# + 2

(,1 1/,1(

Citation: 68 Fed. Reg. 848 2003

Content downloaded/printed from HeinOnline (http://heinonline.org) Thu Jul 22 11:03:25 2010

-- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from uncorrected OCR text.

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Parts 9, 710, and 723

[OPPT-2002-0054; FRL-6767-4]

RIN 2070-AC61

TSCA Inventory Update Rule Amendments

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 8(a) Inventory Update Rule (IUR). The IUR currently requires manufacturers (including importers) ofcertain chemical substances on the TSCA Chemical Substances Inventory to report data oneach chemical's current production volume, site-limited status, andplant site information every 4 years. Through these IUR amendments (IURA), EPA is requiring the reporting of additional data for certain chemicals to assistEPA and others in screening potential exposures and risks resulting from industrial chemical operations and commercial and consumer uses ofTSCA chemical substances. EPAis also modifying the IUR reporting and recordkeeping requirements, removing

one reporting exemption and creating others, and modifying itsprocedures for making Confidential Business Information claims. EPAis also making certain non-substantive technical corrections.
DATES: This final rule is effective February 6, 2003. Forpurposes of judicial review, this rule shallbe promulgated at 1p.m. eastern daylight/ standard time onJanuary 21, 2003.

FOR FURTHER INFORMATION CONTACT: For generalinformationcontact:Barbara Cunningham, Acting Director, Environmental Assistance Division, Office ofPollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-8170; email address: TSCA-Hotline@epa.gov.

Fortechnicalinformationcontact: Susan Sharkey, Project Manager, Economics, Exposure and Technology Division (7406M), Office ofPollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-8789; email address: sharkey.susan@epa.gov. SUPPLEMENTARY INFORMATION:

I. General Information

A. Does thisActionApply toMe?

You may be affected bythis action if you manufacture (defined by statute to include import) chemical substances currently subject to reporting under the Inventory Update Rule (IUR) at40 CFR part 710 or ifyou manufacture inorganic chemical substances. Any use ofthe
term "manufacture" in this document will encompass "import," unless otherwise stated. In the past, persons that only are processors ofchemical substances have not been required to comply withthe requirements of40 CFR part 710. These amendments do not change the status ofprocessors under the regulations at40 CFR part 710. Potentially affected categories and entities may include, but are not limited

to:Chemical manufacturers and importers currently subject to IUR reporting, and chemical manufacturers and importers ofinorganic chemical substances (NAICS codes 325, 32411).

This listing isnot intended to be exhaustive, but rather provides aguide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unitcould also be affected. North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action applies to certain entities. To determine whether you oryour business is affected bythis action, you should carefully examine the applicability provisions in §710.48 in the regulatory
text. Ifyou have any questions regarding the applicability ofthis action to a particular entity, consult the technical
contact person listed under FOR FURTHER INFORMATION CONTACT.

B. How CanI GetCopiesofthis Document orOther Related Information?
1.Docket.EPAhas established an official public docket for this action under docketID number OPPT-2002- 0054. The official public docket consists ofthe documents specifically referenced in this action, any public comments received, and otherinformation related
to this action. Although a part ofthe official docket, the public docket does
not include Confidential Business Information (CBI) or otherinformation whose disclosure is restricted by statute. The official public docketis the collection ofmaterials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPADocket Center is open from 8:30 a.m. to 4:30
p.m., Monday throughFriday, excluding legalholidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPADocket Center, is (202) 566-0280.

2. Electronicaccess.You may access this Federal Register document electronically throughthe EPAInternet underthe "Federal Register" listings at http://www.epa.gov/fedrgstr/. An electronic version ofthe public docket is available through EPA's electronic public docket and comment system, EPADockets. You may use EPA Dockets
athttp://www.epa.gov/edocket/to view public comments, access the index listing ofthe contents ofthe official public docket, and access those documents inthe public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any ofthe publicly available docket materials through the docket facility identified in UnitI.B.1. Once in the system, select "search," then key inthe appropriate docket identification number.

II. Background

A. WhatAction is theAgency Taking?
1.Substantivechangesto the CFR. EPAis promulgating amendments to the IUR (IURA) which were proposed on August 26, 1999 (64 FR46772) (FRL6097-4), taking into consideration
comments received on the proposal. The amendments to the IURthat are contained in this final rule, as well as the inventory update provisions of40 CFR part 710 that are unchanged by these amendments, appear in a new subpart C to 40 CFR part 710. The inventory update provisions that apply
to the 2002 update remain unchanged although the Agency has added subpart headings in order to distinguish the provisions that apply to the 2002 update (i.e., the existing IUR) and the new and revised provisions promulgated in this rule. The following is a brieflisting of the primary changes to the IUR, which do not affectthe regulations in place for IURreporting in 2002. These changes

are described in more detail in this document, along with a summary ofthe
comments received and the Agency's
summary response tothose comments.

First, EPA is amending the existing IURregulations, 40 CFR 710.28 and 710.32, which appear in the new subpart C as §§ 710.48 and 710.52, to raisethe production volume basic 

### 848

HeinOnline -- 68 Fed. Reg. 848 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

reporting threshold from the current 10,000 pounds (lbs.) peryear to 25,000 lbs. per year, and to add a new largervolume reporting threshold of300,000 lbs. per year for the reporting of processing and use information.

Second, EPAis amending 40 CFR 710.32, which appears in the new subpart C as 

### §710.52, to add exposurerelated information tothe existing reporting requirements for chemical substances covered by the IUR. Specifically, the Agency is requiring that manufacturers subject to the amended rule ("submitters") report, in ranges: (1)The number ofworkers reasonably likely to be exposed to the chemical substance at the site of manufacture; (2)the physical form(s) in which the chemical substance is sent off-site; (3)the percentage oftotal reported production volume associated with each physical form; and (4) the maximum concentration ofthe chemical substance atthe time itleaves the submitter's manufacturing site or, ifthe chemical substance is site-limited, the maximum concentration atthe time itis reacted on-site to produce a different chemical substance.

Third, EPAis amending 40 CFR 710.32, which appears in the new subpart C as 

### §710.52, to require chemical manufacturers ofchemical substances with production volumes of 300,000 lbs. or greater to report certain exposure-related information concerning the processing and use of each reportable chemical substance that is conducted at sites thatreceive the reportable chemical substance from the submitter site directly or indirectly (whether the recipient site(s) are controlled by the submitter site or not) (includingthrough abroker/distributor, from a customer ofthe submitter, etc.). Specifically, manufacturers ofthese larger-production volume chemical substances will be required toreport, to the extent the information is readily obtainable:

* The type ofindustrial processing

oruse operation(s) at each site, including downstream sites.

* The five-digit NAICS codes that best describe the industrial activities duringthe processing oruse operation.

* The industrial function ofeach chemical substance during the processing or use operation, for each NAICS code reported.

* The percentages ofthe submitter's production volume used in each industrial function category.

* The number ofsites where the various processing or use operations

occur.

* The number ofworkers reasonably likely to be exposed to the chemical substance in each processing oruse operation.

* The categories ofcommercial and

consumer uses ofthe reportable chemical substance.

* Anindication ofthe presence of the reportable chemical substance in or

on consumer products intended for use by children. * The percentages ofthe submitter's production volume associated with each commercial and consumer product category.

* The maximum concentration of the reportable chemical substance in each commercial and consumer product category.

Fourth, EPA isrevoking the current full exemption from IUR reporting at 40 CFR 710.26(a) for inorganic chemical substances, and is phasing in reporting for these substances, which appears in the new subpart C as 

### §710.46(b)(3). For the first submission period following promulgation ofIURA (i.e., the 2006 submission period), EPAis requiring partial reporting for these substances (i.e., inorganic chemical substances will
not be subject tothe reporting of processing and use information). In subsequent submission periods, manufacturers ofan inorganic substance will be subject to full reporting (i.e., including the processing and use information reporting requirements), to the extent that they manufacture atleast 300,000 lbs. ofthe substance at asite during agiven reporting year.

Fifth, EPA is amending 40 CFR 710.26, which appears in the new subpart C as 

### §710.46(b)(1), to create a partial reporting exemption for certain chemical substances termed "petroleum
process streams" for purposes of reporting under the IURA (i.e., these chemical substances are not subject to the reporting ofprocessing anduse information). Sixth,EPA is providing, in 40 CFR 710.46(b)(2), a partial exemption for specific chemical substances (i.e., these chemical substances are not subject to the reporting ofprocessing anduse information) where EPAhas identified that there is a low current interest in the IURA processing anduse information related to the chemical. EPAhas identified alist ofchemicals that are covered by this partial exemption, and provides a process for revising this list

over time because interest in the IURA processing and use information for a particular chemical can change. Seventh, EPA is amending 40 CFR 710.26, which appears in the new subpart C as 

### §710.46(a)(4), toprovide a full exemption from IUR reporting for certain forms ofnatural gas. Eighth, EPA is amending 40 CFR 710.32, which appears in the new subpart C as 

### §710.52, to require the reporting ofmore specific information
to assist in the accurate identification of plant sitesreporting under IUR.

Ninth, EPAis amending 40 CFR 710.28, 710.32, and 710.33, which
appear in the new subpart C as 

### §§ 710.48, 710.52, and 710.53, to change the period for which reporting is required from a corporate fiscal year to

a calendar year basis.

Tenth, EPA is amending 40 CFR 710.32, which appears in the new subpart C as 

### §710.52, to allow submitters to claim their production volume range as CBI, in addition to the existing requirement that submitters report a specific production volume number and the CBI status ofthat specific number. Under the IURA, some
submitters may choose to assert a confidentiality claim for specific production volume information while releasing the more general production volume range as public information.

Eleventh, EPA is amending 40 CFR 710.38, which appears in the new subpart C as 

### §710.58, to require substantiation ofplant site confidentiality claims at the time such claims are made in IUR submissions to EPA (i.e., "upfront substantiation"), in a

manner similar to the upfront substantiation ofchemical identity, which will continue to be required under40 CFR 710.38, which appears in the new subpart C as 

### §710.58.

Finally, EPAis amending 40 CFR 710.37, which appears in the new subpart C as 

### §710.57, to extend the records retention period from 4 years to 5years.

2. Technicalchanges to the CFR.The amendments that are contained in this final rule, as well as the parts of40 CFR part 710 that are unchanged by these amendments, are codified in a new subpart C in40 CFR part 710. Because promulgation ofIURA will overlap a current IURreporting cycle, EPA must maintain the existing IUR provisions in 40 CFR part 710in effect throughout the 2002 submission period for the existing IUR. Submitters filing IUR reports in 2002 must follow the regulations currently contained in40 CFR part 710, which will now appear under the new heading as subpart B. OnJanuary 1, 2003, the regulations in this final rule that are promulgated in subpart C of40 CFR part 710 will become effective for

use by submitters filing IURAreports in 2006 and beyond. (See 

### §710.1(b) ofthe regulatory text) Since the Agency has duplicated in subpart C those provisions from subpart B (i.e., the existingpart 710) that are unchanged by these 

### 849

HeinOnline -- 68 Fed. Reg. 849 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

## /Rules and Regulations

amendments, once the current reporting cycle is complete, subpart B will no longer be applicable and the Agency will issue a technical amendment to

remove it from the CFR. The creation of subparts in 40 CFR part 710 does not make any substantive changes other than those thathave been presented in this final rule.

Although there are no substantive changes tothe provisions from existing 40 CFR part 710 that havebeen incorporated into the new subpart C, the Agency has made minor technical corrections to those provisions, as well

as technical changes to the existing provisions that now appear in subpart A. Specifically, the Agency is correcting several typographical errors that appear in the existing 40 CFR part 710, and is making other minor non-substantive edits to that text. These technical corrections include the following. (Note wherever a change is being made to a

new regulatory text provision, a regulatory text citation to the corresponding existing40 CFR part 710 provision is provided in parentheses,
e.g., §710.59 (§710.39). This parenthesized citation isprovided in order to identify where the new regulatory text originated.)

In accordance with plain language principles, EPA has substituted "will"

or "must" for "shall." These three terms

are considered to be equivalent, and delineate requirements to be followed or met. Corrections were made in the following sections: §710.1(d) 

### (§710.1(c)); §710.3(a) (§710.2(a)); §710.3(b) (§710.2(b)); §710.3(c) 

### (§710.2(c)); §710.3(d) in the definition for "Administrator" (§710.2(e)); §710.3(d)in the definition for "site" 

### (§710.2(w)); §710.3(d) in the note following the definition for "small quantities for research and development" (§710.2(y)); and §710.4(b)(2) (§710.4(b)(2)).

EPA has corrected some punctuation and spelling errors: commas were added in §710.1(a) (§710.1(a)), in §710.3(d) in the definition for "distribute in commerce" (§710.2(j)) and in the definition for "small quantities for research and development" and in the
note following the same definition (§710.2(y)); commas were removed in the definition for "distribute in commerce" (§710.2(j)) and in the note following the definition for "distribute in commerce" (§710.2(y)); in §710.3(d) "Process 'for commercial purposes'

was substituted for "Process for 'commercial purposes"' in the definition for "Process 'for commercial purposes"' ( §710.2(u)); in §710.3(d) "juridical" was substituted for "juridicial" in the definition for "person" 

### (§710.2(s)) and "appropriate"

was substituted for "appropriated" in the definition for "technically qualified person" (§710.2(aa)(2)); in §710.4(d)(2) "premanufacture" was substituted for "premanufacturing" (§710.4(d)(2)); and in §710.4(d)(5) "photographic films"

was substituted for "photographic, films" (§710.4(d)(5)).

EPA has made certain additional nonsubstantive changes. In §710.3(d), EPA substituted "1,000 lbs. (454 kg)" for "1,000 pounds" in the note following the definition for "small quantities for research and development" (§710.2(y)). EPA has substituted "his/her" for "his" in sections where the word "his" was used: in two instances in §710.3(d) in the definition for "Administrator" (§710.2(e)); in §710.3(d) in the definition for importer (§710.2(l)(2)); and in §710.3(d) in the definition for "technically qualified person" (§710.2(aa)).

EPA has made certain additional nonsubstantive changes andupdated information submission information in §710.59 by substituting "Availability of reporting form and instructions" for "How doI submit the required information for the 1998 reporting cycle?" (§710.39); in §710.59(a) by substituting "http://www.epa.gov/oppt/ iur" for "http://www.epa.gov/opptintr/ iur98" and byremoving "or Fax-onDemand by using a faxphone to call (202) 401-0527 and selecting item 5119" as Fax-on-Demand is no longer available (§710.39(a)); in §710.59(b) by substituting "Guidance for completing the reporting form and preparing an electronic (magnetic media) report will be made available prior to each submission period." for the existing paragraph afterthe heading (§710.39(b)); in §710.59(c) by substituting "will send" for "is mailing" and "reporting package (consisting ofa copy ofForm U and a copy ofthe reporting instructions) tothose submitters that reported in the IUR submission period that occurred immediately prior to the current submission period." for "reporting package to those companies that reported in 1994. " (§710.39(c)); in §710.59(c)(1),EPA substituted "By telephone" for "By phone" and removed "or TDD 202-554-0551" as the TDD number is no longer available (§710.39(c)(1)); in §710.59(c)(2), EPA substituted "TSCA-Hotline@epa.gov" for "TSCA-Hotline@epamail.epa.gov" (§710.39(c)(2)); and in §710.59(c) and (d)EPA substituted "7408M" for "7408," "OPPT Document Control Officer (DCO)" for "Document Control Officer," and "Environmental Protection Agency" for "U.S. Environmental Protection Agency" (§710.39(c)(3)); and by adding §710.59(c)(4) to state that the reporting form and instructions will additionally be available via the Internet.

EPA has also made minor technical corrections to the existing provisions in §710.39 that now appear in subpart B. EPAremoved "for the 1998 reporting cycle" fromthe section heading to clarify that the section applies to the
current reporting cycle. In §710.39(a), EPAreplaced the website address with the current address, www.epa.gov/oppt/ iur/iur02/index.htm, and removed the Fax-on-Demand information, which is

no longer available. In §710.39(c)(1), EPAremoved the TDD number, which is no longer available. The Agency corrected dates and addresses in §710.39(c), (c)(3), and (d)by replacing "1994" with "1998," "Mail Code 7408" with "Mail Code 7408M," and inserting "OPPT" before "Document Control Officer."

EPA made minor revisions to clarify the meaning of certain provisions. In §710.1(a) "and recordkeeping" was inserted after "governing reporting," "(TSCA)" was inserted after "(15 U.S.C. 2607(a))," and "and keeping current"

was inserted after "purpose of compiling" (§710.1(a)); in §710.1(d), the note following the paragraph was added to the end ofthe paragraph and "Note: As a matter oftraditional Agency policy," was removed (§710.1(b)); in §710.52(c)(1) "submitter" was substituted for "respondent" and "as described in §710.59" for "from EPA at the address set forth in §710.39" (§710.32(c)(1)); in §710.52(c)3(ii) "indicating, for each reportable chemical substance at each site," was substituted for "for each substance for which information is being submitted indicating" and added ", or both manufactured inthe United States and imported in the United States" (§710.32(c)(5)); in §710.52(c)(3)(iii) "designation indicating, for each reportable chemical substance at each site," was substituted for "statement for each substance for which information is being submitted indicating" (§710.32(c)(6)); in §§710.45 and 710.55(a) "submission period" was substituted for "reporting period" (§§ 710.25 and 710.35(a)); in §710.48 "section" was substituted for "§ 710.28" 

### (§710.28); in §710.48(b) "paragraphs (a) and (b)" were deleted (§710.28(c)); in §710.52(c)(3)(iv) "reportable" was substituted for "subject" (§710.32(c)(7)); in §710.58(b) "Chemical identity." was added as a sectionheader to more clearly identify the topic ofthe section, and "The following steps must be taken
to assert" was substituted for "To 

### 850

HeinOnline -- 68 Fed. Reg. 850 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 851

assert," and "reportable" was substituted for "specific" (§710.38(c)(b) and (c)); in §710.58(b)(1) "submitter"

was substituted for "person" 

### (§

710.38(c)(1)); in §710.58(b)(1)(i) "subpart" was substituted for "part" 

### (§

710.58(c)(1)(i)); in §710.58(b)(1)(vi) substituted "have been taken" for "have you taken" and "the" for "this" 

### (§

710.38(c)(1)(vi)); in §710.58(c)(2) "listed in paragraph (c)(1) ofthis section" was added for clarification
purposes, "submitter" was substituted for "person" and "clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as 'confidential business information,' 'proprietary,' or 'trade secret."' was substituted for "mark that information

as 'trade secret,' 'confidential,' or other appropriate designation." 

### (§

710.38(c)(2)); and in §710.58(d) "is indicated on the reporting form" was substituted for "accompanies information at the time it is" and "confidentiality claim substantiation"

was substituted for "substantiation" 

### (§710.38(d)).

EPA replaced "manufactured or imported" with "manufactured (includingimported)" to provide consistency and clarification. EPA made this change in: §710.52(c)(3)(iv) 

### (§710.32(c)(7)); §710.58(c)(1)(v) 

### (§

710.38(c)(1)(v)); §710.58(c)(1)(vi) 

### (§

710.38(c)(1)(vi)); §710.58(c)(1)(vii) 

### (§

710.38(c)(1)(vii)); §710.58(c)(1)(viii) 

### (§

710.38(c)(1)(viii)); §710.58(c)(1)(x) 

### (§710.38(c)(1)(x)); and §710.48 

### (§710.28).

EPA moved three definitions that currently appear in §710.2 to §710.23,
to clarify that they apply tothe existing IUR. In §710.3(d), three changes were made in recognition that the definitions

are no longer separated into sections, but are contained within paragraph (d): in the §710.3(d) definition for "Commerce," "paragraph (1)ofthis definition" was substituted for "paragraph (1)ofthis section" 

### (§710.2(i)), and in the §710.3(d) definition for "Technically qualified individual," "this paragraph" was substituted for "paragraph (aa)(3) ofthis section" and "paragraph (1) ofthis definition" was substituted for "paragraph (aa)(1) ofthis section" 

### (§710.2(aa)(3)).

Section 553 ofthe Administrative Procedure Act (APA), 5U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice andpublic procedure are impracticable, unnecessary or contrary tothe public interest, the agency may promulgate a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making these minor regulatory changes in this final rule without prior notice and opportunity for comment because these minor corrections are non-substantive and do not affect the meaning orlegal effect ofthe provisions affected, which remains the same as it

was when the provision appeared in 40 CFR part 710. Thus, notice andpublic procedure are unnecessary for these minor changes to the existing ornew provisions in 40 CFR part 710. EPA finds that this constitutes good cause under 5U.S.C. 553(b)(B).

B. What istheAgency'sAuthority for TakingthisAction?

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current an inventory ofchemical substances in commerce. This inventory is known as the TSCA Chemical Substances Inventory (theTSCA Inventory). In 1977, EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA promulgated the initial IUR at40 CFR part 710 (51 FR 21447, June 12, 1986), alsounder TSCA section 8(a), to facilitate the periodic updating ofthe TSCA Inventory and to support activities associated withthe implementation ofTSCA.

TSCA section 8(a)(1) authorizes the EPA Administrator topromulgate rules under which manufacturers and
processors ofchemical substances and mixtures (referred to hereinafter as "chemical substances") must maintain suchrecords and submit such information as the Administrator may reasonably require. Under TSCA section 8(a), the Agency may collect information associated with chemical substances to the extent that itis known
to or reasonably ascertainable by the submitter. TSCA section 8(a) gives EPA broad discretion in determining the information for which reporting can be required. Some ofthe types of information which canbe required under TSCA section 8(a)(2) include: Categories ofuse for each chemical substance; estimates ofthe amount manufactured orprocessed for each category ofuse; a description ofthe byproducts resulting from the manufacture, processing, use, or disposal ofeach chemical substance; an estimate ofthe number ofindividuals exposed in their places ofemployment; and the duration of such exposure.

TSCA section 8(a)generally excludes small manufacturers andprocessors of chemical substances from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to require TSCA section 8(a) reporting from smallmanufacturers and
processors with respect to any chemical substance that is the subject ofa rule proposed orpromulgated under TSCA section 4, 5(b)(4), or 6, orthat is the subject of an order underTSCA section 5(e), or that is the subject ofreliefthat has been granted pursuant to a civil action under TSCA section 5or 7.The standard for determining whether an entity qualifies as a "small manufacturer" for purposes of40 CFR 710.29, and for 40 CFR part 710 generally, is defined in 40 CFR 704.3. Processors are not currently subject to the regulations at 40 CFR part 710.

This document promulgates the IURA

as subpart C in 40 CFR part 710, which includes provisions copied from the existing IUR regulations in40 CFR part 710 that are not substantively changed

as a part ofthis rulemaking, and the

new IURAprovisions in this final rule. Failure to comply fully with any provision ofthis final rulewill be a violation ofTSCA section 15 and will subject the violator to the penalties of TSCA sections 16 and 17.

C. What is theInventory Update Rule (URY

The IURrequires U.S. manufacturers oforganic chemicals to report toEPA
every 4 years the identity ofchemical substances manufactured annually during the reporting year in quantities of10,000 lbs. or more at each plant site they own or control. The current IUR generally excludes several categories of substances fromits reporting requirements, i.e., polymers, inorganic substances, microorganisms, and naturally occurring chemical substances. Plant sites subject to the rule are currently required to report information such as company name, plant site location, plant site Dun and Bradstreet number(s), identity ofthe reportable chemical substance, and production volume ofeach reportable chemical substance. Data were reported
to EPA underthe IUR in 1986, 1990, 1994, and 1998, and a collection is occurring in 2002.

The data reported underIUR are used
to update the information maintained

on the TSCA Inventory, which is a listing ofchemical substances in

commerce. EPA uses the TSCA Inventory and data reported under the IURto support many TSCA-related activities andto provide overall support for anumber ofEPA and other Federal health, safety, and environmental protection activities (SeeUnit II.E. for

HeinOnline -- 68 Fed. Reg. 851 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

further explanation ofsome ofthese activities).

D. Why isEPA amendingtheIUR?

EPA is amending the IUR for three primary reasons: (1)To tailor the chemical substance reporting requirements to more closely match the Agency's information needs; (2)to obtain new and updated information relating to potential exposures to a subset ofchemical substances listed on the TSCA Inventory; and (3)to improve the utility ofthe information reported. These amendments will enhance the information collected through the IUR, improve the scope ofchemicals covered by the rule, and improve CBIclaims, thereby accomplishing these three goals.

These goals are supported by the policy in section 2(b)(1) ofTSCA, that "adequate data shouldbe developed with respect tothe effect ofchemical substances and mixtures onhealth and the environment and that the development of such data should be the responsibility ofthose who manufacture and those who process such chemical substances and mixtures." The data currently available to EPA are generally inadequate for risk screening purposes. TSCA section 8(a)(2) authorizes EPA to require manufacturers and processors of chemical substances to report a wide variety ofdata, including exposurerelated information which will be reported for certain chemical substances under IURA. These amendments remove certain reporting requirements and add others to focus reporting under the IUR

onthat information which is most needed byEPA and other Federal agencies for screening, assessing, and managing risk. Additionally, the availability ofthese data will enhance public awareness ofbasic information about chemical substances.

Any evaluation ofpotential "risk" is generally based on a combination of hazard information and exposure information. EPA relies on risk screening to indicate which chemical substances pose a potential risk to human health or the environment, and thus warrant amore detailed, resource intensive analysis. The EPA Science Advisory Board's report "Reducing Risk: Setting Priorities and Strategies for Environmental Protection" (Ref.1) and the National Academy ofPublic Administration's report "Setting Priorities, Getting Results, ANew Direction for EPA" (Ref. 2)recognize that EPA's ability to use risk screening
to set priorities and allocate its limited

resources has been significantly impeded by a lack ofexposure data. The manufacturing, processing, and use of chemicals onthe TSCA Inventory result in awide array ofexposure scenarios. The exposure-related data included in IURA will greatly improve EPA's ability
to conduct risk screening to identify chemical substances that could pose an unreasonable risk tohuman health orto the environment, or that otherwise
warrant further investigation.

E. WhatareEPA'sTSCA-Related ChemicalScreeningandAssessment Activities?

TSCA authorizes EPAto gather chemical hazard and exposure data, as well as related information such as production volume, to determine whether a chemical may pose an unreasonable risk ofinjury tohuman health or the environment. The Agency is able to institute risk management actions when necessary to mitigate or avoid unreasonable risk. Important elements in a successful chemical risk management program include identifying the chemical substances, manufacturing sites, and exposure scenarios ofgreatest potential concern, andusing that information to set priorities for more detailed risk assessment, further research, advisory notices, or other appropriate actions. To help fulfill its TSCA responsibilities, EPA has established the IUR and other regulations to collectinformation on commercial chemicals.

The TSCA Inventory currently includes more than 76,000 chemical substances. Approximately 8,900 of these chemical substances are nonpolymer, organic chemical substances manufactured at atleast one sitein quantities of 10,000 lbs. ormore per year, as reported under the 1998 IUR data collection. EPA estimates that IURA will continue to collect information on approximately 8,900 chemical substances. However, the set ofsubstances that will be reported under IURA will be somewhat different than the set ofsubstances that was reported under the previous IUR collections primarily because oftwo changes: Raising the basic reporting threshold (see Unit II.F.2.) and adding reporting on the manufacture of inorganic chemical substances (see Unit II.F.1.a.). Data collected under IURA will enable EPA to more effectively conduct initial risk screening on a subset ofthe chemical substances within its purview, as described in the remaining part ofthis section andin Unit III.A.1.

EPA conducted tiered risk evaluations ofchemical substances even prior tothe
enactment ofTSCA in 1976. A tiered approach allows EPAto sort through many chemicals, focus on those chemical substances ofgreatest concern, and take appropriate actions. The Agency is thus able to optimize

resources while limiting overall regulatory burdens. The essential steps ofthe tiered risk evaluation generally include: An initial evaluation (sometimes preceded by a prescreen of candidate chemicals); basic risk management decisions resulting from the initial screening; more detailedrisk
assessment when appropriate; and resultingrisk management actions, such

as regulatory or voluntary efforts to reduce risk.Each ofthese steps is only

as effective as the available data inputs- -iflittle data exist to inform the process, each step suffers as aresult.

Exposure-related information collected through the IURA willinform the initial risk screening step. Initial risk screening is conducted using readily accessible information from the scientific literature, as well as other data readily available to the Agency, such as those provided bymanufacturers and
processors. This information set often is incomplete or ofinsufficient quality to allow the Agency to reach definitive conclusions about the set ofchemicals underreview, but may be sufficient to decide which chemicals appear to warrant further evaluation, or conversely, appear tobe low priority and therefore do not currently warrant further review.These initial reviews are often more qualitative than quantitative. Also, continual updates to these data, such asthe recurring reporting of exposure-related data under IURA, will

ensure that the most serious concerns willbe addressed even as chemical quantities and exposure potentials change between submission periods.

The effectiveness ofrisk screening, risk assessment, andrisk management is dependent upon the quality as well as the availability ofboth hazard and
exposure information. While past approaches to priority settinghave emphasized relative chemical hazards and usedproduction volume as a simple surrogate for exposure, EPAmust increase its emphasis on the exposure component ofrisk screening and
assessment. EPA no longer believes that reporting under the current IUR is adequate for these purposes. The IURA will provide EPA with data that will

more accurately and realistically gauge potential exposures. The exposurerelated information reported under IURA will be used in combination with hazard information developed under TSCA section 4 test rules and enforceable consent agreements/orders, throughvoluntary efforts such as the High Production Volume (HPV) Challenge Program (see www.epa.gov/ opptintr/chemrtk/volchall.htm), and 

### 852

HeinOnline -- 68 Fed. Reg. 852 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

other sources. These more current and complete data from the IURA will allow the Agency and others to screen and prioritize chemicals based on potential risk more effectively than it is currently able to do.

Although the inherent hazard associated with a chemical substance will generally remain the same over time, exposure ofworkers and affected populations can change significantly. If the amount ofa chemical substance produced increases significantly, releases to the environment and human
exposures would alsobe expected to increase. Conversely, ifthe amount produced remains constant, environmental releases andhuman exposures may decline as engineering controls are added andpollution prevention practices are implemented. Although the hazard associated with a chemical generally remains constant, the risk associated withthe manufacturing, processing, and use of a chemical substance will change as exposure increases or changes. The Agency needs tobe able to identify changes in exposures as well as specific
exposure scenarios, making itimportant
to collect exposure data on a regular basis. Chemicals that present low hazard may still pose a risk ifthey are produced in large amounts and have high exposure potential, are released into the environment at high volumes and/or concentrations, orinvolve
exposures to particularly sensitive subpopulations.

A voluntary effort called the Use and Exposure Information Project (UEIP) demonstrated that useful screening level
exposure information is available to and

canbe reported by industry. The UEIP

was a cooperative effort begun in the fall of1992 between government and industry in recognition ofthe difficulties encountered in obtaining
accurate andup-to-date exposure information on HPVTSCA chemicals. Participants included EPA, the Chemical Manufacturers Association (CMA) (nowthe American Chemistry Council, or ACC), the Chemical Specialty Manufacturers Association (CSMA), the Synthetic Organic Chemical Manufacturers Association (SOCMA), and the American Petroleum Institute (API) (Ref.3). Data collected by EPA under the UEIP were similar to those nowbeing required under IURA, and included the following: Production volume, site location, percentage of production volume for a given use, environmental releases, number of workers, worker activities, monitoring data, and industrial and consumer uses. EPA's experience with UEIP has shown that the types ofdata requested by the UEIP are available from industry and

canbe used to prepare screening level
exposure assessments.

The UEIP, however, provided onetime reporting ofinformation by a subset ofthe manufacturers ofa small number of selected HPV chemicals. Given these efforts, the limitations of the data available from past and current information collections that are described in detail in the proposal for these amendments (64 FR 46772, August 26, 1999), andthe amount of time it would otherwise take to acquire screening level exposure data for the chemical substances onthe TSCA Inventory, it is appropriate to develop a

more systematic and broadly applied approach to the prioritization process. The Agency is doing this byrequiring that certain basic exposure-related information be reported under this amended rule instead ofcollecting the information through a one-time voluntary program.
F. WhatAre theRequirementsoflURA?

The regulatory text ofthis document describes the specific IURA reporting requirements. EPAis also developing a guidance document with specific reporting instructions, andintends to conduct workshops to help potential IURA submitters become familiar with the revised reporting form (FormU) and amended reporting requirements. A draftversion ofthe revised Form U is available in the docket, and EPAintends
to develop an electronic version ofthe revised Form U. EPA will seek additional feedback onthe revised form's structure, format, and layout before finalizing it for use in 2006. Submitters should note that the information in §710.52(c)(1) and (c)(2) ofthe regulatory text (Part Iofthe revised Form U) need onlybe reported

once per reporting cycle for each submitter site manufacturing 25,000 lbs.

ormore of areportable chemical, while the information in §710.52(c)(3) and (c)(4) ofthe regulatory text (Parts II and III ofthe revised Form U, respectively) will be reported for each reportable chemical at areporting site, depending
upon the chemical's production volume.

1. Whatarethechangesto the chemicalsubstancescoveredbyIUR?-

a.Inorganicchemicalsubstances.EPA is requiring partial reporting for inorganic chemical substances for reporting year 2005 information submitted to EPA duringthe 2006 submission period, and full reporting for inorganic chemical substances in subsequent submission periods (see §710.46(b)(3) ofthe regulatory text). Partial reporting means that the submitter must report the information described in §710.52(c)(1), (c)(2), and (c)(3), as well as §710.58 ofthe regulatory text, as applicable (i.e.,Parts Iand II ofrevised Form U.). Full reporting means that the submitter must additionally report the processing and

use information as described in §710.52(c)(4) ofthe regulatory text (i.e., all parts ofrevised Form U).

EPA intends to screen potential risks associated with inorganic chemical substances to set priorities for testing,

more detailed risk assessment and potential risk management. The phasing-in ofinorganic chemical reporting provides manufacturers of these chemicals with the opportunity to familiarize themselves with IUR reporting while providing EPA and others with needed basic manufacturing information on inorganic chemicals. Future fullreporting ofexposure-related information will provide EPA and others with needed additional information for those inorganic chemicals with production volumes of 300,000 lbs. ormore at a site. See Unit III.A.1. for a discussion ofthe importance ofthis exposure-related information to EPA and others for both organic andinorganic chemicals. Unit III.C.l.a. contains a discussion specific
to inorganic chemicals. The basic impetus for collecting information on organic chemicals also holds for inorganic chemicals.

b. Petroleum processstreams.EPAis exempting certain chemical substances, termed "petroleum process streams" for
purposes ofIURA, from reporting the processing and use data contained in the regulatory text at §710.52(c)(4). For purposes ofthis rule, the petroleum process streams included in the exemption are the multi-component complex chemical substances listed by Chemical Abstracts Service (CAS) Registry Number inthe regulatory text at §710.46(b)(1). This listofchemical substances was derived from the 1983 publication ofthe API entitled "Petroleum Process Stream Terms Included in the Chemical Substances Inventory Under the Toxic Substances Control Act (TSCA)" (Ref. 4). Chemical substances listed in the API document consisting of a single component chemical, except for water,will not be considered petroleum process streams for IURAreporting purposes. Water (CAS number 7732-18-5) is partially exemptfrom IURAreporting underthe petroleum process stream exemption.

The basis for this exemption is not because these streams are ofknown low toxicity. EPAbelieves that the chemicals termed "petroleum process streams" for purposes ofIURA are often toxicologically active. However, these 853

HeinOnline -- 68 Fed. Reg. 853 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

chemicals are frequently processed at the site where they are produced in vessels which are designed to minimize losses and, coincidentally, the potential for releases and exposure. In many cases, the flammable nature ofthese products requires that they also be transported, processed, and stored in well controlled vessels. Forthese
reasons, EPA believes worker exposure to the chemicals termed "petroleum
process streams" for purposes ofIURA is diminished and thus full IURA exposure-related reporting is not warranted at this time. Partial IURA reporting includes site location and production volume information which have important usesby EPA and others apart from gauging exposures and risk screening. EPAmay take action to revoke this exemption ifcircumstances
warrant.

In the final rule, EPAis making selected changes tothe partial exemption list ofpetroleum process stream chemicals published in the proposed rule. Certain chemicals are being added to the listbecause they

were inadvertently left offthe proposed list covered bythe exemption. These multi-component chemicals, all of which are listed in the 1983 API publication (Ref.4), include the following chemical substances (CAS numbers): 8052-41-3, 64742-21-8, 64742-26-3, 64742-94-5, 68476-32-4, 68515-29-7,68783-12-0,68918-98-9, 68919- 15-3, 68953-80-0, and 70693- 06-0.

In the final rule, EPAis also removing

anumber ofchemicals from the petroleum process stream partial exemption listpublished in the proposed rule. These chemicals fall into three groups: (1)Certain chemicals that are already part ofthebroader natural gas or polymer exemptions. Those already exempted under the natural gas exemption are: 8006-14-2, 8006-61-9, 64741-48-6, 68410-63-9, 68425-31-0, and 68919-39-1. Additionally, an incorrect CAS number 68425-31-1 was corrected to read 68425-31-0, which, again, has been removed from the partial exemption because it is already fully exempt from IUR reporting under the natural gas exemption. Chemicals removed because they are already fully exempt under the polymer exemption

are: 64741-71-5, 64741-72-6, 67891-
77-4, 67891- 79-3, 68131- 83-9,68131- 01-5,68410- 14-0,68410- 27-4,68425- 37-2, 68477- 46-3, 68477- -5, 68131-77- -6, 68131-81- -7, 68132-00- -6, 68410-13- -2, 68410-59- -5, 68476-87- -0, 68477-45- -9, 68477-51--1,68131- -7,68131- -3,68410- -9,68410- -3,68425- -9,68477- -2,68477- -0,68477- 52-1, 68478-07-9,68478-09-1,68527- 24-2, 68527-25-3,68783-10-8,68783- 11-9, and 68955-30-6.

(2) Single component chemicals, except for water, should not have been included in the petroleum process streamspartial exemption. As statedin the proposed rule, the exemption was intended to include only certain multicomponent chemicals derived from the 1983 API publication (Ref.4). As a result, the following single-component chemicals have been removed from the petroleum process streams partial exemption list asproposed: 8007-45-2 and 10024-97-2.

(3)Certain chemicals that are not included on the TSCA Inventory and therefore are not currently reportable under IUR have also been removed from the exemption list: 64741-93-1, 64741- 94-2, 64742-00- 3, 64742-02-5, 64742- 17-2,64742-66-1,64742-74-1,64742- 84-3, and 64754-96-7.

Inthis final rule, EPA is also making

some additional corrections tothe petroleum process streams partial exemption listpublished in the proposed rule. (1)Incorrect CAS numbers for certain chemicals were provided in the proposed rule. These CAS numbers

were incorrect because oftypographical

errors in the proposed rule. The correct CAS numbers (incorrect CAS numbers

are in parentheses) are as follows: 8006- 20-0 (8006-20-2), 64742-18-3 (64742- 18-2), 64742-20-7 (64742-20-3), 68187-60-0 (68187-60-9), 68459-78-9 (68459-79-8), 68513-14-4 (68514-14- 4), 68513-19-9 (68512-19-9), and 68514-38-5 (68514-38-4). Two additional incorrect CAS numbers were provided inthe proposed rule, i.e., 64742-36-2 and 68741-41-9. The corrected CASnumbers for these chemicals, i.e., 64742-36-5 and 64741- 41-9 respectively, were also provided in the proposed rule. (2) Several duplicate CAS numbers that were included in the proposed rule have been removed. (3)CAS numbers for certain chemicals have been superceded by new CAS numbers. The new CAS numbers

are asfollows (superceded CAS numbers are in parenthesis): 68187-58- 6 (68334-31-6), 68410-13-9 (68477- 56-5), 68308-08-7 (68478-21-7), 68334-30-5 (68512-90-3), 68918-99-0 (68513-26-8), 64742-83-2 (6851-30-7), 68988-79-4 (68515-31-1), 64742-93-4 (68516-21-2), 68606-10-0 (68606-35- 9), and 64742-93-4 (68650-78-2).

c. Naturalgas.EPAis exempting certain forms ofnatural gas from IUR reporting. These substances are listed in the regulatory text at §710.46(a)(4). EPA believes that, to date, adequate IUR information has been collected on these chemical substances to fulfill EPA's and other IURinformation users' current needs. EPA will take action to revoke this exemption ifcircumstances warrant in the future.

d. Specificchemicalsubstances.EPA is exempting certain specific chemical substances for which EPA has determined thatthere is a low current interest in the IURAprocessing and use information from reporting the processing and use information contained in the regulatory text at §710.52(c)(4). These chemicals are still subject to the other requirements of IURA. The chemical substances included in this partial exemption are listed by CAS Number inthe regulatory
text at §710.46(b)(2)(iv). EPAis also establishing a process for revising the listof exempted chemical substances

over time.

EPAis establishing this partial exemption in an effort to improve IURA's efficiency and effectiveness. This partial exemption also provides additional benefits in reducingthe potential reporting burden ofIURA for certain manufacturers ofthese chemicals, and provides an efficient
process for amending the partial exemption list as the need for processing and use information under IURA changes over time. The inclusion ofa chemical substance under this partial exemption is not based on the potential risks of a chemical. This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information under IURA.

In the proposed rule, EPA specifically sought comment on a partial reporting exemption for "low priority" chemicals, and requested comment on the criteria the Agency mightuse to establish such

an exemption, as well as the specific chemicals thatmight qualify for such an exemption. (See Unit IX.3. ofthe preamble to the proposal, at 64 FR 46794). EPA also offered several approaches for identifying the chemicals thatcould be considered for such an exemption. Anumber of
commenters supported the creation ofa partial exemption, and several provided suggestions for additional chemical substances or classes ofsubstances that they wanted EPA to consider including in this or an expanded partial exemption.

In response to the comments received, EPAhas established apartial exemption that applies when EPA has determined that there is a low current interest in the chemical's IURA processing and use information. Because IURAreporting is 

### 854

HeinOnline -- 68 Fed. Reg. 854 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 855

chemical-specific, this exemption applies to the specific chemical substances that are listed within the exemption, which are discussed in more detail below. The need for EPA's collection ofIURA processing and use information related to a particular chemical substance can change over time; therefore, EPAhas also established

aprocess that will allow EPAto revise the listby adding or removing a chemical to reflect the change in interest. The process allows anyone to submit awritten request for EPA to consider revising the list ofchemical substances covered under this partial exemption. EPA may also revise the list

onits own initiative. When a list revision is necessary, EPA's preferred approach will be to issue a direct final rule, which affords an opportunity for public comment, while providing an efficient mechanism for revising the list.

In determining whether there is low
current interest in IURA processing and

use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use

one or more ofthe considerations identified below, and/or considerations
not identified below, to make an informed decision. EPA will consider the totality ofinformation available for the chemical substance, including but
not limited to the following: (A)Whether the chemical qualifies or has qualified in past IUR collections for the reporting ofthe information described in §710.52(c)(4) (i.e., at least

one site manufactures 300,000 pounds

ormore ofthe chemical).

(B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together). (C) The information needs ofEPA, other federal agencies, tribes, states, and local governments, as well as members ofthe public.

(D) The availability ofother complementary risk screening information. (E) The availability ofcomparable processing and use information. (F)Whether the potential risks ofthe chemical substance are adequately managed by EPA or another agency or authority. It is important to note thatthe inclusion ofthese chemical substances under this partial exemption is notbased on the potential risks ofthe chemicals, but is based onthe Agency's current assessment ofthe need for collecting IURA processing anduse information. Additionally, some ofthese chemicals have issues that may renew interest in them in the future, atwhich time EPA will reconsider the applicability ofthis partial exemption for those chemicals.

To create an initial list ofspecific chemical substances covered by this partial exemption, EPA started with: (1)The list ofchemical substances identified aspart ofthe HPV Challenge Program for which, based upon a preliminary review ofknown hazard information, it was determined that the SIDS data setwould not further our understanding ofthe chemical's properties. (2)The list ofthe chemical substances that the European Union (EU) exempted from its reporting requirements for existing chemical substances.

(3)Certain other chemicals identified duringthe Executive Order 12866 interagency review, for which EPA was able to quickly determine, based on a review oftheir chemical structures, properties, existing hazard information, and available exposure information, that IURA processing anduse information is oflow current interest.

This list was then adjusted based upon the totality ofinformation available toEPA during the Executive Order 12866 interagency review period
to ensure that the chemicals included in this partial exemption were those for which EPA determined that IURA processing and use information is oflow
current interest. EPA chosethese chemicals because almost allpreviously underwent a review to have gotten on these lists and, considering the time available during the Executive Order 12866 interagency review, the Agency

was able to utilize these lists, along with the Agency's current knowledge and understanding ofthe individual chemical's structure, properties, indications ofhazards andpotential
exposures, to inform its determination that there is a low current interest in IURA processing anduse information for these specific chemicals (Ref. 5). As indicated previously, EPAhas established aprocess for revising the list ofchemicals covered bythis partial exemption, andintends toreconsider the chemicals identified in comments for applicability under this partial exemption.

The list currently consists ofthe following chemicals: (1)Chemicals for which ithad been determined that the SIDS data set would
not further our understanding ofthe chemical's properties, and not otherwise sponsored under the HPV Challenge Program: 50-70-4, 50-99-7, 56-87-1, 57-50-1,59-02-9,69-65-8,124-38-9, 142-47-2, 1592-23-0, 7440-44-0, 8001-21-6,8001-22-7,8001-26-1, 8001-29-4,8001-30-7,8001-31-8, 8001-78-3, 8001-79-4, 8002-03-7, 8002-75-3,8006-54-0,8016-28-2, 8016-70-4, 8021-99-6, 8029-43-4, 9050-36-6, 16291-96-6, 61789-97-7, 61789-99-9,64147-40-6, 64755-01-7, 65996-63-6,65996-64-7,68188-81-8, 68334- 00-9, 68334-28-1, 68409-76-7, 68425-17-2,68439-86-1,68476-78-8, 68514-27-2, 68514-74-9, 68525-87-1, 68918-42-3,68952-94-3,68989-98-0, and 73138-67-7.

(2)Chemicals from the EU Existing Chemicals Program exempted listthat

are not currently otherwise a part of another Agency program such as the HPV Challenge Program: 50-81-7, 58- 95-7, 59-51-8, 87-79-6, 123-94-4, 137-08-6, 150-30-1, 1317-65-3, 7440- 37-1, 7727-37-9, 7782-42-5, 8001-23- 8, 8002-13-9, 8002-43-5, 9004-53-9, 9005-25-8, 11103-57-4, 26836-47-5, 61789-44-4, 67701-01-3, 68002-85-7, 68131-37-3, 68308-54-3, 68424-45-3, and 68424-61-3.

(3) Chemicals otherwise identified by EPA based on consideration ofthe chemical's structure, properties, existing hazard information, and available information concerning the extent of exposure, and which are not currently a part ofanother Agency program such as the HPV Challenge Program: 1333-74-0, 7782-44-7, 68442-69-3, 68648-86-2, 68648-87-3,129813-58-7,129813-59- 8 and 129813-60-1.

You may use the process established in §710.46(b)(2) to submit arequest for the Agency to consider other chemical substances for inclusion under this partial exemption. Please ensure that you provide sufficient information in your requests to enable EPAto make the necessary determination after considering the totality of available information. Ifyou have any questions about this process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT for additional assistance.

Under the list revision process, EPA will provide a written response to requests within 120 days ofreceipt, and will maintain copies ofthese responses in a public docketthat will be established for each reporting cycle. In order to assistthe Agency in completing any necessary revision to the listbefore the reporting period, any request for revising the list of chemicals under this partial exemption must be received by the Agency no laterthan January 1of the year before the reporting period in question (i.e.,12 months priorto the reporting period). For example, any request for inclusion under thispartial exemption must be submitted toEPA no laterthan January 1, 2004, i.e., 12 months prior to the nextreporting

HeinOnline -- 68 Fed. Reg. 855 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

period, which begins onJanuary 1, 2005, for the 2006 submission period. If the request is submitted after this date, during an actual reporting period, or duringthe submission period, EPA is less likely to have sufficient time to complete its evaluation and make a determination, or issue the necessary rulemaking such thatthe decision can be effective for that submission period. Submitters should check the Federal Register for listrevisions or may check the electronic CFR to identify what chemicals are on the partial exemption list prior to each reporting period.

EPA intends to develop a standard operating procedure (SOP) for this specific chemical partial exemption process, which will outline the process steps, aswell as provide guidance to EPA personnel on making such determinations. EPA would like to seek your input during the development of this SOP, as well as feedback onthe implementation ofthis process, as part ofIURA implementation workshops that

are planned.

One ofthe purposes ofthe Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.,can be achieved through federal agencies working together with the affected industries to design surveys that will achieve multiple purposes with a single survey instrument. EPA plans to identify and initiate dialogue that has the potential for generating additional paperwork burden reductions for the IURA. For example, the current USGS annual survey covers approximately 80 minerals, and
accounts for at least 75% ofthe industrial production and 75% ofthe facilities included in the USGS survey. Ifyou have identified other federal agency information collections that could satisfy the IURApurposes, or for which IURA information might serve as

aviable substitute and have the potential to generate federal paperwork burden reductions, please contact the
person listed under FOR FURTHER INFORMATION CONTACT.

Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless the agency has obtained approval for the activity from the Office ofManagement and Budget (OMB), an approval which mustbe renewed every 3years. As part ofthe PRA approval renewal process, which includes an opportunity for public review and comment prior to OMB review, EPA intends to continue to evaluate this exemption process and will provide information about the chemicals evaluated, requests received, decisions made and related process elements and experiences aspart ofthe information collection request (ICR) submitted to OMB. The Agency will also analyze the information collected from one reporting year to the next, in order to ensure that IURA information collection activities continue to meet the requirements ofthe PRA, including the demonstration ofpractical utility.

e. Polymers.As aresult ofrecent inquiries regarding the exemption of polymers from IUR reporting, EPAis clarifying this existing exemption. The exemption does not apply to a polymeric substance thathas been hydrolyzed, depolymerized, or otherwise chemically modified, except in cases where the intended product of this reaction is totally polymeric in
structure. The Agency's intent under the exemption at 40 CFR 710.26(b) has always been (and continues to be under 40 CFR 710.46(a)(1)) that the products of suchreactions carried out on polymeric materials are excluded from IUR reporting only ifthey are intended to have atotally polymeric composition. There isno change in the IUR status of polymeric materials that have not undergone such reactions and are flagged in the TSCA Inventory.

f.Microorganisms.EPAis clarifying this existing definition to ensure that the definition used for IURA purposes is consistent with the microorganisms rule
at40 CFR part 725 and to clarify the
status ofchemicals produced from living microorganisms.

2. How havethe reportingthresholds changed?EPA is raising the basic IUR reporting threshold from a production volume of 10,000 lbs. per year per site
to 25,000 lbs. per year per site. Every person manufacturing a non-excluded chemical substance at or above the threshold will be required to report the information in Parts Iand II ofthe revised Form U (see the regulatory text at §§ 710.52(c)(1), (c)(2), and (c)(3) and 710.58). The increased IUR reporting threshold makes the IUR and Toxics Release Inventory (TRI)reporting thresholds equivalent for manufacturers. These thresholds also approximate the
current TSCA section 5premanufacture notification (PMN) low volume exemption threshold of 10,000 kg (approximately 22,000 lbs.). EPA is raising the basic IURreporting threshold in order toreduce the number ofreports filed, thus reducing the overall industry burden associated with this regulation. The new reporting threshold does not represent afinding oflow exposure or low risk.

EPA is also instituting a second, higher production volume threshold of 300,000 lbs.per year per site. Persons who manufacture areportable chemical substance at or above this level will be required to report the information in Part III ofthe revised Form U (see §710.52(c)(4) ofthe regulatory text) in addition to the information inParts I and II ofthe revised Form U. The information reported on Part III ofthe formrelates to the processing anduse of chemical substances. EPA is instituting this separate threshold to limit processing and use datareporting to a subset of afew thousand IUR reportable chemicals out ofthe approximately 76,000 chemicals listed on the TSCA Inventory.

Information concerning lower production volume chemical substances is valuable, especially for identifying trends and additional substitute chemicals. However, wherever possible, the Agency has attempted to limit the reporting burden. In the future, EPA may find itnecessary to collect information on chemicals at reporting thresholds below the thresholds introduced inthis action. Although both the 25,000 lbs. and 300,000 lbs. thresholds are significantly higherthan the current IUR 10,000 lbs. threshold, the enhanced information that willbe gathered under the amended rule will enable the Agency and others to more efficiently identify those chemical substances warranting further, more indepth review, as well as chemicals of lesser concern (see Ref.6).

3. Have thereporting year,the submissionperiod,orthe reporting frequencychanged?In order toprovide clarification, two new definitions are being added at40 CFR 710.43: "reporting year" means the calendar
year in which information to be reported to EPA during a submission period is generated and "submission period" means the period in which the information generated duringthe reporting year is submitted to EPA. "Submission period" replaces the term "reporting period," as used under the
current IURregulations at 40 CFRpart 710.

As proposed, EPAis changing the IUR reporting year to a calendar year basis from a corporate fiscal year basis. This change standardizes reporting time frames across IUR submitters and across various otherreporting programs, such

as the TRI program.

Under the current IUR regulations at 40 CFR 710.33(b), submitters are required to report on a recurring basis during a 120-day period fromAugust to December (the "submission period" underIURA) every 4 years. In a separate action following this final rule, EPA intends to change the submission period
to occur earlier in the year, for example fromJanuary 1through May 1.This potential change is related in part to the 

### 856

HeinOnline -- 68 Fed. Reg. 856 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 857

reporting year change in this final rule from fiscal year to calendar year. The August to December submission period

was originally used because many companies' fiscal years end in July, and starting the IUR submission period in late August allowed these companies to report their mostcurrent information. Companies will nowreport on a calendar year basis, making an earlier submission period more appropriate. Changing the submission period to

occur earlier in the year would allow sites to submit their information closer
to the period during which it was generated, as well as allow the Agency
to obtain the information early in the
year, thereby increasing the timeliness ofthe availability ofthe data.

In this final rule, EPA has not changed the reporting frequency (every 4 years), although EPA did consider alternative reporting frequencies (see the "Revised Economic Analysis for the Amended Inventory Update Rule," Ref. 7). This means that the first reporting year for IURA information will be 4 years after the reporting year under the existing IUR, i.e., existing IURreporting year is 2001, so the first reporting year under IURA willbe 2005. The submission period will continue to

occur in the year following the reporting year, i.e., existing IUR submission period isin 2002, so the first submission period for IURA will be in 2006.

The final rule indicates that subsequent reporting years and submission periods will occur every 4 years. In a separate action following this final rule, however, EPAintends to change the reporting frequency after the first reporting year under IURA (i.e., 2005, with submission to EPAin 2006) from every 4 years to every 5years. This would mean that, instead ofoccurring in 2009, the second reporting year under IURA would be 2010 (i.e., 5years after 2005), and would then occur every 5 years thereafter. The submission period would continue to occur in the year following the reporting year, so it too would occur every 5years (i.e., 2011, 2016, etc.). In making this change, EPA also intends to change the recordkeeping period from 5years to 6 years. EPA agreed to make these changes within the next 12 months as part ofthe interagency review under Executive Order 12866 in an effort to further reduce the potential reporting burden related to IURA. EPA estimates that a 5-year frequency would save regulated entities about $50 million over 20 years at a 3% discount rate (about a 16% reduction), and $37 million over 20 years at a 7% discount rate, and would still meet EPA's most critical data needs (Ref. 8). For the first reporting year under IURA, EPA intends to issue guidance and conduct workshops tohelp the regulated community become familiarized withthe revised regulations. A draft copy ofthe guidance for the 2006 submission period can be found in the docketfor this rulemaking (Ref. 9).

4. How havethe recordkeeping requirementschanged?EPAis requiring that persons subject to reporting under IURA retain records that document any information reported to EPAunder IURA for a period of5years beginning with the effective date ofthat submission period (see §710.57 ofthe regulatory text). The effective date ofthe submission period is the last day ofthe submission period (currently December 23, although EPA intends to change this date, see Unit II.F.3.) in a year in which data must be submitted to EPAunder IURA. Previously, submitters were required to retain records for 4 years (see 40 CFR 710.37). Under IURA, ifa person submits a report in the year 2006, that person will retain the records

onwhich the report isbased until December 23, 2011. This change ensures that the submitter will have the previous submission available when determining future reporting. The change will also aid in EPA's enforcement ofIURby requiring that submitters maintain records that span successive submission periods. As described in Unit II.F.3., in a separate action EPA intends to change the reporting frequency from every 4 years to every 5years. In that action, EPA also intends to change the recordkeeping period from 5years to 6 years in order
to continue to span successive submission periods. A 6-year recordkeeping period would require, under IURA, that ifaperson submits a report in the year 2006, that person will retain the records onwhich the report is based until December 23, 2012.

Persons who arenot required toreport under the existing IURbecause they manufacture less than the 10,000 lb. reporting threshold have been required
to retain volume records as evidence to support decisions not to submit a report. In this rulemaking, EPA is eliminating this provision because EPA believes that this type ofinformation isroutinely retained by companies in the normal

course ofbusiness.

5. How havethe dataelements reportedbyallsubmitterschanged?The

new andrevised data elements to be reported under the amended rule are discussed in this section. Data elements that are currently reported under IUR but that are not revised by these amendments are not generally discussed in this document.

a. Technicalcontactidentification (§ 710.52(c)(2)(i)ofthe regulatorytext). In addition to the name of aperson who will serve astechnical contact for the submitter company, the parent company name, the contact person's full mailing address, and the contact person's telephone number, submitters must report the contact person's e-mail address andthe parent company Dun and Bradstreet Number. The technical
contact person must be able to answer questions about the information on the revised Form U that is submitted bythe company to EPA.

b. Plantsiteidentification (§ 710.52(c)(2)(ii)oftheregulatorytext). Submitters must report the plant site county or parish in addition to the information currently required for each plant site that is subject to reporting.

EPA had additionally proposed to require submitters to report aplant site identification number in order to clearly identify the reporting site in away that would allow the cross-linking ofIUR information with information reported about the same plant site contained in other databases. EPA specifically proposed requiring the reporting of a newly assigned FacilityRegistration Identifier (FRI), or, ifthe Facility Registry System were notyet inplace in timefor the publication ofthis final rule, the submitter wouldreport the site's RCRA number, ifone has been assigned tothe site. In this final rule, EPAhas decided not torequire the submission of a site identification number in addition to the Dun and Bradstreet number that submitters must continue to report. The Agency may instead make number assignments either directly on the reporting form after it is submitted to EPA, or prior to mailing out the form at the beginning of

a submission period. Submitters will
notbe responsible for obtaining or reporting this number.

c. Chemicalidentification (§ 710.52(c)(3)(i)oftheregulatorytext). Submitters must indicate which type of chemical identifying number they are reporting, in addition to the number itself.EPAno longer allows the use of certain ofthe previously used substitute identifying numbers (such as EPAassigned numbers for Test Market Exemption Applications, original TSCA Inventory form numbers, and numbers associated with Notices ofBonaFide Intentto Manufacture) because they are difficult to cross-reference to CAS Registry numbers. Submitters must report a CAS Registry number, or, ifa CASRegistry Number is not known to the submitter, the submitter must report

HeinOnline -- 68 Fed. Reg. 857 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

either an EPA-designated accession number for confidential substances or a PMN case number.

d. Confidentialityof production volumerange(§ 710.52(c)(3)(v) ofthe regulatorytext). Submitters must continue to report the specific production volume ofthe reportable chemical and may claim CBIprotection for that production volume. Additionally, submitters may claim as CBI a pre-determined production volume range corresponding to the reported production volume number. This claim, ifneeded, wouldbe separate from a CBI claim for the specific production volume.

Submitters of specific CBIproduction volume data may allow the release of

more general range information. EPA expects thatroughly 50% of submitters ofspecific CBI production volume data will allow the public release ofvolume ranges. This expectation ofreduced CBI claims isbased on the CBIclaim statistics associated withthe development ofthe original TSCA Inventory (See "Inventory Update Rule (IUR)Technical Support Document: Evaluation ofLikelihood ofConfidential Business Information Claims for Production Volume Information" (Ref. 10)) as well as comments received from industry concerning potential TSCA CBI reforms (Ref.11). The range option will allow the public greater access to data

on chemical production volumes, and the Agency will be better equipped to publicly release more aggregate production volume data relevant to its risk screening and other decisions.

The production volume ranges in the final rule are 25,000 to 300,000 lbs.; 300,000 to 1,000,000 lbs.; 1,000,000 to 10,000,000 lbs.; 10,000,000 to 50,000,000 lbs.; 50,000,000 to 100,000,000 lbs.; 100,000,000 to 500,000,000 lbs.; 500,000,000 to 1,000,000,000 lbs.; and greater than 1,000,000,000 lbs. per year. These ranges are similar to those first used in the development ofthe original TSCA Inventory, except for one change, i.e., the lowest range starts at the IURA reporting threshold of25,000 lbs. rather than the 10,000 lb. threshold thatwas used in the current IUR. EPA additionally made one change to the ranges included in the proposed rule, i.e, the upper end ofthe first range and the lower end ofthe second range were raised to 300,000 lbs. from the 100,000 lbs. range limit included in the proposal, resulting in ranges of25,000

- 300,000 lbs. and 300,000

- 1,000,000 lbs. This change makes the ranges consistent with the second reporting threshold of300,000 lbs. or more (see §710.52(c)(4) ofthe regulatory text), and provides additional protection for submitters' production volume range CBI claims.

Under the proposed rule's 100,000 lbs. range limit for the lowest production volume range, submitters who did not claim the production volume range as CBImight have inadvertently provided the public with

more information than they intended. For instance, for a submitter whose production volume was in the 100,000
to 1,000,000 lbs.range, who did not claim their production volume range CBI, andwho did not report any information in Part III ofreporting Form U (the industrial processing and use and the commercial and consumer use information), public users ofthe data would be able to infer that the submitter's production was somewhere between 100,000 to 300,000 lbs. peryear

- information which the submitter might have considered CBI. To protect against such inadvertent disclosures of CBI, EPA changed the production volume ranges toreflect the second reporting threshold of300,000 lbs. EPA does not believe that the change significantly affects the utility ofthe datato the public.

e. Numberof potentiallyexposed workers (§710.52(c)(3)(vi)ofthe regulatorytext). Submitters must report the range code that corresponds to their estimate ofthe total number ofworkers reasonably likelyto be exposed to each reportable chemical substance at each plant site. EPA defines "reasonably likely to be exposed" as an exposure to

a chemical substance which, under foreseeable conditions ofmanufacture, processing, distribution in commerce, or
use ofthe chemical substance, is more likely to occur than to not occur. Such
exposures would normally include, but
not be limited to, exposure during activities such as charging reactor vessels; drumming; bulk loading; cleaning equipment; maintenance operations; materials handling and transfers; and analytical operations. Covered exposures include exposures through any route ofentry (inhalation, ingestion, skin contact or absorption, etc.), but exclude accidental or theoretical exposures.

Workers involved in chemical manufacturing, processing, and use are

a subpopulation ofconcern to EPA, the Occupational Safety andHealth Administration (OSHA) (Ref. 12), the National Institute ofOccupational Safety andHealth (NIOSH) (Ref.13), and other organizations (e.g., labor unions). Workers may often be exposed
to chemical substances in higher doses and with greater frequency than the general population, andmay therefore be atpotentially greater risk ofadverse health effects. The number ofworkers reasonably likely to be exposed to specific chemical substances is important to EPA and other organizations in developing screening level exposure scenarios. These scenarios are thenused to develop priorities for testing, more detailed risk assessment, andrisk management.

Under IURA, submitters are required
to use ranges ratherthan specific values for reporting certain data, including the number ofworkers reasonably likely to be exposed and the number of processing or use sites. The ranges for reporting the estimated number of potentially exposed workers are found in §710.52(c)(3)(vi) ofthe regulatory
text. In general, reporting these ranges reduces the potential burden to submitters ofdeveloping aprecise point estimate forthe data element. The use ofranges should additionally result in fewer CBI claims than ifprecise point estimates were provided because ranges tendto reveal less sensitive information than specific estimates while still conveying sufficient information useful
to effectively screen chemical risks. Submitters are permitted to claim the reported ranges as confidential if revealing even this general information would disclose information of a sensitive nature.

f.Maximum concentration (§710.52(c)(3)(vii)ofthe regulatory text). Submitters must report the maximum concentration, measured by weight, ofthe reportable chemical substance atthe time it leaves the submitter's manufacturing site or, ifitis

a site-limited chemical, at the time it is reacted on-site to produce a different chemical substance. This information is
to be reported regardless ofthe various physical forms in which the chemical maybe sent off-site or reacted on-site. Concentration ranges for use in reporting are found in §710.52(c)(3)(vii) ofthe regulatory text.

Concentration is an important variable to consider when estimating the magnitude ofpotential exposures. Information about the maximum concentration of a chemical substance present at processing and use sites is frequently used in chemical risk screening inthe review ofPMNs for

new chemical substances required by section 5ofTSCA andis used tothe
extentit is available in screening chemicals onthe TSCA Inventory. For example, EPA has developed standard methods to estimate dermal exposures that workers may experience while performing common industrial operations such as sampling and loading chemicals into drums. These 

### 858

HeinOnline -- 68 Fed. Reg. 858 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

standard methods use maximum concentration information to estimate
upper limits to exposure estimates. If EPA is aware that a chemical substance is processed or used only as a fraction ofa mixture with other chemical substances, exposure estimates maybe adjusted downward accordingly. For example, a chemical substance which is

a component ofa liquid mixture exerts

alower vapor pressure than itwould as

apure chemical substance. Because higher vapor pressure is associated with increasing inhalation exposure to a chemical substance, the concentration ofa chemical substance in a liquid mixture impacts the exposure assessment.

A chemical maybe produced in multiple physical forms and in multiple formulations and products. As described in Unit II.F.5.g., EPAis requiring reporting ofeach ofthe physical forms in which a chemical is
sent off-site. For the purpose of
exposure screening, EPA is requiring onlythe reporting ofthe maximum concentration, regardless ofthe various physical forms in which a chemical may be sent off-site.

EPA had proposed that submitters alsoreport the average concentration of the chemical when leaving the manufacturing site (at64 FR 46788). EPA is not promulgating this requirement because ofthe potential difficulty ofdetermining the average concentration. For example, a submitter could produce many formulations containing a particular chemical substance, making a determination of
average concentration difficult.

g. Physical form (§ 710.52(c)(3)(viii)of the regulatorytext). Submitters must report the physical form(s) ofthe chemical at the time itleaves the site of manufacture or, ifthe chemical is sitelimited, at the time itis reacted on site
to produce a different chemical substance. The list ofphysical forms from which submitters must select is found in §710.52(c)(3)(viii) ofthe regulatory text.Further discussion on physical form reporting is found in Unit III.B.1.a.

The physical form of a chemical is an important factor to consider when estimating magnitudes and concentrations ofpotential exposures. EPA's analyses ofTRI and PMN data demonstrated that the physical state of

a chemical is a determining factor in predicting the potential for industrial releases ofchemicals, andhence,
exposures to humans and the environment. The results ofthe analyses

are provided in a technical support document that was developed by EPA in support ofthis rule ("Inventory Update Rule (IUR) Amendments Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening," Ref.14). The physical state, which provides information on volatility andhow the chemical is likely
to be handled duringmanufacturing, processing, anduse, is an important data element for the purpose of
exposure andrisk screening.

h. Percent productionvolume (§710.52(c)(3)(ix)oftheregulatorytext). Submitters are required to report the percentage oftotal production volume (asreported under regulatory text §710.52(c)(3)(iv)) ofthe reportable chemical substance that is associated with each physical form reported. Percent production volume estimates will allow the Agency to aggregate, on

a case-by-case basis, the production volume of aparticular physical form for

agiven chemical across multiple sites. These determinations will allow EPAto better characterize the risk associated with chemicals thatare manufactured in physical forms that typically result in higher exposures, such asvolatile liquids or powders, but that are produced in smallquantities. These percent production volume estimates will help put the physical form information into context. Estimates
must be rounded offto the nearest 10% ofproduction volume.

6. Whatnew definitionshavebeen addedto explainorrewordedto clarify the reportingrequirements?EPA has reorganized the definition section ofthe regulatory text associated withthe original Inventory andIUR. There are

now three definition sections. The existing §710.2 contains definitions relevant primarily to the compilation of the original Inventory, although afew of these definitions are also relevant to both IUR and IURA. EPA has recodified these general definitions in §710.3. Definitions relevant only to IUR, which

were originally in §710.2, are now in §710.23. Section 710.43 contains definitions relevant only to IURA. This reorganization clarifies the relationships between the definitions andthe various rules, and has no substantive effect.

Two existing definitions are being clarified (§710.3 ofthe regulatory text). EPA defines "manufacture" to mean to manufacture, produce, orimport for commercial purposes and "manufacture

orimport 'for commercial purposes"' to

mean to manufacture, produce, or import with the purpose ofobtaining an immediate or eventual commercial advantage, and includes, for example, the manufacture orimport of any amount ofa chemical substance or mixture: (1)For commercial distribution, including for test marketing, or (2)for use bythe manufacturer, including use for product research and development, or as an intermediate.

Certain new definitions are being added to §710.43 as aresult ofthis final rule.

a.Known toorreasonably ascertainable by. TSCA section 8(a)(2) authorizes EPA to require persons to report information that is known to or reasonably ascertainable by the submitter. For the purposes ofreporting underIURA, a submitter willreport information described in the regulatory
text at §710.52(c)(1), (c)(2), and (c)(3) that is known to or reasonably ascertainable bythe submitter. This

means all information in a person's possession or control, plus all information that areasonable person similarly situated might be expected to possess, control, or know.

b. Readilyobtainable information. TSCA section 8(a)(2) authorizes EPAto require persons to report information that is known to or reasonably ascertainable bythe submitter. Under IURA, a submitterwill report processing and use information (i.e., the information reported for sites at which the 300,000 lbs. threshold has been met

or exceeded) onlyto the extentthat such information is "readily obtainable" by the submitter's management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing ofthe reportable chemical substance (see regulatory text §710.43). Extensive file searches are not required. The "readily obtainable" standard for processing and

use information requires less effort on the part ofthe submitter than the "known to or reasonably ascertainable by" standard that applies to all other IURreporting (see regulatory text §710.43), while providing sufficiently precise processing and use information for screening level reviews. In addition, the "readily obtainable" standard limits the reporting burden associated with processing and use reporting and is identical to the standard currently in effect underEPA's TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) (See 40 CFR 712.7). The "readily obtainable" definition is further discussed in UnitIII.D.2.

c. Reasonablylikely tobe exposed. Forthe purposes ofreporting under IURA,reasonably likely to be exposed

means an exposure to a chemical substance which, underforeseeable conditions ofmanufacture (including import), processing, distribution in
commerce, or use ofthe chemical substance, is more likely to occur than
notto occur. Such exposures would 

### 859

HeinOnline -- 68 Fed. Reg. 859 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

normally include, but would notbe limited to, activities such as charging
reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and transfers, and analytical operations. Covered exposures include exposures through any route ofentry (inhalation, ingestion, skincontact, etc.), but excludes accidental or theoretical
exposures.

d. Use.For the purpose ofreporting under IURA, EPA is defining "use" as any utilization of a chemical substance

ormixture that isnot otherwise covered by the terms "manufacture" or "process" (see regulatory text §710.43). For example, the activity ofprocessing

a solvent into a paint formulation is considered "processing" rather than "use" because the activity incorporates the chemical substance (the solvent) into aformulation. Ifthe paint formulation containing the solvent is then applied to a metal or wood surface (e.g., cars), this application would be considered ause activity. Relabeling or redistributing a container holding a chemical substance or mixture where no repackaging occurs does not constitute

use or processing ofthe chemical substance ormixture.

e. Repackaging.For the purpose of reporting under IURA, "repackaging" is defined as the physical transfer of a chemical substance or mixture (asis) from one container to another container

orcontainers in preparation for distributing the chemical substance or mixture in commerce. This definition does not apply to sites that only relabel

orredistribute the reportable chemical substance without removing the chemical substance from the container in which itis received or purchased.

f.Industrialuse.EPA defines "industrial use" for purposes of reporting under IURA as use at a site at which one or more chemical substances

ormixtures are manufactured or processed (see §710.43 ofthe regulatory text).

g. Commercialandconsumeruse.For purposes ofreporting under IURA, EPA defines "commercial use" asthe use of

a chemical substance or mixture in a commercial enterprise providing saleable goods or a service, such as painting contractors using paint products. A "consumer use," on the otherhand, means the use of a chemical substance that is directly, or as part of

amixture, sold to or made available to

consumers for their use in or around a permanent or temporary household or residence, a school, or recreational areas (see §710.43 ofthe regulatory text). Exposures to commercial and consumer products are similar for risk screening purposes because existing screening level assessment methods are not sophisticated enough to distinguish between these exposures.

h. Intended forusebychildren.For purposes ofreporting under IURA, EPA defines "intended for use bychildren"

asthe use of a chemical substance or mixture in or on aproduct that is specifically intended for use by children
age 14 or younger. A chemical substance

ormixture is intended for use by children when the submitter answers "yes" to at least one ofthe following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1)Is the product commonly recognized (i.e., bya reasonable person) asbeing intended for children age 14 or younger; (2)Does the manufacturer ofthe product state through productlabeling or other written materials that the product is intended for or will be used by children age 14 or younger; or (3)Isthe advertising, promotion, or marketing of the product aimed at children age 14 or younger?

i.Reportablechemicalsubstance.For the purposes ofreporting under IURA,

areportable chemical substance is a chemical substance described in §710.45 ofthe regulatory text.

j. Reporting year.For the purposes of reporting under IURA, the reporting year is the calendar year in which information tobe reported to EPA during a submission period is generated, i.e., calendar year 2005 and the calendar year at4-year intervals thereafter. For instance, for information submitted in 2006, the information will be generated duringthe period from January 1to December 31, 2005.

k. Submissionperiod.For the
purposes ofreporting under IURA, the submission period is the period in which the information generated during the reporting year is submitted to EPA. For instance information generated duringthe period from January 1to December 31, 2005 (i.e., when the chemical substance is manufactured) will be submitted duringthe 2006 submission period.

1.Site-limited. For purposes of reporting under IURA, EPA defines "site-limited" to mean thata chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as

a substance or aspart of a mixture or article outside the site. Imported substances arenever site-limited. Although a site-limited chemical substance is not distributed for commercial purposes outside the site at which itis manufactured and processed, the substance is considered to have been manufactured and processed for commercial purposes.

7. Whatnew dataelementsare reportablebyonlylarger production volumemanufacturers?As described in UnitII.F.2., EPAis replacing the current IURreporting threshold of10,000 lbs.
peryear per sitewith two new production volume reporting thresholds of25,000 lbs. and 300,000 lbs. per year per site. Each person manufacturing a reportable substance at or above the 25,000 lbs. peryear per site threshold is required to complete at least apartial report containing the information in Parts Iand II ofthe revised Form U. Persons who manufacture a reportable substance at or above the 300,000lbs. peryear per sitethreshold are required
to complete afull report, providing the information in Part III ofthe revised Form Uin addition tothe information in PartsI and II. Part III concerns the processing and use ofchemical substances.

a.Processinganduse information (§710.52(c)(4) oftheregulatorytext). Submitters with plant sites atwhich a reportable chemical substance is manufactured in annual quantities of 300,000 lbs. ormore must report processing and use information under IURA.EPA requires submitters toreport the information described in §710.52(c)(4) ofthe regulatory text concerning the processing and use of each reportable chemical substance at sites that receive a reportable chemical substance fromthe submitter site either directly or indirectly (including through

abroker/distributor, from a customer of the submitter, etc.), whether the recipient site(s) are controlled bythe submitter site ornot. Processing anduse information must be reported only to the extent that the data, or an estimate, is "readily obtainable" by the submitter (see Unit II.F.6.b.).

i. Industrial processingoruse operations(§710.52(c)(4)(i)(A) ofthe regulatory text). Submitters must report the industrial processing or use operation(s) at each site thatreceives the reportable substance from the submitter site (whether the recipient site(s) are controlled by the submitter site ornot). The categories forreporting are listed in §710.52(c)(4)(i)(A) ofthe regulatory
text.

ii. NorthAmericanIndustrial ClassificationSystem (NAICS) Code (§710.52(c)(4)(i)(B) ofthe regulatory text). Submitters must report the fivedigit NAICS code(s) thatbest describe(s) the industrial processing or use activities at the sites thatreceive a reportable chemical substance from the submitter either directly orindirectly (includingthrough a broker/distributor, 

### 860

HeinOnline -- 68 Fed. Reg. 860 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 861

from a customer ofthe submitter, etc.), whether the recipient site(s) are controlled by the submitter site or not. The NAICS codes, published by the Office ofManagement and Budget (OMB), have superseded the prior system ofStandard Industrial Classification (SIC) codes (Ref. 15). Submitters must report these codes to the extent the information is readily obtainable for processing or use activities at sites that process or use a reportable chemical substance received from the submitter. EPA does not intend for manufacturers to survey their
customers or distributors to precisely identify the appropriate NAICS codes at their downstream sites.

The NAICS classification system is being used in IURA to describe the industrial settingin which chemical
exposures associated with the industrial processing or use ofa chemical substance may occur. Exposure to a chemical substance typically varies amongindustries. The NAICS code in conjunction with the Industrial Function Category (IFC) code and the processing or use operation will define the industrial, commercial, or consumer setting so that the appropriate scenarios

canbe applied to estimate worker, community, and environmental exposures to the chemical substance.

The NAICS codes which best describe the industrial activities associated with each reported industrial processing or
use operation mustbe provided. Ifmore than 10 NAICS codes apply to a reportable chemical substance, submitters need only report the 10 NAICS code, IFC and processing or use operation combinations that cumulatively represent the largest percentage ofthe substance's production volume, measured by weight. Submitters may also report the

same NAICS code multiple times ifthe chemical being reported has several industrial functions or multiple processing or use operations. This limitation on reporting is intended to minimize submitters' reporting burden.

iii. Industrial function category(IFC) (§ 710.52(c)(4)(i)(C) oftheregulatory text). Submitters must report the IFCs that best represent the specific manner in which a chemical substance is used within each NAICS code reported. Submitters may report the same function category under different NAICS codes. The IFCs to be used are listed in the regulatory text at §710.52(c)(4)(i)(C).

A NAICS code and IFC combination sufficiently defines a potential exposure scenario for risk screening and prioritysetting purposes. EPA conducted studies to determine whether information regarding the industrial sectors in which a chemical substance is processed and used, and information regarding the function a chemical substance performs within industrial processes, are useful for the purpose of screening level exposure assessments. These studies demonstrated that this type ofinformation provides indications ofthe route, magnitude, and concentration ofpotential chemical
exposures to humans and to the environment. The results ofthe studies

are provided in two ofthe technical support documents thatEPA developed in support ofthis rule (Refs. 14 and 16).

IFCs are alsouseful in estimating the frequency and duration ofchemical substance exposures by indicating the type of application in which a chemical will be used (e.g., solvents (for cleaning and degreasing) or intermediate). The relationship between industrial function categories and the frequency and duration ofexposure to chemical substances is particularly useful in developing exposure assessments in EPA's New Chemicals Program. These data elements are important elements in developing useful exposure scenarios. In the absence ofthese data, EPA often

uses conservative estimates that may indicate agreater risk than is actually the case. Data that willbe obtained under IURA will enable EPA to make

more realistic characterizations of
exposure, instead of"worst case" assumptions.

iv. Percentageof productionvolume attributable to each combinationof NAICS code andindustrial function categoryin eachprocessingoruse operation(§710.52(c)(4)(i)(D)ofthe regulatorytext). Submitters must estimate the percentage oftotal production volume attributable to each reported combination ofNAICS code and IFC in each processing or use operation, tothe extent that such information isreadily obtainable. Estimates must be rounded offto the
nearest 10% ofproduction volume. Submitters are not permitted to round offto zero percent ifthe production volume attributable to aNAICS code/ IFC/processing or use operation combination is 300,000lbs. ormore and
accounts for 5% or less ofthe total production volume ofa reportable chemical substance. In such cases, submitters must report the percentage of production volume attributable to that combination to the nearest 1% of production volume. This exception to the general rounding rule will ensure that adequate use information is reported for the larger production volume chemical substances.

The total percent production volumes associated with the NAICS code/IFC combinations may add up to more than 100%, given that the submitter is reporting on distribution ofa chemical
to sites in its control as well as downstream sites, some ofwhich are notimmediate purchasers from the original manufacturing site. Additionally, the total percent production volume may add up to less than 100% ifthe submitter cannot readily obtain information about how all ofitsproduction volume is processed or usedby industry.

v. Numberof processingorusesites (§710.52(c)(4)(i)(E)oftheregulatory text). Submitters mustreport estimates ofthe totalnumber ofindustrial sites, including those beyond the submitter's control, thatprocess or use each reportable chemical substance manufactured by the submitter, with respect to each combination ofNAICS code andIFC in each processing oruse operation. The ranges that will be used for reporting the number of sites canbe found at §710.52(c)(4)(i)(E) ofthe regulatory text. For risk screening purposes, the number of sites atwhich chemical substances are manufactured, processed, orused is a useful indicator ofthe number of ecosystems andthe size ofthe general population potentially exposed to the chemical substances.

vi. Numberofworkers (§710.52(c)(4)(i)(F)ofthe regulatory text). Submitters mustreport estimates ofthe totalnumber ofworkers, including those at sites notunder the submitter's control, that are reasonably likely tobe exposed while processing or using the reportable chemical substance, with respect to each combination of NAICS code and IFC in each processing

or use operation. The approximate number ofworkers will be reported using the same definitions and ranges described under Unit II.F.5.e. The difference in reporting worker exposure information under this section is that such information need be reported only
to the extentthat itis readily obtainable.

b. Commercialandconsumeruse information(§710.52(c)(4)(ii)ofthe regulatorytext). Submitters must report information concerning the commercial and consumer uses ofeach reportable chemical substance, whether the site(s)
atwhich the chemical substance is used

are controlled by the submitter site or not.As forthe industrial processing and

use information described in Unit II.F.7.a., commercial and consumer use information must be reported onlyby sites at which a chemical substance is manufactured in annual quantities of 300,000 lbs. ormore, and submitters are onlyrequired toreport the information
to the extentthat itis readily obtainable.

HeinOnline -- 68 Fed. Reg. 861 2003Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

Consumers comprise asubpopulation ofparticular concern to EPA, the Consumer Products Safety Commission (CPSC), and other governmental and non-governmental organizations. Information from submitters about whether the chemical substances they manufacture are used in consumer products is useful in estimating the potential risks to consumers that result from chemical exposures. In the absence ofmore specific data, EPA often

assumes for risk screening purposes that large, unprotected populations may potentially be exposed to the chemical substances in consumer products. EPA is also working with industry and other stakeholders to develop hazard,
exposure, and risk assessments regarding chemicals to which children

are exposed. The commercial and

consumer product information that will be reported under IURA will be used by EPA in the identification ofchemicals that might be included in these programs, and may contribute to exposure assessments for these chemicals.

i. Commercialandconsumer product categories(§ 710.52(c)(4)(ii)(A) ofthe regulatorytext). Submitters must report up to 10 categories that best describe the commercial and consumer products in which the reportable chemical substance is used (whether the recipient site(s) are controlled by the submitter site or not). Ifmore than 10 categories apply, submitters need onlyreport the 10 categories for the chemical substance that cumulatively represent the largest percentage ofthe submitter's production volume, measured byweight. The commercial and consumer product (CCP) categories are listed at §710.52(c)(4)(ii)(A) ofthe regulatory
text. Information onthe use of chemicals in CCPs is useful in estimating the frequency and duration ofchemical substance exposures. In the absence ofother information, consumers

are often assumed to experience less controlled, but less frequent exposures than workers. The data that will be obtained under IURA will enable EPA to make more realistic characterizations of exposure, instead of"worst case," overly conservative assumptions.

ii. Productsintended foruseby children(§710.52(c)(4)(ii)(B)ofthe regulatorytext). Submitters must indicate, within each reported CCP category, whether, based on readily obtainable information, any amount of each reportable chemical substance manufactured by the submitter is or is
not present in (for example, aplasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on atoy) any products intended for use by children, regardless ofthe concentration ofthe substance, or indicate that such information is not readily obtainable.

EPA defines "intended for use by children" in §710.43 ofthe regulatory
text and in Unit II.F.6.h. Usingthis definition, ifa submitter determines, based onreadily obtainable information, that its chemical substance ormixture is usedin or on aproduct that is intended
to be used by children age 14 or younger, the submitter wouldindicate this on Form U. For example, EPA believes that certain products, like
crayons, coloring books, diapers, and toy cars - to name a few

- are typically intended tobe usedby children age 14

oryounger. As such, ifa submitter determines, based on readily obtainable information, that its chemical substance

or mixture is used in crayons and toy
cars, that submitter would report a "Y" in the Children's Use column onForm U for categories Col and C10.

On the other hand, EPAbelieves that certain products, like household cleaning products, automotive products, and lubricants--to name afew--are typicallynot intended tobe used by children age 14 oryounger. As such, if

a submitter determines, based on readily obtainable information, thatits chemical substance or mixture is used in automotive care products and lubricants, that submitter could report a "N" in the Children's Use column on Form U for categories C03 and C09.

For further illustration, some examples ofproducts that are typically intended for use by children 14 or younger are provided for each commercial and consumer use category (thislisting is not intended tobe exhaustive and should therefore not be considered limiting):

Code Category Examples of Children's Products

C01 Artists' supplies Crayons, children's markers

C02 Adhesives and sealants Craft glue, model glue

C03 Automotive care products Typically products in this category are not likely to be intended for use by children 14 or younger
C04 Electrical and electronic products Electronic games, remote control cars, toys

C05 Glass and ceramic products Porcelain dolls

C06 Fabrics, textiles and apparel Pajamas

C07 Lawn and garden products (non-pes- Lawn and gardening tools designed specifically for ticidal) children, e.g., children's rake

C08 Leather products Shoes,jackets, baseball gloves

C09 Lubricants, greases and fuel additives Typically products in this category are not likely to be intended for use by children 14 or younger

C10 Metal products Toy trucks, toy cars, wagon

C11 Paper products Diapers, baby wipes, coloring books

C12 Paints and coatings Finger paints, water color kits intended for children's
use 

### 862

HeinOnline -- 68 Fed. Reg. 862 2003Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

EPA chose the phrase "intended for

use by children" because itappears in the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261 et seq.) and has been applied by the Consumer Product Safety Commission (CPSC) for over 20
years. While not specifically defined in FHSA or its implementing regulations, the CPSC regulations list several factors that CPSC considers in determining whether a product is a "children's product" intended for use by children (16 CFR 1501.2(b)). After consultation with CPSC, EPA adapted these factors for the purpose ofdefining "intended for use by children" for IURA purposes.

EPA based the ages for the definition, i.e., 14 or younger, on the Standard Consumer Safety Specification on Toy Safety issued by the American Society for Testing and Materials (ASTM), Standard: ASTM F963-96a. This standard covers age groups through 14 years and defines "toy" as: "any object designed, manufactured, or marketed as
aplaything for children through the age of14 years" (Ref. 17, section 3.1.33).

Obtaining information indicating that

a chemical substance or mixture is used in a product that isintended for use by children will enable the Agency and others to identify chemicals affecting this particularly sensitive population. EPA has long had an interest in protecting children from unreasonable adverse affects associated with exposure to chemicals. In 1995, EPA established

apolicy to ensure that environmental health risks ofchildren are explicitly and consistently evaluated in our risk assessments, risk characterizations, and environmental and public health standards (see http://yosemite.epa.gov/ ochp/ochpweb.nsf/homepage). Environmental health threats to children are often difficult to recognize and assessbecause oflimited information to identify where children's exposures occur and limited understanding ofwhen and why children's exposures andresponses are different from those of adults.

In 1997, Executive Order 13045, entitled ProtectionofChildren from EnvironmentalHealthRisks andSafety Risks (62 FR 19885, April 23, 1997), specifically directed each Federal
agency to make it a high priority to identify, assess, and address children's environmental health and safety risks. It also created a Task Force on Environmental Health Risks and Safety Risks to Children. On October 9, 2001, President Bush signed Executive Order 13229, entitled Amendment to Executive Order13045,Extendingthe TaskForceonEnvironmentalHealth Risks andSafetyRisks to Children(66 FR 52013, October 11, 2001), extending the work ofthe Task Force by another 18 months. These Executive Orders illustrate the interest in and the importance placed on addressing children's environmental health and safety risks.

The inclusion ofthe children's use category in IURA will provide the Agency and others with valuable information about the relationship between the IUR chemicals and products intended for use by children 14 or younger. This information will allow the Agency to respond to

concerns about chemicals used in the manufacture ofproducts intended for

use by children, enabling the Agency to identify those chemicals that are reported as not being used in children's products, those chemicals that are used in children's products, and those chemicals where it is not known ifthey

are used in children's products. This initial screen will then allow EPA and others to identify those chemicals used in children's products that might
warrant further investigation or assessment, andthereby allow EPA, as well as other interested parties and affected entities, tobetter prioritize such
assessments and maximize available

resources.

iii. Percentage of

productionvolume attributable to each commercialand

consumer productcategory (§ 710.52(c)(4)(ii)(C)oftheregulatory text). Submitters must estimate the percentage oftheir site production volume for each reportable chemical substance that is attributable to each specific commercial and consumer enduse. Thisinformation must be submitted
to the extentthat itis readily obtainable. Estimates mustbe rounded offto the
nearest 10% ofproduction volume. However, a CCP category which
accounts for 5% or less ofthe total production volume ofa reportable chemical substance cannot be rounded offto zero percent ifthe production volume attributable to that CCP category is greater than or equal to 300,000 lbs. In such cases, submitters must report the percentage ofproduction volume attributable to that CCP category to the
nearest 1%ofproduction volume. This exception to the general rounding rule will ensure that adequate use information is reported for the larger production volume chemical substances.

The total percent production volumes reported may add up to more than 100%, given that the submitter is reporting on distribution ofa chemical
to sites in its control as well as downstream sites, some ofwhich are notimmediate purchasers from the original manufacturing site. Additionally, the total percent production volume may add up to less than 100% ifthe submitter cannot readily obtain information about how all ofitsproduction volume is used in commercial and consumer products. Code Category Examples of Children's Products

C13 Photographic chemicals Typically products in this category are not likely to be intended for use by children 14 or younger

C14 Polishes and sanitation goods Typically products in this category are not likely to be intended for use by children 14 or younger

C15 Rubber and plastic products Pacifiers, action figures, balls

C16 Soaps and detergents Baby shampoo, children's bubble bath

C17 Transportation products Child's car seat

C18 Wood and wood furniture Baby cribs, changing tables, wooden toys

C19 Other Other items specifically intended for use by children age 14 or younger 

### 863

HeinOnline -- 68 Fed. Reg. 863 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

iv. Maximum concentrationin commercialandconsumerproducts (§710.52(c)(4)(ii)(D)oftheregulatory text). Submitters must report the maximum concentration (measuredby weight) ofeach reportable chemical substance in each commercial and

consumer product category. In complying with this requirement, submitters will select from the listof concentration ranges provided in §710.52(c)(3)(vii) in the regulatory text. Concentration is further discussed in Unit III.B.i.b. As with the other processing and use information that submitters must report, such information willbe reported only to the
extent that itis readily obtainable by the submitter.

8. Whatchangeshavebeen made to requirements formaking CBIclaims? Submitters are able to claim information submitted to EPA under this amended rule as confidential ifthey have reason to believe thatrelease ofthe information would reveal trade secrets or confidential commercial or financial information, asprovided by section 14 ofTSCA and 40 CFR part 2.Claims of confidentiality must be asserted at the time information is submitted to EPA. EPA's procedures for processing and reviewing confidentiality claims are set forth at 40 CFR part 2,subpart B. EPA strongly encourages submitters to review confidentiality claims carefully
to ensure that the information in question falls within the protection of TSCA section 14, and to limitinvalid confidentiality claims as much as possible.

Submitters will have an opportunity
to make CBI claims for most ofthe information reported under IURA. To claim information as confidential, a submitter must check the appropriate box and sign the certification statement

onthe reporting form. Ifa submitter fails to do so, EPA could release the information tothe public without further notice to the submitter. As in the past TSCA Inventory Update collections and the initial TSCA Inventory collection, by signing the certification
statement the submitter certifies that its claims ofconfidentiality are true and
correct. Procedures for claiming information submitted electronically (such as a submission on diskette) as CBI willbe specified in the instruction manual that will be available each submission period as described in §710.59 ofthe regulatory text. CBI shouldnot be submitted by e-mail. A discussion about CBI claims under IURA is provided in this unit.

a. Upfrontsubstantiation for plantsite identity.Submitters are required to provide upfront substantiation for CBI claims for plant site identity, in a

manner similar tothe upfront substantiation ofchemical identity under the existing IUR (see 40 CFR 710.38). Under IURA (see §710.58(d) of the regulatory text), a submitter may assert a claim ofconfidentiality for a plant site identity ifthe submitter believes that releasing that identity would reveal trade secrets or confidential commercial or financial information, asprovided by TSCA section 14. Submitters in past IUR information collections have claimed in

excess of15% ofplant site identities as CBI. While the Agency does not question the occasional need for this claim, it believes thatthese claims shouldbe limited to onlythose circumstances in which it is necessary. Further discussion onupfront substantiation is found in Unit III.E.2.

In order to assert a claim of confidentiality for a plant site identity under this amended rule, the submitter
must check the appropriate box on the reporting form indicating a confidentiality claim for plant site identity and substantiate the claim in writing by answering certain questions provided in §710.58(d) ofthe regulatory
text. Ifasubmitter fails to substantiate the plant site CBI claim, EPA could make the information available to the public without further notice to the submitter.

b. CBIclaims forchemical production volumeinformation.EPA did not change the ability ofthe submitter to assert a claim ofconfidentiality for production volume information ifthe release ofthatinformation would reveal trade secrets or confidential commercial

orfinancial information as provided by section 14 ofTSCA. However, submitters may now make separate CBI claims for both actual plant site production volume information and a corresponding production volume range. Production volume ranges are similar to those used in the implementation ofthe original TSCA Inventory collection and canbe found at §710.52(c)(3)(v) ofthe regulatory text.

In the last four IUR submission periods when EPA sought actual production volume information, approximately 65% ofthe information

was claimed as confidential. In contrast, only 35% ofproduction volume data collected in ranges in the original TSCA inventory collection were claimed as confidential. This difference indicates that submitters may be significantly less likely to make CBI claims for production volume information reported in ranges than for discrete production volume figures. The high proportion ofCBI claims in IURreports has severely limited EPA's ability to convey production volume information to the public, even in the form ofa national aggregate production volume for the chemical. EPAneeds tobe able to convey production volume information
to the public to explain its chemical risk
assessment and risk management decisions. Effective communication of this information isvital to EPA's overall mission. EPAhas added the abilityto claim production volume range information CBIin an effort to address this problem. In some cases, submitters may choose to claim their actual production volume asCBI, while allowing the more general production volume range tobe made public.

III. Public Comments

EPA carefully considered the
comments it received on the proposed IURA.Major comments are discussed below. Additional comment summaries and more detailed responses are contained in the "Summary ofEPA's Responses to Public Comments Submitted in Response to Proposed TSCAInventory Update Rule Amendments" (Ref. 18).

A. GeneralComments

1. HowwillEPA andothersusethe

newexposure-relateddatacollected undertheseamendments?Several
commenters expressed the view that EPAhas notprovided adequate justification supporting the Agency's need for the new IUR data, nor enough specific examples showing how EPA would use the data for its intended
purpose.

EPA has an obligation under TSCA to protect human health and the environment from unreasonable risks associated with chemicals under its jurisdiction. In order to evaluate potential chemical risks, EPAhas determined that a portion ofthe chemicals (both inorganic and organic)

on the TSCA Inventory currently
warrant the collection ofmanufacturing information, and that a subset ofthose chemicals (i.e., those produced in annual quantities of 300,000 lbs. or

more at a site) currently warrant the collection of supplementary processing and use information. EPA is amending the IURto provide an accurate and readily available source ofbasic exposure-related information for approximately 4,000 ofthe 76,000 substances listed on the TSCA Inventory.The amendments significantly limitindustry's reporting burden while providing EPA with information needed to screen for risks to human health and the environment. 

### 864

HeinOnline -- 68 Fed. Reg. 864 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 865

EPA's primary use ofthese data will be to identify priority TSCA chemicals for more detailed information gathering, risk assessment, and risk management in order to develop targeted programs, allowing the Agency to be proactive in protecting human health and the environment. Screening chemical risks generally requires a combination ofboth hazard and exposure information. The lack ofexposure-related data beyond production volume data in the current IUR has severely limited the usefulness ofthe current IURdata for risk screening. Moreover, the exposurerelated datathat willbe collected under IURA are not otherwise readily available from publicly available data sources (see Unit III.A.3.). This lack ofexposurerelated datahas made itdifficult for EPA and others to identify chemicals with potential exposures ofconcern, andhas resulted in the generation of overly conservative screening level
exposure assessments.

The addition ofmanufacturing, processing and use exposure-related datato IURA, especially when compiled by EPA into a searchable data base format, will enable EPA and others to

more readily screen chemicals for
exposure and risk. These reviews will allow forbetter prioritization of chemicals to identify those warranting

more detailed assessments and to eliminate chemicals oflesser concern from further review.

Data generated byIURA willbe used in a wide variety ofprograms fundamental to fulfilling the Agency's TSCA statutory mandate. These programs range from the more traditional existing chemicals risk screening efforts, to voluntary programs such as EPA's Design for the Environment program (see http:// www.epa.gov/opptintr/dfe), to individual requests for analysis of chemicals not associated with a particular program. The IURA data base will be searched to identify chemicals or

use scenarios meeting specific criteria. For instance, the database could be searched to identify chemicals that, based upon these data, have the greatest potential for consumer exposure, creating a list ofchemicals arranged according to the production volumes associated with different consumer uses. Additional examples ofuses for IURA data are provided in this section and in EPA's "IURA Data Use Plan" (Ref. 19). The Agency anticipates that, as was true

even for thebasic production data reported under the existing IUR, new

uses ofIURA databy EPA andby others will continually emerge and cannot be predicted atthis time. Results from EPAtools such as the Use Cluster Scoring System (UCSS) will be greatly improved by IURA data. The UCSS is a computerized toolthat combines hazard and exposure information from a variety ofdata
sources, analyzes the data in relation to groupings by commercial use, or "clusters," and identifies clusters of potential concern to EPA. EPA's Science Advisory Board (SAB) commented in its evaluation ofthe UCSS that the lack of
exposure information in the systemhas impaired its usefulness (Ref. 20). The IURA data base will provide exposure information that the UCSS will be able
to download directly anduse. (Fora description ofUCSS, see V.B.6. ofthe proposed rule at 64 FR 46780 or www.epa.gov/oppt/cahp/actlocal/ use.html)

EPA will also use IURA data to perform preliminary exposure andrisk screening across aportion ofthe TSCA Inventory chemicals. Some ofthe same types ofdatathat will be collected under IURA have been collected under the Agency's TSCA Existing and New Chemicals Programs and have aided EPA in performing exposure and risk screening. These exposure-related data

were submitted as part ofprograms such

as: The voluntary UEIP (see http:// www.epa.gov/opptintr/exposure/docs/ ueip.htm for a description ofthis project) andthe PMN program under TSCA section 5.Although the UEIP and PMN programs involve the submission ofcertain data that are the same as or similar to databeing submitted under IURA, these programs cannot sufficiently serve the needs that IURA will serve (see Units V.A.l. and V.B.5. ofthe proposed rule at64 FR 46775 and 46780). However, these programs are examples ofthe usefulness ofcertain IURA data elements.

For example, several IURA data elements were used in an Existing Chemicals Program initial review ofthe chemical methyl ethyl ketoxime (MEKO). This review relied in part upon data submittedby industry under the UEIP. Some ofthe data are similar to those that will be reported under IURA and include the following: Production volume, manufacturing process, industry sector, industrial processing/

use activity, functional use, number of sites, number ofworkers, physical/ chemical properties, and consumer product information. OtherUEIP information submitted byindustry on MEKO are not ofthe sortthat willbe collected under IURA, such as environmental releases (releases to air, water, etc.), worker exposure activities, and monitoring data. The IURA is designed to obtain information that is the most critical for generating screening level exposure profiles.

The UEIP submissions for MEKO indicated that there were one manufacturer andtwo importers of MEKO in 1993 and five primary end

uses (submissions provided percentages ofMEKO production andimport volumes devoted to each use). The submissions also reported the number of workers at the manufacturing site, the physical forms ofproducts containing MEKO, and the MEKO weight fraction in each use.

The MEKO use information was combined with information from available workplace monitoring studies and modeling approaches to compile a screening level workplace exposure assessment. The UEIP information on

use provided crucial information to allow EPAto postulate process operations, worker activities, and possible exposures. For example, MEKO's primary use (92% of production and import volume) is as a paint additive. This fact allows EPA to refer to information on paint manufacturing anduse to estimate
exposures to workers who either formulate paints or apply the paints using spray guns or othertechniques. MEKO use in paint indicates a potential for exposure to several large populations (workers and consumers) because
exposure to even small amounts ofpaint

can result in significant exposure levels
to chemicals in paints. Such use information can also be used by EPA to generate estimated numbers ofworkers invery small businesses (< 10 workers) that may be poorly represented by existing National Occupation Exposure Survey (NOES) data. In the MEKO case, such apopulation would be commercial painters. Without the information about MEKO use in paints and the large percentage ofMEKO volume devoted to this use, exposed populations and
exposure level estimates may have been severely underestimated or left as a data gap (not estimated). Such underestimations and data gaps can artificially lower the appropriate level of

concern for potential risk(s) from a chemical.

The usefulness ofIURA data elements is also demonstrated byEPA's use of similar data in its New Chemicals Program. PMNs fornew chemical substances submitted to EPA under TSCA section 5require many ofthe

same exposure-related data elements that will be reported under IURA. Exposure-related data in PMNs include estimates ofproduction volume, categories ofuse, percent production volume in the categories ofuse, maximum number ofworkers exposed,

HeinOnline -- 68 Fed. Reg. 865 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

and concentrations and physical forms ofthe chemical. EPAuses these exposure-related data to generate screening level risk assessments for regulatory decision-making under TSCA section 5.

The manufacturer ofa new chemical provided the following information in a recent PMN submission: An estimated import volume; chemical uses and the percentages ofthe import volume devoted to each use (non-cosmetic applications as a component ofa fragrance formulation used in household products such as detergents, cleaners, soaps, room fresheners, etc.); number ofsites and workers; and

consumer product information (weight percent in products). EPA used this information in combination with technical references and other data to estimate the number ofmanufacturers of household products who may use the

new substance. Releases ofthe new substance as a result ofthe fragrance formulation process and from manufacturers ofthe household products were estimated, resulting in estimated environmental concentrations ofthe new substance due to itsrelease and estimated general population
exposures to the new substance. EPA alsoused the information on processing anduse in combination with modeling techniques to estimate the number of workers and consumers who may be exposed to the new substance and their estimated exposures to the new substance. These exposure-related estimates, when combined with information on the estimated hazards of the new substance, indicated that the estimated risks topotentially-exposed workers, the general population,
consumers, and aquatic species were all below levels ofconcern. Therefore, the Agency could determine that no further regulation under TSCA section 5was needed for this new substance. In contrast, without this information, EPA would have had to rely on generic assumptions for approximating potential exposures. These types of assumptions are intended to be conservative in nature and therefore often result in higher than likely
exposure estimates.

Information from the IURA may also be used in efforts to identify single chemicals to support potential exposure prevention activities. For example, EPA recently learned that certain imports of zinc sulfate were contaminated with cadmium. Using the IURA processing anduse data on inorganic substances, EPA could have quickly identified importers ofzinc sulfate and segments ofindustry or the general population that might use the chemical. EPAthen could have targeted warnings ofthe potential for exposure to cadmium more effectively, thereby preventing
exposures to the groups likely tobe the
most highly exposed. Other Federal agencies have also long recognized the need for and importance ofexposure data. OSHA, NIOSH, and CPSC have written letters supporting EPA's andtheir own need for exposure data (Refs. 12, 13, 21, 22, and 23). In May 2000, the Government Accounting Office (GAO) stated that "Various federal agencies have collected such human exposure data for a number of purposes; historically, these collection efforts have been limited to selected chemicals, subpopulations, and time periods" (Ref. 24). Other government agencies, industry, public interest groups, and the public in general will be able to access and use the non-CBI portion ofIURA information. The IURA exposure-related data will be important tousers beyond those who accessed the existingIUR in the past solelyfor production volume information. The Natural Resources Defense Council (NRDC), for example, has expressed interest in using IURA information (Ref. 25). In another case, persons interested in reviewing the HPV Challenge Program screening level hazard data (see http://www.epa.gov/ opptintr/chemrtk/volchall.htm) will be able to use the non-CBI exposure-related IURA data toput the hazard data into
context. Risks identified via evaluation ofthese screening level hazard and
exposure datathen canbe addressed.

Although EPA can envision a wide variety ofuses for the new IURA exposure-related information as described in this section, the Agency anticipates that even more opportunities existfor use ofthis information, as is
true for the basic production data reported under the current IUR. 2. What is thepracticalutilityofthe

new exposure-relateddata? Commenters have questioned whether the data collected as a part ofthis rulemaking will have "practical utility." Practical utility is defined in the Paperwork Reduction Act of1995 (PRA) (44 U.S.C. 3502(11)) to mean "the ability ofan Agency to use information, particularly the capability to process such information in a timely and useful fashion." The OMB regulatory definition of "practical utility" at 5CFR part 1320.3(1) addresses not only the theoretical or potential usefulness of information to an Agency, but also its actual usefulness, taking into account its accuracy, validity, adequacy, and reliability, the Agency's abilityto process the information in a useful and timely fashion, and whether the Agency demonstrates actual timely use ofthe databy the Agency's own functions. The following discussion addresses commenters' concerns intwo parts: First, the accuracy, validity, adequacy, and reliability ofthe data; and second, the timely use ofthe databy EPA.

a. Howhas theAgencyensuredthat thedatawillbe accurate,valid, adequate,andreliable?Commenters asserted that the dataEPA proposed to collect through IURA would not be adequate for the purposes statedby EPA, and would not be accurate, valid,

or reliable. Commenters stated that the information collected through IURA wouldbe oflimited accuracy andwould be inferior to datathe Agency has collected in otherprograms. Commenters also stated thatthe information would be so uncertain that itwould not be useful to predict chemical risk, and that there are so many other factors that affect exposure, such as engineering controls, that the data would provide a limited and potentially inaccurate view ofpotential exposure. Additionally, commenters asserted that they donot know how their chemicals are used downstream of the manufacturing site, therefore ifthey

were required to report such information, the resulting data would be unreliable.

EPA considered the types of information needed for screening level
exposure andrisk assessments and believes the information that will be collected through IURA will have the necessary level ofaccuracy, validity, adequacy, and reliability for such
assessments. EPA agrees that there are many ways to increase the accuracy, validity, and reliability ofthe data. However, in developing IURA and considering various alternatives, EPA relied on experience from programs such asTSCA's PMN program and the UEIP data collection, and maintained a balance between data needs for
exposure screening andpriority setting and the burden associated with providing the information. Ifthe Agency had required very precise, specific reporting, submitter burden would have increased beyond that which is appropriate for a screening level data collection. EPA also agrees thatthere are many factors that can affect exposure potential; however, the dataprovided by the submitters will provide baseline information sufficient for an initial

screen ofexposure potential.

i.Adequacy ofthedata.Before proposing the IURA, EPA analyzed various exposure data collections and
assessments to determine the data elements needed for a screening level
exposure assessment. This discussion 

### 866

HeinOnline -- 68 Fed. Reg. 866 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 867

and analysis are in the document "Inventory Update Rule (IUR) Amendment Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening" (Ref. 14). Commenters' suggestions on the proposed rule implied that more extensive information about exposures than was included in the proposed rule would be necessary for even a screening level analysis ofpotential exposure. One
commenter statedthat there are many other factors that can significantly affect the potential for exposure. These factors include engineering controls and personal protective equipment practices, the nature ofthe activities in which workers are engaged, and the physicochemical characteristics ofthe chemical substances. This commenter also statedthat the data collected under IURA will provide alimited and potentially inaccurate view ofpotential
exposure. However, as summarized in Unit III.A.1., risk analyses performed by the Agency in general and OPPT in particular are graduated and datadriven. As the initial levels ofconcern and the quantity and quality ofdata increase, the need for methodologies used in risk review become more detailed and exacting, and the reviews become more accurate and reliable. Based on its experience screening chemical risks through suchprograms

as the TSCA New Chemicals Program, the Agency believes IURA data will provide information adequate to perform initial screens ofchemicals. The Agency also will be better able to prioritize and make basic risk management decisions about those chemicals ofgreatest concern as indicated by the available data. These better informed decisions will enhance confidence that the most appropriate chemicals are selected for more detailed
assessments.

ii.Accuracyandreliabilityofthe data.The Agency considered the data
accuracy and reliability needed for screening level exposure analyses, and took several steps to ensure IURA data
meet those needs. Screening level data need not be absolutely precise, but shouldbe accurate andreliable enough
to make usable and defensible technical
assessments. The IURA will supply exposure-related information the Agency currently does not have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses ofchemicals it manufactures and sells. Without this information, EPA either would not

screen these chemicals, would screen them using outdated or anecdotal
exposure information, or would rely on exposure estimates (typically conservative) using modeling data.

Commenters stated that the accuracy andreliability ofmuch ofthe information reported inPart III ofthe proposed revised Form U (§710.32(c)(4) ofthe proposed regulatory text, now §710.52(c)(4)) would be highly questionable because it relates to sites, activities, and products that are not under the direct orindirect control of the reporting company. Industry programs such asthe ACC's Responsible Care Program (see http:// www.americanchemistry.com for more information) require that, as part ofthe program, member companies work with customers, carriers, suppliers, distributors, and contractors to foster the safe use, transport and disposal of chemicals. The Responsible Care Program, coupled with basic marketing and sales force activities, suggests that many companies are well informed about downstream uses oftheir chemicals. EPArecognizes that submitters may not always have detailed information about how the chemical(s) they make areused. As a result, submitters will onlybe required
to report this information tothe extent it is "readily obtainable" (see Unit II.F.6.b.). In addition, the Agency believes, based on its experience with the New Chemicals Program, the UEIP, stakeholder meetings, discussions with industry about voluntary risk management programs, and industry's various self-regulation initiatives, that
most submitters have at least some basic information about downstream uses, such asthe information that will be reported under the IURA. These data are believed to be of sufficient reliability for

use bythe Agency and others for
purposes such as screening level risk
assessments and prioritization.

EPA also requires much ofthe IURA information tobe submitted in EPA specified ranges. This requirement benefits both the Agency and submitters. First, range reporting is less burdensome for the submitter than calculating specific numeric estimates. Demanding greater data accuracy increases theburdens associated with data collection. Second, information reported in discrete numeric values can indicate alevel of accuracy that isnot necessarily present. EPA believes that a higher level ofconfidence in data accuracy canbe achieved by specifying
ranges.

Commenters suggested that EPAuse othermethods to obtain processing and

use information, such as voluntary data collection programs. However, voluntary industry efforts are not uniformly reliable for collecting data, and the Agency generally cannot ensure that data submitted under voluntary efforts will be complete and accurate. Forexample, the UEIP was undertaken by EPAin partnership with industry to collect relatively detailed information

on 60 high production volume chemicals. EPA received data for 48 of the 60 UEIP chemicals. Many ofthe forms received for those 48 chemicals

were not completely filled out, and only

a subset ofmanufacturers submitted data. Thus, while the information that EPAreceived was quite useful, itwas insufficiently complete for the purposes to which IURA information willbe put. EPA's experience with UEIP is an indicator that exposure data collected under avoluntary effort are likelyto be

uneven andfall short ofmeeting EPA's needs.

iii. Validityofthe data.Another
commenter had specific concerns about the validity ofthe worker exposure data and feltthat an auditing program would be necessary to generally ensure an acceptable level ofquality for data collected under IURA.

EPA agrees that validated exposure data are the most useful for the full range ofAgency risk assessment activities. However, EPA's experience with similar data collection efforts such

as TSCA's New Chemicals Program demonstrates thatthe type ofdata EPA is collecting under IURA are sufficient for the purpose of screening to prioritize follow-on efforts for risk assessment and management. A rigorous validation
process for all IURA exposure-related information would impose significant additional burdens onindustry and the Agency thatwould likely outweigh the benefits accruing to the screening
process. As discussed in Unit III.A.1., EPA exposure and risk evaluations are often iterative, with screening level
assessments succeeded by more intensive and data rich assessments, as indicated by the screening level
assessments and as data become available. The IURA data will be useful
to the Agency in evaluating potential
exposures and risks, serving as indicators as to what levels andtypes of
exposures from which chemicals need further review.

b. Will theAgency use thedatain a timelymanner?Many commenters questioned whether EPA would be able
to make effective and timely use of IURAprocessing and use information, stating that the large amount ofdata submitted would overwhelm the Agency. EPA acknowledges that IURA will generate a significant quantity of

new datathat EPA has not handled underpast IUR data collections. However, EPAhas carefully designed

HeinOnline -- 68 Fed. Reg. 867 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

the data collection to facilitate efficient data management and use. Data collected through IURA willbe putinto

arelational database format, which can be easily searched, compared, and used. The collection ofdata organized by codes, rather than narrative information presented in an unstructured manner, lends itselfto such a database format. In addition, providing for electronic IURA submissions allows data to be entered into the database more accurately and expeditiously, resulting in a quick turnaround between the submission ofthe data tothe Agency and the availability ofthe data for use. The Agency anticipates that approximately 95% ofall reports will be submitted electronically oron disks, as opposed to hard copies. This compares with 70% that were submitted on disks in 1998. The IURA will facilitate EPA's information management and the data will be available quickly for the Agency's and others' use. 3. Why doesn'tEPA useother availablesourcesofdataormechanisms
to collectthedatasoughtunderIURA? EPA requested comments on specific mechanisms ordata sources itcould use to obtain needed exposure-related information with greater ease and less burden to industry. Commenters responded with a variety ofsources, ranging from current data collection mechanisms within EPA (such as TSCA 8(a)PAIR, UEIP, and cooperative approaches) topublic data sources such

as the Hazardous Substances Data Bank (HSDB) (HSDB is a toxicology data file

onthe National Library ofMedicine's (NLM) Toxicology Data Network (TOXNET)). In addition, many commenters stated that EPAhas not made effective use ofthe exposurerelated data it has collected already under current or prior programs. For example, they stated that data collected under two other TSCA rules

- the PAIR and the Comprehensive Assessment Information Rule (CAIR) rules

-have not been used effectively to support Agency risk assessment or risk management decisions. Commenters went on further
to say thatunder the voluntary UEIP, EPA was furnished exposure-related data on60 HPV chemicals (actually only 48), but only two reached the initial risk
assessment stage.

The alternate data sources commenters described were generally

sources thatEPA had already evaluated in its analysis for the proposed rule or with which EPA was otherwise familiar. EPA explored a widevariety ofpublic data sources, asdemonstrated in the following: "Inventory Update Rule (IUR) Amendments Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening" (Ref. 14), "Economic Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update Rule" (Ref. 26), and "A Review ofExisting Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response to CMA" (Ref. 27) (see also Unit V.B.5. ofthe proposed rule at 64 FR 46780)). For the most part, commenters did not identify new

sources or provide additional information to support the assertion that these alternate data sources provide the information thatEPA proposed to collectunder IURA. After considering the information provided, EPAbelieves the decision not to use an alternate data

source as a replacement for IURA is still sound. The Agency may, however, evaluate an alternate source for individual chemicals aspart ofits consideration ofa particular chemical under the new exemption process established in the final rule.

EPA has spent considerable effort and

resources evaluating other data sources that could potentially provide the
accurate andup-to-date information that the Agency needs. A primary consideration, as mandated by TSCA,

was not to subject industry to unnecessary or duplicative reporting. The exposure information soughtunder IURA is not currently accessible to EPA. Although some useful exposure-related data existin some sources, the data are insufficient for the purposes to which IURA data will be put, typically because they are neither timely or detailed enough. Without IURA, EPA has difficulty efficiently screening potential risks posed by approximately 4,000 higher production chemicals on the TSCA Inventory.

Commenters stated that, ifEPA were to have specific concerns about information collection for substances or categories of substances, the selective

use ofTSCA section 8(a)PAIR (40 CFR part 712) reporting would be more cost effective than requiring all manufacturers exceeding aproduction trigger to report manufacturing, processing, anduse information. EPA disagrees withthe suggestion that PAIR rules would be an efficient or cost effective way to compile a data base to allow the relatively large-scale risk screening ofchemicals on the TSCA Inventory. PAIR is a veryuseful data collection tool when one or a small group ofchemicals is targeted for risk assessment; however, PAIR is limited when collecting information on alarge number ofchemicals. Additionally, the PAIR rule has fewer, less definitive data elements than IURA, is a one-time collection versus the recurring collection ofIURA, andwill not provide data sufficient to meet the goals of IURA.Use ofPAIR rather than IURA would force EPA to setrisk screening priorities based on hazard and production volume alone, or in response to requests from others. As discussed in the document entitled "A Review of Existing Exposure-Related Data Sources and Approaches to Screening Chemicals: AResponse To CMA" (Ref. 27), this approach greatly hinders EPA's ability to make effective and efficient risk management decisions.

EPA plans to continue using existing data sources and information sets. For example, EPA has used datapreviously collected under PAIR, CAIR, and the UEIP in a variety ofways, such asto support TSCA section 4 test rule analyses, to provide analyses for the Agency's efforts under the OECD SIDS program, and in support ofinternational efforts (Refs. 18 and 27). However, the existing sources are generally best used when conducting a more detailedrisk
assessment of a specific chemical of
concern, rather than preliminary risk screening ofa relatively large set of chemicals. The IURA submissions will provide a consistent set ofscreening level exposure data thatwill allow EPA
to better identify on a relative basis the chemicals ofhighest priority forfurther risk evaluation. EPA will use IURA data
to identify those specific chemicals which are ofpotential concern andneed follow up assessment. For instance, IURA exposure data integrated with HPV Challenge Program hazard data will provide the input needed to effectively develop risk-based priorities for more detailed assessment of chemicals. Once EPA has determined that a specific chemical (orgroup of chemicals) has sufficient potential for
exposure orrisk to warrant further assessment, the Agency will use the other information sources and data gathering tools as appropriate.

4. Can TSCA informationbe used for right-to-know purposes?Some ofthe
commenters stated that TSCA does not authorize EPA topromulgate IURA based in part onEPA's goal ofproviding "right-to-know" information to the public, non-governmental entities and private organizations. In addition, some commenters noted that OSHA and other agencies have their own authorities to collect information on chemicals.

TSCA contains many ofthe principles embodied in the right-to-know concept. Forinstance, TSCA section 14(b) specifically authorizes EPA to disclose health and safety data collected under the statute. TSCA section 14 reflects the legislative determination that certain TSCA data should be available to the 

### 868

HeinOnline -- 68 Fed. Reg. 868 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

public and interested parties. In addition, sections 4, 5,6, as well as section 21, for example, provide opportunities for public participation in chemical management decisions. Participation must be meaningful, and
to be meaningful the public must have

access to TSCA non-confidential information.

TSCA was designed in part to address the lack ofhealth, safety, and exposure information government agencies and the public faced in dealing with chemicals. See, H.R. Rep. 94-1341 at 6 (1976), reprinted in Legislative History ofthe Toxic Substances Control Act, at 414 (1976) ("Presentauthorities for protecting against and regulating hazardous chemicals are fragmented and inadequate

... Most significant amongthe deficiencies are

... (3)No authority exists for collection ofdata to determine the totality ofhuman and environmental exposure to chemicals."). TSCA was seen as a way ofproviding federal agencies and the public with

access tohealth, safety, and exposure data so that the risks ofchemical substances could be more fully evaluated and understood. See, Statement ofSen. Hartke, Cong. Rec., March 26, 1976 [S4397- 4432], reprinted in Legislative History ofthe Toxic Substances Control Act, at 218 (1976) ("[T]he essential element ofthis legislation isthat ithas attempted to provide for the individual- not only who works, but for the rest of American society- the right to know what is in
store as far as the toxicity ofthe chemicals is concerned."). Congress envisioned TSCA as atool for providing the public and others withhealth, safety, and exposure information about chemical substances.

Finally, TSCA does not limit the use
ordisclosure ofdata (except ifdata are considered confidential) collected under the statute. Congress drafted TSCA in part to provide basic health, safety, and
exposure information to other federal agencies, as well as state, local and international governments. TSCA provides several mechanisms--TSCA sections 9, 10, and 12 for example--for sharing health and safety data among various levels ofgovernment. These sections again demonstrate TSCA's role

as a tool for gathering and disseminating information about chemicals.

B. Commentson SpecificDataElements
1.Manufacturinginformation-a. Physical form. EPA requested comment

onits proposed requirement that submitters report the physical form ofa chemical as it leaves the site of manufacture. Several commenters suggested variations onthe specifics of physical form reporting, but generally agreed with reporting the physical form

asthe chemical leaves the site of manufacture. For instance, one commenter suggested expanding the types ofphysical forms that canbe reported. EPA has determined that the six categories asproposed (see §710.52(c)(3)(viii) ofthe regulatory text) will be adequate for risk screening purposes, and is not adding additional physical form categories atthis time. Experience with the same six physical form categories as part ofEPA's
exposure screening assessment ofover 20,000 chemicals in its New Chemicals Program indicates that the categories of physical forms thatEPA isusing under IURA will be adequate. Other commenters recommended that EPA allow submitters to report more than one physical form for each reportable substance, because a substance may leave a sitein more than

one physical form. EPA agrees with this
comment and is requiring in this final rule that submitters report allphysical forms ofa substance when the substance is sent off-site. Reporting on all physical forms in IURA will lead to abetter
assessment ofexposure to a chemical substance. For example, processing a fine, nonagglomerating powder could result in occupational exposure by inhalation ofchemical dust. Processing the same chemical as a liquid solution would eliminate, orat least reduce, the inhalation risk (the liquid could become

an aerosol and be inhaled, depending on the processing activity). By combining data elements on the physical form ofa chemical substance, itsproduction volume, and the fraction directed to each industrial processing oruse activity, a screening estimate ofthe potential exposure associated with manufacturing orprocessing of a chemical substance canbe derived. The resulting exposure assessment will be

more representative and less conservative than ifthe physical form(s)

were unknown. For these reasons, EPA is requiring the reporting ofall physical forms in which a chemical substance leaves the manufacturing site.

b. Concentration. EPA originally proposed to require the reporting of both maximum and average concentrations ofeach reportable chemical substance atthe time the substance is sent off-site. Anumber of
commenters feltthat this information would be difficult to report for the following reasons: Chemicals may be used in many product formulations at a given plant site and there may often be

no consistent average ormaximum concentration of an individual chemical

across these formulations; such information does notreside in any currently available databases and would need tobe generated for IURA reporting (which wouldbe particularly difficult with respect to average concentration information); and average and maximum concentrations mayvary in productformulations during different IURAreporting cycles. Commenters suggested that maximum concentration information will be misleading ifonly a small amount ofthe reportable chemical substance is made available commercially atthat concentration, while the bulk ofthe total quantity leaving the site has a lower concentration. They also indicated that determining average concentration requires a complicated calculation which falls outside the scope of "reasonably ascertainable" information. Commenters suggested that average concentration can be calculated by product orby the weighted average of each product, and each ofthe calculations can result in tremendously different answers.

The Agency has determined that
average concentration information is not critical for purposes of screening level exposure assessment and has not included this element in this final rule. Screening level review is typically meant, in part, to serve as a method of identifying chemicals that even at their maximum concentration are lesslikely
to present a risk to human health orthe environment. Average concentration information cannot be used to make such a determination.

EPA recognizes that the concentration ofan IUR reportable chemical may vary from shipment to shipment leaving a submitter's site, or when reacted on-site
to produce a different chemical substance. However, maximum concentration is to be reported in wide ranges and not specific numbers, thereby alleviating the need to determine specific concentrations. Additionally, EPA does not intend for submitters to go to great lengths to determine what maximum concentration ranges to selectfor IUR reporting. Instead, EPAis simply requiring that submitters select arange ofconcentrations from a list ofgiven ranges. The ranges fromwhich submitters must select are: Less than 1% by weight; 1-30% by weight; 31-60% by weight; 61-90% by weight, and greater than 90% by weight.

One commenter was concerned that EPA did not specify whether itwould require submitters to conduct specific chemical testing or statistical analysis in order to report concentration data, or whether submitters should merely estimate concentrations. In addition,the 

### 869

HeinOnline -- 68 Fed. Reg. 869 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

commenter was unsure whether a submitter should report the maximum concentration level for each product it manufactures/imports, or simply estimate the overall maximum concentration ofthe chemical substance. EPArecognizes that concentration data mayvary from product to product and from shipment
to shipment, and may be difficult to report in some instances, particularly in product formulations. EPA isnot requiring the reporting ofconcentrations in all products and formulations but rather only one maximum concentration, regardless ofthe chemical substance's physical form(s) or product formulation(s). Because concentration information will be reported in ranges and not as individual values, this information or at least an estimate shouldbe known to or reasonably ascertainable bymost submitters. Submitters are not expected
to conduct chemical testing or statistical analysis beyond any testing or analyses already done by the submitter as part of normal operations in order toreport maximum concentration information. EPA anticipates that chemical importers will frequently receive maximum concentration information from their suppliers, and manufacturers will obtain this information from samples analyzed for quality control. This information is often found in the physical property or hazardous constituents sections ofthe MSDS.

2. Industrial processinganduse.The Agency received three comments regarding the IFCs tobe reported by submitters that have plant sites atwhich 300,000 lbs. or more ofa reportable chemical substance are manufactured. The first comment questioned howthe IFCs would apply to chemicals with multiple industrial uses. The second
comment suggested thatthe Agency provide submitters with a "free response" option iftheir industrial function is not represented among the IFCs. The third comment stated that the IFCs proposed by EPA were adequate.

Submitters are required to report up to 10 unique combinations ofprocessing

oruse categories, IFCs, and NAICS codes (see §710.52(c)(4)(i)(A), (c)(4)(i)(B), and (c)(4)(i)(C) ofthe regulatory text). In making their selection from among the IFC codes, submitters must determine which IFC best represents the specific industrial

use ofthe reportable chemical within a given NAICS code/processing and use category. The Agency will provide examples ofhow to select which code "best represents" an industrial use in the instruction manual that willbe available to all submitters (see §710.59 ofthe regulatory text). Submitters may report multiple IFCs for the same NAICS code, and multiple NAICS codes maybe paired with the same IFC. Unit II.F.7. provides further information on reporting industrial processing anduse information.

The set ofIFCs adopted by EPA at §710.52(c)(4)(i)(C) encompasses the vast majority ofuses for chemicals subject to IUR reporting. Rather than include all possible industrial functions, EPA selected categories based upon information developed due to other Agency programs such as the TSCA New Chemicals Program andbelieves that the categories included in this final rule are sufficient for initial risk screening purposes. One commenter suggested that the submitter be allowed
to supply a "free response" for an industrial function that is not on the EPA list. However, a "free response option" could result in a wide array of
answers, which EPA would then have to group. The Agency believes the chemical manufacturer is best equipped
to determine with which industrial function scenario the industrial processing and use data shouldbe matched. Ifnone ofthe categories fit, however, the submitter could report the "other" category. By aggregating similar

uses under a single NAICS and a single IFC code, EPA will be able to more effectively characterize the risk associated with the totality ofthe production ofeach chemical substance. By requiring the submitter to identify the appropriate IFC code(s) from the provided list, EPA seeks to minimize the errors that could occur ifthe Agency, rather than the submitter, attempted to aggregate uses other than those identified in the prescribed list of IFCs.

3. Commercialandconsumeruse-a. Commercialandconsumer product categories.In the proposed rule, the Agency requested comment onthe appropriateness ofthe commercial and

consumer product categories. Commenters had a range ofopinions about the proposed categories. One
commenter felt that EPA should adopt the use categories used bythe European Commission (EC) (Ref.28). Another
commenter statedthat the categories appeared tobe adequate. A third
commenter suggested that the "C-19 Other" category be deleted andthat the Agency consider requiring the submitter
to identify the specific use.

EPA is not changing the commercial and consumer product categories at this time, although the Agency may revisit these categories in the future should a need arise for more specific commercial and consumer use information. EPAhas evaluated the EC's set ofuse categories and has determined that these categories blend functional use information with end use information. They therefore constitute a more complex identification system thanthe one that will be used underIURA. Forthe screening level
purposes ofIURA data, EPA currently believes that focusing on enduse information alone for commercial and

consumer uses provides the necessary level ofdetail for its screening level reviews. EPAis concerned that the use ofEC's scheme for the commercial and

consumer reporting would be overly burdensome for the current needs identified by EPA, due to the greater number of categories (55 EC categories

versus 19 IURA categories). Further guidance onthe relationship between EC and IURA categories canbe found in the instruction manual forIURA (see §710.59 ofthe regulatory text) (Ref.9).

In addition, the EC system does not appear to describe the commercial or

consumer end uses in a way that meets the needs identified by EPA and targeted by IURA. For example, a chemical that is used as apropellant wouldbe listed under the category "aerosol propellants" using the EC system. Such alisting would not provide the Agency with the information it needs about the type of commercial/consumer product inwhich the submitter uses the propellant (e.g., paint, a lubricant). For more information

on EPA's commercial and consumer category analysis, see the document "Inventory Update Rule (IUR)Technical Support Document Selection of Consumer and Commercial End-Use Categories" (Ref. 29). EPA willprovide examples ofthe types ofproducts that fitinto its commercial and consumer product categories in the instruction manual thatwill be made available to all submitters (see §710.59 ofthe regulatory text).

EPA considered requiring submitters
to identify the specific use ofthe product, rather than the use a miscellaneous "Other" category. However, the Agency prefers to require submitters to choose from among the commercial and consumer product categories provided at §710.52(c)(4)(ii)(A) ofthe regulatory
text in order to encourage manufacturers
to more carefully consider the listed categories, as opposed tobeing allowed
to provide their own specific description. In this manner, EPA can

more effectively assign chemicals to the
correct categories, and avoid guessing the appropriate categories because the Agency believes the chemical manufacturer is best equipped to determine with which commercial or 

### 870

HeinOnline -- 68 Fed. Reg. 870 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 871

consumer category their product use best fits. By aggregating similar product categories, EPA will more effectively characterize the risk associated with the totality ofthe use ofeach chemical substance. Requiring the submitter to identify the appropriate product categories from the provided list will minimize the errors that could occur if the Agency, rather than the submitter, attempted to aggregate uses other than those identified in the prescribed list of product categories.

b.Non-TSCA enduses. Three
commenters requested thatEPA not only continue to exempt chemicals that

are manufactured only for non-TSCA
purposes (suchas pesticides, drugs, cosmetics, etc.) from all IURAreporting, but also exempt manufacturers ofIURAreportable TSCA chemicals from the requirement that non-TSCA downstream uses be reported (such as

use ofa TSCA chemical by a downstream processor in making a pesticide, etc.). These commenters assertthat EPA does not have authority under TSCA to implement requirements ofthis sort.

EPA agrees that substances that are manufactured onlyfor non-TSCA purposes, as described in TSCA section 3(2)(B), are exempt from all TSCA requirements and are not subject to reporting under IURA. Therefore, substances that are intended at the time ofmanufacture tobe used for non-TSCA purposes (e.g., asa pesticide, as a drug) donot have to be reported.

The Agency also agrees that submitters under IURA will notbe required to report on the non-TSCA downstream uses ofthe TSCA chemicals that they manufacture. It is important to note thatEPA was able to reach this conclusion without reaching the issue ofwhether it has the authority
to require such reporting. Descriptions ofIFCs (see §710.52(c)(4)(i)(C) ofthe regulatory text) havebeen clarified to reflect the fact that they only include TSCA uses. For example, one ofthe IFCs is called "Agricultural chemicals (non-pesticidal)." The consumer and commercial product categories (see §710.52(c)(4)(ii)(A) ofthe regulatory text) are also restricted to TSCA uses. An example ofone ofthese categories is "Lawn and garden products (nonpesticidal)." This category includes chemicals such as compressed gasses in delivery systems for many pesticides used indoors and outdoors, and other intermediates, but does not include pesticides. Additionally, many lawn amendments such as fertilizers contain chemicals that maybe regulated under TSCA, (e.g., surfactants). c. Exemptreportingofuse information forchemicalsin articles. Two commenters believed thatto the
extent a submitter's reportable chemical is used in an article, the submitter shouldbe exempt from the reporting of

consumer and commercial end-use information (i.e., §710.32(c)(5) ofthe proposed regulatory text). The
commenters statedthat there is no

reason to believe that consumer exposure will result from chemicals in articles.

EPA does not agree that manufacturers ofchemicals that are later incorporated into articles should be exempt from the reporting of

consumer and commercial end-use information. Certain exposures do result from chemicals incorporated in articles. For example, potential dermal and inhalation exposures occur from chemicals incorporated into products in the category "fabrics, textiles and apparel." Specific cases, such as formaldehyde from pressed wood products used in mobile homes or chlorinated flame retardants used on children's sleep wear, also demonstrate that potentially harmful exposures can

occur from chemicals incorporated into articles.

d. Usefulness of percent production dataandmaximum concentrationdata. A commenter felt that in the case of

consumer products in particular, itis unclear whether the percent production data andmaximum concentration data required under §710.32(c)(5)(i)(B) and (c)(5)(i)(C) ofthe proposed regulatory
text would add any material information
to the production volume information already required under the existingIUR. The commenter stated that the volumes ofchemicals they will report as having been manufactured, and for which they will report maximum concentration information, are in the products the
commenter sells. Therefore, the Agency will already have the needed production volume and concentration information and does not need to collect these particular data elements for consumer products.

Production volume and concentration information reported atthe manufacturing siteis typically different information than percent production volume and concentration in consumer and commercial categories. Often manufacturers will sell a chemical for multiple uses, in a variety ofproducts,

orthe chemical will be used multiple times before reaching the consumer/ commercial product. Forinstance, a manufacturer may report that a chemical is used in three different commercial and consumer product categories-20% ofthe manufactured production volume is used in category A, 35% in category B, and 45% in category C. Additionally, while the manufacturer sells the product at a certain concentration (say90%), a final product may have a different concentration. Forinstance, the final product may contain only 5% ofthe chemical. The resultingpotential
exposure scenario associated with such

a product wouldbe very different from

a scenario where the concentration in the final productis 90%. The Agency, therefore, is retaining the commercial and consumer percent production volume and maximum concentration data elements.

4. Generaldataelements commentsa. Workerswho are "reasonably likely to be exposed" to areportablechemical. EPArequested comment on alternative definitions of "potentially exposed worker" and "reasonably likely to be exposed." Specifically, EPArequested
comment on whether OSHA definition of"employee" in its hazard communication standard (29 CFR 1910.1200(c)) is more appropriate for

use in IURA. The hazard communication standard defines "employee" as a worker who may be exposed to hazardous chemicals under normal operating conditions orin foreseeable emergencies. Workers such

as office workers orbank tellers who
encounter hazardous chemicals onlyin non-routine, isolated instances are not covered. OSHA's hazard communication standard also defines "exposure" or "exposed" as the
exposure ofan employee to ahazardous chemical in the course ofemployment through any route ofentry (inhalation, ingestion, skin contact or absorption, etc.) and includes potential (e.g., accidental or possible) exposure.

One commenter stated that OSHA's definition of an employee is appropriate
to identify persons reasonably likelyto be exposed to chemical substances. This
commenter statedthat the Agency shouldbroaden the definition of
exposure in IURA to include potential (accidental orpossible) exposures to chemical substances which workers
may experience in the course oftheir employment. This commenter also statedthat this is what worker exposure entails inthe real world and to exclude

some portion ofthose worker exposures,

as EPA proposed, is inappropriate. A second commenter felt that persons who couldbe exposed to a chemical substance in foreseeable emergencies shouldbe included in EPA's new definition for persons who are reasonably likely to be exposed to a reportable substance.

HeinOnline -- 68 Fed. Reg. 871 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

EPA has determined that the OSHA definition of"employee" does not provide a more appropriate standard than the one proposed and finalized in IURA. Whereas OSHA wanted to provide all persons who could foreseeably be exposed to a chemical substance with knowledge ofthe potential hazards ofthatchemical, EPA is seeking to specifically identify those
persons routinely exposed to chemical substances and for whom engineering controls andpersonal protective equipment are likely to provide the greatest benefit. The definition adopted by EPA for a person "reasonably likely
to be exposed" in this rule will target those individuals who routinely have the potential to be exposed to chemical substances, and for whom chronic risks

are greatest. This definition provides

more useful and realistic information for the risk screening purposes for which EPA envisions IURA data will be used.

b. Personal protectiveequipment.EPA requested comment on whether the Agency should collect information on the use ofPPE during the manufacture ofchemicals reported under IURA. Several commenters statedthat EPA shouldnot collect PPE information for the purposes ofrisk screening. After reviewing these comments, EPA agrees that collecting information on the availability ofPPE would not enhance the initial risk screening process, and has determined that this data element shouldnot be added to the IUR aspart ofthis rulemaking. Because EPA cannot

ensure that protective equipment will be available to all employees and, if available, will be used properly in a well managed hygiene program, the potential risk encountered in the manufacture, processing, or use ofa chemical substance is initially assessed by EPA in the absence ofPPE information. The IURA is designed primarily to collect only screening level information. Inclusion ofPPE in risk
assessment would require collection and integration oflocation-specific information on physical conditions and the PPE used, and would greatly complicate the risk assessment. This type ofinformation ismore likely to be included in assessments more detailed than the initial risk screening
assessment for which IURA information will be used.

A commenter suggested that EPAuse PPE information as a way to submit lower estimates for various IUR data elements, such as the number of workers. For the reasons provided in the previous paragraph, EPA will not use PPE information to lower the estimates ofworkers reasonably likely tobe exposed. Because the reporting ofPPE information would not contribute tothe initial risk screening process and would impose an additional burden onpersons reporting under IUR, EPAis not including information onPPE in the reporting requirements for this rule.

c. Metricsystem reporting.Under IUR, data are currently reported using the U.S. customary system ofmeasurement units (e.g., pounds and yards). EPA requested comment on changing reporting requirements to require metric system reporting instead (e.g., kilograms and meters). Two commenters suggested that EPA convert to metric system units

or atleast give submitters the option of using either metric or U.S. customary units. One commenter requested that EPA continue torequire the use ofU.S. customary units orgive submitters the option ofreporting in either metric or U.S. customary units. EPAhas decided
to continue to require the use ofthe U.S. customary system because at least in the short term, this allows the IUR database
to remain compatible with otherAgency databases, especially TRI, which also typically use the U.S. customary system. EPA believes allowing for reporting using either the U.S. customary or metric systems ofunits would create confusion and increase reporting and administrative error. EPAmay revisit this issue in future IUR amendments.

C.Reporting Universe Comments

EPA received avariety ofcomments concerning which chemicals and sites shouldbe subject to reporting and recordkeeping requirements. 1. Chemicalcategoriesundergoing changesin reportingstatus.In the IURA proposal, EPA created exemptions from reporting for several groups of chemicals that would otherwise be IURreportable. The IUR currently contains full reporting exemptions for inorganic chemicals, polymers, microorganisms, and naturally occurring chemicals. EPA proposed to modify these exemptions by: (1)Requiring partial reporting for inorganic chemicals in lieu ofthe existing full exemption; (2)creating a partial reporting exemption for chemical substances termed "petroleum process streams" for purposes ofreporting under IURA; and, (3) creating a full exemption for certain forms ofnatural
gas. EPA also requested comment onthe creation ofadditional exemptions, but asked that commenters provide a clear supporting rationale for creating such exemptions.

a.Inorganicchemicals

-Many
commenters submitted comments about the removal ofthe full exemption for inorganic chemicals.

EPA originally created the inorganic chemical exemption because itbelieved that the hazard potential ofmany inorganics was "relatively wellestablished" (50 FR 9944, 9947, March 12, 1985) and thathazard information alone was sufficient forprioritization within inorganic chemical substance risk assessments. EPAnowintends to increase the consideration given to exposure, another component ofrisk, in screening chemicals and in setting priorities for risk assessment andrisk management activities. The Agency no longer believes that chemical hazard information alone provides a sufficient basis for prioritization for these
purposes. As aresult, the former basis for this exemption is no longer applicable.

i. Why does theAgency needbasic IUR informationon inorganicchemical substances?During interagency review prior to proposal itwas suggested that EPA first collect the IUR information in §§ 710.52(c)(1), (c)(2), (c)(3), and 710.58 ofthe regulatory text (Parts I andII of the revised Form U) on inorganic substances before collecting the processing and use information in §710.52(c)(4) ofthe regulatory text (Part III ofthe revised Form U). Itwas thought thatpartial reporting would allow EPAto become generally familiar with the production volumes of inorganic chemicals, andwould permit manufacturers ofthese substances to familiarize themselves with the most basic IUR requirements before being required to comply with the processing and use data requirements. Many commenters stated thatEPAhad not demonstrated the practical utility of collecting basic information on inorganic substances. Other commenters feltthe Agency should collectthese data and that inorganic chemicals shouldnot havehad an exemption under IUR.

EPA uses basic IUR information in a widevariety ofways (as described in Units II.C. and E.) and expects thebasic IURinformation oninorganic chemicals
to be used in similar ways. For example, EPAused IUR information in the HPV Challenge Program (see http:// www.epa.gov/opptintr/chemrtk/ volchall.htm) to identify chemicals produced in aggregate national volumes ofone million pounds or more. The HPV Challenge Program has not been able to include inorganic chemicals as EPA did nothave the necessary production volume information on the inorganic chemicals produced in or imported into this country. Additionally, the TSCA Interagency Testing Committee (ITC) has encountered difficulties in its attempts to identify inorganic chemicals for recommendations to EPA for testing or other further evaluations due to the lack 

### 872

HeinOnline -- 68 Fed. Reg. 872 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

ofeven the mostbasic IUR data for these chemicals (Ref.30).

ii. Why is EPAphasingin reporting forinorganicchemicalsubstances?EPA requested comment on completely removing the inorganic chemicals exemption, requiring reporting of all of IURA information, including the information described in §710.52(c)(4) ofthe regulatory text on inorganic chemicals manufactured in volumes of 300,000lbs. or more at a site. Some
commenters supported phased-in reporting ofthis information, where EPA would maintain a partial exemption (i.e., requiring the reporting ofall ofIURA information except the information in §710.52(c)(4)) for the first submission period only and would require full reporting in subsequent submission periods. EPA agrees with this approach because it provides new submitters with an opportunity to become familiar with basic IUR reporting, allows EPA to become familiar with the current inorganic chemical industry, andprovides basic production information in the first submission period. Requiring full reporting for inorganic chemicals in subsequent submission periods provides EPA with the processing anduse exposure-related information needed to continue efforts begun with the first reporting year information.

EPA's primary use ofboth thebasic data collected during the first submission period and the additional exposure-related data collected during subsequent submission periods will be
to identify priority TSCA chemicals for

more detailed information gathering, risk assessment, and risk management in order to develop targeted programs to protect human health and the environment. Screening chemical risks generally requires a combination ofboth hazard and exposure information. The absence ofexposure-related data for inorganic chemicals, beyond even the basic production data collected during the first submission period under IURA, would severely limitthe usefulness of IURA data for risk screening. See Unit III.A.1. for further discussion of additional uses ofIURA exposurerelated data.

While some commenters supported the phasing-in approach, other
commenters suggested thatEPA review the information collected on inorganic chemicals under the partial exemption and collect additional information on these chemicals through afuture rulemaking. Commenters suggested a variety ofways to collect this additional information, including specifically listing chemicals thatwould be subject
to future IUR collections orusing PAIR. However, EPA's experience with using information from other sources or collecting information using PAIR has demonstrated that this approach is insufficient, as discussed in Unit III.A.3.

iii. Why doesn'tEPA usealready availableinformationon inorganic chemicalsubstances?Commenters statedthat the inorganic chemicals data that EPAneeds to conduct screening level risk assessments are already available from a variety of sources, including the USGS's annual reports on mineral production, health assessment documents prepared bythe Agency for Toxic Substances and Disease Registry, studies by OSHA, the TRI compiled by EPA, andliterature published bytrade associations. EPA closely examined these data sources, and concluded that, while useful, these sources are inadequate to meet the Agency's data needs for inorganic chemicals. Some ofthe suggested data sources pertain to naturally occurring substances which are exempted from reporting by aprovision in IUR thatEPA has not proposed to change, i.e., 40 CFR 710.26(a)(3), which is codified as §710.46(a)(3) for IURA. Many ofthe remaining data sources identified by
commenters pertainto metallic alloys or studies ofa single metal species and do
not include information on the multiplicity ofpigments, flocculating agents, oxidants, photochromic salts, flame retardants, catalysts, and other inorganic compounds for which data are soughtthrough IURA. In some cases, the data sources are one-time collections of information and therefore would not provide current information on the inorganic chemical industries. Others, although revised from time totime, do
not identify the chemicals with sufficient specificity, do not identify the manufacturing site or atechnical contact, and/or donot provide information on the use ofthe inorganic chemical. In sum, the data sources identified by commenters andby EPA

are not sufficient toprovide the information sought through IURA. EPA has consulted withUSGS to investigate whether the USGS annual survey of approximately 80 minerals could be amended tobetter serve as a source for

use and exposure data that couldbe used in place ofIURA for those minerals (Ref.31). EPAplans to identify and initiate dialogues with other federal agencies about collection activities that have the potential for generating additional federal paperwork burden reductions, particularly related to the IURA. The new exemption process established in the final rule provides an opportunity for EPA to consider alternate sources ofinformation for individual chemicals. EPAis extremely sensitive to the PRA's directive for federal agencies to reduce unnecessary burden, and will continue to consistently strive to find areas in which burden can be decreased to the maximum extent practical, as well as carefully evaluate new orrevised information collections to ensure that the Agency's informational needs are met with the minimal burden possible. Although none ofthe identified alternate sources appear to be sufficient
to replace IURA,EPA believes that an alternate information source could provide sufficient information for a particular chemical. EPAis also willing
to work with other agencies to perhaps resolve differences in the various information collection activities in an effort to reduce overall reporting burden

on industry.

Additional discussion ofthe applicability ofavailable data sources is foundin "Summary ofEPA's Responses to Public Comments Submitted in Response to Proposed TSCA Inventory Update Rule Amendments" (64 FR 46772) (Ref. 18) and in "Inorganic Chemicals: Sources ofInformation Suggested by Commenters to the Proposed Inventory Update Rule Amendments" (Ref. 32).

b. Partial exemptionforpetroleum
processstreams.EPA proposed a partial exemption from IURAreporting for certain chemical substances that the Agency is calling "petroleum process streams" for purposes ofIURA and requested comment on duplication of reporting under the information collections conducted byDOE's Energy Information Administration (EIA) through EIAforms EIA 810, EIA 816, and EIA 64A. Operators ofall operating and idle petroleum refineries, blending plants, or blending terminals must complete form EIA 810 to provide a monthly refinery report ontheir operations to DOE. Operators that
extract liquid hydrocarbons from a natural gas stream and/or separate a liquid hydrocarbon stream into its component products must complete formEIA 816 to provide a monthly natural gas liquids report to DOE. Operators ofdomestic natural gas processing plants must complete form EIA 64A to provide an annual report of the geographical location and geological formation ofnatural gas liquids production to DOE. In the IURA proposal, EPA stated its intention to work with DOE to identify potential duplication and to further investigate the potential usefulness ofDOE's information collections in fulfilling EPA's statutory obligations underTSCA. 

### 873

HeinOnline -- 68 Fed. Reg. 873 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

One commenter stated thatEPA could

use the DOE data along with other supplemental information sources to generate the type ofpetroleum process stream information that IURA proposed
to collect. Several commenters also statedthat the proposed IURA reporting would be duplicative ofDOE reporting for certain chemicals, particularly fuel oil #2 andkerosene, and thatEPA shouldtherefore fully exempt those chemicals from reporting under IURA.

EPA has investigated the information collection conducted by DOE through EIA forms EIA 64A,EIA 810, and EIA 816, andhas determined that chemical substances are not sufficiently identified for EPA's purposes in the DOE reports. For example, many ofthe chemical substances in the DOE reports are identified by nomenclature otherthan the CAS nomenclature used by EPAfor TSCA purposes, are identified inbroad categories, or are not identified by CAS number. Many ofthe chemical names used by DOE are either generic or represent groups ofchemicals. For example, distillate fuel oil, reported on EIA Form 810, may refer to several chemicals onthe TSCA Inventory, such

as fuel oil #2, fuel oil #4, or fuel oil #6. This lack ofspecific identifier information means thatEPA and others
cannot distinguish which information collected by DOE is attributable to which chemical. More specific identification isneeded to attribute the appropriate hazard and physical and chemical properties to the petroleum
stream.

The DOE information also lacks important exposure components and identifiers that are necessary for exposure and risk screening activities. For example, the DOE information does
not contain the number ofworkers reasonably likely to be exposed to a chemical or the maximum concentration ofthe chemical. In addition, itmay be difficult to discern from the DOE data if

apetroleum process stream is used as a solvent in a consumer product or as a combustible fuel. This is an important distinctionbecause the likelihood of
exposure to a petroleum process stream depends on its use. These data are needed elements that will fill a vital data gap in chemical risk screening.

Several persons commented that there is no need to collect exposure-related data for petroleum process stream manufacturing operations because physical hazards existing at many sites currently necessitate extensive safety precautions that limitworker exposure. Discussed in more detail in Unit II.F.i.b.

c. Exemption forcertain forms of naturalgas.EPA proposed that six natural gas substances be fully exempt from reporting under IURA. In addition, EPA requested comment onwhether reporting for the six substances should be required in upcoming submission periods and whether they were the appropriate natural gas substances for inclusion in the proposed exemption.

Commenters expressed support for the full exemption ofthe six natural gas streams listed in the proposed IURA. These commenters alsorecommended adding fuel oil #2, kerosene, methane, ethane, propane, butane, pentane, and hexane, and liquefied natural gas to the full exemption list. The commenters statedthat an exemption is warranted for these chemicals because: (1)DOE already requires annual andmonthly reports for the chemicals which contain the same information requested by EPA; (2)the chemicals are similar in chemical composition to the six chemicals EPA proposed to exempt; (3)their chemical
structure and identity remain the same throughout processing; (4) a similar
amount ofdata is available for these chemicals asfor the six chemicals EPA proposed to exempt; and, (5)a similar number ofTSCA reports are filed for these chemicals asfor the six chemicals EPA proposed to exempt.

EPA has retained the exemption for certain forms ofnatural gas as proposed. Adequate IUR information has been collected onthe six chemical substances
to fulfill EPA's and other IUR information users' current needs. EPA will take action torevoke this exemption ifcircumstances warrant in the future.

Liquefied natural gas, which is a form ofnatural gas (CASNo. 8006-61-9), is covered underthe natural gas exemption. EPA did not include ethane, methane, propane, butane, other paraffinic hydrocarbons, fuel oil #2, or kerosene in the list ofsubstances included in the natural gas exemption because they are notjustisolated components ofnatural gasbut are also chemical substances which canbe produced from other source materials, chemical process streams, feedstocks, or reactants. These alkanes have significant

uses in chemical manufacturing, including the production of ammonia and methanol from synthesis gas derived from methane, thermal cracking ofethane/propane mixtures to produce ethylene, and vapor-phase oxidation of n-butane to produce maleic anhydride. At present, there isnot a sufficient basis
to conclude that data on all significant

uses ofthese alkanes are adequate.

EPA did not rely on the data contained in the DOE reports discussed in Unit III.C.l.b. in its creation ofthe

new exemption for certain forms of natural gas. While some useful information for these chemicals is included in the DOE reports, itis insufficient for exposure or risk screening (see Unit III.C.l.b.). Downstream processing anduse exposure information collected through IURA for these chemicals will not duplicate information collected by DOE.

2. Exemption ofadditional groupsof chemicals from IURA reportingor from the reportingofspecificdataelements. EPArequested comment in the proposed rule on the selection of chemicals that mightbe exempted from reporting under IURA and on specific criteria to distinguish these chemicals fromthose thatremain subject to reporting. EPAreceived many industry
comments in favor ofcreating a new exemption for chemicals that may be considered to be "low priority," but
commenters did not indicate standard criteria for establishing such exemptions. However, inresponse to these comments and comments received during interagency review, EPA created

a partial exemption (i.e., an exemption fromthe reporting ofinformation required under regulatory text §710.52(c)(4)) for certain chemicals for which the collection ofprocessing and

use information is currently of"low interest." This newpartial exemption is intended to improve IURA's efficiency and effectiveness. EPA has established a process bywhich future changes tothe chemicals included in the partial exemption can be made after careful examination ofthe totality of information available forthe chemical substance, including but notlimited to the considerations provided in §710.46(b)(2) and discussed in Unit II.Fl.d.This partial exemption also provides additional benefits in reducing the potential reporting burden ofIURA for certain manufacturers ofthese chemicals. The inclusion of a chemical substance underthis partial exemption does not address the potential risks of

a chemical. This partial exemption is solelyintended to provide a tool to assist the Agency inbetter managing the collection ofprocessing and use information under IURA. See Unit II.F.i.d for a discussion ofthe exemption and the process to add or

remove chemical substances fromthe exemption.

In addition, commenters suggested classes ofchemicals for exemption. EPA has determined that none ofthese suggested exemptions canbe implemented at this time, as described in the remainder ofthis section.

a. HPVchemicals.A number of
commenters stated that industry is already providing EPA with sufficient hazard data via the HPV Challenge 

### 874

HeinOnline -- 68 Fed. Reg. 874 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 875

Program (see http://www.epa.gov/ opptintr/chemrtk/volchall.htm), as well

as exposure data through other voluntary programs (e.g., International Council ofChemical Associations (ICCA)data collections and UEIP). Therefore, providing exposure-related information on HPV chemicals via IURA would be duplicative and unnecessary.

The Agency recognizes that avariety ofvoluntary and regulatory efforts to collecthazard data are underway, such

as the voluntary HPV Challenge Program. However, the scope and expected output from the HPV Challenge Program differ markedly from those anticipated under IURA. The HPV Challenge Program centers on providing basic hazard data for HPV chemicals,
most ofwhich will also be IURAreportable chemicals. The IURA focus is

ongathering exposure-related information for moderate and high volume chemicals in a wide range of industrial operations, involving multiple sites and covering manufacturing, processing, and use of the chemical substances.

The Agency is unable to limitits IURA information collection efforts to HPV chemicals alone, for several

reasons. The Agency could not know definitively which chemicals are HPV substances in any particular IURA reporting cycle as ofthat reporting year. A chemical substance meets the criteria for an HPV chemical by meeting a one million pound national production volume threshold, based upon the aggregate production volume in the nation (asreported to IUR). Production volumes can vary significantly over a 4- year reporting cycle, and it isnot

uncommon for chemicals torise above

orfall below the HPV threshold each reporting cycle. For instance, EPA used 1990 IURreporting to identify approximately 2,800 HPV substances. An additional 500 substances which

were not HPV chemicals in 1990 were identified asbeing HPVvia the 1994 IUR production volume data. The IURA collection couldbe limited to the HPV Challenge Program chemicals (i.e., the baseline set ofchemicals for the program, consisting ofchemicals that

were HPV according to 1990 IUR information). However, that restricts IURA's abilityto supply screening level
exposure information to only those HPV chemicals. This would severely limit the usefulness ofIURA over time, as the universe ofchemicals that were HPVin 1990 will notbe the same universe of chemicals that are HPVin future years, and would compromise the Agency's broader responsibility for risk screening.

b. ExistingChemicalsProgram"low concern"chemicals.Commenters recommended that the chemicals previously determined byEPA tobe of low concern via the Existing Chemicals Program be exempt from reporting under IURA. However, commenters did
not provide sufficient criteria that would clearly distinguish exempted chemicals from others subject to IUR reporting. EPA cannot create exemptions without a clear basis or justification. During the development of these amendments, EPA considered exempting chemicals previously reviewed bythe Existing Chemicals Program, but was unable to develop standard criteria for such an exemption (SeeRef. 33 andUnit IX.3. ofthe proposal preamble, at 64 FR 46794). Under the Existing Chemicals Program,

no standard criteria were used for determining which chemicals were lower priority, because in the course of the program many different chemicals involve unique risk assessment or risk management issues. For example, many chemicals were analyzed within a specific use, and other uses were not examined. As an alternative to this approach, EPA developed a partial exemption for chemicals which are determined to be oflow current interest for purposes ofIURAprocessing and

use information reporting, based on considerations described in Unit II.F.i.d., andidentified an initial list of chemicals currently covered bythe partial exemption (Ref.5).

c. Organization forEconomic CooperationandDevelopment(OECD) chemicals.Commenters recommended that the chemicals for which EPAhas a minimum set ofhazard and exposure data, such as OECD's SIDS chemicals that have completed the SIDS process, be exempt from reporting under IURA. Commenters also suggested that chemicals in the International Council ofChemical Association (ICCA) screening level data collection programs be included in this exemption.

EPA disagrees that data collection efforts through the OECD and ICCA programs provide sufficient exposure information toreplace IURA information. Data collection efforts under the auspices ofOECD and ICCA
concentrate on the development of hazard assessments andgenerally provide only a small fraction ofthe exposure-related data called for under IURA. A goal ofthe ICCA Program isto process chemical cases through OECD's HPV SIDS Program, which develops hazard information for the program chemicals. Ashazard data do not change from year to year, the data collection supports a one-time report. The IURA will provide current exposure-related information for risk screenings andpreliminary assessments. Exposure information, as collected underIURA, willvary from reporting
year toreporting year and therefore needs tobe collected on a continuing basis. While the OECD HPV SIDS Program does not specifically disallow the collection ofexposure information, the program does leave such collection
to the discretion ofthe sponsor country (Ref.34). Exposure information available via SIDS istherefore generally
not specific to U.S. uses and concerns.

d.Metals.Various commenters stated that either metals as a group, or specific metals such as zinc and copper, should be granted special consideration for IURAreporting. Several commenters asserted thatproviding information on maximum concentrations is unnecessary for the metals, because they will generally have close to 100% concentrations when they leave the manufacturing site or whenever they are presentin consumer or commercial products. Further, commenters indicate that the only exposure potential for these substances in commercial or

consumer products will be dermal (not via otherroutes such asinhalation or ingestion). Additionally, a commenter statedthat workers "in proximity" to or handling solid metal articles should not be considered to be exposed for reporting purposes, because the metal is in a formin which neither inhalation

nor dermal exposure will occur. Other
commenters believed that any IUR reporting on metals is unnecessary because ample information on metals production and exposure potentials is already available from other sources, such asthe USGS, orbecause specific metals, such as copper andzinc, are beneficial to human health and therefore should be ofno exposure

concern.

Metals present some unique issues regarding exposure potential, and the information thatwill be collected under IURA on metals will domuch to improve EPA's and others' knowledge about the uses and exposures associated with these chemicals. Not all metalcontaining products are pure metal. For example, metal powders used in fine arts, metal pastes used in repairs, and commercial metallic paints contain varying percentages ofmetals. In addition, although some metals in trace quantities, such as chromium, are essential nutrients to plants and/or animals, in greater exposure concentrations these same metals can be harmful.

Because metals are ubiquitous and

canbe present in avariety ofphysical forms, different routes ofexposure are possible. Chronic exposure to solutions

HeinOnline -- 68 Fed. Reg. 875 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

containing metals such as nickel may result in contact dermatitis. Milling metal parts containing antimony and beryllium creates dusts which, if inhaled, can result in acute chemical pneumonitis. Inhalation offumes containing chromium resulted in an elevated incidence ofbronchial carcinoma among workers in the U.S. chromate industry before the source of the exposure was recognized and corrected. Exposure byingestion is of

concern for metals that may enter water

sources following improper disposal of used materials, for example. The use of cadmium inbatteries for portable electronic devices, including computers, is increasing; long-term exposure to cadmium has a potential to cause kidney, liver,bone, andblood damage.

EPA has exempted submitters that would otherwise be subject to IUR reporting from reporting with respect to chemicals that are imported in the form ofan article (see 40 CFR 710.30(b) and §710.50(b) ofthe regulatory text). However, submitters that manufacture a reportable chemical and incorporate it into an article will continue to be subject to reporting under the IURA.

The Agency reviewed a number of

sources thatprovide information about metals production and characteristics, including USGS data specifically noted by commenters (Ref. 32). The information, although useful for depicting global mining and production ofthe major commercial metals, is not comparable tothe national scale and domestic exposures datathat willbe provided under IURA. Further, because metals are subject chemicals in many EPA programs, including the Great Lakes Binational Toxics Strategy; the revised drinking water standards; the revised emission standards for secondary metal refinishers; and the Waste Minimization National Plan,
current information about domestic metals production anduse willbenefit many EPA offices and programs.

As indicated previously, EPA will be reconsidering individual chemicals for applicability under the new partial exemption, andplans to identify and initiate dialogues with other federal agencies about collection activities that have the potential for generating additional federal paperwork burden reductions, particularly related to the IURA.

e. Otherchemicalgroups. Commenters suggested EPA exempt a variety ofadditional groups of chemicals from either full or partial IURA reporting. These groups included fossil fuel combustion byproducts such

as coal combustion products; fertilizers; substances encapsulated in apolymer matrix; pesticides; and certain chemicals outside the scope ofTSCA jurisdiction (such as drugs). Commenters stated that exposures associated with fossil fuel combustion byproducts are already well known, and, with information currently being submitted to EPA and other federal organizations such asDOE, well beyond the amount needed for "basic screening." Commenters argued that reporting on these byproducts under IURA would be duplicative (therefore unnecessary) and overly burdensome, especially because these chemicals are considered "beneficially used in an environmentally soundmanner" by EPA's Office of Solid Waste (OSW). A parallel argument was made for fertilizers, in that certain commenters consider them to be well-characterized and generally "safe." Similarly, a commenter believed encapsulated substances are oflittle concern, due to low exposure potentials for the encapsulated chemicals, as implied by the Agency's treatment ofsuch substances under Significant NewUse Rules (SNURs); the commenter believed that, when chemicals are secured within

apolymer matrix, the SNUR requirements no longer apply. Commenters also stated thatpesticides and other chemicals not subject to TSCA shouldbe fully exempt from reporting.

Comments specific to these different groups ofchemicals are addressed below.

i. Fossil fuel combustionbyproducts. Commenters stated that fossil fuel combustion byproducts have been sufficiently studied for beneficial reuse to justify their full exemption from IURA reporting. They asserted that EPA's OSWhad adequately reviewed data onthese substances to allow their

use as solid waste in situations where
exposures were possible, such as in the

case ofsoil amendments. The
commenters believe that EPA offices such as OPPT and OSW must coordinate their efforts related to fossil fuel combustion byproducts prior to undertaking any actionsunder TSCA, and suggested that continued reporting

onthese chemicals would be particularly burdensome.

EPA disagrees with these comments. Review ofthe recent OSWReport to Congress on the subject offossil fuel combustion byproducts (Ref.35) indicates that these products canbe hazardous to human health and the environment when mismanaged. These products not onlytypically contain heavy metals such as cadmium, chromium, lead, and mercury, but leachates from fuel combustion byproducts can contain significant concentrations of arsenic. Despite these
concerns, OSW has decided to exempt these substances from regulation as hazardous waste when they are beneficially reused. While OSWwas not able to identify damage cases or significant risks to human health or the environment associated with these types ofbeneficial uses based on available data, OSW plans to assess new information on risks as that information becomes available. The IURA will be instrumental in providing manufacturing, processing, and use data for fossil fuel combustion byproducts to enable OSW to monitor the potential risk associated with these chemical substances. Additionally, as with any chemical byproduct with a use, EPAin general needs information tobe able to

screen these chemicals forpotential

concerns outside ofthe OSW purview. Review ofsuch contemporary data, as sharedbetween OPPT and OSW, will allow EPAto make well-informed risk management decisions by constructing realistic screening level exposure profiles for these substances. These profiles couldbe adjusted as the production dynamics change between IURAreporting cycles. EPAbelieves the importance of accurate exposure-related data in formulating sound risk management decisions for fossil fuel combustion byproducts justifies the associated reporting burden.

ii. Fertilizers. Fertilizers that qualify for the inorganic exemption have not been subject to IUR reporting in the past.A number ofcommenters emphasized that, in general, fertilizers

are chemicals whose risks have already havebeen well-characterized. According to the commenters, ample
recenthazard and exposure data from studies conducted by EPA's OSW indicate that fertilizers generally are of low toxicity, and some constituents of major fertilizer types are "safe" because the exposure potentials are low. Further,

as the commenter pointed out,recent SIDS program studies onurea, a

common fertilizer, described the chemical to be "oflow priority" for further investigation, thereby implying that the chemical poses little hazard to human health and the environment, and that adequate risk information is available. Commenters stated that because theybelieve the constituents

are not harmful to human health orthe environment, fertilizers shouldbe exemptfrom downstream use and
exposure reporting under IURA (i.e., a partial exemption from IURAreporting). Other commenters statedthat fertilizers shouldbe granted a full exemption from 

### 876

HeinOnline -- 68 Fed. Reg. 876 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 877

IURA reporting, or thatEPA should exempt certain fertilizers by CAS number. One commenter suggested that 20 substances be included in the fertilizer list (see list provided in Comment C4b-6 ofthe comment summary document, Ref. 18).

EPA does not believe the suggested IURA exemptions for fertilizers and fertilizer constituents are warranted at this time. The Agency does not agree with industry comments citing a 1999 EPA OSW risk evaluation on "nonnutritive" components in fertilizers as adequate justification for classifying fertilizers as "safe," and therefore eligible for exemption. The OSW report addresses trace quantities ofmetal contaminants in those fertilizers (i.e., the non-nutritive elements), not the fertilizers themselves. A review ofbasic hazard identification guides, such as the Merck Index, the Condensed Chemical Dictionary, and Dangerous Properties of Industrial Materials, shows that
exposure to many fertilizers and fertilizer materials, including those cited in industry comments such as anhydrous ammonia, potassium sulfate, andurea, can cause both reversible and irreversible adverse health effects ranging from acute to chronic. The availability ofIURA exposure-related data will allow for the risk screening of chemicals used as fertilizers and fertilizer constituents to extend beyond environmental effects and aid the screening ofrisks to workers,
consumers, and the general population. The Agency therefore believes itis appropriate torequire reporting for fertilizers under IURA.

iii. Encapsulated substances.A
commenter statedthat the import volumes ofIUR reportable components contained within compounded imported polymers shouldbe exempt from IURA reporting. The commenter indicated thatvolumes ofthese encapsulated components are difficult
to determine. Such components include antioxidants, colorants, lubricants, and stabilizers that are commonly used additives in polymer products. The polymers are sometimes manufactured by a foreign company and imported into the United States. The commenter stated that these additives, which are encapsulated in apolymer matrix, are typically present in the matrix at a few weight percent. The commenter's understanding was that when chemicals

are secured within a polymer matrix, the SNUR requirements no longer apply, thus their suggestion was for EPA to treat such substances similarly under IURA.

The SNUR requirements in 40 CFR part 721 do not exempt substances encapsulated in apolymer matrix. Although chemicals incorporated into a polymer matrix are not subject to SNURs in certain limited circumstances, for example, when an individual SNUR specifically states that the SNUR requirements donot apply to such substances (see, e.g., 40 CFR 721.8160(a)), such chemicals are not otherwise generally exempt from SNUR requirements.

Although EPA appreciates the difficulty in ascertaining quantitative production information from manufacturers outside direct U.S. jurisdiction, exempting IUR reportable components encapsulated in apolymer matrix from IURA is not warranted. Not allpolymers are inviolable. Additives such as colorants and lubricants, which

canbe hazardous to human health or the environment, can leach from the polymer matrix, resulting in subsequent
exposures. Also, additives which are inherently insoluble in the polymer may migrate tothe surface ofthe polymeric material and be released over time from the polymer. Under IURA, each nonexempted mixture component is reportable ifimported above the stated thresholds. Reasonably ascertainable information can be used to estimate these import quantities.

iv. Pesticides.Some commenters statedthat the Agency should exempt pesticide chemicals from reporting under the IURA, and also should exempt those substances outside the
scope ofTSCA, including drugs and cosmetics.

The original IUR did not require reporting for chemicals manufactured for non-TSCA purposes. Similarly, in IURA, amounts ofan otherwise IURreportable substance that areintended at the time ofmanufacture tobe used for non-TSCA purposes (e.g., as apesticide,

as adrug) do not have to be reported. For example, ifacompany were to manufacture 300,000 lbs. of an IURreportable substance, 170,000 lbs. of which were intended at the time of manufacture to be sold as a drug
precursor, and 130,000 lbs. ofwhich

were intended atthe time of manufacture to be used for aTSCA purpose, only 130,000 lbs. ofthe substance would have to be reported under IUR. The company would not have to report the processing anduse information described in §710.52(c)(4) ofthe regulatory text for that chemical
atthat plant site, since the company did
not manufacture a total ofat least 300,000 lbs. ofthe chemical atthe site for TSCA purposes. Many substances, such asthe pesticide active ingredient pentachlorophenol, are also used in industrial and commercial applications regulated under TSCA. In those cases, the chemicals will continue to be reportable under IURA.

v. Foodadditives.Commenters stated that low hazard chemicals, such as food additives, shouldbe categorically excluded from the new reporting requirements. The commenter stated that food use substances, for example,

are regulated by the Food and Drug Administration (FDA) and must either be generally recognized as safe (GRAS), the subject ofa prior sanction, or the subject of a food additive regulation promulgated by FDA.

According to FDA's Office of Premarket Approval (OPA), food use substances for FDA'spurposes are those that are added directly to food, and could inadvertently contact and be incorporated into food because ofuse in packaging material or in food processing. FDA does not evaluate chemicals for environmental effects-- onlyfor human health effects. The chemicals subject to FDArules are not inherently low hazard in many cases. Forexample, substances such as plasticizers, lubricants, release agents, acids (e.g., hydrochloric acid), boiler
water additives, and solvents (e.g.,
acetone andhexane) are included as fooduse substances. Furthermore, even direct (i.e., listed) GRAS chemicals can be ofconcern when used at industrial concentrations, such as sulfuric acid. Thus, as is true with other chemical substances, food additives can present a risk to human health or the environment depending on use andthe resulting exposure pathways. EPA does not believe a categorical exemption for chemicals that may be used as food additives is warranted at this time. Again, such chemicals are only reportable under IURA to the extentthat they are intended at the time of manufacture to be used for TSCA purposes.

3. Thresholds.EPArequested
comment on the 300,000 lbs. threshold for reporting industrial processing and
use, and consumer and commercial use information (required under §710.52(c)(4) ofthe regulatory text). Commenters generally were supportive ofhaving a second, higher reporting threshold for this exposure-related information. However, one commenter statedthat the 300,000 lbs. threshold is
too low, and that it shouldbe set atone millionpounds to coincide with the HPV Challenge Program threshold.

EPA considered chemicals with aggregate, nationwide U.S. production and importation volumes ofone million pounds or more (based on 1990 IUR data) for the HPV Challenge Program. Thatis, ifone million pounds ofa

HeinOnline -- 68 Fed. Reg. 877 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

certain chemical were reported for the 1990 IUR as being produced or imported collectively, by manufacturers throughout the United States, then that chemical was identified as an HPV chemical for purposes ofthe HPV Challenge Program. The 300,000 lbs. IURA threshold captures at least one report for more than 95% ofthe HPV chemicals reported tothe 1990 IUR.

The production volume that defines chemicals asHPV should notbe confused with the 300,000 lbs. per year reporting threshold for processing and

use data reporting in IURA. The 300,000 lbs. threshold applies to the amount manufactured ata single site and is not

an aggregate, industry-wide production number. EPA isimplementing the 300,000 lbs. per year reporting threshold for individual IUR submitters because it limits the increase inburden associated with the new IURA processing and use reporting requirements and itlimits the number ofchemicals for which exposure-related data will be reported to approximately 4,000. This number is consistent with the "several thousand chemicals" suggested byGAO in its 1995 report "EPA Should Focus Its Chemical Use Inventory on Suspected Harmful Substances" (Ref. 36), and

ensures that exposure-related data will be reported for almost all HPV chemicals (definedby national aggregate production). Increasing the 300,000 lbs. threshold to one million lbs. would drastically undermine the Agency's collection ofprocessing and use exposure-related data. The higher threshold would reduce the number of chemicals for which this information is submitted and eliminate processing and

use data reporting on many ofthe HPV chemicals. The Agency would be left with very little information with which
to conduct the needed screening- level
assessments and the resulting prioritization would be less meaningful.

In the proposed IURA, EPA also solicited comments on the possibility of replacing the chemicals identified using the 300,000 lbs. annual production volume threshold (by site) with any of five other groups ofchemicals. Those
groups include: (1)A set ofHPV chemicals that submitters identify as being produced nationwide in amounts ofone million lbs. or more; (2) chemicals that are currently subject to testing under TSCA section 4 (i.e., test rules and enforceable consent agreements (ECAs)); (3)chemicals identified for voluntary testing; (4) chemicals designated for testing by the ITC; and (5)chemicals listed in the Agency's Master Testing List (the
current edition is available at http:// www.epa.gov/opptintr/chemtest/ mtl.htm).

With respect to the possibility of limiting the collection ofprocessing and

use information to HPV chemicals identified by submitters, the Agency asked for comment on: (1)Whether submitters would be able to determine which chemicals have exceeded the nationally aggregated HPVthreshold in

agiven submission period, especially given how frequently chemical production rises above and falls below this threshold from IUR submission period to submission period; (2)what additional burdens such a determination would place on submitters; and (3)whether IURA data would be less useful ifprocessing and

use data reporting were limited to HPV chemicals.

Many commenters favored use ofthe
set ofHPV chemicals in lieu ofthe proposed IURA reporting with the 300,000 lbs.threshold, yet none directly responded to the specific Agency questions. Commenters failed to take into account the added burden of aggregating chemical production to determine which substances are HPV chemicals. They also offered no justification for substituting the 300,000 lbs. plant site-specific threshold with a

one million lbs. national aggregate threshold, beyond stating thatrelevant information isbeing provided already through otherprograms. Nor did they offer possible solutions to the problem ofreliably aggregating production volumes.

EPA does not believe that submitters will be able to effectively aggregate nationwide production volumes. Aggregation is especially difficult in light ofcontinual, market-driven changes in production andmany submitters' interest in protecting individual plant siteproduction volume information as CBI. Additionally, for a nationally aggregated one million lbs. threshold to be effective, itmust be able
to accommodate the frequency with which individual chemicals may rise above or fall belowthe HPVthreshold criteria ofa U.S. aggregate production volume ofone million lbs. or more per year. For example, 17% ofthe chemicals which were HPVs according to data submitted under the 1990 IUR were not HPVs according to data submitted under the 1994 IUR.

D.DefinitionsandClarification Requests
1.Is miningconsidered manufacturing?Commenters asked whether mining is considered "manufacturing" under TSCA. Under TSCA, the term "manufacture" includes production or importation ofa chemical substance as well as its manufacture (TSCA section 3(7)). Mining, which includes extracting metal ores or minerals from their natural deposits by any means, including secondary recovery ofmetal ore from reuse or other storage piles, wastes, orrock dumps, or from mill tailings derived fromthe mining, cleaning, or concentration ofmetal ores, is production and is considered to be a manufacturing activity under TSCA.

However, chemical substances which

are naturally occurring and which, among other things, are unprocessed or processed only bymanual, mechanical,

or gravitational means (see 40 CFR 710.4(b)(1)) are currently excluded from IURreporting and will continue to be excluded under IURA (see 40 CFR 710.46(a)(3)). For example, rocks, ores, and minerals are not IURA-reportable to the extent they are manufactured only via the means described in 40 CFR 710.4(b). The §710.46(a)(3) exclusion is

a process-specific exclusion rather than

a chemical- or industry-specific one. Therefore, persons who manufacture a substance in a manner otherthan as specified in §710.4(b) are required to report under IURA unless they or the substance they manufacture are otherwise excluded. As a result,many mined materials are listed onthe TSCA Inventory because at least some ofthe timethey are produced by otherthan manual, mechanical, or gravitational

means.

Section 710.46(a)(3) intentionally exempts from IURA reporting any chemical substance which is isolated or removed from nature, for a commercial purpose, by any means listed in §710.4(b). It also exempts any other chemical substance derived or separated fromthe substance originally removed fromnature, provided such derivation involved only the means specified in §710.4(b). For example, when using manual, mechanical, or gravitational
processes to separate one or more substances from anaturally-occurring mixture, these isolated component substances are also considered naturally-occurring and excluded from reporting. However, any substance manufactured from anaturally occurring precursor substance via a chemical reaction is not considered naturally occurring and, therefore, not excluded from reporting under §710.46(a)(3).

2. What is thedifferencebetween "reasonably ascertainable"information and "readilyobtainable"information? Anumber ofcommenters raised

concerns about the meaning of "readily obtainable" and "reasonably 

### 878

HeinOnline -- 68 Fed. Reg. 878 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

ascertainable," what level ofeffort is required for each, and the difference in the level ofeffort required. Commenters also statedthat the expectation that submitters will provide data on users outside their control seems tobe an unworkable and unrealistic mandate. The reporting standard ofTSCA section 8(a)(2) is "reasonably ascertainable," and commenters stated that this should
not be construed to include data that are not in the possession ofthe person reporting.

"Known to or reasonably ascertainable by" is the current standard for data collection under which IUR operates and is the standard authorized by TSCA section 8(a). "Known to or reasonably ascertainable by" means all information in a person's possession or control, plus allinformation that a reasonable person similarly situated might be expected to possess, control, or know. The "known to or reasonably ascertainable by" standard is applicable
to the information required under §710.52(c)(1), (c)(2), and (c)(3) ofthe regulatory text.

"Readily obtainable" is a lesser standard EPAis applying tothe reporting ofinformation concerning the processing and use ofchemicals subject
to IURA (§710.52(c)(4) ofthe regulatory text). The readily obtainable standard is limited to information knownby management and supervisory employees ofthe submitter, and does not require additional effort to collectinformation

onprocessing or use ofchemicals by others not under the control ofthe submitter. Although the Agency is requiring submitters to provide only information that it knows, EPAbelieves that in many cases submitters will
possess some knowledge concerning use ofchemicals sold bythe submitter to their customers, even though the submitter does not control its customers' sites. Forexample, when a company markets the substances for certain enduses. EPA's experience with

over 30,000 TSCA section 5PMNs demonstrates that companies generally doknow the intended ultimate use, as well as intervening processing steps, of their products. In choosing the readily obtainable standard, the Agency is lessening the burden on submitters compared to the "known to or reasonably ascertainable by" standard, while recognizing that the submitter is supplying data on uses ofchemicals that

are beyond his or her control. The standard for reporting information on processing and use ofchemical substances under IURA is the same as the standard adopted in the PAIR, which was also promulgated under the authority ofTSCA section 8(a). (See 40 CFR 712.7)

E. ConfidentialBusinessInformation

The Agency's intent under these regulations is to achieve balance and

ensure that the submitter only claims as confidential thatinformation which is legally entitled to confidential
treatment. EPAbelieves that these amendments will discourage the assertion ofinvalid CBI claims by focusing submitter's attention more closely on their decision to make certain claims.

1. GeneralCBI.-a.Reducingthe
amountofCBIclaims.EPA solicited suggestions from commenters onwhat couldbe done to the IUR reporting
process and data elements to reduce CBI claims, thereby allowing better public

access tothe data. Some commenters suggested thatEPA is trying to discourage legitimate CBI claims by making assertion of such claims overly burdensome. Some commenters stated that the new data elements that are being added by these amendments raise significant CBI concerns and that IURA

canbe expected to result in a significant increase in the number oflegitimate CBI claims.

EPA agrees that submitters will make CBI claims for the new data elements that are being added bythese amendments, most likely resulting in a greater number ofCBI claims overall. However, EPA isrequiring reporting for
most ofthe new data elements in ranges,

areporting method EPAbelieves will result in fewer CBI claims compared to reporting discrete numbers. Additionally, EPA is amending the IUR
to encourage the assertion ofonly legally valid CBI claims, and to ensure that CBI claims are well thought outby the submitter. The IURA includes anew requirement to provide upfront substantiation ofCBI claims for site identity. This requirement will minimize claims byprompting submitters to perform an initial evaluation ofthe need for andvalidity ofa CBI claim for plant site identity, an essential data element. These efforts will greatly assist in limiting CBI claims
to those that are legitimate.

EPA wishes to clarifythat itis not attempting to discourage legitimate confidentiality claims; rather, the Agency intends onlyto discourage inappropriate claims. This allows the Agency toprotect legitimate CBI while also increasing the amount of information available for public use.

EPA has information indicating the existence ofinappropriate or no longer valid CBI claims. For instance, when EPA has selectively challenged CBI claims in the past,many ofthese claims havebeen amended by the companies to make the information available to the public. Additionally, OPPT's administrative record 00125, which contains state CBI data reviews, published articles, industry letters, and other papers discussing CBI issues, provides further indication that inappropriate orno longer valid CBI claims exist. For instance, the Georgia Department ofNatural Resources reported in a 1996 CBI Data Review that IURdata identified as confidential was available in other non-confidential data bases (Ref.37). The administrative record is in the same location as the Docket and is available by following the procedures identified in Unit I.B.1.

Some commenters suggested reducing the number ofdata elements that will be collected under IURA,perhaps using instead a format such as the one used by OECD for SIDS chemicals, which aggregates information for all manufacturers and thus protects company-specific information. EPA considered alternate reporting formats with different data elements, and has determined that the reporting of sitespecific information by the individual sites is the best way to collectthe information needed. EPA will continue
to perform the aggregating function when providing the public with information thatis subject to a sitespecific CBI claim. Collecting only national aggregate values would drastically reduce the usefulness ofthe information to the Agency, even though itmay reduce the number ofCBI claims. The IUR is used to address both national needs and local issues. For example, IURproduction volume information was usedto identify the national list ofHigh Production Volume (HPV)chemicals for the Agency's HPV Challenge Program (see http://www.epa.gov/opptintr/ chemrtk/volchall.htm). Moreover, sitespecific IURinformation is used to

secure abetter overall understanding of activities at individual sites. This information is usedfor site-specific risk
assessments for the use offederal, state and local entities.

b. ProtectionofCBL. Some
commenters expressed concern about the Agency's ability to protect against the inappropriate release ofCBI and statedthat, under section 14 ofTSCA, EPAhas a statutory obligation to protect information properly claimed as CBI. These commenters are concerned about pastreleases ofinformation claimed as confidential, and would liketo see the Agency take steps to guarantee greater protection ofCBI data.

EPA agrees that it has a statutory obligation toprotect information 

### 879

HeinOnline -- 68 Fed. Reg. 879 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

properly claimed CBI and is continually involved in exploring ways to better protect such information. In this light, these amendments reflect the Agency's efforts to assure that information it protects qualifies for thatprotection under the established legal standards. The new IURArequirements will help

assure thatEPA's system ofinformation protection is limited to valid claims.

c. Productionvolume ranges.EPA requested comment on the use of production volume ranges as a mechanism to reduce the number of confidentiality claims by allowing characterizations ofsite-specific chemical and specific production volume information without releasing CBI. In general, commenters felt that the

use ofthe ranges would not necessarily result in reduced CBI claims. Commenters cited a fewexamples where production volume would stillbe claimed CBI, including information reported in ranges. Other commenters suggested using broader ranges.

Despite these comments, the Agency has determined that it is worthwhile to require submitters to consider whether their production volumes, within ranges similar to those used for the original TSCA Inventory, warrant protection as CBI (EPAmade adjustments tothe original TSCA Inventory ranges by making the ranges consistent with the second reporting threshold of 300,000 lbs., as described in Unit II.F.5.d.). EPA recognizes that some submitters will make CBIclaims for both the specific and the ranged production volume information. However, EPA believes that in many cases submitters will allow the release ofranged production volume information. This beliefis supportedby

some industry organizations. For example, in a 1993 letter, a company suggested the use ofthe original Inventory production volume ranges for non-confidential reporting. While the company did state that "conceivably, a submitter couldbe able tojustify a CBI claim for a range," the conclusion was that many companies would be satisfied with non-confidential reporting (Ref. 11). These conclusions are further supported byEPA's experience withthe original TSCA Inventory, where only 35% ofproduction volume values reported were claimed CBI, compared to the typical claim level of65% for production volumes under IUR.

d. Disclosingcustomerconfidential information.A commenter expressed

concern that, as a producer ofchemical feedstocks, they might inadvertently report customer data and not claim the data asCBI, while their customer reports the same data and does claim the data as CBI. EPA does not believe that this will be

a significant issue. The downstream processing and use information that

some submitters will be required to provide under IURA is not tied to customer identities. Submitters will not report where or who their customers are

orhow much their individual customers produce. In addition, CBI claims canbe made asnecessary for any information provided onForm U. 2. Upfrontsubstantiation.-a. Authority forsubstantiation. A
commenter statedthat the plant site identity substantiation requirement is
not authorized under TSCA. Another
commenter felt that requiring upfront substantiation is overly burdensome and

an arbitrary exercise of authority. The
commenter statedthat substantiation should onlybe required ifand when a request for public disclosure ismade, and substantial and reasonable need are demonstrated.

Under TSCA section 14(c), "a [confidential] designation under this paragraph shall be made in writing and in suchmanner as the Administrator
may prescribe." EPA is continuing to require that those reporting under IURA substantiate their chemical identity CBI claims, andis requiring under these amendments that submitters also substantiate any plant site identity CBI claims. Section 710.58 ofthe regulatory
text requires submitters to substantiate these claims submitted under IURby providing answers to specified questions. EPAhas longrequired upfront substantiation for specified CBI claims under the authority specified in TSCA (see, e.g., 40 CFR 710.38(c) ofthe
current regulatory text) andwill continue to require upfront substantiation where appropriate.

The Agency is adding upfront substantiation requirements for plant site identity information because EPA has observed that, onoccasion, plant site information has been claimed as confidential even though, for example, it was revealed in filings required under sections 311, 312, and 313 ofthe Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C. sections 11021 to 11023. EPA believes that many ofthese CBIclaims are inappropriate and that the new substantiation requirement will reduce the occurrence ofinappropriate claims. A decrease in the number ofCBI claims under the new substantiation requirement wouldfacilitate EPA's ability to make current plant site information available to other Federal agencies and the public because more information submitted under IUR could be released publicly. Upfront substantiation ofCBI claims imposes some additional burden, although this burden is not substantial. EPA's economic analysis for this rule estimates 0.2 to 0.3 hour per plant site reporting under IURA for the incremental costs ofreporting all elements ofplant site identity information. The burden ofupfront substantiation forplant site identityCBI claims is included in this estimate.

b.Alternatesubstantiation questions. One commenter suggested a simplified
set ofsubstantiation questions, consisting oftwo questions: (1)Are the specified data confidential? and, (2)In

as much detail as possible, explain why this information should be given CBI protection.

EPA believes that requiring responses to the listof substantiation questions in §710.58 ofthe regulatory text is necessary to ensure that information submitted for confidential protection qualifies forthat protection. The commenter's proposed questions, while providing the opportunity for a submitter to express itsbusiness reasons and preferences regarding the information, do notprovide all ofthe necessary information to definitively evaluate the eligibility ofthe information for confidential treatment.

3. Reassertion. EPA received a number of comments regarding the proposed new CBIreassertion provisions. All ofthese comments were opposed to the proposed new requirement. Some comments expressed the position that reassertion is overly burdensome and even punitive, requiring submitters to retrace old steps by answering all the original substantiation questions anew. Commenters were concerned that reassertion could possibly require the retention ofvoluminous old records. Others feltthe proposed standards wouldviolate the Agency's obligation underTSCA to protect confidential information and thatEPA would exceed its authority ifitrequired the reassertion ofCBI claims.

EPA has considered these industry comments, and weighed the concerns expressed against the public's need for

access to information on chemicals in

commerce in the United States. While the Agency believes the requirement to reassert old claims ofCBI isjustified as

a practical measure to ensure that information withheld meets the legal criteria and that the expressions of

concern relating toburden associated with reassertion, appear to be the result ofa misunderstanding ofthe practical aspects ofthe proposed reassertion requirement, the Agency isnot finalizing the proposed reassertion 

### 880

HeinOnline -- 68 Fed. Reg. 880 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 881

requirement. EPAhas made this decision in an effort toreduce the overall burden ofthese amendments.

F.AdministrativeComments
1.Frequencyofreporting.Several
commenters stated that one-time reporting ofIURA information would be

more appropriate in most cases for the intended purposes expressed by EPA. In general, commenters stated that EPA could use tools such as PAIR to identify changes in a particular chemical's
exposure or use profile at the time the Agency decides to do a risk analysis for that chemical (see Unit III.A.3.). Afew
commenters stated that there is insufficient change in the chemical industry to warrant recurring reporting ofIURA information, especially for higher volume chemicals.

EPA's experience withpast IUR reporting demonstrates that the chemical industry is dynamic, with a 30% change in the number ofchemicals reported from one submission period to the next. The specific chemicals that are reported or not reported in any single submission period change at avariety of production volumes; this change isby

no means limited to lower production volume chemicals.

Although a chemical's hazards may be fully characterized, EPAneeds up-todate exposure information to stay current with developments and adequately screen chemicals for possible risks tohuman health and the environment. While the toxicity of a chemical does not change (although

new information can modify the
assessment or identify new concerns), a chemical's exposure profile can vary greatly over time. Human and/or environmental exposures to the substance can at one timebe minor,but

as uses change from industrial applications to consumer uses, or as production volumes increase, exposures also tend to increase. Because exposures anduses can and do change over time

as technologies develop or innovations arise, updated exposure information is needed to maintain an adequate understanding ofcurrent exposures. EPA did consider one-time reporting for IURA processing anduse data, but the information would quickly become out ofdate.

A primary goal ofIURA isto provide

a database ofexposure-related information which canbe used for screening level purposes to identify chemicals for further assessment, as well as chemicals oflesser concern (see Unit III.A.1.). EPAintends to use other data sources and collection tools, as appropriate, once a chemical has been identified asa candidate for further
assessment.

2. Calendar yearreporting.One
commenter statedthat the requirement
to report data on acalendar year basis instead of a company fiscal year basis would increase systems development needs for companies who report their manufacturing volume on a fiscal year

versus a calendar year (bycreating the need for a second tracking system), while adding no additional value or accuracy in the reporting of manufacturing data. This commenter pointed out thatbecause the mostthat companies' fiscal years can differ from

a calendar year is 6 months and IUR reporting occurs every 4 years (instead ofevery year), there can be little difference in the data with amaximum 6-month time frame shift. Other
commenters supported the change to a calendar year basis, supporting the idea ofhaving aconsistent time frame to better enable linkages with other data bases.

EPA has retained the calendar year reporting cycle as proposed. By moving the collection to a calendar year basis, the IURA data collection becomes more compatible with other databases such

asthe TRI. This compatibility increases the usefulness ofthe IURA collectionby allowing IURA datato be combined with data from other collections. Generally, companies shouldbe sufficiently familiar with their production that this provision should
not present special challenges thatare unaccounted for in the burden estimates provided by survey respondents, as described in the economic analysis.

G. EconomicImpactEstimates

Commenters raised anumber of

concerns about the economic analysis. In response, EPAhas made a number of changes to make the analysis amore readable document and to incorporate changes made to the final IURA requirements. 1. Generalburdencomments. Commenters raised avariety ofconcerns about the size ofthe burden associated with the amendments, andEPA's estimates ofthatburden. In general,
commenters feltthat the Agency's burden estimates were too low. However, few commenters provided evidence as to why they felt EPA underestimated the burden, andnone provided any specific analytical basis for amending the estimates. Some
commenters claimed thatthe revised form represents a 5-, 10-, or 30-fold increase in burden, atleast partly based
upon the fact that the original Form U

was only 1page and the sample revised Form Uprovided in the proposed rule

was 3pages.

In response to these comments, EPA reviewed the burden analysis and, although the estimated burden was adjusted, determined that the comments do notwarrant modifications to the Agency's general approach to the analysis. EPAbased much ofthe burden analysis on a survey of78industry respondents (Ref. 7). In addition, EPA considered the burden associated with suchprograms as the UEIP (described in UnitIII.A.1.), a voluntary project in which EPA collected information similar in some ways to IURA information. UEIP respondents provided estimates ofthe amount oftime they usedto complete the survey forms (Ref. 7). However, EPA did reassess the results oftheburden survey and did make some changes to the analysis. The burden from the analysis associated with the proposed rule was $36 to $51 millionin the first year, and $27 million
to $41 million infuture reporting years. Changes in the rule and methodology raised estimated costs ofthe final rule
to between $72 and $87 million in the first reporting cycle, and $64 to $77 millionin future reporting cycles. These changes are primarily due to revising the analysis from the survey data, revising the analysis to remove the reassertion burden, updating costs to year 2000 dollars, andupdating the number ofreport submissions to incorporate the 1998IUR data collection. These changes are discussed further in "Revised Economic Analysis for the Amended Inventory Update Rule" (Ref. 7).

a.Burdenover time.Commenters raised concerns about specific burden issues. Several commenters feltthat burden associated with IURA will not decrease over time because ofthe 4-year timelapse between submission periods. Those commenters believe thatthe 4-
year period between submission periods will resultin changes to product lines and personnel such that a complete reintroduction to IURreporting willbe necessary in each reporting cycle. EPA disagrees, and expects rule familiarization to require the most effort in the first year ofreporting. EPA believes that there willbe some similarity in the information reported from one submission period tothe next, especially forParts I and II ofthe revised Form U. Subsequent reporting willbe facilitated by the site's maintenance ofitsprevious submission period's records.

b. Characterization ofburden reduction.Commenters asserted that the economic analysis for the proposed rule

was misleading in its characterization of

HeinOnline -- 68 Fed. Reg. 881 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

the actions thatconstitute burden reduction and cost savings. Specifically,
commenters referred to EPA's claim of

aburden reduction and cost savings associated with the 300,000 lbs. threshold for reporting ofForm U, Part III information on industrial processing anduse, and consumer and commercial

use. EPA simply meant thatproviding a partial exemption for chemicals below the 300,000 lbs. threshold is a concession to theburden that the rule imposes on reporting sites, and that the Agency has no other basis for this exemption other than to mitigate the increase inburden. EPA presented a similar discussion comparing options considered under the rule for other partial reporting exemptions such as the petroleum streams exemption. These discussions are putinto the appropriate
context in the economic analysis. A
commenter also took issue with the fact that EPA asserts that reporting processing and use information on the top 10 NAICS codes will reduce costs (versusreporting on an unlimited number ofNAICS codes), given that identifying these top 10 could take considerable effort. EPA continues to believe that reporting onlythe top 10 NAICS codes will be less burdensome than reporting all NAICS codes associated with industrial processing or

use operations. 2. Costcomments.Two commenters asserted that compliance costs for chemicals manufactured in amounts below the 25,000 lbs. threshold are not

zero andthat, as production volume for

a chemical approaches the threshold, tracking costs will accrue to determine ifproduction will cross the threshold.

Compliance determination (theact of determining the need to comply with a regulation) occurs on a per-site basis. This means that all sites thatreport under IURA are assumed to incur the

same average cost for determining compliance, regardless ofthe number of chemicals reported. Some small number offirms that are not required toreport may incur some negligible costs in this regard, but EPA believes the costs to be relatively small given that it is standard business practice for a company to be

aware ofthe volumes itproduces. The existence ofvoluntary submitters does
not imply that below-threshold compliance costs are non-zero; it simply indicates that some firms choose to respond to IURwhen reporting is not required.

Another commenter determined that member companies in its organization would experience no savings from raising the threshold from 10,000 lbs. to 25,000 lbs. as no reports are eliminated. In 1994, EPA received approximately 3,800 reports for chemicals produced in quantities between 10,000 and 25,000 lbs. As a result, the Agency anticipates that a significant number ofreports will be eliminated by raising the reporting threshold.

3.Benefits comments.Commenters statedthat EPAhas overestimated the benefits ofthis rule and should quantify the benefits. However, given that IURA is an information rule and itsbenefits

are therefore indirect, it is currently not possible to quantify the benefits ofthe rule. Only by collecting the information required under the IURA can EPAbegin
to assess thoroughly the risks from a portion ofthe more than 76,000 chemicals in commerce. The actions that result from EPAreview ofthe IURA data will have direct health and environmental benefits, benefits that typically canbe quantified. Commenters offered no alternate assessment, quantitative or otherwise, ofthe benefits from IURA. In the absence ofquantified benefit figures, it isimpossible to make simple comparisons to estimates of reporting costs. Thus, EPA must balance the needs ofthe Agency for data with which to address important environmental andhealth risks, with the burdens ofobtaining such data. In doing so, the uses ofand need for the data are carefully addressed both within the Agency, and during interagency review. EPA has made every attempt to collect onlythe information necessary to meet Agency goals for obtaining screening level exposure-related information.

4. Smallbusinessimpactcomments. Several commenters argued thatEPA's analysis ofthe impacts ofIURA on smallbusinesses isinsufficient to meet the requirements ofthe Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996. EPA's analysis ofsmall business impacts fully complies with the RFA, as amended. For rules subject to the RFA, the Agency is required to undertake specific actions (such as preparing an initial regulatory flexibility analysis and convening a small business advocacy review panel) unless it certifies that the rule will not have a significant impact

on a substantial number of small entities. EPA prepared a thorough small entity analysis that meets the requirements ofthe RFA. The analysis for the final rule canbe found in the "Revised Economic Analysis for the Amended Inventory Update Rule" (Ref. 7). For both the proposed andfinal rules, EPA certified that there will not be a significant impact on a substantial number of small entities. A summary of the analysis and the certification can be foundin UnitV.B.

5. Non-regulatoryalternatives. Commenters also stated thatEPA did
notidentify any non-regulatory alternatives and failed to assess the relative costs and benefits of an alternative approach. Inthe economic analysis for the proposed rule, the Agency did not specifically identify non-regulatory alternatives to the reporting requirements. However, the Agency did consider non-regulatory alternatives and has added a discussion
to the economic analysis.

The Agency primarily considered two non-regulatory alternatives. First, the Agency considered using publicly available information, as discussed in UnitIII.A.3. The Agency foundthat the information tobe collected through IURA was not publicly available and therefore this was not aviable option. Second, the Agency considered a voluntary approach to collecting this information, similar to the UEIP collection discussed in Unit III.A.1. However, information collected through

avoluntary program may lack consistency, may not be sufficiently comprehensive, or maynot occur on a recurring basis, and therefore would not fully serve the purposes ofIURA information. Therefore, avoluntary approach was not a viable option.

IV.Materials in the Rulemaking Record

The public version ofthe official record for this rulemaking has been established as described in Unit I.B.1. under docketID number OPPT-2002- 0054. Thisrecord includes the documents located in the docket aswell

as the documents that are referenced in those documents. The following is a listing ofthe documents that are specifically referenced inthis final rule. These documents, and the documents referenced therein, are also included in the public version ofthe official record. Please note that some referenced documents are already publicly available and this listincludes the relevant location information.

1. U.S.EPA, "Reducing Risk: Setting Priorities and Strategies for Environmental Protection," Science Advisory Board, (SAB-EC-90-021), 1990.

2. National Academy ofPublic Administration, "Setting Priorities, Getting Results

-A New Direction for EPA," 1995.

3. Chemical Manufacturers Association, Synthetic Organic Chemical Manufacturers Association, U.S. EPA, Chemical Specialties Manufacturing Association, American Petroleum Institute, "Round 3ofthe 

### 882

HeinOnline -- 68 Fed. Reg. 882 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

UEIP (Use and Exposure Information Project)," June 3, 1996.

4. American Petroleum Institute, "Petroleum Process Stream Terms Included in the Chemical Substances Inventory Under the Toxic Substances Control Act (TSCA)," Health and Safety Regulation Committee Task Force on Toxic Substances Control, February 1985.

5.USEPA, "Methodology Used for the Initial Selection ofChemicals for the Inventory Update Rule Amendments (IURA) 'Low Current Interest' Partial Reporting Exemption," OPPT,July 24, 2002.

6. USEPA, "EPA Needs ExposureRelated Data: A Discussion ofthe Justification for Collecting ExposureRelated Data Through the IUR Amendments," OPPT/EETD/EPAB, 1998.

7.USEPA, "Economic Analysis for the Amended Inventory Update Final Rule," OPPT, August 2002.

8. USEPA, "Incremental Cost Estimates for IURA: Interagency Review Comparison and Five Year Reporting Cycle," OPPT/EETD/EPAB, July 17, 2002.

9. USEPA, "Draft Instructions Manual for the 2006 Inventory Update Rule Reporting," OPPT, August 2002. 10. USEPA, "Inventory Update Rule (IUR)Technical Support Document: Evaluation ofLikelihood ofConfidential Business Information Claims for Production Volume Information," OPPT, August 26, 1996.

11. Letter from Mark N. Duvall, Union Carbide, to EPA, "Additional Comments ofUnion Carbide Corporation on EPA's Preliminary Actions to Reform TSCA Confidential Business Information, Docket No. OPPTS-00125," August 31, 1993.

12. Letter from Stephen A. Newell, Occupational Safety andHealth Administration, toWardner G. Penberthy, EPA, October 15, 1996. 13. Letter from Paul A. Schulte, Ph.D., National Institute for Occupational Safety and Health, toWardner G. Penberthy, EPA, October 8, 1996. 14. USEPA, "Inventory Update Rule (IUR)Amendment Technical Support Document: Exposure-Related Data Useful for Chemical Risk Screening," Volumes 1 and 2, OPPT,July 19, 1996. 15. U.S. Census Bureau, North American Industrial Classification System (NAICS), http://

www.census.gov/epcd/www/ naics.html, 1999. 16. USEPA, "Preliminary Assessment Information Rule (PAIR)Database, Manufacturing Process Type/Release Analysis and Number ofWorkers/ Production Quantity Analysis," OPPT, September 26, 1996.

17. Standard Consumer Safety Inspection ASTM F963-96A (sec. 3.1- 3.3).

18. USEPA, "Summary ofEPA's Responses to Public Comments Submitted in Response to Proposed TSCA Inventory Update Rule Amendments (64 FR 46772)," OPPT/ EETD, September 6, 2002. 19. USEPA, "IURA Data Use Plan," OPPT/EETD, August 23, 2002.

20. USEPA, "A SAB Report: Improving the Use Cluster Scoring System, Recommendations for the Use Cluster Scoring System Prepared by the Environmental Engineering Committee," Science Advisory Board, SAB-EEC-95-017, September 1995. Also available at www.epa.gov/sab/pdf/ eec95017.pdf.

21. Letter from Michael A. Babich, U.S. Consumer Product Safety Commission, toWardner G. Penberthy, EPA, June 24, 1996. 22. Letter from Robert Franklin, U.S. Consumer Product Safety Commission,
to EPA, December 23, 1999. 23. Letter from Paul A. Schulte, Ph.D., National Institute for Occupational Safety &Health, to EPA, December 21, 1999.

24. General Accounting Office, "Toxic Chemicals: Long-Term Coordinated StrategyNeeded to Measure Exposures in Humans," GAO/HEHS-00-80, May 2, 2000.

25. Letter from Linda Greer, Ph.D., Natural Resources Defense Council, to Carol Browner, EPA,February 12, 1999.

26. USEPA, "Economic Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update Rule," OPPT/EETD/EPAB, March 1, 1999.

27. USEPA, "A Review ofExisting Exposure-Related Data Sources and Approaches to Screening Chemicals: A Response to CMA," OPPT, March 1999. 28. European Commission, "Technical Guidance Document in Support ofCommission Directive 93/67/ EEC on RiskAssessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances; Part III." 29. USEPA, "'Inventory Update Rule (IUR)Technical Support Document: Selection ofConsumer and Commercial End-Use Categories," OPPT, 1996. 30. Letter from the TSCA Interagency Testing Committee providing a response to an Interagency proposed rule review question, undated.

31. Letter from John DeYoung, Chief Scientist,U.S. Geological Survey, to Mary Ellen Weber, EPA, July 25, 2002. 32. USEPA, "Inorganic Chemicals: Sources ofInformation Suggested by Commenters to the Proposed Inventory Update Rule Amendments," OPPT, June 2000.

33. Memorandum from Sandy Zavolta, U.S. EPA, to Heidi King, Office ofManagement and Budget,May 21, 1999.

34. OECD, "Guidance for Collection and Transmission ofExposure Information for SIDS Initial Assessment," OECD SIDS Manual (Third Revision), Section 2.5, July 1997, available at http://www.epa.gov/ opptintr/sids/sidsman.htm.

35. USEPA, "Report to Congress: Wastes from the Combustion ofFossil Fuels (EPADocket #F-2000-FF2FFFFFF)Public Comment Summary and Response Document," OSW, April 25, 2000, available at http://www.epa.gov/ epaoswer/other/fossil/ffc-resp.pdf.

36. General Accounting Office, "EPA Should Focus Its Chemical Use Inventory on Suspected Harmful Substances," GAO/RCED-95-165, July 7, 1995.

37. Confidential Business Information DataReview, Georgia Department of Natural Resources, Docket entry 00125 B2a-010 filed June 19, 1996, page 4.

V. Statute and Executive Order Reviews

A.Executive Order 12866

Under Executive Order 12866, entitled RegulatoryPlanning and Review(58 FR 51735, October 4, 1993), the Office ofManagement and Budget (OMB) has determined that thisis a "significant regulatory action" under section 3(f)ofthe Executive Order, because itraises "novel legal orpolicy issues arising out oflegal mandates" relating to information collection. This action was therefore submitted to OMB for review under this Executive Order, and any comments or changes made during thatreview havebeen documented in the public record.

In addition, EPAhas prepared an economic analysis ofthe potential impacts ofthis action, which is contained in a document entitled EconomicAnalysis for theAmended Inventory UpdateRule (Ref. 7). The Agency, in promulgating this rule, is required under TSCA to consider the potential costs and benefits associated with IURA. The analysis was therefore usedby the decision-makers to help in the selection ofthe final rule requirements presented in this document. This document is available

as a part ofthe public version ofthe official record for this action and is briefly summarized here.

EPA estimates thatthese amendments will costbetween $72 and $87 million in the first reporting cycle, and $64 to 883

HeinOnline -- 68 Fed. Reg. 883 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

$77 million in future reporting cycles, resulting in an annualized cost of$17 to $21 million over the next 20years at a 3% discount rate, and $19 to $22 million at a 7%discount rate.

Under these amendments, approximately 8,900 chemicals will be subject to reporting, and the Agency expects that it will receive approximately 26,800 submissions duringthe first submission period. In the first submission period, approximately 9,800 ofthose submissions (providing information on about 4,000 chemicals) will be full reports which include information found in Part III ofrevised reporting Form U. The remainder will report only company, site and chemical identification and manufacturing information (Parts Iand II ofrevised Form U). In future submission periods with the addition offull reporting for inorganic chemicals, EPA expects to receive over 12,300 full forms, covering 4,600 chemicals. In order to keep the reporting burden as low as possible, EPA is requiring that certain information be reported in ranges, that onlythe top 10 NAICS codes be accounted for when reporting industrial processing and use information, and that only readily obtainable information in Part III ofrevised Form Ube reported.

EPA analyzed the effects ofa number ofdifferent alternatives for the rule, including variations in exemptions, different thresholds for both partial- (i.e., Parts Iand II ofrevised Form U) and full-form (i.e., all parts ofrevised Form U)reporting, and various frequencies ofcollection. These options

are explored further in the Economic Analysis (Ref.6).

EPA considered continuing the existing full exemption from IUR reporting for inorganic chemicals and adding afull exemption for site-limited petroleum streams. EPA examined the effects ofkeeping the partial-form threshold at 10,000 lbs. and considered full-form thresholds of 100,000, 300,000, 500,000, and one million lbs.,

as well as a phased-in 100,000/500,000 full-form threshold. EPA also considered changes in the reporting cycle, such as a one-time collection, and

a 2-year cycle.

EPAbelieves thatthis final rule represents an appropriate balance between the burden placed on industry
to provide information and the Agency's need for that information to fill its statutory obligations and fulfill its mission under TSCA and, as part ofthat mission, to provide information needed by other agencies (OSHA, NIOSH, CPSC, etc.). The costs ofthese amendments will be borne by two groups: the chemical industry and EPA. Industry costs are associated with complying with the regulation, while EPA costs are associated with administering the regulation and maintaining the collected data. In this rulemaking effort, EPA has made every attemptto balance data needs with collection costs andburden. Wherever possible, EPAhas used exemptions or partial exemptions to reduce the number ofreports that would potentially be filedby industry. EPA has provided a second threshold for reporting use information required in Part III ofrevised Form U, reducing the
per report burden for submitters. Recognizing that this information will be used for screening level purposes, EPA has reduced the specificity ofthe information that will be required in three ways: (1)By requiring the reporting ofonlyreadily obtainable information for the processing and use exposure-related data; (2)byrequiring that submitters report much ofthe information in ranges, reducing the need to generate specific estimates; and, (3)byrequiring processing anduse exposure-related information on only the top 10 uses/NAICS codes/IFCs, as determined by percent ofthe chemical's volume. These steps limitthe amount of information required, reducing the time and effort spent bythe chemical industry in complying with the amendments.

EPA assumes that the burden associated with reporting under IURA will decrease over time as industry's familiarity with the reporting rule increases and tothe extent that the information being reported remains somewhat constant from one submission period to the next. Projected
coststo EPA are relatively small and are estimated to be $576,000 in the first reporting year, and $270,000 in subsequent reporting years.

Substantial changes in the economic analysis have occurred since the economic analysis produced for the proposed rule, which is summarized in Unit XI. ofthe proposed rule (at 64 FR 46799). The economic analysis was revised primarily due to changes in the final rule and changes to the cost methodology that more fully reflect potential industry burden. The revised economic analysis in support ofthis final rule can be found in the public version ofthe official record for this rulemaking (Ref. 6).

Changes made since the proposal due
to public comments or interagency review include deleting the average concentration data element, phasing-in full reporting for inorganic chemicals, adding a partial exemption for specific chemical substances for which the Agency has determined that the IURA processing and use information is oflow
current interest, and deleting the proposed CBIreassertion requirement. Changes made tothe costmethodology include increasing burden estimates for reporting processing anduse data. The increase in burden estimate was initiated in response to industry comment, and stemmed from differences inthe survey instrument usedto estimate costs ofIURA in 1996, and the sample Form U in 1999.

Estimates for reporting processing and

use data were revised upward after reviewing public comments and the survey data. Differences between the survey instrument and the proposed Form Urequired EPA to aggregate certain responses. After reading the comments, EPA isusing more conservative assumptions in this
process. Therefore, it is more likely that EPA cost estimates overestimate, rather thanunderestimate, actual costs.

B.Paperwork ReductionAct
The OMB has approved the information collection requirements contained in this rule under the provisions ofthe PaperworkReduction Act (PRA), 44 U.S.C. 3501 etseq., and has assigned OMB control number 2070-0162. In accordance with the procedures at 5 CFR 1320.11, EPA submitted an Information Collection Request (ICR) document to OMB in 1999 (identified asEPA ICRNo. 1884.02), which is also included in the public docket that is described in Unit I.B.1.

The information that will be reported underIURA will better enable EPA to

screen thousands ofchemical substances for potential risk. Risk screening is necessary in order to

conserve limited Agency andindustry

resources by focusing risk assessment work on chemical substances for which

some level ofpotential risk has been indicated. The new information that willbe reported under this rule is critical to the risk screening process and is unavailable through other sources. Responses to this collection of information will be mandatory, pursuant to TSCA section 8(a), 15 U.S.C. 2607(a). The regulations codifying the reporting requirements appear at 40 CFR part 710. CBI claims maybe made for all or part ofthe information that will be reported under IURA. This action includes new substantiation procedures for CBIclaims regarding plant site identity (See §710.58(d) in the regulatory text).

As a result ofIURA, reporting sites will submit either a full report for a 

### 884

HeinOnline -- 68 Fed. Reg. 884 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 885

chemical (which includes site identification, manufacturing information and processing anduse data)or a partial report (which does not include processing and use data). For the first reporting cycle, inorganic chemical manufacturers will only submitpartial reports while organic chemical manufacturers will submit a mix ofpartial and full reports. The IURA increases the average reporting burden for both partial and full reports compared to previous IURreporting.

Companies will continue to report under IURA once every 4 years, so the average annual IURAreporting burden and costis calculated in the ICR as one quarter ofthe burden and cost in a reporting cycle. Thus, the results in the ICR differ slightly from those in the economic analysis prepared under Executive Order 12866, which calculates the annualized cost of multiple reporting cycles over a 20-year period. In addition,the economic analysis calculates the incremental increase inburden due to IURA, while the ICRcalculates the total reporting andrecordkeeping burden for IURA (i.e., the sum ofthe incremental IURA burden andthe baseline IURburden). Companies may continue toreport for multiple chemicals on a single Form U (asrevised). Companies generally submit one Form U per site, so the burden per Form Uis approximately equivalent to the burden per site.

For the first reporting cycle, the annual averageburden for organic chemical manufacturers is estimated to be 121.5 to 152.4 hours per site at a cost of$8,313 to $10,448 (reflecting an average of5.1 partial reports and 3.8 full reports per site). For inorganic chemical manufacturers, the annual average burden is estimated at 43.3 to 66.1 hours per site at a cost of$2,936 to $4,547 (reflecting an average of8.3 reports per site). These estimates include the time needed to review instructions; search data sources; gather and maintain the data needed; complete and review the collection ofinformation; and transmit

orotherwise disclose the information. The actual burden on any specific site may be different from this estimate depending on the complexity ofthe site, the number ofIURAreportable chemicals atthe site, and the profile of the site's operations. There will be approximately 2,500 submitters for organic chemicals (includingpetroleum process streams), and 500 submitters for inorganic chemicals. For the first reporting cycle, the total annual burden is estimated to be approximately 325,000 to 414,000 hours at a total estimated industry costof $22.2 to $28.4 million per year. Under the PRA, "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose orprovide information to orfor aFederal agency. This includes the time needed to: Review instructions; develop, acquire, install, andutilize technology and systems for the purposes ofcollecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able
to respond to a collection of information; search data sources; complete and review the collection of information; and transmit orotherwise disclose the information.

As part ofthe PRA approval renewal
process, which occurs every 3years and includes an opportunity for public review and comment prior to OMB review, EPA intends to evaluate this collection activity, particularly the new exemption process, in order to demonstrate the practical utility of IURA information collection activities. The Agency will provide information in the ICRrenewal document that details the chemicals evaluated under the exemption process, the exemption requests received, and the Agency's decisions made, aswell as provide information about the process elements and experiences.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection ofinformation unless it displays a currently valid OMB control number. The currently approved ICR control numbers issued by OMB for various EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. EPA is amending the table in 40 CFR part 9
to listthe OMB approval number for the information collection requirements contained in this final rule. This listing ofthe OMB control numbers and their subsequent codification in the CFR satisfies the display requirements ofthe PRA and OMB's implementing regulations at 5CFR part 1320. This ICR

was previously subject to public notice and comment prior to OMB approval. Due to the technical nature ofthe table, EPA finds that further notice and
comment is unnecessary. As a result, EPA finds that there is "good cause" under section 553(b)(B) ofthe Administrative Procedure Act, 5U.S.C. 553(b)(B), to amend this table without further notice and comment.
C.RegulatoryFlexibility Act
Pursuant to section 605(b) ofthe Regulatory Flexibility Act (5U.S.C. 601 etseq.),the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity impact analysis prepared as part ofthe economic analysis for this rule (Ref. 6), and is briefly summarized here.

Small entities include small businesses, small not-for-profit organizations, and small governmental jurisdictions (5U.S.C. 601(6)). Because not-for-profit organizations and governmental jurisdictions will not be affected by this rule, "small entity" for
purposes ofthis final rule is
synonymous with "small business." Section 601(3) ofthe RFA establishes as the default definition of smallbusiness the definition used in section 3ofthe Small Business Act (15 U.S.C. 632) underwhich the Small Business Administration (SBA) establishes small business size standards (13 CFR 121.201). The RFA recognizes, however, that itmay be appropriate at times for Federal agencies to use an alternate definition of smallbusiness. As aresult, RFA section 601(3) provides that an Agency may establish a different definition of smallbusiness after consultation with the SBA Office of Advocacy and after notice and an opportunity for public comment. EPA established a different definition of smallbusiness, found in the existing IUR at 40 CFR 704.3, in accordance with these requirements. Manufacturers who
meet the 40 CFR 704.3 definition of smallbusiness are generally exempted fromIUR reporting in 40 CFR 710.29. This exemption is retained under these amendments in §710.49 and was not reopened for comment. In general, EPA strives to minimize potential adverse impacts on small entities when developing regulations to achieve the environmental andhuman health protection goals ofthe statute and the Agency.

Despite the fact that small manufacturers that fully meet the 40 CFR 704.3 definition are generally exemptfrom reporting under IUR, and thus are not significantly impacted by IURA,EPA conducted an analysis ofthe potential impact for submitters that
meet only part ofthe 40 CFR 704.3 definition. Specifically, an analysis of the potential impact was conducted onlyfor those submitters that meet the first criterion in the 40 CFR 704.3 definition of "small manufacturer or importer," i.e., total annual sales ofless than $40 million, but that do not meet the second criterion, i.e., production or import volume ofless than 100,000 pounds at all sites.

HeinOnline -- 68 Fed. Reg. 885 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

For small manufacturers oforganic chemicals subject toreporting, the Agency estimates the impact tobe 0.15% to 0.18% of sales. For small manufacturers ofinorganic chemicals subject to reporting, the Agency estimates the impact to be 0.07% to 0.20% of sales.

D. UnfundedMandatesReformAct

Pursuant to Title II ofthe Unfunded Mandates Reform Act of1995 (Public Law 104-4), EPA has determined that this regulatory action does not contain

aFederal mandate thatmay result in expenditures of$100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector in any 1year. The analysis ofthe costs associated with this action are described in Unit V.A. In addition, EPA has determined that this rule does not significantly oruniquely affect small governments. Accordingly, this rule is
not subject tothe requirements of sections 202, 203, 204, and 205 of UMRA.

E.Executive Order13132

Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure "meaningful and timely inputby State and local officials in the development of regulatory policies thathave federalism implications." "Policies that have federalism implications" is defined in the Executive Order to include regulations thathave "substantial direct effects on the States, on the relationship between the national government and the States, or onthe distribution of
power and responsibilities among the various levels ofgovernment."

This final rule does not have federalism implications, because it will
not have substantial direct effects on the States, on the relationship between the national government and the States, or

onthe distribution ofpower and responsibilities among the various levels ofgovernment, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.

F.Executive Orders13084 and13175

Under Executive Order 13084, entitled ConsultationandCoordination with IndianTribalGovernments(63 FR 27655, May 19, 1998), EPAmay not issue a regulation that is not required by statute, that significantly or uniquely affects the communities ofIndian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds
necessary to pay the direct compliance costsincurred by the tribal governments, orEPA consults with those governments.

IfEPA complies by consulting, Executive Order 13084 requires EPA to provide to OMB, in a separately identified section ofthe preamble to the rule, a description ofthe extent ofEPA's prior consultation with representatives ofaffected tribal governments, a summary ofthe nature oftheir concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives ofIndian tribal governments "to provide meaningful and timely input in the development of regulatory policies on matters that significantly oruniquely affect their communities."

This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose substantial direct compliance
costs on such communities. Accordingly, the requirements of section 3(b) ofExecutive Order 13084 donot apply to this rule.

OnNovember 6, 2000, the President issued Executive Order 13175, entitled ConsultationandCoordinationwith Indian TribalGovernments(65 FR 67249). Executive Order 13175 took effect onJanuary 6, 2001, andrevokes Executive Order 13084 asofthat date. EPA developed this rule, however, duringthe period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084.
G. Executive Order13211

This rule is not a "significant energy action" as defined in Executive Order 13211, Actions Concerning Regulations ThatSignificantly Affect EnergySupply, Distribution,or Use(66 FR 28355, May 22, 2001) because itis not likely to have

a significant adverse effect onthe supply, distribution, or use ofenergy. This final rule modifies the existing IUR reporting and recordkeeping requirements that apply to chemical manufacturers andimporters. As such,

we have concluded that this rule is not likely to have adverse energy effects.

H. Executive Order13045

This rulemaking does not require special consideration pursuant to the
terms ofExecutive Order 13045, entitled ProtectionofChildren from EnvironmentalHealthRisks andSafety Risks (62 FR 19885, April 23, 1997), because itis not likely to have an annual effect onthe economy of$100 million ormore and it does not have a potential effect or impact on children. As discussed in this preamble, this rule will provide the Agency with information needed to screen and prioritize chemical substances, including information onpotential
exposures to children. This information will allow the Agency and others to determine which chemical substances havepotential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

L NationalTechnology Transfer and AmendmentAct

This regulatory action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) ofthe National Technology Transfer andAdvancement Act of1995 (NTTAA), Public Law 104- 113, 12(d) (15 U.S.C. 272 note). Section 12(d) ofNTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so wouldbe inconsistent with applicable law or otherwise impractical. Voluntary

consensus standards are technical standards (e.g., materials specifications,
test methods, sampling procedures, and business practices) that are developed or adoptedby voluntary consensus standards bodies. The NTTAA requires EPAto provide Congress, through OMB, explanations when the Agency decides
notto use available and applicable voluntary consensus standards.

J.Executive Order12898

Pursuant to Executive Order 12898, entitled Federal ActionstoAddress EnvironmentalJusticeinMinority Populations andLow-Income Populations (59 FR 7629, February 16, 1994), the Agency has considered environmental justice-related issues with regard to the potential impacts of this action onthe environmental and health conditions in minority and lowincome populations. The Agency believes that the information collected underthis rule will assistEPA and others in determining the risks and
exposures associated with the chemicals covered by the rule. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to protect human health and the environment bybeing better able to prioritize chemical substances of

concern.
K.Executive Order12630

EPA has complied with Executive Order 12630, entitled Governmental Actions andInterferencewith 

### 886

HeinOnline -- 68 Fed. Reg. 886 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 887

Constitutionally ProtectedProperty Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the "Attorney General's Supplemental Guidelines for the Evaluation ofRisk and Avoidance ofUnanticipated Takings" issued under the Executive Order.

L. Executive Order12988

In issuing this rule, EPAhas takenthe
necessary steps to eliminate drafting

errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3ofExecutive Order 12988, titled CiviljusticeReform (61 FR 4729, February 7, 1996).


### VI. Submission to Congress andthe Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit arule report, which includes a copy ofthe rule, to each House ofthe Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House ofRepresentatives and the Comptroller General ofthe United States prior to publication ofthe rule in the FederalRegister. This rule is not a "major rule" as defined by 5U.S.C. 804(2).

List of Subjects in 40 CFRPart9

Environmental protection, Reporting andrecordkeeping requirements.
List of Subjects in 40 CFRPart710

Environmental protection, Chemicals, Hazardous materials, Reporting and recordkeeping requirements.

List of Subjects in 40 CFRPart723

Environmental protection, Chemicals, Hazardous materials, Reporting and recordkeeping requirements.

Dated: December 18, 2002. Stephen L.Johnson, AssistantAdministrator forPrevention, PesticidesandToxicSubstances.

Therefore, 40 CFR chapter I is amended as follows:

1.Part 9 is amended as follows:

PART 9-[AMENDED]

a. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

b. In §9.1, the table is amended by revising the heading "Inventory Reporting Regulations" to read "TSCA Chemical Inventory Regulations"; removing the existing entryunder the heading; and adding the following entries to read as follows:
§9.1 OMB approvals under the Paperwork Reduction Act.

* * * * * * 40 CFR citation OMB Control No.

TSCA Chemical Inventory Regulations

Part 710, Sub- 2070-0070

part B. Part 710, Sub- 2070-0162

part C.

* * * * * *

2.Part 710 is amended as follows:

PART 710-[AMENDED]

a. The authority citation for part 710 continues to read asfollows:

Authority: 15 U.S.C. 2607(a). b. Revise the part heading and table ofcontents for part 710 to read as follows:

PART 710-TSCA CHEMICAL INVENTORY REGULATIONS

Subpart A-General Provisions

Sec. 710.1 Scope and compliance. 710.3 Definitions. 710.4 Scope ofthe inventory.
Subpart B-2002 Inventory Update Reporting

710.23 Definitions. 710.25 Chemical substances forwhich information must be reported. 710.26 Chemical substances forwhich information isnot required. 710.28 Persons who must report. 710.29 Persons not subject to this subpart. 710.30 Activities for which reporting is not required. 710.32 Reporting information to EPA. 710.33 When toreport. 710.35 Duplicative reporting. 710.37 Recordkeeping requirements. 710.38 Confidentiality. 710.39 How do I submit the required information?
Subpart C-Inventory Update Reporting for 2006 and Beyond

710.43 Definitions. 710.45 Chemical substances for which information must be reported. 710.46 Chemical substances for which information is notrequired. 710.48 Persons who must report. 710.49 Persons not subject to this subpart. 710.50 Activities forwhich reporting is not required. 710.52 Reporting information to EPA. 710.53 When to report. 710.55 Duplicative reporting. 710.57 Recordkeeping requirements. 710.58 Confidentiality. 710.59 Availability ofreporting form and instructions.

c. Sections 710.1 through 710.4 are designated as subpart A andthe subpart heading is added to read as follows:
Subpart A-General Provisions

d. Revise § 710.1 to read as follows:
§710.1 Scope and compliance.

(a) This part establishes regulations governing reporting and recordkeeping by certain persons who manufacture, import, or process chemical substances for commercial purposes under section 8(a) ofthe Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a) authorizes the Administrator to require reporting ofinformation necessary for administration ofthe Act and requires EPAto issue regulations forthe purpose ofcompiling and keeping current an inventory ofchemical substances manufactured or processed for a commercial purpose, as required by section 8(b) ofthe Act. Following an initial reporting period,EPA published

an initial inventory ofchemical substances manufactured, processed, or imported for commercial purposes. In accordance with section 8(b), EPA periodically amends the inventory to include new chemical substances which

are manufactured or imported for a commercial purpose andreported under section 5(a)(1) ofthe Act. EPA also revises the categories ofchemical substances and makes other amendments as appropriate.

(b)The regulations in this part apply
to the activities associated with the compilation ofthe TSCA Chemical Inventory and the update ofinformation

on a subset ofthe chemical substances included on the Inventory.The Inventory Update regulations were

HeinOnline -- 68 Fed. Reg. 887 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

amended in 2002; however, these amendments apply toupdates after 2002, not to the 2002 update. In order
to prevent confusion as to which regulations apply to which update, EPA has preserved the provisions that apply
to the 2002 update in subpart B. The

new andrevised requirements that apply to updates after 2002 appear in subpart C. Prior to January 1,2003, the regulations in subpart B ofthis part are effective for purposes ofInventory update activities. As ofJanuary 1,2003, subpart C is effective for purposes of Inventory update activities. The Agency intends toremove subpart B from the CFR once the 2002 update is complete. (c) Section 15(3) ofTSCA makes it unlawful for any person to fail or refuse
to submit information required under these reporting regulations. In addition, section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by these regulations. Section 16 provides that any person who violates a provision of section 15 is liable tothe United States for acivil penalty and maybe criminally prosecuted. Pursuant to section 17, the Government may seek judicial reliefto compel submission of section 8(a)information and to otherwise restrain any violation of section 15. (EPA does not intend to concentrate its enforcement efforts on insignificant clerical errors in reporting.) (d)Each person who reports under these regulations must maintain records that document information reported under these regulations and, in accordance with the Act, permit access to, and the copying of, such records by EPA officials.

§710.2 [Removed]

e. Remove §710.2. f.Add §710.3 to subpart A to read as follows: §710.3 Definitions.

In addition tothe definitions in §704.3 ofthis chapter, the following definitions apply to this part:

(a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321
etseq., and the regulations issued under suchAct: Cosmetic,device, drug, food, andfoodadditive.In addition, the term foodincludes poultry andpoultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453
etseq.;meats and meat food products,

as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 etseq.; and
eggs and eggproducts, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 etseq. (b)The term pesticidewill have the meaning contained in the Federal Insecticide, Fungicide, and Rodenticide Act, 7U.S.C. 136 et seq., and the regulations issued thereunder. (c) The following terms will have the meaning contained in the Atomic Energy Act of1954, 42 U.S.C. 2014 et seq., andthe regulations issued thereunder: Byproductmaterial,source material,and specialnuclearmaterial. (d)The following definitions also apply to this part:

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

Administrator means the Administrator ofthe U.S. Environmental Protection Agency, any employee or authorized representative ofthe Agency to whom the Administrator may either herein or by order delegate his/her authority to carry outhis/her functions, orany other
person who will by operation oflawbe authorized to carry out such functions.

An articleis amanufactured item: (1)Which isformed to a specific shape or design during manufacture,

(2)Which has enduse function(s) dependent in whole or in part upon its shape or design during end use, and

(3)Which has either no change of chemical composition duringits end

use or only those changes of composition which have no commercial
purpose separate from that ofthe article and that may occur as described in §710.4(d)(5); except that fluids and particles are not considered articles regardless ofshape or design.

Byproductmeans a chemical substance produced without separate commercial intent during the manufacture or processing ofanother chemical substance(s) ormixture(s).

Chemicalsubstancemeans any organic orinorganic substance ofa particular molecular identity, including any combination ofsuch substances occurring in whole orin part as a result ofa chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that "chemical substance" does notinclude:

(1)Any mixture, (2)Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide, (3)Tobacco or any tobacco product, but not including any derivative products, (4) Any source material, special nuclear material, or byproduct material, (5)Any pistol, firearm, revolver, shells, and cartridges, and

(6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. Commercemeans trade, traffic, transportation, or other commerce:

(1)Between a place in a State and any place outside of such State, or

(2)Which affects trade, traffic, transportation, or commerce described in paragraph (1)ofthis definition.

Distributein commerceand distributionin commerce,when used to describe an action taken with respect to

a chemical substance ormixture or article containing a substance or mixture, mean to sell orthe sale ofthe substance, mixture, or article in
commerce; to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce ofthe substance, mixture, or article; or to hold or the holding ofthe substance, mixture, or article after its introduction into

commerce.

EPA means the U.S. Environmental Protection Agency.

Importermeans any person who imports any chemical substance or any chemical substance aspart ofa mixture

or article into the customs territory of the U.S. and includes:

(1)The person primarily liable for the payment of any duties on the merchandise, or

(2)An authorized agent acting on his/ herbehalf (as defined in 19 CFR 1.11).

Impuritymeans a chemical substance which is unintentionally present with another chemical substance.

Intermediatemeans any chemical substance:

(1)Which is intentionally removed fromthe equipment in which it is manufactured, and

(2)Which either is consumed in whole orin partin chemical reaction(s) usedfor the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s).

Note: The equipmentin whichitwas manufacturedincludes thereaction vessel in which the chemical substance was manufactured and other equipment whichis strictlyancillary to thereaction vessel, and anyother equipment through which the chemical substance may flow during a continuous flow process,but does not include tanks or other vessels inwhich the chemical substance is stored afterits manufacture.

Manufacturemeans to manufacture, produce, or import for commercial
purposes.

Manufactureorimport "for commercial purposes"means to manufacture, produce, orimport with the purpose ofobtaining an immediate

or eventual commercial advantage, and includes, for example, the manufacture 

### 888

HeinOnline -- 68 Fed. Reg. 888 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

orimport ofany amount ofa chemical substance ormixture:

(1)Forcommercial distribution, including for test marketing, or (2)Foruse bythe manufacturer, including use for product research and development, or as an intermediate.

Mixturemeans any combination of
two ormore chemical substances ifthe combination does not occur in nature and is not,in whole or in part, the result ofa chemical reaction; except that "mixture" does include:

(1)Any combination which occurs, in whole or in part, as a result ofa chemical reaction ifthe combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined and if,after the effective date or premanufacture notification requirements, none ofthe chemical substances comprising the combination is a new chemical substance, and

(2)Hydrates ofa chemical substance

orhydrated ions formedby association ofa chemical substance with water.

New chemicalsubstancemeans any chemical substance which is not included in the inventory compiled and published under section 8(b) ofthe Act.

Personmeans any natural orjuridical
person including any individual, corporation, partnership, or association,
any State or political subdivision thereof, or any municipality, any interstate body and any department,
agency, or instrumentality ofthe Federal Government.

Processmeans the preparation ofa chemical substance or mixture, after its manufacture, for distribution in

commerce:

(1)In the same form or physical state
as, or in a different form or physical
state from, that in which it was received by the person so preparing such substance ormixture, or

(2)As part of a mixture or article containing the chemical substance or mixture.

Process "forcommercialpurposes"

means to process: (1)Fordistribution in commerce, including for test marketing purposes,

or(2)Foruse as an intermediate.

Processor means any person who
processes a chemical substance or mixture. Sitemeans a contiguous property unit. Property divided only by apublic right-of-way will be considered one site. There maybe more than one manufacturing plant on a single site. For the purposes ofimported chemical substances, the sitewill be the business address ofthe importer.

Smallquantities for purposesof scientificexperimentationoranalysisor chemicalresearchon, oranalysisof, such substanceoranothersubstance, includinganysuch researchoranalysis forthedevelopmentofaproduct (hereinafter sometimes shortened to smallquantities forresearchand development)means quantities of a chemical substance manufactured, imported, orprocessed or proposed to be manufactured, imported, or processed that: (1)Are no greater than reasonably necessary for such purposes, and (2)After the publication ofthe revised inventory, areused by, ordirectly under the supervision of,a technically qualified individual(s).

Note: Any chemical substances manufactured, imported, orprocessed in quantities less than 1,000 lbs. (454 kg) annually will be presumedtobe manufactured, imported, orprocessed for research and development purposes. No person mayreport forthe inventory any chemical substance in suchquantities unless that person can certify thatthe substance was not manufactured, imported, orprocessed solelyin small quantities forresearch and development, as defined in this section.

Statemeans any State ofthe United States, the District ofColumbia, the Commonwealth ofPuerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any otherterritory or possession ofthe United States. Technicallyqualifiedindividual

means aperson: (1)Who because ofhis/her education, training, or experience, or a combination ofthese factors, is capable ofappreciating the health and environmental risks associated with the chemical substance which isused under his/her supervision, (2)Who is responsible for enforcing appropriate methods ofconducting scientific experimentation, analysis, or chemical research in order to minimize suchrisks, and

(3)Who is responsible for the safety
assessments and clearances related to the procurement, storage, use, and disposal ofthe chemical substance as may be appropriate or required within the scope ofconducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or otherindividuals, as long as each meets the criteria in paragraph (1) ofthis definition.

Testmarketingmeans the distribution in commerce ofno more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by

a manufacturer orprocessor to no more than a defined number ofpotential
customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution ofthat chemical substance, mixture, or article in

commerce.

UnitedStates,when used in the geographic sense, means all ofthe States, territories, andpossessions ofthe United States.

§710.4 [Amended]

g. Section 710.4 is amended as follows:

i. Inparagraphs (a), (c)(1), (c)(2), (c)(3), and the Note at the end of paragraph (d)(8), change the references
to "§ 710.2", "§ 710.2(h)", "§ 710.2(q)", "§ 710.2(y)", and "§ 710.2(n)", respectively to "§ 710.3(d)".

ii. In paragraph (b)(2), change "shall"
to "will".

iii. Inthe Note toparagraph (d)(2), change "premanufacturing" to "premanufacture".

iv. In paragraph (d)(5), change "photographic, films" to "photographic films".

h. Sections 710.25 through 710.39 are designated as subpart B andthe subpart heading is added to read as follows:
Subpart B-2002 Inventory Update Reporting

i. Add §710.23 to subpart B toread

as follows:
§710.23 Definitions.

In addition to the definitions in §704.3 ofthis chapter and §710.3, the following definitions also apply to subpart B ofthis part.

MasterInventoryFilemeans EPA's comprehensive list ofchemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) ofthe Act. Itincludes substances reported under subpart A ofthis part and substances reported under part 720 ofthis chapter for which a Notice ofCommencement of Manufacture or Import has been received under §720.120 ofthis chapter.

Non-isolatedintermediatemeans any intermediate that is not intentionally removed from the equipment in which itismanufactured, including the reaction vessel in which itis manufactured, equipment which is ancillary to the reaction vessel, and any equipment throughwhich the substance
passes during a continuous flow
process, but not including tanks or other vessels in which the substance is stored after its manufacture. 

### 889

HeinOnline -- 68 Fed. Reg. 889 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

Site-limitedmeans a chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as

a substance oras part of a mixture or article outside the site. Imported substances are never site-limited.

§710.39 [Amended]

j. Section 710.39 is amended as follows:

i. Revise the sectionheading to read "How do I submit the required information?"

ii. In paragraph (a), the second
sentence is revised to read: "Copies of the Form U are available from EPA at the address set forth in paragraph (c) of this section and from the EPA Internet Home Page at http://www.epa.gov/oppt/ iur/iur02/index.htm."

iii. In the introductory text of paragraph (c), change "1994" to "1998".

iv. In paragraph (c)(1), insert a period after "554-1404" and remove the remainder ofthe sentence.

v. In paragraph (c)(3), change "7408,"
to "7408M,".

vi. In paragraph (d), change "Document Control Officer" to "OPPT Document Control Officer" and change "7407," to "7407M,".

k. Add a new subpart C toread as follows:
Subpart C-Inventory Update Reporting for 2006 and Beyond
§710.43 Definitions.

In addition tothe definitions in §704.3 ofthis chapter and §710.3, the following definitions also apply to subpart C ofthis part:

Commercialusemeans the use ofa chemical substance or mixture in a commercial enterprise providing saleable goods or services (e.g., dry cleaning establishment, painting contractor).

Consumerusemeans the use of a chemical substance that is directly, or as part ofa mixture, soldto or made available to consumers for their use in

oraround apermanent or temporary household or residence, in or around a school, orin or around recreational

areas.

Industrialusemeans use ata site at which one or more chemical substances

ormixtures are manufactured (including imported) or processed.

Intended foruse by childrenmeans the chemical substance or mixture is used in or on a product thatis specifically intended for use by children age 14 oryounger. A chemical substance

ormixture is intended for use by children when the submitter answers "yes" to at least one ofthe following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1)Isthe product commonly recognized (i.e., by a reasonable person)

asbeing intended for children age 14 or younger? (2)Does the manufacturer ofthe product state through product labeling

or otherwritten materials that the product is intended for orwill be used by children age 14 or younger? (3)Isthe advertising, promotion, or marketing ofthe product aimed at children age 14 or younger?

Known to orreasonablyascertainable bymeans allinformation in a person's possession or control, plus all information that areasonable person similarly situated might be expected to possess, control, or know.

MasterInventoryFilemeans EPA's comprehensive list ofchemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) ofthe Act. It includes substances reported under subpart A ofthis part and substances reported under part 720 ofthis chapter for which a Notice ofCommencement of Manufacture orImport has been received under §720.120 ofthis chapter.

Non-isolatedintermediatemeans any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment throughwhich the substance
passes during acontinuous flow
process, but not including tanks orother vessels in which the substance is stored after its manufacture.

Readily obtainableinformationmeans information which is knownby management and supervisory employees ofthe submitter company who are responsible for manufacturing, processing, distributing, technical services, andmarketing ofthe reportable chemical substance. Extensive file searches are not required.

Reasonablylikelytobe exposed

means an exposure to a chemical substance which, under foreseeable conditions ofmanufacture (including import), processing, distribution in
commerce, or use ofthe chemical substance, ismore likely to occur than
not to occur. Such exposures would normally include, but would not be limited to, activities such as charging
reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling and transfers, and analytical operations. Covered exposures include exposures through any route ofentry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental ortheoretical
exposures.

Repackagingmeans the physical transfer ofa chemical substance or mixture, as is, from one container to another container or containers in preparation for distribution ofthe chemical substance ormixture in

commerce.

Reportablechemicalsubstancemeans

a chemical substance described in §710.45.

Reportingyearmeans the calendar
year in which information to be reported to EPA during an IUR submission period is generated, i.e., calendar year 2005 and the calendar
year at 4-year intervals thereafter. Site-limitedmeans a chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes as

a substance or aspart ofa mixture or article outside the site. Imported substances are never site-limited. Although a site-limited chemical substance is not distributed for commercial purposes outside the site at which it is manufactured and processed, the substance is considered to have been manufactured and processed for commercial purposes.

Submissionperiodmeans the period in which the information generated during the reporting year is submitted to EPA.

Usemeans any utilization ofa chemical substance ormixture that is
not otherwise covered by the terms manufactureorprocess.Relabeling or redistributing a container holding a chemical substance ormixture where no repackaging ofthe chemical substance

or mixture occurs does not constitute

use or processing ofthe chemical substance or mixture. 

### §710.45 Chemical substances forwhich information must be reported.

Any chemical substance which is in the Master Inventory File atthe beginning of a submission period described in §710.53, unless the chemical substance is specifically excluded by §710.46. 

### §710.46 Chemical substances forwhich information isnot required.

The following groups or categories of chemical substances are exempted from

some or all ofthe reporting requirements ofthis subpart, with the following exception: A chemical substance described in paragraph (a)(1), (a)(2), or (a)(4), or (b) ofthis section is
not exempted from any ofthe reporting requirements ofthis subpart ifthat substance is the subject of arule 

### 890

HeinOnline -- 68 Fed. Reg. 890 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 891

proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 ofthe Act, oris the subject of an order issued under section 5(e) or 5(f) ofthe Act, or isthe subject ofreliefthat has been granted under a civil action under section 5or 7ofthe Act.

(a)Fullexemptions. The following categories ofchemical substances are exempted from the reporting requirements ofthis subpart. (1)Polymers.(i) Any chemical substance described with the word fragments "*polym*", "*alkyd", or "*oxylated" in the Chemical Abstracts Service Index or Preferred Nomenclature in the Chemical Substance Identities section ofthe 1985 edition ofthe Inventory or in the Master Inventory File, where the asterisk (*) indicates that any sets ofcharacters may precede, or follow, the character string defined.

(ii)Any chemical substance which is identified in the 1985 edition ofthe Inventory or the Master Inventory File

as siloxane and silicone, silsesquioxane,

aprotein (albumin, casein, gelatin, gluten, hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), rubber, orlignin. (iii)This exclusion does not apply to

apolymeric substance thathas been hydrolyzed, depolymerized, or otherwise chemically modified, except in cases where the intended product of this reaction is totally polymeric in
structure.

(2)Microorganisms. Any combination ofchemical substances that is a living organism, andthat meets the definition of"microorganism" at §725.3 ofthis chapter. Any chemical substance produced from aliving microorganism is reportable under this subpart unless otherwise excluded.

(3)Naturallyoccurringchemical substances.Any naturally occurring chemical substance, as described in §710.4(b). The applicability ofthis exclusion is determined in each case by the specific activities ofthe person who manufactures the substance in question. Some chemical substances can be manufactured both as described in §710.4(b) and bymeans other than those described in §710.4(b). Ifa person described in §710.48 manufactures a chemical substance by means other than those described in §710.4(b), the person must report regardless ofwhether the substance also could have been produced as described in §710.4(b). Any chemical substance that is produced from such anaturally occurring chemical substance described in §710.4(b) is reportable unless otherwise excluded.

(4) Certain forms ofnaturalgas. Chemical substances withthe following Chemical Abstract Service (CAS) Registry Numbers: CAS No. 64741-48- 6, Natural gas (petroleum), raw liquid mix; CAS No. 68919-39-1, Natural gas condensates; CAS No. 8006-61-9, Gasoline natural; CAS No. 68425-31-0, Gasoline (natural gas), natural; CAS No. 8006-14-2, Natural gas; and CAS No. 68410-63-9, Natural gas, dried.

(b)Partial exemptions. The following
groups ofchemical substances are partially exempted from the reporting requirements ofthis subpart (i.e., the information described in §710.52(c)(4) need not be reported for these substances). Such chemical substances

are not excluded from the other reporting requirements under this subpart. Achemical substance described in paragraph (b)(3) ofthis section qualifies for a partial reporting exemption during the 2006 submission period; in subsequent submission periods, the chemical substances described in paragraph (b)(3) ofthis section willbe subject to full reporting underthis subpart (i.e., all ofthe information described in this subpart
mustbe reported), unless otherwise exempted.

(1)Petroleumprocessstreams.EPA has designated the following chemical substances, listed by CAS Number, as partially exempt from reporting under the IUR.



### CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING

CAS No.

7732-18-5

............... 8002-05-9

............... 8002-74-2

............... 8006-20-0

............... 8008-20-6

............... 8009-03-8

............... 8012-95-1

............... 8030-30-6

............... 8032-32-4

............... 8042-47-5

............... 8052-41-3

............... 8052-42-4

............... 63231-60-7

............. 64741-41-9

............. 64741-42-0

............. 64741-43-1

............. 64741-44-2

............. 64741-45-3

............. 64741-46-4

............. 64741-47-5

............. 64741-49-7

............. 64741-50-0

............. 64741-51-1

............. 64741-52-2

............. 64741-53-3

............. 64741-54-4

............. 64741-55-5

............. 64741-56-6

............. 64741-57-7

............. 64741-58-8

............. 64741-59-9

............. Product


### Water Petroleum Paraffin waxes and hydrocarbon waxes Fuel gases, low and medium B.T.U. Kerosine (petroleum) Petrolatum Paraffin oils Naphtha Ligroine White mineral oil (petroleum) Stoddard solvent Asphalt Paraffin waxes and hydrocarbon waxes, microcryst. Naphtha (petroleum), heavy straight-run Naphtha (petroleum), full-range straight-run Gas oils (petroleum), straight-run Distillates (petroleum), straight-run middle Residues (petroleum), atm. tower Naphtha (petroleum), light straight-run Natural gas condensates (petroleum) Condensates (petroleum), vacuum tower Distillates (petroleum), light paraffinic Distillates (petroleum), heavy paraffinic Distillates (petroleum), light naphthenic Distillates (petroleum), heavy naphthenic Naphtha (petroleum), heavy catalytic cracked Naphtha (petroleum), light catalyticcracked Residues (petroleum), vacuum Gas oils (petroleum), heavyvacuum Gas oils (petroleum), light vacuum Distillates (petroleum), light catalytic cracked

HeinOnline -- 68 Fed. Reg. 891 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

64741-60-2

............. 64741-61-3

............. 64741-62-4

............. 64741-63-5

............. 64741-64-6

............. 64741-65-7

............. 64741-66-8

............. 64741-67-9

............. 64741-68-0

............. 64741-69-1

............. 64741-70-4

............. 64741-73-7

............. 64741-74-8

............. 64741-75-9

............. 64741-76-0

............. 64741-77-1

............. 64741-78-2

............. 64741-79-3

............. 64741-80-6

............. 64741-81-7

............. 64741-82-8

............. 64741-83-9

............. 64741-84-0

............. 64741-85-1

............. 64741-86-2

............. 64741-87-3

............. 64741-88-4

............. 64741-89-5

............. 64741-90-8

............. 64741-91-9

............. 64741-92-0

............. 64741-95-3

............. 64741-96-4

............. 64741-97-5

............. 64741-98-6

............. 64741-99-7

............. 64742-01-4

............. 64742-03-6

............. 64742-04-7

............. 64742-05-8

............. 64742-06-9

............. 64742-07-0

............. 64742-08-1

............. 64742-09-2

............. 64742-10-5

............. 64742-11-6

............. 64742-12-7

............. 64742-13-8

............. 64742-14-9

............. 64742-15-0

............. 64742-16-1

............. 64742-18-3

............. 64742-19-4

............. 64742-20-7

............. 64742-21-8

............. 64742-22-9

............. 64742-23-0

............. 64742-24-1

............. 64742-25-2

............. 64742-26-3

............. 64742-27-4

............. 64742-28-5

............. 64742-29-6

............. 64742-30-9

............. 64742-31-0

............. 64742-32-1

............. 64742-33-2

............. 64742-34-3

............. 64742-35-4

............. 64742-36-5

............. 64742-37-6

............. Product

Distillates (petroleum), intermediate catalytic cracked Distillates (petroleum), heavy catalytic cracked Clarified oils (petroleum), catalytic cracked Naphtha (petroleum), light catalytic reformed Naphtha (petroleum), full-range alkylate Naphtha (petroleum), heavy alkylate Naphtha (petroleum), light alkylate Residues (petroleum), catalytic reformer fractionator Naphtha (petroleum), heavy catalytic reformed Naphtha (petroleum), light hydrocracked Naphtha (petroleum), isomerization Distillates (petroleum), alkylate Naphtha (petroleum), light thermal cracked Residues (petroleum), hydrocracked Distillates (petroleum), heavy hydrocracked Distillates (petroleum), light hydrocracked Naphtha (petroleum), heavy hydrocracked Coke (petroleum) Residues (petroleum), thermal cracked Distillates (petroleum), heavy thermal cracked Distillates (petroleum), light thermal cracked Naphtha (petroleum), heavy thermal cracked Naphtha (petroleum), solvent-refined light Raffinates (petroleum), sorption process Distillates (petroleum), sweetened middle Naphtha (petroleum), sweetened Distillates (petroleum), solvent-refined heavy paraffinic Distillates (petroleum), solvent-refined light paraffinic Gas oils (petroleum), solvent-refined Distillates (petroleum), solvent-refined middle Naphtha (petroleum), solvent-refined heavy Residual oils (petroleum), solvent deasphalted Distillates (petroleum), solvent-refined heavy naphthenic Distillates (petroleum), solvent-refined light naphthenic Extracts (petroleum), heavy naphtha solvent Extracts (petroleum), light naphtha solvent Residual oils (petroleum), solvent-refined Extracts (petroleum), light naphthenic distillate solvent Extracts (petroleum), heavy paraffinic distillate solvent Extracts (petroleum), light paraffinic distillate solvent Extracts (petroleum), middle distillate solvent Raffinates (petroleum), residual oil decarbonization Raffinates (petroleum), heavy naphthenic distillate decarbonization Raffinates (petroleum), heavy paraffinic distillate decarbonization Extracts (petroleum), residual oil solvent Extracts (petroleum), heavy naphthenic distillate solvent Gas oils (petroleum), acid-treated Distillates (petroleum), acid-treated middle Distillates (petroleum), acid-treated light Naphtha (petroleum), acid-treated Petroleum resins Distillates (petroleum), acid-treated heavy naphthenic Distillates (petroleum), acid-treated light naphthenic Distillates (petroleum), acid-treated heavy paraffinic Distillates (petroleum), acid-treated light paraffinic Naphtha (petroleum), chemically neutralized heavy Naphtha (petroleum), chemically neutralized light Sludges (petroleum), acid Lubricating oils (petroleum), acid-treated spent Hydrocarbon waxes (petroleum), acid-treated Distillates (petroleum), chemically neutralized heavy paraffinic Distillates (petroleum), chemically neutralized light paraffinic Gas oils (petroleum), chemically neutralized Distillates (petroleum), chemically neutralized middle Distillates (petroleum), chemically neutralized light Lubricating oils (petroleum), chemically neutralized spent Hydrocarbon waxes (petroleum), chemically neutralized Distillates (petroleum), chemically neutralized heavy naphthenic Distillates (petroleum), chemically neutralized light naphthenic Distillates (petroleum), clay-treated heavy paraffinic Distillates (petroleum), clay-treated light paraffinic 

### i 892

HeinOnline -- 68 Fed. Reg. 892 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

64742-38-7

............. 64742-39-8

............. 64742-40-1

............. 64742-41-2

............. 64742-42-3

............. 64742-43-4

............. 64742-44-5

............. 64742-45-6

............. 64742-46-7

............. 64742-47-8

............. 64742-48-9

............. 64742-49-0

............. 64742-50-3

............. 64742-51-4

............. 64742-52-5

............. 64742-53-6

............. 64742-54-7

............. 64742-55-8

............. 64742-56-9

............. 64742-57-0

............. 64742-58-1

............. 64742-59-2

............. 64742-60-5

............. 64742-61-6

............. 64742-62-7

............. 64742-63-8

............. 64742-64-9

............. 64742-65-0

............. 64742-67-2

............. 64742-68-3

............. 64742-69-4

............. 64742-70-7

............. 64742-71-8

............. 64742-72-9

............. 64742-73-0

............. 64742-75-2

............. 64742-76-3

............. 64742-78-5

............. 64742-79-6

............. 64742-80-9

............. 64742-81-0

............. 64742-82-1

............. 64742-83-2

............. 64742-85-4

............. 64742-86-5

............. 64742-87-6

............. 64742-88-7

............. 64742-89-8

............. 64742-90-1

............. 64742-91-2

............. 64742-92-3

............. 64742-93-4

............. 64742-94-5

............. 64742-95-6

............. 64742-96-7

............. 64742-97-8

............. 64742-98-9

............. 64742-99-0

............. 64743-00-6

............. 64743-01-7

............. 64743-02-8

............. 64743-03-9

............. 64743-04-0

............. 64743-05-1

............. 64743-06-2

............. 64743-07-3

............. 64754-89-8

............. 64771-71-7

............. 64771-72-8

............. 67674-12-8

............. 67674-13-9

............. Product

Distillates (petroleum), clay-treated middle Neutralizing agents (petroleum), spent sodium carbonate Neutralizing agents (petroleum), spent sodium hydroxide Residual oils (petroleum), clay-treated Hydrocarbon waxes (petroleum), clay-treated microcryst. Paraffin waxes (petroleum), clay-treated Distillates (petroleum), clay-treated heavy naphthenic Distillates (petroleum), clay-treated light naphthenic Distillates (petroleum), hydrotreated middle Distillates (petroleum), hydrotreated light Naphtha (petroleum), hydrotreated heavy Naphtha (petroleum), hydrotreated light Lubricating oils (petroleum), clay-treated spent Paraffin waxes (petroleum), hydrotreated Distillates (petroleum), hydrotreated heavy naphthenic Distillates (petroleum), hydrotreated light naphthenic Distillates (petroleum), hydrotreated heavy paraffinic Distillates (petroleum), hydrotreated light paraffinic Distillates (petroleum), solvent-dewaxed light paraffinic Residual oils (petroleum), hydrotreated Lubricating oils (petroleum), hydrotreated spent Gas oils (petroleum), hydrotreated vacuum Hydrocarbon waxes (petroleum), hydrotreated microcryst. Slack wax (petroleum) Residual oils (petroleum), solvent-dewaxed Distillates (petroleum), solvent-dewaxed heavy naphthenic Distillates (petroleum), solvent-dewaxed light naphthenic Distillates (petroleum), solvent-dewaxed heavy paraffinic Foots oil (petroleum) Naphthenic oils (petroleum), catalytic dewaxed heavy Naphthenic oils (petroleum), catalytic dewaxed light Paraffin oils (petroleum), catalyticdewaxed heavy Paraffin oils (petroleum), catalyticdewaxed light Distillates (petroleum), catalytic dewaxed middle Naphtha (petroleum), hydrodesulfurized light Naphthenic oils (petroleum), complex dewaxed heavy Naphthenic oils (petroleum), complex dewaxed light Residues (petroleum), hydrodesulfurized atmospheric tower Gas oils (petroleum), hydrodesulfurized Distillates (petroleum), hydrodesulfurized middle Kerosine (petroleum), hydrodesulfurized Naphtha (petroleum), hydrodesulfurized heavy Naphtha (petroleum), light steam-cracked Residues (petroleum), hydrodesulfurized vacuum Gas oils (petroleum), hydrodesulfurized heavy vacuum Gas oils (petroleum), hydrodesulfurized light vacuum Solvent naphtha (petroleum), medium aliph. Solvent naphtha (petroleum), light aliph. Residues (petroleum), steam-cracked Distillates (petroleum), steam-cracked Petroleum resins, oxidized Asphalt, oxidized Solvent naphtha (petroleum), heavy arom. Solvent naphtha (petroleum), light arom. Solvent naphtha (petroleum), heavy aliph. Distillates (petroleum), oxidized heavy Distillates (petroleum), oxidized light Residual oils (petroleum), oxidized Hydrocarbon waxes (petroleum), oxidized Petrolatum (petroleum), oxidized Alkenes, C>10 alpha.- Phenols (petroleum) Coke (petroleum), recovery Coke (petroleum), calcined Extracts (petroleum), gas oil solvent Sludges (petroleum), chemically neutralized Naphthenic acids (petroleum), crude Paraffins (petroleum), normal C>10 Paraffins (petroleum), normal C5-20 Residual oils (petroleum), oxidized, compounds with triethanolamine Petrolatum (petroleum), oxidized, partially deacidified 

### i 893

HeinOnline -- 68 Fed. Reg. 893 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

67674-15-1

............. 67674-16-2

............. 67674-17-3

............. 67674-18-4

............. 67891-79-6

............. 67891-80-9

............. 67891-82-1

............. 67891-83-2

............. 67891-85-4

............. 68131-05-5

............. 68131-49-7

............. 68131-75-9

............. 68153-22-0

............. 68187-57-5

............. 68187-58-6

............. 68187-60-0

............. 68307-98-2

............. 68307-99-3

............. 68308-00-9

............. 68308-01-0

............. 68308-02-1

............. 68308-03-2

............. 68308-04-3

............. 68308-05-4

............. 68308-06-5

............. 68308-07-6

............. 68308-08-7

............. 68308-09-8

............. 68308-10-1

............. 68308-11-2

............. 68308-12-3

............. 68308-27-0

............. 68333-22-2

............. 68333-23-3

............. 68333-24-4

............. 68333-25-5

............. 68333-26-6

............. 68333-27-7

............. 68333-28-8

............. 68333-29-9

............. 68333-30-2

............. 68333-81-3

............. 68333-88-0

............. 68334-30-5

............. 68409-99-4

............. 68410-00-4

............. 68410-05-9

............. 68410-12-8

.............
68410-71-9

............. 68410-96-8

............. 68410-97-9

............. 68410-98-0

............. 68411-00-7

............. 68425-29-6

............. 68425-33-2

............. 68425-34-3

............. 68425-35-4

............. 68425-39-8

............. 68441-09-8

............. 68459-78-9

............. 68475-57-0

............. 68475-58-1

............. 68475-59-2

............. 68475-60-5

............. 68475-61-6

............. 68475-70-7

............. 68475-79-6

............. 68475-80-9

............. 68476-26-6

............. 68476-28-8

............. Product

Petrolatum (petroleum), oxidized, Me ester Hydrocarbon waxes (petroleum), oxidized, partially deacidified Distillates (petroleum), oxidized light, compounds with triethanolamine Distillates (petroleum), oxidized light, Bu esters Distillates (petroleum), heavy arom. Distillates (petroleum), light arom. Hydrocarbon waxes (petroleum), oxidized, compounds with ethanolamine Hydrocarbon waxes (petroleum), oxidized, compounds with isopropanolamine Hydrocarbon waxes (petroleum), oxidized, compounds with triisopropanolamine Hydrocarbon oils, process blends Aromatic hydrocarbons, C6-10, acid-treated, neutralized Gases (petroleum), C3-4 Paraffin waxes and Hydrocarbon waxes, oxidized Pitch, coal tar-petroleum Pitch, petroleum, arom. Hydrocarbons, C4, ethane-propane-cracked Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, hydrogen sulfide-free Tail gas (petroleum), cracked distillate hydrotreater stripper Tail gas (petroleum), distn., hydrogen sulfide-free Tail gas (petroleum), gas oil catalytic cracking absorber Tail gas (petroleum), gas recovery plant Tail gas (petroleum), gas recovery plant deethanizer Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized naphtha fractionator, acid-free Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, hydrogen sulfide-free Tail gas (petroleum), isomerized naphtha fractionation stabilizer Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen sulfide-free Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen sulfide-free Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen sulfide-free Fuel gases, refinery Residues (petroleum), atmospheric Naphtha (petroleum), heavy coker Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine Distillates (petroleum), hydrodesulfurized light catalytic cracked Clarified oils (petroleum), hydrodesulfurized catalytic cracked Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked Distillates (petroleum), hydrodesulfurized heavy catalytic cracked Residues (petroleum), light naphtha solvent extracts Distillates (petroleum), oxidized heavy thermal cracked Alkanes, C4-12 Aromatic hydrocarbons, C9-17 Fuels, diesel Gases (petroleum), catalytic cracked overheads Distillates (petroleum), crude oil Distillates (petroleum), straight-run light Distillates (petroleum), steam-cracked, C5-10 fraction, high-temp. stripping products with light steamcracked petroleum naphtha C5 fraction polymers Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts. Distillates (petroleum), hydrotreated middle, intermediate boiling Distillates (petroleum), light distillate hydrotreating process, low-boiling Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads Alkenes, C>8 Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending Petrolatum (petroleum), oxidized, barium salt Petrolatum (petroleum), oxidized, calcium salt Raffinates (petroleum), reformer, Lurgi unit-sepd. Alkenes, C>10 alpha.-, oxidized Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. polyethylene, oxidized Alkenes, C18-24 alpha.-, dimers Alkanes, C1-2 Alkanes, C2-3 Alkanes, C3-4 Alkanes, C4-5 Alkenes, C5, naphtha-raffinate pyrolyzate-derived Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived Distillates (petroleum), catalytic reformed depentanizer Distillates (petroleum), light steam-cracked naphtha Fuel gases Fuel gases, C6-8 catalytic reformer 

### i 894

HeinOnline -- 68 Fed. Reg. 894 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 895

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68476-29-9

............. 68476-30-2

............. 68476-31-3

............. 68476-32-4

............. 68476-33-5

............. 68476-34-6

............. 68476-39-1

............. 68476-40-4

............. 68476-42-6

............. 68476-43-7

............. 68476-44-8

............. 68476-45-9

............. 68476-46-0

............. 68476-47-1

............. 68476-49-3

............. 68476-50-6

............. 68476-52-8

............. 68476-53-9

............. 68476-54-0

............. 68476-55-1

............. 68476-56-2

............. 68476-77-7

............. 68476-81-3

............. 68476-84-6

............. 68476-85-7

............. 68476-86-8

............. 68477-25-8

............. 68477-26-9

............. 68477-29-2

............. 68477-30-5

............. 68477-31-6

............. 68477-33-8

............. 68477-34-9

............. 68477-35-0

............. 68477-36-1

............. 68477-38-3

............. 68477-39-4

............. 68477-40-7

............. 68477-41-8

............. 68477-42-9

............. 68477-44-1

............. 68477-47-4

............. 68477-48-5

............. 68477-53-2

............. 68477-54-3

............. 68477-55-4

.............

68477-58-7

............. 68477-59-8

............. 68477-60-1

............. 68477-61-2

............. 68477-62-3

............. 68477-63-4

............. 68477-64-5

............. 68477-65-6

............. 68477-66-7

............. 68477-67-8

............. 68477-68-9

............. 68477-69-0

............. 68477-70-3

............. 68477-71-4

............. 68477-72-5

............. 68477-73-6

............. 68477-74-7

............. 68477-75-8

............. 68477-76-9

............. 68477-77-0

............. 68477-79-2

............. 68477-80-5

............. 68477-81-6

............. 68477-82-7

............. Product

Fuel gases, crude oil distillates Fuel oil, no. 2 Fuel oil, no. 4 Fuel oil, residues-straight-run gas oils, high-sulfur Fuel oil, residual Fuels, diesel, no. 2 Hydrocarbons, aliph.-arom.-C4-5-olefinic Hydrocarbons, C3-4 Hydrocarbons, C4-5 Hydrocarbons, C4-6, C5-rich Hydrocarbons, C>3 Hydrocarbons, C5-10 arom. conc., ethylene-manuf.-by-product Hydrocarbons, C3-11, catalytic cracker distillates Hydrocarbons, C2-6, C6-8 catalytic reformer Hydrocarbons, C2-4, C3-rich Hydrocarbons, C_>5, C5-6-rich Hydrocarbons, C4, ethylene-manuf.-by-product Hydrocarbons, C>20, petroleum wastes Hydrocarbons, C3-5, polymn. unit feed Hydrocarbons, C5-rich Hydrocarbons, cyclic C5 and C6 Lubricating oils, refined used Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts Petroleum products, gases, inorg. Petroleum gases, liquefied Petroleum gases, liquefied, sweetened Waste gases, vent gas, C1-6 Wastes, petroleum Distillates (petroleum), catalytic reformer fractionator residue, high-boiling Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling Distillates (petroleum), catalytic reformer fractionator residue, low-boiling Gases (petroleum), C3-4, isobutane-rich Distillates (petroleum), C3-5, 2-methyl-2-butene-rich Distillates (petroleum), C3-6, piperylene-rich Distillates (petroleum), cracked steam-cracked, C5-18 fraction Distillates (petroleum), cracked steam-cracked petroleum distillates Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction Gases (petroleum), extractive, C3-5, butadiene-butene-rich Gases (petroleum), extractive, C3-5, butene-isobutylene-rich Distillates (petroleum), heavy naphthenic, mixed with steam-cracked petroleum distillates C5-12 fraction Distillates (petroleum), mixed heavy olefin vacuum, heart-cut Distillates (petroleum), mixed heavy olefin vacuum, low-boiling Distillates (petroleum), steam-cracked, C5-12 fraction Distillates (petroleum), steam-cracked, C8-12 fraction Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha

C5 fraction Distillates (petroleum), steam-cracked petroleum distillates, C5-18 fraction Distillates (petroleum), steam-cracked petroleum distillates cyclopentadiene conc. Extracts (petroleum), cold-acid Extracts (petroleum), cold-acid, C4-6 Extracts (petroleum), cold-acid, C3-5, butene-rich Extracts (petroleum), reformer recycle Gases (petroleum), acetylene manuf. off Gases (petroleum), amine system feed Gases (petroleum), benzene unit hydrodesulfurizer off Gases (petroleum), benzene unit recycle, hydrogen-rich Gases (petroleum), blend oil, hydrogen-nitrogen-rich Gases (petroleum), butane splitter overheads Gases (petroleum), C2-3 Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3-5-rich Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-rich acid-free Gases (petroleum), catalytic cracker Gases (petroleum), catalytic cracker, C1-5-rich Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2-4-rich Gases (petroleum), catalytic reformed naphtha stripper overheads Gases (petroleum), catalytic reformer, C1-4-rich Gases (petroleum), C6-8 catalytic reformer recycle Gases (petroleum), C6-8 catalytic reformer Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich 

### i

HeinOnline -- 68 Fed. Reg. 895 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68477-83-8

............. 68477-84-9

............. 68477-85-0

............. 68477-86-1

............. 68477-87-2

............. 68477-88-3

............. 68477-89-4

............. 68477-90-7

............. 68477-91-8

............. 68477-92-9

............. 68477-93-0

............. 68477-94-1

............. 68477-95-2

............. 68477-96-3

............. 68477-97-4

............. 68478-00-2

............. 68478-01-3

............. 68478-02-4

............. 68478-03-5

............. 68478-04-6

............. 68478-05-7

............. 68478-08-0

............. 68478-10-4

............. 68478-12-6

............. 68478-13-7

............. 68478-15-9

............. 68478-16-0

............. 68478-17-1

............. 68478-18-2

............. 68478-19-3

............. 68478-20-6

.............

68478-22-8

............. 68478-24-0

............. 68478-25-1

............. 68478-26-2

............. 68478-27-3

............. 68478-28-4

............. 68478-29-5

............. 68478-30-8

............. 68478-32-0

............. 68478-33-1

............. 68478-34-2

............. 68512-61-8

............. 68512-62-9

............. 68512-78-7

............. 68512-91-4

............. 68513-02-0

............. 68513-11-1

............. 68513-12-2

............. 68513-13-3

............. 68513-14-4

............. 68513-15-5

............. 68513-16-6

............. 68513-17-7

............. 68513-18-8

............. 68513-19-9

............. 68513-62-2

............. 68513-63-3

............. 68513-65-5

............. 68513-66-6

............. 68513-67-7

............. 68513-68-8

............. 68513-69-9

............. 68513-74-6

............. 68514-15-8

............. 68514-29-4

............. 68514-31-8

............. 68514-32-9

............. 68514-33-0

............. 68514-34-1

............. Product

Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed Gases (petroleum), C2-return stream Gases (petroleum), C4-rich Gases (petroleum), deethanizer overheads Gases (petroleum), deisobutanizer tower overheads Gases (petroleum), deethanizer overheads, C3-rich Distillates (petroleum), depentanizer overheads Gases (petroleum), depropanizer dry, propene-rich Gases (petroleum), depropanizer overheads Gases (petroleum), dry sour, gas-concn.-unit-off Gases (petroleum), gas concn. reabsorber distn. Gases (petroleum), gas recovery plant depropanizer overheads Gases (petroleum), Girbatol unit feed Gases (petroleum), hydrogen absorber off Gases (petroleum), hydrogen-rich Gases (petroleum), recycle, hydrogen-rich Gases (petroleum), reformer make-up, hydrogen-rich Gases (petroleum), reforming hydrotreater Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich Gases (petroleum), thermal cracking distn. Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc. Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene conc. Residues (petroleum), butane splitter bottoms Residues (petroleum), catalytic reformer fractionator residue distn. Residues (petroleum), C6-8 catalytic reformer Residual oils (petroleum), deisobutanizer tower Residues (petroleum), heavy coker gas oil and vacuum gas oil Residues (petroleum), heavy olefin vacuum Residual oils (petroleum), propene purifn. splitter Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadienefree Tail gas (petroleum), catalytic cracked naphtha stabilization absorber Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurizer combined fractionater Tail gas (petroleum), catalytic cracker refractionation absorber Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer Tail gas (petroleum), catalytic reformed naphtha separator Tail gas (petroleum), catalytic reformed naphtha stabilizer Tail gas (petroleum), cracked distillate hydrotreater separator Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator Tail gas (petroleum), saturate gas plant mixed stream, C4-rich Tail gas (petroleum), saturate gas recovery plant, C1-2-rich Tail gas (petroleum), vacuum residues thermal cracker Residues (petroleum), heavy coker and light vacuum Residues (petroleum), light vacuum Solvent naphtha (petroleum), light arom., hydrotreated Hydrocarbons, C3-4-rich, petroleum distillates Naphtha (petroleum), full-range coker Fuel gases, hydrotreater fractionation, scrubbed Fuel gases, saturate gas unit fractionater-absorber overheads Fuel gases, thermal cracked catalytic cracking residue Gases (petroleum), catalytic reformed straight-run naphtha stabilizer overheads Gases (petroleum), full-range straight-run naphtha dehexanizer off Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich Gases (petroleum), light straight-run naphtha stabilizer off Gases (petroleum), reformer effluent high-pressure flash drum off Gases (petroleum), reformer effluent low-pressure flash drum off Disulfides, C5-12-alkyl Distillates (petroleum), catalytic reformed straight-run naphtha overheads Butane, branched and linear Residues (petroleum), alkylation splitter, C4-rich Residues (petroleum), cyclooctadiene bottoms Residues (petroleum), deethanizer tower Residues (petroleum), steam-cracked light Waste gases, ethylene oxide absorber-reactor Gasoline, vapor-recovery Hydrocarbons, amylene feed debutanizer overheads nonextractable raffinates Hydrocarbons, C1-4 Hydrocarbons, C10 and C12, olefin-rich Hydrocarbons, C12 and C14, olefin-rich Hydrocarbons, C9-14, ethylene-manuf.-by-product 

### i 896

HeinOnline -- 68 Fed. Reg. 896 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 897

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68514-35-2

............. 68514-38-5

............. 68514-36-3

............. 68514-37-4

............. 68514-79-4

............. 68515-25-3

............. 68515-26-4

............. 68515-27-5

............. 68515-28-6

............. 68515-29-7

............. 68515-30-0

............. 68515-32-2

............. 68515-33-3

............. 68515-34-4

............. 68515-35-5

............. 68515-36-6

............. 68516-20-1

............. 68526-52-3

............. 68526-53-4

............. 68526-54-5

............. 68526-55-6

............. 68526-56-7

............. 68526-57-8

............. 68526-58-9

............. 68526-77-2

............. 68526-99-8

............. 68527-00-4

............. 68527-11-7

............. 68527-13-9

............. 68527-14-0

............. 68527-15-1

............. 68527-16-2

............. 68527-18-4

............. 68527-19-5

............. 68527-21-9

............. 68527-22-0

............. 68527-23-1

............. 68527-26-4

............. 68527-27-5

............. 68553-00-4

............. 68553-14-0

............. 68602-79-9

............. 68602-81-3

............. 68602-82-4

............. 68602-83-5

............. 68602-84-6

............. 68602-96-0

............. 68602-97-1

............. 68602-98-2

............. 68602-99-3

............. 68603-00-9

............. 68603-01-0

............. 68603-02-1

............. 68603-03-2

............. 68603-08-7

............. 68603-09-8

............. 68603-10-1

............. 68603-11-2

............. 68603-12-3

............. 68603-13-4

............. 68603-14-5

............. 68603-31-6

............. 68603-32-7

............. 68606-09-7

............. 68606-10-0

............. 68606-11-1

............. 68606-24-6

............. 68606-25-7

............. 68606-26-8

............. 68606-27-9

............. 68606-28-0

............. Product
Hydrocarbons, C14-30, olefin-rich Hydrocarbons, C4-10-unsatd. Hydrocarbons, C1-4, sweetened Hydrocarbons, C4-5-unsatd. Petroleum products, hydrofiner-powerformer reformates Benzene, C1-9-alkyl derivs. Benzene, di-C12-14-alkyl derivs. Benzene, di-C10-14-alkyl derivs., fractionation overheads, heavy ends Benzene, di-C1 0-14-alkyl derivs., fractionation overheads, light ends Benzene, di-C10-14-alkyl derivs., fractionation overheads, middle cut Benzene, mono-C20-48-alkyl derivs. Benzene, mono-C12-14-alkyl derivs., fractionation bottoms Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, heavy ends Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, heavy ends Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, light ends Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, light ends Naphtha (petroleum), steam-cracked middle arom. Alkenes, C6 Alkenes, C6-8, C7-rich Alkenes, C7-9, C8-rich Alkenes, C8-10, C9-rich Alkenes, C9-11, C10-rich Alkenes, C10-12, C11-rich Alkenes, C11-13, C12-rich Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum Alkenes, C6-9 alpha.- Alkenes, C8-9 alpha.- Alkenes, C5 Gases (petroleum), acid, ethanolamine scrubber Gases (petroleum), methane-rich off Gases (petroleum), oil refinery gas distn. off Hydrocarbons, C1-3 Gas oils (petroleum), steam-cracked Hydrocarbons, C1-4, debutanizer fraction Naphtha (petroleum), clay-treated full-range straight-run Naphtha (petroleum), clay-treated light straight-run Naphtha (petroleum), light steam-cracked arom. Naphtha (petroleum), light steam-cracked, debenzenized Naphtha (petroleum), full-range alkylate, butane-contg. Fuel oil, no. 6 Hydrocarbons, C8-11 Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads Distillates, hydrocarbon resin prodn. higher boiling Gases (petroleum), benzene unit hydrotreater depentenizer overheads Gases (petroleum), C1-5, wet Gases (petroleum), secondary absorber off, fluidized catalytic cracker overheads fractionater Distillates (petroleum), oxidized light, strong acid components, compds. with diethanolamine Distillates (petroleum), oxidized light, strong acid components, sodium salts Distillates (petroleum), oxidized light, strong acid components Distillates (petroleum), oxidized light, strong acid-free Distillates (petroleum), thermal cracked naphtha and gas oil Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg. Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized Distillates (petroleum), thermal cracked naphtha and gas oil, extractive Naphtha (petroleum), arom.-contg. Hydrocarbon waxes (petroleum), oxidized, calcium salts Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts Petrolatum (petroleum), oxidized, esterwith sorbitol Residual oils (petroleum), oxidized, calcium salts Alkenes, C10, tert-amylene concentrator by-product Alkenes, C15-20 alpha.-, isomerized Fuel gases, expander off Gasoline, pyrolysis, debutanizer bottoms Gasoline, straight-run, topping-plant Hydrocarbons, C4, butene concentrator by-product Hydrocarbons, C2-4 Hydrocarbons, C3 Gases (petroleum), alkylation feed Hydrocarbons, C5 and C10-aliph. and C6-8-arom. 

### i

HeinOnline -- 68 Fed. Reg. 897 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68606-31-5

............. 68606-34-8

............. 68606-36-0

............. 68607-11-4

............. 68607-30-7

............. 68608-56-0

............. 68647-60-9

............. 68647-61-0

............. 68647-62-1

............. 68650-36-2

............. 68650-37-3

............. 68782-97-8

............. 68782-98-9

............. 68782-99-0

............. 68783-00-6

............. 68783-01-7

............. 68783-02-8

............. 68783-04-0

............. 68783-05-1

............. 68783-06-2

............. 68783-07-3

............. 68783-08-4

............. 68783-09-5

............. 68783-12-0

............. 68783-13-1

............. 68783-15-3

............. 68783-61-9

............. 68783-62-0

............. 68783-64-2

............. 68783-65-3

............. 68783-66-4

............. 68814-47-1

............. 68814-67-5

............. 68814-89-1

............. 68814-87-9

............. 68814-90-4

............. 68814-91-5

............. 68855-57-2

............. 68855-58-3

............. 68855-59-4

............. 68855-60-7

............. 68911-58-0

............. 68911-59-1

............. 68915-96-8

............. 68915-97-9

............. 68918-69-4

............. 68918-73-0

............. 68918-93-4

............. 68918-98-9

............. 68918-99-0

............. 68919-00-6

............. 68919-01-7

............. 68919-02-8

............. 68919-03-9

............. 68919-04-0

............. 68919-05-1

............. 68919-06-2

............. 68919-07-3

............. 68919-08-4

............. 68919-09-5

............. 68919-10-8

............. 68919-11-9

............. 68919-12-0

............. 68919-15-3

............. 68919-17-5

............. 68919-19-7

............. 68919-20-0

............. 68919-37-9

............. 68920-06-9

............. 68920-07-0

............. 68920-64-9

............. Product
Hydrocarbons, C3-5, butadiene purifn. by-product Gases (petroleum), depropanizer bottoms fractionation off Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product Petroleum products, refinery gases Residues (petroleum), topping plant, low-sulfur Waste gases, from carbon black manuf. Hydrocarbons, C>4 Hydrocarbons, C4-5, tert-amylene concentrator by-product Hydrocarbons, C4-5, butene concentrator by-product, sour Aromatic hydrocarbons, C8, o-xylene-lean Paraffin waxes (petroleum), oxidized, sodium salts Distillates (petroleum), hydrofined lubricating-oil Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg. Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-contg. Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc. Extracts (petroleum), intermediate clarified oil solvent, condensed-ring-arom.-contg. Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent Gases (petroleum), ammonia-hydrogen sulfide, water-satd. Gases (petroleum), hydrocracking low-pressure separator Gases (petroleum), refinery blend Gas oils (petroleum), heavy atmospheric Naphtha (petroleum), catalytic cracked light distd. Naphtha (petroleum), unsweetened Residues (petroleum), coker scrubber, condensed-ring-arom.-contg. Alkenes, C6-7 alpha.- Fuel gases, refinery, sweetened Fuel gases, refinery, unsweetened Gases (petroleum), catalytic cracking Gases (petroleum), C2-4, sweetened Naphtha (petroleum), light, sweetened Waste gases, refinery vent Gases (petroleum), refinery Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted Distillates (petroleum), full-range straight-run middle Gases (petroleum), platformer products separator off Alkenes, C5-9 alpha.- Alkenes, C6-12 alpha.- Alkenes, C10-16 alpha.- Alkenes, C14-18 alpha.- Alkenes, C14-20 alpha.- Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off Gases (petroleum), hydrotreated sour kerosine flash drum Distillates (petroleum), heavy straight-run Gas oils (petroleum), straight-run, high-boiling Petrolatum (petroleum), oxidized, zinc salt Residues (petroleum), clay-treating filter wash Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts Fuel gases, refinery, hydrogen sulfide-free Gases (petroleum), crude oil fractionation off Gases (petroleum), dehexanizer off Gases (petroleum), distillate unifiner desulfurization stripper off Gases (petroleum), fluidized catalytic cracker fractionation off Gases (petroleum), fluidized catalytic cracker scrubbing secondary absorber off Gases (petroleum), heavy distillate hydrotreater desulfurization stripper off Gases (petroleum), light straight run gasoline fractionation stabilizer off Gases (petroleum), naphtha unifiner desulfurization stripper off Gases (petroleum), platformer stabilizer off, light ends fractionation Gases (petroleum), preflash tower off, crude distn. Gases (petroleum), straight-run naphtha catalytic reforming off Gases (petroleum), straight-run stabilizer off Gases (petroleum), tar stripper off Gases (petroleum), unifiner stripper off Hydrocarbons, C6-12, benzene-recovery Hydrocarbons, C12-20, catalytic alkylation by-products Gases (petroleum), fluidized catalytic cracker splitter residues Gases (petroleum), fluidized catalytic cracker splitter overheads Naphtha (petroleum), full-range reformed Hydrocarbons, C7-9 Hydrocarbons, C<10-linear Disulfides, di-Cl-2-alkyl 

### i 898

HeinOnline -- 68 Fed. Reg. 898 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68921-07-3

............. 68921-09-5

............. 68921-08-4

............. 68921-67-5

............. 68952-76-1

............. 68952-77-2

............. 68952-78-3

............. 68952-79-4

............. 68952-80-7

............. 68952-81-8

............. 68952-82-9

............. 68953-80-0

............. 68955-27-1

............. 68955-28-2

............. 68955-31-7

............. 68955-32-8

............. 68955-33-9

.............

68955-34-0

............. 68955-35-1

............. 68955-36-2

............. 68955-76-0

............. 68955-96-4

............. 68956-47-8

............. 68956-48-9

............. 68956-52-5

............. 68956-54-7

............. 68956-55-8

............. 68956-70-7

............. 68988-79-4

............. 68988-99-8

............. 68989-88-8

............. 68990-35-2

............. 68991-49-1

............. 68991-50-4

............. 68991-51-5

............. 68991-52-6

............. 69013-21-4

............. 69029-75-0

............. 69430-33-7

............. 70024-88-3

............. 70528-71-1

............. 70528-72-2

............. 70528-73-3

............. 70592-76-6

............. 70592-77-7

............. 70592-78-8

............. 70592-79-9

............. 70693-00-4

............. 70693-06-0

............. 70913-85-8

............. 70913-86-9

............. 70955-08-7

............. 70955-09-8

............. 70955-10-1

............. 70955-17-8

............. 71243-66-8

............. 71302-82-4

............. 71329-37-8

............. 71808-30-5

............. 72230-71-8

............. 72623-83-7

............. 72623-84-8

.............

72623-85-9

............. 72623-86-0

............. 72623-87-1

............. 93762-80-2

............. Product

Distillates (petroleum), hydrotreated light catalytic cracked Distillates (petroleum), naphtha unifiner stripper Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads Hydrocarbons, ethylene-manuf.-by-product distn. residues Gases (petroleum), catalytic cracked naphtha debutanizer Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation stabilizer, hydrogen sulfide-free Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator Tail gas (petroleum), straight-run naphtha hydrodesulfurizer Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking Benzene, mixed with toluene, dealkylation product Distillates (petroleum), petroleum residues vacuum Gases (petroleum), light steam-cracked, butadiene conc. Gases (petroleum), butadiene process, inorg. Natural gas, substitute, steam-reformed desulfurized naphtha Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead

fractionation Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead Naphtha (petroleum), catalytic reformed Residues (petroleum), steam-cracked, resinous Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich Disulfides, dialkyl and di-Ph, naphtha sweetening Fuel oil, isoprene reject absorption Fuel oil, residual, wastewater skimmings Hydrocarbons, C4-8 Hydrocarbons, C4-unsatd. Hydrocarbons, C5-unsatd. Petroleum products, C5-12, reclaimed, wastewater treatment Benzene, C10-12-alkyl derivs., distn. residues Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues Gases (petroleum), crude distn. and catalytic cracking Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich Alkanes, C10-13, arom.-free desulfurized Alkanes, C14-17, arom.-free desulfurized Alkanes, C10-13, desulfurized Alkenes, C10-16 Fuel oil, pyrolysis Oils, reclaimed Hydrocarbons, C6-30 Ethene, thermal cracking products Distillates (petroleum), heavy distillate solvent ext. heart-cut Distillates (petroleum), heavy distillate solvent ext. vacuum overheads Residues (petroleum), heavy distillate solvent ext. vacuum Distillates (petroleum), intermediate vacuum Distillates (petroleum), light vacuum Distillates (petroleum), vacuum Residues (petroleum), atm. tower, light Hydrocarbon waxes (petroleum), oxidized, sodium salts Aromatic hydrocarbons, C9-11 Residues (petroleum), solvent-extd. vacuum distilled atm. residuum Alkanes, C18-70 Alkanes, C4-6 Alkenes, C13-14 alpha.- Alkenes, C15-18 alpha.- Aromatic hydrocarbons, C12-20 Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, potassium salts Hydrocarbons, C5-8, Houdry butadiene manuf. by-product Residues (petroleum), catalytic cracking depropanizer, C4-rich Tail gas (petroleum), thermal cracking absorber Distillates (petroleum), cracked steam-cracked, C5-17 fraction Lubricating oils (petroleum), C>25, hydrotreated bright stock-based Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, contg. solvent deasphalted residual

oil Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based Alkenes, C15-18 

### 899

HeinOnline -- 68 Fed. Reg. 899 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

(2)Specific exemptedchemical substances-(i) Exemption.EPAhas determined that, at this time, the information in §710.52(c)(4) associated with the chemicals listed in paragraph (b)(2)(iv)ofthis section is oflow current interest. (ii) Considerations. In making its determination ofwhether this partial exemption should apply to a particular chemical substance, EPA will consider the totality ofinformation available for the chemical substance in question, including but not limited to, one or

more ofthe following considerations: (A)Whether the chemical qualifies or has qualified in past IUR collections for the reporting ofthe information described in §710.52(c)(4) (i.e., at least

one site manufactures 300,000 pounds

ormore ofthe chemical).

(B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together). (C) The information needs ofEPA, other federal agencies, tribes, states, and local governments, as well as members ofthe public. (D) The availability ofother complementary risk screening information. (E) The availability of comparable processing and use information. (F)Whether the potential risks ofthe chemical substance are adequately managed byEPA or another agency or authority.

(iii)Amendments.EPA may amend the chemical listin paragraph (b)(2)(iv) ofthis section on its own initiative or in response to a request from the public based onEPA's determination of whether the information in §710.52(c)(4) is oflow interest.

(A)Any person may request thatEPA amend the chemical list in paragraph (b)(2)(iv)ofthis section. Your request must be in writing and must be submitted to the address provided in §710.59(d). Requests must identify the chemical in question, as well as its CAS Number or other chemical identification number as identified in §710.52(c)(3)(i). Your request should provide sufficient information for EPA to determine whether collection ofthe information in §710.52(c)(4) for the chemical in question is oflow interest. In preparing
your request, please refer tothe considerations outlined in paragraph (b)(2)(ii)ofthis section. Ifarequest related to a particular chemical is resubmitted, any subsequent request must clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA will issue awritten
response to each request within 120 days ofreceipt ofthe request, andwill maintain copies ofthese responses in a public docket that will be established for each reporting cycle.

(B) As needed, the Agency will initiate rulemaking to make revisions to the list inparagraph (b)(2)(iv)ofthis section.

(C) To assist EPAin reaching a decision regarding a particular request prior to a given reporting year, requests mustbe submitted to EPA nolater than 12 months prior to the start ofthe reporting year, i.e., byJanuary 1, 2004,

orby each January 1 at 4-year intervals thereafter.

(iv)Listofchemicalsubstances.EPA has designated the following chemical substances, listed by CAS Number, as partially exempt from reporting under the IUR.



### CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER §

### 710.46(B)(2)

CAS No.

50-70-4

................... 50-81-7

................... 50-99-7

................... 56-87-1

................... 57-50-1

................... 58-95-7

................... 59-02-9

................... 59-51-8

................... 69-65-8

................... 87-79-6

................... 123-94-4

................. 124-38-9

................. 137-08-6

................. 142-47-2

................. 150-30-1

................. 1317-65-3

............... 1333-74-0

............... 1592-23-0

............... 7440-37-1

............... 7440-44-0

............... 7727-37-9

............... 7782-42-5

............... 7782-44-7

............... 8001-21-6

............... 8001-22-7

............... 8001-23-8

............... 8001-26-1

............... 8001-29-4

............... 8001-30-7

............... 8001-31-8

............... 8001-78-3

............... 8001-79-4

............... 8002-03-7

............... 8002-13-9

............... 8002-43-5

............... 8002-75-3

............... Chemical

D-Glucitol L-Ascorbic acid D-Glucose L-Lysine .alpha.- D-Glucopyranoside, .beta.-D-fructofu ranosyl 2H-1 -Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-, acetate, (2R)- 2H-1 -Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-, (2R)- Methionine D-Mannitol L-Sorbose Octadecanoic acid, 2,3-dihydroxypropyl ester Carbon dioxide .beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-dimethyl-1 -oxobutyl]-, calcium alt (2:1) L-Glutamic acid, monosodium salt Phenylalanine Limestone Hydrogen Octadecanoic acid, calcium salt Argon Carbon Nitrogen Graphite Oxygen Sunflower oil Soybean oil Safflower oil Linseed oil Cottonseed oil Corn oil Coconut oil Castor oil, hydrogenated Castor oil Peanut oil Rape oil Lecithins Palm oil 

### 900

HeinOnline -- 68 Fed. Reg. 900 2003Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 901



### CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER §710.46(B)(2)-Continued

CAS No.

8006-54-0

............... 8016-28-2

............... 8016-70-4

............... 8021-99-6

............... 8029-43-4

............... 9004-53-9

............... 9005-25-8

............... 9050-36-6

............... 11103-57-4

............. 16291-96-6

............. 26836-47-5

............. 61789-44-4

............. 61789-97-7

............. 61789-99-9

............. 64147-40-6

............. 64755-01-7

............. 65996-63-6

............. 65996-64-7

............. 67701-01-3

............. 68002-85-7

............. 68131-37-3

............. 68188-81-8

............. 68308-54-3

............. 68334-00-9

............. 68334-28-1

............. 68409-76-7

............. 68424-45-3

............. 68424-61-3

............. 68425-17-2

............. 68439-86-1

............. 68442-69-3

............. 68476-78-8

............. 68514-27-2

............. 68514-74-9

............. 68525-87-1

............. 68648-86-2

............. 68648-87-3

............. 68918-42-3

............. 68952-94-3

............. 68989-98-0

............. 73138-67-7

............. 129813-58-7

........... 129813-59-8

........... 129813-60-1

........... Chemical

Lanolin Lard, oil Soybean oil, hydrogenated Charcoal, bone 

### Syrups, hydrolyzed starch Dextrin Starch Maltodextrin Vitamin A Charcoal D-Glucitol, monooctadecanoate Fatty acids, castor-oil Tallow Lard 

### Castor oil, dehydrated Fatty acids, tallow, calcium salts 

### Starch, acid-hydrolyzed Starch, enzyme-hydrolyzed Fatty acids, C12-18 Fatty acids, C14-22 and C16-22-unsatd. Syrups, hydrolyzed starch, dehydrated Grease, poultry Glycerides, tallow mono-, di- and tri-, hydrogenated Cottonseed oil, hydrogenated Fats and glyceridic oils, vegetable, hydrogenated Bone meal, steamed Fatty acids, linseed-oil Glycerides, C16-18 and C18-unsatd. mono- and diSyrups, hydrolyzed starch, hydrogenated Bone,ash Benzene, mono-C10-14-alkyl derivs. Molasses Grease, catch basin Palm oil, hydrogenated Corn oil, hydrogenated Benzene, C14-16-alkyl derivs. Benzene, C10-16-alkyl derivs. Soaps, stocks, soya Soaps, stocks, vegetable-oil Fats and glyceridic oils, vegetable, residues Lard, hydrogenated Benzene, mono-C10-13-alkyl derivs. Benzene, mono-C12-14-alkyl derivs. Benzene, mono-C14-16-alkyl derivs.

(3)Inorganicchemicalsubstances. For purposes ofthis subpart, an inorganic chemical substance is any chemical substance which does not contain carbon or contains carbon only in the form ofcarbonato [=CO3], cyano [--CN], cyanato [--OCN], isocyano [--NC],

orisocyanato [--NCO] groups or the chalcogen analogues of such groups. During the 2006 submission period, manufacturers are excluded only from the reporting requirements under §710.52(c)(4) for inorganic chemical substances. During the 2006 submission period, manufacturers ofinorganic chemical substances are not excluded from the other reporting requirements under this part. During submission periods following the 2006 submission period, manufacturers ofinorganic chemical substances are subject to all of the reporting requirements in this subpart.
§710.48 Personswho must report.

Except as provided in § §710.49 and 710.50, the following persons are subject to the requirements ofthis subpart. Persons must determine whether they must report under this section for each chemical substance that they manufacture (including import) at

an individual site.

(a)Personssubjectto recurring reporting.Any person who manufactured (including imported) for commercial purposes 25,000 lbs. (11,340kg) ormore of a chemical substance described in §710.45 at any single site owned or controlled bythat
person at any time during calendar year 2005 or during the calendar year at4- year intervals thereafter is subject to reporting.

(b)Specialprovisions forimporters. Forpurposes ofthis section, the site for

a person who imports a chemical substance described in §710.45 is the site ofthe operating unit withinthe person's organization which is directly responsible forimporting the substance and which controls the import transaction. The import sitemay in

some cases be the organization's headquarters in the United States (see also §710.55(b)). 

### §710.49 Persons notsubjecttothis subpart.

A person described in §710.48 is not subject to the requirements ofthis subpart ifthatperson qualifies as a small manufacturer as that term is defined in §704.3 ofthis chapter. Notwithstanding this exclusion, a

HeinOnline -- 68 Fed. Reg. 901 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject of a ruleproposed or promulgated under section 4, 5(b)(4), or 6 ofthe Act, or is the subject ofan order in effect under section 5(e) ofthe Act,

oris the subject ofreliefthat has been granted under a civil action under section 5or 7ofthe Act. 

### §710.50 Activitiesforwhich reporting is not required.

A person described in §710.48 is not subject to the requirements ofthis subpart with respect to any chemical substance described in §710.45 that the
person solely manufactured or imported under the following circumstances: (a) The person manufactured or imported the chemical substance described in §710.45 solely in small quantities for research and development.

(b)The person imported the chemical substance described in §710.45 aspart ofan article.

(c) The person manufactured the chemical substance described in §710.45 in a manner described in §720.30(g) or (h)ofthis chapter.
§710.52 Reporting informationto EPA.

Any person who must report under this subpart, as described in §710.48,
must submit the information described in this section for each chemical substance described in §710.45 that the
person manufactured (including imported) for commercial purposes in

an amount of25,000 lbs. (11,340kg) or

more at any one site during calendar
year 2005 or during the calendar year at 4-year intervals thereafter. (See §710.48(b) for the "site" for importers). A separate form must be submitted for each chemical substance at each site for which the submitter is required to report. A submitter ofinformation under this subpart must report information as described in paragraphs (c)(1), (c)(2), and (c)(3) ofthis section tothe extent that such information is known to or reasonablyascertainable bythatperson whereas a submitter must report information as described in paragraph (c)(4) ofthis section only to the extent that such information is readily obtainable by thatperson. A submitter under this subpart must report information that applies tothe calendar
year for which the person isrequired to report (i.e., calendar year 2005 and the calendar year at 4-year intervals thereafter). (a)Reportingin writing.Any person who chooses to report information to EPA in writing must do so by completing the reporting form available from EPA at the address set forth in §710.59. The form must include all information described in paragraph (c) ofthis section. Persons reporting in writing must submit a separate form for each site for which the person is required to report. (b)Reportingbymagneticmedia.Any person who chooses to report information toEPA bymeans of magnetic media must submitthe information described in paragraph (c) ofthis section. Magnetic media submitted in response to this subpart
must meet EPA specifications, as described in the instruction booklet available from EPA atthe address set forth in §710.59. (c) Informationtobe reported. Manufacturers (including importers) of

areportable chemical substance in an amount of25,000 

### lbs. (11,340 kg) or
more at a site during a reporting year must report the information described in paragraphs (c)(1), (c)(2), and (c)(3) of this section. Manufacturers (including importers) of areportable chemical substance in an amount of300,000 lbs. (136,077 kg) ormore at a site during a reporting year must report the information described in paragraph (c)(4) ofthis section in addition to the information described in paragraphs (c)(1), (c)(2), and (c)(3) ofthis section. As described in §710.46(b)(3), manufacturers ofcertain inorganic chemical substances are not required to report the information described in paragraph (c)(4) ofthis section during the 2006 submission period, but are required to report this information during subsequent submission periods. As described in §710.46(b)(1) and (b)(2), manufacturers ofcertain chemicals are not required toreport the information described in paragraph (c)(4) ofthis section.

(1)A certificationstatementsigned anddatedbyan authorizedofficialof thesubmittercompany.Persons reporting bymeans ofmagnetic media
must submitthis information on the reporting form available as described in 

### §710.59.

(2) Companyand plantsite information.The following company andplant site information mustbe reported for each site at which at least 25,000 lbs. (11,340 kg) ofa reportable chemical substance is manufactured (including imported) during calendar year 2005 or during the calendar year at 4-year intervals thereafter (see §710.48(b) for the "site" for importers):

(i) The name ofa person who will

serve as technical contact for the submitter company, andwho will be able to answer questions about the information submitted bythe company to EPA, the parent company name and Dun and Bradstreet Number, the contact person's full mailing address, the
contact person's telephone number and the contact person's e-mail address.

(ii)The name and full street address ofeach site. A submitterunder this subpart must include the appropriate Dun and Bradstreet Number for each plant site reported, andthe county or parish (or other jurisdictional indicator) in which the plant siteis located.

(3)Specific information forchemicals manufacturedin amountsof25,000lbs.

ormore.The following chemicalspecific information mustbe reported for each reportable chemical substance manufactured at (including imported into) each site in amounts of25,000lbs. (11,340kg) ormore during calendar year 2005 or during the calendar year at4-
year intervals thereafter: (i) The specific chemical name and CASNumber ofeach reportable chemical substance at each site. A submitter underthis subpart may use an EPA-designated Accession Number for confidential substances, or a premanufacture notice (PMN) case number (see §720.65 ofthis chapter) in lieu of aCAS Number when a CAS Number is not known to orreasonably ascertainable bythe submitter. In addition to reporting the number itself, submitters must specify the type of number they are reporting by selecting from amongthe following codes:

CODES TO SPECIFY TYPE OF CHEMICAL IDENTIFYING NUMBER

Codes Number Type

A

................. Accession Number C

................. CAS Registry Number P

................. PMNNumber

(ii)A statement indicating, for each reportable chemical substance at each site, whether the substance is manufactured inthe United States, imported into the United States, or both manufactured inthe United States and imported into the United States.

(iii)A designation indicating, for each reportable chemical substance at each site, whether the substance is sitelimited.

(iv)The totalvolume (inpounds) of each reportable chemical substance manufactured (including imported) at each site. This amount must be reported
to two significant figures ofaccuracy provided that the reported figures are within plus or minus 10% ofthe actual volume. (v)Any person claiming that the volume reported under paragraph (c)(3)(iv) ofthis section is confidential 902

HeinOnline -- 68 Fed. Reg. 902 2003Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

business information under §710.58
must indicate, for each reportable chemical substance at each site, whether the totalvolume range (inpounds) which corresponds with the specific volume figure reported in response to paragraph (c)(3)(iv)ofthis section is also confidential. Volume ranges are listed in the following table:

VOLUME RANGES

From To

25,000 lbs

................. 300,000 lbs. 300,000 lbs

............... 1,000,000 lbs. 1,000,000 lbs

............ 10,000,000 lbs. 10,000,000 lbs

.......... 50,000,000 lbs. 50,000,000 lbs

.......... 100,000,000 lbs. 100,000,000 lbs

........ 500,000,000 lbs. 500,000,000 lbs

........ 1,000,000,000 lbs. Greater than

1,000,000,000 lbs..

(vi)The total number ofworkers reasonably likely to be exposed to each reportable chemical substance at each site. Foreach reportable substance at each site, the submitter must select from amongthe ranges ofworkers listed in the following table andreport the corresponding code (i.e., W1 through W8):

CODES FOR REPORTING NUMBER OF

WORKERS REASONABLY LIKELY TO
BE EXPOSED

Codes Range

W1

.............. Less than 10 workers W2

.............. At least 10 but lessthan 25 workers W3

.............. At least 25 but lessthan 50 workers W4

.............. At least 50 but lessthan 100 workers W5

.............. At least 100 but less than 500 workers W6

.............. At least 500 but less than 1,000 workers W7

.............. At least 1,000 but lessthan 10,000workers W8

.............. At least 10,000workers

(vii)The maximum concentration, measured bypercentage ofweight, of each reportable chemical substance at the time itis sent off-site from each site. Ifthe chemical is site-limited, you must report the maximum concentration, measured bypercentage ofweight, of the reportable chemical substance at the time it isreacted on-site to produce a different chemical substance. This information must be reported regardless ofthe physical form(s) in which the substance is sent off-site/reacted on-site. For each substance at each site, select the maximum concentration ofthe substance from among the ranges listed in the following table and report the corresponding code (i.e., M1 through M5):

CODES FOR REPORTING MAXIMUM

CONCENTRATION OF CHEMICAL SUBSTANCE

Codes Concentration Range (% weight)

M1

.............. Less than 1%byweight M2

.............. From 1to 30% by weight M3

.............. From 31 to 60% byweight M4

.............. From 61 to 90% byweight M5

.............. Greater than 90% by weight

(viii)The physical form(s) ofthe reportable chemical substance as itis
sent off-site from each site. Ifthe chemical is site-limited, you must report the physical form(s) ofthe reportable chemical substance atthe time itis reacted on-site to produce a different chemical substance. For each substance
at each site, the submitter must report

asmany physical forms as apply from amongthe physical forms listed below:

(A)Dry powder. (B) Pellets or large crystals. (C) Water- or solvent-wet solid. (D) Other solid. (E) Gas or vapor. (F)Liquid. (ix) Submitters must report the percentage, rounded offtothe closest 10%, oftotal production volume ofthe reportable chemical substance, reported in response to paragraph (c)(3)(iv) of this section, that is associated with each physical form reported under paragraph (c)(3)(viii) ofthis section. The sum of the percentages reported must not add
up to more than 100%. (4) Specific information for chemical substances manufactured in amounts of 300,000 lbs. ormore. In addition tothe information required under paragraphs (c)(1), (c)(2), and (c)(3) ofthis section, the following information must be reported for each reportable chemical substance manufactured (including imported) in an amount of300,000 lbs. (136,077 kg) ormore at any one site during calendar year 2005 or during the calendar year at4-year intervals thereafter. Persons subject to paragraph (c)(4) ofthis section must report the information described in paragraphs (c)(4)(i) and (c)(4)(ii) ofthis section for each reportable chemical substance at sites under their control and at sites that receive areportable chemical substance from the submitter directly or indirectly (includingthrough a broker/distributor, from a customer ofthe submitter, etc.). Information reported in response to this paragraph must be reported only tothe
extentthat itis readily obtainable bythe submitter. Ifinformation responsive to a given datarequirement underthis paragraph, including information in the form ofan estimate, isnot readily obtainable, the submitter is notrequired
to respond tothe requirement.

(i) Industrial processing and use information.

(A)A designation indicating the type ofindustrial processing oruse operation(s) at each site thatreceives a reportable substance from the submitter site directly or indirectly (whetherthe recipient site(s) are controlled bythe submitter site ornot). For each chemical substance, report the letters which correspond to the appropriate processing or use operation(s). A particular designation may need to be reported more than once, tothe extent that a submitter reports more than one NAICS code (underparagraph (c)(4)(i)(B) ofthis section) that applies to

a given designation under this paragraph.

Designa- Operation

tion

PC

............ Processing as a reactant PF

............. Processing

- incorporation into formulation, mixture or reaction product PA

............ Processing

- incorporation into article PK

............ Processing

- repackaging U

............... Use

- non-incorporative activities

(B) The five-digit North American Industrial Classification System (NAICS) codes which best describe the industrial activities associated with each industrial processing or use operation reported under paragraph (c)(4)(i)(A) ofthis section. Information about howto find these codes is provided in the instruction booklet available from EPA at the address set forth in §710.59. Aparticular NAICS code may need tobe reported more than
once, to the extent that a submitter reports more than one industrial function code (underparagraph (c)(4)(i)(C) ofthis section) that applies to

a given NAICS code underthis paragraph.

(C) For each NAICS code reported underparagraph (c)(4)(i)(B) ofthis section, code(s) from the following list
mustbe selected to designate the industrial function category(ies) that best represents the specific manner in which the chemical substance is used. Aparticular industrial function category may need to be reported more than
once, to the extent that a submitter reports more than one industrial processing or use operation/NAICS code 

### 903

HeinOnline -- 68 Fed. Reg. 903 2003Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations

combination (under paragraphs (c)(4)(i)(A) and (c)(4)(i)(B) ofthis section)that applies to a given industrial function category under this paragraph. Ifmore than 10 unique combinations ofindustrial processing or

use operations/NAICS codes/industrial function categories apply to a chemical substance, submitters need only report the 10 unique combinations for the chemical substance that cumulatively represent the largest percentage ofthe submitter's production volume for that chemical, measured by weight.

CODES FOR REPORTING INDUSTRIAL FUNCTION CATEGORIES

Codes Category

U01

............. U02

............. U03

............. U04

.............

U05

............. U06

............. U07

............. U08

............. U09

.............

Ul0

............. Ull

............. U12

............. U13

............. U14

............. U15

............. U16

............. U17

............. U18

............. U19

............. U20

............. U21

............. U22

.............
U23

.............

U24

.............

U25

.............

U26

............. U27

.............

U28

.............

U29

.............

U30

............. U31

............. U32

............. U33

............. Adsorbents and absorbents Adhesives and binding agents Aerosol propellants Agricultural chemicals (nonpesticidal) Anti-adhesive agents Bleaching agents Coloring agents, dyes Coloring agents, pigments Corrosion inhibitors and antiscaling agents Fillers Fixing agents Flame retardants Flotation agents Fuels Functional fluids Intermediates Lubricants Odor agents Oxidizing agents pH-regulating agents Photosensitive chemicals Plating agents and metal surface treating agents Processing aid, not otherwise

listed Process regulators, used in

vulcanization or polymerization processes Process regulators, other than

polymerization or vulcanization processes Reducing agents Solvents (for cleaning or

degreasing) Solvents (which become part

of product formulation or mixture) Solvents (for chemical manufacture and processing and

are not part of product at greater than one percent by weight) Stabilizers Surface active agents Viscosity adjustors Other

(D) The estimated percentage, rounded offto the closest 10%, oftotal production volume ofthe reportable chemical substance associated with each combination ofindustrial processing or use operation, NAICS code andindustrial function category. Where a particular combination of industrial processing or use operation, NAICS code andindustrial function category accounts for 5%or less ofthe submitter's site's total production volume of areportable chemical substance, the percentage must not be rounded offto zero %ifthe production volume attributable to that industrial processing or use operation, NAICS code andindustrial function category combination is 300,000 lbs. (136,077 kg)

ormore during the reporting year. Instead, in such a case, submitters must report the percentage, rounded offtothe closest 1%, ofthe submitter's site's total production volume ofthe reportable chemical substance associated with the particular combination ofindustrial processing or use operation, NAICS code andindustrial function category.

(E) For each combination ofindustrial processing or use operation, NAICS code andindustrial function category, the submitter must estimate the number ofsites at which each reportable chemical substance is processed or used. For each combination associated with each substance, the submitter must select from among the ranges ofsites listed in the following table and report the corresponding code (i.e., S1 through S7):

CODES FOR REPORTING NUMBERS OF SITES

Codes Range

S1

............... Less than 10 sites S2

............... From 10 to 25 sites S3

............... From 25 to 100 sites S4

............... From 100 to 250 sites S5

............... From 250 to 1,000 sites S6

............... From 1,000 to 10,000 sites S7

............... More than 10,000 sites

(F)For each combination ofindustrial processing or use operation, NAICS code andindustrial function category, the submitter must estimate the number ofworkers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each substance, the submitter must selectfrom amongthe worker ranges listed in paragraph (c)(3)(vi) ofthis section and report the corresponding code (i.e., Wi though W8). (ii) Commercialandconsumeruse information.

(A)Using the codes listed in this paragraph, submitters must designate the commercial and consumer product category or categories thatbest describe the commercial and consumer products in which each reportable chemical substance is used (whetherthe recipient site(s) are controlled by the submitter site ornot). Ifmore than 10 codes apply
to a chemical substance, submitters need only report the 10 codes for the chemical substance that cumulatively represent the largest percentage ofthe submitter's production volume for that chemical, measured by weight:

CODES FOR REPORTING COMMERCIAL

AND CONSUMER PRODUCT CATEGORIES

Codes Category

C01

............. Artists' supplies C02

............. Adhesives and sealants C03

............. Automotive care products C04

............. Electrical and electronic products C05

............. Glass and ceramic products C06

............. Fabrics, textiles and apparel C07

............. Lawn and garden products (non-pesticidal) C08

............. Leather products C09

............. Lubricants, greases and fuel additives C10

............. Metal products C11

............. Paper products C12

............. Paints and coatings C13

............. Photographic chemicals C14

............. Polishes and sanitation goods C15

............. Rubber and plastic products C16

............. Soaps and detergents C17

............. Transportation products C18

............. Wood and wood furniture C19

............. Other

(B) Submitters must determine, within each commercial and consumer product category reported under paragraph (c)(4)(ii)(A) ofthis section, whether any amount ofeach reportable chemical substance manufactured (including imported)by the submitter is presentin (for example, aplasticizer chemical used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children up to the age of14, regardless ofthe concentration ofthe substance remaining in or on the product. Submitters must select from the following options: the chemical substance is used in or on any consumer products intended for use by children, the chemical substance is not used in or

on any consumer products intended for

use by children, or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not readily obtainable.

(C) The estimated percentage, rounded offto the closest 10%, ofthe submitter's site's totalproduction volume ofthe reportable chemical substance associated with each commercial and consumer product 

### 904

HeinOnline -- 68 Fed. Reg. 904 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003/Rules and Regulations 905

category. Where a particular commercial and consumer product category accounts for 5% or less ofthe total production volume of a reportable chemical substance, the percentage must not be rounded offto zero %ifthe production volume attributable to that commercial and consumer product category is 300,000 lbs. (136,077 kg) or
more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded offto the closest 1%, ofthe submitter's site's total production volume ofthe reportable chemical substance associated with the particular commercial and consumer product category. (D) Where the reportable chemical substance is used in commercial or

consumer products, the estimated typical maximum concentration, measured byweight, ofthe chemical substance in each commercial and

consumer product category reported under paragraph (c)(4)(ii)(A) ofthis section. Foreach substance in each commercial and consumer product category reported under paragraph (c)(4)(ii)(A) ofthis section, submitters
must select from among the ranges of concentrations listed in the table in paragraph (c)(3)(vii) ofthis section and report the corresponding code (i.e., M1 through M5).
§710.53 When to report.

All information reported toEPA in
response to the requirements ofthis subpart must be submitted during an applicable submission period. The first submission period is from August 25, 2006, to December 23, 2006. Subsequent recurring submission periods are from August 25 to December 23 at 4-year intervals after the first submission period. Any person described in §710.48(a) must report during each submission period for each chemical substance described in §710.45 that the
person manufactured (including imported) during the preceding calendar year (i.e., the "reporting year").
§710.55 Duplicative reporting.

(a) With regard to section 8(a)rules. Any person subject to the requirements ofthis part who previously has complied with reporting requirements ofa rule under section 8(a) ofthe Act by submitting the information described in §710.52 for a chemical substance described in §710.45 to EPA, and has done so within 1year ofthe start ofa submission period described in §710.53, is not required to report again

onthe manufacture ofthat substance at that site during that submission period. (b) With regardto importers. This part requires that only one report be submitted on each import transaction involving a chemical substance described in §710.45. When two or

more persons areinvolved in a particular import transaction and each
person meets the Agency's definition of "importer" as set forth in §§710.3 and 704.3 ofthis chapter, they may determine among themselves who should submitthe required report; ifno report is submitted asrequired under this part, EPA will hold each such person liable for failure to report.
§710.57 Recordkeeping requirements.

Each person who is subject to the reporting requirements ofthis subpart
must maintain records thatdocument any information reported toEPA. Records relevant to reporting during a submission period must be retained for

aperiod of 5years beginning with the effective date ofthat submission period.
§710.58 Confidentiality.

(a) Any person submitting information under this subpart may assert abusiness confidentiality claim for the information atthe time itis submitted. These claims will apply only
to the information submitted with the claim. New confidentiality claims, if necessary, must be asserted with regard
to information submitted duringthe
next submission period. Guidance for asserting confidentiality claims is provided in the instruction booklet identified in §710.59. Information claimed as confidential in accordance with this section willbe treated and disclosed in accordance withthe procedures in part 2 ofthis chapter. (b) Chemical identity. Aperson may assert a claim ofconfidentiality for the chemical identity ofa specific chemical substance onlyifthe identity ofthat substance is treated as confidential in the Master Inventory File as ofthe time the report is submitted for that substance under this subpart. The following steps must be taken to assert

a claim ofconfidentiality for the identity ofa reportable chemical substance:

(1)The submitter must submitwith the report detailed written answers to the following questions signed and dated by an authorized official.

(i) What harmful effects to your competitive position, ifany, doyou think would result from the identity of the chemical substance being disclosed in connection withreporting under this subpart? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure andthe harmful effects? (ii)How long should confidential
treatment be given? Until a specific date, the occurrence ofa specific event,

or permanently? Why?

(iii)Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? Ifthe chemical substance has been patented and therefore disclosed through the patent, why should itbe treated as confidential?

(iv)Has the identity ofthe chemical substance been kept confidential to the
extentthat your competitors do not know itis being manufactured or imported for a commercial purpose by anyone?

(v)Is the fact that the chemical substance is being manufactured (including imported) for a commercial
purpose available to the public, for example in technical journals, libraries,

or State, local, or Federal agency public files?

(vi)What measures havebeen taken to preventundesired disclosure ofthe fact that the chemical substance is being manufactured (including imported) for a commercial purpose?

(vii)To what extenthas the fact that this chemical substance is manufactured (including imported) for commercial
purposesbeen revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

(viii)Does thisparticular chemical substance leave the site ofmanufacture (including import) in any form, e.g., as product, effluent, emission? Ifso, what

measures havebeen taken to guard against the discovery ofits identity?

(ix)Ifthe chemical substance leaves the site in a product thatis available to the public or your competitors, canthe substance be identified by analysis of the product?

(x)Forwhat purpose doyou manufacture (includingimport) the substance?

(xi)Has EPA, another Federal agency,

or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? Ifso, please attach copies of such determinations.

(2)Ifany ofthe information contained in the answers to the questions listed in paragraph (b)(1) ofthis sectionis asserted to contain confidential business information, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with alabel such as "confidential business information," "proprietary," or "trade secret."

HeinOnline -- 68 Fed. Reg. 905 2003

### Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003

### /Rules and Regulations

(c) Site identity. A submitter may assert aclaim ofconfidentiality for a site onlyifthe linkage ofthe site with a reportable chemical is confidential and
not publicly available. The following steps mustbe taken to assert a claim of confidentiality for a site identity:

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

(i) Has site information been linked with a chemical identity in any other Federal, state or local reporting scheme? For example, is the chemical identity linked to a facility in a filing underthe Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through aMaterial Safety Data Sheet (MSDS)? Ifso, identify all such schemes. Was the linkage claimed as confidential in any ofthese instances?

(ii)What harmful effect, ifany, to your competitive position do you think would result from the identity ofthe site and the chemical substance being disclosed in connection with reporting under this subpart? How could a competitor use such information? Would the effects ofdisclosure be substantial? What is the causal relationship between the disclosure and the harmful effects? (2)Ifany ofthe information contained in the answers to the questions listed in paragraph (c)(1) ofthis section is asserted to contain confidentialbusiness information, the submitter must clearly identify the information that is claimed confidentialby marking the specific information on each page with a label such as "confidential business information," "proprietary," or "trade secret."

(d)Ifno claim ofconfidentiality is indicated on the reporting form submitted to EPA under this subpart, or ifconfidentiality claim substantiation required under paragraphs (c) and (d) of this section is not submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter. 

### §710.59 Availabilityof reporting form and instructions.

(a) Use theproper EPA form. You
must use the EPA form identified as "Form U" to submit written information in response to the requirements ofthis subpart. Copies ofForm U are available from EPA at the address set forth in paragraph (c) ofthis section and from the EPAInternet Home Page at http:// www.epa.gov/oppt/iur. (b) Followthe reportinginstructions. Guidance for completing the reporting form andpreparing an electronic (magneticmedia) report willbe made available prior to each submission period. (c) Obtainthe reporting packageand copiesofthe form. EPA will send a reporting package (consisting of a copy ofForm U and a copy ofthe reporting instructions) to those submitters that reported in the IUR submission period that occurred immediately prior to the
current submission period. Failure to receive areporting package does not obviate or otherwise affect the requirement to submit a timely report. If you did not receive a reporting package, but arerequired to report, you may obtain a copy ofthe reporting package from EPA by submitting a request for this information as follows: (1)By telephone.Call the EPA TSCA Hotline at 202-554-1404. (2)Bye-mail.Send an e-mail request for this information tothe EPATSCA Hotline at TSCA-Hotline@epa.gov. (3)Bymail.Send a written request for this information to the following address: TSCA Hotline, Mailcode 7408M, ATTN: Inventory Update Rule, Office ofPollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

(4) ByInternet.To download a copy ofthe form and/orinstructions go to: http://www.epa.gov/oppt/iur.

(d) Submitthe completedreports.You
must submityour completed reporting form(s) and/or magnetic mediato EPA
atthe following address: OPPT DocumentControl Officer (DCO), Mailcode 7407M, ATTN: Inventory Update Rule, Office ofPollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Part 723 is amended as follows:

PART 723-[AMENDED]

a. The authority citation for part 723 continues to read as follows:

Authority: 15 U.S.C. 2604.

b. In §723.175, revise paragraph (b)(3)
to read asfollows:
§723.175 Premanufacture Notification Exemptions

* * * * *

(b)Definitions. * * * (3)The terms byproduct,EPA, impurities, person,and sitehave the

same meanings as in §710.3 ofthis chapter.

[FR Doc. 02-32909 Filed 12-31-02; 9:56 am]

BILLING CODE 6560-50-S 

### 906

HeinOnline -- 68 Fed. Reg. 906 2003