** Working Draft  Do Not Cite or Quote  Not for Public Release ** OMB Submission Draft 02/ 05/ 2002  Do not cite or quote. 1 ENVIRONMENTAL PROTECTION AGENCY 2 40 CFR Part 710 3 [ OPPTS 82053A; FRL 6767 4] 4 RIN 2070 AC61 5 TSCA Inventory Update Rule Amendments 6 AGENCY: Environmental Protection Agency ( EPA). 7 ACTION: Final rule. 8 _______________________________________________________________________ 9 SUMMARY: EPA is promulgating amendments to the Toxic Substances Control Act ( TSCA) 10 section 8( a) Inventory Update Rule ( IUR). The IUR currently requires manufacturers ( including 11 importers) of certain chemical substances on the TSCA Chemical Substances Inventory to report 12 data on each chemical's current production volume, site limited status, and plant site information 13 every four years. Through these IUR amendments ( IURA), EPA is requiring the reporting of 14 additional data for certain chemicals to assist EPA and others in screening potential exposures and 15 risks resulting from industrial chemical operations and commercial and consumer uses of TSCA 16 chemical substances. EPA is also modifying the IUR reporting and recordkeeping requirements, 17 removing one reporting exemption and creating others, and modifying its procedures for making 18 and retaining Confidential Business Information ( CBI) claims. EPA is also making certain non 19 substantive technical corrections. 20 DATES: This final rule is effective on [ insert date 90 days after date of publication in the 21 Federal Register]. For purposes of judicial review, this rule shall be promulgated at 1pm eastern 22 daylight/ standard time on [ insert date 2 weeks after publication in the FR] ( See 40 CFR 23.5). 23 FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara 24 2 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention 25 and Toxics ( 7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 26 Washington, DC 20460; telephone number: ( 202) 564 8170; e mail address: 27 TSCA Hotline@ epa. gov. 28 For technical information contact: Susan Sharkey, Project Manager, Economics, 29 Exposure and Technology Division, ( 7406), Office of Pollution Prevention and Toxics, 30 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 31 telephone number: 202 564 8789; e mail address: sharkey. susan@ epa. gov. 32 SUPPLEMENTARY INFORMATION: 33 I. General Information 34 A. Does this Action Apply to Me? 35 You may be affected by this action if you manufacture ( defined by statute to include 36 import) chemical substances currently subject to reporting under the Inventory Update Rule 37 ( IUR) at 40 CFR part 710 or if you manufacture inorganic chemical substances. Any use of the 38 term " manufacture" in this document will encompass " import," unless otherwise stated. In the 39 past, persons that only are processors of chemical substances have not been required to comply 40 with the requirements of 40 CFR part 710. These amendments do not change the status of 41 processors under the regulations at 40 CFR part 710. Potentially affected categories and entities 42 may include, but are not limited to: 43 ° Chemical manufacturers ( defined by statute to include importers) currently subject to 44 IUR reporting, and chemical manufacturers ( defined by statute to include importers) of inorganic 45 chemical substances ( NAICS codes 325, 32411). 46 3 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** This listing is not intended to be exhaustive, but rather provides a guide for readers 47 regarding entities likely to be affected by this action. Other types of entities not listed in the table 48 in this unit could also be affected. North American Industrial Classification System ( NAICS) 49 codes have been provided to assist you and others in determining whether this action applies to 50 certain entities. To determine whether you or your business is affected by this action, you should 51 carefully examine the applicability provisions in section 710.28 in the regulatory text. If you have 52 any questions regarding the applicability of this action to a particular entity, consult the technical 53 contact person listed under " FOR FURTHER INFORMATION CONTACT." 54 B. How Can I Get Additional Information, Including Copies of this Document or Other Related 55 Documents? 56 1. Electronically. You may obtain electronic copies of this document, and certain other 57 related documents that are available electronically, from the EPA Internet Home Page at 58 http:// www. epa. gov/. To access this document, on the Home Page select " Laws and 59 Regulations" and then, using the publication date, look up the entry for this document under 60 " Federal Register Environmental Documents." You can also go directly to the Federal 61 Register listings at http:// www. epa. gov/ fedrgstr/. 62 EPA's Office of Pollution Prevention and Toxics ( OPPT) has a homepage at 63 www. epa. gov/ opptintr. You may also find more information on the IUR and IURA at 64 www. epa. gov/ opptintr/ iuramend. 65 2. In person. The Agency has established an official record for this action under docket 66 control number OPPTS 82053. The official record consists of the documents specifically 67 referenced in this action, any public comments received during an applicable comment period, and 68 4 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** other information related to this action, including any information claimed as Confidential 69 Business Information ( CBI). The official record includes the documents that are physically 70 located in the docket, as well as the materials that are referenced in those documents. The public 71 version of the official record does not include any information claimed as CBI. The public version 72 of the official record, which includes printed, paper versions of any electronic comments 73 submitted during an applicable comment period, is available for inspection in the TSCA 74 Nonconfidential Information Center, North East Mall Rm. B 607, Waterside Mall, 401 M St., 75 SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, 76 excluding legal holidays. The telephone number for the Center is ( 202) 260 7099. 77 II. Background 78 A. What Action is the Agency Taking? 79 1. Substantive Changes to the CFR. EPA is promulgating amendments to the IUR which 80 were proposed on August 26, 1999 ( 64 FR 46772). By this action, EPA is making several 81 changes to the current IUR reporting requirements described at 40 CFR part 710, taking into 82 consideration comments received on the proposal. The following is a brief listing of the primary 83 changes, which are described in more detail in this document, along with a summary of the 84 comments received and the Agency's summary response to those comments. A sample copy of 85 revised reporting Form U is located in Unit II. F. of this preamble. 86 First, EPA is amending 40 CFR 710.28 and 710.32 to raise the production volume basic 87 reporting threshold from the current 10,000 pounds ( lbs.) per year to 25,000 lbs. per year, and to 88 add a new larger volume reporting threshold of 300,000 lbs. per year for the reporting of 89 exposure related processing and use information. 90 5 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Second, EPA is amending 40 CFR 710.32 to add exposure related information to the 91 reporting requirements for chemical substances covered by the IUR. Specifically, the Agency is 92 requiring that manufacturers subject to the amended rule (" submitters") report, in ranges: ( 1) the 93 number of workers reasonably likely to be exposed to the chemical substance at the site of 94 manufacture; ( 2) the physical form( s) in which the chemical substance is sent off site; ( 3) the 95 percentage of total reported production volume associated with each physical form; and, ( 4) the 96 maximum concentration of the chemical substance at the time it is reacted on site to produce a 97 different chemical substance or it leaves the submitter's manufacturing site. 98 Third, EPA is amending 40 CFR 710.32 to require chemical manufacturers of chemical 99 substances with production volumes of 300,000 lbs. or greater to report certain exposure related 100 information concerning the processing and use of each reportable chemical substance that is 101 conducted at sites controlled by the submitter and at    downstream'' sites that receive the 102 reportable chemical substance from the submitter directly or indirectly ( including through a 103 broker/ distributor, from a customer of the submitter, etc.). Specifically, manufacturers of these 104 larger production volume chemical substances will be required to report, to the extent the 105 information is readily obtainable: 106 1. The type of industrial processing or use operation at each site, including downstream 107 sites. 108 2. The five digit North American Industrial Classification System (" NAICS") codes that 109 best describe the industrial activities during the processing or use operation. 110 3. The " industrial functions" of each chemical substance during the processing or use 111 operation, for each NAICS code reported. 112 4. The percentages of the submitter's production volume used in each industrial function 113 6 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** category. 114 5. The number of sites where the various processing and use operations occur. 115 6. The number of workers reasonably likely to be exposed to the chemical substance in 116 each processing or use operation. 117 7. The categories of commercial and consumer uses of the reportable chemical substance. 118 8. An indication of the presence of the reportable chemical substance in consumer 119 products intended for use by children. 120 9. The percentages of the submitter's production volume associated with each commercial 121 and consumer product use category. 122 10. The maximum concentration of the reportable chemical substance in each commercial 123 and consumer product use category. 124 Fourth, EPA is revoking the current full exemption from IUR reporting at 40 CFR 125 710.26( a) for inorganic chemical substances, and is phasing in reporting for these substances. For 126 the first submission period following promulgation of these amendments, EPA is requiring partial 127 reporting for these substances ( i. e., inorganic chemical substances would not be subject to the 128 reporting of processing and use information). In subsequent submission periods, manufacturers of 129 an inorganic substance will be subject to the processing and use information reporting 130 requirements, to the extent that they manufacture at least 300,000 lbs. of the substance at a site. 131 Fifth, EPA is amending 40 CFR 710.26 to create a partial reporting exemption for certain 132 chemical substances termed " petroleum process streams" for purposes of reporting under the 133 amended IUR. 134 Sixth, EPA is amending 40 CFR 710.26 to provide a full exemption from IUR reporting 135 for certain forms of natural gas. 136 7 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Seventh, EPA is amending 40 CFR 710.32 to require the reporting of more specific 137 information to assist in the accurate identification of plant sites reporting under IUR. 138 Eighth, EPA is amending 40 CFR 710.28, 710.32, and 710.33 to change the period for 139 which reporting is required from a corporate fiscal year to a calendar year basis. 140 Ninth, EPA is amending 40 CFR 710.32 to allow submitters to claim their production 141 volume range as CBI, in addition to the existing requirement that submitters report a specific 142 production volume number and the CBI status of that specific number. Under the IURA, some 143 submitters may choose to assert a confidentiality claim for specific production volume information 144 while releasing the more general production volume range as public information. 145 Tenth, EPA is amending 40 CFR 710.38 to require substantiation of plant site 146 confidentiality claims at the time such claims are made in IUR submissions to EPA ( i. e., " upfront 147 substantiation"), in a manner similar to the upfront substantiation of chemical identity, which will 148 continue to be required under 40 CFR 710.38. 149 Eleventh, EPA is adding a new section, 40 CFR 710.39, to require submitters in reporting 150 years after the 2006 submission period to reassert CBI claims made in reports submitted to EPA 151 under the IURA in order to retain their confidential status. 152 Finally, EPA is amending 40 CFR 710.37 to extend the records retention period from four 153 years to five years. 154 2. Necessary Conforming Technical Changes to the CFR. The amendments to the IUR 155 that are contained in this final rule, as well as the parts of 40 CFR part 710 that are unchanged by 156 these amendments, are codified in new 40 CFR part 711. EPA believes that establishing a new 40 157 CFR part 711 will avoid confusion within the regulated community and will enable EPA to 158 publish these amendments in a timely fashion. Because promulgation of these regulations 159 8 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** overlaps a current reporting cycle, EPA must maintain 40 CFR part 710 as it currently stands until 160 December 31, 2002. The existing regulations at 40 CFR part 710 will therefore be in effect 161 throughout the 2002 reporting cycle and submission period. Submitters filing IUR reports in 162 2002 must follow the regulations at 40 CFR part 710. On January 1, 2003, the regulations at 40 163 CFR part 711 will become effective. Since the Agency has duplicated in 40 CFR part 711 those 164 provisions from 40 CFR part 710 that are unchanged by these amendments, once the current 165 reporting cycle is complete, 40 CFR part 710 will no longer be applicable and the Agency will 166 issue a technical correction to remove it from the CFR. The creation of 40 CFR part 711 does 167 not make any substantive changes other than those that have been presented as corrections in this 168 final rule. 169 Although there are no substantive changes to the provisions from 40 CFR part 710 that 170 have been incorporated into the new 40 CFR part 711, the Agency has made a few minor 171 technical corrections to those provisions. Specifically, the Agency is correcting several 172 typographical errors that appear in the text from 40 CFR part 710, and is making a few other 173 minor non substantive edits to that text. These technical corrections are more completely 174 described in this section. 175 In accordance with plain language principles, EPA has substituted " will" or " must" for 176 " shall." These three terms are considered to be equivalent, and delineate requirements to be 177 followed or met. Corrections were made in the following sections: sec. 711.1( e) [ sec. 710.1( c)]; 178 711.3( a) [ sec. 710.2( a)]; sec. 711.3( b) [ sec. 710.2( b)]; sec. 711.3( c) [ sec. 710.2( c)]; sec. 711.3( d) 179 in the definition for " Administrator" [ sec. 710.2( e)]; sec. 711.3( d) in the definition for " site" [ sec. 180 710.2( w)]; sec. 711.3( d) in the note following the definition for " small quantities for research and 181 development" [ sec. 710.2( y)]; sec. 711.4( b)( 2) [ sec 710.4( b)( 2)]; and sec. 711.4( d) in the note 182 9 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** following the section [ sec. 710.4( d)]. 183 EPA has corrected some punctuation and spelling errors: in sec. 711.3( d) a comma was 184 added in the definition for " small quantities for research and development" and a comma was 185 removed in the note following the definition " small quantities for research and development" [ sec. 186 710.2( y)]; in sec. 711.3( d) " appropriate" was substituted for " appropriated" in the definition for 187 " technically qualified person" [ sec. 710.2( aa)( 2)]; and in sec. 711.4( d)( 5) " photographic films" 188 was substituted for " photographic, films" [ sec. 710.4( d)( 5)]. 189 EPA has made certain additional non substantive changes. In sec. 711.3( d), EPA 190 substituted " 1,000 lbs. ( 455 kg)" for " 1,000 pounds" in the note following the definition for 191 " small quantities for research and development" [ sec. 710.2( y)]; in sec. 711.40( c)( 1), EPA 192 substituted " By telephone" for " By phone" [ sec. 710.39( c)( 1)]; in sec. 711.40( c)( 2), EPA 193 substituted " TSCA Hotline@ epa. gov" for " TSCA Hotline@ epamail. epa. gov" [ sec. 710.39( c)( 2)]; 194 and in secs. 711.40( c) and 711.40( d) EPA substituted " Environmental Protection Agency" for 195 " U. S. Environmental Protection Agency" [ sec. 710.39( c)( 3)]. EPA has substituted " his/ her" for 196 " his" in sections where the word " his" was used: in two instances in sec. 711.3( d) in the definition 197 for " Administrator" [ Sec 710.2( e)]; in sec. 711.3( d) in the definition for importer [ sec. 198 710.2( l)( 2)]; and in sec. 711.3( d) in the definition for " technically qualified person" [ Sec 199 710.2( aa)]. 200 EPA made minor revisions to clarify, but not change, the meaning of certain provisions. 201 In sec. 711.32( c)( 1) " submitter" was substituted for " respondent" and " as described in section 202 711.40" for " from EPA at the address set forth in sec. 710.39"[ secs 710.32( c)( 1)]; in sec. 203 711.32( c)( 3)( iii) " designation indicating, for each reportable chemical substance at each site, " 204 was substituted for " statement for each substance for which information is being submitted 205 10 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** indicating"[ sec. 710.32( c)( 6)]; in sec. 711.32( c)( 3)( iv) " reportable" was substituted for 206 " subject"[ sec. 710.32( c)( 7)]; in sec. 711.38( c) " Chemical identity." was added as a section header 207 to more clearly identify the topic of the section [ sec. 710.38( c)]; in sec. 711.38( c)( 1)( vi) 208 substituted " have been taken" for " have you taken" and " the" for " this"[ sec. 710.38( c)( 1)( vi)]; in 209 sec. 711.38( c)( 2) " listed in section 711.38( c)( 1)" was added for clarification purposes, 210 " submitter" was substituted for " person" and " clearly identify the information that is claimed 211 confidential by marking the specific information on each page with a label such as ` confidential 212 business information,' ` proprietary,' or ` trade secret.'" was substituted for " mark that information 213 as ` trade secret,' ` confidential,' or other appropriate designation." [ sec. 710.38( c)( 2)]; and in sec. 214 711.38( e) " is indicated on the reporting form" was substituted for " accompanies information at 215 the time it is" and " confidentiality claim substantiation" was substituted for " substantiation" 216 [ sec. 710.38( d)]. 217 EPA replaced " manufactured or imported" with " manufactured ( including imported)" to 218 provided consistency and clarification. EPA made this change in: sec. 711.32( c)( 3)( iv) [ sec. 219 710.32( c)( 7)]; sec. 711.38( c)( 1)( v) [ sec. 710.38( c)( 1)( v)]; sec. 711.38( c)( 1)( vi) [ sec. 220 710.38( c)( 1)( vi)]; sec. 711.38( c)( 1)( vii) [ sec. 710.38( c)( 1)( vii)]; sec. 711.38( c)( 1)( viii) [ sec. 221 710.38( c)( 1)( viii)]; sec. 711.38( c)( 1)( x) [ sec. 710.38( c)( 1)( x)]; and sec. 711.28 [ sec. 710.28]. 222 EPA made certain changes in recognition of the different numbering system and 223 organization of part 711: in sec. 711.38( c)( 1)( i) " subpart" was substituted for " part"[ sec. 224 710.38( c)( 1)( i)]; in sec. 711.3( d) " definition" was substituted for " section" [ sec. 710.2( i)]; in sec. 225 711.3( d) " this paragraph" was substituted for " paragraph ( aa)( 3) of this section" [ sec. 226 710.2( aa)( 3)]; and in sec. 711.3( d) " paragraph ( 1) of this definition" was substituted for 227 " paragraph ( aa)( 1) of this section" [ Sec 710.2( aa)( 3)]. The last three changes were made in 228 11 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** recognition that the definitions are no longer separated into sections, but are contained within 229 section ( d). EPA also corrected references to section numbers in accordance with the new part 230 711 numbering. For instance, in sec. 711.3( d) " sec. 711.4( d)( 5)" was substituted for " sec. 231 710.4( d)( 5)" [ sec. 710.2( f)]. 232 Section 553 of the Administrative Procedure Act ( APA), 5 U. S. C. 553( b)( B), provides 233 that, when an agency for good cause finds that notice and public procedure are impracticable, 234 unnecessary or contrary to the public interest, the agency may issue a final rule without providing 235 notice and an opportunity for public comment. EPA has determined that there is good cause for 236 making these minor regulatory changes in this final rule without prior proposal and opportunity 237 for comment because the provisions affected were promulgated after notice and comment and 238 these minor corrections are non substantive and do not affect the meaning or legal affect of the 239 provisions affected, which remains the same as it was when the provision appeared in 40 CFR part 240 710. Thus, notice and public procedure are unnecessary for these minor changes to the provisions 241 from 40 CFR part 710 that are incorporated into the new 40 CFR part 711. EPA finds that this 242 constitutes good cause under 5 U. S. C. 553( b)( B). 243 B. What is the Agency's Authority for Taking this Action? 244 EPA is required under TSCA section 8( b), 15 U. S. C. 2607( b), to compile and keep 245 current an inventory of chemical substances in commerce. This inventory is known as the TSCA 246 Chemical Substances Inventory (" the TSCA Inventory"). In 1977, EPA promulgated a rule ( 42 247 FR 64572, December 23, 1977) under TSCA section 8( a), 15 U. S. C. 2607( a), to compile an 248 inventory of chemical substances in commerce at that time. In 1986, EPA promulgated the initial 249 IUR at 40 CFR 710 ( 51 FR 21447, June 12, 1986), also under TSCA section 8( a), to facilitate the 250 12 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** periodic updating of the inventory and to support activities associated with the implementation of 251 TSCA. 252 TSCA section 8( a)( 1) authorizes the EPA Administrator to promulgate rules under which 253 manufacturers and processors of chemical substances and mixtures ( referred to hereafter as 254    chemical substances'') must maintain such records and submit such information as the 255 Administrator may reasonably require. Under TSCA section 8( a), the Agency may collect 256 information associated with chemical substances to the extent that it is known to, or reasonably 257 ascertainable by the submitter. TSCA section 8( a) gives EPA broad discretion in determining the 258 information for which reporting can be required. Some of the types of information which can be 259 required under TSCA section 8( a)( 2) include: categories of use for each chemical substance, 260 estimates of the amount manufactured or processed for each category of use, a description of the 261 byproducts resulting from the manufacture, processing, use, or disposal of each chemical 262 substance, an estimate of the number of individuals exposed in their places of employment, and 263 the duration of such exposure. 264 TSCA section 8( a) generally excludes small manufacturers and processors of chemical 265 substances from the reporting requirements established in TSCA section 8( a). However, EPA is 266 authorized by TSCA section 8( a)( 3) to require TSCA section 8( a) reporting from small 267 manufacturers and processors with respect to any chemical substance that is the subject of a rule 268 proposed or promulgated under TSCA section 4, 5( b)( 4), or 6, or that is the subject of an order 269 under TSCA section 5( e), or that is the subject of relief that has been granted pursuant to a civil 270 action under TSCA sections 5 or 7. The standard for determining whether an entity qualifies as a 271 " small manufacturer" for purposes of 40 CFR section 710.29, and for 40 CFR part 710 generally, 272 is defined in 40 CFR 704.3. Processors are not currently subject to the regulations at 40 CFR 273 13 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** part 710. 274 This document amends 40 CFR part 710, which contains the Inventory Update Reporting 275 regulations. Failure to comply fully with any provision of this final rule will be a violation of 276 TSCA section 15 and will subject the violator to the penalties of TSCA sections 16 and 17. 277 C. What is the Inventory Update Rule ( IUR)? 278 The IUR requires U. S. manufacturers of organic chemicals to report to EPA every 4 279 years the identity of chemical substances manufactured annually during the reporting year in 280 quantities of 10,000 lbs. or more at each plant site they own or control. The current IUR excludes 281 several categories of substances from its reporting requirements, including polymers, inorganic 282 substances, microorganisms, and naturally occurring chemical substances. Plant sites subject to 283 the rule are currently required to report information such as company name, plant site location, 284 plant site Dun and Bradstreet number( s), identity of the reportable chemical substance, and 285 production volume of each reportable chemical substance. Data were reported to EPA under the 286 IUR in 1986, 1990, 1994, and 1998, and a collection will occur in 2002. 287 The data reported under IUR are used to update the information maintained on the TSCA 288 Inventory, which is a listing of chemical substances in commerce. EPA uses the TSCA Inventory 289 and data reported under the IUR to support many TSCA related activities and to provide overall 290 support for a number of EPA and other Federal health, safety, and environmental protection 291 activities ( See Unit II. E. of this preamble for further explanation of some of these activities). 292 D. Why is EPA amending the IUR? 293 EPA is amending the IUR for three primary reasons: ( 1) to tailor the chemical substance 294 14 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** reporting requirements to more closely match the Agency's information needs; ( 2) to obtain new 295 and updated information relating to potential exposures to a subset of chemical substances listed 296 on the TSCA Inventory; and ( 3) to improve the utility of the information reported. EPA believes 297 that these amendments will enhance the information collected through the IUR, improve the scope 298 of chemicals covered by the rule, and improve specification of CBI requirements, thereby 299 accomplishing these three goals. 300 These goals are supported by the policy in section 2( b)( 1) of TSCA, that    adequate data 301 should be developed with respect to the effect of chemical substances and mixtures on health and 302 the environment and that the development of such data should be the responsibility of those who 303 manufacture and those who process such chemical substances and mixtures.'' EPA believes that 304 the data currently available to EPA are generally inadequate for risk screening purposes. TSCA 305 section 8( a)( 2) authorizes EPA to require manufacturers and processors of chemical substances to 306 report a wide variety of data, including exposure related information which would be reported for 307 certain chemical substances under these amendments to the IUR. These amendments remove 308 certain reporting requirements and add others to focus reporting under the IUR on that 309 information which is most needed by EPA and other Federal agencies for screening, assessing, 310 and managing risk. The availability of these data will enhance public awareness of basic 311 information about chemical substances. 312 Any evaluation of potential    risk'' is generally based on a combination of hazard 313 information and exposure information. EPA relies on risk screening to indicate which chemical 314 substances pose a potential risk to human health or the environment, and thus warrant a more 315 detailed, resource intensive analysis. The EPA Science Advisory Board's report    Reducing Risk: 316 Setting Priorities and Strategies for Environmental Protection'' ( Ref. 1) and the National 317 15 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Academy of Public Administration's report    Setting Priorities, Getting Results, A New Direction 318 for EPA'' ( Ref. 2) recognize that EPA's ability to use risk screening to set priorities and allocate 319 its limited resources has been significantly impeded by a lack of exposure data. The 320 manufacturing, processing, and use of chemicals on the TSCA Inventory result in a wide array of 321 exposure scenarios. The exposure related data included in these IUR amendments will greatly 322 improve EPA's ability to conduct risk screening to identify chemical substances that could pose 323 an unreasonable risk to human health or to the environment, or that otherwise warrant further 324 investigation. 325 E. What are EPA's TSCA Related Chemical Screening and Assessment Activities? 326 TSCA authorizes EPA to gather chemical hazard and exposure data, as well as related 327 information such as production volume, to determine whether a chemical may pose an 328 unreasonable risk of injury to human health or the environment. The Agency is able to institute 329 risk management actions when necessary to mitigate or avoid unreasonable risk. Important 330 elements in a successful chemical risk management program include identifying the chemical 331 substances, manufacturing sites, and exposure scenarios of greatest potential concern, and using 332 that information to set priorities for more detailed risk assessment, further research, advisory 333 notices, or other appropriate actions. To help fulfill its TSCA responsibilities, EPA has 334 established the IUR and other regulations to collect information on commercial chemicals. 335 The TSCA Inventory currently includes more than 76,000 chemical substances. 336 Approximately 8,900 of these chemical substances are non polymer, organic chemical substances 337 manufactured in quantities of 10,000 lbs. or more per year, as reported under the 1998 IUR data 338 collection. EPA estimates that the amended IUR will continue to collect information on 339 16 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** approximately 8,900 chemical substances. However, the set of substances that will be reported 340 under the amended IUR will be somewhat different than the set of substances that was reported 341 under the previous IUR collections primarily because of two changes: raising the basic reporting 342 threshold ( see Unit II. F. 2. of this preamble) and adding reporting on the manufacture of inorganic 343 chemical substances ( see Unit II. F. 1. a. of this preamble). Data collected under the amended IUR 344 will enable EPA to more effectively conduct initial risk screening on a subset of the chemical 345 substances within its purview, as described in the remaining part of this section and in Unit 346 III. A. 1. of this preamble. 347 EPA conducted tiered risk evaluations of chemical substances even prior to the enactment 348 of TSCA in 1976. A tiered approach allows EPA to sort through many chemicals, focus on 349 those of greatest concern, and take appropriate actions. The Agency is thus able to optimize 350 resources while limiting overall regulatory burdens. The essential steps of the tiered risk 351 evaluation include: an initial evaluation ( sometimes preceded by a prescreen of candidate 352 chemicals); basic risk management decisions resulting from the initial screening; more detailed risk 353 assessment when appropriate; and resulting risk management actions, such as regulatory or 354 voluntary efforts to reduce risk. Each of these steps is only as effective as the available data 355 inputs if little data exist to inform the process, each step suffers as a result. 356 Exposure related information collected through the IURA will inform the initial risk 357 screening step. Initial risk screening is conducted using readily accessible information from the 358 scientific literature, as well as other data readily available to the Agency, such as those provided 359 by manufacturers and processors. This information set often is incomplete or of insufficient 360 quality to allow the Agency to reach definitive conclusions about the set of chemicals under 361 review, but may be sufficient to decide which chemicals appear to warrant further evaluation, or 362 17 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** conversely, appear to be low priority and therefore do not currently warrant further review. These 363 initial reviews are often more qualitative than quantitative. Also, continual updates to these data, 364 such as the recurring reporting of exposure related data under these IURA, will ensure that the 365 most serious concerns will be addressed even as chemical quantities and exposure potentials 366 change between submission periods. 367 The effectiveness of risk screening, risk assessment, and risk management are dependent 368 upon the quality as well as the availability of both hazard and exposure information. While past 369 approaches to priority setting have emphasized relative chemical hazards and used production 370 volume as a simple surrogate for exposure, EPA must increase its emphasis on the exposure 371 component of risk screening and assessment. EPA no longer believes that reporting under the 372 current IUR is adequate for these purposes. The IURA will provide EPA with data that will more 373 accurately and realistically gauge potential exposures. The exposure related information reported 374 under the IURA will be used in combination with hazard information developed under TSCA 375 section 4 test rules and enforceable consent agreements/ orders, through voluntary efforts such as 376 the High Production Volume( HPV) Challenge Program ( see www. epa. gov/ opptintr/ chemrtk/), 377 and other sources. These more current and complete data from the IURA will allow the Agency 378 and others to screen and prioritize chemicals based on potential risk more effectively than it is 379 currently able to do. 380 Although the inherent hazard associated with a chemical substance will often remain the 381 same over time, exposure to workers and affected populations can change significantly. If the 382 amount of a chemical substance produced increases significantly, releases to the environment and 383 human exposures would also be expected to increase. Conversely, if the amount produced 384 remains constant, environmental releases and human exposures may decline as engineering 385 18 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** controls are added and pollution prevention practices are implemented. Although the hazard 386 associated with a chemical generally remains constant, the risk associated with the manufacturing, 387 processing, and use of a chemical substance will change as exposure increases or changes. The 388 Agency needs to be able to identify changes in exposures as well as specific exposure scenarios, 389 making it important to collect exposure data on a regular basis. Chemicals that present low 390 hazard may still pose a risk if they are produced in significant amounts and have high exposure 391 potential, are released into the environment at high volumes and/ or concentrations, or involve 392 exposures to particularly sensitive subpopulations. 393 A voluntary effort called the Use and Exposure Information Project ( UEIP) demonstrated 394 that useful screening level exposure information is available to and can be reported by industry. 395 The UEIP was a cooperative effort begun in the fall of 1992 between government and industry in 396 recognition of the difficulties encountered in obtaining accurate and up to date exposure 397 information on TSCA chemicals. Participants included EPA, the Chemical Manufacturers 398 Association ( CMA) ( now the American Chemistry Council, or ACC), the Chemical Specialty 399 Manufacturers Association ( CSMA), the Synthetic Organic Chemical Manufacturers Association 400 ( SOCMA), and the American Petroleum Institute ( API) ( Ref. 3). Data collected by EPA under 401 the UEIP were similar to those required under the IURA, and included the following: production 402 volume, site location, percentage of production volume for a given use, environmental releases, 403 number of workers, worker activities, monitoring data, and industrial and consumer uses. EPA's 404 experience with UEIP has shown that the types of data requested by the UEIP are available from 405 industry and can be used to prepare screening level exposure assessments. 406 The UEIP, however, provided one time reporting of information by a subset of the 407 manufacturers of a small number of selected high production volume ( HPV) chemicals. Given 408 19 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** these efforts, the limitations of the data available from past and current information collections 409 that are described in detail in the proposal for these amendments ( 64 FR 46772, August 26,1999), 410 and the amount of time it would otherwise take to acquire screening level exposure data for the 411 chemical substances on the Inventory, it is appropriate to develop a more systematic and broadly 412 applied approach to the prioritization process. The Agency is doing this by requiring that new, 413 key, additional exposure related information be reported under this amended rule instead of 414 collecting the information through a one time voluntary program. 415 F. What Are the Requirements of the Amended IUR? 416 The revised reporting form, Form U, reflects the requirements of the final rule and is 417 included in this unit to help explain the reporting requirements, as amended. The regulatory text 418 describes the specific reporting requirements. EPA is also developing an electronic version of 419 Form U, which may look different from the Form U below. Additionally, the Agency may change 420 the format of Form U in future reporting years; should the format of Form U change, EPA will 421 make the revised Form U available to submitters. Submitters should note that the information in 422 sections 710.32( c)( 1) and ( 2) of the new regulatory text ( Part I of Form U) and the CBI 423 reassertion information ( Part IV of Form U) need only be reported once per reporting cycle per 424 submitter, while the information in sections 710.32( c)( 3) and ( 4) of the new regulatory text ( Parts 425 II and III of Form U, respectively) will be reported for each reportable chemical. 426 20 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Form U page 1 427 21 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Form U page 2 428 22 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Form U page 3 429 23 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** 1. What are the changes to the chemical substances covered by IUR? a. Inorganic 430 Chemical Substances. EPA is requiring partial reporting for inorganic chemical substances for 431 reporting year 2005 information submitted to EPA during the 2006 submission period, and full 432 reporting for inorganic chemical substances in subsequent submission periods ( see the amended 433 regulatory text at section 710.26( a)). Partial reporting means that the submitter must report the 434 information described in sections 710.32( c)( 1), ( 2), and ( 3), as well as sections 710.38 and 710.39 435 of the amended regulatory text, as applicable ( i. e., Parts I, II, and IV of revised reporting Form 436 U.). Full reporting means that the submitter must additionally report the information described in 437 section 710.32( c)( 4) of the amended regulatory text ( i. e., all parts of revised reporting Form U). 438 EPA intends to screen potential risks associated with inorganic chemical substances to set 439 priorities for testing, more detailed risk assessment and potential risk management. The phasing in 440 of inorganic chemical reporting provides manufacturers of these chemicals with the opportunity to 441 familiarize themselves with IUR reporting while providing EPA and others with needed basic 442 manufacturing information on inorganic chemicals. Future full reporting of exposure related 443 information will provide EPA and others with needed additional information for those inorganic 444 chemicals with production volumes of 300,000 lbs. or more at a site. See Unit III. A. 1. for a 445 discussion of the importance of this exposure related information to EPA and others for both 446 organic and inorganic chemicals. Unit III. C. 1. a. contains a discussion specific to inorganic 447 chemicals. The basic impetus for collecting information on organic chemicals also holds for 448 inorganic chemicals. 449 b. Petroleum process streams. EPA is exempting certain chemical substances, termed 450    petroleum process streams'' for purposes of IURA, from reporting the exposure related data 451 contained in the regulatory text at 710.32( c)( 4) ( Part III of Revised Form U). For purposes of 452 24 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** this rule, the petroleum process streams included in the exemption are the multi component 453 complex chemical substances listed by Chemical Abstracts Service ( CAS) Registry Number in the 454 new regulatory text at Sec. 710.26( d). Chemical substances listed as petroleum process streams in 455 the new regulatory text were derived from the 1983 publication of the API entitled    Petroleum 456 Process Stream Terms Included in the Chemical Substances Inventory Under the Toxic 457 Substances Control Act ( TSCA)'' ( Ref. 4). Chemical substances listed in the API document 458 consisting of a single component chemical, except for water, will not be considered petroleum 459 process streams for IURA reporting purposes. Water ( CAS number 7732 18 5) is partially 460 exempt from IURA reporting under the petroleum process stream exemption. 461 The basis for this exemption is not because these streams are of known low toxicity. EPA 462 believes that petroleum process streams are often toxicologically active. However, nearly all 463 petroleum process streams are processed at the site where they are produced in vessels which are 464 closed to minimize losses and, coincidentally, the potential for exposure. The processing of these 465 petroleum streams is accomplished by remotely controlled, electro mechanical systems which 466 minimize contact with workers involved in refining the petroleum process streams. The 467 flammable nature of these products requires that they also be transported, processed, and stored 468 in closed containers. For these reasons, EPA believes worker exposure to petroleum process 469 streams is minimal. EPA will take action to revoke this exemption if circumstances warrant. 470 In the final rule, EPA is making selected changes to the partial exemption list of petroleum 471 process stream chemicals published in the proposed rule. Certain chemicals are being added to 472 the list because they were inadvertently left off the proposed list covered by the exemption. 473 These multi component chemicals, all of which are listed in the 1983 API publication entitled 474 " Petroleum Process Stream Terms Included in the Chemical Substances Inventory Under the 475 25 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Toxic Substances Control Act ( TSCA)" ( Ref. 4), include the following chemical substances ( CAS 476 numbers): 8052 41 3, 64742 21 8, 64742 26 3, 64742 94 5, 68476 32 4, 68515 29 7, 68783 477 12 0, 68918 98 9, 68919 15 3, 68953 80 0, and 70693 06 0. 478 In the final rule, EPA is also removing a number of chemicals from the petroleum process 479 stream partial exemption list published in the proposed rule. These chemicals fall into three 480 groups: ( 1) Certain chemicals that are already part of the broader natural gas or polymer 481 exemptions. Those already exempted under the natural gas exemption are: 8006 14 2, 8006 61 482 9, 64741 48 6, 68410 63 9, 68425 31 0, and 68919 39 1. Additionally, an incorrect CAS 483 registry number 68425 31 1 was corrected to read 68425 31 0, which, again, has been removed 484 from the partial exemption because it is already fully exempt from IUR reporting under the natural 485 gas exemption. Chemicals removed because they are already fully exempt under the polymer 486 exemption are: 64741 71 5, 64741 72 6, 67891 77 4, 67891 78 5, 68131 77 1, 68131 79 3, 487 68131 80 6, 68131 81 7, 68131 83 9, 68131 99 7, 68132 00 3, 68410 01 5, 68410 10 6, 488 68410 13 9, 68410 14 0, 68410 16 2, 68410 59 3, 68425 27 4, 68425 28 5, 68476 87 9, 489 68477 37 2, 68477 43 0, 68477 45 2, 68477 46 3, 68477 50 9, 68477 51 0, 68477 52 1, 490 68478 07 9, 68478 09 1, 68527 24 2, 68527 25 3, 68783 10 8, 68783 11 9, and 68955 30 6. 491 ( 2) Single component chemicals, except for water, should not have been included in the petroleum 492 process streams partial exemption. As stated in the proposed rule, the exemption was intended 493 to include only certain multi component chemicals derived from the 1983 API publication. As a 494 result, the following single component chemicals have been removed from the petroleum process 495 streams partial exemption list as proposed: 8007 45 2 and 10024 97 2. ( 3) Certain chemicals that 496 are not included on the TSCA Inventory and therefore are not currently reportable under IUR 497 have also been removed from the exemption list: 64741 93 1, 64741 94 2, 64742 00 3, 64742 498 26 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** 02 5, 64742 17 2, 64742 66 1, 64742 74 1, 64742 84 3, and 64754 96 7. 499 In this final rule, EPA is also making some additional corrections to the petroleum 500 process streams partial exemption list published in the proposed rule. ( 1) Incorrect CAS numbers 501 for certain chemicals were provided in the proposed rule. These CAS numbers were incorrect 502 because of typographical errors in the proposed rule. The correct CAS numbers are as follows: 503 8006 20 0, 64742 18 3, 64742 20 7, 68187 60 0, 68459 78 9, 68513 14 4, 68513 19 9, and 504 68514 38 5. Two additional incorrect CAS numbers were provided in the proposed rule, i. e. 505 64742 36 2 and 68741 41 9. The corrected CAS numbers for these chemicals, i. e. 64742 36 5 506 and 64741 41 9 respectively, were also provided in the proposed rule. ( 2) Several duplicate CAS 507 numbers that were included in the proposed rule have been removed. ( 3) CAS numbers for 508 certain chemicals have been superceded by new CAS numbers. The new CAS numbers are as 509 follows ( superceded CAS numbers are in parenthesis): 68187 58 6( 68334 31 6), 68410 13 510 9( 68477 56 5), 68308 08 7( 68478 21 7), 68334 30 5( 68512 90 3), 68918 99 0( 68513 26 8), 511 64742 83 2( 6851 30 7), 68988 79 4( 68515 31 1), 64742 93 4( 68516 21 2), 68606 10 512 0( 68606 35 9), and 64742 93 4( 68650 78 2). 513 c. Natural gas. EPA is exempting certain forms of natural gas from IUR reporting. These 514 substances are listed in the new regulatory text at section 710.26( f). EPA believes that, to date, 515 adequate IUR information has been collected on these chemical substances to fulfill EPA's and 516 other IUR information users' current needs. , EPA will take action to revoke this exemption if 517 circumstances warrant in the future. 518 d. Polymers. As a result of recent inquiries regarding the exclusion of polymers from 519 IUR reporting, EPA is clarifying this existing exemption. The exemption does not apply to a 520 polymeric substance that has been hydrolyzed, depolymerized, or otherwise chemically modified, 521 27 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** except in cases where the intended product of this reaction is totally polymeric in structure. The 522 Agency's intent under the exemption at 40 CFR section 710.26( b) has always been that the 523 products of such reactions carried out on polymeric materials are excluded from IUR reporting 524 only if they are intended to have a totally polymeric composition. There is no change in the IUR 525 status of polymeric materials that have not undergone such reactions and are identified with the 526 " XU" flag in the Inventory. 527 e. Microorganisms. EPA is clarifying this existing definition to ensure that the definition 528 used for IURA purposes is consistent with the microorganisms rule at 40 CFR part 725 and to 529 clarify the status of chemicals produced from living microorganisms. 530 2. How have the reporting thresholds changed? EPA is raising the basic IUR reporting 531 threshold from a production volume of 10,000 lbs. per year per site to 25,000 lbs. per year per 532 site. Every person manufacturing a non excluded chemical substance at or above the threshold 533 will be required to report the information in Parts I, II, and IV of Revised Reporting Form U ( see 534 the regulatory text at sections 710.32( c)( 1), ( 2), and ( 3), 710.38, and 710.39). The increased 535 IUR reporting threshold makes the IUR and Toxics Release Inventory ( TRI) reporting thresholds 536 equivalent for manufacturers. These thresholds also approximate the current TSCA section 5 537 premanufacture notification ( PMN) low volume exemption threshold of 10,000 kg ( approximately 538 22,000 lbs.). EPA is raising the basic IUR reporting threshold in order to reduce the number of 539 reports filed, thus reducing the overall industry burden associated with this regulation. The new 540 reporting threshold does not represent a finding of low exposure or low risk. 541 EPA is also instituting a second, higher production volume threshold of 300,000 lbs. per 542 year per site. Persons who manufacture a non excluded substance at or above this level will be 543 required to report the information in Part III of Revised Reporting Form U ( see the regulatory 544 28 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** text at section 710.32( c)( 4)) in addition to the information in Parts I, II, and IV. The information 545 reported on Part III of the form relates to the processing and use of chemical substances. EPA is 546 instituting this separate threshold to limit processing and use data reporting to a subset of a few 547 thousand IUR reportable chemicals out of the approximately 76,000 chemicals listed on the 548 TSCA Inventory. 549 Information concerning lower production volume chemical substances is valuable, 550 especially for identifying trends and additional substitute chemicals. However, wherever possible, 551 the Agency has attempted to limit the reporting burden. In the future, EPA may find it necessary 552 to collect information on chemicals at reporting thresholds below the thresholds introduced in this 553 action. Although both the 25,000 lbs. and 300,000 lbs. thresholds are significantly higher than the 554 current IUR 10,000 lbs. threshold, the enhanced information will be gathered under the amended 555 rule will enable the Agency and others to more efficiently identify those chemical substances 556 warranting further, more in depth review, as well as chemicals of lesser concern ( see Ref. 5). 557 3. Have the reporting year, the submission period, or the reporting frequency changed? 558 EPA is changing the IUR reporting year to a calendar year basis from a corporate fiscal 559 year basis. This change standardizes reporting time frames across IUR submitters and across 560 various other reporting programs, such as the TRI program. 561 Under the current IUR regulations at 40 CFR 710.33( b), submitters are required to report 562 on a recurring basis between August 25 and December 23 (   the submission period'') every 4 563 years. In a separate action following this final rule, EPA intends to propose changing the 564 submission period from August 25 through December 23 to April 1 through July 31. This 565 potential change is related in part to the change in this final rule from fiscal year to calendar year 566 29 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** for the development of the data reported during the submission period. The August 25 date was 567 originally used as a result of the fact that many companies' fiscal years end in July, and starting 568 the IUR submission period in late August allowed these companies to report their most current 569 information. Companies will now report on a calendar year basis, making an earlier submission 570 period more appropriate. EPA may propose to change the beginning of the submission period to 571 April 1: ( 1) to allow the Agency to obtain the information early in the year, thereby increasing the 572 timeliness of the data by allowing the Agency to process the data more closely in time to their 573 generation and ( 2) to allow sites to submit their information closer to the period during which it 574 was generated. The Agency does not intend to choose a date earlier in the year than April 1 in 575 order to give sites time to generate tax reports, and therefore allow the possible use of 576 information from those reports for IUR reporting. 577 EPA has not changed the reporting frequency ( every four years), although EPA did 578 consider alternative reporting frequencies ( see the " Revised Economic Analysis for the Amended 579 Inventory Update Rule," Ref. 6.). This means, for example, that the information reported under 580 the IURA during the first submission period ( i. e. from August 25 to December 23 or, as may be 581 proposed, April 1 to July 31, in the year 2006) would be from calendar year 2005. Subsequent 582 submission periods will occur every four years. Guidance can be found in " Guidance Document: 583 2006 Reporting for Updating the Chemical Substances Inventory Database Under the Toxic 584 Substances Control Act ( TSCA)." EPA had proposed an effective date for these amendments 585 which would have required reporting calendar year 2001 data in 2002. Since the final rule is 586 being promulgated in 2002, the effective date has been changed to require reporting of calendar 587 year 2005 data in 2006. 588 In a separate action following this final rule, EPA intends to propose changing the initial 589 30 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** reporting year from 2006 ( reporting calendar year 2005 data) to 2004 ( reporting calendar year 590 2003 data). The four year cycle would continue from that date, with the next reporting occurring 591 in 2008 ( reporting calendar year 2007 data). EPA may propose to change the initial reporting 592 year to 2004: ( 1) to allow the Agency to obtain needed exposure based information for the HPV 593 Challenge program and ( 2) to allow the Agency to meet its GPRA requirements to screen all 594 chemicals by 2005. 595 4. How have the recordkeeping requirements changed? 596 EPA is requiring that persons subject to reporting under the amended IUR retain records 597 that document any information reported to EPA under the IURA for a period of 5 years beginning 598 with the effective date of that submission period ( see section 710.37 of the regulatory text). The 599 effective date of the submission period is the last day of the submission period ( currently 600 December 23, although EPA intends to propose to change this to July 1, see Unit II. F. 3.) in a year 601 in which data must be reported under IURA. Previously, submitters were required to retain 602 records for 4 years. Under the IURA, if a person submits a report in the year 2006, that person 603 will retain the records on which the report is based until December 23, 2011. This change ensures 604 that the submitter will have the previous submission available when determining future reporting. 605 The change will also aid in EPA's enforcement of the IUR by requiring that submitters maintain 606 records that span successive submission periods, which will continue to occur every 4 years as 607 under the existing IUR. 608 Persons who are not required to report under the existing IUR because they manufacture 609 less than the 10,000 lb. reporting threshold have been required to retain volume records as 610 evidence to support decisions not to submit a report. In this rulemaking, EPA is eliminating this 611 provision because EPA believes that this type of information is routinely retained by companies in 612 31 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** the normal course of business. 613 5. How have the data elements reported by all submitters changed? 614 The new and revised data elements to be reported under the amended rule are discussed in 615 this section. Data elements that are currently reported under IUR but that are not revised by these 616 amendments are not generally discussed. 617 a. Technical contact identification ( Section 710.32( c)( 2)( i) of the regulatory text; Part I, 618 Section II of Revised Reporting Form U ). In addition to the name of a person who will serve as 619 technical contact for the submitter company, the parent company name, the contact person's full 620 mailing address, and the contact person's telephone number, submitters must report the contact 621 person's e mail address and the parent company Dun and Bradstreet Number. The technical 622 contact person must be able to answer questions about the IUR and IURA information submitted 623 by the company to EPA. 624 b. Plant site identification ( Section 710.32( c)( 2)( ii) of the regulatory text; Part I, Section 625 III of Revised Reporting Form U). Submitters must report the plant site county or parish in 626 addition to the information currently required for each plant site that is subject to reporting . 627 EPA had additionally proposed to require submitters to report a plant site identification 628 number in order to clearly identify the reporting site in a way that would allow the cross linking of 629 IUR information with information reported about the same plant site contained in other databases. 630 EPA had proposed requiring the reporting of a newly assigned Facility Registration Identifier 631 ( FRI), or, if the Facility Registry System was not yet in place, the submitter would report the 632 site's RCRA number, if one had been assigned to the site. In this final rule, EPA has decided not 633 to require the submission of a site identification number in addition to the Dun and Bradstreet 634 32 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** number that submitters must continue to report. The Agency may instead make number 635 assignments either directly on the reporting form after it is returned to EPA, or prior to mailing 636 out the form to a submitter. Submitters will not be responsible for obtaining or reporting this 637 number. 638 c. Chemical identification ( Section 710.32( c)( 3)( i) of the regulatory text; Part II, Section 639 I of Revised Reporting Form U). Submitters must indicate which type of chemical identifying 640 number they are reporting, in addition to the number itself. EPA no longer allows the use of 641 certain of the previously used substitute identifying numbers ( such as EPA assigned numbers for 642 Test Market Exemption Applications, original Inventory form numbers, and Notices of Bona Fide 643 Intent to Manufacture) because they are difficult to cross reference to CAS Registry Numbers. 644 Submitters may report a CAS registry number, an EPA designated accession number for 645 confidential substances, or a PMN case number. 646 d. Confidentiality of production volume range ( Section 710.32( c)( 3)( v) of the regulatory 647 text; Part II, Section II of revised reporting Form U). Submitters must continue to report the 648 specific production volume of the reportable chemical and may claim CBI protection for that 649 production volume. Additionally, submitters may claim as CBI a pre determined production 650 volume range corresponding to the reported production volume number. This claim, if needed, 651 would be separate from a CBI claim for the specific production volume. 652 Submitters of CBI production volume data may allow the release of more general range 653 information. EPA expects that roughly 50% of submitters of CBI production volume data will 654 allow the public release of volume ranges. This expectation of reduced CBI claims is based on the 655 CBI claim statistics associated with the development of the original TSCA Inventory ( See 656 " Inventory Update Rule ( IUR) Technical Support Document: Evaluation of Likelihood of 657 33 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** Confidential Business Information Claims for Production Volume Information" ( Ref. 7)) as well 658 as comments received from industry concerning potential TSCA CBI reforms ( Ref. 8). The range 659 option will allow the public greater access to data on chemical production volumes, and the 660 Agency will be better equipped to publicly release more aggregate production volume data 661 relevant to its risk screening decisions. 662 The production volume ranges in the final rule are 25,000 to 300,000 lbs.; 300,000 to 663 1,000,000 lbs.; 1,000,000 to 10,000,000 lbs.; 10,000,000 to 50,000,000 lbs.; 50,000,000 to 664 100,000,000 lbs.; 100,000,000 to 500,000,000 lbs.; 500,000,000 to 1,000,000,000 lbs.; and 665 greater than 1,000,000,000 lbs. These ranges are similar to those first used in the development of 666 the original TSCA Inventory, except for two changes. First, the lowest range starts at the 667 amended IUR reporting threshold of 25,000 lbs. rather than the 10,000 lb. threshold that was used 668 in the original IUR. Second, the upper end of the first range and the lower end of the second 669 range was raised to 300,000 lbs. from the 100,000 lbs. range limit included in the proposal, 670 resulting in ranges of 25,000  300,000 lbs. and 300,000  1,000,000 lbs. The second change 671 makes the ranges consistent with the second reporting threshold of 300,000 lbs. or more ( see 672 section 710.32( c)( 4) of the regulatory text), and provides additional protection for submitters' 673 production volume range CBI claims. 674 Under the proposed rule's 100,000 lbs. range limit for the lowest production volume 675 range, submitters who did not claim the production volume range as CBI might have inadvertently 676 provided the public with more information than they intended. For instance, for a submitter 677 whose production volume was in the 100,000 to 1,000,000 lbs. range, who did not claim their 678 production volume range CBI, and who did not report any information in Part III of reporting 679 Form U ( the industrial processing and use and the commercial and consumer use information), 680 34 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** public users of the data would be able to infer that the submitter's production was somewhere 681 between 100,000 to 300,000 lbs   information which the submitter might have considered CBI. 682 To protect against such inadvertent disclosures of CBI, EPA changed the production volume 683 ranges to reflect the second reporting threshold of 300,000 lbs. EPA does not believe that the 684 change significantly affects the utility of the data to the public. 685 e. Number of potentially exposed workers ( Section 710.32( c)( 3)( vi) of the regulatory 686 text; Part II, Section II of Revised Reporting Form U). Submitters must report the range code 687 that corresponds to their estimate of the total number of workers reasonably likely to be exposed 688 to each reportable chemical substance at each plant site. EPA defines    reasonably likely to be 689 exposed'' as an exposure to a chemical substance which, under foreseeable conditions of 690 manufacture, processing, distribution in commerce, or use of the chemical substance, is more 691 likely to occur than to not occur. Such exposures would normally include, but not be limited to, 692 exposure during activities such as charging reactor vessels; drumming; bulk loading; cleaning 693 equipment; maintenance operations; materials handling and transfers; and analytical operations. 694 Covered exposures include exposures through any route of entry ( inhalation, ingestion, skin 695 contact or absorption, etc.), but exclude accidental or theoretical exposures. 696 Workers involved in chemical manufacturing, processing and use are a subpopulation of 697 concern to EPA, the Occupational Safety and Health Administration ( OSHA) ( Ref. 9), the 698 National Institute of Occupational Safety and Health ( NIOSH) ( Ref. 10), and other organizations 699 ( e. g., labor unions). Workers may often be exposed to chemical substances in higher doses and 700 with greater frequency than the general population, and may therefore be at potentially greater 701 risk of adverse health effects. The number of workers reasonably likely to be exposed to specific 702 chemical substances is important to EPA and other organizations in developing the most accurate 703 35 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** screening level exposure scenarios possible. These scenarios are then used to develop priorities 704 for testing, more detailed risk assessment, and risk management. 705 Submitters are required to use ranges rather than specific values for reporting certain 706 data, including the number of workers reasonably likely to be exposed and the number of 707 processing or use sites. The ranges for reporting the estimated number of potentially exposed 708 workers are found in section 710.32( c)( 3)( vi) of the regulatory text. In general, reporting these 709 ranges reduces the potential burden to submitters of developing a precise point estimate for the 710 data element. The use of ranges should reduce CBI claims because ranges tend to reveal less 711 sensitive information than specific estimates while still conveying sufficient information useful to 712 effectively screen chemical risks. Submitters are permitted to claim the reported ranges as 713 confidential if revealing even this general information would disclose information of a sensitive 714 nature. 715 f. Maximum concentration ( Section 710.32( c)( 3)( vii) of the regulatory text; Part II, 716 Section II of Revised Reporting Form U). Submitters must report the maximum concentration, 717 measured by weight, of the reportable chemical substance at the time it is reacted on site to 718 produce a different chemical substance or it leaves the submitter's manufacturing site. This 719 information is to be reported regardless of the various physical forms in which the chemical may 720 be sent off site. Concentration ranges for use in IUR reporting under the amended rule are found 721 in section 710.32( c)( 3)( vii) of the regulatory text. 722 Concentration is an important variable to consider when estimating the magnitude of 723 potential exposures. Information about the maximum concentration of a chemical substance 724 present at processing and use sites is frequently used in chemical risk screening in the review of 725 Premanufacture Notices ( PMNs) for new chemical substances required by Section 5 of TSCA and 726 36 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** is used to the extent it is available in screening chemicals on the TSCA Inventory. For example, 727 EPA has developed standard methods to estimate dermal exposures that workers may experience 728 while performing common industrial operations such as sampling and loading chemicals into 729 drums. These standard methods use maximum concentration to estimate upper limits to exposure 730 estimates. If EPA is aware that a chemical substance is processed or used only as a fraction of a 731 mixture with other chemical substances, exposure estimates may be adjusted downward 732 accordingly. For example, a chemical substance which is a component of a liquid mixture exerts a 733 lower vapor pressure than it would as a pure chemical substance. Because higher vapor pressure 734 is associated with increasing inhalation exposure to a chemical substance, the concentration of a 735 chemical substance in a liquid mixture impacts the exposure assessment. 736 A chemical may be produced in multiple physical forms and in multiple formulations and 737 products. As described in Unit II. F. 5. g. of this preamble, EPA is requiring reporting of each of 738 the physical forms in which a chemical is sent off site. For the purpose of exposure screening, 739 EPA is requiring only the reporting of the maximum concentration, regardless of various physical 740 forms in which a chemical may be sent off site. 741 EPA had proposed that submitters also report the average concentration of the chemical 742 when leaving the manufacturing site ( 64 FR 46772, 46788). EPA eliminated this requirement 743 because of the potential difficulty of determining the average concentration. For example, a 744 submitter could produce many formulations containing a particular chemical substance, making a 745 determination of average concentration difficult. 746 g. Physical Form ( Section 710.32( c)( 3)( viii) of the regulatory text; Part II, Section II of 747 Revised Reporting Form U). Submitters must report the physical form( s) of the chemical at the 748 time it is reacted on site or as it leaves the site of manufacture. The list of physical forms from 749 37 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** which submitters must select is found in section 710.32( c)( 3)( viii) of the regulatory text. Further 750 discussion on physical form reporting is found in Unit III. B. 1. a. of this preamble. 751 The physical form of a chemical is an important factor to consider when estimating 752 magnitudes and concentrations of potential exposures. EPA's analyses of TRI and PMN data 753 demonstrated that the physical state of a chemical is a determining factor in predicting the 754 potential for industrial releases of chemicals, and hence, exposures to humans and the 755 environment. The results of the analyses are provided in a technical support document that was 756 developed by EPA in support of this rule (" Inventory Update Rule ( IUR) Amendments Technical 757 Support Document: Exposure Related Data Useful for Chemical Risk Screening," Ref. 11). The 758 physical state, which provides information on volatility and how the chemical is likely to be 759 handled during manufacturing, processing, and use, is an important data element for the purposes 760 of exposure and risk screening. 761 h. Percent production volume ( Section 710.32( c)( 3)( ix) of the regulatory text; Part II, 762 Section II of Revised Reporting Form U). Submitters are required to report the percentage of 763 total production volume ( as reported under regulatory text section 710.32( c)( 3)( iv)) of the 764 reportable chemical substance that is associated with each physical form reported. Percent 765 production volume estimates will allow the Agency to aggregate, on a case by case basis, the 766 production volume of a particular physical form for a given chemical across multiple sites. These 767 determinations will allow EPA to better characterize the risk associated with chemicals that are 768 manufactured in physical forms that typically result in higher exposures, such as volatile liquids or 769 powders, but that are produced in small quantities. These percent production volume estimates 770 will help put the physical form information into context. Estimates must be rounded off to the 771 nearest 10% of production volume. However, for a particular physical form which accounts for 772 38 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** 5% or less of the total production volume of a reportable chemical substance, submitters are not 773 permitted to round off to zero percent if the production volume attributable to that physical form 774 is 300,000 lbs. or more. In such cases, submitters must report the percentage of production 775 volume attributable to that physical form to the nearest 1% of production volume. This exception 776 to the general rounding off rule will ensure that adequate use information is reported for the larger 777 production volume chemical substances. The break off of 300,000 lbs. was selected for 778 consistency with the processing and use data reporting threshold. 779 6. What new definitions have been added to explain the requirements associated with 780 reporting by larger production volume manufacturers? ( Section 710.23 of the regulatory text). 781 EPA has reorganized the definition section of the regulatory text associated with the original 782 Inventory and the IUR. There are now two definition sections. Section 710.2 contains definitions 783 relevant primarily to the compilation of the original Inventory, although a few of these definitions 784 are also relevant to both the IUR and the IURA. Section 710.23 contains definitions relevant only 785 to the IUR and the IURA. Any changes to the definitions themselves were included in the 786 proposed rule. This reorganization simply clarifies the relationships between the definitions and 787 the various rules, and has no substantive effect. 788 Certain new definitions are being added to 40 CFR part 710 as a result of this final rule: 789 a. Readily obtainable information. TSCA section 8( a)( 2) authorizes EPA to require 790 persons to report information that is known to or reasonably ascertainable by the submitter. Under 791 the amended IUR, a submitter will report processing and use information ( i. e., the information 792 reported for sites at which the 300,000 lbs. threshold has been met or exceeded) only to the extent 793 that such information is    readily obtainable'' by the submitter's management and supervisory 794 employees responsible for manufacturing, processing, distributing, technical services, and 795 39 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** marketing ( see regulatory text section 710.23). Extensive file searches are not required. The 796    readily obtainable'' standard for processing and use information requires less effort on the part 797 of the submitter than the    known to or reasonably ascertainable by'' standard that applies to all 798 other IUR reporting ( see regulatory text section 710.23), while providing sufficiently precise 799 processing and use information for screening level reviews. In addition, the " readily obtainable" 800 standard limits the reporting burden associated with processing and use reporting and is identical 801 to the standard currently in effect under EPA's TSCA Section 8( a) Preliminary Assessment 802 Information Rule ( PAIR) ( See 40 CFR 712.7). The " readily obtainable" definition is further 803 discussed in Unit III. D. 3. of this preamble. 804 b. Use. For the purpose of IUR reporting, EPA is defining " use" as any utilization of a 805 chemical substance or mixture that is not otherwise covered by the terms " manufacture" or 806 " process" ( see regulatory text section 710.23). For example, the activity of processing a solvent 807 into a paint formulation is considered " processing" rather than " use" because the activity 808 incorporates the chemical substance ( the solvent) into a formulation. If the paint formulation 809 containing the solvent is then applied to a metal or wood surface ( e. g. cars), this application 810 would be considered a use activity. 811 c. Industrial Use. EPA defines    industrial use'' for purposes of IUR reporting as use at a 812 site at which one or more chemical substances or mixtures are manufactured or processed ( see 813 regulatory text section 710.23). 814 d. Commercial and consumer use. For purposes of IUR reporting, EPA defines 815 " commercial use" as the use of a chemical substance or mixture in a commercial enterprise 816 providing saleable goods or a service, such as painting contractors using paint products. A 817 " consumer use," on the other hand, means the use of a chemical substance that is directly, or as 818 40 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** part of a mixture, sold to or made available to consumers for their use in or around a permanent 819 or temporary household or residence, a school, or recreational areas ( see regulatory text section 820 710.23). Exposures to commercial and consumer products are similar for risk screening purposes 821 because existing screening level assessment methods are not sophisticated enough to distinguish 822 between these exposures. 823 e. Repackaging. For the purpose of IUR reporting, " repackaging" is defined as the 824 physical transfer of a chemical substance or mixtures ( as is) from one container to another 825 container or containers in preparation for distributing the chemical substance or mixture in 826 commerce. This definition does not apply to sites that only relabel or redistribute the reportable 827 chemical substance without removing the chemical substance from the container in which it is 828 received or purchased. 829 7. What new data elements are reportable by only larger production volume 830 manufacturers? As described in Unit II. F. 2. of this preamble, EPA is replacing the current IUR 831 reporting threshold of 10,000 lbs. per year per site with two new production volume reporting 832 thresholds of 25,000 lbs. and 300,000 lbs. per year per site. Each person manufacturing a 833 reportable substance at or above the 25,000 lbs. per year per site threshold is required to complete 834 at least a partial report containing the information in Parts I, II, and IV of Revised Reporting 835 Form U. Persons who manufacture a reportable substance at or above the 300,000 lbs. per year 836 per site threshold are required to complete a full report, providing the information in Part III in 837 addition to the information in Parts I, II, and IV. Part III concerns the processing and use of 838 chemical substances. 839 a. Processing and Use Information ( Section 710.32( c)( 4) of the regulatory text; Part III 840 of revised reporting Form U). Submitters with plant sites at which a reportable chemical 841 41 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** substance is manufactured in annual quantities of 300,000 lbs. or more must report processing and 842 use information under the amended IUR. EPA requires submitters to report the information 843 described in section 710.32( c)( 4) of the regulatory text concerning the processing and use of each 844 reportable chemical substance both at sites the submitter controls, and at sites receiving a 845 reportable chemical substance from the submitter either directly or indirectly ( including through a 846 broker/ distributor, from a customer of the submitter, etc.). Processing and use information must 847 be reported only to the extent that the data, or an estimate, is " readily obtainable" by the submitter 848 ( see Unit II. F. 6. a. of this preamble). 849 i. Industrial processing or use operations ( Section 710.32( c)( 4)( i)( A) of the regulatory 850 text; Part III, Section I a of revised reporting Form U). Submitters must report the industrial 851 process or use operation( s) at the site that are associated with each reportable chemical. The 852 categories for reporting are listed in section 710.32( c)( 4)( i)( A) of the regulatory text. 853 ii. North American Industrial Classification System ( NAICS) Code ( Section 854 710.32( c)( 4)( i)( B) of the regulatory text; Part III, Section I b of revised reporting Form U). 855 Submitters must report the five digit NAICS code( s) that best describe( s) the industrial 856 processing or use activities at the sites under the control of the submitter, as well as at the sites 857 that receive a reportable chemical substance from the submitter either directly or indirectly 858 ( including through a broker/ distributor, from a customer of the submitter, etc.). The NAICS 859 codes, published by the Office of Management and Budget ( OMB), have superseded the prior 860 system of Standard Industrial Classification ( SIC) Codes ( Ref. 12). Submitters must report these 861 codes to the extent the information is readily obtainable for processing or use activities at sites 862 within the submitter's control as well as at downstream sites. EPA does not intend for 863 manufacturers to survey their customers or distributors to precisely identify the appropriate 864 42 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** NAICS codes at their downstream sites. 865 The NAICS classification system is being used in the amended IUR to describe the 866 industrial setting in which chemical exposures associated with the industrial processing or use of a 867 chemical substance may occur. Exposure to a chemical substance typically varies among 868 industries. The NAICS code in conjunction with the industrial function category ( IFC) code will 869 define the industrial, commercial, or consumer setting so that the appropriate scenarios can be 870 applied to estimate worker, community, and environmental exposures to the chemical substance. 871 The NAICS codes which best describe the industrial activities associated with each 872 reported industrial processing or use operation must be provided. If more than 10 NAICS codes 873 apply to a reportable chemical substance, submitters need only report the NAICS codes that 874 cumulatively represent the largest percentage of the substance's production volume, measured by 875 weight. This limitation on reporting is intended to minimize submitters' reporting burden. 876 iii. Industrial Function Category ( Section 710.32( c)( 4)( i)( C) of the regulatory text; Part 877 III, Section I c of revised reporting Form U ). Submitters must report the industrial function 878 categories that best represent the specific manner in which a chemical substance is used within 879 each NAICS code reported. Submitters may report the same function category under different 880 NAICS codes. Submitters may also report the same NAICS code multiple times if the chemical 881 being reported has several industrial functions. The industrial function categories to be used are 882 listed in the regulatory text at section 710.32( c)( 4)( i)( C). 883 A NAICS code and industrial function category combination sufficiently defines a 884 potential exposure scenario for risk screening and priority setting purposes. EPA conducted 885 studies to determine whether information regarding the industrial sectors in which a chemical 886 substance is produced and used, and information regarding the function a chemical substance 887 43 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** performs within industrial processes, are useful for the purpose of screening level exposure 888 assessments. These studies demonstrated that this type of information provides indications of the 889 route, magnitude, and concentration of potential chemical exposures to humans and to the 890 environment. The results of the studies are provided in two of the technical support documents 891 that EPA developed in support of this rule ( Refs. 11 and 13). 892 Industrial function categories are also useful in estimating the frequency and duration of 893 chemical substance exposures by indicating the type of application in which a chemical will be 894 used ( eg. Solvents( for Cleaning and Degreasing) or Intermediate). The relationship between 895 industrial function categories and the frequency and duration of exposure to chemical substances 896 is particularly useful in developing exposure assessments in EPA's New Chemicals Program. 897 These data elements are important elements in developing useful exposure scenarios. In the 898 absence of these data, EPA often uses conservative estimates that may indicate a greater risk than 899 is actually the case. Data that will be obtained under the amended IUR will enable EPA to make 900 more realistic characterizations of exposure, instead of    worst case'' assumptions. 901 iv. Percentage of production volume attributable to each combination of NAICS code 902 and industrial function category in each processing and use operation ( Section 903 710.32( c)( 4)( i)( D) of the regulatory text; Part III, Section I d of revised reporting Form U). 904 Submitters must estimate the percentage of total production volume attributable to each reported 905 combination of NAICS code and industrial function category ( IFC) in each processing and use 906 operation, to the extent that such information is readily obtainable. Estimates must be rounded off 907 to the nearest 10% of production volume. Submitters are not permitted to round off to zero 908 percent if the production volume attributable to a NAICS/ IFC combination is 300,000 lbs. or 909 more and accounts for 5% or less of the total production volume of a reportable chemical 910 44 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** substance. In such cases, submitters must report the percentage of production volume 911 attributable to that NAICS/ IFC combination to the nearest 1% of production volume. This 912 exception to the general rounding rule will ensure that adequate use information is reported for 913 the larger production volume chemical substances. The 300,000 lbs. level was selected for 914 consistency with the threshold for reporting processing and use data. 915 The total percent production volumes associated with the NAICS code/ IFC combinations 916 may add up to more than 100%, given that the submitter is reporting on distribution of a chemical 917 to sites in its control as well as downstream sites, some of which are not immediate purchasers 918 from the original manufacturing site. Additionally, the total percent production volume may add 919 up to less than 100% if the submitter cannot readily obtain information about how all of its 920 production volume is processed or used by industry. 921 v. Number of processing and use sites ( Section 710.32( c)( 4)( i)( E) of the regulatory text; 922 Part III, Section I e of revised reporting Form U). Submitters must report estimates of the total 923 number of industrial sites, including those beyond the submitter's control, that process or use each 924 reportable chemical substance manufactured by the submitter, with respect to each combination of 925 NAICS code and industrial function category in each processing and use operation. The ranges 926 that will be used for reporting the number of sites can be found at section 710.32( c)( 4)( i)( E) of 927 the regulatory text. For risk screening purposes, the number of sites at which chemical substances 928 are manufactured, processed, and used is a useful indicator of the number of ecosystems and the 929 size of the general population potentially exposed to the chemical substances. 930 vi. Number of workers ( Section 710.32( c)( 4)( i)( F) of the regulatory text); Part III, 931 Section I f of revised reporting Form U). Submitters must report estimates of the total number of 932 workers, including those at sites not under the submitter's control, that are reasonably likely to be 933 45 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** exposed while processing or using the reportable chemical substance, with respect to each 934 combination of NAICS code and industrial function category in each processing and use 935 operation. The approximate number of workers will be reported using the same definitions and 936 ranges described under Unit II. D. 5. e. of this preamble. The difference in reporting worker 937 exposure information under this section is that such information need be reported only to the 938 extent that it is readily obtainable. 939 b. Commercial and Consumer Use Information ( Section 710.32( c)( 4)( ii) of the regulatory 940 text; Part III, Section II of revised reporting Form U). Submitters must report information 941 concerning the commercial and consumer uses of each reportable chemical substance that is 942 manufactured at sites the submitter controls and at sites controlled by persons to whom the 943 submitter either directly or indirectly distributes the reportable chemical substance ( including 944 through a broker/ distributor or from a customer of the submitter, etc.). As for the industrial 945 processing and use information described in Unit II. D. 7. of this preamble, commercial and 946 consumer use information must be reported only by sites at which a chemical substance is 947 manufactured in annual quantities of 300,000 lbs. or more, and submitters will only be required to 948 report the information to the extent that it is readily obtainable. 949 Consumers comprise a subpopulation of particular concern to EPA, the Consumer 950 Products Safety Commission ( CPSC), and other governmental and non governmental 951 organizations. Information from submitters about whether the chemical substances they 952 manufacture are used in consumer products is useful in estimating the potential risks to consumers 953 that result from chemical exposures. In the absence of more specific data, EPA often assumes for 954 risk screening purposes that large, unprotected populations may potentially be exposed to the 955 chemical substances in consumer products. EPA is also working with industry and other 956 46 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** stakeholders to develop hazard, exposure, and risk assessments regarding chemicals to which 957 children are exposed. The commercial and consumer product information that will be reported 958 under these IUR amendments will be used by EPA in the identification of chemicals that might be 959 included in these programs, and may contribute to exposure assessments for these chemicals. 960 i. Commercial and consumer product categories ( Section 710.32( c)( 4)( ii)( A) of the 961 regulatory text; Part III, Section II a of revised reporting Form U). Submitters must report up to 962 10 categories that best describe the commercial and consumer products that the reportable 963 chemical substance is used in, both at sites under the control of the submitter, as well as at sites 964 that receive a reportable chemical substance from the submitter either directly or indirectly 965 ( including through a broker/ distributor, from a customer of the submitter, etc.). This information 966 must be submitted to the extent that this information is readily obtainable. If more than 10 967 categories apply, submitters need only report the categories for the chemical substance that 968 cumulatively represent the largest percentage of production volume, measured by weight. The 969 commercial and consumer product ( CCP) categories are listed at section 710.32( c)( 4)( ii)( A) of 970 the regulatory text. Information on the use of chemicals in CCPs is useful in estimating the 971 frequency and duration of chemical substance exposures. In the absence of other information, 972 consumers are often assumed to experience less controlled, but less frequent exposures than 973 workers. The data that will be obtained under the IURA will enable EPA to make more realistic 974 characterizations of exposure, instead of    worst case,'' overly conservative assumptions. 975 ii. Products intended for use by children ( Section 710.32( c)( 4)( ii)( B) of the regulatory 976 text; Part III, Section II a of revised reporting Form U ). Submitters must indicate, within each 977 reported CCP category, whether any amount of each reportable chemical substance manufactured 978 47 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** by the submitter is present in ( for example, a plasticizer chemical used to make pacifiers) or on 979 ( for example, as a component in the paint on a toy) any products intended for use by children 980 ( aged 14 or younger), regardless of the concentration of the substance ( see section 981 710.32( c)( 4)( ii)( B) of the regulatory text). 982 Information indicating the use of a chemical in a product intended for use by children will 983 enable the Agency and others to focus attention on chemicals affecting this particularly sensitive 984 population. Submitters are required to indicate, within each CCP category reported, that the 985 reportable chemical substance is used in the manufacture of a product intended for use by 986 children, is not used in any such product, or that such information is not readily obtainable. 987 In the proposed rule, EPA stated its intent to use the consumer use information collected 988 under the amended IUR " to propose a test rule to develop hazard data regarding chemicals in 989 consumer products to which children are exposed." 64 FR 46772, 46791. EPA believes 990 information indicating the potential presence of a chemical in a product intended for use by 991 children will enable the Agency and others to focus attention on chemicals that could affect this 992 particularly sensitive population. Examples of products intended for use by children include, but 993 are not limited to: 994 Code 995 Category Examples of Children's Products C01 996 Artists' supplies Crayons, children's markers C02 997 Adhesives and sealants Craft glue, model glue C03 998 Automotive care products NA C04 999 Electrical and electronic products Electronic games, remote control cars, toys C05 1000 Glass and ceramic products Porcelain dolls C06 1001 Fabrics, textiles and apparel Pajamas C07 1002 Lawn and garden products ( non NA 48 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** pesticidal) C08 1003 Leather products Shoes, jackets, baseball gloves C09 1004 Lubricants, greases and fuel additives NA C10 1005 Metal products Toy trucks, toy cars C11 1006 Paper products Diapers, baby wipes, coloring books C12 1007 Paints and coatings Finger paints, interior paints marketed for children's rooms C13 1008 Photographic chemicals NA C14 1009 Polishes and sanitation goods NA C15 1010 Rubber and plastic products Pacifiers, action figure, balls C16 1011 Soaps and detergents Baby shampoo, children's bubble bath C17 1012 Transportation products NA C18 1013 Wood and wood furniture Baby cribs, changing tables, wooden toys C19 1014 Other Other items specifically intended for use by children 1015 iii. Percentage of production volume attributable to each commercial and consumer 1016 product category ( Section 710.32( c)( 4)( ii)( C) of the regulatory text; Part III, Section II b of 1017 revised reporting Form U). Submitters must estimate the percentage of their production volume 1018 for each reportable chemical substance that is attributable to each specific commercial and 1019 consumer end use carried out at sites under the control of the submitter, as well as at sites that 1020 receive a reportable chemical substance from the submitter either directly or indirectly ( including 1021 through a broker/ distributor, from a customer of the submitter, etc.). This information must be 1022 submitted to the extent that it is readily obtainable. Estimates must be rounded off to the nearest 1023 10% of production volume. However, a CCP category which accounts for 5% or less of the total 1024 production volume of a reportable chemical substance cannot be rounded off to zero percent if the 1025 production volume attributable to that CCP category is greater than or equal to 300,000 lbs. In 1026 such cases, submitters must report the percentage of production volume attributable to that CCP 1027 49 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** category to the nearest 1% of production volume. This exception to the general rounding rule will 1028 ensure that adequate use information is reported for the larger production volume chemical 1029 substances. The 300,000 lbs. level was selected for consistency with the threshold for reporting 1030 processing and use data ( see Unit II. F. 2. of this preamble). 1031 The total percent production volumes reported may add up to more than 100%, given 1032 that the submitter is reporting on distribution of a chemical to sites in its control as well as 1033 downstream sites, some of which are not immediate purchasers from the original manufacturing 1034 site. Additionally, the total percent production volume may add up to less than 100% if the 1035 submitter cannot readily obtain information about how all of its production volume is used in 1036 commercial and consumer products. 1037 iv. Maximum concentration in commercial and consumer products ( Section 1038 710.32( c)( 4)( ii)( D) of the regulatory text; Part III, Section II c of revised reporting Form U). 1039 Submitters must report the maximum concentration ( measured by weight) of each reportable 1040 chemical substance in each commercial and consumer product category. In complying with this 1041 requirement, submitters will select from the list of concentration ranges provided in section 1042 710.32( c)( 3)( vii) in the regulatory text. Concentration is further discussed in Unit III. B. 1. b. of 1043 this preamble. As with the other processing and use information that submitters must report, such 1044 information will be reported only to the extent that it is readily obtainable by the submitter. 1045 8. What changes have been made to requirements for making confidential business 1046 information claims? Submitters are able to claim information submitted to EPA under this 1047 amended rule as confidential if they have reason to believe that release of the information would 1048 reveal trade secrets or confidential commercial or financial information, as provided by section 14 1049 of TSCA and 40 CFR part 2. Claims of confidentiality must be asserted at the time information is 1050 50 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** submitted to EPA. EPA's procedures for processing and reviewing confidentiality claims are set 1051 forth at 40 CFR part 2, subpart B. EPA strongly encourages submitters to review confidentiality 1052 claims carefully to ensure that the information in question falls within the protection of TSCA 1053 section 14, and to limit invalid confidentiality claims as much as possible. 1054 Submitters will have an opportunity to make CBI claims for most of the information 1055 reported under the amended IUR. To claim information as confidential, a submitter must check 1056 the appropriate box and sign the certification statement on the reporting form. If a submitter fails 1057 to do so, EPA could release the information to the public without further notice to the submitter. 1058 As in the last four TSCA Inventory Update collections and the initial TSCA Inventory collection, 1059 by signing the certification statement the submitter certifies that its claims of confidentiality are 1060 true and correct. Procedures for claiming information submitted electronically ( such as a 1061 submission on diskette) as CBI will be specified in the instruction manual that will be available 1062 each submission period as described in section 710.40 of the regulatory text. CBI should not be 1063 submitted by e mail. A discussion about CBI claims under the amended IUR is provided in this 1064 unit. 1065 a. Upfront Substantiation for Plant Site Identity. Submitters are required to provide 1066 upfront substantiation for CBI claims for plant site identity, in a manner similar to the upfront 1067 substantiation of chemical identity under the existing IUR ( see 40 CFR 710.38). Under the 1068 amended IUR, a submitter may assert a claim of confidentiality for a plant site identity if the 1069 submitter believes that releasing that identity would reveal trade secrets or confidential 1070 commercial or financial information, as provided by TSCA section 14. Submitters in past IUR 1071 information collections, have claimed in excess of 15% of plant site identities as CBI. While the 1072 Agency does not question the occasional need for this claim, it believes that these claims should 1073 51 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** be limited to only those circumstances in which it is necessary. Further discussion on upfront 1074 substantiation is found in Unit III. E. 2. of this preamble. 1075 In order to assert a claim of confidentiality for a plant site identity under this amended 1076 rule, the submitter must check the appropriate box on the reporting form indicating a 1077 confidentiality claim for plant site identity and substantiate the claim in writing by answering 1078 certain questions provided in Sec. 710.38( d) of the regulatory text. If a submitter fails to 1079 substantiate the plant site CBI claim, EPA could make the information available to the public 1080 without further notice to the submitter. 1081 b. CBI claims for Chemical Production Volume Information. EPA did not change the 1082 ability of the submitter to assert a claim of confidentiality for production volume information if the 1083 release of that information would reveal trade secrets or confidential commercial or financial 1084 information as provided by section 14 of TSCA. However, submitters may make separate CBI 1085 claims for both actual plant site production volume information and a corresponding production 1086 volume range. Production volume ranges are similar to those used in the implementation of the 1087 original TSCA Inventory collection and can be found at section 710.32( c)( 3)( v) of the regulatory 1088 text. 1089 In the last four IUR submission periods when EPA sought actual production volume 1090 information, approximately 65% of the information was claimed as confidential. 1091 In contrast, only 35% of production volume data collected in ranges in the original TSCA 1092 inventory collection were claimed as confidential.. This difference indicates that submitters may 1093 be significantly less likely to make CBI claims for production volume information reported in 1094 ranges than for discrete production volume figures. The high proportion of CBI claims in IUR 1095 reports has severely limited EPA's ability to convey production volume information to the public, 1096 52 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** even in the form of a national aggregate production volume for the chemical. EPA needs to be 1097 able to convey production volume information to the public to explain its chemical risk 1098 assessment and risk management decisions. Effective communication of this information is vital to 1099 EPA's overall mission. EPA has added the ability to claim production volume range information 1100 CBI in an effort to address this problem. In some cases, submitters may choose to claim their 1101 actual production volume as CBI, while allowing the more general production volume range to 1102 be made public. 1103 c. Reasserting Claims. Submitters must reassert CBI claims made in their previous IUR 1104 reporting to retain the CBI claim ( see section 710.39 of the regulatory text; Part IV of revised 1105 reporting Form U). CBI claims made in IUR submissions prior to 2006 ( the first IUR reporting 1106 year under these amendments) are not subject to this reassertion requirement. A submitter who is 1107 reasserting a previous claim ( made during reporting year 2006 or in subsequent years), is 1108 communicating to EPA that it believes that the information continues to qualify as CBI and that 1109 EPA should continue protecting the information as CBI. Reassertion must be made on a per 1110 chemical basis, i. e., each reassertion covers information associated with only one previously 1111 reported chemical for which some or all of the previously reported information was claimed as 1112 CBI, and for which the submitter would like to retain some or all of the previous claims. 1113 Since 1990, EPA has been engaged in a dialogue with the public on issues associated with 1114 TSCA CBI. During this dialogue, industry has confirmed EPA's understanding that the need for 1115 certain confidentiality claims is reduced or eliminated over time ( Ref. 14). See the discussion 1116 located in Unit III. E. 3. b. in this preamble. The new procedures in this amended rule will help 1117 ensure that the submitter has an on going need for continued CBI protection. Under these 1118 procedures, submitters will be required, in subsequent submission periods, to affirmatively 1119 53 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** represent the need for the continued CBI protection of the claims made in previous IURA 1120 submission periods. These requirements begin in the second submission period under the 1121 amended IUR, i. e., reassertion of CBI claims made during the 2006 submission period will occur 1122 in the 2010 reporting period, as necessary. 1123 To illustrate, in the 2014 submission period, a submitter will be required to affirmatively 1124 represent on the reporting form that: ( 1) The specific CBI claims made for the first time in 1125 reporting year 2010 and ( 2) the specific CBI claims reasserted in reporting year 2010 ( i. e., claims 1126 originally made in reporting year 2006) continue to be necessary in order to protect trade secrets 1127 or confidential commercial or financial information as provided by TSCA section 14. The CBI 1128 reassertion statements are contained in Part IV. of Revised Reporting Form U. If the submitter 1129 does not reassert prior CBI claims, EPA will assume that the submitter is waiving those claims of 1130 confidentiality to the underlying information contained in the earlier filings and the information 1131 will be subject to public disclosure without further notice. 1132 For data elements requiring upfront substantiation of CBI claims ( i. e., chemical identity 1133 and plant site identity), submitters must revisit their answers to the substantiation questions in 1134 section 710.38 of the regulatory text when reasserting these CBI claims. The submitter must 1135 submit amended answers if the original answers to any of the questions have changed. If the 1136 answers have not changed, the submitter does not need to take any special action. 1137 A submitter who asserts a CBI claim in a prior submission period may not be required to 1138 report under the current IUR submission period because of low production volume or other 1139 applicable exclusions. However, if that submitter wishes to retain the claim, it must nevertheless 1140 reassert its prior CBI claim during the current submission period by filling out and submitting only 1141 Parts I and IV on Form U ( along with amended answers to any substantiation questions, if 1142 54 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** necessary). Submitters must send a separate reassertion for each chemical for which the submitter 1143 is reasserting CBI claims. Again, CBI claims made in IUR submissions prior to 2006 ( the first 1144 IUR reporting year under these amendments) are not be subject to this reassertion requirement. 1145 EPA will undertake certain precautions in order to ensure that persons who make CBI 1146 claims in IUR submissions in the 2006 submission period and subsequent submission periods are 1147 aware of the requirement that these claims be reasserted, as appropriate, in subsequent submission 1148 periods in order to retain CBI protections. Prior to each IUR submission period, EPA will send an 1149 IUR reporting package to each person who submitted an IUR report or CBI reassertion in the 1150 previous submission period. This package will contain a cover letter which will: ( 1) Remind the 1151 submitters of the reassertion requirements and ( 2) advise that failure to affirmatively reassert prior 1152 CBI claims will result in the removal of CBI protections for this information. The package will 1153 also contain a reporting form and reporting instructions which will reiterate these reminders. In 1154 addition, EPA intends to publish a Federal Register notice at least 2 weeks before the end of each 1155 submission period which will remind those persons who have not reasserted their prior CBI claims 1156 of the pending declassification of these claims if they do not reassert by the end of the submission 1157 period. In addition to these reminders, EPA also intends to publicize the need to reexamine and 1158 reassert past CBI claims via the EPA/ OPPT Homepage ( http:// www. epa. gov) on the Internet, and 1159 in communications with trade associations through their publications as well as through other 1160 relevant publications. 1161 III. Public Comments 1162 EPA carefully considered the comments it received on the proposed IUR amendments. 1163 Major comments are discussed below. Additional comment summaries and more detailed 1164 55 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** responses are contained in the " Summary of EPA's Responses to Public Comments Submitted in 1165 Response to Proposed TSCA Inventory Update Rule Amendments ( 64 FR 46772)." ( Ref. 15) 1166 A. General Comments 1167 1. How will EPA and others use the new exposure related data collected under these 1168 amendments? Several commenters expressed the view that EPA has not provided 1169 adequate justification supporting the Agency's need for the new IUR data, nor enough specific 1170 examples showing how EPA would use the data for its intended purpose. 1171 EPA has an obligation under TSCA to protect human health and the environment from 1172 unreasonable risks associated with chemicals under its jurisdiction. In order to evaluate potential 1173 chemical risks, EPA has determined that a portion of the chemicals ( both inorganic and organic) 1174 on the TSCA Inventory currently warrant the collection of manufacturing information, and that a 1175 subset of those chemicals ( i. e., those produced in annual quantities of 300,000 lbs. or more at a 1176 site) currently warrant the collection of supplementary processing and use information. EPA is 1177 amending the IUR to provide an accurate and readily available source of basic exposure related 1178 information for approximately 4,000 of the 76,000 substances listed on the Inventory. The 1179 amendments significantly limit industry's reporting burden while providing EPA with information 1180 needed to screen for risks to human health and the environment. 1181 EPA's primary use of these data will be to identify priority TSCA chemicals for more 1182 detailed information gathering, risk assessment, and risk management in order to develop targeted 1183 programs, allowing the Agency to be proactive in protecting human health and the environment. 1184 Screening chemical risks generally requires a combination of both hazard and exposure 1185 information. The lack of exposure related data beyond production volume data in the current IUR 1186 has severely limited the usefulness of the current IUR data for risk screening. Moreover, the 1187 56 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** exposure related data that will be collected under the amended IUR are not otherwise readily 1188 available from publicly available data sources ( see Unit III. A. 3. of this preamble). This lack of 1189 exposure related data has made it difficult for EPA and others to identify chemicals with potential 1190 exposures of concern, and has resulted in the generation of overly conservative screening level 1191 exposure assessments. 1192 The addition of manufacturing, processing and use exposure related data to the IURA, 1193 especially when compiled by EPA into a searchable database format, will enable EPA and others 1194 to more readily screen chemicals for exposure and risk. These reviews will allow for better 1195 prioritization of chemicals to identify those warranting more detailed assessments and to eliminate 1196 chemicals of lesser concern from further review. 1197 Data generated by the IURA will be used in a wide variety of programs fundamental to 1198 fulfilling the Agency's TSCA statutory mandate. These programs range from the more traditional 1199 existing chemicals risk screening efforts, to voluntary programs such as EPA's Design for the 1200 Environment program ( see http:// www. epa. gov/ opptintr/ dfe), to individual requests for analysis of 1201 chemicals not specifically associated with a particular program. The IURA database will be 1202 searched to identify chemicals or use scenarios meeting specific criteria. For instance, the 1203 database could be searched to identify chemicals that have the greatest potential for consumer 1204 exposure, creating a list of chemicals arranged according to the production volumes associated 1205 with different consumer uses. Additional examples of uses for the amended IUR data are 1206 provided in this section and in EPA's " IURA Data Use Plan" ( Ref. 16). The Agency anticipates 1207 that, as was true even for the basic production data reported under the existing IUR, new uses of 1208 IURA data by EPA and by others will continually emerge and cannot be predicted at this time. 1209 Results from EPA tools such as the Use Cluster Scoring System ( UCSS) will be greatly 1210 57 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** improved by the amended IUR data. The UCSS is a computerized tool that combines hazard and 1211 exposure information from a variety of data sources, analyzes the data in relation to groupings by 1212 commercial use, or " clusters," and identifies clusters of potential concern to EPA. EPA's Science 1213 Advisory Board ( SAB) commented in its evaluation of the UCSS that the lack of exposure 1214 information in the system has impaired its usefulness ( The SAB report is found at 1215 http:// www. epa. gov/ sab/ eec95017. pdf). The amended IUR database will provide exposure 1216 information that the UCSS will be able to download directly and use. ( For a description of 1217 UCSS, see http:// www. epa. gov/ opptintr/ cbep/ actlocal/ 39 use. htm.) 1218 EPA will also use IUR data to perform preliminary exposure and risk screening across a 1219 portion of the Inventory chemicals. Some of the same type of data that will be collected under the 1220 amended IUR have been collected under the Agency's TSCA Existing and New Chemicals 1221 Programs ( ECP) and ( NCP) and have aided EPA in performing exposure and risk screening. 1222 These exposure related data were submitted as part of programs such as: the voluntary Use and 1223 Exposure Information Project ( UEIP) ( see http:// www. epa. gov/ opptintr/ sids/ vueip. txt for a 1224 description of this project) and the Premanufacture Notice ( PMN) program under TSCA section 1225 5. Although the UEIP and PMN programs involve the submission of certain data that are the 1226 same as or similar to data being submitted under IURA, these programs cannot sufficiently serve 1227 the needs that IURA will serve ( see Units V. A. 1. and V. B. 5. of the proposed rule ( 64 FR 46772, 1228 46775 and 46780)). However, these programs are examples of the usefulness of certain IURA 1229 data elements. 1230 For example, several IURA data elements were used in an Existing Chemicals Program 1231 initial review of the chemical methyl ethyl ketoxime ( MEKO). This review relied in part upon data 1232 submitted by industry under the UEIP. Some of the data are similar to those that will be reported 1233 58 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** under the IUR Amendments and include the following: production volume, manufacturing 1234 process, industry sector, industrial processing/ use activity, functional use, number of sites, number 1235 of workers, physical/ chemical properties, and consumer product information. Other UEIP 1236 information submitted by industry on MEKO are not of the sort that will be collected under the 1237 amended IUR, such as environmental releases ( releases to air, water, etc.), worker exposure 1238 activities and monitoring data. The IUR Amendments are designed to obtain information that is 1239 the most critical for generating screening level exposure profiles. 1240 The UEIP submissions for MEKO indicated that there were one manufacturer and two 1241 importers of MEKO in 1993 and five primary end uses ( with the percentages of MEKO 1242 production and import volumes devoted to each use). The submissions also reported the number 1243 of workers at the manufacturing site, the physical forms of products containing MEKO, and the 1244 MEKO weight fraction in each use. 1245 The MEKO use information was combined with data and information from available 1246 workplace monitoring studies and modeling approaches to compile a screening level workplace 1247 exposure assessment. The UEIP information on use provided crucial information to allow EPA to 1248 postulate process operations, worker activities, and possible exposures. For example, MEKO's 1249 primary use ( 92% of production and import volume) is as a paint additive. This fact allows EPA 1250 to refer to information on paint manufacturing and use to estimate exposures to workers who 1251 either formulate paints or apply the paints using spray guns or other techniques. MEKO use in 1252 paint indicates a potential for exposure to several large populations ( workers and consumers) 1253 because exposure to even small amounts of paint can result in significant exposure levels to 1254 chemicals in paints. Such use information can also be used by EPA to generate estimated 1255 numbers of workers in very small businesses (< 10 workers) that may be poorly represented by 1256 59 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** existing National Occupation Exposure Survey ( NOES) data. In the MEKO case, such a 1257 population would be commercial painters. Without the information about MEKO use in paints 1258 and the large percentage of MEKO volume devoted to this use, exposed populations and 1259 exposure level estimates may have been severely underestimated or left as a data gap ( not 1260 estimated). Such underestimations and data gaps can artificially lower the appropriate level of 1261 concern for potential risk( s) from a chemical. 1262 The usefulness of IURA data elements is also demonstrated by EPA's use of similar data 1263 in its New Chemicals Program. Premanufacture Notices ( PMNs) for new chemical substances 1264 submitted to EPA under TSCA section 5 require many of the same exposure related data 1265 elements that will be reported under the IUR Amendments. Exposure related data in PMNs 1266 include estimates of production volume, categories of use, percent production volume in the 1267 categories of use, maximum numbers of workers exposed, and concentrations and physical forms 1268 of the chemical. EPA uses these exposure related data to generate screening level risk 1269 assessments for regulatory decision making under TSCA section 5. 1270 The manufacturer of a new chemical provided the following information in a recent PMN 1271 submission: an estimated import volume; chemical uses and the percentages of the import volume 1272 devoted to each use ( cosmetic applications exempt from TSCA ( 25%) and non cosmetic 1273 applications as a component of a fragrance formulation used in household products such as 1274 detergents, cleaners, soaps, room fresheners, etc. ( 75%)); numbers of sites and workers; and, 1275 consumer product information ( weight percent in products). EPA used this information in 1276 combination with technical references and other research to estimate the number of manufacturers 1277 of household products who may use the new substance. Releases of the new substance from the 1278 fragrance formulation process and from the household products manufacturers were estimated, 1279 60 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** resulting in estimated environmental concentrations of the new substance due to its release and 1280 estimated general population exposures to the new substance. EPA also used the information on 1281 processing and use in combination with modeling techniques to estimate the numbers of workers 1282 and consumers who may be exposed to the new substance and their estimated exposures to the 1283 new substance. These exposure related estimates, when combined with information on the 1284 estimated hazards of the new substance, indicated that the estimated risks to potentially exposed 1285 workers, the general population, consumers, and aquatic species were all below levels of concern. 1286 Therefore, because EPA did not identify any significant risks, the Agency could determine that no 1287 further regulation under TSCA section 5 was needed for this new substance. In contrast, without 1288 this information, EPA would have had to rely on generic assumptions for approximating potential 1289 exposures. These types of assumptions are intended to be conservative in nature and therefore 1290 often result in higher than likely exposure estimates. 1291 Information from the amended IUR may also be used in efforts to identify single chemicals 1292 to support potential exposure prevention efforts. For example, EPA recently learned that certain 1293 imports of zinc sulfate were contaminated with cadmium. Using the IURA processing and use 1294 data on inorganic substances, EPA could have quickly identified importers of zinc sulfate and 1295 segments of industry or the general population that might use the chemical. EPA then could have 1296 targeted warnings of the potential for exposure to cadmium more effectively, thereby preventing 1297 exposures to these groups likely to be the most highly exposed. 1298 Other Federal Agencies have also long recognized the need for and importance of 1299 exposure data. OSHA, NIOSH, and CPSC have written letters supporting EPA's and their own 1300 need for exposure data ( Refs. 9, 10, 17, 18, and 19). In May 2000, the Government Accounting 1301 Office ( GAO) stated that " Various federal agencies have collected such human exposure data for 1302 61 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** a number of purposes; historically, these collection efforts have been limited to selected chemicals, 1303 subpopulations, and time periods"( Ref. 20). 1304 Other government agencies, industry, public interest groups, and the public in general will 1305 also be able to access and use the non CBI portion of the IURA information. The IURA 1306 exposure related data will be important to users beyond those who accessed the original IUR in 1307 the past solely for production volume information. The Natural Resources Defense Council, for 1308 example, has expressed interest in using the IURA information ( Ref. 21). In another case, 1309 persons interested in reviewing the HPV Challenge Program screening level hazard data ( see 1310 http:// www. epa. gov/ opptintr/ chemrtk/ volchall. htm) will be able to use the exposure related IURA 1311 data ( non CBI data) to put the hazard data into context. Risks identified via evaluation of these 1312 screening level hazard and exposure data then can be addressed. 1313 This section described a wide variety of uses for the new IURA exposure related data. 1314 However, the Agency anticipates that even more opportunities exist for use of this information, as 1315 was true for the basic production data reported under the current IUR. 1316 2. What is the practical utility of the new exposure related data? Commenters have 1317 questioned whether the data collected as a part of this rulemaking will have " practical utility." 1318 Practical utility is defined in the Paperwork Reduction Act of 1995 ( PRA) ( 44 U. S. C. 3502( 11)) 1319 to mean " the ability of an Agency to use information, particularly the capability to process such 1320 information in a timely and useful fashion." The Office of Management and Budget's ( OMB) 1321 regulatory definition of " practical utility" at 5 CFR Part 1320.3( l) addresses not only the 1322 theoretical or potential usefulness of information to an Agency, but also its actual usefulness, 1323 taking into account its accuracy, validity, adequacy, and reliability, the Agency's ability to 1324 process the information in a useful and timely fashion, and whether the Agency demonstrates 1325 62 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** actual timely use of the data by the Agency's own functions. The following discussion addresses 1326 commenters' concerns in two parts: first, the adequacy, accuracy, validity, and reliability of the 1327 data; and second, the timely use of the data by EPA. 1328 a. How has the Agency ensured that the data will be accurate, valid, adequate, and 1329 reliable? Commenters asserted that the data EPA proposed to collect through the amended IUR 1330 will not be adequate for the purposes stated by EPA, and will not be accurate, valid, or reliable. 1331 Commenters stated that the information collected through the IURA would be of limited accuracy 1332 and would be inferior to data the Agency has collected in other programs. Commenters also 1333 stated that the information will be so uncertain that it will not be useful to predict chemical risk, 1334 and that there are so many other factors that affect exposure, such as engineering controls, that 1335 the data will provide a limited and potentially inaccurate view of potential exposure. Additionally, 1336 commenters asserted that they do not know how their chemicals are used downstream of the 1337 manufacturing site, resulting in data that are unreliable. 1338 EPA considered the types of information needed for screening level exposure and risk 1339 assessments and believes the information that will be collected through the amended IUR will 1340 have the necessary level of adequacy, accuracy, validity, and reliability for such assessments. EPA 1341 agrees that there are many ways to increase the accuracy, validity, and reliability of the data. 1342 However, in developing the amended IUR and considering various alternatives, EPA relied on 1343 experience from programs such as TSCA's PMN program and the UEIP data collection, and 1344 maintained a balance between data needs for exposure screening and priority setting and the 1345 burden associated with providing the information. If the Agency had required very precise, 1346 specific reporting, submitter burden would have increased beyond that which is appropriate for a 1347 screening level data collection. EPA also agrees that there are many factors that can affect 1348 63 ** Working Draft  Do Not Cite or Quote  Not for Public Release ** exposure potential; however, the data provided by the submitters will provide baseline information 1349 sufficient for an initial screen of exposure potential. 1350 i. Adequacy of the data. Before proposing the IUR Amendments, EPA analyzed various 1351 exposure data collections and assessments to determine the data elements needed for a screening 1352 level exposure assessment. This discussion and analysis are in the document    Inventory Update 1353 Rule ( IUR) Amendment Technical Support Document: Exposure Relat