical substance and the site identity is not also 1370

claimed as CBI for that chemical substance. 1371
2. Explanation of Byproduct Reporting. During the 2006 submission period, EPA 1372
received questions about the requirements for reporting byproducts. The q uestions 1373
included whether byproduct manufacturers (including importers) were required to report 1374
the byproducts under the IUR rule. Based on those and subsequent inquiries, and from 1375
the public comments from the proposed rule, it is apparent that scope of t he IUR 1376
obligation to report byproducts is not well understood by industry. The scope of 1377
byproduct reporting has become a particularly pertinent issue because (by the terms of 1378
the 2003 Amendments to the IUR) inorganic chemicals chemical s ubstance s are now no 1379
longer exempt from reporting under IUR, including (beginning with the 2011 201 2 IUR) 1380
the information collection requirements for processing and use information. Inorganic 1381

chemicals chemical s ubstance s are often recycled, thereby triggering which may trigger 1382
the need to report a byproduct substan ce that is recycled. In an effort to further clarify 1383
reporting obligations, EPA is providing additional information on byproduct reporting, 1384
including circumstances under which reporting is not required, in the instruction manual 1385

and in other two guidance materials documents included in the docket for this final rule 1386*** Interagency EO 12866 Review Draft

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64 (Refs. 5, 11, and 12 7 and16 ) and on EPA‘s website at www.epa.gov/iur

. 1387
http://

www.epa.gov/iur

. For purposes of IUR, a byproduct is a chemical substance 1388
produced without a separate commercial intent during the manufacture, processing, use 1389
or disposal of another chemical substance or mixture (40 CFR 704.3). Thus, for example, 1390
when a chemical substance or mixture is used for the purpose of manufacturing an article, 1391
and that manufacture results in the production of a different chemical substance, that 1392

different chemical su bstance is a byproduct for purposes of the IUR. Chemical 1393
substances that are byproducts of the manufacture, processing, use, or disposal of another 1394
chemical substance or mixture, like any other manufactured chemical substances, are 1395
subject to IUR reportin g if they are listed in o n the TSCA Inventory, are not otherwise 1396
excluded from reporting, and their manufacturer is not specifically exempted from IUR 1397
reporting requirements. 1398

The 40 CFR 704.3 definition of manufacture for commercial purposes states that 1399
―[m] anufacture for commercial purposes also applies to substances that are produced 1400
coincidentally during the manufacture, processing, use, or disposal of another substance 1401
or mixture, including both byproducts that are separated from that other substance or 1402

m ixture and impurities that remain in that substance or mixture. Such byproducts and 1403
impurities may, or may not, in themselves have commercial value. They are nonetheless 1404
produced for the purpose of obtaining a commercial advantage since they are part of th e 1405
manufacture of a chemical product for a commercial purpose.‖ Thus, byproducts of the 1406
manufacture, processing, use, or disposal of another chemical substance or mixture for a 1407
commercial purpose are themselves both ―manufactured‖ and ―manufactured for 1408

com mercial purposes.‖ Also, considering the overall context of this definition, EPA 1409*** Interagency EO 12866 Review Draft

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65 interprets ―chemical product‖ broadly to include any product of the manufacturing, 1410
processing, use, or disposal of another chemical substance or mixture, other than a 1411
byprodu ct. 1412

1413
Byproducts that are manufactured (including imported) in volumes of 25,000 lb

. 1414
or more at a single site are potentially subject to IUR requirements. However, 40 CFR 1415
711.10(c) excludes from reporting those chemical substances meeting the requirements o f 1416
40 CFR 720.30(g) or (h). Manufacturers (including importers) of byproducts are not 1417
required to report the manufacture (including import) of a byproduct if the byproduct is 1418
not used for commercial purposes. See 40 CFR 720.30(h)(2). Thus, even where a 1419
byp roduct is manufactured (including imported) for a commercial purpose, if the 1420
byproduct is not subsequently put to use for another commercial purpose, the byproduct 1421
is excluded from IUR reporting. Furthermore, if the byproduct‘s ―only commercial 1422
purpose i s for use by public or private organizations that: (1) burn it as a fuel, (2) dispose 1423
of it as a waste, including in a landfill or for enriching soil, or (3) extract component 1424
chemical substances from it for commercial purposes,‖ 40 CFR 720.30(g), that byp roduct 1425
is also excluded from IUR reporting. This exclusion applies only to the byproduct; it 1426
does not apply to the component chemical substances extracted from the byproduct. The 1427

Instructions document includes a decision tree to assist a byproduct manufa cturer 1428
(including importer) in its determination of the need to report its byproduct chemicals. 1429

(Ref 7 ) 1430
Some manufacturers (including importers) of byproducts have expressed a belief 1431
that a chemical substance that is regulated by another EPA program, suc h as under the 1432
Resource Conservation and Recovery Act (RCRA), or that is exempt from certain 1433*** Interagency EO 12866 Review Draft

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66 requirements by the other program based on certain treatments or disposals, should not be 1434
required to be reported for IUR purposes. However, under this rule, when such chemical 1435
substances have a commercial purpose not exempted by 40 CFR 720.30(g), the 1436
manufacturer (including importer) of such a chemical substance may have IUR reporting 1437
obligations, and is not relieved of those obligations based on exemptions under other 1438

laws. 1439
Although the need to report for byproduct chemical s ubstances is not a new 1440
requirement, EPA recognizes that there were many comments and concerns rai sed about 1441
byproduct chemical s ubstances
, as stated earlier in this section, and that there may be 1442
byproduct manufacturers that remain unsure of their reporting obligations under the IUR. 1443
In particular, the Agency recognizes that this may be an issue for those byproduct 1444
manufacturers who recycle byproducts by sending them off

- site to a recycler. Th e 1445
Agency is committed to helping byproduct manufacturers report according to the IUR 1446
requirements and views the 2012 reporting cycle as an opportunity for the Agency and 1447
byproduct manufacturers to work together. Among other things, the Agency will use thi s 1448
opportunity to determine whether additional guidance tailored to these manufacturers is 1449

needed. In addition, EPA intends to provide training specific to byproduct reporting and 1450
to make available Agency personnel to answer questions on an individual basi s. 1451
EPA also intends to continue to work with industry and the interested public. 1452
EPA encourages recycling. The Agency intends to examine the collected information 1453
related to byproducts, recognizing the importance of recycling, to identify whether there 1454

ar e segments of byproduct manufacturing for which EPA can determine that there is no 1455
need for the IUR information for the 2016 or other future reporting cycles

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67 V. Public Comments 1457
EPA carefully considered the comments it received on the proposed IUR 1458

modifica tions. Major comments are discussed below. Additional comment summaries 1459
and more detailed responses, including responses to most of the additional issues that 1460
EPA requested comment on, are contained in the  ̳ ̳Summary of EPA‘s Responses to 1461

Public Comments Submitted in Response to Proposed TSCA Inventory Update Report ing 1462
Modifications‘‘ ( document  ̳( Ref. 13 12 ). 1463

1464 A. General Comments 1465

1466 1 . Justification for Proposed Modifications. Several commenters supported many 1467
of EPA‘s proposed reporting changes, stating that the changes will facilitate EPA‘s 1468
ability to track chemicals chemical s ubstance s used and made in the United States, which 1469

wou ld strengthen EPA‘s ability to identify chemicals chemical s ubstance s for further 1470
assessment. They also noted that the IUR data not only supports activities under EPA 1471
authorities, but is also used by other Federal agencies, the states, and other interested 1472

stakehol ders to identify potential chemicals chemical s ubstance s of concern. Other 1473
commenters expressed the view that EPA has not provided adequate justification 1474
supporting the Agency‘s need for the IUR data and has not sufficiently tailored the 1475
requested information to me et EPA‘s goals. One commenter did not agree that the 1476
modifications will increase the ―usability of collected information‖ or ―focus reporting‖ 1477
on what is ―most needed‖ by EPA. Another commenter mentioned that the Agency does 1478
not explain how the existing IU R fails to meet these goals or why an IUR expansion is 1479
needed to carry out its Congressionally

- mandated TSCA duties. Additionally, 1480*** Interagency EO 12866 Review Draft

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68 commenters suggested that EPA should clearly indicate how the IUR data will be utilized 1481
in programs that systematically revie w hazard and exposure of existing chemicals. 1482

1483 EPA has an obligation under TSCA to protect human health and the environment 1484

from unreasonable risks associated with chemicals chemical s ubstance s under its 1485
jurisdiction. EPA is amending the IUR rule to improve and enhan ce data reporting 1486
requirements under IUR reporting beyond that required during the 2006 reporting 1487
cycle. submission period

. There were problems associated with many 2006 IUR data 1488
submissions that severely limited EPA‘s ability to screen chemicals chemical s ubstance s 1489
for exposure and risks and to make data available to the public. These problems included 1490

the fact that many submissions were incomplete or improperly completed, contained 1491
invalid chemical identities, and/or inappropriately or incorrectly claimed certain data 1492

elements as CBI. EPA anticipates that today‘s amendments this final rule will (1) ensure 1493
the required information is properly reported and that the information in the Agency‘s 1494
database reflects the information provided in the IUR reports; (2) increase the usability of 1495

the collected info rmation; (3) increase the availability of information for the public; and 1496
(4) focus reporting on information that is most needed by the Agency. Additionally, EPA 1497
believes that the modifications to the rule will supply manufacturing
, and processing and 1498

use information the Agency did not previously possess and should be accurate and 1499
reliable enough to develop screening level assessments. 1500

1501 Data collected under the IUR will be used in a wide variety of programs 1502
fundamental to fulfilling the Agency‘s TSCA statut ory mandate. EPA believes that the 1503
IUR data is the most basic data set that will give EPA and the public an understanding of 1504*** Interagency EO 12866 Review Draft

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69 the volume of chemicals chemical s ubstance s produced or imported into the United States, 1505

how the chemicals chemical s ubstance s are or may be used, and the types of exposures 1506
(occupational, consumer, environmental, etc.) potentially associated with the 1507

chemicals. chemical s ubstance s. Many chemicals are exempted from reporting under the 1508
IUR rule, which further tailors IUR requirements to EPA‘s information needs. D ata 1509
about production volume, exposures, and/or environmental releases are required to make 1510
some of the findings necessary to require testing under section 4, and helps EPA to 1511
prioritize chemicals for further data gathering or risk management action. chemical 1512

s ubstances for further data gathering or risk management acti on. For example, data 1513
supplied by the IUR have supported a series of test rules in the HPV Challenge Program, 1514

which were implemented to generate health and environmental effects data on HPV 1515

chemical s ubstances for risk assessment purposes. The IUR support ed these test rules by 1516
providing production volume and exposure information needed to make the findings for 1517

these test rules. Without the IUR information, EPA might not have been able to make 1518

the se finding s

. The Agency anticipates that t he data collected under the 2012 IUR will 1519
better support the development of test rules. 1520
The Agency‘s Existing Chemicals program will use the IUR data to assess 1521
whether the Agency needs additional data about the hazards or exposures to a particular 1522

chemical substance under sections 4 or 8 of TSCA, and may use IUR data to inform risk 1523
management actions such as those identified in TSCA Sections 5 and 6. EPA‘s extensive 1524
use of the 2006 IUR data in the Agency‘s Existing Chemicals Program is consistent with 1525

how EPA envisioned th e data would be used when the 2003 Amendments were 1526
promulgated. For example, in 2007, the Agency began to develop and pos t screening

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70 level hazard, exposure, and risk characterizations for HPV chemicals, which are those 1528
chemicals produced nationally at aggregated volumes of one million lb. or more per year. 1529
In developing these characterizations, EPA identified areas where used the 2006 IUR data 1530
could be improved and enhanced. The amendments in today‘s final rule will allow EPA 1531
to better identify and take follow

- up action together with other available information in 1532
developing Action Plans on chemical s ubstances that may pose potential risks to human 1533

health or

beginning in 2009, and noted the limitations inherent in those data. An y future 1534
program is expected to be similar in analytical approach regarding the environment. use of 1535
screening

- level hazard and screening

- level exposure data to develop risk prioritizations

. 1536
EPA‘s future Existing Chemicals program will build on the experience of this p ast 1537
program, and the modified IUR data collected during the 2012 and future submission 1538
periods will enable the Agency to further enhance its program.
, More detailed 1539
discussions are in the Responses to Comments document (Ref. 13 12 ). 1540

1541 2 . Transitioning to 2011 20 1 2

. Commenters stated the new requirements are 1542
overly burdensome and unrealistic considering the time constraints. Another commenter 1543

stated there would be insufficient time for c ollecting and verifying data, conducting 1544
quality checks, or completing Commenters supported delaying the necessary paperwork 1545
for the report. Many commenters suggested that EPA should extend the IUR submission 1546

deadline period in a variety of ways, including: (1) extending by several months and 1547

make delaying the impleme ntation of changes that are finalized effective in until the next 1548
submission period, (2) delaying the submission period until 9 to 12 months following the 1549
promulgation of the final rule, or (3) moving the submission period to 2012 and changing 1550
the principal reporting period year to 2011

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71 1552 EPA disagrees that transitioning into In li ght of these comments, to provide 1553
sufficient time for companies to comply with the new 2011 amended reporting 1554
requirements is overly burdensome
, and unrealistic. to finalize the proposed 1555

modifications, EPA promulgated a rule (Ref. 6 ) to suspend the 2011 IUR submission 1556
period. In this action , EPA su persedes the suspension of the submission period by 1557
establishing a new sequence of submission period, beginning with one from February 1, 1558

2012, throu gh June 30 , 2012

. EPA believes that the four month timing of the 201 2 1559
submission period provides companies sufficient time to collect and submit the required 1560
data, and that steps taken by the Agency provided have and will provide the opportunity 1561
for companies to gain an understanding of the submission process and to prepare their 1562
internal electronic systems as needed. For example , EPA was asked by several 1563
companies and trade organizations to provide an overview of the reporting software tool

. 1564
Acknowledging that companies were concerned about the time needed to develop their 1565
internal databases to collect the required information, on Novembe r 30, 2010, the Agency 1566
held an informational workshop and webinar to help companies develop a better 1567
understanding of the CDX registration process and the e

- IURweb electronic reporting 1568

tool

. A recording of the workshop and a summary of the questions and a nswers is 1569

available on the IUR website ( www.epa.gov/iur ). ( http://www.epa.gov/iur ). EPA used 1570
stakeholders‘ comments from the workshop and additional comments obtained during the 1571

tool‘s beta

- test to help ensure the tool would address the needs of the submitters. The In 1572

addition, the Agency plans to provide an opportunity, prior to finali zation of the e

1573
IURweb, for stakeholders to test a pre

- release version of the tool. EPA plans to conduct a 1574
training webinar shortly after the publication of this final rule to provide detailed 1575*** Interagency EO 12866 Review Draft

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72 instructions on the reporting requirements and on using the reporting software, e

1576

IURw eb
, to complete and submit Form U. Finally, to the extent that the timing of the 1577
next submission period actually presents a substantial obstacle to the submission of any 1578
particular data element, notwithstanding EPA‘s efforts to familiarize submitters with t he 1579
draft and final reporting software tool
, and EPA‘s post

- promulgation efforts to familiarize 1580
submitters with the reporting requirements, the IUR reporting standard of ―known to or 1581
reasonably ascertainable‖ addresses such circumstances without the need for a delay in 1582
implementation (see Unit V.E.1.). 1583

1584 One commenter suggested that EPA continue under the old IUR rule for this 1585
submission period. The Agency does not agree that it should revert to the existing 2006 1586
IUR rule because the enhancements addressed in the proposal will significantly increase 1587
the amount of exposure information available to th e public and Agency. The new and 1588
updated information collected under this final rule will increase the Agency‘s ability to 1589
understand exposure concerns. continue under the IUR rule in effect for the 2006 1590
submission period ; however, the Agency recognizes that additional time may be 1591
necessary for many submitters to become familiar with the updated IUR reporting 1592
requirements and develop processes for collecting the information. Therefore, the Agency 1593
will be phasing in certain requiremen ts so that the scope of exposure

- related information 1594

to be collected will be increased for the 2012 IUR data collection and then further 1595

increased for the 2016 data collection and subsequent reporting years

. As mentioned by 1596

one commenter, the ―IUR rule is one of the very few means by which the federal 1597
government can obtain and provide public access to robust information on the identity, 1598
production, processing and use of‖ chemical substances (Ref. 1 7 ). In order to fulfill the 1599*** Interagency EO 12866 Review Draft

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73 Administrator‘s goal of enhancin g EPA‘s TSCA chemical management program, EPA 1600

needs to begin collecting some of the new and updated information in the 2012 1601
submission period

. As described on EPA‘s website 1602

( ht tp://www.epa.gov/opptintr/existingchemicals/pubs/enhanchems.html ), EPA‘s 1603
comprehensive approach to enhancing the Agency‘s current chemicals management 1604
program includes obtaining information needed to understand chemical substance risks 1605
and increasing tran sparency and public access to information about chemical s ubstances

. 1606
The proposed changes to the IUR are specifically identified as a key component for these 1607
aspects of the enhanced program, including required electronic reporting and the 1608
expanded manufac turing, processing and use information. For example, the expansion of 1609
reporting processing and use information for all chemical s ubstances addresses the 1610
identified lack or insufficiency of such information for most chemical s ubstances

– 1611
including HPV chem ical s ubstances

. EPA‘s efforts to understand and prioritize chemical 1612

s ubstances based on risk, using the 2006 IUR data, were instrumental in identifying the 1613

needed changes to the IUR requirements. These included: 1614

EPA‘s Risk

- Based Prioritization Process (RBP) was developed to take the 1615

hazard data assembled for HPV chemical s ubstances under EPA‘s HPV 1616
Challenge Program to conduct screening

- level hazard assessments and use the 1617
2006 IUR data to develop screening

- level exposure assessments, with the goal 1618

of u sing the two types of assessments to develop screening

- level risk 1619
prioritizations for the HPV chemical s ubstances with fairly complete SIDS 1620
data sets. EPA quickly discovered that while the hazard data allowed EPA to 1621
make a screening

- level conclusion about hazard, the 2006 IUR data rarely 1622*** Interagency EO 12866 Review Draft

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74 provided sufficient information for EPA to reach a screening

- level conclusion 1623
about exposure. 1624

EPA discovered with the 2006 IUR that a larger than expected portion of HPV 1625

chemical substance manufacturers produced below the 300,000 lb threshold at 1626
individual sites, resulting in many submitters not being required to provide 1627
processing and use information for those volumes. In some cases, all of the 1628
reporters fell below the threshold. 1629

For Moderate Production Volume chemical s ubstances , with national 1630
production volumes between 25,000 and one million pounds, even fewer 1631
individual sites reported production volumes over the 300,000 lb threshold. 1632
Although EPA desired to include these chemical s ubstances in its risk

- based 1633
prioriti zation process, the screening

- level exposure information was not 1634

available. 1635

For those chemical s ubstances for which EPA had some processing and use 1636
data, the Agency had difficulty evaluating exposure for commercial workers 1637

and consumers because the 2006 IU R data did not differentiate between these 1638
populations. The separation of these populations for future IUR collections, 1639
and including other information such as that related to children‘s use of the 1640

chemical s ubstances , will help EPA better identify potent ial risks to more 1641
targeted populations. 1642
These examples illustrate several obstacles EPA encountered in understand ing 1643

chemical substance risks , which stemmed from the scope of the 2006 IUR data 1644
collection. They also illustrate how the revised IUR data co llection will increase the 1645*** Interagency EO 12866 Review Draft

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75 Agency‘s ability to understand exposure concerns so that EPA will be better able to 1646
identify steps needed to manage risks associated with chemical substances. Not only will 1647
the revised IUR data collection provide information that would have been helpful for 1648
past programs, it is directly applicable to the Agency‘s current and future programs. 1649

EPA will be able to use the 2012 IUR data to identify additional chemical s ubstances for 1650
its Chemical Action Plan program, will also be able to identify if any of the current 1651
action plans may need to be revised, and will be able to develop other aspects of the 1652
enhanced existing chemical s ubstance management program that are associated with 1653
understanding chemical substance risk. 1654

In addition, re quiring the use of electronic reporting will help ensure that data are 1655
available in a timely manner and it will reduce data entry errors, thereby increasing the 1656
usability and reliability of the data for EPA and other federal agencies as well as . It will 1657

also help to fulfill the Administrator‘s commitment to increase public access to 1658

information on chemicals chemical s ubstances

. 1659

1660 3 . EPA’s use of IUR data. The Agency received comments related to how IUR 1661
data can best be used to assist in assessing, prioritizing, and taking action on 1662

chemicals chem ical s ubstance s that pose unreasonable risks. Commenters stated that the 1663
current IUR was sufficient for EPA to use as a screening tool for the prioritization of 1664

chemicals chemical s ubstance s in commerce, and that EPA should use the Agency‘s wide 1665
variety of regulato ry tools and authorities to collect more detailed information. 1666
Commenters also expressed interest in providing input on using the IUR and the 1667
Agency‘s prioritization process. 1668

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76 EPA disagrees that the current IUR is sufficient for its purposes. B etween A ugust 1670

2007 and mid

- 2009, EPA developed screening

- level hazard, exposure, and risk 1671

characterizations for some chemicals chemical s ubstance s produced or imported in 1672
quantities of 25,000 pounds lb or greater a year. Based on those characterizations, EPA 1673
developed either a ris k

- based prioritization (RBP) or a hazard

- based prioritization (HBP) 1674

for individual chemicals chemical s ubstance s or a group of chemicals chemical s ubstance s 1675
that were similar in some way, e.g., structure, properties, toxicity. Those prioritizations 1676

did not constitute definit ive determinations regarding hazard, risk, or the sufficiency of 1677
available information for any regulatory purpose, but were rather initial evaluations of 1678
data and understanding currently available to EPA. EPA‘s experience using the IUR 1679

information to deve lop the prioritizations was that the 2006 IUR data were not sufficient 1680
to provide the needed exposure

- related information. When EPA was developing RBPs 1681

for its HPV chemicals chemical s ubstance s , it needed both hazard and exposure 1682
screening

- level information. Lackin g sufficient exposure information, EPA found it 1683
necessary in many cases to make assumptions about exposure and the resulting 1684
prioritization decision was primarily hazard

- based, as opposed to risk

- based, as 1685
evidenced by statements in many of the RBP as well as HBP documents that EPA 1686
developed (available at 1687
http://iaspub.epa.gov/oppthpv/existchem_hpv_prioritizations.INDEX_HTML) that 1688
further information on exposure was needed to confirm the prioritization. Thus the 1689
exposure information provided in the 2006 IU R reporting did not provide EPA with 1690
sufficient information to prioritize chemicals chemical s ubstance s for which it generally 1691
possessed a base set of hazard data. Therefore, for some of the RBPs the next steps 1692*** Interagency EO 12866 Review Draft

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77 indicated that additional exposure information would be necessary to validate the 1693
prioritizations before determining whether any further action was needed. In developing 1694

these characterizations, EPA identified areas where the IUR data collection should be 1695
improved and enhanced. These improvements, which ar e reflected in the modifications 1696
to the reporting requirements in the current rule, will allow EPA to better prioritize 1697

chemicals chemical s ubstance s for further assessment as well as make appropriate risk 1698
management decisions for follow

- up action on chemical substa nces that may pose 1699
potential risks to human health or the environment. 1700

1701 EPA is considering using other regulatory tools and authorities to collect more in

1702
depth information, but believes the IUR is the correct mechanism for the data collection 1703

finalized in this notice. EPA also is considering ways to obtain public input on its use of 1704

the IUR data and its chemical substance prioritization process, as suggested by the 1705

commenters. 1706

1707 4. Canada’s prioritization approach. Some commenters recommended that EPA 1708 adopt Canada‘s prioritization approach. EPA assumes that the commenters were 1709 referring to the Domestic Substances List Categorization that Canada completed in 2006. 1710 The DSL Categorization was a statutorily mandated risk

- based prioritization which 1711 required revi ew of both hazard and exposure information for 23,000 chemicals chemical 1712

s ubstance s in a very short period of time. Health Canada was required to identify 1713 chemicals chemical s ubstance s presenting human health hazards as well as the greatest 1714 potential for exposure to Canadian s. Even though categorization was a legally mandated 1715 process with a deadline for consideration of all chemicals chemical s ubstance s on the 1716 DSL, Health Canada felt that production volume alone was not a sufficient surrogate for 1717 exposure and developed a complex process for the exposure portion that required 1718 extensive literature review, input of . In order to move beyond prod uction volume, Health 1719 Canada sought additional information from industry , and used , including some of the 1720 types of data that EPA is requesting requiring for the 2011 201 2 IUR reporting period 1721 (Ref. 14 ). 1722 1723*** Interagency EO 12866 Review Draft

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78 1 8 ). Based on its review of hazard and IUR data collected on HPV and medium 1724
production volume ( MPV ) chemicals chemical s ubstances
, EPA also believes that using 1725
large production volume as the sole surrogate for exposure is not sufficient to identify 1726

chemicals chemical s ubstance s of highest concern. Some of the risk

- based prioritizations 1727

of HPV chemicals chemical s ubstance s resulted in low priority decisions for the HPV 1728

chemicals chemical s ubstance s that were low hazard, used in closed systems and 1729

consumed as intermediates. On the other hand, some of the MPV chemicals chemical 1730

s ubstance s were identified as potentially high or medium priority, because they had high 1731

or medium haza rd and would present high or medium risk concerns if they had 1732
widespread exposure or dispersive uses. The only way for the Agency to move from 1733
prioritizations based primarily on hazard to truly risk

- based prioritization is for it to 1734
receive regularly upda ted information on exposure and use for chemical substances being 1735

made and used in the United States. The chemical substance manufacturing industry has 1736
indicated in several ways, including in comments on the proposed rule, that it supports 1737

risk

- based as o pposed to hazard

- based prioritization. A commenter also noted that 1738
industry strongly supports risk

- based decisions and for that reason needs to provide 1739
robust production, processing and use data. 1740

1741 B. Comments on Electronic Reporting 1742

1743 EPA received various comments on the proposed requirement to use the reporting 1744

software tool
, e

- IURweb, to submit all IUR submissions. In general, comments were 1745
submitted on the reporting software, tool phasing

- in electronic reporting registering with 1746*** Interagency EO 12866 Review Draft

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79 CDX, and electronic signatures. See Sectio n B. in the Responses to Comments document 1747

(Ref. 13 12 ) for further discussion on electronic reporting. 1748

1749 1. Comments on the reporting software tool and phasing

- in electronic reporting. 1750 In general, commenters supported electronic reporting. Some commenters suggested that 1751 the Agency develop a phased

- in process for electronic reporting, in order to provide more 1752 time for companies to become familiar with the new format and to develop their own data 1753 systems. Some commenters wanted to be able to upload data via an XML fil e into the 1754 web

- based tool. The requirement to use electronic submissions over the internet was a 1755 concern for some commenters. 1756 1757 EPA, based on its experience collecting and managing the 2006 IUR reports, has 1758
concluded that mandatory electronic reporting is a critical next step for collection of the 1759

2011 201 2 data. Optional electronic reporting for the 2006 IUR provided the Agency with 1760
experience relating to both industry and Agency needs, and the Agency has applied this 1761
experience in the course of developing of th e 2011 201 2 electronic reporting tool (e

1762
IURweb). For example, t he use of a web

- based solution tool for the 2011 201 2 IUR will 1763
eliminate many of the software compatibility and firewall setting issues that were 1764
encountered during the 2006 submission period. In addition, the 2011 e

- I URweb utilizes 1765
other Agency systems, such as SRS, enabling the submitter to readily select the chemical 1766
identity in the correct format, thereby eliminating problems relating to the previous need 1767
to type or write in the chemical name. With these enhancemen ts, EPA believes the use of 1768

e

- IURweb will substantially reduce error rates and burden; consequently, EPA does not 1769
believe it is necessary to have another optional electronic reporting period. 1770

1771 In addition, the Agency‘s CDX service is increasingly being used by a variety of 1772
programs, as the Agency moves toward comprehensive electronic reporting. EPA is 1773
continually looking for ways to improve CDX, to better address submitter and Agency 1774*** Interagency EO 12866 Review Draft

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80 needs. For example, the EPA has developed an eTSCA registration for CDX which
, 1775
when fully implemented, will eliminate the need to register separately for eIUR to use the 1776

e

- IURweb and ePMN . For the 2011 eIUR, systems

. ePMN registrations using the 1777

current eTSCA are will be acceptable eIUR e

- IURweb registrations. 1778

1779 The Agency believes that commenters‘ concerns regarding mandatory use of the 1780 new electronic reporting tool reflect a lack of understanding of the tool‘s capabilities and 1781 enhancements. The reporting tool provides the ability to submit data in an XML format 1782 and includes enhancements to CDX that are designed to a llow for multi

- user capabilities 1783 and otherwise facilitate electronic reporting. EPA has provided training opportunities and 1784 guidance materials to facilitate electronic reporting, as well as product testing 1785 opportunities, to alleviate particular commenters‘ concern s. 1786 1787 For example, the Agency held an informational workshop and webinar in on 1788

November 30, 2010. The workshop was designed to help companies develop a better 1789
understanding of the CDX registration process and the e

- IURweb electronic reporting 1790

tool. In early January, 2011, EPA provided The worksho p, which was recorded live as a 1791
webinar, was posted to the IUR website at http://www.epa.gov/iur along with 1792
accompanying slides, a question and answer document, and a draft XML schema
, 1793
allowing com panies to ensure their internal systems will be able to directly upload data to 1794

the e

- IURweb

. In addition, EPA invited plans to invite several companies to test e

1795

IURweb . EPA invited each company to identify areas where it believed ne eding 1796
improvements

. The comments and concerns o f industry representatives will be taken int o 1797
consideration as EPA further develops the reporting tool could be improved. A recording 1798
of the workshop, summary questions and answers, the final schema, and additional 1799
webinar training that provides detailed instructions of using the reporting tool are 1800

available on the IUR website, www.epa. gov/IUR . In 2011, EPA

. EPA also intends to 1801
hold further training and outreach sessions at which industry rep resentatives may express 1802*** Interagency EO 12866 Review Draft

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81 remaining questions and concerns regarding the operation of the e

- IURweb software tool
, 1803

which EPA will address

. Additionally, EPA has publish ed a revised Instructions 1804

document (Ref. 7 ) explain ing the reporting requirements and how to compl ete Form U 1805
using the reporting tool

. 1806

1807 Electronic reporting was first offered as an option for the 2006 IUR. As 1808
explained in the preamble to the proposed rule and the Responses to Comments 1809
document, there were many problems, errors, and delays associated wi th paper 1810
submissions of the 2006 IUR data, which make the continued use of paper reporting 1811
highly inefficient and therefore undesirable. In light of the substantial disadvantages 1812
associated with allowing paper submissions, and the reporting tool improveme nts and 1813
training opportunities outlined in this unit (and explained in greater detail in the proposed 1814
rule and the Responses to Comments document) EPA does not believe it is reasonable to 1815
phase in electronic reporting over another reporting period and is c onfident that 1816
submitters will be able to successfully use the e

- IURweb tool to electronically report 1817

under the IUR rule in 2011 201 2

. 1818

1819 2. Comments on registering with CDX and providing electronic signatures. 1820
Commenters thought the modified Electronic Signature Authority Form, in particular the 1821
need for multiple notarized signatures, was burdensome and unnecessary. Commenters 1822
stated that there should be more than one individual with an electronic signature and that 1823
multiple persons may need to be able to input and submit IUR data for a company‘s U.S. 1824
sites. The commenters noted that the actual preparer/drafter would rarely be the 1825*** Interagency EO 12866 Review Draft

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82 signatory. Another respondent noted that companies should be allowed, but not required, 1826

to have the same authorized official for the P MN and IUR submission. 1827

1828 EPA understands and is cognizant of the concerns presented by industry regarding 1829
the revised Electronic Signature form. An electronic signature agreement is required for 1830
CDX registration and is necessary t o submit electronic data to EPA. Regarding the prior 1831
need for multiple notarized signatures, EPA has determined that requiring a notarized 1832
signature as part of the electronic signature agreement is no longer necessary. EPA is also 1833
exploring an approach to eliminate the need for an individual to register multiple times 1834
with CDX to submit to various TSCA programs. As with PMN electronic submissions, 1835
multiple people from the same site or company are able to register with CDX and 1836
participate in completing the site‘s Form U. Although o ne individual will be designated 1837
as an authorized official who will sign and submit the completed Form U, the e

- IURweb 1838
tool allows for more than one individual to edit a submission. Ultimately, EPA‘s goal is 1839
to provide one electronic signature agreement a cross all TSCA programs and is exploring 1840

the reuse of e

- electronic signatures issued under the e

- PMN New Chemicals program , as 1841
well as other EPA programs

. Regarding notarized signatures, EPA has determined that 1842
requiring a notarized signature as part of the electronic signature agreement is no longer 1843

necessary

. 1844

1845 C. Comments on Reporting Thresholds 1846

1847 1. Method for determining whether you must report. EPA proposed to modi fy the 1848 method used to determine whether a person is subject to IUR reporting. The new method 1849 requires persons to report under the IUR if they manufactured (including imported) 1850 25,000 lb

. or more of a chemical substance at any single site in any calendar yea r since 1851 the last principal reporting year , (note . This method becomes effective after the 201 2 IUR 1852*** Interagency EO 12866 Review Draft

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83 submission period. (Note : there is no also a lowered production volume threshold for 1853 certain chemicals, see chemical substances, effective after the 2012 IUR submission 1854 period. See 40 CFR 711.8(b )). This method becomes effective after the 2011 IUR 1855 submission period. 1856 1857 ).) Several commenters believed the change is appropriate and should be 1858
implemented for the 2015 reporting cycle. submission period following the upcoming 1859
submission period (i.e., in the submission period following the proposed 2011 submission 1860
period)

. They noted that the new requirement is essential to effectively capture the 1861
substantial year

- to

– year fluctuation in production/import volumes that was missed in past 1862
IUR reporting cycles, thereby skewing the picture of how many and which 1863

chemicals chemical s ubstance s are actua lly in commerce at a given time and what levels 1864
of production or import. One commenter went further to say that the modification would 1865
eliminate gaps and uncertainties in the information collected under the current IUR that 1866
result from infrequent collectio ns and reporting of data. Another said that this will keep 1867
manufacturers from disguising their actual output by producing certain specialty 1868

chemicals chemical s ubstance s only in years that are not currently subject to IUR 1869
reporting. Two commenters supported the chan ge but opposed the proposal to delay 1870
implementation until after the 2015 reporting cycle proposed 201 1 submission period
, 1871

because it would further delay the ability to obtain accurate annual production 1872

information. 1873

1874 In contrast, others had mixed opinions or did not think the ch ange was needed. 1875 Some commenters felt that unless the value of collecting and analyzing 1876 retroactive historical data could be clearly demonstrated such that the resource for the 1877 Agency and regulatory community can be justified, EPA should retain the mechanism 1878 whereby t he need to report is based on consideration of a single reporting year and 1879 current threshold

. Some commenters stated that EPA had not shown special utility for the 1880 information generated. Another commenter believes that there is no significant 1881*** Interagency EO 12866 Review Draft

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84 incremental benefit to require repo rting from companies that produce or import less than 1882 25,000 lb

. of a reportable chemical substance for four out of five years. 1883 1884 The Agency realizes that the new multi

- year consideration of production volume 1885
will increase reporting burden on industry, but be lieves that there is sufficient evidence 1886
that wide fluctuations in production volumes from year to year indicate the past IUR 1887
reporting was not accurately characterizing the chemical production. As EPA noted in the 1888
proposed rule preamble
, production volumes of chem ical substances vacillating above 1889
and below reporting thresholds in different IUR reporting periods resulted in a change of 1890
approximately 30% in the composition of the chemicals chemical s ubstance s being 1891
reported from one IUR reporting period to the next. For examp le, EPA prepared a 1892
prioritization document for the Butenedioic Acid Dialkyl Esters Cluster, which consists 1893
of 10 butenedioic acid dialkyl esters, seven of which were MPVs and three HPVs in 2006 1894

(Ref. 15 19 ). Three of the chemicals chemical s ubstance s have had fluctuat ing production 1895
volumes above and below one million pounds. In 1990 and 1994 when the HPV 1896
Challenge program was being developed, the CASRNs 68921

- 51

- 7, 141

- 05

- 9, and 624

- 1897

48

- 6 had production volumes below one million pounds and so were not included in the 1898
HPV Challenge for completion of SIDS datasets. In 1998 and 2006, CASRN 68921

- 51

- 1899
7‘s production volumes have been above one million pounds, making it an HPV in those 1900
years. In 2002, CASRNs 141

- 05

- 9 and 624

- 48

- 6 had production volumes above one 1901
million pou nds. In part because of their fluctuating production volumes, neither SIDS 1902
datasets nor consistent exposure and use information were available for these 1903

chemicals chemical s ubstance s and so they were included in a cluster for an HBP as 1904
opposed to an RBP. One commen ter also submitted an analysis of the degree of 1905

fluctuation of chemicals chemical s ubstance s and production volumes in the 2002 and 1906*** Interagency EO 12866 Review Draft

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85 2006 IUR reporting years. This analysis found that about 32% of the organic 1907

chemicals chemical s ubstance s reported in 2002, including 400 HPVs, were not reported 1908

for 2006 and that about 26% of the chemicals chemical s ubstance s reported in 2006, 1909
including more than 200 organic HPVs, were not reported in 2002. 1910

1911 In addition, in comments submitted to the Agency in response to other programs, 1912
industry representa tives expressed concern that short reporting determination periods 1913
would drastically misrepresent the chemical substances that currently are in commerce. 1914
They stated they manufactured or imported some chemical substances only occasionally, 1915

and that these chemical substances would not be captured if the reporting covered too 1916
short a period. The proposed rule preamble provides a more detailed discussion of these 1917

comments ( see 75 FR 49664 Ref. 1 ). 1918

1919 EPA believes that most sites will be able to gather production volume information 1920

wit hout a substantial effort. In many instances, production volumes for recent past years 1921
are tracked under standard business practices. For example, EPA believes it is standard 1922
business practice for a company to furnish records of recent operations in the case of a 1923
proposed sale or merger, and that companies therefore typically retain such records so as 1924
to be prepared for such eventualities. EPA also notes that in the case that prior years‘ 1925
production volume information is not known to or reasonably ascert ainable by the 1926
submitter (EPA expects that such cases would be extremely rare), those data would not 1927
be subject to reporting under the IUR and therefore would not trigger an obligation to 1928

report Furthermore, persons who have submitted a PMN to the Agency‘ s New 1929
Chemicals program are required to maintain records of production volume for the first 3 1930*** Interagency EO 12866 Review Draft

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86 years of production or import, including but not limited to the names, addresses of any 1931
person to whom the chemical substance is distributed ( info includes any d istributed) . 1932
They must be maintained for 5 years from the date of commencement of manufacture or 1933
import (See 720.78). EPA expects that many companies would also track production 1934
volumes for planning, marketing, and sales projection purposes. Several TSCA 1935
regulations, such as 5(a)(2) SNURs and 5(e) orders also require that production volume 1936
records be kept for five years for certain chemicals chemical s ubstance s , and several 1937
commenters indicated that they archived these records. 1938

1939 2. Elimination of the 300,000 lb

. t hreshold. The Agency received a substantial 1940 number of comments on the proposed elimination of the 300,000 lb

. threshold for 1941 reporting processing and use information. Comments submitted on various topics are 1942 described in this unit. 1943 1944

a. Increased numbers of co vered chemical substances. Commenters asserted that 1945
the influx of inorganic chemicals chemical s ubstance s , coupled with the threshold change 1946
for processing and use information, will result in a substantial increase in the amount of 1947
data being submitted to the Agenc y. Commenters felt that EPA staff will need significant 1948
time to compile, review, and analyze the data submitted. One commenter suggested the 1949
Agency use a phased

- in approach to adequately collect and process the increased 1950

information. 1951

1952 In response to these comments and comments received during interagency review, 1953

EPA decided to phase in the eventual elimination of the 300,000 lb threshold as a 1954
separate reporting threshold. For the 2012 submission period , all submitters of non

1955

excluded chemical substances ar e required to report processing and use information if 1956
they manufactured (including imported) 100,000 lb or more of a chemical substance in 1957*** Interagency EO 12866 Review Draft

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87 2011. For subsequent submission periods , the reporting threshold for processing and use 1958

information will be the sam e as for other types of information: 25, 000 lb (or 2,500 lb. for 1959
chemicals subject to 40 CFR 711.8(b))

. Thus, there will be no separate threshold for the 1960
reporting of production and use information after 2012

— the applicable reporting 1961

threshold will be th e same as for other types of information. EPA believes this is a 1962
reasonable approach because it provides new submitters with an opportunity to become 1963
familiar with the reporting requirements, and provides much needed processing and use 1964

information on addi tional chemical substances. Future full reporting of exposure

- related 1965
information will provide EPA and others with needed additional information for those 1966
chemical substances with production volumes of 25,000 lb or more at a site. While it is 1967

true that th e amount of data in the IUR reports is expected to increase substantially in the 1968

2011 201 2 and subsequent reporting years submission periods
, EPA is better prepared now 1969
than it was for the 2006 IUR to compile, review, and analyze the anticipated increase of 1970

data. With the new e

- IURweb electronic tool, large amounts of data will be able to be 1971
submitted with less difficulty on the part of the submitter, and will be more readily 1972
organized, analyzed, and made available to the public by the Agency. In addition, the use 1973

of SRS for identifying chemical substances and validation process built into the e

1974
IURweb tool will eliminate most or all of the problems EPA had with missing 1975
information (which necessitated phone calls and emails to submitters), and manual entry 1976

of data, which was t ime

- consuming and resulted in many mistakes. Given the 1977
requirement for mandatory electronic submissions and the corresponding improvements 1978

to the e

- IURweb tool, the Agency is confident that the increase in data submissions will 1979*** Interagency EO 12866 Review Draft

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88 be easily managed for this reporting th e 2 012 submission period and the next
, and both 1980
EPA and the public will quickly have a useable set of exposure

- related IUR data. 1981

1982 b. Reporting Burden. Numerous commenters were concerned about the increased 1983
reporting burden, particularly for smaller companies, and the complexity of IUR Form U 1984

Part III. One commenter stated that EPA should assess the benefits of the additional 1985
reporting requirements to establish a cost justification of the proposal. Other commenters 1986

were concerned that the lowered threshold woul d increase the number of imported 1987
mixtures and that it would be difficult to calculate and aggregate across products for 1988

lower volume chemicals chemical s ubstances

. 1989

1990 EPA analyzed the potential impacts of this requirement to all submitters, 1991 including potential burden to small businesses, in the Economic Analysis (Ref. 19 14 ). 1992 EPA recognizes that reducing the reporting threshold for processing and use information 1993 increases the reporting burden ; however, phasing in the lower threshold reduces the 1994 burden for this reporting cycle , but and the cost to industry will decrease in all future 1995 reporting cycles. 1996 1997 EPA disagrees with comments suggesting that the requirement may have a 1998
disproportionate effect on smaller companies (commenters suggested that smaller 1999
companies are more likely to manufacture below the 300,000 lb

. threshold that is 2000
eventually being eliminated.) The quantity of a chemical substance that is manufactured 2001
(including imported) at a site is not necessarily dependent on the number of employees, 2002
which is the criteria by whi ch a company is considered to be small. For example, a highly 2003
automated facility could produce large volumes of a chemical substance with a relatively 2004
small number of employees . Additionally, as noted in the Economic Analysis, the 2005
Agency determined that be cause the small businesses affected by today‘s this final rule 2006
actually have average sales of more than $11 million, and because any potentially 2007*** Interagency EO 12866 Review Draft

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89 affected companies with sales of $ 1.02 0. 81 million or less (the level at which the cost

- to

2008

sales ratio of the final rule wo uld exceed 1%) would generally be exempt from reporting 2009
obligations under the IUR, small entities will not be significantly affected by today‘s this 2010

final amendments to the IUR rule. 2011

2012 EPA recognizes that, with the reduction and eventual elimination of the 300,000 2013

lb

. threshold, importers may face an increase in burden to identify more component 2014

chemicals chemical s ubstance s contained within more imported mixtures. However,
, EPA 2015
disagrees believes that due to the deferral of the threshold reduction until the 2012 2016
submission period (which involves reporting on the processing and use of imports 2017
occurring in 2011) and the deferral of the threshold elimination until the 2016 submission 2018
period (which includes reporting on the processing and use of imports occurring in 2015)
, 2019
importers are unprepared will have had sufficient time t o conduct a reasonable a n inquiry 2020
as to the specific chemicals chemical s ubstance s they import in mixtures. Furthermore, 2021
the inquiry need only be as extensive as a reasonable person, similarly situated, might be 2022
expected to perform. 2023
EPA has several reasons to expect that impo rters have a reasonable awareness of 2024
the component chemical substances contained within imported mixtures. Importers have 2025
long been responsible for certifying that their imported chemical substances, including 2026
those chemical substances present as part of mixtures, are in compliance with TSCA (See 2027
19 CFR 12.119). Furthermore, importers have long been required to provide chemical

- 2028
specific information as to the constituents of imported mixtures under the IUR (see the 2029
definition of ―importer‖ at 40 CFR 704.3 and the note at 40 CFR 710.4(c)(2)) and under 2030
the PMN program (40 CFR 720.30(b). Furthermore, importers are often required to 2031*** Interagency EO 12866 Review Draft

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90 report chemical

- specific information regarding imported mixtures under other EPA

2032
administered statutes, such as the Emergency Pla nning and Community Right

- To

- Know 2033

Act (EPCRA) and the Resource Conservation and Recovery Act (RCRA). RCRA. While 2034
reporting under the IUR differs in many significant respects from reporting under the 2035
EPCRA and RCRA programs, in all cases the importer is required to know the 2036
identify identi t y of the chemical substanc es they import. EPA notes that one commenter 2037
described, in detail, its practice of accounting for component chemical substances in 2038
imported mixtures. The commenter stated that ―[w]ith the advent of the [ R egistration, 2039

E valuation, A uthoris ation and Restrict ion of Ch emical s ] REACH we recently 2040
implemented an application that is capable of tracking volumes of individual substances 2041
in mixtures and summing them up over a period of time. The system automatically looks 2042
at the current formulation of any product that is crossing a border and adds the volume of 2043
each component to the cumulative total for that substance‖ (Ref. 18). EPA expects that 2044
the burden associated with reporting these chemicals will decline in reporting periods 2045
subsequent to 2011, as additional recordkeeping procedures are put into practice. 2 0 )

. 2046
Finally, EPA notes that a chemical substance that is imported solely in small quantities 2047
for research and development, as an impurity, as par t of an article, or in certain other 2048
forms, see 40 CFR 720.30(g) and (h), is not subject to the IUR reporting requirements. 2049

See 40 CFR 711.10. 2050

2051

c. Justification for data. Several commenters strongly supported EPA‘s proposed 2052 change, stating that the inform ation is essential for the completion of prioritizations for 2053 IUR reportable chemical substances; is critical for evaluating the potential for release of 2054 and exposure to chemicals chemical s ubstance s in commerce; and that the information 2055 requested is basic, screening

- level data that should be required for all reported 2056 chemicals. chemical s ubstance s. Additional commenters generally supported the 2057 cha nges change
, but wanted the change it to take effect after the 2011 reporting cycle. 2058*** Interagency EO 12866 Review Draft

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91 Other commenters had concerns about the value of the information th at is reported in Part 2059 III. One commenter stated that EPA has not made public documentation of the past use of 2060 this information to address screening and prioritization of chemicals. chemical s ubstance s. 2061 Another commenter believes that EPA should provide more specific ity on its needs and 2062 explain why other, more tailored, options do not provide the necessary data. 2063 2064 EPA‘s information needs have changed since the last major amendment of the 2065
IUR rule in 2003. Production volume changes from year to year, so chemicals chemical 2066

s ubstan ce s can easily fluctuate above and below a relatively high reporting threshold, 2067
such as the previous 300,000 lb

. threshold for reporting processing and use, making it 2068
difficult for EPA to collect regular exposure information on many chemicals. chemical 2069

s ubstance s. Re quiring the reporting of processing and use information on an expanded 2070

list of chemicals chemical s ubstance s will assist the Agency and others in screening 2071
potential exposures and risks resulting from industrial chemical substance operations and 2072

commercial and consu mer uses of chemical substances. The information will also help to 2073
provide an accurate and readily available source of, as noted in Unit V.A.1, basic 2074

exposure

- related information for a subset of chemicals chemical s ubstance s listed on the 2075
TSCA Inventory. Furthermore , collection of this data is consistent with the 2076
Administrator‘s strong commitment to provide the public with more information on a 2077
greater number of chemicals. chemical s ubstances

. 2078

2079 As mentio ned in the preamble of the proposed rule and as explained in Units 2080
V.A.3 and V.A.4 herein, the data reported in 2006 did not provide an adequate amount of 2081

exposure

- related information, especially for HPV chemicals. As EPA discusses below and 2082
elsewhere, the 2006 IUR information did not provide suffi cient useable exposure

- related 2083
data for EPA‘s screening level assessments. If EPA delay ed reducing the processing and 2084

use re porting threshold until the 2016 submission period , EPA w ould have to wait several 2085*** Interagency EO 12866 Review Draft

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9 2 more years before more useful exposure

- related i nformation is received for chemical 2086

s ubstances for which EPA has already determined are currently in need of such 2087

information. With the phased

- in approach, EPA will be able to collect much needed 2088
processing and use information on additional chemical substa nces during the 2012 2089
submission period

. Requiring full reporting for all chemical substances in subsequent 2090

r eporting cycl es (i.e., eliminating the separate, higher, threshold for production and use 2091

information) provides EPA with the exposure

- related inform ation needed to continue 2092
efforts begun with the 2012 data. For example , the data reported in 2006 did not provide 2093
an adequate amount of exposure

- related information, especially for HPV chemical 2094

s ubstance s. When attempting to use the 2006 IUR data for its s creening level exposure 2095

assessments, EPA found that numerous chemicals chemical s ubstance s previously 2096
identified as HPVs were reported in amounts classifying them as MPV 2097

chemicals chemical s ubstance s , below the 300,000 lb

. cut off, and thus processing and use 2098

information was n ot provided for chemicals chemical s ubstance s for which EPA had a 2099
relatively complete hazard data set from the HPV Challenge. For example, an RBP was 2100
prepared for the Chlorobenzenes Category, which consisted of four chlorobenzenes 2101
sponsored under the HPV Challenge ( Ref. 18 2 1 )

. Only one of the four substances, 1,3

- 2102

dichloro benzene (CASRN 541

- 73

- 1), was considered high priority; however, because it 2103

was an MPV chemical s ubstance in 2006, no exposure and use data was available from 2104
the IUR reporting, so the high priority d etermination was based on high human health 2105
hazard and assumptions made about exposure. 2106

2107 The 2006 IUR data did not provide sufficient information on moderate production 2108 volume ( MPV ) chemicals chemical s ubstances for use by the Agency‘s Existing 2109 Chemicals Program. Screening chemical substance r isks generally requires a combination 2110*** Interagency EO 12866 Review Draft

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93 of both hazard and exposure information. Because most MPV chemicals chemical 2111

s ubstance s were produced below the 300,000 lb

. reporting threshold, EPA did not have 2112 exposure information available from the 2006 IUR and therefore, dev eloped hazard based 2113 prioritizations which were supported by a screening level hazard characterization and 2114 consideration of very limited exposure and use data. The lack of information on exposure 2115 and use was especially problematic in those instances where t he screening level hazard 2116 characterization identified either a medium or high hazard. Basic hazard data is easier 2117 to find in existing databases; however, specific exposure data is needed to make a priority 2118 determination risk

- based. EPA believes that the lower lower ing of the reporting threshold 2119 will provide more exposure

- related information on a greater number of MPV chemicals. 2120 2121 chemical s ubstance s. EPA disagrees with the comment that it has not made public 2122 documentation of the past use of processing and use information to address screening and 2123 prioritization of chemi cals. chemical s ubstance s. As discussed above in Unit V.A.3, EPA 2124 used 2006 IUR data starting in 2007 in its development of RBPs and HBPs which it has 2125 made available on its website. More recently, the Existing Chemicals Pr ogram used the 2126 IUR database when developing the Chemical Action Plans. For some Action Plan 2127 chemicals chemical s ubstance s , the 2006 IUR data were not sufficiently complete to be 2128 useful. An example is the Action Plan for Dyes Derived from Benzidine and Its 2129 Congene rs, where the chemical substances of concern are known or reasonably 2130 anticipated human carcinogens; however, those listed were produced in amounts below 2131 the 300,000 lb

. threshold and so little exposure data was reported. Based on IUR data 2132 from prior report ing periods, some of the other dyes had been reported in the 10,000 to 2133 25,000 lb

. range, but there was no 2006 IUR data available to determine whether these 2134 chemicals chemical s ubstance s were still being used in amounts beyond the small 2135 amounts used as analytical rea gents. The Action Plans are available on EPA‘s web site at 2136 http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html

. 2137 2138 By lowering the reporting threshold for proces sing and use information to 25,000 2139

lb in 201 6
, EPA is increasing consistency for the IUR with reporting requirements of the 2140
TRI program. Under the TRI program, chemicals chemical s ubstance s that are not 2141

chemicals chemical s ubstance s of special concern listed at 40 CFR section 372.28 (e.g., 2142
mercury, lead) are required to be reported if they are manufactured or processed in 2143

volumes of 25,000 lb

. or more annually or otherwise used in volumes of 10,000 lb

. or 2144
more annually. Though the chemicals chemical s ubstance s on the TRI toxic chemical 2145

su bstance list may be different from those reported under the IUR, an analysis showed 2146
that over 80 percent of the sites that reported under the 2006 IUR also reported under TRI 2147*** Interagency EO 12866 Review Draft

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94 in 2006. Given that there is some overlap in the companies that report and the 2148

in formation collected on activities and uses of chemicals chemical s ubstance s under both 2149
programs, EPA believes that many companies are already accustomed to reporting on 2150

lower volume chemicals chemical s ubstances

. 2151

2152 d. Lack of data for chemical substances. Several commenters no ted that the 2010 2153 reporting year will be over by the time the rule is finalized, and companies would not 2154 have had the opportunity to establish systems for collecting the information for 2155 chemicals chemical s ubstance s in the 25,000 to 300,000 lb

. range. Other commenter s 2156 asserted that EPA was seeking data that are limited or unavailable because manufacturers 2157 do not know how their chemicals are used by their customers downstream from the 2158 manufacturing customers use their chemical s ubstance s . Another commenter asserted that 2159 the lowered threshold will not enhance the quality or integ rity of the resulting IUR data 2160 due to uncertainties in making estimates. 2161 2162 EPA recognizes that submitters may not always have detailed information about 2163 how the chemical substance (s) they manufacture (including import) are used. As a result, 2164 submitters will be required only to report this information to the extent that it is known or 2165 can be reasonably ascertained. Based on its experience with the New Chemicals Program, 2166 discussions with industry about voluntary risk management programs, and industry‘s 2167 various self

- regulation initiatives, the Agency believes that most submitters have at least 2168 some basic information about downstream uses, such as the information that is required 2169 by the IUR rule. 2170 2171 EPA acknowledges that the final rule will be published shortly before the start of 2172
the submission period. EPA does not anticipate that the quality of the data collected in 2173

2011 201 2 will significantly decrease due to the timing of the amendment to the reporting 2174

threshold. Many As mentioned earlier , EPA published a final rule (Ref. 6 ) to suspend the 2175
2011 submission period to provide sufficient time for companies to comply with the 2176
upda ted IUR reporting requirements. This final rule is published in advance of the 2012 2177
submission period, which is February 1, 2012 to June 30, 2012. For these reason s , 2178
companies should have the opportunity to establish systems fo r collecting the information 2179

on their reportable chemical substances. Furthermore, m any of the reporting elements are 2180*** Interagency EO 12866 Review Draft

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95 the same as in past IUR reporting periods, and EPA notes that the rule affords sufficient 2181
flexibility to account for those circumstances in which information is truly unknown and 2182
not reasonably ascertainable. The Agency believes that the data will be of sufficient 2183
reliability for use by the Agency and others for purposes such as screening

- level risk 2184
assessments and prioritization. 2185

2186 3 . Eliminate 25,000 lb

. threshold for selected specific regulated chemical 2187

substances. EPA proposed to eliminate the 25,000 lb

. reporting threshold for certain 2188
chemical substances subject to particular TSCA rules and/or orders and to require 2189
manufacturers (including importers) of such chemical substances to r eport under the IUR, 2190
regardless of the production volume. Comments submitted on various topics are 2191

described in this unit. 2192

2193

a. Burden. One commenter stated that companies not expecting this significant 2194
change will be unprepared to gather required informati on. Several commenters expressed 2195
the view that the requirement will increase the burden upon industry without any real 2196

benefit to the environment and will create a situation where manufacturers (including 2197
importers) are responsible for knowing all byproduc ts of their process, no matter how 2198
small. Others felt that enacting this requirement without a de minimis concentration 2199
threshold would add an unnecessary additional layer of complexity to IUR analysis and 2200
would result in each reporting entity responsible for a far greater number of Form U 2201

submittals. 2202

2203 The Agency believes it is unlikely that recordkeeping practices were not already 2204 in place for companies to track the volumes of the chemicals they are manufacturing. 2205 EPA analyzed the potential impacts of this requirement to submitters a nd recognizes that 2206*** Interagency EO 12866 Review Draft

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96 eliminating the 25,000 lb threshold for these substances increases the reporting burden 2207 (see the Economic Analysis). However, the burden of reporting will be ameliorated by 2208 the use of electronic reporting. 2209 2210 The Agency believes it is likely that recordkeeping practices were already in place 2211

for a compan y to track the volumes of the chemical s ubstance s it is manufacturing 2212
(including importing)

. In response to co mmenters, EPA decided to take two steps to limit 2213
the burden increase associated with IUR reporting for the specific regulated chemical 2214

substances. As a result, EPA is reducing the reporting threshold for these chemical 2215

substances to 2,500 lb , instead of en tirely eliminating the reporting threshold. In 2216
addition, EPA is phasing in this chang e to the IUR: it will not affect IUR submissions 2217
until the 2016 submission period (i.e., it applies to the submission in 2016, of records of 2218
production occurring between 2012 and 2015)

. EPA believes this should help to reduce 2219
the reporting burden for submitters because it provides sufficient time for companies to 2220
put in place recordkeeping procedures to collect and report the required data for 2221

situations where the recordke eping procedures do not already exist

. The burden of 2222
reporting will also be greatly diminished by the use of the reporting tool. The Economic 2223
Analysis contains EPA‘s analysis of the burden associat ed with this reporting (Ref. 14 )

. 2224
EPA disagrees that the i ncreased burden will not yield any real benefit and agrees 2225

with the commenters who supported eliminating the 25,000 pound threshold for certain 2226

TSCA

- subject chemicals so that more useful information would be received benefit s

. 2227
Chemical substances that are the subject of particular TSCA rules and/or orders are of 2228
demonstrated high interest to the Agency. Receipt of up

- to

- date exposure and use 2229

information on these chemicals, regardless of production volume chemical s ubsta nces , 2230
produced at 2,500 lb or more
, will help EPA as it develops risk management strategies 2231*** Interagency EO 12866 Review Draft

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97 for those chemicals chemical s ubstance s subject to proposed rules. Additionally, EPA 2232

will use the 2016 IUR data as it monitors chemical substance production and compliance 2233

w ith the rules. The new requirement will also contribute to the Administrator‘s 2234
commitment to increase the availability of chemical information to the public. EPA 2235
expects instances when the required information is not known or reasonably ascertainable 2236
will decline substantially in reporting cycles subsequent to 2011, as additional 2237
recordkeeping procedures are put int o practice. substance information to the public. 2238

2239 b. Imports and Mixtures. Commenters thought this requirement will be difficult to 2240 meet in practice, particularly for imported chemicals chemical s ubstance s or mixtures. 2241 One commenter felt the requirement would create a needle

- in

- a

- haystack situation in 2242 which a company would need to examine all chemicals chemical s ubstance s and/or 2243 mixtures imported, regardless of the concentration of the chemical s ubstance or volume 2244 of the import. Other commenters believed that importers would have great difficulty 2245 knowing that low

- concentration ingredients are present in formulated mixtures, especially 2246 when they are not subjec t to inclusion on a label or Material Safety Data Sheets (MSDS). 2247 2248 EPA recognizes that eliminating the 25,000 lb

. reporting threshold may, in some 2249
instances, make it more difficult for importers to determine the production information 2250
for component chemical su bstances in imported products. However, the IUR incorporates 2251
Consequently, the reporting threshold will be 2,500 lb, instead of zero, and will be phased 2252

in to begin with the 2016 IUR . T he IUR also inc ludes a number of exemptions that 2253

address the ―needle

- in

- a

- haystack‖ concern expressed by the commenter. IUR reporting 2254
is not required for a chemical substance that is imported solely in small quantities for 2255
research and development, as an impurity, as part of an article, or in certain other forms. 2256
See 40 CFR 711.10, 40 CFR 720.30(g) and ( h). Furthermore, for the reasons discussed in 2257

Unit II.D.5., companies should be accustomed to reporting chemical

- specific information 2258
to EPA because the Agency has always sought information on individual chemical 2259*** Interagency EO 12866 Review Draft

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98 substances in mixtures under the IUR and PMN programs. Similar to the requirement to 2260
report processing and use information for lower volume chemicals (see Unit E.5.b), EPA 2261
believes that instances where this information is not known or reasonably ascertainable 2262
will decline substantially for reporting periods subsequent to 2011 as additiona l 2263
recordkeeping procedures are established. TSCA regulations. For example , TSCA section 2264
13 requires chemical importers to certify that the chemical substance or mixture it is 2265
importing is not being imported in violation of TSCA; an importer must, therefore, have 2266
knowledge of the regulatory status of the chemical substances it is importing. I f an 2267
importer does not know, or can‘t reasonably ascertain that a particular chemical 2268

substance is present in a mixture, it is not required to report the chemical substance . If an 2269
MSDS makes no mention of the presence of an ingredient, and the importer doe s not 2270
otherwise know that the ingredient is present, EPA would generally agree that the 2271
importer does not know, and cannot reasonably ascertain that it is importing that 2272
ingredient. Therefore, no IUR report for that ingredient would be required. In additio n, 2273
manufacturers (including importers ) are not required to report impurities. 2274

2275 I f an importer does not know and cannot reasonably ascertain that a particular 2276

chemical s ubstance is present in a n imported mixture, it is not required to report the 2277

chemical su bstance under the IUR

. Importers of mixtures with constituents of 2278
proprietary or othe rwise unknown chemical identity should ask the supplier for the 2279
chemical identity to help determine whether an IUR report must be completed. If an 2280
importer knows that it is importing a particular chemical substance above the relevant 2281
threshold, but does not know the chemical identity because the supplier is unwilling to 2282
share the chemical identity with the importer, it is sufficient for the importer to follow the 2283*** Interagency EO 12866 Review Draft

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99 procedure s in 40 CFR 711.15(b)(3)(i)(A), requesting that the foreign supplier provide the 2284
chemical identity directly to EPA in a joint submission

. 2285
The IUR reporting related to mixtures and UVCB substances (chemical 2286
substances that are of Unknown or Variable composi tion, Complex reaction products, or 2287
Biological materials) requires careful consideration by submitters. Whenever a submitter 2288
has manufactured or imported a combination of several chemical s ubstances , the 2289
submitter must first determine whether for TSCA pur poses it is a mixture or a single 2290

UVCB chemical substance. A mixture is any combination of chemical s ubstances that 2291
meets the statutory definition of ―mixture‖ at TSCA section 3(8) . Mixtures are not 2292
reported to IUR

– rather the mixture's component chemic al substance s, the chemical 2293

substance s that make it up, are potentially subject to reporting, as described below . A 2294

UVCB substance is an indefinite combination of chemicals , that does not meet the 2295
statutory definition of ―mixture‖ at TSCA section 3(8), wh ose number and individual 2296
identities and/or composition are not precisely or completely known. A UVCB 2297

combination of chemical s ubstances is subject to reporting under IUR and is considered a 2298
single chemical substance

. Generally, the determination of whet her a combination of 2299

chemical s ubstances is a mixture or a UVCB substance is made by the time that chemical 2300
substance has been commercialized and, as such, would be clear early in the IUR process. 2301
The following discussion is presented with this generality in mind. 2302

If you imported a mixture, you will need to report the individual chemical 2303
components of the mixture to the extent that your total volume for the individual 2304
chemical substance triggers reporting (i.e., generally to the extent that such 2305

volume rea ches the 25,000 lb threshold). 2306*** Interagency EO 12866 Review Draft

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100 If you domestically manufactured a mixture, you will need to determine whether 2307
any chemical substances were formed from a chemical reaction that occurred as 2308
part of manufacturing the mixture. If a chemical reaction has occur red, a chemical 2309
substance formed from the chemical reaction may be subject to reporting, based 2310
on its production volume or the applicability of other exemptions. If a chemical 2311
reaction has not occurred, you have not manufactured any reportable chemical 2312

sub stances in the production of the mixture. In such a case, the production of the 2313
mixture has not triggered any IUR reporting requirement. 2314

Domestic manufacturers and importers should also consider whether the 2315

combination of chemical s they have domestically manufactured or imported 2316
(respectively) should be chemically identified for TSCA purposes as a single 2317

UVCB chemical substance instead of a mixture. 2318
EPA has developed two Inventory nomenclature guidance documents related to 2319

the mixture

- UVCB determination t itled: (1) Toxic Substances Control Act Inventory 2320
Representation For Chemical Substances Of Unknown Or Variable Composition, 2321
Complex Reaction Products And Biological Materials: UVCB Substances a vailable on

2322

line at: http://www.epa.gov/oppt/newchems/pubs/uvcb.txt ; (2) Toxic Substances Control 2323
Act Inventory Representation For Combinations Of Two Or More Substan ces: Complex 2324

Reaction Products a vailable on

- line at: 2325
http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt

. 2326

c . List of subject chemical substances. Commenters suggested that EPA provide 2327

an up

- to

- date list of the chemical substances impacted at the beginning of the information 2328

collec tion year to ensure more accurate and complete reporting. EPA provides just such a 2329*** Interagency EO 12866 Review Draft

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101 list. It is titled ―Chemical Substances that are the Subject of Certain TSCA Orders, 2330
Proposed or Final TSCA Rules, or Relief Granted under Civil Actions .‖ ‖ It can be found 2331

i n Appendix C B of the Instructions f or Reporting Guidance Document. d ocument (Ref. 2332

7)

. The pertinent chemicals are listed both by CASRNs (for non

- confidential chemical 2333
substances) or by Accession Numbers (for confidential substances) that are the subject of 2334

a rule. This document, which wil l be updated for the 2011 IUR reporting, is available in 2335

the docket for this final rule and on EPA‘s IUR website at www.epa.gov/iur . This list is 2336
intended to be a helpful information resource, but it is not legally determinative of the 2337
status of any partic ular chemical substance. 2338

2339 d. Reporting for chemicals chemical substance s subject to a proposed rule. Some 2340 commenters supported EPA‘s suggestion to eliminate the 25,000 lb

. threshold for certain 2341 chemical substances that are the subject of a rule proposed under TSCA s ection 5(a)(2), 2342 5(b)(4), or 6. Another commenter believed it was inappropriate to impose expanded 2343 reporting requirements on substances subject to proposed rules which might not be 2344 finalized. 2345 2346 The Agency generally agrees with the commenters who stated that if 2347

chemicals chemical substance s that would typically be exempted from reporting are 2348
subject of a rule proposed under TSCA Section 5(a)(2), 5(b)(4) or 6, the reporting 2349

threshold should be eliminated and the chemicals chemical substance s should be reported 2350
despite the lower volumes produced. However, as discussed elsewhere in Unit IV.C.3, 2351
EPA has decided to reduce the reporting threshold for these chemical substances to 2,500 2352
lb, instead of entirely eliminating the reporting threshold. In addition, EPA is phasing in 2353
this change to the IUR: it will not affect IUR submissions until the 2016 submission 2354
period. 2355*** Interagency EO 12866 Review Draft

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102 The Agency disagrees with the commenter who argued that the elimination 2356

of

change to the 25,000 lb reporting threshold at (at 40 CFR 711.8(b)
, promulgated under 2357

TSCA § 8(a)) should not be triggered by the mere issuance of a proposed rul e for a 2358
chemical. The latter commenter suggested that it would be inappropriate to collect more 2359

detailed information on such a chemical s ubstance until the proposed rule had been fully 2360
vetted and analyzed, noting that finalization can often take a number o f years. However, 2361
EPA believes that the issuance of one of the proposed rules described above represents an 2362
appropriate circumstance to trigger enhanced information collection under the IUR. 2363
EPA issues a proposed rule under TSCA sections 5, or 6 only aft er making proposed 2364
findings that a chemical substance or some specified use of a chemical substance presents 2365

some level of concern. Precisely because the regulatory status of the chemical s ubstance 2366
would be under analysis and because there might be an opp ortunity for a fuller IUR 2367
dataset to help inform that analysis and the development of risk management actions, 2368
EPA believes it is appropriate for the elimination reduction of the 25,000 lb reporting 2369
threshold to be triggered at rule proposal. Furthermore, those chemicals chemic al 2370

substance s that are the subject of a rule proposed under sections 5(a)(2), 5(b)(4), or 6 are 2371
of demonstrated high interest to the Agency. In an effort to better understand the extent 2372
of manufacture, use, and potential exposure to such chemicals chemical s ubstanc e s , EPA 2373
believes it is appropriate to eliminate reduce the 25,000 lb

. threshold for and require 2374
reporting on their manufacture these chemical substances during the 2016 reporting cycle 2375
if they are manufactured (including imported) in volumes of 2,500 lb or more

. 2376

2377

e. De minimis threshold vo lume. EPA asked for comment on whether a de 2378

minimis production volume threshold should be set for these chemical substances. 2379*** Interagency EO 12866 Review Draft

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103 Some Several commenters opposed setting a new supported the concept of a de minimis 2380

threshold

. Other , although one of the commenters suggested a variety of methods for 2381
establishing a de minimis threshold. Specifically, one commenter recomme nded indicated 2382

that EPA set a it would be diffi cult to choose an appropriate level to decrease the 2383
reporting burden due to the difficulty associated with definitively identifying a 2384
production volume level below which there are not chemicals of interest

. A few of these 2385
commenters supported setting a d e minimis threshold of 2,500 lb
., , as this is 10% of the 2386
25,000 lb reporting threshold and is similar to the de minimis under the European Union‘s 2387

REACH regulation‘s registration threshold of 2,200 lb regulations

. One commenter 2388
thought a de minimis volume should be set on a chemical

- by

- chemical basis for 2389
chemicals for which EPA needs specific information. Another commenter Some 2390
commenters opposed setting a de minimis threshold, either because they felt that there 2391

should be no threshold level for persistent, bioaccumulative, or toxic chemicals (PBTs). 2392
Other commenters thought the reporting threshold volume or they felt that the threshol d 2393

should be kept remain at 25,000 lb

. One commenter speci fically opposed a de minimis 2394
threshold for any persistent, bioaccumulative and toxic (PBT) chemical substances

. 2395

2396 The Agency agrees with the commenters who opposed setting a de 2397

minimis level. While a 2,500 lb. de minimis threshold level would harmonize more 2398
closely with the European REACH regulations‘ reporting threshold, the two programs are 2399
not completely analogous, e.g., REACH does not require periodic reporting. EPA 2400

also EPA agrees with some commenters who noted that a 2,500 lb threshold would 2401
provide sufficient data for the Agency to monitor production and comp liance with certain 2402
proposed or promulgated rules and/or actions. Therefore , t he Agency has decided to 2403*** Interagency EO 12866 Review Draft

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104 lower the reporting threshold to 2,500 lb
, instead of zero , beginning with the 2016 IUR

. 2404

EPA believes that, at this time, the 2,500 lb threshold is a rea sonable de minimis 2405

threshold that is low enough to help decrease the burden on submitters
, yet will provide 2406

much needed data on chemical substances of known concern to the Agency

. The reduced 2407
threshold is essential to ensuring that information is available on chemical substances that 2408
could pose health or environmental concerns at levels of production or import below the 2409

25,000 lb threshold. In the future, EPA may find it necessary to collect information on 2410

these chemical substances at a reporting threshold below the 2,500 lb threshold 2411

introduced in this action. 2412

EPA also believes that the regulated community should be sufficiently familiar 2413

with th e 2,500 lb threshold as it is similar to the threshold that is used under the EU‘s 2414
REACH regulations to submit r egistration dossiers . Under REACH, a person who 2415

manufactures or imports a chemical substance in quantities of 1 tonne (metric tonne (mt) 2416
or if converted to pounds, about 2,205 lb) or more per year within the European 2417

Economic Area ( EEA ) must register the c hemical substance (Ref. 2 2 ). 2418

EPA believes that setting a de minimis threshold on a chemical

- by

- chemical basis 2419
or special thresholds for PBTs or carcinogens would require more time and resources 2420
than are presently available. Chemicals regulated or propo sed for regulation under the 2421
rules listed in 40 CFR 711.8(b) are of demonstrated high interest to the Agency, and may 2422
present unreasonable risks at even relatively low concentrations. At this time, EPA does 2423

not have an informed basis to set a uniform de m inimis concentration (such as the 1% or 2424
0.1% concentrations suggested by the commenter) for these chemicals. However, if an 2425
importer does not know, or can‘t reasonably ascertain that a particular chemical is present 2426*** Interagency EO 12866 Review Draft

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105 in a mixture, they are not required to report it T he Agency recognizes that be cause of this 2427

de minimis threshold
, there may be some chemical substances for which the Agency will 2428

have an interest in the IUR data (e.g., for evaluating potential exposures), but for which 2429
IUR data are not reported because production volume is below 2,50 0 lb per site

. 2430

However , EPA believes the 2,500 lb threshold will be sufficient for most circumstances

. 2431
To address any future need for additional exposure

- related information respecting 2432
chemical substances with per

- site production volume below 2,500 lb, E PA may propose 2433

to amend the IUR further in the f uture, or may evaluate whether o ther action under TSCA 2434

would be appropriate

. 2435

2436 D. Comments on Specific Data Elements 2437

2438 1 . Parent company and site identity. 1

. Parent company and site identity. Two 2439
comments were received in support of using th e co mpany name, address, and D&B 2440

n umber for reporting purposes, and clarifying the meaning of "company name." 2441
Respecting the clarification, o ne commenter suggested that the word ―ultimate‖ be 2442
removed from the phrase ―ultimate domestic parent company‖ and tha t instead 2443
companies should be allowed to name their domestic company, as is understood within 2444
their particular corporate organization. The commenter also noted that the intended 2445
clarification was not reflected in the actual regulatory text at proposed 40 C FR 2446
711.15(b)(2)(i), which only referred to "parent company name." 2447
During the 2006 submission period, submitters indicated that further clarification 2448
was needed to identify the correct company name for reporting purposes. Based on these 2449
previous comments, EPA has determined that the parent company‘s name, address, and 2450*** Interagency EO 12866 Review Draft

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106 Dun and Bradstreet Number D & B n umber is necessary to provide clarity as to which 2451
company name to use for reporting under the IUR. This EPA agrees that further 2452
specification of "company name" is appropriate, and that the ap propriate name for 2453
reporting requirement, at 40 CFR 711.15(b)( 2)(ii), should be clearly identified in the rule, 2454
but disagrees that "domestic parent company name" is sufficiently specifi c. As noted in 2455

the proposed rule (Ref. 1), EPA believes that using an approach that is consistent with the 2456

TRI reporting requirements would be most clear both for reporters and users of the data. 2457
EPA is therefore amending 40 CFR 711.15(b)(2)(i) to refer to "U.S. parent company 2458

name" and defining "U.S. parent company," at 40 CFR 711.3, to mean "the highest level 2459
company, located in the United States, that directly owns at least 50 percent of the voting 2460
stock of the manufacturer." The IUR definition of "U.S. parent company name" is 2461
consistent with the use of the term of "parent company" in Section 5 of the 2009 Tox ic 2462

Chemical Release Inventory (TRI) requirements for parent company name and it will 2463
help to better identify reporting sites that are under the same parent company. Reporting 2464

Forms and Instructions (Ref. 15 ). EPA provides further clarification regarding the 2465
correct domestic (U.S.) parent company name in the ― Instructions for 2011 Inventory 2466
Update Reporting document (Ref. 5 7 ). 2467

2468 2 . Technical contact. EPA requested comment on requiring that the technical 2469
contact be a person knowledgeable about the reported chemical substance and be located 2470
at the manufacturing (including importing) site. Several commenters stated that 2471
companies should be able to use their discretion in identif ying the most appropriate 2472
contact or contacts. They believe that the technical contact need not be physically located 2473
at the reporting site, and that information may be more reasonably generated by a 2474*** Interagency EO 12866 Review Draft

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107 corporate contact rather than a technical contact at the production site. Some commenters 2475
said that the technical contact should be an employee of the submitting company. 2476

2477 EPA agrees with commenters who stated that companies should use their 2478
discretion in selecting a technical contact or multiple technical conta cts, as permitted by 2479

the new e

- IURweb software tool

. However, EPA believes that a technical contact must be 2480

someone who can answer detailed follow

- up questions that EPA may have regarding the 2481
submission. EPA has found that technical contacts not at the reporting site generally are 2482
less knowledgeable about the submission or chemical substance and therefore may not be 2483

able to discuss follow

- up questions. Also, it has been EPA's general experience that 2484

short

- term contractors have not been suitable technical contacts, because they may no 2485
longer be under contract with the submitting company when EPA contacts them a year or 2486

more after the submission is made. 2487

2488 3 . Correct chemical name. 2489

2490

a. Comments on imported chemicals chemical s ubstance s and joint submissions. 2491

EPA received sever al comments regarding its proposal to require that importers ensure 2492
that their supplier completes the joint reporting of the CA Index Name currently used to 2493
list the chemical substance on the TSCA Inventory. The comments indicated that it would 2494

be difficul t for an importer to require that another party complete a joint submission 2495
because foreign suppliers are not subject to the same Federal regulations as U.S. 2496
companies, compliance with U.S. regulations is not their top priority, and in some cases 2497
they are slow to comply. 2498

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108 EPA agrees with the commenters that its proposed joint submission procedures 2500
for importers, which required the importer to ensure that a foreign supplier prepared a 2501
secondary submission on its behalf, presented implementation difficulties . This is 2502
because, as the commenters suggested, the foreign supplier may not be subject to any 2503
direct legal obligation to provide the information to EPA. The Agency also notes that 2504
this issue extends to the regulations at 40 CFR 711.15(b)(3)(i)(B), as th ere may be 2505
circumstances in which the manufacture of a chemical substance is reportable under the 2506
IUR, yet the supplier of a reactant used in manufacturing that chemical substance would 2507
not have an independent legal obligation to report the chemical identi ty of the reactant 2508

under the IUR. 2509

2510 Therefore, the Agency has modified the regulatory requirements at 40 CFR 2511
711.15(b)(3)(i) to reflect the primary submitter‘s underlying obligation to provide what it 2512
knows or can reasonably ascertain respecting the identit y of a chemical substance subject 2513
to reporting. The joint submission requirement is no longer to ensure that suppliers 2514
provide secondary submissions to EPA, but to properly ask that they do so. Consistent 2515
with 40 CFR 711.15(b)(3)(i), a request for a seco ndary submission to EPA must be 2516
prepared using e

- IURweb, include instructions for electronically submitting the 2517
information to EPA, and explain how to provide a clear reference to the primary 2518
submission. Documentation of the request to the supplier must b e submitted to EPA 2519
along with the rest of the primary submission. 2520

2521 Finally, EPA has also modified the regulatory requirements to more clearly 2522

reflect, see proposal at 75 FR 49666, propos ed rule (Ref. 1)
, that they only apply in cases 2523*** Interagency EO 12866 Review Draft

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109 where a supplier will not reveal the pertinent chemical identity information to the 2524
submitter. In the event that a manufacturer (including importer) actually knows the 2525
chemical identity of a chemical substance subject to IUR reporting, the manufacturer 2526
must provide that information irrespective of a supplier‘s confidentiality claims. EPA 2527
has modified the substantiation question at 40 CFR 711.30(b)(1)(i) to include information 2528
about harm to the submitter‘s competitive position ―or to your supplier‘s competitive 2529
position.‖ 2530

2531 b. Comments on reporting ( International Union of Pure and Applied Chemistry) 2532

IUPAC names as an alternate . A commenter recommended allowing IUPAC names as a 2533

substitute for CA Index Names for discrete chemicals chemical s ubstance s , because the 2534
IUPAC nomenclature provides the exact chemical structure and because the commenter 2535
was concerned that submitters would be required to go through a particular fee

- based 2536

service to obtain CA Index Names for chemicals. chemical s ubstances

. 2537

2538 The Agency disagrees that IUPAC names should be allowed as a substitute for 2539

C A Index Names in reporting discrete chemicals chemical s ubstance s for the IUR. 2540

Chemicals Chemical s ubstances are listed on the TSCA Inventory using CA Index 2541
Names, and only c hemicals chemical s ubstance s listed on the TSCA Inventory are to be 2542
reported for IUR. The requirement for usin g CA Index names is directly related to 2543
positively identifying the listed TSCA Inventory chemical substance. Using a different 2544
nomenclature for the purposes of reporting for IUR could create confusion, both for 2545
Industry i ndustry and for EPA. 2546

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110 Additionally, there will generally be no need for submitters to use a fee

- based 2548
service to obtain the CA Index Name and corresponding CASRN for IUR reporting 2549
purposes. As part of the electronic reporting process for the IUR, submitters will be able 2550
to easily connect electro nically from the IUR reporting software tool directly to the 2551
Agency's SRS database in order to obtain CA Index Names and corresponding CASRNs 2552

for all of their non

- confidential chemical substances on the TSCA Inventory. These data 2553
can then be electronically copied back to the IUR reporting tool. 2554

2555 4 . Chemical Identifying Number . Some commenters were opposed to removing 2556
the PMN number as an allowed identifying number, suggesting that the Agency might be 2557
inundated with requests for Accession Numbers, and that for his torical products, this may 2558
pose an extra burden for both industry and EPA. It was suggested that the Agency 2559
provide a cross

- reference list of PMN numbers to Accession Numbers so that the 2560
information can be easily obtained without additional burden on indu stry and the Agency. 2561

2562 The Agency has added PMN numbers to the SRS listing to provide a cross

2563
reference list, as suggested by the commenters. The e

- IURweb reporting tool allows the 2564
user to search SRS using the PMN number in order to populate the IUR report with the 2565
pertinent chemical identification information for confidential chemical substances listed 2566

on the TSCA Inventory. 2567

2568 There are certain circumstances where a submitter occasionally may not be sure 2569
of the particular PMN case number and Accession Number the Agency has assigned to 2570
one of its confidential substances, such that the submitter would not be able to definitely 2571
determine this solely from searching in the SRS. This could happen, for example, if the 2572*** Interagency EO 12866 Review Draft

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111 chemical substance were originally reported as part of a consolidated PMN and the 2573
submitter did not learn from EPA which particular case number in the consolidated PMN 2574
number sequence corresponds to which of the several reported confidential substances. 2575
This could also happen if a certain PMN represen ted a mixture of two or more 2576
confidential substances, such that multiple Accession Numbers were assigned to the 2577
different substances reported in that single PMN, and the submitter didn't already request 2578
the particular Accession Numbers from EPA for the ind ividual chemical substances 2579
comprising that multi

- component type of PMN. In such circumstances, a submitter 2580
should contact EPA in writing, well before initiating IUR reporting, to obtain the required 2581
Accession Numbers from the Agency. The Agency will res pond to such inquiries in as 2582
timely a manner as possible. It is the responsibility of the submitter to contact the EPA 2583
for such information in sufficient time to allow for the Agency to respond. 2584

2585 5 . Production volume 2586

2587

a . Report production volume for each y ear. EPA requested comment on the 2588
requirement to report production volume for each of the five years since the last IUR 2589
principal reporting year. Comments submitted on various topics are described in this unit. 2590

2591 i. Insufficient time to collect data . Most c ommenters stated that companies were 2592
prepared to compile and report the required information for the 2010 reporting year; 2593
some companies indicated, however, that they had not established systems to collect and 2594
compile information for 2006

- 2009. Several com menters recommended that EPA delay 2595
the implementation of the reporting requirement until the next reporting cycle to allow 2596
companies sufficient time to prepare for the additional data collection effort. One 2597*** Interagency EO 12866 Review Draft

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112 commenter was concerned that the short period of time given by EPA to collect the 2598
information will result in significantly decreased data quality and reliability. Another 2599
commenter said that most companies archive data after 18

- 24 months. Some found it 2600
confusing that the threshold to determine the need to report in the 2015 cycle one 2601
submission period would change to include production data from previous years, but that 2602
the reporting of production data from previous years would take effect in the 2011 2603
cycle. an earlier submission period

. 2604

2605 EPA acknowledges that there will be submitters for whom certain information for 2606 2006 to 2009 will not be known or reasonably ascertainable. However, EPA believes it is 2607 unlikely that normal business practices would not include tracking the volumes of the 2608 chemicals a company was manufacturing, at least for a few years. In many instances, 2609 production volumes for recent past months and years are tracked under standard business 2610 practices. For example, seve ral TSCA regulations, such as 5(a)(2) SNURs and 5(e) 2611 orders, require that production volume records be kept for five years for certain 2612 chemicals, and several commenters indicated that they archived these records. EPA does 2613 not anticipate that the quality o f the data reported will decrease because of the new 2614 reporting requirement, particularly for the data elements that are not new. EPA believes 2615 that the data will be of sufficient reliability for use by the Agency and others for purposes 2616 such as screening

- le vel risk assessments and prioritization. To the extent that required 2617 information is indeed not known or reasonably ascertainable, EPA expects such 2618 circumstances to be less frequent in reporting periods subsequent to 2011, as additional 2619 recordkeeping proce dures are put into practice. 2620 2621 EPA acknowledges the possibility that certai n information respecting past 2622
production volume , for the years between 2006 and 2009
, might not be known or 2623
reasonably ascertainable to a submitter in 2012 . While submitters are free to designate as 2624

―not known or reasonably ascertainable ‖ any information that has indeed passed out of 2625
the scope of reporting due to the passage of time, EPA has determined it is nevertheless 2626
appropriate to reduce the extent to which submitters will need to resort to such 2627
designations, and to focus on more recent production. E PA believes that phas ing in the 2628*** Interagency EO 12866 Review Draft

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113 reporting of past production volumes as follows will both improve the quality of the 2629
information collected and reduce the burden of collecting it

. 2630
Based on the comments received, EPA is requiring that f or the 2012 submissi on 2631
period, manufacture r s (including importers) are required to report the total annual volume 2632
(domestically manufactured and imported volumes in pounds) of each reportable 2633
chemical substance at each site during the calendar year s 2010 and 2011 . For submiss ion 2634
periods subsequent to the 2012 submission period, the total annual volume (domestically 2635
manufactured and imported volumes in pounds) of each reportable chemical substance at 2636
each site for each complete calendar year since the last principal reporting y ear are 2637
required to be reported

. EPA believes it s decision to require the reporting of 2010 2638
production volumes in a 2012 submission period is consistent with the comments noting 2639
that companies were prepared to report 2010 data and that the Agency‘s decisio n to phase 2640
in reporting for each complete calendar year since the last principal reporting year is 2641
warranted in light of other simultaneous changes to the IUR rule which increased 2642
reporting burden. The Agency also believes the delay to report the producti on volume for 2643
each year since the last principal reporting year will give companies adequate time to 2644
establish systems to collect and compile the required information. 2645
ii. Reporting burden . Several commenters stated that the requirement is overly 2646

burdens ome, especially for chemical substance importers and manufacturers who 2647
(according to the commenters) will need to analyze all products to track the volumes of 2648
all component chemicals. Another commenter acknowledges that, while the burden of 2649
reporting the d ata for each principal reporting year was minor, the information would be 2650
of little value to the Agency. On the other hand, one commenter stated that this 2651*** Interagency EO 12866 Review Draft

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114 requirement could increase the burden by at least three fold. Another commenter said 2652

that in some ca ses, businesses have no need to capture past production volumes. One 2653
commenter asserted that many companies will consider the production volume in every 2654
year to be CBI and will take the necessary steps to request CBI coverage of this 2655

information. The comme nter acknowledged that the information will still be available to 2656
EPA for consideration, but was concerned that the burden on EPA of keeping the 2657
information confidential will increase substantially due to the potential number of CBI 2658

claims. 2659

2660 EPA‘s burden estimates represent the average burden across all sites for providing 2661
production volumes. As such, commenters should be aware that their particular 2662
circumstance may not be average and
, therefore
, the estimate may not accurately reflect 2663

their own
, individu al , circumstance. circumstances. However, because the estimate 2664
represents an average across all sites, EPA is confident that the estimate does reflect the 2665
average burden and, when taken as a whole encompasses across all sites and encompass 2666
the range of burdens faced by submitters. 2667

2668 In addition, some comments identified a misunderstanding of the reporting 2669
requirements . For example, one commenter stated that many electronics manufacturers 2670

have nev er considered themselves w ith respect to be engaged in chemical manufacturing 2671
when they recycle their spent chemicals, and therefore have not been collecting and 2672
tracking the production volume of each component chemical substance comprising their 2673
byproducts. As described elsewhere in this Unit, accounting for the manufacture of a 2674
byproduct does not necessarily entail accounting for each individual component chemical 2675*** Interagency EO 12866 Review Draft

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115 substance in the byproduct. Therefore, EPA believes See the commenter is 2676
overestimating the burden associat ed with developing production volume information

. In 2677
any event, it is not a new requirement that byproduct manufacturers are subject more 2678

detailed discussion of is sues related to the IUR

— that is an established feature of the IUR 2679
that predates the amendments being finalized byproducts in this rule. Unit F.3 of the 2680

Respons es to Comments document (Ref. 12 ). The Agency does expect that the reporting 2681
burden will decrease in reporting cycles beyond 2011 2016
, as submitters put additional 2682
recordkeeping procedures into practice. 2683
As with any data element, CBI claims should only be made when warranted. 2684
While more CBI claims may increase EPA‘s burden slightly, the Economic Analysis 2685

estimates the amendments will save EPA approximately $ 180 68 ,000 in the first 2686
reporting year and $17 5 ,000 in subsequent reporting cycles through efficiencies from 2687
electronic reporting. CBI claims on production volumes are unlikely to create any 2688
significant burden beyond what is estimated in the Economic Analysis. Inappro priate CBI 2689

claims will do
, however, prevent valuable infor mation about chemical s ubstance 2690
manufacture (including import) from becoming publicly available. 2691

2692 iii. Retroactive reporting . Several commenters expressed concerns asserting that 2693
EPA retroactively is requiring historical data and that the requirement for past production 2694
information was beyond the scope of EPA‘s TSCA authority for IUR reporting. Another 2695
commenter said it was not feasible to accurately produce this historical data for the many 2696
byproducts that companies produce and send for recycling, primar ily because 2697
manufacturers did not know they needed to have such data gathering mechanisms in 2698
place. 2699*** Interagency EO 12866 Review Draft

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116 2700 EPA disagrees with commenters‘ suggestion that requiring reporting information 2701
on past production constitutes an imposition of retroactive reporting requir ements. While 2702
the rule establishes new requirements to report production volumes from several previous 2703
years prior to the finalization of the rule, it does not alter the reporting requirements for 2704
the 2006 reporting cyc le, or any other prior reporting cycles. Neither does the final rule 2705

T h is is because the final rule does not establish a new legal requirement to have taken 2706
some particular recordkeeping action in the past. Instead, it holds submitters to a 2707
prospective standard of reasonableness. EPA acknowle dges that for the 2011 reporting 2708
period, some companies may neither know nor be able to reasonably ascertain all of the 2709
newly requested information. However, EPA does not expect such circumstances to be 2710
prevalent in 2011, and it would expects such circums tances will further decline in 2711
reporting periods subsequent to 2011, as additional recordkeeping procedures are put into 2712
practice. To the extent that a particular p iece of information about the past is indeed not 2713
known or reasonably ascertainable at the time that a person is obligated to make a 2714
submission (either because of the timing of a change in the reporting requirements or for 2715

some other reason), the submitter may simply indicate that the information is ―not known 2716
or reasonably ascertainable.‖ 2717

2718 iv. Alternate approaches

. iv. Alternate approaches

. Several com menters 2719
recommended that EPA delay the implementation of the reporting requirement until the 2720
next reporting cycle to allow companies sufficient time to prepare for the additional data 2721

collection effort. A few commenters suggested that burden would be reduced if 2722
companies reported in ranges or provided best estimates. Other commenters suggested 2723*** Interagency EO 12866 Review Draft

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117 th at reporting be limited to a subset of industries or chemicals chemical s ubstance s , based 2724

on criteria to focus on data collection and evaluation activities that are more valuable to 2725
the Agency. Examples of criteria include substances with a history of fluctuations in 2726

chemical substance manufacture and import practices or substances that are considered 2727

hazardous. With the advent of REACH, one commenter said they recently implemented 2728
an application that is capable of tracking volumes of individual substances in mixtures 2729

and summi ng them up over a period of time. 2730

2731 EPA disagrees that a delay is needed to allow submitters time to gather the 2732
information. As discussed in Unit V.B, production volumes can vary significantly over a 2733
five year reporting cycle and it is not uncommon for ch emicals to rise above or fall below 2734
the reporting threshold each reporting cycle. As some commenters pointed out, the 2735
requirement is essential to effectively capture the substantial year

- to

- year fluctuations 2736

that occur in manufactured volumes that were fou nd to be missing in past IUR reporting 2737
cycles (Ref EDF comments). EPA does not believe it practicable to provide a definitive 2738
list of chemicals with a ―known history of fluctuations.‖ EPA The Agency does not have 2739

such a list, and believes that because year to year fluctuation could be caused by such a 2740
wide variety of circumstances, including circumstances such as economic changes and 2741
manufacturing practices, that developing and maintaining such a list is not only not 2742
practicable, but confining t hat list to substances with a ―history‖ of fluctuations would not 2743
capture the industry variability that EPA is seeking. 2744

2745 EPA also disagrees that reporting production volume in ranges or estimates would 2746
provide data of comparable value. Though EPA requires some of the IUR infor mation to 2747*** Interagency EO 12866 Review Draft

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118 be reported in specified ranges, EPA sees little value in allowing submitters to report the 2748
production volumes in ranges or . Similarly, EPA sees little value in allowing submitters 2749
to provide estimates , or requiring the that do not reflect all information for only 2750

chemicals that are hazardous. known or re asonably ascertainable

. EPA believes that a 2751
higher level of confidence in data accuracy will be achieved by requiring specific 2752

numeric data

. that reflect all information known or reasonably ascertainable to the 2753

submitter. It is important to note that EPA i s interested in use and other exposure and use

2754

related data on all chemicals chemical s ubstance s that are not exempted from IUR 2755
reporting , and manufacturing exposure

- related data on partially exempted chemical 2756

s ubstances

. Especially since there is a multi

- year gap between I UR submission periods, 2757

the mere fact that a chemical substance is not known to be hazardous at this time does not 2758
mean that EPA is not interested in exposures and uses of that chemical substance . Under 2759
a contrary policy, EPA would potentially need to wait several years before obtaining the 2760
basic exposure information necessary to determine whether a hazardous chemical 2761

substance may present an unreasonable risk (since the collection of screening

- level 2762
exposure information would not be triggered until hazard d ata had been assessed). In 2763
summary, after considering the suggestions, EPA believes its decision to collect multi

2764
year production volume under starting with the 2011 2016 IUR submission period is still 2765

sound. 2766

2767 EPA disagrees with the suggestion that reporting be limit ed to a subset of 2768
industries or chemical substances. The IUR data are used extensively in the Agency‘s 2769
screening and prioritization process. As such, identifying a list of chemicals or industries 2770
prior to screening would not provide EPA with the data ne eded for its programs and 2771*** Interagency EO 12866 Review Draft

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119 defeats the purpose of collecting the data. EPA does not believe it practicable to provide 2772
a definitive list of chemical substances with a ―known history of fluctuations.‖ The 2773
Agency does not have such a list, and believes that because year to year fluctuation could 2774
be caused by such a wide variety of circumstances, including circumstances such as 2775
economic changes and manufacturing practices, that developing and maintaining such a 2776
list is not only not practicable, but confining t hat list to substances with a ―history‖ of 2777
fluctuations would not capture the industry variability that EPA is seeking. 2778
b. Volume of chemical substances used on site. One commenter stated that this 2779
data element was essential to improving accuracy and uti lity of the reported production 2780
volume and two commenters stated they thought there was no value in this data element 2781
and that the Agency should retain the site

- limited check box because, the commenters 2782
stated, it was more informative for screening

- level r isk assessment. Five commenters 2783
expressed confusion about the requirements of reporting this data element. Specific 2784
concerns included a concern about duplicative reporting for this data element and the 2785
industrial processing and use information for chemicals chemic al s ubstance s used on

- site; 2786
whether this applied to chemicals used in synthesis or also to chemicals that were 2787
repackaged; and the need to identify the amount of a chemical substance present on site 2788
during a specific time period. 2789

2790 EPA agrees with the comme nter who felt that reporting volumes of chemical 2791

s ubstance used at a site will increase the accuracy and utility of the IUR reporting 2792
information. Reporting the volume used on

- site provides valuable information related to 2793
potential exposures associated wit h the on

- site volumes, providing the Agency with better 2794
information for exposure assessments. The usefulness of this IUR data element has been 2795*** Interagency EO 12866 Review Draft

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120 demonstrated by EPA‘s use of similar data in the New Chemicals Program. PMNs for 2796

new chemical substances submitte d to EPA under TSCA section 5 require many of the 2797

same exposure

- related data elements that will be reported under the IUR. Exposure

2798
related data in PMNs include estimates of production volume, categories of use, percent 2799
production volume in the categories of use, maximum numbers of workers exposed, and 2800
concentrations and physical forms of the chemical s ubstance . EPA uses these exposure

2801
related data to generate screening

- level risk assessments for regulatory decision making 2802
under TSCA section 5. The reportin g obligation and the phrase ―site use‖ applies to all 2803
nonexempt substances produced for commercial purposes that are on the TSCA 2804

I nventory. 2805
Some of the commenters have misunderstood this data element, which provides 2806

more detailed and clearer information th an did the previous site

- limited check box. 2807
Previously, submitters checked a box to indicate that a reported chemical substance was 2808

site limited

– in other words, that it was both manufactured and used on the site. Some 2809
submitters misreported, identifyin g an imported chemical substance as site

- limited (a 2810
situation that is not possible because the imported chemical substance , by definition, is 2811
brought onto the site from outside of the U.S., and therefore is not physically 2812
manufactured and used at the repor ting site) or reporting the same substance twice, once 2813

for the volume that is site limited and once for the volume that is sent off site. Because of 2814
this confusion, EPA replaced the site

- limited check box with reporting the volume of the 2815

chemical substanc e production volume reported on the form that is used on the site. For 2816
example, if 50,000 lb

. of a substance was manufactured and used on the same site, the 2817
submitter would report 50,000 lb

. for domestically manufactured and 50,000 lb

. for the 2818*** Interagency EO 12866 Review Draft

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121 volume used on

- site. If 70,000 lb

. of a substance was manufactured, 25,000 lb

. was used 2819

on

- site and 45,000 lb

. was shipped to a different site, the submitter would report 70,000 2820

lb

. for domestically manufactured and 25,000 lb

. for the volume used on

- site. If a site 2821
importe d 30,000 lb

. and used it at the import site, the submitter would report 30,000 lb

. 2822
for imported production volume and 30,000 lb

. for the volume used on

- site. If a site 2823
imported 100,000 lb

. and shipped it to an alternate site, the submitter would report 2824

100,00 0 lb

. for imported production volume and 0 lb

. for the volume used on

- site. As 2825
these examples illustrate, the submitter is not identifying the amount of a chemical 2826

substance on

- site during a particular time period, but rather that amount of a chemical 2827

subst ance that is manufactured (including imported) and used at the same site. 2828

2829 Commenters also asked for clarification regarding the activities considered to be 2830
―used at the reporting site.‖ For a domestically manufactured substance, if the volume 2831

would have b een considered to be site

- limited, then the chemical substance is used on 2832

site. If the chemical substance is domestically manufactured, temporarily stored, and 2833
then packaged for shipment off of the site, that volume would not be considered ―used at 2834

the re porting site.‖ For an imported substance, any use at the importing site (e.g. 2835
consumed in a reaction or crosslinked or cured in an article) would be considered ―used 2836
at the reporting site.‖ 2837

2838 EPA does not believe reporting the portion of the production volu me that is both 2839
manufactured and used on site will result in duplicative reporting. Even with the 2840
previous site

- limited check box, submitters provided information about the use of a 2841

chemical substance in both the manufacturing and industrial processing an d use sections 2842*** Interagency EO 12866 Review Draft

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122 of the IUR Form U. The information reported under the manufacturing section identifies 2843
that this substance is processed or used at that particular site and reports the number of 2844

workers associated with the manufacture of that substance. In the same report, the 2845
information reported under the industrial processing and use section provides more 2846

details about how the chemical substance is processed or use and, in the event that a 2847
substance has a use identified by the same combination of use, fu nction, and NAICS code 2848
by another site, the production volumes, sites, and workers would be combined with the 2849
information describing the other sites‘ processing or uses. 2850

2851 c. Report volume exported. The majority of the comments against reporting the 2852

volume d irectly exported stated that capturing the volumes for each chemical substance 2853
in each exported product was difficult and burdensome. These comments indicated a 2854
misunderstanding of the reporting requirement, and EPA believes that a better 2855
understanding wi ll eliminate those concerns. For the chemical substance that was 2856
manufactured and is being reported, the submitter is to report the volume of that chemical 2857
substance that is directly exported. If the chemical substance is processed in any way 2858
(e.g., combi ned with other substances to form a mixture), the chemical substance is not 2859
directly exported. Also, if a chemical is sent to a distributor who then exports it, the 2860
chemical is not directly exported. In both of these examples, the manufacturer would 2861

inst ead report either the processing to form a mixture or the transfer to a distributor under 2862
the processing and use portion of the IUR reporting form. ―Directly Exported‖ and 2863
―Domestically Processed or Used‖ are mutually exclusive designations; only one 2864
desig nation applies to any particular portion of the production volume. 2865

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123 6 . Identify whether a chemical substance is to be recycled, remanufactured, 2867
reprocessed, reused or reworked. EPA received several comments on the proposal to add 2868
a checkbox indicating whet her a manufactured chemical substance was or is expected to 2869
be recycled, including remanufactured, reprocessed, reused, or reworked. Some 2870
commenters were supportive of adding this reporting element, but several of the 2871

commenters were concerned that the te rm ―recycle‖ has been difficult to define in other 2872
programs, indicated confusion about EPA‘s purpose in including the checkbox, and 2873
expressed doubt that this data element would yield useful information. 2874

2875 EPA intends that this checkbox would be used by man ufacturers to indicate 2876
whether a chemical substance they manufactured, such as a byproduct, which might 2877
otherwise be disposed of as waste, was or is expected to be recycled. EPA also included 2878
the terms remanufactured, reprocessed, reused, or reworked, int ending to capture a broad 2879
array of similar, and perhaps synonymous, activities by which a substance (that would 2880
otherwise be disposed of as waste) may be put to use. EPA is interested in the exposures 2881
from these activities, and believes that having more in formation about which 2882

chemicals chemical s ubstance s are being recycled will help the Agency to refine future 2883
IUR reporting requirements (i.e., if EPA knows enough about exposures to a chemical 2884

substance from an on

- site recycling use, EPA could consider an exemption in the future). 2885

2886 EPA also believes that this information would help the Agency to identify where 2887
this activity is already occurring, and could be used to recognize companies, industries, 2888
and sectors that are using ―green‖ practices. This information woul d also help to identify 2889
sectors where recycling is not occurring, providing useful data to measure the 2890*** Interagency EO 12866 Review Draft

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124 effectiveness of various EPA programs, such as the Resource Conservation Challenge 2891
(RCC) Program, and informing other Agency efforts to encourage practic es that reduce 2892
waste. EPA disagrees that a precise definition of ―recycle‖ is needed to make this data 2893
element useful for the purposes that EPA has identified. Submitters should simply 2894
indicate, to the extent that they know or can reasonably ascertain, w hether the reported 2895

volume of the chemical substance that they manufactured, which would otherwise be 2896
disposed of as waste, was or is expected to be recycled, remanufactured, reprocessed, or 2897
reused, as those terms are understood by the submitter. 2898

2899 One com menter indicated that many chemicals chemical s ubstance s are 2900
―reworked‖ in many industrial processes, at least at some point, so this box would be 2901
checked so often that it would provide little meaningful data. EPA agrees that the term 2902
may be interpreted and applied too broadly to provide the type of information that EPA is 2903
trying to collect, so has removed ―reworked‖ from the list of recycling synonyms. Two 2904
commenters expressed concern that revealing whether a substance they manufactured 2905
was recycled would reveal c onfidential business information. In such a situation, the 2906

submitter will be able to claim the information as confidential. Another commenter 2907
suggested that EPA collect information about recycling under a separate rule. EPA 2908
disagrees that this would be an efficient way to collect the desired information. A 2909
separate rulemaking for one ―yes or no‖ data element would be extremely inefficient and 2910
needlessly time

- consuming for both the Agency and industry, particularly when the IUR 2911
rule already provides a su itable vehicle to collect chemical substance manufacturing, 2912
processing, and use information. 2913

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125 7 . Industrial processing and use information 2915

2916

a . Industrial function categories. The Agency received several comments 2917
regarding revising the list of industrial fun ction categories for processing and use 2918
information. Some commenters were in favor of the changes and supported EPA‘s efforts 2919
to work collaboratively with Canada to align the categories. Other commenters said that 2920
this would require additional effort by t he regulated community to assign the new codes, 2921
and a clear explanation of the changes with the reporting instructions, e.g., a ―read 2922
across‖ of old and new codes, including additional definitions to ensure that activities are 2923
consistently coded across com panies. Commenters stated that providing a description for 2924
―other‖ will be challenging, may not provide useful information (e.g., due to lack of 2925
information from the downstream customers), and would require additional burden to 2926
report. One commenter felt that the list of industrial function category codes is too 2927
limited for inorganic chemicals chemical s ubstance s , and suggested that the Agency add 2928
an IFC code for ―Solid Manufacturing Materials.‖ The comment stated that such a code 2929

would alleviate the need to addre ss many industrial uses in the "other" category, thereby 2930
reducing reporting burden. 2931

2932 EPA agrees with the commenters that a table indicating the relationship between 2933

the 2006 IFC codes and the new 2011 201 2 IFC codes would be useful, along with clear 2934

definitions for each code. Such information is contained in the 2011 201 2 IUR 2935

Instructions for Reporting. d ocument (Ref 7 )

. 2936

2937 EPA also recognizes that the requirement to report a description when the 2938
submitter selects the IFC code ―Other‖ may be more burdensome than for the other IFC 2939*** Interagency EO 12866 Review Draft

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126 codes, but expects any increase to be minor. The descriptive information is essential to 2940
enable users of the data to estimate potential exposures associated with the overall 2941
processing or use of the chemical substance , of which the function is an importa nt 2942
component. The Agency‘s experience with the 2006 IUR data was that the category of 2943
―other,‖ with no further description, was insufficient for the data to be of much use. 2944

2945 EPA disagrees with the suggestion to include a ―Solid Manufacturing Materials‖ 2946

I FC code and believes such a code will not accurately describe the industrial function of 2947
the chemical substance. In addition, EPA believes the proposed list of IFC codes covers 2948
the majority of the industrial functions. This belief is based on the past exp erience of 2949
both the U.S. 2006 IUR and Canadian reporting. However, EPA does recognize that it 2950
did not collect such information for inorganic chemicals chemical s ubstance s in the past, 2951
and therefore will use the written description for ―Other‖ to help evaluate and i mprove 2952
the inclusiveness of future IFC codes, including those applicable to inorganic 2953

chemicals chemical s ubstance s

. 2954

2955 b . Industrial sectors. EPA proposed to replace the five digit NAICS code with a 2956
new code, Industrial Sector (IS), to describe the industrial setting. Some commenters 2957
were in favor of this change, noting that using code harmonized with Canadian codes 2958
would be helpful to both industry and data users. Other commenters stated that many 2959
companies have already begun the process of data collection based on the former system, 2960
which has precedent. The commenters believe NAICS codes are the classification 2961
system with which industry and regulators are most familiar, and in some cases, the IS 2962
codes are less descriptive than the NAICS codes. Commenters also asser ted that the 2963*** Interagency EO 12866 Review Draft

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127 Agency should recognize that these changes will result in increased reporting burden and 2964

time. 2965

2966 EPA disagrees with the commenters that the use of IS codes in place of the 2967
NAICS codes will present increased burden on industry. The IS codes simp ly group 2968
together similar NAICS codes while still providing the sufficient differentiation needed 2969
to differentiate overall industrial processing and use scenarios. The IS codes span the 2970
entire range of NAICS codes and can be translated from known NAICS co des. Both the 2971

e

- IURweb reporting tool and the 2011 201 2 IUR Instructions for Repo rting document 2972

(Ref. 7 ) contain cross

- walk tables for submitters to use to determine the proper IS code, 2973
based on the NAICS code information they may already have collected. 2974

2975 Information on th e Agency‘s development of the IS codes is described in the 2976
technical support document ―Inventory Update Reporting (IUR) Technical Support 2977

Document

-- Replacement of 5

- digit NAICS Codes with Industrial Sector (IS) Codes‖ 2978

( EPA

- HQ

- OPPT

- 2009

- 0187

- 0005 Ref. 16 ). In developing the IS code s, EPA considered 2979
the level of detail required for developing use and exposure scenarios, the number of 2980
2006 IUR submissions using the code, the code definition, and the level of difficulty 2981
required in reporting more detailed codes. Submissions to the 200 6 IUR reported over 2982
340 unique five

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

- code combination of 2983
processing and use (P/U) code, NAICS code, and IFC codes resulted in a large number of 2984
possible exposure scenarios that could be reported. Although not a ll of the NAICS codes 2985
are applicable to chemical substance manufacturing and processing, the 2006 IUR 2986
database has over 2,300 unique combinations of P/U, NAICS, and IFC. Many of the 2987*** Interagency EO 12866 Review Draft

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128 NAICS codes reported are from similar industries that would have similar exposure 2988

scenarios. 2989

2990 EPA agrees that the new IS codes are less descriptive than NAICS codes, but 2991
believes the reduction in specificity will not adversely affect, and will actually improve, 2992
the Agency‘s ability to use the processing and use data for screeni ng

- level purposes. The 2993
large number of unique combinations increases the difficulty and time required to sort 2994
and classify chemicals chemical s ubstance s since EPA would either need to develop 2995
exposure scenarios for each unique combination or determine which three

- c ode 2996
combinations have similar exposure scenarios and can be grouped together. By replacing 2997
the NAICS codes with the IS code, the number of potential three

- code combinations is 2998
reduced from in excess of 100,000 possible combinations to 7,920 combinations. Based 2999
on information collected from the last reporting cycle the number of combinations 3000
actually reported would be significantly less. Additionally, the IS codes will more closely 3001
align to the EU Sector of Use codes which will allow EPA to compare U.S. dat a with that 3002
collected by the European Union. 3003

3004 8 . Consumer and commercial use 3005

3006

a . Consumer and commercial product categories. Many commenters supported 3007
revising the list of consumer and commercial product categories for consumer and 3008

commercial use information . Those commenters stated that harmonizing codes with 3009
Canada, revising the product categories, and requiring descriptive information when the 3010
―other‖ category is reported are essential to improving the consumer and commercial 3011

data. The commenters stated also that these changes will provide a better understanding 3012*** Interagency EO 12866 Review Draft

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129 of how chemicals chemical s ubstance s are used in downstream products and will help 3013
facilitate consistent reporting of chemical substance use information in the United States 3014

and Canada. Other commenters wa nted more explanation as to why the categories are 3015
being revised and requested that the Agency provide more descriptive information for 3016
each product category, including a table identifying how the new categories relate to the 3017
previous categories. Some com menters stated that providing a description for the 3018
category ―other‖ will be challenging and may not provide useful information. One 3019
commenter stated that the Agency should not further complicated downstream reporting, 3020
noting that was already challenging to choose the top ten categories for substances with a 3021
large number of uses. 3022

3023 EPA appreciates the support for the harmonized consumer and commercial 3024
product categories, and agrees that the changes finalized in this rule will improve the IUR 3025

data. As descr ibed in Unit III.G.8.a., information from data collected during the 2006 3026
IUR and from Canada was used to develop a more useable listing of product categories. 3027
EPA eliminated categories for which few chemicals chemical s ubstance s were reported, 3028
added categories iden tified as needed, and eliminated overlap in categories. In addition, 3029
some categories were renamed to better match their definitions, other categories 3030
descriptors were improved, and categories were grouped to allow for easier identification. 3031

EPA believes these changes will make reporting easier for the submitter, and does not 3032
agree that these changes result in more complicated reporting. The Agency is providing 3033
more detailed descriptive information in the 2011 201 2 IUR Instructions for 3034
Reporting document (Ref. 7 ) and other guidance materials. 3035*** Interagency EO 12866 Review Draft

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130 EPA recognizes that the requirement to report a description when the submitter 3036
selects the product code ―Other‖ may be more burdensome than for the other product 3037
codes, but expects any increase to be minor. The descriptive informatio n is essential to 3038
enable users of the data to estimate potential exposures associated with the consumer or 3039

commercial use of the chemical substance . The Agency‘s experience with the 2006 IUR 3040
data was that the category of ―other,‖ with no further descripti on, was insufficient for the 3041

data to be of much use. 3042

3043 b . Designation of consumer or commercial use. Commenters had mixed 3044
viewpoints regarding the need to designate whether the indicated product category is 3045

consumer use, commercial use, or both. One commente r strongly in support of making 3046
this designation stated that such distinctions are critical to EPA‘s ability to assess 3047
exposure at even the most basic level. Others didn‘t oppose the added designation, but 3048

did ask for further clarification between consumer and commercial uses. Commenters 3049
opposing the added designation stated that they were too removed from the consumer and 3050
commercial uses to have a clear understanding of the uses at that level of distinction, 3051
especially for commodity chemicals chemical s ubstance s wit h a large number of uses. 3052
One commenter said suppliers to formulated products were less likely to know the 3053
distinction because of the confidentiality of the downstream user formulations. 3054

3055 The intent of the consumer and commercial use data element is to c learly identify 3056
the exposed populations. These two populations (i.e., consumers and commercial 3057
workers) are very different from each other, and the ability to distinguish uses between 3058
the two enables better exposure

- based screening of chemicals. chemical s ubstance s. EPA 3059*** Interagency EO 12866 Review Draft

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131 recognizes that submitters may not always have detailed information about how the 3060

chemical substance (s) they make are used and to what extent they are used. However, 3061
EPA believes a manufacturer generally has a certain awareness of the downstream uses 3062

o f chemicals chemical s ubstance s it manufactures and sells, even if it does not control its 3063
customers‘ sites, and can report this information, based on what is known to or 3064
reasonably ascertainable by the submitter. 3065

3066

c . Number of commercial workers. Commenters strong ly opposed EPA‘s 3067
proposal to require that submitters report the number of commercial workers reasonably 3068
likely to be exposed while using a product containing a reportable substance. Most 3069
commenters indicated that they do not have sufficient information ab out the work 3070
practices of eventual commercial users to estimate this number, that such information is 3071
not typically shared upstream, and that any such data EPA received would be, at best, an 3072
educated guess. It was suggested that the Agency rely on worker s tatistics from the 3073
Bureau of Labor as it conducts risk assessments, or gather additional data under a 3074
separate TSCA Section 8(a) rule. 3075

3076 EPA is requiring this information to better assess the size of the commercial 3077
population in screening risk assessments. I n the past, the Agency has used the Bureau of 3078
Labor Statistics for general workers statistics to conduct chemical

- specific risk 3079
assessments; however, these worker statistics, which are industry

- specific, overestimate 3080
the exposures associated with a chemica l substance because a chemical substance is 3081
likely to be used by only a portion of the industry. Identifying chemical

- specific worker 3082
populations for downstream activities will fill this gap for the Agency. The knowledge of 3083*** Interagency EO 12866 Review Draft

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132 a chemical‘s chemical substance ‘s uses in industry and the respective commercial 3084
population potentially affected by their uses provides the Agency a more complete 3085
picture of the potential risks associated with a chemical substance

. 3086

3087 EPA recognizes that submitters may not always have detailed inform ation about 3088

how the chemical substance (s) they manufacture are used and to what extent they are 3089
used in commercial enterprises. However, EPA believes that a manufacturer generally 3090

has a certain awareness of downstream uses of chemicals chemical s ubstance s it 3091

manufac tures and sells, even if it does not control its customers‘ sites. Based on its 3092
experience with the PMN program, many stakeholder meetings, discussions about 3093
voluntary risk management programs, and industry‘s various self

- regulation initiatives, 3094
the Agen cy believes that most submitters can report on downstream uses, including the 3095
information that would be reported under IUR, based on what is known to or reasonably 3096
ascertainable by the submitter. To reduce the burden in reporting, the IUR provides that 3097

the number of commercial workers need only be reported in ranges, and the ranges are 3098
the same as for manufacturing and industrial workers. Reporting in ranges will lessen the 3099
reporting burden when the precise number of workers for multiple end uses is not kn own. 3100
Although this may result in some uncertainty in the data reported, the chemical substance 3101
manufacturer or importer has fulfilled his obligation by providing information to the 3102
extent it is known or reasonably ascertainable. EPA believes that the data will be 3103
sufficiently reliable for the Agency and others to use for screening

- level risk assessments 3104
and prioritization. 3105

3106 E. Definitions and Clarification Requests 3107*** Interagency EO 12866 Review Draft

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133 3108 1 . Changing the reporting standard for processing and use information to 3109

“known to or reason ably ascertainable.” A number of commenters requested further 3110
clarification (beyond that offered in Section 4.0 of the Reporting Instructions ) document 3111

(Ref. 7 )) of the scope of pre

- reporting inquiry that would be required under the ―known to 3112
or reasonably ascertaina ble by‖ reporting standard. Specifically, the commenters 3113
requested further clarification of how this reporting standard would apply in the case of 3114
information reported under 40 CFR 711.15(b)(4) (―specific information related to 3115
processing and use‖). The commenters also expressed some confusion about how this 3116

standard would differ from the ― not readily obtainable ‖ standard ,‖
, previously applicable 3117
to such reporting, and whether the change of standard indicates that ―extensive file 3118
searches and customer surveys‖ would now be expected of submitters. Other commenters 3119
from the chemical industry expressed their understanding that the change in reporting 3120
standard only altered the level of diligence with which submitters must search for 3121
information within their own orga nization. They requested confirmation that, as under 3122
the ―not readily obtainable‖ standard, submitters would not be required to conduct 3123
customer surveys in order to assemble data for purposes of inventory update 3124
reporting IUR

. 3125

3126 The term ―known to or reasonably ascertainable by‖ is defined at 40 CFR 704.3. 3127
It means ―all information in a person‘s possession or control, plus all information that a 3128
reasonable person similarly situated might be expected to possess, control, or know.‖ By 3129
contrast, ―readily obtainable‖ information does not even cover all the information in a 3130
submitter‘s possession or control. As defined for the 2006 IUR, it was limited to what 3131*** Interagency EO 12866 Review Draft

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134 was known by certain ―management and supervisory employees of the submitter.‖ See 3132

68 FR 879 (2003). 3133

Under the ―known to ‖ port ion of the ―known to or reasonably ascertainable by‖ 3134

standard, a submitter must would therefore ascertain what it knows about the processing 3135

and use of a chemical substance it manufactures
, (including imports)
, without confining 3136
its inquiry solely to what is kno wn to managerial and supervisory employees

. , but would 3137
also be expected to review other information which the manufacturer (including 3138
importer) may have in its possession. In response to comments regarding the level of 3139
diligence with which submitters must s earch for information within their organization, 3140
this standard requires that submitters conduct a reasonable inquiry within the full scope 3141
of their organization (not just the information known to managerial or supervisory 3142
employees). The inquiry must would be as extensive as a reasonable person, similarly 3143
situated, might be expected to perform within the organization . Information derived from 3144
customer surveys or other customer contacts, like any other information, would be 3145

―known to or reasonably ascertainable by‖ to ‖ the submitter if it is ava ilable after a 3146
reasonably extensive reasonable inquiry

. within the organization

. The standard does not 3147
necessarily require that the manufacturer conduct an exhaustive survey of all employees. 3148

3149 EPA agrees that further clarification would be useful regarding what is 3150
―reasonably ascertainable‖ to submitters about processing and use information because 3151
this component of the reporting standard potentially may require submitters to obtain 3152
information previously unknown to them, for the purposes of reporting. This would 3153

occur circumstance could arise if a submitter knows less than that what is reasonably 3154*** Interagency EO 12866 Review Draft

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135 ascertainable to it. EPA is therefore offering the following further guidance regarding the 3155
interpretation of this term. 3156

3157 For many of the reasons identified by industry commenters (e.g., the expe nse and 3158
burden of surveying customers, and uncertainty as to the extent to which customers will 3159
respond to such surveys), EPA agrees that if particular information cannot be 3160
developed derived or reasonably estimated without conducting further customer surveys
, 3161

(i.e., without sending a comprehensive set of identical questions to multiple customers), it 3162
is generally would not be ―reasonably ascertainable‖ to the submitter . Thus there is not a 3163
need to conduct new customer surveys for purposes of the IUR . However, to the extent 3164

that customer surveys are already in the submitter‘s possession or control, and to the 3165
extent that reasonable efforts to locate or analyze those surveys may result in additional 3166
processing and use information (or reasonable estimates of such information), the 3167
information is generally ―reasonably ascertainable.‖ Also, as illustrated by the examples 3168
in Unit III.H., inquiry under the ―reasonably ascertainable‖ standard may entail inquiries 3169
outside the organization to fill gaps in the submitter‘s knowledge. Furth er examples of 3170
actions that would meet the ―known to or reasonably ascertainable by‖ reporting standard 3171
are provided in Unit III.H. 3172

3173 A number of commenters requested that EPA specify the precise degree of effort 3174 required of manufacturers if they must survey their customers to generate data for the 3175 IUR; e.g., how far down the chain of commerce must such inquiries go? How persistent 3176 must the manufacturer be in seeking such information? As described earlier, EPA does 3177 not anticipate that the IUR will generally require any degree of effort to s urvey 3178 customers. However, where surveys have already been performed, and the results are 3179 already in the submitters‘ possession or control, EPA expects that submissions will be 3180 informed by the submitters‘ reasonable efforts to identify and interpret the re sults. 3181 3182*** Interagency EO 12866 Review Draft

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136 A number of commenters objected to the ―known to or reasonably ascertainable 3183
by‖ standard on the grounds that it was subject ive or too vague to be appropriately 3184
applied to the collection of processing and use information outside of the submitter‘s 3185
direct control. Other commenters objected to the standard‘s reference to what a 3186
reasonable person similarly situated ―might‖ be exp ected to possess, control, or know. 3187
They suggested that the standard be amended to what a reasonable person ―should‖ be 3188
expected to know. 3189

3190 EPA does not agree that the ―known to or reasonably ascertainable‖ standard is 3191 subjective or excessively vague. Th e standard is set forth in EPA‘s statutory authority to 3192 collect information under Section 8(a) of TSCA, and EPA‘s definition is consistent with 3193 Congressional intent to establish an objective standard: ―The conferees intend that the 3194  ̳reasonably ascertainabl e‘ standard be an objective rather than a subjective one. Thus, 3195 the manufacturer or processor must provide information of which a reasonable person 3196 similarly situated might be expected to have knowledge .‖ ‖ (Ref. 2 3
, H.R. Rep. 94

- 1679 3197 at 80 (1976). )

. Thus, whether a particular level of diligence meets this standard does not 3198 depend on the submitter‘s subjective view of what seems a reasonable person ―should‖ be 3199 expected to know. It turns on an objective question: the level of diligence that a 3200 reasonable person, simil arly situated, might expect to undertake. EPA believes it is 3201 appropriate to define the standard consistently for all persons reporting under Section 8(a) 3202 of TSCA, and that the existing definition appropriately reflects Congressional intent. 3203 Finally, EPA does not think the standard of objective reasonableness will be unfamiliar to 3204 submitters. It is incorporated inc luded into a wide variety of legal standards under state 3205 and federal law, and in the 2006 IUR it applied to all aspects of the information collection 3206 other than processing and use information. 3207 3208

2 . Clarifications to byproduct reporting. a. Concern that new byproduct 3209
reporting requirements are being added. In general, some commenters asserted that 3210
EPA‘s explanation of the IUR byproduct

- related reporting requ irements reflect new 3211
requirements, inconsistent with current byproduct exemptions. 3212

3213 EPA is clarifying, not enlarging, the reporting requirements for byproducts, which 3214
have been in place for decades. Byproducts are defined The definitions of ― Byproduct ‖ 3215*** Interagency EO 12866 Review Draft

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137 and ―Manufacture for com mercial purpose s ‖ (referencing byproducts) at 40 CFR 704.3
, 3216
under an existing definition that has been in place since 1988. have been in place since 3217

198 3 (Ref. 24) , and have been applicable to the IUR since the IUR‘s inception in 1986 3218

(Ref. 3, 51 FR at 21447 (incorporating definitions from 40 CFR 704.3) )

. The reporting 3219
exemptions for byproducts at 40 CFR 720.30(g) and (h)) (cross referenced at 40 CFR 3220

711.10) have also been in place since 1983

. , (Ref. 25) , and have also been applicable to 3221
the IUR since the IUR‘s inception (Ref. 3, 51 FR at 21447 )

. While this final rule is 3222
modifying the applicable definition of ―manufacture,‖ the pertinent language portion of 3223

the revised definition (providing that manufacture includes ―the extraction, for 3224
commercial purposes, of a component chemical substance from a previously existing 3225

chemical substance or co mplex combination of chemical substances‖) is consolidated 3226
from materially identical in all material respects to language found in the previously 3227
applicable definition of ― manufacture‖ and ― manufacturer‖ at 40 CFR 704.3 That 3228
language

. T his specification of the scope of ―manufacture‖ has been in force
, and 3229
applicable to the for IUR
, purposes since 1988. See 51 FR at 21447 (1986 incorporation 3230

of definitions from 40 CFR 704.3 into the IUR ) (Ref. 3) and 53 FR at 51716 (1988 3231

revision to 40 CFR 704.3) (Ref. 26)

. 3232

3233 In 1983, EPA promulgated a rule that made clear (for subsequent IUR and PMN 3234 purposes) that the reporting exemption for the manufacture of byproducts is only 3235 potentially applicable to the manufacture of the byproduct and would in no case apply to 3236 the manufacture of component substances extracted from the byproduct. 40 CFR 3237 720.30(g)(3). Furthermore, it has been the Agency‘s position since at least 1991 that, in 3238 order for byproduct manufacture to qualify for the 720.30(g)(3) exemption, ―the 3239 component to be extracted must be already existing as a distinct chemical substa nce in 3240 the waste stream .‖ ‖ (Ref. 20 27 ). When the chemical substance present in the byproduct 3241 and the chemical substance extracted from the byproduct are distinct chemical 3242 substances, neither the manufacture of the byproduct nor the manufacture of the extracted 3243 chemical substance qualify for the 720.30(g)(3) exemption. 3244*** Interagency EO 12866 Review Draft

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138 3245 See also the discussion in Unit IV.2. The guidance docketed with today‘s 3246

notice this final rule
, which explains existing byproducts reporting requirements under the 3247
IUR, is consistent with past guidance issued i n connection with the IUR and TSCA new 3248
chemicals program. N ew C hemicals P rogram. For example: In a 2002 response to public 3249
comments on a previous proposed amendment to the TSCA Inventory Update Rule ( see 3250

2003 fi nal rule published at 68 FR 848, Ref. 18 Ref. 4 ), EPA explained that ―distillation, 3251
extraction, refining, and similar a ctivities may result in the manufacture of a chemical 3252

substance.‖ In a 2006 letter to the Aluminum Association, EPA described a circumstance 3253
in which the extraction of aluminum from aluminum dross byproduct constituted the 3254
reportable manufacture of alumin um, while cautioning that if the aluminum is 3255
―chemically changed during the extraction process,‖ then not only the extracted 3256
aluminum but also the dross byproduct would be reportable under the IUR (Ref. 21 28 ). 3257
In 2008, EPA provided similar guidance by lette r to IPC, another trade group (Ref. 22 29 ). 3258

3259 Due to the 2003 expansion of the IUR reporting requirements to inorganic 3260

chemicals chemical s ubstance s , many companies have recently become aware of their 3261

status as chemical substance manufacturers when they recycle their wa ste materials. 3262
Instead of disposing of those waste materials, the manufacturers return them to commerce 3263
by recycling the materials

– either themselves or through a third party. Recycling may be 3264
beneficial for many reasons: it conserves resources, may re duce the expense of 3265
purchasing new raw or starting materials, may reduce the reliance of the United States on 3266
foreign suppliers of raw materials, reduces the need for landfill or other disposal sites, 3267
and returns a waste to commerce. However, many recycli ng activities fit the TSCA and 3268*** Interagency EO 12866 Review Draft

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139 IUR rule definition of manufacture, and are likely to be considered ―manufacture for a 3269
commercial purpose.‖ EPA has finalized the draft IUR guidance documents that were 3270
published with the proposed rule. These documents inclu de examples of many common 3271
manufacturing scenarios to assist individuals in determining whether their company is 3272
manufacturing a chemical substance that needs to be reported under the IUR (Refs. 11 7 3273

and 12 30 ). 3274

3275 b. Concerns about the IUR byproduct reporting re quirements, in relation to 3276
RCRA and the Toxics Release Inventory. Some commenters asserted that byproducts 3277
should be regulated, if at all, under RCRA and/or reported under TRI, and should not 3278
subject to IUR reporting requirements. One commenter suggested that EPA revisit the 3279
entire issue of the management of recycled materials to determine the appropriate roles 3280
for the TSCA and RCRA programs. Some commenters also asserted that reporting under 3281
IUR presents a disincentive for recycling. 3282

3283 In broad terms, the purpose of TSCA sections 8 (governing the IUR) and 5 3284
(governing PMN reporting) is to understand the universe of chemicals chemical 3285

s ubstance s in commerce in the United States. (Section 5 also provides EPA with the 3286
ability to control for risks of new chemicals chemical s ubsta nce s before they are placed 3287
into commerce.) The IUR requires reporting of manufacture, processing, and use 3288

information for chemicals chemical s ubstance s in commerce, and exemptions exist for 3289
those substances or manufacturing activities for which EPA has a low curre nt interest. 3290
With limited exception, such as those included in 40 CFR 720.30, all chemical substances 3291
in commerce in the United States are to be listed on the TSCA Inventory; companies can 3292*** Interagency EO 12866 Review Draft

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140 trigger the addition of a chemical substance to the TSCA Inventory by filing a PMN and 3293
meeting certain other requirements. 3294

3295 RCRA is focused on waste

– it is concerned with the generation, transportation, 3296
treatment, storage, and disposal of hazardous wastes and the management of non

3297

hazardous solid wastes. RCRA is also focused on waste minimization, phasing out land 3298
disposal of hazardous waste, corrective action for releases, and recycling. EPA notes that 3299
while RCRA or other statutes may exempt a certain chemical substance from reporting 3300
requirements based on certain tr eatments or disposals, RCRA exemptions do in most 3301

cases are not apply relevant to TSCA reporting obligations , and, given the different 3302
purposes of RCRA reporting and the TSCA IUR rule, are not necessarily relevant to IUR 3303
reporting . It is important to note that finding a commercial use for a substance previously 3304

treated as a waste under RCRA can relieve the manufacturer of that substa nce from some 3305
RCRA requirements, but may then subject that manufacturer to TSCA reporting 3306
requirements. EPA i s aware that, in Also note that 40 CFR 720.30(g) provides IUR 3307
exemptions for certain uses of byproducts. In certain circumstances, reporting under both 3308

RCRA and TSCA m ay be required. It is As noted earlier, the Agency‘s intention to 3309
identify and address such circumstances, retaining purposes for reporting under the 3310

rule RCRA and the TSCA IUR are different, and therefore the required data sets are 3311

different. While the data sets are not duplicative, EPA recognizes that best fits Agency 3312

needs. However, there may be limited circumstances wh ere particular elements of the 3313
data sets overlap. EPA strives to reduce such overlap, while ensuring that it is important 3314

to note that the administratively feasible to collect and collate the data that are needed for 3315
TSCA purposes. The TSCA program is working continuing its work with the RCRA 3316*** Interagency EO 12866 Review Draft

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141 program

-- to maintain coordination between the two programs. It is important to note 3317

that the application of RCRA regulations varies state

- by

- state, and recent changes to 3318
RCRA regulations have not been adopted by all states. Therefore the overlap betw een 3319
RCRA reporting and IUR reporting may vary depending upon the state in which a 3320

submitter‘s site is located. 3321

3322 A similar situation exists for some sites that meet the requirements to report under 3323
both TRI and IUR. The TRI program goal is to provide c ommunities with information 3324

about toxic chemical s ubstance releases and waste management, and the TRI reporting 3325
requirements are designed to address that goal. Because the IUR program goals differ, 3326
the specific information collected under each program is not the same. Where a person 3327
must report for both for the same site, EPA and the public will have a broader picture of 3328
the exposure scenarios at that site, including environmental releases from that site; while 3329
the two information collections may be comple mentary, neither is an adequate substitute 3330

for the other. A more in

- depth discussion is provided in the Responses to Comments 3331

document (Ref. 13 12 ). 3332

3333 EPA believes that commenters‘ concern that reporting under IUR would be a 3334
disincentive to recycle reflect s certain misunderstandings of the IUR requirements. The 3335
Agency expects that revised byproduct guidance materials, as well as EPA‘s responses to 3336
the comments concerning, for instance, byproduct chemical identification requirements, 3337
will help to alleviate the majority of those concerns. EPA believes that many factors play 3338
into whether a company chooses to recycle, including the value of the recovered 3339
materials, the expense of disposal, desire to maintain or build a ―green‖ reputation, 3340*** Interagency EO 12866 Review Draft

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142 technical limitations or flexibility, state and local requirements or incentives, and the 3341
incentives offered or requirements imposed by other federal laws (such as RCRA). EPA 3342
strongly believes that the benefits of recycling usually outweigh the burden associated 3343
with IUR repo rting for these materials, and, just as with any other chemical substance 3344
whose manufacture must be reported under the IUR, production volume, worker 3345
exposure and other IUR data collected on byproduct chemicals chemical s ubstance s 3346
supports the Agency‘s mandate to pr otect human health and the environment. 3347

3348 c. Concerns about how to identify the byproduct chemical substance and with 3349
reporting both the byproduct and a substance extracted from the byproduct. 3350
Commenters stated that it is very difficult to identify the chemicals c hemical s ubstance s in 3351
a byproduct mixture, and that the mixture can vary over time, depending upon the 3352
specific manufacturing situation. Commenters also argued that there would be duplicative 3353
reporting by the byproduct manufacturer and the recycler/process or who extracted a 3354
component chemical substance from the byproduct mixture. 3355

3356 The comments reflect a misperception that characterizing the identity of complex 3357
chemical substances, as are found in or comprise many byproducts, necessarily involves a 3358

detailed a nalysis of the ―individual components of the chemical substance.‖ In reality, a 3359
byproduct may be listed in o n the TSCA Inventory as a single chemical substance that 3360
represents, for TSCA purposes, what may be a complex composition of 3361

chemicals. chemical s ubstance s. In t his way, the chemical identity of a byproduct may 3362
represent a chemical substance process stream. Complex chemical substances are listed 3363

(or can be listed) on the TSCA Inventory as chemical substances of Unknown or Variable 3364*** Interagency EO 12866 Review Draft

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143 composition, Complex reaction pr oducts and Biological materials (―UVCB‖ chemical 3365
substances). As described by the commenters, the byproduct ―mixture‖ is often complex 3366
and varies over time, making the identification of the individual components a very 3367
difficult task. This description its elf indicates that the proper identification of such a 3368
reaction product is as a UVCB chemical substance. As stated in EPA‘s on

- line guidance, 3369
―Each combination of substances resulting from a reaction is considered by the Agency 3370

to be either (1) a mixture, composed of two or more well

- defined chemical substances to 3371
be named and listed separately, or (2) a reaction product, to be listed as a single chemical 3372
substance, using one name that collectively describes the products, or, failing that, the 3373

reactants us ed to make the products . ― (see

. ‖ ( S ee 3374
http://www.epa.gov/oppt/newchems/pubs/rxnprods.txt ) Situations may exist where the 3375
byproduct substance is actually a mixture, but as further described in the aforementioned 3376
guidance, ―A combination of products resulting f rom a chemical reaction is considered a 3377
mixture provided that all of the component product substances are unambiguously 3378
identified and are represented as forming each time the reaction is run.‖ 3379

3380 UVCB chemical substances in some cases include an a TSCA Invent ory definition 3381

to further describe the chemical substance. Here is one example from EPA‘s on

- line 3382
guidance (see http://www.epa.gov/oppt/newchems/pubs/uvcb.txt ): 3383

3384 Dust, iron

- ore, sinter 3385

CASRN 69012

- 53

- 9 3386
Definition: Dust generated during the making, break ing and handling of sinter 3387
which is recovered through the use of pollution abatement equipment. 3388*** Interagency EO 12866 Review Draft

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144 3389 A byproduct manufacturer, therefore, would potentially report the UVCB name 3390
for the byproduct composition, while the subsequent recycler of the byproduct would 3391
potentially report the specific chemical identity of the chemical substance they 3392
chemically manufacture from the byproduct. EPA does not agree that such reporting is 3393
duplicative, because reporting will fall into one of following two scenarios. If the 3394

ch emical substance manufactured from the UVCB byproduct is already present as a 3395
constituent of the UVCB byproduct, then the byproduct manufacturer need not report the 3396
byproduct that is sent for such processing/recycling. If the chemical substance 3397

manufactur ed from the UVCB byproduct is distinct from any chemical substance present 3398
in the UVCB byproduct as a constituent, then the separate reporting by the byproduct 3399
manufacturer and the processor/recycler reflects a change in chemical composition. 3400
Either way, there is no duplication of reporting between the manufacturer of the UVCB 3401
byproduct and the processor/recycler. As a general matter, if there is to be appropriate 3402
stewardship of potential chemicals chemical s ubstance risks, EPA believes that chemical 3403

substance manu facturers, processors, and users should know and understand the identities 3404

of chemicals chemical s ubstance s they handle. 3405

3406 Some commenters stated that many byproduct mixtures in the metals industry are 3407
processed to recover the metal values and indicated that the metal value should be 3408
considered a component chemical substance (i.e., that if Nickel (II) hydroxide (Ni(OH) 2 ) 3409
is present in a byproduct mixture, then the elemental substance Nickel (Ni) should be 3410
considered the component chemical substance). EPA disagrees wit h this statement. (See 3411

Ref. 20 27 for a precedent from a 1991 prenotice communication.) Under TSCA, 3412*** Interagency EO 12866 Review Draft

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145 Ni(OH) 2 and elemental Ni are two different chemical substances, with separate listings 3413
on the TSCA Inventory. If the byproduct contains Ni(OH) 2 but not elem ental Ni, only 3414

Ni(OH) 2 is considered a component chemical substance of the byproduct. The 3415

manufacture of elemental Ni from either the Ni(OH) 2 – bearing byproduct (or Ni(OH) 2 3416
itself) results in a potential need to report under IUR. That is, if the extracte d component 3417

substance is an oxide and used as an intermediate to form an elemental metal, then both 3418
the oxide and elemental metal are subject to reporting by their manufacturer(s). Note that 3419
information pertaining to manufacture of a chemical substance ne ed only be reported to 3420
the extent that the information is known to or reasonably ascertainable by the submitter. 3421

3422 A second example of a metal

- containing byproduct is: 3423

3424 Electrolytes, copper

- manufg., spent 3425

CASRN 69012

- 54

- 0 3426
Definition: Spent copper sulfate electrolyte consisting of copper sulfate and 3427
sulfuric acid resulting from the electrolytic refining of copper. 3428

3429 This spent material is a UVCB chemical substance that is likely to be recycled. If 3430
the only commercial purpose for this spent material is to extract the component chemical 3431
substance copper sulfate, then the manufacture of the spent material is exempted from 3432
reporting (but the manufacture of the copper sulfate [via extraction from the byproduct] is 3433
subject to reporting). On the other hand, if t he spent material is used directly to 3434
manufacture elemental copper, then both the spent material and the elemental copper are 3435
subject to reporting under the IUR by their respective manufacturers, because elemental 3436
copper is not a component chemical substan ce in the spent material byproduct. 3437*** Interagency EO 12866 Review Draft

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146 3438 d. Concerns regarding determining when a byproduct is manufactured. 3439
Commenters stated that clarification is needed regarding purification and extraction and 3440

when a chemical substance is considered manufactured versus pur ified. Commenters 3441

asserted that where there is no change in chemical identity, only a change in purity, a 3442

chemical substance should not be considered manufactured, regardless of the method of 3443
purification. 3444

3445 Much of the commenters‘ confusion regarding the differences between 3446
purification and extraction appears to concern whether extraction or purification involves 3447
a change in chemical identity; the potential for a change in chemical identity is closely 3448
linked with the proper identification of the manufactu red substance, as described in the 3449
previous comment response. Where there is no change in chemical identity but rather 3450
just a change in purity (an impure chemical substance correctly identified for TSCA 3451
purposes as ―substance A,‖ for example, undergoing p urification to a more pure form of 3452
―substance A‖), the Agency agrees with the commenter that, for purposes of IUR, the 3453

chemical s ubstance is not being manufactured. The chemical substance that appears on 3454

the TSCA Inventory may actually represent a categor y consisting of the same chemical 3455
substance in various degrees of purity. For example, if a company manufactures a 3456
specific, discrete chemical substance at 90% purity and it is correctly identified as that 3457
discrete substance (not having a UVCB name), then increasing the purity of the chemical 3458
substance (such that it retains its chemical identity) is considered purification and, for 3459
purposes of IUR, such purification is not considered manufacture. 3460

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147 Note, however, that the extraction of component chemica l substances from certain 3462
complex byproduct mixtures or process streams (i.e., UVCB chemical substances), is not 3463
considered purification, because the complex byproduct mixture and the extracted 3464
substance do not have the same chemical identity. For example , a manufacturing process 3465
involving the use of solvent A results in the manufacture of a spent solvent. As a 3466
variable, complex mixture of solvent A, finished product, unreacted reactants, individual 3467
byproduct substances, and other impurities, the spent so lvent is considered to be a UVCB 3468

chemical substance. It is not unusual for the manufacture manufacture r to extract solvent 3469

A from this UVCB chemical substance. In such a case, the extracted solvent A is 3470
considered to be manufactured, and therefore is reportable for purposes of IUR. When 3471
the spent solvent is a byproduct whose only commercial purpose is the extraction of a 3472
component chemical substance, solvent A, the byproduct exemption at 40 CFR 720(g)(3) 3473
can be applied and the spent solvent byproduct does not need t o be reported. The 3474
extracted solvent A is nevertheless reportable for purposes of IUR. 3475

3476 3 . Definitions of Manufacture and manufacturer. EPA received several 3477
comments on the definition of ―manufacture,‖ asserting that the definition of manufacture 3478

include d in the proposed rule was inconsistent with past definitions, over

- broad, and 3479
confusing. 3480

3481 EPA disagrees, except with respect to minor typographical errors noted below. 3482
EPA consolidated existing definitions into a single ―manufacture‖ definition to reduc e 3483
confusion. EPA also added a very short clarifying definition that ―a manufacturer is a 3484
person who manufactures a chemical substance,‖ to direct the reader to the relevant 3485*** Interagency EO 12866 Review Draft

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148 language in the definition of ―manufacture,‖ and to avoid confusion with an existi ng 3486

definition of ―manufacturer‖ in 704.3. The definition of ―manufacture‖ is consistent with 3487
established regulatory and statutory definitions, and is sufficiently flexible to 3488
accommodate the actual allocation of knowledge between toll manufacturers and 3489

co ntracting companies. EPA has separately addressed the comments received relating to 3490
the extraction of component chemical substances. (See the discussion on reporting 3491
byproducts and recycling elsewhere in this Unit.) 3492

3493 The first part of the definition of m anufacture in today‘s this final rule is as 3494
follows: ―Manufacture means to manufacture, produce, or import, for commercial 3495
purposes. Manufacture includes the extraction, for commercial purposes, of a component 3496
chemical substance from a previously existing chemica l substance or complex 3497

combination of substances.‖ It is similar to the definitions of ―manufacture‖ and 3498
―manufacturer‖ used for past IUR reporting

. (Ref.3 1 )

. F or example, the definition of 3499
manufacturer in effect for the 2006 IUR reporting period is in 40 CFR 704.3: 3500
―Manufacturer means a person who imports, produces, or manufactures a chemical 3501
substance. A person who extracts a component chemical substance from a previously 3502
existing chemical substance or a complex combination of substances is a manufacture r of 3503
that component chemical substance.‖ The two similar definitions of ―manufacture‖ in 3504
effect for the 2006 IUR reporting period were found in 40 CFR 710.3 (―to manufacture, 3505
produce, or import for commercial purposes,‖ and 40 CFR 704.3 (―to manufacture f or 3506
commercial purposes‖). The Part 711 definition of ―manufacture‖ is also consistent with 3507
the established definition of ―manufacturer‖ used for purposes of PMN reporting, at 40 3508
CFR 720.3. Existing Part 704.3, which was not modified in today‘s t his final rule, a lso 3509*** Interagency EO 12866 Review Draft

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149 includes a definition of manufacture: ―Manufacture means to manufacture for 3510
commercial purposes,‖ and a definition of ―manufacture for commercial purposes‖ that 3511
makes clear that byproducts produced during manufacturer are also ―manufactured for a 3512

comme rcial purpose.‖ 3513

3514 The definition of ―manufacture‖ in today‘s t his final rule is also similar to and 3515

consistent with TSCA‘s definition of ―manufacture‖ at Section 3: ―‘manufacture‘ means 3516
to import in the customs territory of the United States, produce, or manufactu re,‖ and 3517
Section 8: (―For purposes of this section, the term ―manufacture‖ . . . mean[s] 3518
manufacture . . . for commercial purposes.‖) Finally, EPA disagrees with one 3519
commenter‘s suggestion that a new definition of ―produce‖ is necessary to clarify that 3520

pro duction involves a chemical substance that is ―chemically different‖ from the 3521
chemical substance in the starting materials. ―Chemically different‖ is itself an undefined 3522
term, so it would not bring additional clarity to a new definition of ―produce.‖ 3523

Fur thermore, the difference between one chemical substance and another (and hence, the 3524
question of whether a chemical substance is being produced) already has a basis in the 3525
statutory definition of ―chemical substance‖ at TSCA 3(2), and in the differences 3526

bet ween the entries of the TSCA Inventory. 3527

3528 The second part of the definition, as noted in the preamble to the proposed rule, 3529
adds an explanation, derived from the definition of ―manufacturer‖ in Part 720, of the 3530

conditions under which a contract manufactur er would be considered to ―manufacture,‖ 3531
and therefore be responsible for IUR reporting. Persons contracting with a toll 3532

manufacturer and toll manufacturers are now considered to be co

- joint manufacturers of 3533*** Interagency EO 12866 Review Draft

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150 what is produced at the toll manufacturer‘s site. Co nsistent with 40 CFR 711.22(c), such 3534
parties should coordinate amongst themselves to submit a single report, rather than 3535
duplicative individual reports, respecting what they have co

- manufactured. The joint 3536

submission mechanism, under 40 CFR 711.15(b)(3)(i ), is not available to co

- joint 3537
manufacturers. The joint submission mechanism addresses distinct circumstances: those 3538
in which one party is the manufacturer/importer, and a second party (not a manufacturer 3539
of the chemical substance in question) possesses confid ential information needed to 3540
determine the chemical identity of what the first party has manufactured/imported. In the 3541

final rule, EPA uses the term ―co

- manufactured‖ rather than the proposed term ―jointly 3542
manufactured.‖ This change of terminology is int ended to avoid confusion between the 3543
reporting provisions at 40 CFR 711.22(c) and those at 40 CFR 711.15(b)(3)(i). 3544

3545 EPA notes that one change to the definition of ―manufacture‖ was made to correct 3546
a typographical error in the definition as proposed and to a ddress a comment that the 3547
definition used confusing syntax. The word ―and‖ should have been included between 3548
the paragraphs numbered (1) and (2), and the text should have been formatted 3549
differently, The word s ―and‖ and ―then‖ were added to make clear that the conditions in 3550
paragraph (1), and the conditions in paragraph (2) (up to the comma), must both be 3551

satisfied before a chemical substance will be considered ―co

- manufactured‖ by the 3552
producing manufacturer (i.e., the toll manufacturer) and the person contracting for such 3553
production (i.e., the contracting company). 3554

3555 Several commenters suggested that the toll manufacturer should be primarily or 3556
solely responsible for IUR reporting, or expressed concern that the rule would compel 3557*** Interagency EO 12866 Review Draft

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151 contracting companies to submit information on behalf of toll manufacturers. Another 3558
commenter supported the assignment of responsibility as proposed. Some commenters 3559
also suggested that EPA should ―acknowledge the complexity of contractual mechanisms 3560
and not offer a blanket,  ̳one size fits all‘ requirement for reporting responsibilities.‖ 3561

3562 EPA agrees that a diversity of contractual arrangements may exist, and notes th at 3563
there was nothing in the proposed IUR rule to prevent toll and contracting manufacturers 3564
from sharing information and agreeing between themselves that one or the other will 3565
undertake all or a portion of the work associated with IUR reporting for a given che mical 3566

substance , though comments indicated that there was some confusion caused by EPA‘s 3567
assignment of ―primary‖ responsibility for reporting to the contracting manufacturer (see 3568
40 CFR 711.22(c)). EPA expects that in most instances, a person that contrac ts with a 3569
toll manufacturer will generally know more about the particular chemical substances, and 3570
will usually be a better position to report on industrial processing and use of a chemical 3571
substance, and on commercial and consumer uses of products contain ing the chemical 3572
substance. Similarly, EPA expects that the toll manufacturer will generally be in a better 3573
position to report on the number of workers and other information about their plant. In 3574
light of the contracting company‘s control over the ―total amount produced and the basic 3575
technology for the plant process,‖ and based on EPA‘s expectations of the relative 3576
knowledge of the contracting company, EPA initially indicated, in proposed section 3577
711.22(c), that the contracting company would be ―primarily responsible‖ for IUR 3578
reporting. However, given the confusion introduced by indicating that one party or the 3579
other is ―primarily‖ responsible for reporting, and not wishing to interfere in contractual 3580
agreements to the contrary, EPA has decided not to all ocate ―primary‖ responsibility to 3581*** Interagency EO 12866 Review Draft

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152 either party in the final rule. Conforming changes have been made to section 711.22(c) 3582
in this final rule. However, the enforceability of the rule requires EPA to specify the 3583
persons who are legally responsible for repor ting. In fairness, EPA has chosen to make 3584
both parties responsible for reporting on the chemical substances they have co

3585
manufactured, as specified in the proposed rule. 3586

3587 4 . Definition of Site. Several commenters asserted that the proposed revision to 3588
the definition of ―site‖ would force different companies that are at the same site to report 3589
together. EPA disagrees with this assertion. In the proposal propos ed rule
, EPA added 3590
explanations to accommodate manufacturing under contract and for portable 3591

manufactur ing units, and clarified that an importer‘s site must be a US address. The 3592
definition of site used in the past, at 40 CFR 710.3, was not otherwise significantly 3593
changed. The old definition states that ―Site means a contiguous property unit. Property 3594

div ided only by a public right

- of

- way will be considered one site. There may be more 3595
than one manufacturing plant on a single site. ...‖ This portion of the definition was 3596
retained, with slight wording change (―More than one plant may be located on a singl e 3597
site.‖), in the proposed rule. 3598

3599 The statement ―More than one plant may be located on a single site‖ is meant to 3600
guide companies that have multiple plants at one site to sum production volumes and 3601

other IUR

- reportable data across all of their plants at o ne site and produce one report for 3602
each reportable substance at each site (not at each plant). The definition does not require 3603
different companies located at the same site to report together. 3604

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153 5 . Processing and use

- related definitions. EPA received commen ts in favor of the 3606

amended definitions for commercial and consumer use. However, a commenter indicated 3607

that the definitions of "industrial," "commercial," "function," and "use," were unclear and 3608
referred to problems in reporting both product

- and substance

- level information. EPA 3609
appreciates the support for the amending the terms commercial and consumer use to 3610
harmonize the definitions developed by the U.S. and Canada. 3611

3612 EPA feels the terms industrial and commercial are adequately defined. To clarify, 3613

EPA def

ines industrial function as ―the intended physical or chemical characteristic for 3614
which a chemical substance or mixture is consumed as a reactant; incorporated into a 3615
formulation, mixture, reaction product, or article; repackaged; or used.‖ This definition 3616

can be found in the document ―IUR Modifications Rule: Development of Definitions for 3617

40 CFR 711.3 ‖, which is located in EPA IUR docket (EPA

- HQ

- OPPT

- 2009

- 0187

- 0032) 3618
and will be part of the proposed regulation changes. ‖ ( Ref. 8)

. EPA also notes that the 3619
terms ―use‖, ―industrial use,‖ ―consumer use,‖ and ―commercial use‖ have already been 3620
in use for IUR and were previously defined i n 40 CFR Part 710.43 (relocated in 3621
today‘s t his final rule to 711.3). 3622

3623 F. Confidential Business Information 3624

3625 1 . Release of information not validly claimed as CBI. The Agency received 3626
comments about the proposed change to make information claimed as CBI available to 3627
the public without further notice to the submitter, in the circumstance that the required 3628
substantiation is not submitted with the claim. Opponents of the change are concerned 3629
that a reporting error could result in public release of legitimate CBI. They s uggested 3630*** Interagency EO 12866 Review Draft

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154 notifying the submitter if further substantiation is needed prior to releasing data to the 3631
public. The commenters are in favor of a warning system that would allow submitters 3632
time to provide additional substantiation on CBI claims before the Agen cy determines the 3633

data is non

- CBI and releases it as public information. 3634

3635 There are three situations during which the Agency will release IUR information 3636

claimed as CBI without further notice to the submitter. First is the circumstance that a 3637

CBI claim is made for the identity of a chemical substance already listed on the non

3638
confidential portion of the Master Inventory File. Any such CBI claims were invalid 3639
under the previous IUR regulations (applicable to the 2006 and earlier submission 3640
periods). 3641

3642 The s econd is the circumstance that a submission lacks the certification required 3643
under 40 CFR 711.15(b)(1). 40 CFR 711.15(b)(1) requires a certification stating that the 3644
submitted information has been completed in compliance with the requirements of this 3645

part and that the confidentiality claims made on the Form U are true and correct. The 3646
certification must be signed and dated by the authorized official for the submitter 3647
company, and provide that person‘s name, official title, and e

- mail address. Consistent 3648

w ith this regulatory provision, the e

- IUR software IUR web tool is designed to entirely 3649
block the submission of a Form U lacking an appropriate certification. 3650

3651 The third is the circumstance that a particular CBI claim is not accompanied by 3652
upfront substantiation required under 40 CFR 711.30(b ),( ), ( c), or (d) (e.g., upfront 3653
substantiation of processing and use information). The e

- IURweb reporting tool is 3654
designed to protect against a company not providing an upfront substantiation. When a 3655*** Interagency EO 12866 Review Draft

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155 CBI claim is made and substantiati on is required, the reporting tool will open the 3656
substantiation question page. Should the submitter choose not to complete the 3657
substantiation at that time, or to only partially complete it, the validation portion of the 3658
tool will again alert the submitter to the need for substantiation. The tool also includes 3659
warnings that information with unsubstantiated CBI claims will be released without 3660
further notice to the submitter. EPA believes these reminders provide sufficient notice to 3661

the submitter of the nee d to substantiate these claims. 3662

3663 2 . Upfront substantiation for processing and use information. The Agency 3664
received comments both for and against the proposed upfront substantiation requirement 3665
when processing and use information is claimed as confidenti al. Commenters opposing 3666
the proposed change explained that processing and use information is often considered 3667
confidential by customers to protect their competitive positions in the market. 3668
Commenters voiced concern that the proposed change will impact th eir ability to remain 3669
competitive or will reduce innovation. These commenters were concerned that the 3670
manufacturers of the chemical substances would not correctly identify CBI associated 3671
with downstream uses, and that confidentiality agreements between the chemical 3672

substance manufacturer and the downstream users would not provide sufficient 3673
substantiation for the processing and use information. The Agency believes that the 3674
processing and use information in the publicly

- released IUR reports is sufficiently 3675
agglomerated to address these concerns. However, the Agency also recognizes that there 3676
are circumstances when the release of information about a particular use could harm the 3677
competitive position of the submitter‘s customer. Therefore, EPA has modified th e 3678
substantiation question at proposed 40 CFR 711.30(d)(1)(ii) to include information about 3679*** Interagency EO 12866 Review Draft

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156 harm to the submitter‘s competitive position ―or to your customer‘s competitive 3680
position.‖ EPA also notes that under its confidentiality regulations, the Agency norm ally 3681
solicits input from all affected businesses when making a final confidentiality 3682
determination respecting information claimed as CBI. 3683

3684 Some commenters stated that providing written explanations for multiple 3685

scenarios would be burdensome. Another comment er argued, however, that requiring 3686
such explanations will help to limit CBI claims to information that in fact warrants 3687
protection as a legitimate trade secret. The commenter asserted that the frequency with 3688
which site information was claimed as CBI dropp ed from 28% to 7% after EPA added an 3689
upfront substantiation requirement for that data element, and suggested that the drop 3690
represented an elimination of ―excessive‖ trade secrecy claims. 3691

3692 The Agency recognizes that there is a burden associated with providin g written 3693
explanations. However, based on the significant number of CBI claims for processing 3694
and use information in the last information collection, EPA believes that allowing 3695
submitters to assert CBI claims merely by checking a box encourages submitters to assert 3696
such claims without sufficiently considering whether there is a basis for the claim. While 3697
EPA believes that such claims are appropriate under certain circumstances, the Agency 3698
wants to ensure that all such claims are carefully considered and o nly information that is 3699
truly confidential, the release of which would substantially injure the competitive position 3700
of the submitter, is claimed as CBI. A substantiation requirement for such claims helps 3701
ensure that this consideration takes place. 3702

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157 3. Pr ohibition of confidentiality claims for data elements designated as “not 3704
known or reasonably ascertainable.” Commenters agreed with prohibiting CBI claims 3705
for processing and use information when designated as ―not known or reasonably 3706
ascertainable." The p rimary reason cited by supporters was that the proposed change will 3707
reduce the potential for unwarranted CBI claims. 3708

3709 G. Administrative Comments 3710

3711 1 . Changes to reporting frequency. The Agency received comments regarding the 3712
proposed change to increase the IU R reporting frequency from every 5 years to every 4 3713
years. Some commenters suggested a change to the reporting frequency would still 3714
present a burden to industry and that EPA has not provided adequate justification to 3715
warrant or support any increase in the reporting frequency. Other commenters expressed 3716
support for the return to the reporting frequency of every 4 years but some felt that to 3717
increase the frequency further would be problematic. Additional commenters suggesting 3718
even more frequent reporting cy cles and these comments are addressed in more detail in 3719

the  ̳ ̳Summary of EPA‘s Responses to Public Comments Submitted in Response to 3720
Proposed TSCA Inventory Update Reporting Modifications‘‘ document (Ref. 13 1 2 ). 3721

3722 In the 2003 IUR Amendments, EPA changed its reporting requirement from every 3723
4 years to every 5 years to lessen the burden associated with complying with the 3724
amendments. However, EPA has decided to return to the reporting frequency of every 4 3725
years, in order to better meet Agency needs. EPA has determined that reporting every 5 3726
years is too infrequent, and does not provide enough data to sufficiently cover the 3727
Agency's and public's needs. As discussed in Unit III.D.1 of the proposed rule, many 3728*** Interagency EO 12866 Review Draft

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158 chemical substances, even larger volume chemical substances, often experience wide 3729
fluctuations in manufacturing volume from year to year. This can result in the prod uction 3730
volume of a chemical substance exceeding the threshold for several years, then falling 3731
below the threshold during the IUR principal reporting year. A review of the previous 3732
reporting under the IUR indicates an approximately 30% change in the 3733

chemicals chemica l s ubstance s that are reported from one reporting period to the next. 3734

Therefore, the 1

– year snapshot of production volume does not provide an accurate 3735
picture of the chemical substances in commerce, and may provide an erroneous view of 3736
the exposure scenari os associated with a particular chemical substance. In addition, EPA 3737
has been criticized for using outdated information, which will be remedied with more 3738
frequent reporting. As such, EPA has determined that the value gained through obtaining 3739

more current and useful data is essential to fulfilling the Agency‘s statutory obligations 3740
under TSCA, and outweighs the incremental burden to submitters. 3741

3742 2

. Delete Remove superfluous text regarding production volume. The Agency 3743
received comments on the proposal to delete remove s uperfluous text associated with 3744
reporting production volumes, in particular the +/

- 10 percent standard of precision. All 3745
commenters opposed changing the current language. Several commenters indicated that 3746
reporting accurately to two significant figures is not equivalent to reporting to a precision 3747

of +/

- 10%. One commenter indicated that, if reporting to two significant figures, at 3748
higher production volumes there would be a narrower allowable range of variation. 3749

3750 EPA is replacing ―provided that the repor ted figures are within +/

- 10% of the 3751
actual volume‖ currently found in 40 CFR 710.52(c)(3)(iv) with ―This amount must be 3752*** Interagency EO 12866 Review Draft

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159 reported to two significant figures of accuracy.‖ The deleted phrase that was removed is 3753
superfluous because any number reported accurately to two significant figures is within 3754
10% of the correct value. EPA recognizes some commenters‘ concern that this will result 3755
in a sliding precision scale between 1% and 10% that is solely based on the reported 3756
digits. However, EPA believes that reporting to two significant figures will maintain a 3757
balance between data needs for exposure screening and the industry burden associated 3758
with data collection. In the 2006 IUR data collection, nearly all manufacturers reported 3759
production volumes in greater precision (i .e., more significant figures) than is required 3760

for 2011 201 2 reporting. Based on years of experience assessing chemical substance risks 3761
through programs such as the New Chemicals Program, the Agency believes requiring 3762
reporting to two or more significant figu res is appropriate to facilitate the Agency‘s initial 3763
exposure screens of chemicals chemical s ubstance s , and to prioritize and make basic risk 3764
management decisions about those chemicals chemical s ubstance s of greatest concern. 3765
Those decisions then can prompt more detailed ass essments as necessary. 3766

3767 H. Economic Impact Estimates 3768

3769 1 . General burden comments. The Agency received a number of comments 3770
expressing concerns about the Economic Analysis (Ref. 19 14 ); the majority of which 3771
suggest that the Agency has significantly underest imated t he effort required to collect, 3772
organize, verify and report IUR data . Commenters disagreed with EPA‘s burden 3773
estimates for several proposed modifications to the rule, including the retroactive 3774
reporting of production volumes, reporting on imported m ixtures, mandatory electronic 3775
submission, the lowering of the threshold for downstream processing and use 3776*** Interagency EO 12866 Review Draft

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160 information, the change in the standard of reporting from ―readily obtainable‖ to ―known 3777
to or reasonably ascertainable by ‖,
, ‖ and the change in the rep orting cycle from every 3778
five to every four years. Several commenters asserted that the reporting burden will 3779
increase to between two and six times the burden for reporting in 2006. However, few 3780
commenters provided specific reasons for why they believe that the Agency‘s estimates 3781
were low, and no commenters provided any analytical basis for revising EPA‘s estimates 3782
or substantiated their alternative estimates. The Agency has used the best available data 3783

to estimate the burden associated with the modification s to the IUR rule, and disagrees 3784
with the commenters. The burden estimates presented in the economic analysis are 3785
reasonable estimates for the average IUR submitter. 3786

3787

a. Identification of affected entities. In general, commenters stated that the 3788

Economic Analysis does not identify all affected entities, and EPA has inaccurately 3789
assumed that the proposed rule will affect only chemical s ubstance manufacturers. 3790
Another commenter noted that a wide range of industries manufacture byproducts, so to 3791
accurately es timate the burden of the proposed rule, EPA must identify all affected 3792
industries and facilities. The commenter further stated that byproducts sent for recycling 3793

are new chemicals chemical s ubstance s reportable under the IUR rule and the Economic 3794
Analysis fails to identify these manufacturers. 3795

3796 The Economic Analysis assumes that all companies manufacturing or (including 3797
importing chemicals ) chemical s ubstances annually in amounts of 25,000 lb

. or greater 3798
that are listed on the TSCA Inventory will report under this rule. Chemical s ubstance 3799
users and processors who may manufacture a byproduct chemical substance for a 3800
commercial purpose, e.g., utilities, paper manufacturers, primary metal manufacturers, 3801*** Interagency EO 12866 Review Draft

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161 and semiconductor and other electronic component manufacturers (NAICS codes 22, 3802

322, 331, and 3344), are considered to be chemical s ubstance manufacturers for the 3803
purposes of the IUR rule. Sites that manufactured a byproduct in a volume above the 3804

25,000 lb

. threshold during the 2006 reporting cy cle submission period were required to 3805
report under IUR, and therefore are included in the 2006 baseline estimates. 3806

3807 b . Total industry compliance determination burden. Commenters made a number 3808
of specific points regarding the compliance determination burden. According to one 3809
commenter, provisions requiring repor ting of more data for many chemicals chemical 3810

s ubstance s , replacing NAICS codes with European IS codes, and requiring upfront 3811

substantiation for CBI claims for Part III information will contribute to the increased 3812
effort required to report. 3813

3814 EPA disagrees that the E conomic Analysis underestimates the reporting costs and 3815

burdens of today‘s IUR t his final rule amendments as asserted by the commenters. EPA 3816
does agree that many of the amended rule requirements, including provisions requiring 3817
reporting of more data for many chemicals chemical s ubstance s , replacing NAICS codes 3818
with Industrial Sector codes, and requiring upfront substantiation for CBI claims for Part 3819

III information, will cause an increase in burden and cost. While EPA does state 3820
throughout the EA that the burdens and costs may b e overestimated, the analysis also 3821
says that they may be underestimated. The statements regarding limitations of the study 3822
serve to make the analysis more transparent. EPA does not have the ability to take into 3823
account the effects of individual company cir cumstances concerning downsizing, growth, 3824*** Interagency EO 12866 Review Draft

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162 mergers and acquisitions, on estimates of reporting burden and cost, as mentioned by one 3825

commenter. 3826

3827 Several commenters assert assert ed that EPA has underestimated the burden 3828
associated with IUR compliance determination by estimating the burden on a per

- report 3829
basis. According to the comments, this methodology does not capture the burden 3830
associated with tracking, screening, and keeping records for chemicals chemical 3831

s ubstance s that ultimately are not required to be reported to IUR bec ause they are 3832
manufactured or imported in quantities below the reporting threshold. 3833

3834 Compliance determination occurs on a per

- site basis and is based on a 3835
manufacturer (including importer) determining that it manufactures at least one chemical 3836

s ubstance a t or above the threshold, thus necessitating that the site complete and submit a 3837
Form U. The Economic Analysis assumes all sites that report to the IUR incur the same 3838
average cost for compliance determination regardless of the number of 3839

chemicals chemical s ubstance s reported. EPA expects that it is standard company practice 3840
to track and maintain records of production volumes for all chemicals chemical 3841

s ubstance s manufactured at a given site. Therefore, EPA expects that the burden 3842
associated with compliance determination should not be substantial. The commenters 3843
appear to have misinterpreted EPA‘s compliance determination burden to include the 3844
burden of actually reporting for the chemicals chemical s ubstance s subject to the IUR, but 3845

this is not the case. See Section 4.2.2 of Ref. 19 14 for f urther clarification. 3846

3847 Finally, EPA notes that the IUR does not require submitters to retain 3848
documentation showing that particular chemicals chemical s ubstance s did not need to be 3849*** Interagency EO 12866 Review Draft

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163 included in a given year‘s report. In addition, once a submitter has made a complianc e 3850
determination that it has reporting obligations under the IUR, it can rely on production 3851
volume information already reasonably available, in the ordinary course of business, to 3852
determine that particular chemicals chemical s ubstance s do not need to be reported unde r 3853

the IUR. For this reason, EPA believes it is unreasonable to attribute to the rule the costs 3854
of tracking, screening, and keeping records of the various production volumes of 3855

chemicals chemical s ubstance s that ultimately are not required to be reported to IUR 3856

bec ause they are below the reporting threshold. 3857

3858

c . Underlying assumptions and data: baseline costs. Commenters 3859
question question ed the baseline number of reports EPA used in calculating baseline 3860

costs. One commenter questions question ed whether EPA‘s estimate included inorganic 3861

substances. Another commenter questions question ed whether EPA has adjusted the 3862
baseline estimates to account for new manufacturing facilities that never previously 3863
reported under the IUR rule, the elimination the 300,000 lb

. threshold for processing and 3864

use data, a nd the change in the method of determining the eligibility to report. 3865

3866 The 2006 IUR submission data provide the best estimate for the number of reports 3867

that would be submitted under the baseline scenario. The baseline scenario in the 3868
Economic Analysis as sumes no changes have been made to the 2006 reporting 3869
requirements. This cost is used as a basis on which to calculate the incremental cost of 3870
the rule. Therefore, in the baseline, the number of reports should not be adjusted to 3871
account for any proposed mo difications. The Economic Analysis does estimate the 3872
additional number of Part III reports that will be submitted as a result of today‘s this final 3873*** Interagency EO 12866 Review Draft

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***

164 rule amendments
, including the elimination of the 300,000 lb

. threshold (see Section 3874

4.4.4 of Ref. 19 14 ), as well as the additiona l number of reports submitted as a result of 3875
the change in the method of determining the eligibility to report (see Section 4.4.3 of Ref. 3876

19 14 )

. In addition, the Economic Analysis accounts for rule familiarization costs for any 3877
new companies submitting data (see Section 4.2.2 of Ref. 19 14 ). The 2006 data do 3878
include reports for inorganic chemicals chemical s ubstance s , because while inorganic 3879

chemical s ubstance manufacturers were exempt from submitting downstream processing 3880

and use information in the 2006 reporting cycle submission period
, they were required to 3881

submit Parts I and II of Form U, and therefore are included in the baseline number of 3882

reports. 3883

3884 G

I

. Request for Comment on Additional Issues

. 3885
EPA requested comment on several additional topics in Unit V of the preamble to 3886
the propo sal, at p. 49676

. (Ref. 1)

. The comment summaries and responses to these issues 3887

are contained in the ―Summary of EPA‘s Responses to Public Comments Submitted in 3888
Response to Proposed TSCA Inventory Update Reporting Modifications Rule‖ (Ref 3889

13 document (Ref

. 12 ). 3890

3891 IV. References 3892

As indicated under ADDRESSES , a docket has been established for this 3893
rulemaking under docket ID n umber EPA

– HQ

– OPPT

– 2009

– 0187. The following is a 3894
listing of the documents that are specifically referenced in this document. The docket 3895
includes these documents and other information considered by EPA in developing this 3896
final rule, including documents tha t are referenced within the documents that are included 3897*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review

***

165 in the docket, even if the referenced document is not physically located in the docket. 3898
For assistance in locating these other documents, please consult the technical person 3899

listed under FOR FURTHER INFORMATION CONTACT

. 3900

1. EPA. TSCA Inventory Update Reporting Modifications; Proposed rule. 3901
Federal Register (75 FR 49656, August 13, 2010) (FRL

– 8833

– 5). 3902

2. EPA. Inventory Reporting Regulations; Final rule. Federal Register (42 FR 3903

64572, December 23, 1977) (FRL

– 817

– 1). 3904

2 3

. EPA. Partial Updating of TSCA Inventory Data Base; Production and Site 3905
Reports; Final rule. Federal Register (51 FR 21438, June 12, 1986) (FRL

– 2973

– 3). 3906

3 4

. EPA. TSCA Inventory Update Rule Amendments; Final rule. Federal 3907
Register (68 FR 848, January 7, 2003) (FRL

– 6767

– 4). 3908

4 5

. EPA. OPPT. Enhancing EPA's Chemical Management Program. Available 3909

on

- line at: http

// : // www.epa.gov/oppt/existingchemicals/pubs/enhanchems.html

. 3910

5. 6. EPA. TSCA Inventory Reporting Modifications; Submission Period 3911
Suspension; F inal rule. Federal Register (76 FR 27271, May 11, 2011) (FRL

– 8874

– 2). 3912

7. EPA. Instructions for 2011 201 2 Inventory Update Reporting , July 2010 . May 3913

201 1

. 3914

6 8

. EPA. OPPT. IUR Modifications Rule: Development of Definitions for 3915
Proposed 40 CFR 711.3. July 8, 2010. 3916

7 9

. EPA. TSC A Inventory Update Reporting Revisions; Final rule. Federal 3917
Register (70 FR 75059, December 19, 2005) (FRL

– 7743

– 9). 3918

8 10

. EPA. OPPT. Electronic Signature Agreement. August 2009. 3919*** Interagency EO 12866 Review Draft

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***

166 9 11

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

- 3920

Canada In dustrial Function and Consumer and Commercial Product Codes for Chemical 3921
Inventory Reporting. June 2009, Revised November 2009. 3922

10 12

. EPA. OPPT. Summary of EPA‘s Responses to Public Comments Submitted 3923
in Response to Proposed TSCA Inventory Update Reporting M odifications Rule. Federal 3924
Register (75 FR 49656 , August 13, 2010) (FRL

- 8833

- 5). ) . May 2011. 3925

11 13

. EPA. OPPT. 2006 IUR Database Statistics for the IUR Modifications Rule. 3926

December 17, 2008. 3927

14. EPA. OPPT. Economics, Exposure and Technology Division (EETD). 3928
Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule. 3929

June, 2011. 3930

15. EPA. Toxic Chemical Release Inventory Reporting Forms and Instructions. 3931

October 2009. Available online at: http://www.epa.gov/tri/report/rfi/ry2009rfi121709.pdf

. 3932

16

. EPA. OPPT. EETD. Inventory Update Rep orting (IUR) Technical Support 3933

Document

— Replacement of 5

– digit NAICS Codes with Industrial Sector (IS) Codes. 3934

October 2009. 3935

12. E PA. OPPT. Fact Sheet: Recycling and the TSCA Inventory of Chemical 3936 Substances Premanufacture Notification and Inventory Update Reporting Requirements. 3937 July 2010. 3938
13. EPA. OPPT. Q&A Document: Recycling and the TSCA Inventory of 3939 Chemical Substances Premanufa cture Notification and Inventory Update Reporting 3940 Requirements. July 2010. 3941

14 1 7 . Environmental Defense Fund, Letter to Docket ID Number EPA

- HQ

3942

OPPT

- 2009

- 0187 (on behalf of 32 organizations), from Richard De nison, PhD, October 3943

12, 2010. 3944*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review

***

167 1 8

. Proposal for Priority Setting for Existing Substances on the Domestic 3945

Substances List under the Canadian Environmental Protection Act, 1999. Greatest 3946
Potential for Human Exposure, Canada, 2003. 3947

15 19

. EPA. OPPT. Screening

- Lev el Hazard Characterization and Prioritization 3948

Document. March 2009. Available on

- line at: 3949
http://ww w.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP 3950
_March%202009.pdf

. Available on

- line at: 3951
http://www.epa.gov/chemrtk/hpvis/rbp/Butenedioic%20Acid%20Dialkyl%20Esters_HBP 3952
_March%202009.pdf

. 3953
16. EPA. OPPT. Economics, Exposure and Technology Division (EETD). 3954 Economic Analysis for the Proposed Inventory Update Reporting (IUR) Modifications 3955 Rule. July 20, 201 0. 3956

17. 2 0

. NOVA Chemicals, Letter to Docket ID No. EPA

- HQ

- OPPT

- 2009

- 0187, 3957

fr om Linda Santry. October 7, 2010. 3958

18 2 1

. EPA. OPPT. Initial Risk

- Based Prioritization of High Production Volume 3959
(HPV) Chemicals. April 2009. Available on

- line at : 3960
http://www.epa.gov/chemrtk/hpvis/rbp/Category_Chlorobenzenes_Web_April%202009.p 3961
df

. 3962

19. Environmental Defense Fund, Letter to Docket # EPA

- HQ

- OPPT

- 2009

- 0187 3963 (on behalf of 32 organizations), from Richard Denison, PhD, October 12, 2010. 3964

20 2 2

. European Commission. REACH. January 2011. Available online at: 3965
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

. 3966

2 3 .H.R. Rep. 94

- 1679, 94th Cong., 2d Sess. (1976), reprint ed in Environmental 3967
and Natural Resources Policy Division of the Library of Congress, 94th Cong. 2d Sess., 3968*** Interagency EO 12866 Review Draft

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– Do Not Cite, Quote or Release During Review

***

168 A Legislative History of the Toxic Substances Control Act, (Com. Print 1976) (―Leg. 3969
Hist.‖) at 667

- 721. 3970

2 4 . EPA. Recordkeeping and Reporting Requi rements. Final rule/ 3971
Redesignation. Federal Register (48 FR 23420, May 25, 1983) (FRL

- 2370

- 70). 3972

2 5 . EPA. Premanufacture Notification. Premanufacture Notice Requirements 3973

and Review Procedures. Final Rule and notice form. Federal Register (48 FR 21722
, 3974
May 13, 1983) (FRL 2998

- 5). 3975

2 6 . EPA. Comprehensive Assessment Information Rule. Final Rule. Federal 3976
Register (53 FR 51698, December 12, 1988) (FRL

- 3368

- 1). 3977

2 7

. Prenotice Communication Letter from Mary E. Cushmac, EPA, July 29, 1991. 3978

21 2 8

. Letter f rom Susan Sharkey, EPA, to Robert P. Strieter, The Aluminum 3979

Association, October 24, 2006. 3980

22. 29

. Letter from Charles M. Auer, EPA, to Fern Abrams, IPC, August 27, 3981

2008. 3982

30 . EPA. OPPT. Q&A Document: Recycling and the TSCA Chemical Substance 3983

Inventory

- Prema nufacture Notification and Inventory Update Reporting Requirements. 3984
May 2011. 3985

3 1 . EPA Table of Comparison of 2012 v 2006 IUR Definitions, February 9, 2011 3986

3 2 . EPA. Agency Information Collection Activities; Final Collection; Partial 3987
Update of the TSCA Sect ion 8(b) Inventory Data Base, Production and Site Reports; 3988

EPA ICR No. 1884.04, OMB Control No. 2070

– 0162; Notice. Federal Register (73 FR 3989
51805, September 5, 2008) (FRL

– 8370

– 3). 3990
V. Statutory and Executive Order Reviews 3991*** Interagency EO 12866 Review Draft

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***

169 3992 A. Executive Order 12866 3993

Under Ex ecutive Order 12866, entitled Regulatory Planning and Review (58 FR 3994
51735, October 4, 1993), this action has been designated a ―significant regulatory action‖ 3995
by the Office of Management and Budget (OMB). Accordingly, EPA submitted this 3996

action to OMB for review under Executive Order 12866 and any changes made in 3997
response to OMB recommendations have been documented in the docket for this action. 3998
In addition, EPA has prepared an economic analysis of the potential impacts 3999
associated with this action. A copy of this economic analysis, entitled, Economic 4000
Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (Ref. 19 14 ), 4001
is available in the docket and is briefly summarized in this unit. The Agency, in 4002
promulgating this rule, is required unde r TSCA to consider the potential costs and 4003
benefits associated with IUR. The analysis was therefore used by the decision

- makers to 4004
help in the selection of the final rule requirements presented in this document. 4005

4006

The amendments in this rule affect the nu mber of reports submitted during a 4007
submission period, the burden to prepare a report, and the reporting frequency. EPA 4008
estimates that the combined impact of all the amendments will increase the total burden 4009
and cost to industry associated with IUR reporti ng. 4010
In its Economic Analysis, EPA estimated industry cost and burden on a per

- report 4011
and a per

- site basis and at the industry level. Industry cost and burden are incurred by 4012
performing activities to comply with the amendments, including compliance 4013

determ ination, rule familiarization, preparation and submission of reports, and 4014
recordkeeping. 4015*** Interagency EO 12866 Review Draft

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***

170 On a per

- report basis, EPA estimated incremental increases of 4.28 0.47 hours and 4016

$ 350 118 for a site to complete a partial report for one chemical substance and 17.38 13.57 4017

hours an d $1, 408 176 to complete a full report for one chemical substance, in the first 4018
reporting cycle after the effective date of the rule amendments. A partial report includes 4019
Parts I and II of Form U. A full report includes Parts I, II, and III of Form U. For f uture 4020
reporting cycles, EPA estimated incremental increases of 3.28 2.26 hours and $ 275 212 for 4021
a site to complete a partial report for one chemical substance and 12.98 11.96 hours and 4022
$1, 075 0 12 to complete a full report for one chemical substance

. 4023

As a result of the amendme nts, EPA estimates that the average site will submit 4024
approximately 0.90 and 2.01 fewer partial reports and 2.98 additional in the first reporting 4025
cycle and future reporting cycles, respectively. An increase in full reports in a 4026

submission per site of 0 .89 in the first reporting period

. and 2. 88 in future reporting 4027
periods is expected. For the average site, this will increase the burden by 341 121 hours 4028
during the first reporting cycle and 264 249 hours for all subsequent reporting cycles. 4029
EPA estimates that the average site will incur a net cost incr ease of $ 22,493 9,000 during 4030
the first reporting cycle and $ 17,517 16, 551 during all future reporting cycles. 4031
At the industry level for all sites submitting a Form U, EPA estimates a net total 4032

burden increase of 1.39 0.50 million hours in the first reporting cycle, and 1. 21 14 million 4033
hours for all subsequent reporting cycles. EPA estimates a net cost increase of 4034

$ 91.87 36.76 million in the first reporting cycle of the rule, and $ 79.29 75.1 2 million in all 4035
subsequent reporting cycles. When the reporting cycle costs are averaged over the four

– 4036
year reporting cycle, the average annualized increase in industry cost attributable to the 4037*** Interagency EO 12866 Review Draft

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***

171 amendments is approximate ly $21.61 million over a 25

– year period (at a 3% discount 4038

rate). 4039
EPA estimates that the Agency will experience a reduct ion in both burden and 4040
cost to administer the IUR rule as a result of the amendments. Specifically, EPA expects 4041
to experience a net burden reduction of 1,721 940 hours in the first reporting cycle and 4042

all 1,67 8 in subsequent reporting cycles. The Agency estimates i t will experience a net 4043
savings of $179,600 approximately $ 6 8,000 during each the first reporting cycle and 4044

$17 5,000 in subsequent reporting cycle s . This information will be reflected in the ICR 4045
that is submitted every three years to OMB under the Paperwork Reduction A ct (PRA), 4046

44 U.S.C. 3501 et seq

. 4047
EPA believes that this final rule represents an appropriate balance between the 4048
burden placed on industry to provide information and the Agency‘s need for that 4049
information to fill its statutory obligations and fulfill its mission under TSCA and, as part 4050
of that mission, to provide information needed by other agencies (OSHA, NIOSH, CPSC, 4051

etc.). 4052

4053 B. Paperwork Reduction Act 4054
The information collection requirements in 40 CFR part 710 related to the 4055

submission of Form Us are al ready approved by OMB under PRA. That ICR has been 4056
assigned EPA ICR No. 1884 and OMB control no. 2070

– 0162. Because this final rule 4057
involves new or revised information collection activities that require additional OMB 4058
approval, EPA has prepared an addend um to the currently approved ICR (Ref. 20 3 2 ). An 4059
agency may not conduct or sponsor, and a person is not required to respond to an 4060
information collection request subject to PRA, unless it displays a currently valid OMB 4061*** Interagency EO 12866 Review Draft

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***

172 control number. The OMB control number s for EPA‘s regulations are listed in 40 CFR 4062
part 9 and included on any related collection instrument (e.g., on the form or survey). 4063
Under PRA, the term ―burden‖ is interpreted as the total time, effort, or financial 4064
resources expended by people to genera te, maintain, retain, disclose, or provide 4065
information to or for a Federal agency. This includes the time needed by regulated 4066
entities to review instructions and to develop, acquire, install, and use technology and 4067
systems to collect, validate, verify, and disclose information. Time taken to adjust 4068
existing ways to comply with any previously applicable instructions and requirements 4069
and to train personnel to respond to the information collection task is also included. In 4070
this analysis, total industry burden hours represent the sum of time spent on reporting and 4071
on other administrative activities. Industry respondents will spend time on the following 4072
activities associated with the IUR rule: Compliance determination, rule familiarization, 4073
preparation and submission of re ports, and recordkeeping. 4074
As presented in the Economic Analysis (Ref. 19 14 ) and the addendum ICR
, ( 30 )
, 4075
EPA estimates that the final rule would generate a total incremental industry burden of 4076

1. 39 0.50 million hours in the first reporting cycle. The burden fo r a site to complete a 4077
full IUR report for one chemical substance in the first reporting cycle is estimated to be 4078

140.38 136.57 hours, which includes is an incremental burden increase of 17.38 13.57 4079
hours over the current estimated burden. The burden for a site to complete a p artial IUR 4080
report for one chemical substance in the first reporting cycle is estimated to be 4081

57.36 53.55 hours, which includes is an incremental burden increase of 5.28 0.47 hours 4082
over the current estimated burden. For future reporting cycles, EPA estimates that the 4083

final ru le would create a total incremental industry burden of 1. 21 14 million hours. The 4084*** Interagency EO 12866 Review Draft

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***

173 burden to complete a full report is estimated to be 95.03 94.01 hours, which is an 4085

incremental increase of 12.98 11.9 4 hours over the current estimated future burden. The 4086
burden for a par tial report is estimated to be 29.40 28.38 hours, which is an incremental 4087

increase of 3.28 2.2 4 hours over the current estimate. 4088
C. Regulatory Flexibility Act 4089
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 4090

et seq .), the Agency here by certifies that this action will not have a significant adverse 4091
economic impact on a substantial number of small entities. The Agency‘s basis is briefly 4092
summarized here and is detailed in the Economic Analysis (Ref. 19 14 ). 4093

Under RFA, small entities inclu de small businesses, small organizations, and 4094
small governmental jurisdictions. For purposes of assessing the impacts of this rule on 4095
small entities, small entity is defined as: 4096
1. A small business, as defined by the SBA's regulations at 13 CFR 121.201. T he 4097
SBA definitions typically are based upon either a sales or an employment level, 4098
depending on the nature of the industry. Companies engaged in chemical substance 4099
manufacturing (NAICS Code 325) or petroleum refining (NAICS Code 324110) are the 4100
most likely to report under the IUR rule. These employee size standards range from 500 4101
employees to 1,500 employees for NAICS Codes 325 and 324110. 4102
2. A small governmental jurisdiction that is a government of a city, county, town, 4103
school district, or special district with a population of less than 50,000. 4104
3. A small organization that is any not

- for

- profit enterprise which is 4105
independently owned and operated and is not dominant in its field. 4106*** Interagency EO 12866 Review Draft

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***

174 Since the regulated community does not include small governmental jurisdict ions or 4107

small not

- for

- profit organizations, the analysis focuses on small businesses. 4108
The existing IUR rule, at 40 CFR 710. 59 4 9 , generally exempts from reporting 4109
small businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 4110

millio n and less than 100,000 lb

. production of any given chemical substance at a site; or 4111
annual sales of less than $4 million. This exemption is maintained in today‘s this final 4112

amendments rule

. A small business would be required to report under the final rule, 4113
however, if it pro duces any chemical substance that is the subject of a regulation 4114
proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an 4115
order under TSCA section 5(e), or that is the subject of relief that has been granted 4116

pursuant to a c ivil action under TSCA section 5 or 7

. (40 CFR 711.9 and TSCA section 4117

8(a)(3)(A)(ii))

. A small business may also report voluntarily. 4118
EPA analyzed potential small business impacts from this final rule using both the 4119
SBA employee size standards and the TSC A sales

- based definition of small business. 4120
EPA estimates that 466 small firms potentially would be affected by this final rule using 4121
the employment

- based definition, and 280 small firms potentially would be affected 4122
using the sales

- based definition. Based on costs annualized over a four

– year period and 4123
average sales data for the parent companies, EPA estimated that the cost

- to

- sales ratio of 4124
the final rule would be less than 0.1% for an average small company subject to the rule. 4125
For a company to have a cos t

- to

- sales ratio larger than 1%, company sales would have to 4126

be less than $ 1.02 0.8 1 million. Because the small businesses affected by the final rule 4127
have average sales of more than $412.7 million under the employment

- based definition, 4128*** Interagency EO 12866 Review Draft

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***

175 and $ 11.8 11 6 million under th e sales

- based definition, small entities will not be affected 4129
by the amendments to the IUR rule at a cost

- to

- sales ratio of greater than 1% (Ref. 19 14 ). 4130
D. Unfunded Mandates Reform Act 4131
This action does not contain any Federal mandates for State, local, or tribal 4132
governments or the private sector under the provisions of Title II of the Unfunded 4133

Mandates Reform Act (UMRA), 2 U.S.C. 1531

– 1538. EPA has determined that this 4134
regulatory action will not result in annual expenditures of $100 million or more for Sta te, 4135
local, and tribal governments, in the aggregate, or for the private sector. The costs 4136
associated with this action are briefly described in Unit V.A., and is contained in the 4137
Economic Analysis (Ref. 19 14 ). 4138
Based on EPA's past experience, State, local, a nd tribal governments have not 4139
been affected by this reporting requirement, and EPA does not have any reason to believe 4140
that any State, local, or tribal government will be affected by this final rule. As such, EPA 4141

has determined that this final rule does n ot impose any enforceable duty, contain any 4142
unfunded mandate, or otherwise have any effect on small governments. Accordingly, 4143
this final rule is not subject to the requirements of sections 202, 203, or 205 of UMRA. 4144

E. Executive Order 13132 4145

Pursuant to E xecutive Order 13132, entitled Federalism (64 FR 43255, August 4146
10, 1999), EPA has determined that this final rule does not have federalism implications 4147
because it will not have substantial direct effects on the States, on the relationship 4148

between the natio nal government and the States, or on the distribution of power and 4149
responsibilities among the various levels of government, as specified in the Executive 4150
Order. This final rule simply amends the IUR rule in several ways to provide information 4151*** Interagency EO 12866 Review Draft

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***

176 to better add ress Agency and public information needs, improve the usability and 4152
reliability of the reported data, and ensure that data are available in a timely manner. 4153
Because EPA has no information to indicate that any State or local government 4154
manufactures or proce sses the chemical substances covered by this action, the final rule 4155
does not apply directly to States and localities and will not affect State and local 4156
governments. Thus, Executive Order 13132 does not apply to the final rule. 4157

F. Executive Order 13175 4158

A s required by Executive Order 13175, entitled Consultation and Coordination 4159

with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined 4160
that this final rule does not have tribal implications because it will not have any effect on 4161

tri bal governments, on the relationship between the Federal Government and the Indian 4162
tribes, or on the distribution of power and responsibilities between the Federal 4163
Government and Indian tribes, as specified in the Order. Thus, Executive Order 13175 4164

does n ot apply to this final rule. 4165

G. Executive Order 13045 4166
EPA interprets Executive Order 13045, entitled Protection of Children from 4167
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 4168
only to those regulatory actions that concern health or safety risks, such that the analysis 4169
required under section 5

– 501 of Executive Order 13045 has the potential to influence the 4170
regulation. This action is not subject to Executive Order 13045 because it does not 4171

establish an environmental standard intended to mitigate health or safety risks. 4172
Nevertheless, the information obtained by the reporting required by this final rule will be 4173
used to inform the Agency‘s decision making process regarding chemical substances to 4174*** Interagency EO 12866 Review Draft

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***

177 which children may be di sproportionately exposed. This information will also assist the 4175
Agency and others in determining whether the chemical substances in this final rule 4176
present potential risks, allowing the Agency and others to take appropriate action to 4177
investigate and mitiga te those risks. 4178

H. Executive Order 13211 4179
This action is not a ―significant energy action‖ as defined in Executive Order 4180

13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 4181

Distribution, or Use (66 FR 28355, May 22, 200 1), because it is not likely to have a 4182
significant adverse effect on the supply, distribution, or use of energy as described in the 4183

Executive Order. 4184
I. National Technology Transfer and Advancement Act 4185
Since this action does not involve any technical stan dards, section 12(d) of the 4186
National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 4187

104

– 113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. 4188

J. Executive Order 12898 4189
The final rule does not have an adverse impact o n the environmental and health 4190

conditions in low

- income and minority communities that require special consideration by 4191
the Agency under Executive Order 12898, entitled Federal Actions to Address 4192
Environmental Justice in Minority Populations and Low

- Income Populations (59 FR 4193
7629, February 16, 1994). The Agency believes that the information collected under this 4194
final rule will assist EPA and others in determining the potential hazards and risks 4195
associated with the chemical substances covered by the rule. Bec ause the IUR rule is an 4196
information collection requirement, the information that will become available through 4197*** Interagency EO 12866 Review Draft

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***

178 the rule will enable the Agency to target educational, regulatory, or enforcement activities 4198
towards industries or chemical substances that pose the greatest risks and/or to target 4199
programs for geographic areas that are at the highest risk. Thus, the information to be 4200
gathered under the rule will help EPA make decisions that will benefit potentially at

- risk 4201
communities, some of which may be disadva ntaged. 4202
The final rule is directed at manufacturers (including importers) of chemical 4203
substances. All consumers of these chemical products and all workers who come into 4204
contact with these chemical substances could benefit if data regarding the chemical 4205

su bstances‘ health and environmental effects were developed. Therefore, it does not 4206
appear that the costs and the benefits of the final rule will be disproportionately 4207
distributed across different geographic regions or among different categories of 4208

individua ls. 4209

IV V1

. Congressional Review Act 4210

4211 The Congressional Review Act, 5 U.S.C. 801 et seq ., generally provides that 4212
before a rule may take effect, the agency promulgating the rule must submit a rule report 4213
to each House of the Congress and the Comptroller Genera l of the United States. EPA 4214
will submit a report containing this rule and other required information to the U.S. 4215
Senate, the U.S. House of Representatives, and the Comptroller General of the United 4216
States prior to publication of the rule in the Federal Re gister . This rule is not a ―major 4217
rule‖ as defined by 5 U.S.C. 804(2). 4218

4219 List of Subjects in 40 CFR Parts 704, 710, and 711 4220*** Interagency EO 12866 Review Draft

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***

179 Environmental protection, Chemicals, Confidential Business Information (CBI), 4221
Hazardous materials, Imports, Reporting and recordkeep ing requirements. 4222

Dated:

_____

_________________ ________________ 4223

________________________________________________ 4224

____________________________________ 4225
Assistant Administrator, Office of Chemical Safety and Pollution Prevention. 4226

4227
Therefore, 40 CFR chapter I is amended as follows: 4228

PART 704

— [AMENDED] 4229
1. The authority citation fo r part 704 continues to read as follows: 4230
Authority: 15 U.S.C. 2607(a). 4231

§ 704.3 [Amended] 4232

2. In § 704.3, remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph 4233

(1)(ii) of the definition importer

. 4234

PART 710

— COMPILATION OF THE TSCA CHEMICAL INVENTORY 4235
3. The authority citation for part 710 continues to read as follows: 4236

Autho rity: 15 U.S.C. 2607(a). 4237
4. Revise the heading for part 710 to read as set forth above. 4238
5. Remove the heading ―Subpart A

— General Provisions.‖ 4239
6. Revise paragraph (b) of § 710.1 to read as follows: 4240

§ 710.1 Scope and compliance. 4241

* * * * * 4242*** Interagency EO 12866 Review Draft

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***

180 (b) This part applies to the activities associated with the compilation of the TSCA 4243
Chemical Substance Inventory (TSCA Inventory) and the update of information on a 4244
subset of the chemical substances included on the TSCA Inventory. 4245

* * * * * 4246

7. Section 710.3 is amended as follows: 4247
i. Remove the phrase ―(as defined in 19 CFR 1.11)‖ in paragraph (2) of the definition 4248

importer

. 4249

ii. Remove the definition non

- isolated intermediate

. 4250
iii. Revise the introductory text o f the section to read as follows: 4251

§ 710.3 Definitions. 4252
For purposes of this part: 4253

* * * * * 4254
Subpart B §§ 710.23

– 710.39 [Removed] 4255
8. Remove subpart B, consisting of §§ 710.23

– 710.39. 4256
Subpart C §§ 710.43

– 710.59 [Removed] 4257

9. Remove subpart C, consisting of §§ 710.43

– 710.59. 4258
10. Add new part 711 to subchapter R to read as follows: 4259

PART 711

— TSCA INVENTORY UPDATE REPORTING REQUIREMENTS 4260

Sec. 4261

4262 711.1 Scope and compliance. 4263

711.3 Definitions. 4264

711.5 Chemical substances for which informa tion must be reported. 4265

711.6 Chemical substances for which information is not required. 4266*** Interagency EO 12866 Review Draft

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***

181 711.8 Persons who must report. 4267

711.9 Persons not subject to this part. 4268
711.10 Activities for which reporting is not required. 4269
711.15 Reporting information to EPA. 4270

711.2 0 When to report. 4271
711.22 Duplicative reporting. 4272
711.25 Recordkeeping requirements. 4273
711.30 Confidentiality claims. 4274
711.35 Electronic filing. 4275

4276 Authority: 15 U.S.C. 2607(a). 4277

4278 § 711.1 Scope and compliance. 4279
(a) This part specifies reporting and recordkeeping p rocedures under section 8(a) 4280

of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain 4281
manufacturers (including importers) of chemical substances. Section 8(a) of TSCA 4282
authorizes the EPA Administrator to require reporting of information n ecessary for 4283
administration of TSCA, including issuing regulations for the purpose of compiling and 4284
keeping current the TSCA Chemical Substance Inventory (TSCA Inventory) 4285
manufactured or processed in the United States as required by TSCA section 8(b). In 4286

accordance with TSCA section 8(b), EPA amends th e TSCA Inventory to include new 4287
chemical substances manufactured (including imported) in the United States and reported 4288
under TSCA section 5(a)(1). EPA also revises the categories of chemical substances and 4289
makes other amendments as appropriate. 4290*** Interagency EO 12866 Review Draft

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***

182 (b) This part applies to the activities associated with the periodic update of 4291
information on a subset of the chemical substances included on the TSCA Inventory. 4292
(c) Section 15(3) of TSCA makes it unlawful for any person to fail or refuse to 4293

submit information re quired under this part. In addition, TSCA section 15(3) makes it 4294
unlawful for any person to fail to keep, and permit access to, records required by this 4295
part. Section 16 of TSCA provides that any person who violates a provision of TSCA 4296

section 15 is liable to the United States for a civil penalty and may be criminally 4297
prosecuted. Pursuant to TSCA section 17, the Federal Government may seek judicial 4298
relief to compel submission of TSCA section 8(a) information and to otherwise restrain 4299
any violation of TSCA s ection 15. (EPA does not intend to concentrate its enforcement 4300
efforts on insignificant clerical errors in reporting.) 4301
(d) Each person who reports under this part must maintain records that document 4302
information reported under this part and, in accordance with TSCA, permit access to, and 4303
the copying of, such records by EPA officials. 4304

§ 711.3 Definitions

. 4305
The definitions in this section and the definitions in TSCA section 3 apply to this 4306
part. In addition, the definitions in 40 CFR 704.3 also apply to this part, except the 4307

definitions manufacture and manufacturer in 40 CFR 704.3. 4308
CDX or Central Data Exchange means EPA's centralized electronic document 4309
receiving system, or its successors. 4310

Commercial use means the use of a chemical substance or a mixture conta ining a 4311
chemical substance (including as part of an article) in a commercial enterprise providing 4312
saleable goods or services. 4313*** Interagency EO 12866 Review Draft

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***

183 Consumer use means the use of a chemical substance or a mixture containing a 4314
chemical substance (including as part of an article) when sold to or made available to 4315

consumers for their use. 4316

e

- IURweb means the electronic, web

- based IUR software tool provided by EPA 4317
for the completion and submission of the IUR data. 4318
Industrial function means the intended physical or chemical characteristic for 4319

w hich a chemical substance or mixture is consumed as a reactant; incorporated into a 4320
formulation, mixture, reaction product, or article; repackaged; or used. 4321

Industrial use means use at a site at which one or more chemical substances or 4322

mixtures are manufac tured (including imported) or processed. 4323
Intended for use by children means the chemical substance or mixture is used in 4324
or on a product that is specifically intended for use by children age 14 or younger. A 4325

chemical substance or mixture is intended for us e by children when the submitter answers 4326
―yes‖ to at least one of the following questions for the product into which the submitter's 4327
chemical substance or mixture is incorporated: 4328
(1) Is the product commonly recognized (i.e., by a reasonable person) as be ing 4329
intended for children age 14 or younger? 4330
(2) Does the manufacturer of the product state through product labeling or other 4331
written materials that the product is intended for or will be used by children age 14 or 4332
younger? 4333
(3) Is the advertising, promot ion, or marketing of the product aimed at children 4334
age 14 or younger? 4335*** Interagency EO 12866 Review Draft

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***

184 Manufacture means to manufacture, produce, or import, for commercial purposes. 4336
Manufacture includes the extraction, for commercial purposes, of a component chemical 4337
substance from a pre viously existing chemical substance or complex combination of 4338

chemical substances. When a chemical substance, manufactured other than by import, 4339

is: 4340
(1) Produced exclusively for another person who contracts for such production, 4341

and 4342
(2) that other person s pecifies the identity of the chemical substance and controls 4343
the total amount produced and the basic technology for the plant process, then that 4344

chemical substance is co

- manufactured by the producing manufacturer and the person 4345
contracting for such product ion. 4346

Manufacturer means a person who manufactures a chemical substance. 4347
Master Inventory File means EPA's comprehensive list of chemical substances 4348
which constitutes the TSCA Inventory compiled under TSCA section 8(b). It includes 4349
chemical substances repor ted under 40 CFR part 710 and substances reported under 40 4350
CFR part 720 for which a Notice of Commencement of Manufacture or Import has been 4351

received under 40 CFR 720.120. 4352
Principal reporting year means the latest complete calendar year preceding the 4353

subm ission period. 4354
Reasonably likely to be exposed means an exposure to a chemical substance 4355
which, under foreseeable conditions of manufacture (including import), processing, 4356
distribution in commerce, or use of the chemical substance, is more likely to occur than 4357
not to occur. Such exposures would normally include, but would not be limited to, 4358*** Interagency EO 12866 Review Draft

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***

185 activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, 4359
maintenance operations, materials handling and transfers, and analytical operati ons. 4360
Covered exposures include exposures through any route of entry (inhalation, ingestion, 4361
skin contact, absorption, etc.), but excludes accidental or theoretical exposures. 4362
Repackaging means the physical transfer of a chemical substance or mixture, as 4363

is , from one container to another container or containers in preparation for distribution of 4364

the chemical substance or mixture in commerce. 4365
Reportable chemical substance means a chemical substance described in § 711.5. 4366

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

- of

4367
way shall be considered one site. More than one manufacturing plant may be located on a 4368
single site. 4369

(1) For chemical substances manufactured under contract, i.e., b y a toll 4370
manufacturer, the site is the location where the chemical substance is physically 4371

manufactured. 4372
(2) The site for an importer who imports a chemical substance described in § 4373
711.5 is the U.S. site of the operating unit within the person's organiza tion that is directly 4374
responsible for importing the chemical substance. The import site, in some cases, may be 4375
the organization's headquarters in the United States. If there is no such operating unit or 4376
headquarters in the United States, the site address for the importer is the U.S. address of 4377
an agent acting on behalf of the importer who is authorized to accept service of process 4378
for the importer. 4379
(3) For portable manufacturing units sent to different locations from a single 4380

distribution center, the dist ribution center shall be considered the site. 4381*** Interagency EO 12866 Review Draft

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***

186 Site

- limited means a chemical substance is manufactured and processed only 4382
within a site and is not distributed for commercial purposes as a chemical substance or as 4383
part of a mixture or article outside the sit e. Imported chemical substances are never site

4384
limited. Although a site

- limited chemical substance is not distributed for commercial 4385
purposes outside the site at which it is manufactured and processed, the chemical 4386

substance is considered to have been manu factured and processed for commercial 4387

purposes. 4388
Submission period means the period in which the manufacturing, processing, and 4389

use data are submitted to EPA. 4390

Use means any utilization of a chemical substance or mixture that is not otherwise 4391
covered by the terms manufacture or process. Relabeling or redistributing a container 4392
holding a chemical substance or mixture where no repackaging of the chemical substance 4393
or mixture occurs does not constitute use or processing of the chemical substance or 4394

mixture. 4395

U.S. parent company means the highest level company, located in the United 4396
States, that directly owns at least 50 percent of the voting stock of the manufacturer. 4397

§ 711.5 Chemical substances for which information must be reported. 4398
Any chemical substance that is in the Master Inventory File at the beginning of a 4399
submission period described in § 711.20, unless the chemical substance is specifically 4400
excluded by § 711.6. 4401

§ 711.6 Chemical substances for which information is not required. 4402
The following groups or categories of chemical substances are exempted from 4403
some or all of the reporting require ments of this part, with the following exception: A 4404*** Interagency EO 12866 Review Draft

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***

187 chemical substance described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is 4405
not exempted from any of the reporting requirements of this part if that chemical 4406
substance is the subject of a rule proposed or promulgated under TSCA section 4, 5(a)(2), 4407
5(b)(4), or 6, or is the subject of a a n enforceable consent agreement (ECA) developed 4408
under the procedures of 40 CFR part 790, or is the subject of an order issued under TSCA 4409

section 5(e) or 5(f ), or is the subject of relief that has been granted under a civil action 4410

under TSCA section 5 or 7. 4411

(a) Full exemptions . The following categories of chemical substances are 4412
exempted from the reporting requirements of this part. 4413

(1) Polymers

— (i) Any chem ical substance described with the word fragments 4414
―*polym,‖ ―*alkyd,‖ or ―*oxylated‖ in the Chemical Abstracts (CA) Index Name in the 4415
Master Inventory File, where the asterisk (*) in the listed word fragments indicates that 4416
any sets of characters may preced e, or follow, the character string defined. 4417
(ii) Any chemical substance that is identified in the Master Inventory File as 4418
siloxane and silicone, silsesquioxane, a protein (albumin, casein, gelatin, gluten, 4419
hemoglobin), an enzyme, a polysaccharide (starch , cellulose, gum), rubber, or lignin. 4420
(iii) This exclusion does not apply to a polymeric substance that has been 4421
hydrolyzed, depolymerized, or otherwise chemically modified, except in cases where the 4422
intended product of this reaction is totally polymeric in structure. 4423

(2) Microorganisms . Any combination of chemical substances that is a living 4424
organism, and that meets the definition of ―microorganism‖ at 40 CFR 725.3. Any 4425
chemical substance produced from a living microorganism is reportable under this part 4426

unless otherwise excluded. 4427*** Interagency EO 12866 Review Draft

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***

188 (3) Naturally occurring chemical substances . Any naturally occurring chemical 4428
substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is 4429
determined in each case by the specific activities of the person w ho manufactures the 4430
chemical substance in question. Some chemical substances can be manufactured both as 4431
described in 40 CFR 710.4(b) and by means other than those described in 40 CFR 4432
710.4(b). If a person described in § 711.8 manufactures a chemical subst ance by means 4433
other than those described in 40 CFR 710.4(b), the person must report regardless of 4434
whether the chemical substance also could have been produced as described in 40 CFR 4435
710.4(b). Any chemical substance that is produced from such a naturally oc curring 4436
chemical substance described in 40 CFR 710.4(b) is reportable unless otherwise 4437

excluded. 4438

(4) Certain forms of natural gas and water . Chemical substances with the 4439
following CASRN: CASRN 64741

– 48

– 6, natural gas (petroleum), raw liq. mix; CASRN 4440

68919

– 39

– 1, natural gas condensates; CASRN 8006

– 61

– 9, gasoline, natural; CASRN 4441

68425

– 31

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

– 14

– 2, natural gas; CASRN 4442

68410

– 63

– 9, natural gas, dried; and CASRN 7732

– 18

– 5, water. 4443

(b) Partial exemptions . The following gr oups of chemical substances are partially 4444
exempted from the reporting requirements of this part (i.e., the information described in § 4445
711.15(b)(4) need not be reported for these chemical substances). Such chemical 4446
substances are not excluded from the other reporting requirements under this part. 4447

(1) Petroleum process streams . EPA has designated the chemical substances 4448

listed in Table 1 of this paragraph by CASRN, as partially exempt from reporting under 4449

the IUR. 4450*** Interagency EO 12866 Review Draft

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***

189 Table 1.

— CAS Registry Numbers CAS RNs of Partially Exempt Chemical 4451 Substances Termed ―Petroleum Process Streams‖ for Purposes of Inventory Update 4452 Reporting 4453 CASRN Product 8002

– 05

– 9 Petroleum 8002

– 74

– 2 Paraffin waxes and hydrocarbon waxes 8006

– 20

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

– 20

– 6 Kerosine (petroleum) 8009

– 03

– 8 Petrolatum 8012

– 95

– 1 Paraffin oils 8030

– 30

– 6 Naphtha 8032

– 32

– 4 Ligroine 8042

– 47

– 5 White mineral oil (petroleum) 8052

– 41

– 3 S toddard solvent 8052

– 42

– 4 Asphalt 61789

– 60

– 4 Pitch 63231

– 60

– 7 Paraffin waxes and hydrocarbon waxes, microcryst. 64741

– 41

– 9 Naphtha (petroleum), heavy straight

- run 64741

– 42

– 0 Naphtha (petroleum), full

- range straight

- run 64741

– 43

– 1 Gas oils (petroleum) , straight

- run 64741

– 44

– 2 Distillates (petroleum), straight

- run middle 64741

– 45

– 3 Residues (petroleum), atm. tower T ower 64741

– 46

– 4 Naphtha (petroleum), light straight

- run 64741

– 47

– 5 Natural gas condensates (petroleum) 64741

– 49

– 7 Condensates (petroleum), va cuum tower 64741

– 50

– 0 Distillates (petroleum), light paraffinic 64741

– 51

– 1 Distillates (petroleum), heavy paraffinic 64741

– 52

– 2 Distillates (petroleum), light naphthenic 64741

– 53

– 3 Distillates (petroleum), heavy naphthenic 64741

– 54

– 4 Naphtha (petroleu m), heavy catalytic cracked 64741

– 55

– 5 Naphtha (petroleum), light catalytic cracked 64741

– 56

– 6 Residues (petroleum), vacuum 64741

– 57

– 7 Gas oils (petroleum), heavy vacuum 64741

– 58

– 8 Gas oils (petroleum), light vacuum 64741

– 59

– 9 Distillates (petroleum), light catalytic cracked 64741

– 60

– 2 Distillates (petroleum), intermediate catalytic cracked 64741

– 61

– 3 Distillates (petroleum), heavy catalytic cracked 64741

– 62

– 4 Clarified oils (petroleum), catalytic cracked 64741

– 63

– 5 Naphtha (petroleum), light catal ytic reformed 64741

– 64

– 6 Naphtha (petroleum), full

- range alkylate 64741

– 65

– 7 Naphtha (petroleum), heavy alkylate 64741

– 66

– 8 Naphtha (petroleum), light alkylate 64741

– 67

– 9 Residues (petroleum), catalytic reformer fractionator 64741

– 68

– 0 Naphtha (petrol eum), heavy catalytic reformed 64741

– 69

– 1 Naphtha (petroleum), light hydrocracked*** Interagency EO 12866 Review Draft

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***

190 64741

– 70

– 4 Naphtha (petroleum), isomerization 64741

– 73

– 7 Distillates (petroleum), alkylate 64741

– 74

– 8 Naphtha (petroleum), light thermal cracked 64741

– 75

– 9 Residues (pet roleum), hydrocracked 64741

– 76

– 0 Distillates (petroleum), heavy hydrocracked 64741

– 77

– 1 Distillates (petroleum), light hydrocracked 64741

– 78

– 2 Naphtha (petroleum), heavy hydrocracked 64741

– 79

– 3 Coke (petroleum) 64741

– 80

– 6 Residues (petroleum), thermal cracked 64741

– 81

– 7 Distillates (petroleum), heavy thermal cracked 64741

– 82

– 8 Distillates (petroleum), light thermal cracked 64741

– 83

– 9 Naphtha (petroleum), heavy thermal cracked 64741

– 84

– 0 Naphtha (petroleum), solvent

- refined light 64741

– 85

– 1 Raffina tes (petroleum), sorption process 64741

– 86

– 2 Distillates (petroleum), sweetened middle 64741

– 87

– 3 Naphtha (petroleum), sweetened 64741

– 88

– 4 Distillates (petroleum), solvent

- refined heavy paraffinic 64741

– 89

– 5 Distillates (petroleum), solvent

- refined li ght paraffinic 64741

– 90

– 8 Gas oils (petroleum), solvent

- refined 64741

– 91

– 9 Distillates (petroleum), solvent

- refined middle 64741

– 92

– 0 Naphtha (petroleum), solvent

- refined heavy 64741

– 95

– 3 Residual oils (petroleum), solvent deasphalted 64741

– 96

– 4 Disti llates (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 64742

– 03

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

– 04

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

– 05

– 8 Extracts (petroleum), light paraffinic distillate solvent 64742

– 06

– 9 Extracts (petroleum), middle distillate solvent 64742

– 07

– 0 Raffinates (petroleum), residual oil decarbonization 64742

– 08

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

– 09

– 2 Raffinates (petroleum), heavy paraffinic distillate decarbonization 64742

– 10

– 5 Extracts (petroleum), residual oil solvent 64742

– 11

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

– 12

– 7 Gas oils (petroleum), acid

- treated 64742

– 13

– 8 Distillates (petroleum), acid

- treated middle 64742

– 14

– 9 Distillates (petroleum), acid

- treated light 64742

– 15

– 0 Naphtha (petroleum), acid

- treated 64742

– 16

– 1 Petroleum resins 64742

– 18

– 3 Distillates (petroleum), acid

- treated heavy naphthenic 64742

– 19

– 4 Distillates (petroleum), acid

- treated light naphthenic 64742

– 20

– 7 Distillates (petroleum), acid

- treated heavy paraffinic 64742

– 21

– 8 Distillates (petroleum), acid

- treated light paraffinic*** Interagency EO 12866 Review Draft

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***

191 64742

– 22

– 9 Naphtha (petroleum), chemically neutralized heavy 64742

– 23

– 0 Naphtha (petroleum), chemically neutralized light 64742

– 24

– 1 Sludges (petroleum), acid 64742

– 25

– 2 Lubricating oils (petroleum), acid

- treated spent 64742

– 26

– 3 Hydrocarbon waxes (petroleum), acid

- treated 64742

– 27

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

– 28

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

– 29

– 6 Gas oils (petroleum), chemically neutralized 64742

– 30

– 9 Distillates (petroleum), chemically neutralized middle 64742

– 31

– 0 Distillates (petroleum), chemically neutralized light 64742

– 32

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

– 33

– 2 Hydrocarbon waxes (petroleum), chemically neutralized 64742

– 34

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

– 35

– 4 Distillates (petroleum), chemically neutra lized light naphthenic 64742

– 36

– 5 Distillates (petroleum), clay

- treated heavy paraffinic 64742

– 37

– 6 Distillates (petroleum), clay

- treated light paraffinic 64742

– 38

– 7 Distillates (petroleum), clay

- treated middle 64742

– 39

– 8 Neutralizing agents (petroleum ), spent sodium carbonate 64742

– 40

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

– 41

– 2 Residual oils (petroleum), clay

- treated 64742

– 42

– 3 Hydrocarbon waxes (petroleum), clay

- treated microcryst. 64742

– 43

– 4 Paraffin waxes (petroleum), cl ay

- treated 64742

– 44

– 5 Distillates (petroleum), clay

- treated heavy naphthenic 64742

– 45

– 6 Distillates (petroleum), clay

- treated light naphthenic 64742

– 46

– 7 Distillates (petroleum), hydrotreated middle 64742

– 47

– 8 Distillates (petroleum), hydrotreated ligh t 64742

– 48

– 9 Naphtha (petroleum), hydrotreated heavy 64742

– 49

– 0 Naphtha (petroleum), hydrotreated light 64742

– 50

– 3 Lubricating oils (petroleum), clay

- treated spent 64742

– 51

– 4 Paraffin waxes (petroleum), hydrotreated 64742

– 52

– 5 Distillates (petroleum), hydrotreated heavy naphthenic 64742

– 53

– 6 Distillates (petroleum), hydrotreated light naphthenic 64742

– 54

– 7 Distillates (petroleum), hydrotreated heavy paraffinic 64742

– 55

– 8 Distillates (petroleum), hydrotreated light paraffinic 64742

– 56

– 9 Distillates (petroleum), solvent

- dewaxed light paraffinic 64742

– 57

– 0 Residual oils (petroleum), hydrotreated 64742

– 58

– 1 Lubricating oils (petroleum), hydrotreated spent 64742

– 59

– 2 Gas oils (petroleum), hydrotreated vacuum 64742

– 60

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

– 61

– 6 Slack wax (petroleum) 64742

– 62

– 7 Residual oils (petroleum), solvent

- dewaxed 64742

– 63

– 8 Distillates (petroleum), solvent

- dewaxed heavy naphthenic 64742

– 64

– 9 Distillates (petroleum), solvent

- dewaxed light naphthenic 6 4742

– 65

– 0 Distillates (petroleum), solvent

- dewaxed heavy paraffinic 64742

– 67

– 2 Foots oil (petroleum)*** Interagency EO 12866 Review Draft

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***

192 64742

– 68

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

– 69

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

– 70

– 7 Paraffin oil s (petroleum), catalytic dewaxed heavy 64742

– 71

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

– 72

– 9 Distillates (petroleum), catalytic dewaxed middle 64742

– 73

– 0 Naphtha (petroleum), hydrodesulfurized light 64742

– 75

– 2 Naphthenic oils (petrol eum), complex dewaxed heavy 64742

– 76

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

– 78

– 5 Residues (petroleum), hydrodesulfurized atmospheric tower 64742

– 79

– 6 Gas oils (petroleum), hydrodesulfurized 64742

– 80

– 9 Distillates (petroleum), hydrod esulfurized middle 64742

– 81

– 0 Kerosine (petroleum), hydrodesulfurized 64742

– 82

– 1 Naphtha (petroleum), hydrodesulfurized heavy 64742

– 83

– 2 Naphtha (petroleum), light steam

- cracked 64742

– 85

– 4 Residues (petroleum), hydrodesulfurized vacuum 64742

– 86

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

– 87

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

– 88

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

– 89

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

– 90

– 1 Residues (petroleum), steam

- cracked 64742

– 91

– 2 Distillates (petroleum), steam

- cracked 64742

– 92

– 3 Petroleum resins, oxidized 64742

– 93

– 4 Asphalt, oxidized 64742

– 94

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

– 95

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

– 96

– 7 Sol vent naphtha (petroleum), heavy aliph. 64742

– 97

– 8 Distillates (petroleum), oxidized heavy 64742

– 98

– 9 Distillates (petroleum), oxidized light 64742

– 99

– 0 Residual oils (petroleum), oxidized 64743

– 00

– 6 Hydrocarbon waxes (petroleum), oxidized 64743

– 01

– 7 P etrolatum (petroleum), oxidized 64743

– 02

– 8 Alkenes, C>10 .alpha.

- 64743

– 03

– 9 Phenols (petroleum) 64743

– 04

– 0 Coke (petroleum), recovery 64743

– 05

– 1 Coke (petroleum), calcined 64743

– 06

– 2 Extracts (petroleum), gas oil solvent 64743

– 07

– 3 Sludges (petroleu m), chemically neutralized 64754

– 89

– 8 Naphthenic acids (petroleum), crude 64771

– 71

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

– 72

– 8 Paraffins (petroleum), normal C5

- 20 67254

– 74

– 4 Naphthenic oils 67674

– 12

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

– 13

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

– 15

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

– 16

– 2 Hydrocarbon waxes (petroleum), oxidized, partially deacidified*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

193 67674

– 17

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

– 18

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

– 79

– 6 Distillates (petroleum), heavy arom. 67891

– 80

– 9 Distillates (petroleum), light arom. 67891

– 81

– 0 Distillates (petroleum), oxidized l ight, potassium salts 67891

– 82

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

ethanolamine 67891

– 83

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

isopropanolamine 67891

– 85

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

triisopropanolamine 67891

– 86

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

diisopropanolamine 68131

– 05

– 5 Hydrocarbon oils, process blends 68131

– 49

– 7 Aromatic hydrocarbons, C6

- 10, acid

- treated, neutralized 68131

– 75

– 9 Gases (petroleum), C3

- 4 6 8153

– 22

– 0 Paraffin waxes and Hydrocarbon waxes, oxidized 68187

– 57

– 5 Pitch, coal tar

- petroleum 68187

– 58

– 6 Pitch, petroleum, arom. 68187

– 60

– 0 Hydrocarbons, C4, ethane

- propane

- cracked 68307

– 98

– 2 Tail gas (petroleum), catalytic cracked distillate and catal ytic cracked

naphtha fractionation absorber 68307

– 99

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

– 00

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

hydrogen sulfide

- free 68308

– 01

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

– 02

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

- free 68308

– 03

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

– 04

– 3 Tail gas (petroleum), gas recovery plant 68308

– 05

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

– 06

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

naphtha fractionator, acid

- free 68308

– 07

– 6 Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper,

hydrogen sulfide

- free 68308

– 08

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

– 09

– 8 Tail gas (petroleum), light straight

- run naphtha stabilizer, hydrogen

sulfide

- free 68308

– 10

– 1 Tail gas (petroleum), straight

- run distillate hydrodesulfu rizer, hydrogen

sulfide

- free 68308

– 11

– 2 Tail gas (petroleum), propane

- propylene alkylation feed prep deethanizer 68308

– 12

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

sulfide

- free 68308

– 27

– 0 Fuel gases, refinery 68333

– 22

– 2 Residue s (petroleum), atmospheric 68333

– 23

– 3 Naphtha (petroleum), heavy coker*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

194 68333

– 24

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

– 25

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

– 26

– 6 Clarified o ils (petroleum), hydrodesulfurized catalytic cracked 68333

– 27

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

– 28

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

– 29

– 9 Residues (petroleum), ligh t naphtha solvent extracts 68333

– 30

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

– 81

– 3 Alkanes, C4

- 12 68333

– 88

– 0 Aromatic hydrocarbons, C9

- 17 68334

– 30

– 5 Fuels, diesel 68409

– 99

– 4 Gases (petroleum), catalytic cracked overheads 68410

– 0 0

– 4 Distillates (petroleum), crude oil 68410

– 05

– 9 Distillates (petroleum), straight

- run light 68410

– 12

– 8 Distillates (petroleum), steam

- cracked, C5

- 10 fraction, high

- temp.

stripping products with light steam

- cracked petroleum naphtha C5 fraction polymers 68410

– 71

– 9 Raffinates (petroleum), catalytic reformer ethylene glycol

- water

countercurrent exts. 68410

– 96

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

– 97

– 9 Distillates (petroleum), light distillate hydrotreating process, l ow

- 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), o xidized, barium salt 68425

– 34

– 3 Petrolatum (petroleum), oxidized, calcium salt 68425

– 35

– 4 Raffinates (petroleum), reformer, Lurgi unit

- sepd. 68425

– 39

– 8 Alkenes, C>10 .alpha.

- , oxidized 68441

– 09

– 8 Hydrocarbon waxes (petroleum), clay

- treated microcryst., contg.

polyethylene, oxidized 68459

– 78

– 9 Alkenes, C18

- 24 .alpha.

- , dimers 68475

– 57

– 0 Alkanes, C1

- 2 68475

– 58

– 1 Alkanes, C2

- 3 68475

– 59

– 2 Alkanes, C3

- 4 68475

– 60

– 5 Alkanes, C4

- 5 68475

– 61

– 6 Alkenes, C5, naphtha

- raffinate pyrolyzate

- derived 68475

– 70

– 7 Ar omatic hydrocarbons, C6

- 8, naphtha

- raffinate pyrolyzate

- derived 68475

– 79

– 6 Distillates (petroleum), catalytic reformed depentanizer 68475

– 80

– 9 Distillates (petroleum), light steam

- cracked naphtha 68476

– 26

– 6 Fuel gases 68476

– 27

– 7 Fuel gases, amine syste m 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

195 68476

– 31

– 3 Fuel oil, no. 4 68476

– 32

– 4 Fuel oil, residues

- straight

- run gas oils, high

- sulfur 68476

– 33

– 5 Fuel oil, residua l 68476

– 34

– 6 Fuels, diesel, no. 2 68476

– 39

– 1 Hydrocarbons, aliph.

- arom.

- C4

- 5

- olefinic 68476

– 40

– 4 Hydrocarbons, C3

- 4 68476

– 42

– 6 Hydrocarbons, C4

- 5 68476

– 43

– 7 Hydrocarbons, C4

- 6, C5

- rich 68476

– 44

– 8 Hydrocarbons, C>3 68476

– 45

– 9 Hydrocarbons, C5

- 10 arom . conc., ethylene

- manuf.

- by

- product 68476

– 46

– 0 Hydrocarbons, C3

- 11, catalytic cracker distillates 68476

– 47

– 1 Hydrocarbons, C2

- 6, C6

- 8 catalytic reformer 68476

– 49

– 3 Hydrocarbons, C2

- 4, C3

- rich 68476

– 50

– 6 Hydrocarbons, C≥5, C5

- 6

- rich 68476

– 52

– 8 Hydrocarbons, C4, ethylene

- manuf.

- by

- product 68476

– 53

– 9 Hydrocarbons, C≥20, petroleum wastes 68476

– 54

– 0 Hydrocarbons, C3

- 5, polymn. unit feed 68476

– 55

– 1 Hydrocarbons, C5

- rich 68476

– 56

– 2 Hydrocarbons, cyclic C5 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

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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

196 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 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

197 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 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

198 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 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.*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

199 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 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

200 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.

-

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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

201 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 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

202 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 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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

203 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 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,*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

204 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 4454 (2) Specific exempted chemical substances

— (i) Exemption . EPA has determined 4455

that, at this time, the information in § 711.15(b)(4) associated with the chemical 4456

substances listed in paragraph (b)(2)(iv) of this section is of low current interest. 4457

(ii) Considerations . In making its determination of whether this partial exemption 4458
should apply to a particular chemical substance, EPA will consider the totality of 4459

information available for the chemical substance in question, including but not limited to, 4460
one or more of the following considerations: 4461
(A) Whether the chemical substance qualifies or has qualified in past IUR 4462
collections for the reporting of the information described in § 711.15(b)(4 ) (i.e., at least 4463
one site manufactures 300,000 pounds (lb.) or more of the chemical substance). )

. 4464
(B) The chemical substance's chemical and physical properties or potential for 4465
persistence, bioaccumu lation, health effects, or environmental effects (considered 4466
independently or together). 4467
(C) The information needs of EPA, other Federal agencies, tribes, States, and 4468
local governments, as well as members of the public. 4469
(D) The availability of other comp lementary risk screening information. 4470
(E) The availability of comparable processing and use information. 4471
(F) Whether the potential risks of the chemical substance are adequately managed. 4472*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

205 (iii) Amendments . EPA may amend the chemical substance list in par agraph 4473
(b)(2)(iv) of this section on its own initiative or in response to a request from the public 4474

based on EPA's determination of whether the information in § 711.15(b)(4) is of low 4475

interest. 4476
(A) Any person may request that EPA amend the chemical substa nce list in Table 4477
2 in paragraph (b)(2)(iv) of this section. Your request must be in writing and must be 4478
submitted to the following address: OPPT IUR Submission Coordinator (Mail Code 4479
7407M), Attention: Inventory Update Reporting, Office of Pollution Prev ention and 4480
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, 4481

DC 20460

– 0001. Requests must identify the chemical substance in question, as well as 4482

its CASRN or other chemical identifica tion number as identified in § 711.15(b)(3)(i), and 4483
must contain a written rationale for the request that provides sufficient specific 4484
information, addressing the considerations listed in § 711.6(b)(2)(ii), including cites and 4485

relevant documents, to demons trate to EPA that the collection of the information in § 4486
711.15(b)(4) for the chemical substance in question either is or is not of low current 4487
interest. If a request related to a particular chemical substance is resubmitted, any 4488
subsequent request must cl early identify new information contained in the request. EPA 4489
may request other information that it believes necessary to evaluate the request. EPA will 4490
issue a written response to each request within 120 days of receipt of the request, and will 4491

maintain co pies of these responses in a docket that will be established for each reporting 4492
cycle. 4493
(B) As needed, the Agency will initiate rulemaking to make revisions to Table 2 4494
in paragraph (b)(2)(iv) of this section. 4495*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

206 (C) To assist EPA in reaching a decision regar ding a particular request prior to a 4496
given principal reporting year, requests must be submitted to EPA no later than 12 4497
months prior to the start of the next principal reporting year. 4498

(iv) List of chemical substances . EPA has designated the chemical subst ances 4499
listed in Table 2 of this paragraph by CASRN, as partially exempt from reporting under 4500

the IUR. 4501

Table 2.

— CASRN of Partially Exempt Chemical Substances 4502 CASRN Chemical 50

– 70

– 4 D

- Glucitol 50

– 81

– 7 L

- Ascorbic acid 50

– 99

– 7 D

- Glucose 56

– 81

– 5 1,2,3

- Prop anetriol 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)

- 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 Octade canoic acid, 2,3

- dihydroxypropyl ester 124

– 38

– 9 Carbon dioxide 137

– 08

– 6 .beta.

- Alanine, N

- [(2R)

- 2,4

- dihydroxy

- 3,3

- dimethyl

- 1

- oxobutyl]

- ,

calcium alt (2:1) 142

– 47

– 2 L

- Glutamic acid, monosodium salt 150

– 30

– 1 Phenylalanine 563

– 43

– 9 Aluminum, dichloroethy l

1070

– 00

– 4 Aluminum, trioctyl

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*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

207 7440

– 37

– 1 Argon 7440

– 44

– 0 C arbon 7727

– 37

– 9 Nitrogen 7782

– 42

– 5 Graphite 7782

– 44

– 7 Oxygen 8001

– 21

– 6 Sunflower oil 8001

– 22

– 7 Soybean oil 8001

– 23

– 8 Safflower oil 8001

– 26

– 1 Linseed oil 8001

– 29

– 4 Cottonseed oil 8001

– 30

– 7 Corn oil 8001

– 31

– 8 Coconut oil 8001

– 78

– 3 Castor oil, hydr ogenated 8001

– 79

– 4 Castor oil 8002

– 03

– 7 Peanut oil 8002

– 13

– 9 Rape oil 8002

– 43

– 5 Lecithins 8002

– 75

– 3 Palm oil 8006

– 54

– 0 Lanolin 8016

– 28

– 2 Lard, oil 8016

– 70

– 4 Soybean oil, hydrogenated 8021

– 99

– 6 Charcoal, bone 8029

– 43

– 4 Syrups, hydrolyzed starch 1 1103

– 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 64 147

– 40

– 6 Castor oil, dehydrated 64755

– 01

– 7 Fatty acids, tallow, calcium salts 65996

– 63

– 6 Starch, acid

- hydrolyzed 65996

– 64

– 7 Starch, enzyme

- hydrolyzed 67701

– 01

– 3 Fatty acids, C12

- 18 68002

– 85

– 7 Fatty acids, C14

- 22 and C16

- 22

- unsatd. 68131

– 37

– 3 Syrups, hydrolyzed starch, dehydrated 68188

– 81

– 8 Grease, poultry 68308

– 36

– 1 Soybean meal 68308

– 54

– 3 Glycerides, tallow mono

- , di

- and tri

- , hydrogenated 68334

– 00

– 9 Cottonseed oil, hydrogenated 68334

– 28

– 1 Fats and glyceridic oils, vegetable, hydrogenated 6840 9

– 76

– 7 Bone meal, steamed 68424

– 45

– 3 Fatty acids, linseed

- oil*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

208 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 glycerid ic 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

- C 14

- 16

- alkyl derivs. 4503

§ 711.8 Persons who must report. 4504
Except as provided in § 711.9 and § 711.10, the following persons are subject to 4505
the requirements of this part. Persons must determine whether they must report under this 4506

section for each chemical su bstance that they manufacture (including import) at an 4507

individual site. 4508

(a) Persons subject to recurring reporting

— (1) For the 2011 201 2 submission 4509
period, any person who manufactured (including imported) for commercial purposes 4510

25,000 lb

. (11,340 kilogram (kg) ) or more of a chemical substance described in § 711.5 at 4511
any single site owned or controlled by that person during the principal reporting year 4512
(i.e., calendar year 2010 201 1 ) is subject to reporting. 4513
(2) For the submission periods subsequent to the 2011 201 2 su bmission period, 4514
any person who manufactured (including imported) for commercial purposes 25,000 lb

. 4515
(11,340 kg) or more of a chemical substance described in § 711.5 at any single site 4516*** Interagency EO 12866 Review Draft

– Deliberative

– Do Not Cite, Quote or Release During Review

***

209 owned or controlled by that person during any calendar year since the la st principal 4517
reporting year (e.g., for the 2015 201 6 submission period, consider calendar years 2011, 4518

2012, 2013, and 2014, and 201 5
, given that 2010 201 1 was the last principal reporting 4519
year). 4520

(b) Exceptions

. Any For the 2016 submission period and subsequent submission 4521
period s , a ny person who manufactured (including imported) for commercial purposes any 4522
chemical substance that is the subject of a rule proposed or promulgated under TSCA 4523
section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 4524

5 (e), or is the subject of relief that has been granted under a civil action under TSCA 4525
section 5 or 7 is subject to reporting for as described in § 711.8(a), except that chemical 4526
substance, regardless of the the applicable production volume

. threshold is 2,500 lb (1,134 4527
kg)

. 4528

§ 711.9 Persons not su bject to this part. 4529
A person described in § 711.8 is not subject to the requirements of this part if that 4530
person qualifies as a small manufacturer as that term is defined in 40 CFR 704.3. 4531
Notwithstanding this exclusion, a person who qualifies as a small m anufacturer is subject 4532
to this part with respect to any chemical substance that is the subject of a rule proposed or 4533
promulgated under TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect 4534
under TSCA section 5(e), or is the subject of reli ef that has been granted under a civil 4535

action under TSCA section 5 or 7. 4536

§ 711.10 Activities for which reporting is not required. 4537*** Interagency EO 12866 Review Draft

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210 A person described in § 711.8 is not subject to the requirements of this part with 4538
respect to any chemical substance described in § 711.5 that the person solely 4539
manufactured or imported under the f ollowing circumstances: 4540
(a) The person manufactured or imported the chemical substance described in § 4541
711.5 solely in small quantities for research and development. 4542
(b) The person imported the chemical substance described in § 711.5 as part of an 4543

article

. 4544
(c) The person manufactured the chemical substance described in § 711.5 in a 4545
manner described in 40 CFR 720.30(g) or (h). 4546

§ 711.15 Reporting information to EPA. 4547

For the 2011 For the 201 2 submission period, any person who must report under 4548
this part, as described in § 711.8, must submit the information described in this section 4549

for each chemical substance described in § 711.5 that the person manufactured (including 4550
imported) for commercial purposes in an amount of 25,000 lb (11,340 kg) or more at any 4551
one site during the principal reporting year (i.e., calendar year 201 1 ). For the submission 4552
periods subsequent to the 201 2 submission period, any person who must report under this 4553
part, as described in § 711.8, must submit the information described in this section for 4554

ea ch chemical substance described in § 711.5 that the person manufactured (including 4555
imported) for commercial purposes in an amount of 25,000 lb

. (11,340 kg) or more (or 4556

lower volume for ch emical substances subject to the rules, orders, or actions described in 4557

§ 711.8(b)) at any one site during the principal reporting year (i.e., calendar year 2010). 4558
For the submission periods subsequent to the 2011 submission period, any person who 4559

must re port under this part, as described in § 711.8(b), must submit the information 4560*** Interagency EO 12866 Review Draft

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211 described in this section for each chemical substance described in § 711.5 that the person 4561
manufactured (including imported) for commercial purposes in an amount of 4562

25,000 2,500 lb . (1 1,340 [1,134 kg ) ] or more (or lower volume for chemical substances 4563
subject to the rules , orders, or actions described in § 711.8(b)) at any one site during any 4564
calendar year since the last principal reporting year (e.g., for the 2015 201 6 submission 4565
period, consider calendar years 2011, 2012, 2013, and 2014, since 2010 and 201 5
, 4566

because 201 1 was the last principal re porting year). The principal reporting year for each 4567
submission period is the previous calendar year (e.g., the principal reporting year for the 4568

2015 201 6 submission period is calendar year 2014 201 5 ). For all submission periods, a 4569
separate report must be submitted for each chemical substance at each site for which the 4570
submitter is required to report. A submitter of information under this part must report 4571

information as described in this section to the extent that such information is known to or 4572
reasonably ascertaina ble by that person. 4573

(a) Reporting information to EPA . Any person who reports information to EPA 4574
must do so using the e

- IURweb reporting software tool provided by EPA at the address 4575

set forth in § 711.35. The submission must include all information described in par agraph 4576
(b) of this section. Persons must submit a separate Form U for each site for which the 4577
person is required to report. The e

- IURweb reporting software tool is described in the 4578

instructions available from EPA at the website set forth in § 711.35. 4579

(b) Informati on to be reported

. Manufacturers For the 2012 submission period, 4580

m anufacturers (including importers) of a reportable chemical substance in an amount of 4581

25,000 lb

. (11,340 kg) or more at a site during any calendar year since the l ast principal 4582
reporting year (i.e., 2011) must report the information d escribed in this section. As 4583*** Interagency EO 12866 Review Draft

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212 described in § 711.6 paragraphs (b)(1 ) )
, (b)(2), and (b)( 2), manufacturers 3) of certain 4584
chemical substances are not required to this section. For the 2012 submission period, 4585

m anufacture r s (including importers) of a reportable chemical substance in an amount of 4586

100,000 lb ( 45,359 kg) or more at a site during the principal reportin g year (i.e., 2011) 4587

must additionally report the information described in paragraph (b)(4) of this section. For 4588
submission periods subsequent to the 2012 submission period, the information described 4589
in paragraph s (b)(1), (b)(2), (b)(3), and (b)(4) of this section must be reported for each 4590
chemical substance manufactured (including imported) in an amount of 25,000 lb (11,340 4591
kg) or more (or in an amount of 2,500 lb [1,134 kg] or more for chemical substances 4592
subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any 4593
calendar year since the last principal reporting year. The requirement to report 4594

information described in (b)(4) of this section is subject to exemption a s described in § 4595

711.6 4596

(1) A certification statement signed and dated by an authorized official of the 4597
submitter company

. Persons reporting must submit this information using e

- IURweb as 4598

described in § 711.35. The authorized official must certify that the submitted information 4599
has been completed in compliance with the requirements of this part and that the 4600
confidentiality claims made on the Form U a re true and correct. The certification must be 4601
signed and dated by the authorized official for the submitter company, and provide that 4602
person‘s name, official title, and e

- mail address. 4603

(2) Company and plant site information . The following currently corr ect company 4604
and plant site information must be reported for each site at which at least 25,000 lb. 4605
(11,340 kg) of a reportable chemical substance is manufactured (including imported) 4606*** Interagency EO 12866 Review Draft

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213 during any calendar year since above the last principal reporting year applicable 4607
production volume threshold, as described in this section (see § 711.3 for the ―site‖ f or 4608
importers): 4609

(i) The U.S. parent company name, address, and Dun and Bradstreet Number. D

4610

U

- N

- S® (D&B) n umber. A submitter under this part must obtain a Dun and Bradstreet 4611

Number D & B n umber for the parent company if none exists. 4612
(ii) The name of a person who will serve as technical con tact for the submitter 4613
company, and who will be able to answer questions about the information submitted by 4614
the company to EPA, the contact person's full mailing address, telephone number, and e

4615

mail address. 4616

(iii) The name and full street address of each site. A submitter under this part must 4617
include the appropriate Dun and Bradstreet Number D & B n umber for each plant site 4618
reported, and the county or parish (or other jurisdictional indicator) in which the plant site 4619
is located. A submitter under this part must obtain a Dun and Bradstreet Number DB 4620

n umber fo r the site reported if none exists. 4621

(3) Specific information for chemical subs tances manufactured in amounts of 4622

25,000 lb. or more Chemical

- s pecific information

. The following chemical

- specific 4623
information must be reported for each reportable chemical substance manufactured 4624
(including imported) at each site in amounts of 25,000 lb. (11,340 kg) or more during any 4625
calendar year since above the last principal reporting year applicable production volume 4626

threshold, as described in paragraph (b) of this section : 4627
(i) The specific, currently correct Chemical Abstracts ( CA) Index name as used to 4628
list the chemical substance on the TSCA Inventory and the correct corresponding 4629*** Interagency EO 12866 Review Draft

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***

214 Chemical Abstracts Service (CAS) Registry Numb er ( CASRN) for each reportable 4630
chemical substance at each site. A submitter under this part may use an EPA

- designated 4631

TSCA Accession Number for a chemical substance in lieu of a CASRN when a CASRN 4632
is not known to or reasonably ascertainable by the submitte r. Submitters who wish to 4633
report chemical substances listed on the confidential portion of the TSCA Inventory will 4634
need to report the chemical substance using a TSCA Accession Number. 4635
In addition to reporting the number itself, submitters must specify th e type of 4636
number they are reporting by selecting from among the codes in Table 3 of this 4637
paragraph. 4638

Table 3.

— Codes to Specify Type of Chemical Identifying Number 4639 Code Number Type A Accession Number C Chemical Abstracts Service Registry Number (CASRN) 4640

4641
( A) If an importer submitting a report cannot provide the information specified in 4642

§ 711.15(b)(3)(i) of this section because it is unknown to the importer and claimed as 4643
confidential by the supplier of the chemical substance or mixture, the importer must us e 4644

e

- IURweb to ask the supplier to provide the correct chemical identity information directly 4645
to EPA in a joint submission. Such request must include instructions for submitting 4646
chemical identity information electronically, using e

- IURweb and CDX (see § 71 1.35), 4647
and for clearly referencing the importer's submission. Contact information for the 4648
supplier, a trade name or other designation for the chemical substance or mixture, and a 4649
copy of the request to the supplier must be included with the importer‘s su bmission 4650
respecting the chemical substance. 4651*** Interagency EO 12866 Review Draft

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215 (B) If a manufacturer submitting a report cannot provide the information specified 4652

in § 711.15(b)(3)(i) of this section because the reportable chemical substance is 4653
manufactured using a reactant having a specifi c chemical identity that is unknown to the 4654
manufacturer and claimed as confidential by its supplier, the manufacturer must use e

4655
IURweb to ask the supplier of the confidential reactant to provide the correct chemical 4656
identity of the confidential reactant d irectly to EPA in a joint submission. Such request 4657
must include instructions for submitting chemical identity information electronically 4658
using e

- IURweb and CDX (see § 711.35), and for clearly referencing the manufacturer's 4659

submission. Contact information for the supplier, a trade name or other designation for 4660
the chemical substance, and a copy of the request to the supplier must be included with 4661
the importer‘s submission respecting the chemical substance. 4662
(C) EPA will only accept joint submissions that a re submitted electronically using 4663

e

- IURweb and CDX (see § 711.35) and that clearly reference the primary submission to 4664
which they refer. 4665
(ii) For the principal reporting year only, a statement indicating, for each 4666
reportable chemical substance at each sit e, whether the chemical substance is 4667
manufactured in the United States, imported into the United States, or both manufactured 4668
in the United States and imported into the United States. 4669
(iii) For the principal reporting year, the total annual volume (in pou nds) of each 4670
reportable chemical substance domestically manufactured and or imported at each site. 4671
The total annual domestically manufactured volume (not including imported volume) and 4672
the total annual imported volume must be separately reported. This amount Th ese 4673

amount s must be reported to two significant figures of accuracy. For each complete 4674*** Interagency EO 12866 Review Draft

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216 calendar year since the last principal reporting year In addition, f or the 2012 submission 4675
period only
, the total annual volume (domestically manufactured and plus imported 4676
volumes in pounds) of each reportable chemical substance at each site during calend ar 4677
year 2010

. In addition, f or submis sion periods subsequent to the 2012 submission period, 4678
the total annual volume (domestically manufactured plus imported volumes in pounds) of 4679
each reportable chemical substance at each site for each complete calendar ye ar since the 4680
last principal reporting year

. 4681
(iv) For the principal reporting year only, the volume used on site and the volume 4682
directly exported of each reportable chemical substance domestically manufactured a nd or 4683
imported at each site. This amount Th ese amount s must b e reported to two significant 4684
figures of accuracy. 4685
(v) For the principal reporting year only, a designation indicating, for each 4686
imported reportable chemical substance at each site, whether the imported chemical 4687
substance is physically present at the repo rting site. 4688
(vi) For the principal reporting year only, a designation indicating, for each 4689
reportable chemical substance at each site, whether the chemical substance is being 4690
recycled, remanufactured, reprocessed, reused, or otherwise used for a commercia l 4691
purpose instead of being disposed of as a waste or included in a waste stream. 4692
(vii) For the principal reporting year only, the total number of workers reasonably 4693
likely to be exposed to each reportable chemical substance at each site. For each 4694
reportab le chemical substance at each site, the submitter must select from among the 4695
ranges of workers listed in Table 4 of this paragraph and report the corresponding code 4696
(i.e., W1 through W8): 4697*** Interagency EO 12866 Review Draft

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217 Table 4.

— Codes for Reporting Number of Workers Reasonably Likely To Be 4698 Exposed 4699 Code Range W1 Fewer than 10 workers W2 At least 10 but fewer than 25 workers W3 At least 25 but fewer than 50 workers W4 At least 50 but fewer than 100 workers W5 At least 100 but fewer than 500 workers W6 At least 500 but fewer than 1,000 workers W7 At least 1,000 but fewer than 10,000 workers W8 At least 10,000 workers 4700 (viii) For the principal reporting year only, the maximum concentration, measured 4701
by percentage of weight, of each reportable chemical substance at the time it is sent off

4702

site from each site. If the chemical substance is site

- limited, you must report the 4703
maximum concentration, measured by percentage of weight of the reportable chemical 4704

substance at the time it is reacted on

- site to produce a different chemical substanc e. This 4705
information must be reported regardless of the physical form(s) in which the chemical 4706

substance is sent off

- site/reacted on

- site. For each chemical substance at each site, select 4707
the maximum concentration of the chemical substance from among the ra nges listed in 4708
Table 5 of this paragraph and report the corresponding code (i.e., M1 through M5): 4709

Table 5.

— Codes for Reporting Maximum Concentration of Chemical Substance 4710 Code Concentration Range (% weight) M1 Less than 1% by weight M2 At least 1 but les s 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 4711 (ix) For the principal reporting year only, the physical form(s) of the reportable 4712

chemical substance as it is sent o ff

- site from each site. If the chemical substance is site

4713
limited, you must report the physical form(s) of the reportable chemical substance at the 4714

time it is reacted on

- site to produce a different chemical substance. For each chemical 4715*** Interagency EO 12866 Review Draft

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218 substance at each si te, the submitter must report as many physical forms as applicable 4716
from among the physical forms listed in this unit: 4717
(A) Dry powder. 4718
(B) Pellets or large crystals. 4719

(C) Water

- or solvent

- wet solid. 4720

(D) Other solid. 4721
(E) Gas or vapor. 4722
(F) Liquid. 4723

(x) For the principal reporting year only, submitters must report the percentage, 4724
rounded off to the closest 10%, of total production volume of the reportable chemical 4725

substance, reported in response to paragraph (b)(3)(iii) of this section, that is associated 4726
with each physical form reported under paragraph (b)(3)(ix) of this section. 4727

(4) Specific Chemical

- s pecific information related to processing and use

. The 4728
following chemical

- specific information must be reported for each reportable chemical 4729

substance manufactu red (including imported) above the applicable production volume 4730

threshold, as described in this section. Persons subject to paragraph (b)( 3 4 ) of this section 4731
must report the information described in paragraphs (b)(4)(i) and (b)(4)(ii) of this section 4732

for ea ch reportable chemical substance at sites under their control and at sites that receive 4733
a reportable chemical substance from the submitter directly or indirectly (including 4734
through a broker/distributor, from a customer of the submitter, etc.). Information reported 4735
in response to this paragraph must be reported for the principal reporting year only and 4736
only to the extent that it is known to or reasonably ascertainable by the submitter. 4737
Information required to be reported under this paragraph is limited to do mestic (i.e., 4738*** Interagency EO 12866 Review Draft

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***

219 within the customs territory of the United States) processing and use activities. If 4739
information responsive to a given data requirement under this paragraph, including 4740
information in the form of an estimate, is not known or reasonably ascerta inable, the 4741
submitter is not required to respond to the requirement. 4742

(i) Industrial processing and use information

— (A) A designation indicating the 4743
type of industrial processing or use operation(s) at each site that receives a reportable 4744

chemical substanc e from the submitter site directly or indirectly (whether the recipient 4745
site(s) are controlled by the submitter site or not). For each chemical substance, report the 4746
letters which correspond to the appropriate processing or use operation(s) listed in Table 4747
6 of this paragraph. A particular designation may need to be reported more than once, to 4748
the extent that a submitter reports more than one sector (under paragraph (b)(4)(i)(B) of 4749
this section) that applies to a given designation under this paragraph. 4750

Tabl e 6.

— Codes for Reporting Type of Industrial Processing or Use Operation 4751 Designation Operation PC Processing as a reactant PF Processing

— incorporation into formulation, mixture or reaction

product PA Processing

— incorporation into article PK Processing

— r epackaging U Use

— non

- incorporative activities 4752 (B) A code indicating the sector(s) that best describe the industrial activities 4753
associated with each industrial processing or use operation reported under paragraph 4754

(b)(4)(i)(A) of this section. For each c hemical substance, report the code that corresponds 4755
to the appropriate sector(s) listed in Table 7 of this paragraph. A particular sector code 4756
may need to be reported more than once, to the extent that a submitter reports more than 4757

one industrial function code (under paragraph (b)(4)(i)(C) of this section) that applies to a 4758
given sector code under this paragraph. 4759*** Interagency EO 12866 Review Draft

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220 Table 7.

— Codes for Reporting Industrial Sectors 4760 Code Sector Description IS1 Agriculture, Forestry, Fishing and Hunting IS2 Oil and Gas Drilling, Extraction, and support activities IS3 Mining (except Oil and Gas) and support activities IS4 Utilities IS5 Construction IS6 Food, beverage, and tobacco product manufacturing IS7 Textiles, apparel, and leather manufacturing IS8 Wood Product Manufact uring IS9 Paper Manufacturing IS10 Printing and Related Support Activities IS11 Petroleum Refineries IS12 Asphalt Paving, Roofing, and Coating Materials Manufacturing IS13 Petroleum Lubricating Oil and Grease Manufacturing IS14 All other Petroleum an d Coal Products Manufacturing IS15 Petrochemical Manufacturing IS16 Industrial Gas Manufacturing IS17 Synthetic Dye and Pigment Manufacturing IS18 Carbon Black Manufacturing IS19 All Other Basic Inorganic Chemical Manufacturing IS20 Cyclic Crude and Intermediate Manufacturing IS21 All Other Basic Organic Chemical Manufacturing IS22 Plastics Material and Resin Manufacturing IS23 Synthetic Rubber Manufacturing IS24 Organic Fiber Manufacturing IS25 Pesticide, Fertilizer, and Other Agricultural Chemi cal

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 Manuf acturing IS32 Custom Compounding of Purchased Resins IS33 Photographic Film, Paper, Plate, and Chemical Manufacturing IS34 All Other Chemical Product and Preparation Manufacturing IS35 Plastics Product Manufacturing IS36 Rubber Product Manufacturing IS37 Non

- metallic Mineral Product Manufacturing (includes clay, glass,

cement, concrete, lime, gypsum, and other non

- metallic mineral product manufacturing) IS38 Primary Metal Manufacturing IS39 Fabricated Metal Product Manufacturing IS40 Machinery Manu facturing*** Interagency EO 12866 Review Draft

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221 IS41 Computer and Electronic Product Manufacturing IS42 Electrical Equipment, Appliance, and Component Manufacturing IS43 Transportation Equipment Manufacturing IS44 Furniture and Related Product Manufacturing IS45 Miscellaneous Manufacturin g IS46 Wholesale and Retail Trade IS47 Services IS48 Other (requires additional information) 4761 (C) For each sector reported under paragraph (b)(4)(i)(B) of this section, code(s) 4762
from Table 8 of this paragraph must be selected to designate the industria l function 4763
category(ies) that best represents the specific manner in which the chemical substance is 4764
used. A particular industrial function category may need to be reported more than once, 4765
to the extent that a submitter reports more than one industrial pro cessing or use 4766
operation/sector combination (under paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this 4767
section) that applies to a given industrial function category under this paragraph. If more 4768
than 10 unique combinations of industrial processing or use oper ations/sector/industrial 4769
function categories apply to a chemical substance, submitters need only report the 10 4770
unique combinations for the chemical substance that cumulatively represent the largest 4771
percentage of the submitter's production volume for that c hemical substance, measured 4772
by weight. If none of the listed industrial function categories accurately describes a use of 4773
a chemical substance, the category ―Other‖ may be used, and must include a description 4774

of the use. 4775

Table 8.

— Codes for Reporting Indust rial Function Categories 4776 Code Category U001 Abrasives U002 Adhesives and sealant chemicals U003 Adsorbents and absorbents U004 Agricultural chemicals (non

- pesticidal) U005 Anti

- adhesive agents U006 Bleaching agents U007 Corrosion inhibitors and anti

- scaling agents*** Interagency EO 12866 Review Draft

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222 U008 Dyes U009 Fillers U010 Finishing agents U011 Flame retardants U012 Fuels and fuel additives U013 Functional fluids (closed systems) U014 Functional fluids (open systems) U015 Intermediates U016 Ion exchange agents U017 Lubric ants and lubricant additives U018 Odor agents U019 Oxidizing/reducing agents U020 Photosensitive chemicals U021 Pigments U022 Plasticizers U023 Plating agents and surface treating agents U024 Process regulators U025 Processing aids, specific to pet roleum 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) 4777 (D) The estimated percentage, rounded off to the closest 10%, of total production 4778

vol ume of the reportable chemical substance associated with each combination of 4779
industrial processing or use operation, sector, and industrial function category. Where a 4780
particular combination of industrial processing or use operation, sector, and industrial 4781
function category accounts for less than 5% of the submitter's site's total production 4782
volume of a reportable chemical substance, the percentage must not be rounded off to 0% 4783
if the production volume attributable to that industrial processing or use operat ion, sector, 4784*** Interagency EO 12866 Review Draft

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223 and industrial function category combination is 25,000 lb

. (11,340 kg) or more during the 4785
reporting year. Instead, in such a case, submitters must report the percentage, rounded off 4786
to the closest 1%, of the submitter's site's total production volume of the reportable 4787
chemical substance associated with the particular combination of industrial processing or 4788
use operation, sector, and industrial function category. 4789
(E) For each combination of industrial processing or use operation, sector, and 4790

ind ustrial function category, the submitter must estimate the number of sites at which 4791
each reportable chemical substance is processed or used. For each combination associated 4792
with each chemical substance, the submitter must select from among the ranges of si tes 4793
listed in Table 9 of this paragraph and report the corresponding code (i.e., S1 through 4794

S7): 4795

Table 9.

— Codes for Reporting Numbers of Sites 4796 Code Range S1 Fewer than 10 sites S2 at least 10 but fewer than 25 sites S3 at least 25 but fewer than 100 sit es 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 4797 (F) For each combination of industrial processing or use operation, sector, and 4798

industrial function category, the submitter must estimate the number of workers 4799
reasonably likely to be exposed to each reportable chemical substance. For each 4800

combination associated with each chemical substance, the submitter must select from 4801
among the worker ranges listed in paragraph (b)(3)(ii) of this section and report the 4802
corresponding code (i.e., W1 though W8). 4803*** Interagency EO 12866 Review Draft

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224 (ii) Consumer and commercial use information

— (A) Using the codes listed in 4804
Table 10 of this paragraph, submitters must designate the consumer and comme rcial 4805
product category or categories that best describe the consumer and commercial products 4806
in which each reportable chemical substance is used (whether the recipient site(s) are 4807
controlled by the submitter site or not). If more than 10 codes apply to a c hemical 4808
substance, submitters need only report the 10 codes for the chemical substance that 4809
cumulatively represent the largest percentage of the submitter's production volume for 4810
that chemical, measured by weight. If none of the listed consumer and commerc ial 4811
product categories accurately describes the consumer and commercial products in which 4812
each reportable chemical substance is used, the category ―Other‖ may be used, and must 4813
include a description of the use. 4814

Table 10.

— Codes for Reporting Consumer and Co mmercial Product Categories 4815 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 Che mical Substances in Construction, Paint, Electrical, and Metal Products C201 Adhesives and Sealants C202 Paints and Coatings C203 Building/Construction Materials

- Wood and Engineered Wood Products C204 Building/Construction Materials not covered else where 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*** Interagency EO 12866 Review Draft

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225 C303 Plastic and Rubber Products n ot covered elsewhere C304 Toys, Playground, and Sporting Equipment C305 Arts, Crafts, and Hobby Materials C306 Ink, Toner, and Colorant Products C307 Photographic Supplies, Film, and Photochemicals Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products C401 Automotive Care Products C402 Lubricants and Greases C403 Anti

- Freeze and De

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

- pesticidal) C407 Lawn and Garden Care Pr oducts

Chemical Substances in Products not Described by Other Codes C980 Non

- TSCA Use C909 Other (specify) 4816 (B) An indication, within each consumer and commercial product category 4817
reported under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a 4818

commercial use. 4819
(C) Submitters must determine, within each consumer and commercial product 4820
category reported under paragraph (b)(4)(ii)(A) of this section, whether any amount of 4821
each reportable chemical substance manufactured (includin g imported) by the submitter 4822
is present in (for example, a plasticizer chemical substance used to make pacifiers) or on 4823
(for example, as a component in the paint on a toy) any consumer products intended for 4824
use by children age 14 or younger, regardless of the concentration of the chemical 4825
substance remaining in or on the product. Submitters must select from the following 4826
options: The chemical substance is used in or on any consumer products intended for use 4827
by children, the chemical substance is not used in or on any consumer products intended 4828
for use by children, or information as to whether the chemical substance is used in or on 4829
any consumer products intended for use by children is not known to or reasonably 4830
ascertainable by the submitter. 4831*** Interagency EO 12866 Review Draft

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226 (D) The estima ted percentage, rounded off to the closest 10%, of the submitter's 4832
site's total production volume of the reportable chemical substance associated with each 4833
consumer and commercial product category. Where a particular consumer and 4834
commercial product categor y accounts for less than 5% of the total production volume of 4835
a reportable chemical substance, the percentage must not be rounded off to 0% if the 4836
production volume attributable to that commercial and consumer product category is 4837

25,000 lb

. (11,340 kg) or m ore during the reporting year. Instead, in such a case, 4838
submitters must report the percentage, rounded off to the closest 1%, of the submitter's 4839
site's total production volume of the reportable chemical substance associated with the 4840
particular consumer and commercial product category. 4841
(E) Where the reportable chemical substance is used in consumer or commercial 4842
products, the estimated typical maximum concentration, measured by weight, of the 4843
chemical substance in each consumer and commercial product catego ry reported under 4844
paragraph (b)(4)(ii)(A) of this section. For each chemical substance in each commercial 4845
and consumer product category reported under paragraph (b)(4)(ii)(A) of this section, 4846
submitters must select from among the ranges of concentrations l isted in Table 5 in 4847
paragraph (b)(3)(viii) of this section and report the corresponding code (i.e., M1 through 4848

M5). 4849
(F) Where the reportable chemical substance is used in a commercial product, the 4850

submitter must estimate the number of commercial workers r easonably likely to be 4851
exposed to each reportable chemical substance. For each combination associated with 4852
each substance, the submitter must select from among the worker ranges listed in Table 4 4853*** Interagency EO 12866 Review Draft

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227 in paragraph (b)(3)(vii) of this section and report the corr esponding code (i.e., W1 though 4854

W8). 4855

§ 711.20 When to report. 4856
All information reported to EPA in response to the requirements of this part must 4857
be submitted during an applicable submission period . For the 2012 IUR, the submission 4858
period is from February 1, 2012 to June 30, 2012. Subsequent recurring submission 4859
periods are from June 1 to September 30 at 4

– year intervals, beginning in 2011. Any 4860

201 6

. In each submission period, any person described in § 711.8 (a) must report during 4861
each submission period for each chemical substance as described in § 711.5 that the 4862
person manufactured (including imported) during any calendar year since the last 4863
principal reporting year (e.g., for the 2011 submission period, cons ider calendar years 4864
2006, 2007, 2008, 2009, and 2010, since 2005 was the last principal reporting year). this 4865

part. 4866

§ 711.22 Duplica tive reporting. 4867

(a) With regard to TSCA section 8(a) rules . Any person subject to the 4868
requirements of this part who previously has complied with reporting requirements of a 4869
rule under TSCA section 8(a) by submitting the information described in § 711.15 f or a 4870

chemical substance described in § 711.5 to EPA, and has done so within 1 year of the 4871
start of a submission period described in § 711.20, is not required to report again on the 4872
manufacture of that chemical substance at that site during that submission period. 4873

(b) With regard to importers . This part requires that only one report be submitted 4874
on each import transaction involving a chemical substance described in § 711.5. When 4875
two or more persons are involved in a particular import transaction and each pe rson 4876*** Interagency EO 12866 Review Draft

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228 meets the Agency's definition of ―importer‖ as set forth in 40 CFR 704.3, they may 4877
determine among themselves who should submit the required report; if no report is 4878
submitted as required under this part, EPA will hold each such person liable for failu re to 4879

report. 4880

(c) Toll manufacturers and persons contracting with a toll manufacturer . This 4881
part requires that only one report per site be submitted on each chemical substance 4882

described in § 711.5. When a company contracts with a toll manufacturer to manufacture 4883
a chemical substance, and each party meets the Agency's definition of ―manufac turer‖ as 4884

set forth in § 711.3, they may determine among themselves who should submit the 4885
required report for that site. However, both the contracting company and the toll 4886
manufacturer are liable if no report is made. 4887

§ 711.25 Recordkeeping requirements. 4888
Each person who is subject to the reporting requirements of this part must retain 4889
records that document any information reported to EPA. Records relevant to reporting 4890
during a submission period must be retained for a period of 5 years beginning on the las t 4891
day of the submission period. Submitters are encouraged to retain their records longer 4892
than 5 years to ensure that past records are available as a reference when new 4893
submissions are being generated. 4894

§ 711.30 Confidentiality claims. 4895

(a) Confidentiality claims . Any person submitting information under this part may 4896
assert a business confidentiality claim for the information at the time it is submitted. Any 4897
such confidentiality claims must be made at th e time the information is submitted. 4898
Confidentiality claims cannot be made when a response is left blank or designated as not 4899*** Interagency EO 12866 Review Draft

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229 known or reasonably ascertainable. These claims will apply only to the information 4900
submitted with the claim. New confidentiality claim s, if appropriate, must be asserted 4901
with regard to information submitted during a different submission period. Guidance for 4902
asserting confidentiality claims is provided in the instructions identified in § 711.35. 4903

Information claimed as confidential in acco rdance with this section will be treated and 4904
disclosed in accordance with the procedures in 40 CFR part 2. 4905

(b) Chemical identity . A person may assert a claim of confidentiality for the 4906
chemical identity of a specific chemical substance only if the identit y of that chemical 4907
substance is treated as confidential in the Master Inventory File as of the time the report 4908
is submitted for that chemical substance under this part. The following steps must be 4909
taken to assert a claim of confidentiality for the identity of a reportable chemical 4910

substance: 4911
(1) The submitter must submit with the report detailed written answers to the 4912
following questions signed and dated by an authorized official. 4913
(i) What harmful effects to your competitive position, if any, or to your s upplier‘s 4914
competitive position, do you think would result from the identity of the chemical 4915
substance being disclosed in connection with reporting under this part? How could a 4916
competitor use such information? Would the effects of disclosure be substantial? What is 4917
the causal relationship between the disclosure and the harmful effects? 4918
(ii) How long should confidential treatment be given? Until a specific date, the 4919
occurrence of a specific event, or permanently? Why? 4920
(iii) Has the chemical substance been p atented? If so, have you granted licenses to 4921
others with respect to the patent as it applies to the chemical substance? If the chemical 4922*** Interagency EO 12866 Review Draft

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230 substance has been patented and therefore disclosed through the patent, why should it be 4923

treated as confidential? 4924

(iv) Has the identity of the chemical substance been kept confidential to the extent 4925
that your competitors do not know it is being manufactured or imported for a commercial 4926
purpose by anyone? 4927
(v) Is the fact that the chemical substance is being manufactured (i ncluding 4928
imported) for a commercial purpose available to the public, for example in technical 4929
journals, libraries, or State, local, or Federal agency public files? 4930
(vi) What measures have been taken to prevent undesired disclosure of the fact 4931

that the che mical substance is being manufactured (including imported) for a commercial 4932
purpose? 4933

(vii) To what extent has the fact that this chemical substance is manufactured 4934
(including imported) for commercial purposes been revealed to others? What precautions 4935

have been taken regarding these disclosures? Have there been public disclosures or 4936
disclosures to competitors? 4937
(viii) Does this particular chemical substance leave the site of manufacture 4938
(including import) in any form, e.g., as product, effluent, emission? I f so, what measures 4939
have been taken to guard against the discovery of its identity? 4940
(ix) If the chemical substance leaves the site in a product that is available to the 4941
public or your competitors, can the chemical substance be identified by analysis of th e 4942
product? 4943
(x) For what purpose do you manufacture (including import) the substance? 4944*** Interagency EO 12866 Review Draft

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231 (xi) Has EPA, another Federal agency, or any Federal court made any pertinent 4945
confidentiality determinations regarding this chemical substance? If so, please attach 4946
copi es of such determinations. 4947
(2) If any of the information contained in the answers to the questions listed in 4948
paragraph (b)(1) of this section is asserted to contain confidential business information 4949
(CBI), the submitter must clearly identify the informati on that is claimed confidential by 4950
marking the specific information on each page with a label such as ―confidential business 4951
information,‖ ―proprietary,‖ or ―trade secret.‖ 4952

(c) Site identity . A submitter may assert a claim of confidentiality for a site on ly if 4953
the linkage of the site with a reportable chemical substance is confidential and not 4954
publicly available. The following steps must be taken to assert a claim of confidentiality 4955
for a site identity: 4956
(1) The submitter must submit with the report detail ed written answers to the 4957
following questions signed and dated by an authorized official: 4958
(i) Has site information been linked with a chemical identity in any other Federal, 4959
State, or local reporting scheme? For example, is the chemical identity linked to a facility 4960
in a filing under the Emergency Planning and Community Right

- to

- Know Act (EPCRA) 4961
section 311, namely through a Material Safety Data Sheet (MSDS)? If so, identify all 4962
such schemes. Was the linkage claimed as confidential in any of these instance s? 4963
(ii) What harmful effect, if any, to your competitive position do you think would 4964
result from the identity of the site and the chemical substance being disclosed in 4965
connection with reporting under this part? How could a competitor use such information? 4966*** Interagency EO 12866 Review Draft

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232 Would the effects of disclosure be substantial? What is the causal relationship between 4967

the disclosure and the harmful effects? 4968
(2) If any of the information contained in the answers to the questions listed in 4969
paragraph (c)(1) of this section is asserted to contain CBI, the submitter must clearly 4970
identify the information that is claimed confidential by marking the specific information 4971
on each page with a label such as ―confidential business information,‖ ―proprietary,‖ or 4972

―trade secret.‖ 4973

(d) Processing a nd use information . A submitter may assert a claim of 4974
confidentiality for each data element required by § 711.15(b)(4) only if the linkage of the 4975
information with a reportable chemical substance is confidential and not publicly 4976
available. The following ste ps must be taken to assert a claim of confidentiality for each 4977
data element, individually, required by § 711.15(b)(4): 4978
(1) The submitter must submit with the report detailed written answers to the 4979
following questions signed and dated by an authorized offi cial: 4980
(i) Is the identified use of this chemical substance publicly known? For example, 4981
is information on the use available in advertisements or other marketing materials, 4982
professional journals or other similar materials, or in non

- confidential mandatory or 4983
voluntary government filings or publications? Has your company ever provided use 4984

information on the chemical substance that was not claimed as confidential? 4985
(ii) What harmful effect, if any, to your competitive position or to your 4986
customer‘s competiti ve position do you think would result from the information reported 4987
as required by § 711.15(b)(4) and the chemical substance being disclosed in connection 4988
with reporting under this part? How could a competitor use such information? Would the 4989*** Interagency EO 12866 Review Draft

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233 effects of dis closure be substantial? What is the causal relationship between the 4990

disclosure and the substantial harmful effects? 4991
(2) If any of the information contained in the answers to the questions listed in 4992
paragraph (d)(1) of this section is asserted to contain C BI, the submitter must clearly 4993
identify the information that is claimed confidential by marking the specific information 4994
on each page with a label such as ―confidential business information,‖ ―proprietary,‖ or 4995

―trade secret.‖ 4996

(e) No claim of confidentiali ty . If no claim of confidentiality is indicated on Form 4997
U submitted to EPA under this part; if Form U lacks the certification required by 4998
§ 711.15(b)(1); if confidentiality claim substantiation required under paragraphs (b), (c), 4999

and (d) of this section is not submitted with Form U; or if the identity of a chemical 5000

substance listed on the non

- confidential portion of the Master Inventory File is claimed as 5001
confidential, EPA may make the information available to the public without further 5002

n otice to the submitter. 5003

§ 711.35 Electronic filing. 5004

(a) You must use e

- IURweb to complete and submit Form U; EPA Form 7740

– 8. 5005
Submissions may only be made as set forth in this section. 5006
(b) Submissions must be sent electronically to EPA via CDX. 5007

(c) A ccess e

- IURweb and instructions, as follows: 5008

(1) By website . Go to the EPA Inventory Update Reporting Internet homepage at 5009
http://www.epa.gov/iur and follow the appropriate links. 5010

(2) By phone or e

- mail . Contact the EPA TSCA Hotline at (202) 554

– 1404 or 5011 TSCA

- Hotline@epa.gov for a CD

- ROM containing the instructions. 5012