[Federal Register Volume 68, Number 4 (Tuesday, January 7, 2003)]
[Rules and Regulations]
[Pages 848-906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32909]



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Part II





Environmental Protection Agency





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40 CFR Parts 9, 710, and 723



TSCA Inventory Update Rule Amendments

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

[[Page 848]]


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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.

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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) of certain chemical 
substances on the TSCA Chemical Substances Inventory to report data on 
each chemical's current production volume, site-limited status, and 
plant site information every 4 years. Through these IUR amendments 
(IURA), EPA is requiring the reporting of additional data for certain 
chemicals to assist EPA and others in screening potential exposures and 
risks resulting from industrial chemical operations and commercial and 
consumer uses of TSCA chemical substances. EPA is also modifying the 
IUR reporting and recordkeeping requirements, removing one reporting 
exemption and creating others, and modifying its procedures for making 
Confidential Business Information claims. EPA is also making certain 
non-substantive technical corrections.

DATES: This final rule is effective February 6, 2003. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. eastern 
daylight/standard time on January 21, 2003.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division, 
Office of Pollution Prevention and Toxics (7401M), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 564-8170; e-mail address: [email protected].
    For technical information contact: Susan Sharkey, Project Manager, 
Economics, Exposure and Technology Division (7406M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
564-8789; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you manufacture (defined by 
statute to include import) chemical substances currently subject to 
reporting under the Inventory Update Rule (IUR) at 40 CFR part 710 or 
if you manufacture inorganic chemical substances. Any use of the term 
``manufacture'' in this document will encompass ``import,'' unless 
otherwise stated. In the past, persons that only are processors of 
chemical substances have not been required to comply with the 
requirements of 40 CFR part 710. These amendments do not change the 
status of processors under the regulations at 40 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 of inorganic 
chemical substances (NAICS codes 325, 32411).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could 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 or your 
business is affected by this action, you should carefully examine the 
applicability provisions in Sec.  710.48 in the regulatory text. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical contact person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document or Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPPT-2002-0054. The official public 
docket consists of the documents specifically referenced in this 
action, any public comments received, and other information related to 
this action. Although a part of the official docket, the public docket 
does not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public docket is the collection of materials that is available for 
public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA 
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket 
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The EPA Docket Center Reading Room telephone 
number is (202) 566-1744 and the telephone number for the OPPT Docket, 
which is located in EPA Docket Center, is (202) 566-0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. An electronic version of the 
public docket is available through EPA's electronic public docket and 
comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing 
of the contents of the official public docket, and access those 
documents in the public docket that are available electronically. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. Once in the system, 
select ``search,'' then key in the appropriate docket identification 
number.

II. Background

A. What Action is the Agency Taking?

    1. Substantive changes to the CFR. EPA is promulgating amendments 
to the IUR (IURA) which were proposed on August 26, 1999 (64 FR 46772) 
(FRL-6097-4), taking into consideration comments received on the 
proposal. The amendments to the IUR that are contained in this final 
rule, as well as the inventory update provisions of 40 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 brief listing of the primary changes 
to the IUR, which do not affect the regulations in place for IUR 
reporting in 2002. These changes are described in more detail in this 
document, along with a summary of the comments received and the 
Agency's summary response to those comments.
    First, EPA is amending the existing IUR regulations, 40 CFR 710.28 
and 710.32, which appear in the new subpart C as Sec. Sec.  710.48 and 
710.52, to raise the production volume basic

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reporting threshold from the current 10,000 pounds (lbs.) per year to 
25,000 lbs. per year, and to add a new larger-volume reporting 
threshold of 300,000 lbs. per year for the reporting of processing and 
use information.
    Second, EPA is amending 40 CFR 710.32, which appears in the new 
subpart C as Sec.  710.52, to add exposure-related information to the 
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 
of workers 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 of total reported 
production volume associated with each physical form; and (4) the 
maximum concentration of the chemical substance at the time it leaves 
the submitter's manufacturing site or, if the chemical substance is 
site-limited, the maximum concentration at the time it is reacted on-
site to produce a different chemical substance.
    Third, EPA is amending 40 CFR 710.32, which appears in the new 
subpart C as Sec.  710.52, to require chemical manufacturers of 
chemical 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 that receive the reportable chemical substance from 
the submitter site directly or indirectly (whether the recipient 
site(s) are controlled by the submitter site or not) (including through 
a broker/distributor, from a customer of the submitter, etc.). 
Specifically, manufacturers of these larger-production volume chemical 
substances will be required to report, to the extent the information is 
readily obtainable:
    [sbull] The type of industrial processing or use operation(s) at 
each site, including downstream sites.
    [sbull] The five-digit NAICS codes that best describe the 
industrial activities during the processing or use operation.
    [sbull] The industrial function of each chemical substance during 
the processing or use operation, for each NAICS code reported.
    [sbull] The percentages of the submitter's production volume used 
in each industrial function category.
    [sbull] The number of sites where the various processing or use 
operations occur.
    [sbull] The number of workers reasonably likely to be exposed to 
the chemical substance in each processing or use operation.
    [sbull] The categories of commercial and consumer uses of the 
reportable chemical substance.
    [sbull] An indication of the presence of the reportable chemical 
substance in or on consumer products intended for use by children.
    [sbull] The percentages of the submitter's production volume 
associated with each commercial and consumer product category.
    [sbull] The maximum concentration of the reportable chemical 
substance in each commercial and consumer product category.
    Fourth, EPA is revoking 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 Sec.  710.46(b)(3). For the first submission period 
following promulgation of IURA (i.e., the 2006 submission period), EPA 
is requiring partial reporting for these substances (i.e., inorganic 
chemical substances will not be subject to the reporting of processing 
and use information). In subsequent submission periods, manufacturers 
of an inorganic substance will be subject to full reporting (i.e., 
including the processing and use information reporting requirements), 
to the extent that they manufacture at least 300,000 lbs. of the 
substance at a site during a given reporting year.
    Fifth, EPA is amending 40 CFR 710.26, which appears in the new 
subpart C as Sec.  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 of processing and 
use 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 of processing and use 
information) where EPA has identified that there is a low current 
interest in the IURA processing and use information related to the 
chemical. EPA has identified a list of chemicals 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 Sec.  710.46(a)(4), to provide a full exemption from IUR 
reporting for certain forms of natural gas.
     Eighth, EPA is amending 40 CFR 710.32, which appears in the new 
subpart C as Sec.  710.52, to require the reporting of more specific 
information to assist in the accurate identification of plant sites 
reporting under IUR.
    Ninth, EPA is amending 40 CFR 710.28, 710.32, and 710.33, which 
appear in the new subpart C as Sec. Sec.  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 Sec.  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 of that 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 Sec.  710.58, to require substantiation of plant 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 of chemical identity, which will 
continue to be required under 40 CFR 710.38, which appears in the new 
subpart C as Sec.  710.58.
    Finally, EPA is amending 40 CFR 710.37, which appears in the new 
subpart C as Sec.  710.57, to extend the records retention period from 
4 years to 5 years.
    2. Technical changes to the CFR. The amendments that are contained 
in this final rule, as well as the parts of 40 CFR part 710 that are 
unchanged by these amendments, are codified in a new subpart C in 40 
CFR part 710. Because promulgation of IURA will overlap a current IUR 
reporting cycle, EPA must maintain the existing IUR provisions in 40 
CFR part 710 in effect throughout the 2002 submission period for the 
existing IUR. Submitters filing IUR reports in 2002 must follow the 
regulations currently contained in 40 CFR part 710, which will now 
appear under the new heading as subpart B. On January 1, 2003, the 
regulations in this final rule that are promulgated in subpart C of 40 
CFR part 710 will become effective for use by submitters filing IURA 
reports in 2006 and beyond. (See Sec.  710.1(b) of the regulatory text) 
Since the Agency has duplicated in subpart C those provisions from 
subpart B (i.e., the existing part 710) that are unchanged by these

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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 that 
have been presented in this final rule.
    Although there are no substantive changes to the provisions from 
existing 40 CFR part 710 that have been 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 existing 40 CFR part 710 provision 
is provided in parentheses, e.g., Sec.  710.59 (Sec.  710.39). This 
parenthesized citation is provided 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: Sec.  710.1(d) (Sec.  
710.1(c)); Sec.  710.3(a) (Sec.  710.2(a)); Sec.  710.3(b) (Sec.  
710.2(b)); Sec.  710.3(c) (Sec.  710.2(c)); Sec.  710.3(d) in the 
definition for ``Administrator'' (Sec.  710.2(e)); Sec.  710.3(d) in 
the definition for ``site'' (Sec.  710.2(w)); Sec.  710.3(d) in the 
note following the definition for ``small quantities for research and 
development'' (Sec.  710.2(y)); and Sec.  710.4(b)(2) (Sec.  
710.4(b)(2)).
    EPA has corrected some punctuation and spelling errors: commas were 
added in Sec.  710.1(a) (Sec.  710.1(a)), in Sec.  710.3(d) in the 
definition for ``distribute in commerce'' (Sec.  710.2(j)) and in the 
definition for ``small quantities for research and development'' and in 
the note following the same definition (Sec.  710.2(y)); commas were 
removed in the definition for ``distribute in commerce'' (Sec.  
710.2(j)) and in the note following the definition for ``distribute in 
commerce'' (Sec.  710.2(y)); in Sec.  710.3(d) ``Process `for 
commercial purposes''' was substituted for ``Process for `commercial 
purposes''' in the definition for ``Process `for commercial purposes''' 
( Sec.  710.2(u)); in Sec.  710.3(d) ``juridical'' was substituted for 
``juridicial'' in the definition for ``person'' (Sec.  710.2(s)) and 
``appropriate'' was substituted for ``appropriated'' in the definition 
for ``technically qualified person'' (Sec.  710.2(aa)(2)); in Sec.  
710.4(d)(2) ``premanufacture'' was substituted for ``premanufacturing'' 
(Sec.  710.4(d)(2)); and in Sec.  710.4(d)(5) ``photographic films'' 
was substituted for ``photographic, films'' (Sec.  710.4(d)(5)).
    EPA has made certain additional non-substantive changes. In Sec.  
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'' (Sec.  710.2(y)). EPA has substituted ``his/
her'' for ``his'' in sections where the word ``his'' was used: in two 
instances in Sec.  710.3(d) in the definition for ``Administrator'' 
(Sec.  710.2(e)); in Sec.  710.3(d) in the definition for importer 
(Sec.  710.2(l)(2)); and in Sec.  710.3(d) in the definition for 
``technically qualified person'' (Sec.  710.2(aa)).
    EPA has made certain additional non-substantive changes and updated 
information submission information in Sec.  710.59 by substituting 
``Availability of reporting form and instructions'' for ``How do I 
submit the required information for the 1998 reporting cycle?'' (Sec.  
710.39); in Sec.  710.59(a) by substituting ``http://www.epa.gov/oppt/iur'' for ``http://www.epa.gov/opptintr/iur98'' and by removing ``or 
Fax-on-Demand by using a faxphone to call (202) 401-0527 and selecting 
item 5119'' as Fax-on-Demand is no longer available (Sec.  710.39(a)); 
in Sec.  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 after the heading (Sec.  710.39(b)); in Sec.  710.59(c) by 
substituting ``will send'' for ``is mailing'' and ``reporting package 
(consisting of a copy of Form U and a copy of the reporting 
instructions) to those 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. '' (Sec.  710.39(c)); in Sec.  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 (Sec.  710.39(c)(1)); in Sec.  
710.59(c)(2), EPA substituted ``[email protected]'' for ``[email protected]'' (Sec.  710.39(c)(2)); and in Sec.  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'' (Sec.  
710.39(c)(3)); and by adding Sec.  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 Sec.  710.39 that now appear in subpart B. EPA removed 
``for the 1998 reporting cycle'' from the section heading to clarify 
that the section applies to the current reporting cycle. In Sec.  
710.39(a), EPA replaced 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 Sec.  710.39(c)(1), EPA 
removed the TDD number, which is no longer available. The Agency 
corrected dates and addresses in Sec.  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 Sec.  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'' (Sec.  710.1(a)); in Sec.  710.1(d), the note following the 
paragraph was added to the end of the paragraph and ``Note: As a matter 
of traditional Agency policy,'' was removed (Sec.  710.1(b)); in Sec.  
710.52(c)(1) ``submitter'' was substituted for ``respondent'' and ``as 
described in Sec.  710.59'' for ``from EPA at the address set forth in 
Sec.  710.39'' (Sec.  710.32(c)(1)); in Sec.  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 in the United 
States and imported in the United States'' (Sec.  710.32(c)(5)); in 
Sec.  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'' 
(Sec.  710.32(c)(6)); in Sec. Sec.  710.45 and 710.55(a) ``submission 
period'' was substituted for ``reporting period'' (Sec. Sec.  710.25 
and 710.35(a)); in Sec.  710.48 ``section'' was substituted for ``Sec.  
710.28'' (Sec.  710.28); in Sec.  710.48(b) ``paragraphs (a) and (b)'' 
were deleted (Sec.  710.28(c)); in Sec.  710.52(c)(3)(iv) 
``reportable'' was substituted for ``subject'' (Sec.  710.32(c)(7)); in 
Sec.  710.58(b) ``Chemical identity.'' was added as a section header to 
more clearly identify the topic of the section, and ``The following 
steps must be taken to assert'' was substituted for ``To

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assert,'' and ``reportable'' was substituted for ``specific'' (Sec.  
710.38(c)(b) and (c)); in Sec.  710.58(b)(1) ``submitter'' was 
substituted for ``person'' (Sec.  710.38(c)(1)); in Sec.  
710.58(b)(1)(i) ``subpart'' was substituted for ``part'' (Sec.  
710.58(c)(1)(i)); in Sec.  710.58(b)(1)(vi) substituted ``have been 
taken'' for ``have you taken'' and ``the'' for ``this'' (Sec.  
710.38(c)(1)(vi)); in Sec.  710.58(c)(2) ``listed in paragraph (c)(1) 
of this 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.'' (Sec.  710.38(c)(2)); and in Sec.  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'' (Sec.  
710.38(d)).
    EPA replaced ``manufactured or imported'' with ``manufactured 
(including imported)'' to provide consistency and clarification. EPA 
made this change in: Sec.  710.52(c)(3)(iv) (Sec.  710.32(c)(7)); Sec.  
710.58(c)(1)(v) (Sec.  710.38(c)(1)(v)); Sec.  710.58(c)(1)(vi) (Sec.  
710.38(c)(1)(vi)); Sec.  710.58(c)(1)(vii) (Sec.  710.38(c)(1)(vii)); 
Sec.  710.58(c)(1)(viii) (Sec.  710.38(c)(1)(viii)); Sec.  
710.58(c)(1)(x) (Sec.  710.38(c)(1)(x)); and Sec.  710.48 (Sec.  
710.28).
    EPA moved three definitions that currently appear in Sec.  710.2 to 
Sec.  710.23, to clarify that they apply to the existing IUR. In Sec.  
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 Sec.  710.3(d) definition for ``Commerce,'' 
``paragraph (1) of this definition'' was substituted for ``paragraph 
(1) of this section'' (Sec.  710.2(i)), and in the Sec.  710.3(d) 
definition for ``Technically qualified individual,'' ``this paragraph'' 
was substituted for ``paragraph (aa)(3) of this section'' and 
``paragraph (1) of this definition'' was substituted for ``paragraph 
(aa)(1) of this section'' (Sec.  710.2(aa)(3)).
    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 
553(b)(B), provides that, when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary or contrary 
to the 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 or legal effect of the provisions affected, which 
remains the same as it was when the provision appeared in 40 CFR part 
710. Thus, notice and public procedure are unnecessary for these minor 
changes to the existing or new provisions in 40 CFR part 710. EPA finds 
that this constitutes good cause under 5 U.S.C. 553(b)(B).

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

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to 
compile and keep current an inventory of chemical substances in 
commerce. This inventory is known as the TSCA Chemical Substances 
Inventory (the TSCA 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 at 40 CFR part 710 (51 
FR 21447, June 12, 1986), also under TSCA section 8(a), to facilitate 
the periodic updating of the TSCA Inventory and to support activities 
associated with the implementation of TSCA.
    TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate 
rules under which manufacturers and processors of chemical substances 
and mixtures (referred to hereinafter as ``chemical substances'') must 
maintain such records 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 it 
is 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 of the types of information which 
can be required under TSCA section 8(a)(2) include: Categories of use 
for each chemical substance; estimates of the amount manufactured or 
processed for each category of use; a description of the byproducts 
resulting from the manufacture, processing, use, or disposal of each 
chemical substance; an estimate of the number of individuals exposed in 
their places of employment; and the duration of such exposure.
    TSCA section 8(a) generally excludes small manufacturers and 
processors 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 small 
manufacturers and processors with respect to any chemical substance 
that is the subject of a rule proposed or promulgated under TSCA 
section 4, 5(b)(4), or 6, or that is the subject of an order under TSCA 
section 5(e), or that is the subject of relief that has been granted 
pursuant to a civil action under TSCA section 5 or 7. The standard for 
determining whether an entity qualifies as a ``small manufacturer'' for 
purposes of 40 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 in 
40 CFR part 710 that are not substantively changed as a part of this 
rulemaking, and the new IURA provisions in this final rule. Failure to 
comply fully with any provision of this final rule will be a violation 
of TSCA section 15 and will subject the violator to the penalties of 
TSCA sections 16 and 17.

C. What is the Inventory Update Rule (IUR)?

    The IUR requires U.S. manufacturers of organic chemicals to report 
to EPA every 4 years the identity of chemical substances manufactured 
annually during the reporting year in quantities of 10,000 lbs. or more 
at each plant site they own or control. The current IUR generally 
excludes several categories of substances from its 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 
of the reportable chemical substance, and production volume of each 
reportable chemical substance. Data were reported to EPA under the IUR 
in 1986, 1990, 1994, and 1998, and a collection is occurring in 2002.
    The data reported under IUR are used to update the information 
maintained on the TSCA Inventory, which is a listing of chemical 
substances in commerce. EPA uses the TSCA Inventory and data reported 
under the IUR to support many TSCA-related activities and to provide 
overall support for a number of EPA and other Federal health, safety, 
and environmental protection activities (See Unit II.E. for

[[Page 852]]

further explanation of some of these activities).

D. Why is EPA amending the IUR?

    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 of chemical substances 
listed on the TSCA Inventory; and (3) to improve the utility of the 
information reported. These amendments will enhance the information 
collected through the IUR, improve the scope of chemicals covered by 
the rule, and improve CBI claims, thereby accomplishing these three 
goals.
     These goals are supported by the policy in section 2(b)(1) of 
TSCA, that ``adequate data should be developed with respect to the 
effect of chemical substances and mixtures on health and the 
environment and that the development of such data should be the 
responsibility of those 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 of data, including 
exposure-related 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 
on that information which is most needed by EPA and other Federal 
agencies for screening, assessing, and managing risk. Additionally, the 
availability of these data will enhance public awareness of basic 
information about chemical substances.
    Any evaluation of potential ``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 a 
more 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 of Public 
Administration's report ``Setting Priorities, Getting Results, A New 
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 of exposure data. The manufacturing, 
processing, and use of chemicals on the TSCA Inventory result in a wide 
array of exposure 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 to 
human health or to the environment, or that otherwise warrant further 
investigation.

E. What are EPA's TSCA-Related Chemical Screening and Assessment 
Activities?

    TSCA authorizes EPA to 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 of injury to human 
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 of greatest potential concern, and using 
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 collect information on commercial chemicals.
    The TSCA Inventory currently includes more than 76,000 chemical 
substances. Approximately 8,900 of these chemical substances are non-
polymer, organic chemical substances manufactured at at least one site 
in quantities of 10,000 lbs. or more 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 of substances that will be reported under IURA will be 
somewhat different than the set of substances that was reported under 
the previous IUR collections primarily because of two 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 of the chemical 
substances within its purview, as described in the remaining part of 
this section and in Unit III.A.1.
    EPA conducted tiered risk evaluations of chemical substances even 
prior to the enactment of TSCA in 1976. A tiered approach allows EPA to 
sort through many chemicals, focus on those chemical substances of 
greatest concern, and take appropriate actions. The Agency is thus able 
to optimize resources while limiting overall regulatory burdens. The 
essential steps of the 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 detailed risk assessment when appropriate; and 
resulting risk management actions, such as regulatory or voluntary 
efforts to reduce risk. Each of these steps is only as effective as the 
available data inputs--if little data exist to inform the process, each 
step suffers as a result.
    Exposure-related information collected through the IURA will inform 
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 by manufacturers and processors. This information set often is 
incomplete or of insufficient quality to allow the Agency to reach 
definitive conclusions about the set of chemicals under review, but may 
be sufficient to decide which chemicals appear to warrant further 
evaluation, or conversely, appear to be 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 as the recurring reporting of exposure-related data under 
IURA, will ensure that the most serious concerns will be addressed even 
as chemical quantities and exposure potentials change between 
submission periods.
    The effectiveness of risk screening, risk assessment, and risk 
management is dependent upon the quality as well as the availability of 
both hazard and exposure information. While past approaches to priority 
setting have emphasized relative chemical hazards and used production 
volume as a simple surrogate for exposure, EPA must increase its 
emphasis on the exposure component of risk 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 exposure-
related information reported under IURA will be used in combination 
with hazard information developed under TSCA section 4 test rules and 
enforceable consent agreements/orders, through voluntary efforts such 
as the High Production Volume (HPV) Challenge Program (see www.epa.gov/opptintr/chemrtk/volchall.htm), and

[[Page 853]]

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 of workers and 
affected populations can change significantly. If the amount of a 
chemical substance produced increases significantly, releases to the 
environment and human exposures would also be expected to increase. 
Conversely, if the amount produced remains constant, environmental 
releases and human exposures may decline as engineering controls are 
added and pollution prevention practices are implemented. Although the 
hazard associated with a chemical generally remains constant, the risk 
associated with the manufacturing, processing, and use of a chemical 
substance will change as exposure increases or changes. The Agency 
needs to be able to identify changes in exposures as well as specific 
exposure scenarios, making it important to collect exposure data on a 
regular basis. Chemicals that present low hazard may still pose a risk 
if they are produced in large amounts and have high exposure potential, 
are released into the environment at high volumes and/or 
concentrations, or involve 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 can be reported by industry. The UEIP was a 
cooperative effort begun in the fall of 1992 between government and 
industry in recognition of the difficulties encountered in obtaining 
accurate and up-to-date exposure information on HPV TSCA chemicals. 
Participants included EPA, the Chemical Manufacturers Association (CMA) 
(now the 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 now being 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 of data requested by the 
UEIP are available from industry and can be used to prepare screening 
level exposure assessments.
    The UEIP, however, provided one-time reporting of information by a 
subset of the manufacturers of a 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), and the amount of time it would otherwise take to acquire 
screening level exposure data for the chemical substances on the TSCA 
Inventory, it is appropriate to develop a more systematic and broadly 
applied approach to the prioritization process. The Agency is doing 
this by requiring that certain basic exposure-related information be 
reported under this amended rule instead of collecting the information 
through a one-time voluntary program.

F. What Are the Requirements of IURA?

    The regulatory text of this document describes the specific IURA 
reporting requirements. EPA is also developing a guidance document with 
specific reporting instructions, and intends to conduct workshops to 
help potential IURA submitters become familiar with the revised 
reporting form (Form U) and amended reporting requirements. A draft 
version of the revised Form U is available in the docket, and EPA 
intends to develop an electronic version of the revised Form U. EPA 
will seek additional feedback on the revised form's structure, format, 
and layout before finalizing it for use in 2006. Submitters should note 
that the information in Sec.  710.52(c)(1) and (c)(2) of the regulatory 
text (Part I of the revised Form U) need only be reported once per 
reporting cycle for each submitter site manufacturing 25,000 lbs. or 
more of a reportable chemical, while the information in Sec.  
710.52(c)(3) and (c)(4) of the regulatory text (Parts II and III of the 
revised Form U, respectively) will be reported for each reportable 
chemical at a reporting site, depending upon the chemical's production 
volume.
    1. What are the changes to the chemical substances covered by 
IUR?--a. Inorganic chemical substances. EPA is requiring partial 
reporting for inorganic chemical substances for reporting year 2005 
information submitted to EPA during the 2006 submission period, and 
full reporting for inorganic chemical substances in subsequent 
submission periods (see Sec.  710.46(b)(3) of the regulatory text). 
Partial reporting means that the submitter must report the information 
described in Sec.  710.52(c)(1), (c)(2), and (c)(3), as well as 
Sec. 710.58 of the regulatory text, as applicable (i.e., Parts I and II 
of revised Form U.). Full reporting means that the submitter must 
additionally report the processing and use information as described in 
Sec.  710.52(c)(4) of the regulatory text (i.e., all parts of revised 
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 of inorganic 
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 full reporting of exposure-related 
information will provide EPA and others with needed additional 
information for those inorganic chemicals with production volumes of 
300,000 lbs. or more at a site. See Unit III.A.1. for a discussion of 
the importance of this exposure-related information to EPA and others 
for both organic and inorganic chemicals. Unit III.C.1.a. contains a 
discussion specific to inorganic chemicals. The basic impetus for 
collecting information on organic chemicals also holds for inorganic 
chemicals.
    b. Petroleum process streams. EPA is exempting certain chemical 
substances, termed ``petroleum process streams'' for purposes of IURA, 
from reporting the processing and use data contained in the regulatory 
text at Sec.  710.52(c)(4). For purposes of this rule, the petroleum 
process streams included in the exemption are the multi-component 
complex chemical substances listed by Chemical Abstracts Service (CAS) 
Registry Number in the regulatory text at Sec.  710.46(b)(1). This list 
of chemical substances was derived from the 1983 publication of the 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 IURA reporting purposes. Water (CAS 
number 7732-18-5) is partially exempt from IURA reporting under the 
petroleum process stream exemption.
    The basis for this exemption is not because these streams are of 
known low toxicity. EPA believes that the chemicals termed ``petroleum 
process streams'' for purposes of IURA are often toxicologically 
active. However, these

[[Page 854]]

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 of these products requires that they also be transported, 
processed, and stored in well controlled vessels. For these reasons, 
EPA believes worker exposure to the chemicals termed ``petroleum 
process streams'' for purposes of IURA 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 uses by EPA and others apart from gauging 
exposures and risk screening. EPA may take action to revoke this 
exemption if circumstances warrant.
    In the final rule, EPA is making selected changes to the partial 
exemption list of petroleum process stream chemicals published in the 
proposed rule. Certain chemicals are being added to the list because 
they were inadvertently left off the proposed list covered by the 
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, EPA is also removing a number of chemicals from 
the petroleum process stream partial exemption list published in the 
proposed rule. These chemicals fall into three groups:
    (1) Certain chemicals that are already part of the broader 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, 67891-78-5, 68131-77-1, 68131- 79-3, 68131-80-
6, 68131-81-7, 68131-83-9, 68131-99-7, 68132-00-3, 68410-01-5, 68410-
10-6, 68410-13-9, 68410-14-0, 68410-16-2, 68410-59-3, 68425-27-4, 
68425-28-5, 68476-87-9, 68477- 37-2, 68477-43-0, 68477-45-2, 68477-46-
3, 68477-50-9, 68477-51-0, 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 streams partial exemption. As 
stated in the proposed rule, the exemption was intended to include only 
certain multi-component 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 
as proposed: 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.
    In this final rule, EPA is also making some additional corrections 
to the petroleum process streams partial exemption list published in 
the proposed rule.
    (1) Incorrect CAS numbers for certain chemicals were provided in 
the proposed rule. These CAS numbers were incorrect because of 
typographical 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 in the proposed rule, i.e., 64742-
36-2 and 68741-41-9. The corrected CAS numbers 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 as follows (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. Natural gas. EPA is exempting certain forms of natural gas from 
IUR reporting. These substances are listed in the regulatory text at 
Sec.  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 IUR information users' current needs. EPA will take 
action to revoke this exemption if circumstances warrant in the future.
    d. Specific chemical substances. EPA is exempting certain specific 
chemical substances for which EPA has determined that there is a low 
current interest in the IURA processing and use information from 
reporting the processing and use information contained in the 
regulatory text at Sec.  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 in the 
regulatory text at Sec.  710.46(b)(2)(iv). EPA is also establishing a 
process for revising the list of exempted chemical substances over 
time.
    EPA is establishing this partial exemption in an effort to improve 
IURA's efficiency and effectiveness. This partial exemption also 
provides additional benefits in reducing the potential reporting burden 
of IURA for certain manufacturers of these 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 of a 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 might use to establish such an 
exemption, as well as the specific chemicals that might qualify for 
such an exemption. (See Unit IX.3. of the preamble to the proposal, at 
64 FR 46794). EPA also offered several approaches for identifying the 
chemicals that could be considered for such an exemption. A number of 
commenters supported the creation of a partial exemption, and several 
provided suggestions for additional chemical substances or classes of 
substances that they wanted EPA to consider including in this or an 
expanded partial exemption.
    In response to the comments received, EPA has established a partial 
exemption that applies when EPA has determined that there is a low 
current interest in the chemical's IURA processing and use information. 
Because IURA reporting is

[[Page 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 of IURA processing and 
use information related to a particular chemical substance can change 
over time; therefore, EPA has also established a process that will 
allow EPA to revise the list by adding or removing a chemical to 
reflect the change in interest. The process allows anyone to submit a 
written request for EPA to consider revising the list of chemical 
substances covered under this partial exemption. EPA may also revise 
the list on its 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 of the considerations 
identified below, and/or considerations not identified below, to make 
an informed decision. EPA will consider the totality of information 
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 of the information described in Sec.  
710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or 
more of the 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 of EPA, other federal agencies, tribes, 
states, and local governments, as well as members of the public.
    (D) The availability of other complementary risk screening 
information.
    (E) The availability of comparable processing and use information.
    (F) Whether the potential risks of the chemical substance are 
adequately managed by EPA or another agency or authority.
It is important to note that the inclusion of these chemical substances 
under this partial exemption is not based on the potential risks of the 
chemicals, but is based on the Agency's current assessment of the need 
for collecting IURA processing and use information. Additionally, some 
of these chemicals have issues that may renew interest in them in the 
future, at which time EPA will reconsider the applicability of this 
partial exemption for those chemicals.
    To create an initial list of specific chemical substances covered 
by this partial exemption, EPA started with:
    (1) The list of chemical substances identified as part of the HPV 
Challenge Program for which, based upon a preliminary review of known 
hazard information, it was determined that the SIDS data set would not 
further our understanding of the chemical's properties.
    (2) The list of the chemical substances that the European Union 
(EU) exempted from its reporting requirements for existing chemical 
substances.
    (3) Certain other chemicals identified during the Executive Order 
12866 interagency review, for which EPA was able to quickly determine, 
based on a review of their chemical structures, properties, existing 
hazard information, and available exposure information, that IURA 
processing and use information is of low current interest.
    This list was then adjusted based upon the totality of information 
available to EPA 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 of low current interest. EPA chose these chemicals 
because almost all previously 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 of 
the individual chemical's structure, properties, indications of hazards 
and potential exposures, to inform its determination that there is a 
low current interest in IURA processing and use information for these 
specific chemicals (Ref. 5). As indicated previously, EPA has 
established a process for revising the list of chemicals covered by 
this partial exemption, and intends to reconsider the chemicals 
identified in comments for applicability under this partial exemption.
     The list currently consists of the following chemicals:
    (1) Chemicals for which it had been determined that the SIDS data 
set would not further our understanding of the 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 list 
that 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 of 
the chemical's structure, properties, existing hazard information, and 
available information concerning the extent of exposure, and which are 
not currently a part of another 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 Sec.  710.46(b)(2) to submit 
a request 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 EPA to make the 
necessary determination after considering the totality of available 
information. If you 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 of receipt, and will maintain 
copies of these responses in a public docket that will be established 
for each reporting cycle. In order to assist the Agency in completing 
any necessary revision to the list before the reporting period, any 
request for revising the list of chemicals under this partial exemption 
must be received by the Agency no later than January 1 of the year 
before the reporting period in question (i.e.,12 months prior to the 
reporting period). For example, any request for inclusion under this 
partial exemption must be submitted to EPA no later than January 1, 
2004, i.e., 12 months prior to the next reporting

[[Page 856]]

period, which begins on January 1, 2005, for the 2006 submission 
period. If the request is submitted after this date, during an actual 
reporting period, or during the submission period, EPA is less likely 
to have sufficient time to complete its evaluation and make a 
determination, or issue the necessary rulemaking such that the decision 
can be effective for that submission period. Submitters should check 
the Federal Register for list revisions 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, as well 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 on the implementation 
of this process, as part of IURA implementation workshops that are 
planned.
    One of the purposes of the 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% of the industrial production and 75% of the 
facilities included in the USGS survey. If you have identified other 
federal agency information collections that could satisfy the IURA 
purposes, or for which IURA information might serve as a viable 
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 of 
Management and Budget (OMB), an approval which must be renewed every 3 
years. As part of the 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 as part of the 
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 of the PRA, including the 
demonstration of practical utility.
    e. Polymers. As a result of recent inquiries regarding the 
exemption of polymers from IUR reporting, EPA is clarifying this 
existing exemption. The exemption does not apply to a polymeric 
substance that has 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 such reactions carried 
out on polymeric materials are excluded from IUR reporting only if they 
are intended to have a totally polymeric composition. There is no 
change in the IUR status of polymeric materials that have not undergone 
such reactions and are flagged in the TSCA Inventory.
    f. Microorganisms. EPA is clarifying this existing definition to 
ensure that the definition used for IURA purposes is consistent with 
the microorganisms rule at 40 CFR part 725 and to clarify the status of 
chemicals produced from living microorganisms.
    2. How have the reporting thresholds 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 I and II 
of the revised Form U (see the regulatory text at Sec. Sec.  
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 5 premanufacture notification 
(PMN) low volume exemption threshold of 10,000 kg (approximately 22,000 
lbs.). EPA is raising the basic IUR reporting threshold in order to 
reduce the number of reports filed, thus reducing the overall industry 
burden associated with this regulation. The new reporting threshold 
does not represent a finding of low 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 a 
reportable chemical substance at or above this level will be required 
to report the information in Part III of the revised Form U (see Sec.  
710.52(c)(4) of the regulatory text) in addition to the information in 
Parts I and II of the revised Form U. The information reported on Part 
III of the form relates to the processing and use of chemical 
substances. EPA is instituting this separate threshold to limit 
processing and use data reporting to a subset of a few thousand IUR 
reportable chemicals out of the 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 it 
necessary to collect information on chemicals at reporting thresholds 
below the thresholds introduced in this action. Although both the 
25,000 lbs. and 300,000 lbs. thresholds are significantly higher than 
the current IUR 10,000 lbs. threshold, the enhanced information that 
will be gathered under the amended rule will enable the Agency and 
others to more efficiently identify those chemical substances 
warranting further, more in-depth review, as well as chemicals of 
lesser concern (see Ref. 6).
    3. Have the reporting year, the submission period, or the reporting 
frequency changed? In order to provide clarification, two new 
definitions are being added at 40 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 during the reporting year is 
submitted to EPA. ``Submission period'' replaces the term ``reporting 
period,'' as used under the current IUR regulations at 40 CFR part 710.
    As proposed, EPA is 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 other 
reporting 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 
from August to December (the ``submission period'' under IURA) 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 
from January 1 through May 1. This potential change is related in part 
to the

[[Page 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 most current information. Companies will now report 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 of the 
availability of the 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 IUR reporting year is 2001, so 
the first reporting year under IURA will be 2005. The submission period 
will continue to occur in the year following the reporting year, i.e., 
existing IUR submission period is in 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, EPA intends to change the reporting 
frequency after the first reporting year under IURA (i.e., 2005, with 
submission to EPA in 2006) from every 4 years to every 5 years. This 
would mean that, instead of occurring in 2009, the second reporting 
year under IURA would be 2010 (i.e., 5 years 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 5 years (i.e., 2011, 2016, etc.). In making this 
change, EPA also intends to change the recordkeeping period from 5 
years to 6 years. EPA agreed to make these changes within the next 12 
months as part of the 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 to help the regulated community become 
familiarized with the revised regulations. A draft copy of the guidance 
for the 2006 submission period can be found in the docket for this 
rulemaking (Ref. 9).
    4. How have the recordkeeping requirements changed? EPA is 
requiring that persons subject to reporting under IURA retain records 
that document any information reported to EPA under IURA for a period 
of 5 years beginning with the effective date of that submission period 
(see Sec.  710.57 of the regulatory text). The effective date of the 
submission period is the last day of the 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 EPA under IURA. 
Previously, submitters were required to retain records for 4 years (see 
40 CFR 710.37). Under IURA, if a person submits a report in the year 
2006, that person will retain the records on which the report is based 
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 of IUR by 
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 5 years. In that action, EPA also intends to change the 
recordkeeping period from 5 years to 6 years in order to continue to 
span successive submission periods. A 6-year recordkeeping period would 
require, under IURA, that if a person submits a report in the year 
2006, that person will retain the records on which the report is based 
until December 23, 2012.
    Persons who are not required to report under the existing IUR 
because 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 of 
information is routinely retained by companies in the normal course of 
business.
    5. How have the data elements reported by all submitters changed? 
The new and revised 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. Technical contact identification (Sec.  710.52(c)(2)(i) of the 
regulatory text). In addition to the name of a person who will serve as 
technical 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 and the 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 by the company to EPA.
    b. Plant site identification (Sec.  710.52(c)(2)(ii) of the 
regulatory text). 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 a 
plant site identification number in order to clearly identify the 
reporting site in a way that would allow the cross-linking of IUR 
information with information reported about the same plant site 
contained in other data bases. EPA specifically proposed requiring the 
reporting of a newly assigned Facility Registration Identifier (FRI), 
or, if the Facility Registry System were not yet in place in time for 
the publication of this final rule, the submitter would report the 
site's RCRA number, if one has been assigned to the site. In this final 
rule, EPA has decided not to require 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 not be responsible for obtaining or 
reporting this number.
    c. Chemical identification (Sec.  710.52(c)(3)(i) of the regulatory 
text). Submitters must indicate which type of chemical identifying 
number they are reporting, in addition to the number itself. EPA no 
longer allows the use of certain of the previously used substitute 
identifying numbers (such as EPA-assigned numbers for Test Market 
Exemption Applications, original TSCA Inventory form numbers, and 
numbers associated with Notices of Bona Fide Intent to Manufacture) 
because they are difficult to cross-reference to CAS Registry numbers. 
Submitters must report a CAS Registry number, or, if a CAS Registry 
Number is not known to the submitter, the submitter must report

[[Page 858]]

either an EPA-designated accession number for confidential substances 
or a PMN case number.
    d. Confidentiality of production volume range (Sec.  
710.52(c)(3)(v) of the regulatory text). Submitters must continue to 
report the specific production volume of the reportable chemical and 
may claim CBI protection 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, if 
needed, would be separate from a CBI claim for the specific production 
volume.
    Submitters of specific CBI production volume data may allow the 
release of more general range information. EPA expects that roughly 50% 
of submitters of specific CBI production volume data will allow the 
public release of volume ranges. This expectation of reduced CBI claims 
is based on the CBI claim statistics associated with the development of 
the original TSCA Inventory (See ``Inventory Update Rule (IUR) 
Technical Support Document: Evaluation of Likelihood of Confidential 
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 of the original TSCA Inventory, 
except for one change, i.e., the lowest range starts at the IURA 
reporting threshold of 25,000 lbs. rather than the 10,000 lb. threshold 
that was used in the current IUR. EPA additionally made one change to 
the ranges included in the proposed rule, i.e, the upper end of the 
first range and the lower end of the second range were raised to 
300,000 lbs. from the 100,000 lbs. range limit included in the 
proposal, resulting in ranges of 25,000 - 300,000 lbs. and 300,000 - 
1,000,000 lbs. This change makes the ranges consistent with the second 
reporting threshold of 300,000 lbs. or more (see Sec.  710.52(c)(4) of 
the 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 CBI might 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, and who did not report 
any information in Part III of reporting Form U (the industrial 
processing and use and the commercial and consumer use information), 
public users of the data would be able to infer that the submitter's 
production was somewhere between 100,000 to 300,000 lbs. per year - 
information which the submitter might have considered CBI. To protect 
against such inadvertent disclosures of CBI, EPA changed the production 
volume ranges to reflect the second reporting threshold of 300,000 lbs. 
EPA does not believe that the change significantly affects the utility 
of the data to the public.
    e. Number of potentially exposed workers (Sec.  710.52(c)(3)(vi) of 
the regulatory text). Submitters must report the range code that 
corresponds to their estimate of the total number of workers reasonably 
likely to 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 of 
manufacture, processing, distribution in commerce, or use of the 
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 of entry (inhalation, ingestion, skin 
contact or absorption, etc.), but exclude accidental or theoretical 
exposures.
    Workers involved in chemical manufacturing, processing, and use are 
a subpopulation of concern to EPA, the Occupational Safety and Health 
Administration (OSHA) (Ref. 12), the National Institute of Occupational 
Safety and Health (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, 
and may therefore be at potentially greater risk of adverse health 
effects. The number of workers 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 then used to develop priorities for testing, more 
detailed risk assessment, and risk management.
    Under IURA, submitters are required to use ranges rather than 
specific values for reporting certain data, including the number of 
workers 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 Sec.  710.52(c)(3)(vi) of the regulatory 
text. In general, reporting these ranges reduces the potential burden 
to submitters of developing a precise point estimate for the data 
element. The use of ranges should additionally result in fewer CBI 
claims than if precise point estimates were provided because ranges 
tend to 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 (Sec.  710.52(c)(3)(vii) of the regulatory 
text). Submitters must report the maximum concentration, measured by 
weight, of the reportable chemical substance at the time it leaves the 
submitter's manufacturing site or, if it is 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 of the various 
physical forms in which the chemical may be sent off-site or reacted 
on-site. Concentration ranges for use in reporting are found in Sec.  
710.52(c)(3)(vii) of the regulatory text.
    Concentration is an important variable to consider when estimating 
the magnitude of potential exposures. Information about the maximum 
concentration of a chemical substance present at processing and use 
sites is frequently used in chemical risk screening in the review of 
PMNs for new chemical substances required by section 5 of TSCA and is 
used to the extent it is available in screening chemicals on the 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

[[Page 859]]

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 of a mixture with 
other chemical substances, exposure estimates may be adjusted downward 
accordingly. For example, a chemical substance which is a component of 
a liquid mixture exerts a lower vapor pressure than it would as a pure 
chemical substance. Because higher vapor pressure is associated with 
increasing inhalation exposure to a chemical substance, the 
concentration of a chemical substance in a liquid mixture impacts the 
exposure assessment.
    A chemical may be produced in multiple physical forms and in 
multiple formulations and products. As described in Unit II.F.5.g., EPA 
is requiring reporting of each of the physical forms in which a 
chemical is sent off-site. For the purpose of exposure screening, EPA 
is requiring only the reporting of the maximum concentration, 
regardless of the various physical forms in which a chemical may be 
sent off-site.
    EPA had proposed that submitters also report the average 
concentration of the chemical when leaving the manufacturing site (at 
64 FR 46788). EPA is not promulgating this requirement because of the 
potential difficulty of determining 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 (Sec.  710.52(c)(3)(viii) of the regulatory text). 
Submitters must report the physical form(s) of the chemical at the time 
it leaves the site of manufacture or, if the chemical is site-limited, 
at the time it is reacted on site to produce a different chemical 
substance. The list of physical forms from which submitters must select 
is found in Sec.  710.52(c)(3)(viii) of the 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 of potential exposures. 
EPA's analyses of TRI and PMN data demonstrated that the physical state 
of a chemical is a determining factor in predicting the potential for 
industrial releases of chemicals, and hence, exposures to humans and 
the environment. The results of the analyses are provided in a 
technical support document that was developed by EPA in support of this 
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 
and how the chemical is likely to be handled during manufacturing, 
processing, and use, is an important data element for the purpose of 
exposure and risk screening.
    h. Percent production volume (Sec.  710.52(c)(3)(ix) of the 
regulatory text). Submitters are required to report the percentage of 
total production volume (as reported under regulatory text Sec.  
710.52(c)(3)(iv)) of the 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 a particular physical form for a given 
chemical across multiple sites. These determinations will allow EPA to 
better characterize the risk associated with chemicals that are 
manufactured in physical forms that typically result in higher 
exposures, such as volatile liquids or powders, but that are produced 
in small quantities. These percent production volume estimates will 
help put the physical form information into context. Estimates must be 
rounded off to the nearest 10% of production volume.
    6. What new definitions have been added to explain or reworded to 
clarify the reporting requirements? EPA has reorganized the definition 
section of the regulatory text associated with the original Inventory 
and IUR. There are now three definition sections. The existing Sec.  
710.2 contains definitions relevant primarily to the compilation of the 
original Inventory, although a few of these definitions are also 
relevant to both IUR and IURA. EPA has recodified these general 
definitions in Sec.  710.3. Definitions relevant only to IUR, which 
were originally in Sec.  710.2, are now in Sec.  710.23. Section 710.43 
contains definitions relevant only to IURA. This reorganization 
clarifies the relationships between the definitions and the various 
rules, and has no substantive effect.
    Two existing definitions are being clarified (Sec.  710.3 of the 
regulatory text). EPA defines ``manufacture'' to mean to manufacture, 
produce, or import for commercial purposes and ``manufacture or import 
`for commercial purposes''' to mean to manufacture, produce, or import 
with the purpose of obtaining an immediate or eventual commercial 
advantage, and includes, for example, the manufacture or import of any 
amount of a chemical substance or mixture: (1) For commercial 
distribution, including for test marketing, or (2) for use by the 
manufacturer, including use for product research and development, or as 
an intermediate.
    Certain new definitions are being added to Sec.  710.43 as a result 
of this final rule.
    a. Known to or reasonably 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 of 
reporting under IURA, a submitter will report information described in 
the regulatory text at Sec.  710.52(c)(1), (c)(2), and (c)(3) that is 
known to or reasonably ascertainable by the submitter. This means all 
information in a person's possession or control, plus all information 
that a reasonable person similarly situated might be expected to 
possess, control, or know.
    b. Readily obtainable information. TSCA section 8(a)(2) authorizes 
EPA to require persons to report information that is known to or 
reasonably ascertainable by the submitter. Under IURA, a submitter will 
report processing and use information (i.e., the information reported 
for sites at which the 300,000 lbs. threshold has been met or exceeded) 
only to the extent that such information is ``readily obtainable'' by 
the submitter's management and supervisory employees responsible for 
manufacturing, processing, distributing, technical services, and 
marketing of the reportable chemical substance (see regulatory text 
Sec.  710.43). Extensive file searches are not required. The ``readily 
obtainable'' standard for processing and use information requires less 
effort on the part of the submitter than the ``known to or reasonably 
ascertainable by'' standard that applies to all other IUR reporting 
(see regulatory text Sec.  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 under EPA's TSCA Section 8(a) 
Preliminary Assessment Information Rule (PAIR) (See 40 CFR 712.7). The 
``readily obtainable'' definition is further discussed in Unit III.D.2.
    c. Reasonably likely to be exposed. For the purposes of reporting 
under IURA, reasonably likely to be exposed means an exposure to a 
chemical substance which, under foreseeable conditions of manufacture 
(including import), processing, distribution in commerce, or use of the 
chemical substance, is more likely to occur than not to occur. Such 
exposures would

[[Page 860]]

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 of entry (inhalation, ingestion, skin contact, etc.), but 
excludes accidental or theoretical exposures.
    d. Use. For the purpose of reporting under IURA, EPA is defining 
``use'' as any utilization of a chemical substance or mixture that is 
not otherwise covered by the terms ``manufacture'' or ``process'' (see 
regulatory text Sec.  710.43). For example, the activity of processing 
a solvent into a paint formulation is considered ``processing'' rather 
than ``use'' because the activity incorporates the chemical substance 
(the solvent) into a formulation. If the paint formulation containing 
the solvent is then applied to a metal or wood surface (e.g., cars), 
this application would be considered a use activity. Relabeling or 
redistributing a container holding a chemical substance or mixture 
where no repackaging occurs does not constitute use or processing of 
the chemical substance or mixture.
    e. Repackaging. For the purpose of reporting under IURA, 
``repackaging'' is defined as the physical transfer of a chemical 
substance or mixture (as is) from one container to another container or 
containers in preparation for distributing the chemical substance or 
mixture in commerce. This definition does not apply to sites that only 
relabel or redistribute the reportable chemical substance without 
removing the chemical substance from the container in which it is 
received or purchased.
    f. Industrial use. EPA defines ``industrial use'' for purposes of 
reporting under IURA as use at a site at which one or more chemical 
substances or mixtures are manufactured or processed (see Sec.  710.43 
of the regulatory text).
    g. Commercial and consumer use. For purposes of reporting under 
IURA, EPA defines ``commercial use'' as the 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 other hand, means the use of a chemical 
substance that is directly, or as part of a mixture, 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 
Sec.  710.43 of the 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 for use by children. For purposes of reporting under 
IURA, EPA defines ``intended for use by children'' as the use of a 
chemical substance or mixture in or on a product that is specifically 
intended for use by children age 14 or younger. A chemical substance or 
mixture is intended for use by children when the submitter answers 
``yes'' to at least one of the following questions for the product into 
which the submitter's chemical substance or mixture is incorporated: 
(1) Is the product commonly recognized (i.e., by a reasonable person) 
as being intended for children age 14 or younger; (2) Does the 
manufacturer of the product state through product labeling or other 
written materials that the product is intended for or will be used by 
children age 14 or younger; or (3) Is the advertising, promotion, or 
marketing of the product aimed at children age 14 or younger?
    i. Reportable chemical substance. For the purposes of reporting 
under IURA, a reportable chemical substance is a chemical substance 
described in Sec.  710.45 of the regulatory text.
    j. Reporting year. For the purposes of reporting under IURA, the 
reporting year is the calendar year in which information to be reported 
to EPA during a submission period is generated, i.e., calendar year 
2005 and the calendar year at 4-year intervals thereafter. For 
instance, for information submitted in 2006, the information will be 
generated during the period from January 1 to December 31, 2005.
    k. Submission period. For the purposes of reporting 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 during the period from January 1 to December 31, 2005 (i.e., 
when the chemical substance is manufactured) will be submitted during 
the 2006 submission period.
    l. Site-limited. For purposes of reporting under IURA, EPA defines 
``site-limited'' to mean that a chemical substance is manufactured and 
processed only within a site and is not distributed for commercial 
purposes as a substance or as part of a 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.
    7. What new data elements are reportable by only larger production 
volume manufacturers? As described in Unit II.F.2., EPA is replacing 
the current IUR reporting threshold of 10,000 lbs. per year per site 
with two new production volume reporting thresholds of 25,000 lbs. and 
300,000 lbs. per year per site. Each person manufacturing a reportable 
substance at or above the 25,000 lbs. per year per site threshold is 
required to complete at least a partial report containing the 
information in Parts I and II of the revised Form U. Persons who 
manufacture a reportable substance at or above the 300,000 lbs. per 
year per site threshold are required to complete a full report, 
providing the information in Part III of the revised Form U in addition 
to the information in Parts I and II. Part III concerns the processing 
and use of chemical substances.
    a. Processing and use information (Sec.  710.52(c)(4) of the 
regulatory text). Submitters with plant sites at which a reportable 
chemical substance is manufactured in annual quantities of 300,000 lbs. 
or more must report processing and use information under IURA. EPA 
requires submitters to report the information described in Sec.  
710.52(c)(4) of the regulatory text concerning the processing and use 
of each reportable chemical substance at sites that receive a 
reportable chemical substance from the submitter site either directly 
or indirectly (including through a broker/distributor, from a customer 
of the submitter, etc.), whether the recipient site(s) are controlled 
by the submitter site or not. Processing and use 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 processing or use operations (Sec.  
710.52(c)(4)(i)(A) of the regulatory text). Submitters must report the 
industrial processing or use operation(s) at each site that receives 
the reportable substance from the submitter site (whether the recipient 
site(s) are controlled by the submitter site or not). The categories 
for reporting are listed in Sec.  710.52(c)(4)(i)(A) of the regulatory 
text.
    ii. North American Industrial Classification System (NAICS) Code 
(Sec.  710.52(c)(4)(i)(B) of the regulatory text). Submitters must 
report the five-digit NAICS code(s) that best describe(s) the 
industrial processing or use activities at the sites that receive a 
reportable chemical substance from the submitter either directly or 
indirectly (including through a broker/distributor,

[[Page 861]]

from a customer of the submitter, etc.), whether the recipient site(s) 
are controlled by the submitter site or not. The NAICS codes, published 
by the Office of Management and Budget (OMB), have superseded the prior 
system of Standard 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 setting in which chemical exposures associated with the 
industrial processing or use of a chemical substance may occur. 
Exposure to a chemical substance typically varies among industries. 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 can 
be 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 
must be provided. If more 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 of the substance's production volume, 
measured by weight. Submitters may also report the same NAICS code 
multiple times if the 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) (Sec.  710.52(c)(4)(i)(C) 
of the regulatory 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 Sec.  710.52(c)(4)(i)(C).
    A NAICS code and IFC combination sufficiently defines a potential 
exposure scenario for risk screening and priority-setting 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 
of information provides indications of the route, magnitude, and 
concentration of potential chemical exposures to humans and to the 
environment. The results of the studies are provided in two of the 
technical support documents that EPA developed in support of this rule 
(Refs. 14 and 16).
    IFCs are also useful in estimating the frequency and duration of 
chemical 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 of exposure 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 of these data, EPA often uses conservative estimates that may 
indicate a greater risk than is actually the case. Data that will be 
obtained under IURA will enable EPA to make more realistic 
characterizations of exposure, instead of ``worst case'' assumptions.
    iv. Percentage of production volume attributable to each 
combination of NAICS code and industrial function category in each 
processing or use operation (Sec.  710.52(c)(4)(i)(D) of the regulatory 
text). Submitters must estimate the percentage of total production 
volume attributable to each reported combination of NAICS code and IFC 
in each processing or use operation, to the extent that such 
information is readily obtainable. Estimates must be rounded off to the 
nearest 10% of production volume. Submitters are not permitted to round 
off to zero percent if the production volume attributable to a NAICS 
code/IFC/processing or use operation combination is 300,000 lbs. or 
more and accounts for 5% or less of the total production volume of a 
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 of a chemical to sites in its 
control as well as downstream sites, some of which are not immediate 
purchasers from the original manufacturing site. Additionally, the 
total percent production volume may add up to less than 100% if the 
submitter cannot readily obtain information about how all of its 
production volume is processed or used by industry.
    v. Number of processing or use sites (Sec.  710.52(c)(4)(i)(E) of 
the regulatory text). Submitters must report estimates of the total 
number of industrial sites, including those beyond the submitter's 
control, that process or use each reportable chemical substance 
manufactured by the submitter, with respect to each combination of 
NAICS code and IFC in each processing or use operation. The ranges that 
will be used for reporting the number of sites can be found at Sec.  
710.52(c)(4)(i)(E) of the regulatory text. For risk screening purposes, 
the number of sites at which chemical substances are manufactured, 
processed, or used is a useful indicator of the number of ecosystems 
and the size of the general population potentially exposed to the 
chemical substances.
    vi. Number of workers (Sec.  710.52(c)(4)(i)(F) of the regulatory 
text). Submitters must report estimates of the total number of workers, 
including those at sites not under the submitter's control, that are 
reasonably likely to be 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 of workers 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 extent that it is readily obtainable.
    b. Commercial and consumer use information (Sec.  710.52(c)(4)(ii) 
of the regulatory text). Submitters must report information concerning 
the commercial and consumer uses of each reportable chemical substance, 
whether the site(s) at which the chemical substance is used are 
controlled by the submitter site or not. As for the industrial 
processing and use information described in Unit II.F.7.a., commercial 
and consumer use information must be reported only by sites at which a 
chemical substance is manufactured in annual quantities of 300,000 lbs. 
or more, and submitters are only required to report the information to 
the extent that it is readily obtainable.

[[Page 862]]

    Consumers comprise a subpopulation of particular 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 of more 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 of chemicals that might be included 
in these programs, and may contribute to exposure assessments for these 
chemicals.
    i. Commercial and consumer product categories (Sec.  
710.52(c)(4)(ii)(A) of the regulatory text). 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). If 
more than 10 categories apply, submitters need only report the 10 
categories for the chemical substance that cumulatively represent the 
largest percentage of the submitter's production volume, measured by 
weight. The commercial and consumer product (CCP) categories are listed 
at Sec.  710.52(c)(4)(ii)(A) of the regulatory text. Information on the 
use of chemicals in CCPs is useful in estimating the frequency and 
duration of chemical substance exposures. In the absence of other 
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. Products intended for use by children (Sec.  
710.52(c)(4)(ii)(B) of the regulatory text). 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, a 
plasticizer chemical used to make pacifiers) or on (for example, as a 
component in the paint on a toy) any products intended for use by 
children, regardless of the concentration of the substance, or indicate 
that such information is not readily obtainable.
    EPA defines ``intended for use by children'' in Sec.  710.43 of the 
regulatory text and in Unit II.F.6.h. Using this definition, if a 
submitter determines, based on readily obtainable information, that its 
chemical substance or mixture is used in or on a product that is 
intended to be used by children age 14 or younger, the submitter would 
indicate 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 to be used by children age 14 or 
younger. As such, if a 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 on Form U for categories C01 and C10.
    On the other hand, EPA believes that certain products, like 
household cleaning products, automotive products, and lubricants--to 
name a few--are typically not intended to be used by children age 14 or 
younger. As such, if a submitter determines, based on readily 
obtainable information, that its 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 of products that are 
typically intended for use by children 14 or younger are provided for 
each commercial and consumer use category (this listing is not intended 
to be exhaustive and should therefore not be considered limiting):

 
------------------------------------------------------------------------
                                                         Examples of
              Code                    Category       Children's Products
------------------------------------------------------------------------
C01                              Artists' supplies   Crayons, children's
                                                      markers
------------------------------------------------------------------------
C02                              Adhesives and       Craft glue, model
                                  sealants            glue
------------------------------------------------------------------------
C03                              Automotive care     Typically products
                                  products            in this category
                                                      are not likely to
                                                      be intended for
                                                      use by children 14
                                                      or younger
------------------------------------------------------------------------
C04                              Electrical and      Electronic games,
                                  electronic          remote control
                                  products            cars, toys
------------------------------------------------------------------------
C05                              Glass and ceramic   Porcelain dolls
                                  products
------------------------------------------------------------------------
C06                              Fabrics, textiles   Pajamas
                                  and apparel
------------------------------------------------------------------------
C07                              Lawn and garden     Lawn and gardening
                                  products (non-      tools designed
                                  pesticidal)         specifically for
                                                      children, e.g.,
                                                      children's rake
------------------------------------------------------------------------
C08                              Leather products    Shoes, jackets,
                                                      baseball gloves
------------------------------------------------------------------------
C09                              Lubricants,         Typically products
                                  greases and fuel    in this category
                                  additives           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          Finger paints,
                                  coatings            water color kits
                                                      intended for
                                                      children's use
------------------------------------------------------------------------

[[Page 863]]

 
C13                              Photographic        Typically products
                                  chemicals           in this category
                                                      are not likely to
                                                      be intended for
                                                      use by children 14
                                                      or younger
------------------------------------------------------------------------
C14                              Polishes and        Typically products
                                  sanitation goods    in this category
                                                      are not likely to
                                                      be intended for
                                                      use by children 14
                                                      or younger
------------------------------------------------------------------------
C15                              Rubber and plastic  Pacifiers, action
                                  products            figures, balls
------------------------------------------------------------------------
C16                              Soaps and           Baby shampoo,
                                  detergents          children's bubble
                                                      bath
------------------------------------------------------------------------
C17                              Transportation      Child's car seat
                                  products
------------------------------------------------------------------------
C18                              Wood and wood       Baby cribs,
                                  furniture           changing tables,
                                                      wooden toys
------------------------------------------------------------------------
C19                              Other               Other items
                                                      specifically
                                                      intended for use
                                                      by children age 14
                                                      or younger
------------------------------------------------------------------------

    EPA chose the phrase ``intended for use by children'' because it 
appears 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 of 
defining ``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 a 
plaything for children through the age of 14 years'' (Ref. 17, section 
3.1.33).
    Obtaining information indicating that a chemical substance or 
mixture is used in a product that is intended 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 a policy to ensure that 
environmental health risks of children 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 assess because of limited 
information to identify where children's exposures occur and limited 
understanding of when and why children's exposures and responses are 
different from those of adults.
    In 1997, Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety 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 Order 13045, Extending the Task Force on Environmental Health 
Risks and Safety Risks to Children (66 FR 52013, October 11, 2001), 
extending the work of the 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 of the 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 of products 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 if they 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, and thereby allow EPA, as well as other 
interested parties and affected entities, to better prioritize such 
assessments and maximize available resources.
    iii. Percentage of production volume attributable to each 
commercial and consumer product category (Sec.  710.52(c)(4)(ii)(C) of 
the regulatory text). Submitters must estimate the percentage of their 
site production volume for each reportable chemical substance that is 
attributable to each specific commercial and consumer end-use. This 
information must be submitted to the extent that it is readily 
obtainable. Estimates must be rounded off to the nearest 10% of 
production volume. However, a CCP category which accounts for 5% or 
less of the total production volume of a reportable chemical substance 
cannot be rounded off to zero percent if the production volume 
attributable to that CCP category is greater than or equal to 300,000 
lbs. In such cases, submitters must report the percentage of production 
volume attributable to that CCP category 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 reported may add up to more 
than 100%, given that the submitter is reporting on distribution of a 
chemical to sites in its control as well as downstream sites, some of 
which are not immediate purchasers from the original manufacturing 
site. Additionally, the total percent production volume may add up to 
less than 100% if the submitter cannot readily obtain information about 
how all of its production volume is used in commercial and consumer 
products.

[[Page 864]]

    iv. Maximum concentration in commercial and consumer products 
(Sec.  710.52(c)(4)(ii)(D) of the regulatory text). Submitters must 
report the maximum concentration (measured by weight) of each 
reportable chemical substance in each commercial and consumer product 
category. In complying with this requirement, submitters will select 
from the list of concentration ranges provided in Sec.  
710.52(c)(3)(vii) in the regulatory text. Concentration is further 
discussed in Unit III.B.1.b. As with the other processing and use 
information that submitters must report, such information will be 
reported only to the extent that it is readily obtainable by the 
submitter.
    8. What changes have been made to requirements for making CBI 
claims? Submitters are able to claim information submitted to EPA under 
this amended rule as confidential if they have reason to believe that 
release of the information would reveal trade secrets or confidential 
commercial or financial information, as provided by section 14 of TSCA 
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 limit invalid 
confidentiality claims as much as possible.
    Submitters will have an opportunity to make CBI claims for most of 
the information reported under IURA. To claim information as 
confidential, a submitter must check the appropriate box and sign the 
certification statement on the reporting form. If a submitter fails to 
do so, EPA could release the information to the 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 of 
confidentiality are true and correct. Procedures for claiming 
information submitted electronically (such as a submission on diskette) 
as CBI will be specified in the instruction manual that will be 
available each submission period as described in Sec.  710.59 of the 
regulatory text. CBI should not be submitted by e-mail. A discussion 
about CBI claims under IURA is provided in this unit.
    a. Upfront substantiation for plant site identity. Submitters are 
required to provide upfront substantiation for CBI claims for plant 
site identity, in a manner similar to the upfront substantiation of 
chemical identity under the existing IUR (see 40 CFR 710.38). Under 
IURA (see Sec.  710.58(d) of the regulatory text), a submitter may 
assert a claim of confidentiality for a plant site identity if the 
submitter believes that releasing that identity would reveal trade 
secrets or confidential commercial or financial information, as 
provided by TSCA section 14. Submitters in past IUR information 
collections have claimed in excess of 15% of plant site identities as 
CBI. While the Agency does not question the occasional need for this 
claim, it believes that these claims should be limited to only those 
circumstances in which it is necessary. Further discussion on upfront 
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 Sec.  710.58(d) of the 
regulatory text. If a submitter fails to substantiate the plant site 
CBI claim, EPA could make the information available to the public 
without further notice to the submitter.
    b. CBI claims for chemical production volume information. EPA did 
not change the ability of the submitter to assert a claim of 
confidentiality for production volume information if the release of 
that information would reveal trade secrets or confidential commercial 
or financial information as provided by section 14 of TSCA. 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 of the original TSCA Inventory collection and can be 
found at Sec.  710.52(c)(3)(v) of the regulatory text.
    In the last four IUR submission periods when EPA sought actual 
production volume information, approximately 65% of the information was 
claimed as confidential. In contrast, only 35% of production 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 of CBI claims in IUR reports has severely 
limited EPA's ability to convey production volume information to the 
public, even in the form of a national aggregate production volume for 
the chemical. EPA needs to be able to convey production volume 
information to the public to explain its chemical risk assessment and 
risk management decisions. Effective communication of this information 
is vital to EPA's overall mission. EPA has added the ability to claim 
production volume range information CBI in an effort to address this 
problem. In some cases, submitters may choose to claim their actual 
production volume as CBI, while allowing the more general production 
volume range to be 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 of EPA's 
Responses to Public Comments Submitted in Response to Proposed TSCA 
Inventory Update Rule Amendments'' (Ref. 18).

A. General Comments

    1. How will EPA and others use the new exposure-related data 
collected under these amendments? Several commenters expressed the view 
that EPA has not provided 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, EPA has 
determined that a portion of the chemicals (both inorganic and organic) 
on the TSCA Inventory currently warrant the collection of manufacturing 
information, and that a subset of those 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 IUR to provide an accurate and readily available 
source of basic exposure-related information for approximately 4,000 of 
the 76,000 substances listed on the TSCA Inventory. The amendments 
significantly limit industry's reporting burden while providing EPA 
with information needed to screen for risks to human health and the 
environment.

[[Page 865]]

    EPA's primary use of these 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 of both 
hazard and exposure information. The lack of exposure-related data 
beyond production volume data in the current IUR has severely limited 
the usefulness of the current IUR data for risk screening. Moreover, 
the exposure-related data that will be collected under IURA are not 
otherwise readily available from publicly available data sources (see 
Unit III.A.3.). This lack of exposure-related data has made it 
difficult for EPA and others to identify chemicals with potential 
exposures of concern, and has resulted in the generation of overly 
conservative screening level exposure assessments.
    The addition of manufacturing, processing and use exposure-related 
data to 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 for better 
prioritization of chemicals to identify those warranting more detailed 
assessments and to eliminate chemicals of lesser concern from further 
review.
    Data generated by IURA will be used in a wide variety of programs 
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 
data base could be searched to identify chemicals that, based upon 
these data, have the greatest potential for consumer exposure, creating 
a list of chemicals arranged according to the production volumes 
associated with different consumer uses. Additional examples of uses 
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 the 
basic production data reported under the existing IUR, new uses of IURA 
data by EPA and by others will continually emerge and cannot be 
predicted at this time.
    Results from EPA tools such as the Use Cluster Scoring System 
(UCSS) will be greatly improved by IURA data. The UCSS is a 
computerized tool that combines hazard and exposure information from a 
variety of data 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 of the UCSS that the lack of exposure information in the 
system has impaired its usefulness (Ref. 20). The IURA data base will 
provide exposure information that the UCSS will be able to download 
directly and use. (For a description of UCSS, see V.B.6. of the 
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 and 
risk screening across a portion of the TSCA Inventory chemicals. Some 
of the same types of data that 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 of programs such as: The 
voluntary UEIP (see http://www.epa.gov/opptintr/exposure/docs/ueip.htm 
for a description of this project) and the PMN program under TSCA 
section 5. Although the UEIP and PMN programs involve the submission of 
certain data that are the same as or similar to data being submitted 
under IURA, these programs cannot sufficiently serve the needs that 
IURA will serve (see Units V.A.1. and V.B.5. of the proposed rule at 64 
FR 46775 and 46780). However, these programs are examples of the 
usefulness of certain IURA data elements.
    For example, several IURA data elements were used in an Existing 
Chemicals Program initial review of the chemical methyl ethyl ketoxime 
(MEKO). This review relied in part upon data submitted by industry 
under the UEIP. Some of the 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 of workers, physical/
chemical properties, and consumer product information. Other UEIP 
information submitted by industry on MEKO are not of the sort that will 
be 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 and two importers of MEKO in 1993 and five primary end 
uses (submissions provided percentages of MEKO production and import 
volumes devoted to each use). The submissions also reported the number 
of workers at the manufacturing site, the physical forms of products 
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 EPA to 
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 and use to estimate exposures to 
workers who either formulate paints or apply the paints using spray 
guns or other techniques. MEKO use in paint indicates a potential for 
exposure to several large populations (workers and consumers) because 
exposure to even small amounts of paint can result in significant 
exposure levels to chemicals in paints. Such use information can also 
be used by EPA to generate estimated numbers of workers in very small 
businesses (< 10 workers) that may be poorly represented by existing 
National Occupation Exposure Survey (NOES) data. In the MEKO case, such 
a population would be commercial painters. Without the information 
about MEKO use in paints and the large percentage of MEKO 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 of IURA data elements is also demonstrated by EPA's 
use of similar data in its New Chemicals Program. PMNs for new chemical 
substances submitted to EPA under TSCA section 5 require many of the 
same exposure-related data elements that will be reported under IURA. 
Exposure-related data in PMNs include estimates of production volume, 
categories of use, percent production volume in the categories of use, 
maximum number of workers exposed,

[[Page 866]]

and concentrations and physical forms of the chemical. EPA uses these 
exposure-related data to generate screening level risk assessments for 
regulatory decision-making under TSCA section 5.
    The manufacturer of a new chemical provided the following 
information in a recent PMN submission: An estimated import volume; 
chemical uses and the percentages of the import volume devoted to each 
use (non-cosmetic applications as a component of a fragrance 
formulation used in household products such as detergents, cleaners, 
soaps, room fresheners, etc.); number of sites 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 of manufacturers of household products who 
may use the new substance. Releases of the new substance as a result of 
the fragrance formulation process and from manufacturers of the 
household products were estimated, resulting in estimated environmental 
concentrations of the new substance due to its release and estimated 
general population exposures to the new substance. EPA also used the 
information on processing and use 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 to potentially-exposed workers, the general 
population, consumers, and aquatic species were all below levels of 
concern. Therefore, the Agency could determine that no further 
regulation under TSCA section 5 was 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 and use data 
on inorganic substances, EPA could have quickly identified importers of 
zinc sulfate and segments of industry or the general population that 
might use the chemical. EPA then could have targeted warnings of the 
potential for exposure to cadmium more effectively, thereby preventing 
exposures to the groups likely to be the most highly exposed.
    Other Federal agencies have also long recognized the need for and 
importance of exposure data. OSHA, NIOSH, and CPSC have written letters 
supporting EPA's and their 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 of IURA information. The IURA exposure-related data will be 
important to users beyond those who accessed the existing IUR in the 
past solely for 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 to put the hazard data into 
context. Risks identified via evaluation of these screening level 
hazard and exposure data then can be addressed.
    Although EPA can envision a wide variety of uses for the new IURA 
exposure-related information as described in this section, the Agency 
anticipates that even more opportunities exist for use of this 
information, as is true for the basic production data reported under 
the current IUR.
    2. What is the practical utility of the new exposure-related data? 
Commenters have questioned whether the data collected as a part of this 
rulemaking will have ``practical utility.'' Practical utility is 
defined in the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3502(11)) to mean ``the ability of an 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 5 CFR part 1320.3(l) 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 ability to process the information in a 
useful and timely fashion, and whether the Agency demonstrates actual 
timely use of the data by the Agency's own functions. The following 
discussion addresses commenters' concerns in two parts: First, the 
accuracy, validity, adequacy, and reliability of the data; and second, 
the timely use of the data by EPA.
    a. How has the Agency ensured that the data will be accurate, 
valid, adequate, and reliable? Commenters asserted that the data EPA 
proposed to collect through IURA would not be adequate for the purposes 
stated by EPA, and would not be accurate, valid, or reliable. 
Commenters stated that the information collected through IURA would be 
of limited accuracy and would be inferior to data the Agency has 
collected in other programs. Commenters also stated that the 
information would be so uncertain that it would 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 of potential 
exposure. Additionally, commenters asserted that they do not know how 
their chemicals are used downstream of the manufacturing site, 
therefore if they were required to report such information, the 
resulting data would be unreliable.
    EPA considered the types of information needed for screening level 
exposure and risk assessments and believes the information that will be 
collected through IURA will have the necessary level of accuracy, 
validity, adequacy, and reliability for such assessments. EPA agrees 
that there are many ways to increase the accuracy, validity, and 
reliability of the data. However, in developing IURA and considering 
various alternatives, EPA relied on experience from programs such as 
TSCA's PMN program and the UEIP data collection, and maintained a 
balance between data needs for exposure screening and priority setting 
and the burden associated with providing the information. If the 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 that there are many factors that can 
affect exposure potential; however, the data provided by the submitters 
will provide baseline information sufficient for an initial screen of 
exposure potential.
    i. Adequacy of the data. 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

[[Page 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 of potential exposure. One commenter stated 
that 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 of the activities 
in which workers are engaged, and the physicochemical characteristics 
of the chemical substances. This commenter also stated that the data 
collected under IURA will provide a limited and potentially inaccurate 
view of potential exposure. However, as summarized in Unit III.A.1., 
risk analyses performed by the Agency in general and OPPT in particular 
are graduated and data-driven. As the initial levels of concern and the 
quantity and quality of data 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 such programs as the TSCA New Chemicals Program, 
the Agency believes IURA data will provide information adequate to 
perform initial screens of chemicals. The Agency also will be better 
able to prioritize and make basic risk management decisions about those 
chemicals of greatest 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. Accuracy and reliability of the 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 should be 
accurate and reliable 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 of chemicals 
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 and reliability of much of the 
information reported in Part III of the proposed revised Form U (Sec.  
710.32(c)(4) of the proposed regulatory text, now Sec.  710.52(c)(4)) 
would be highly questionable because it relates to sites, activities, 
and products that are not under the direct or indirect control of the 
reporting company. Industry programs such as the ACC's Responsible Care 
Program (see http://www.americanchemistry.com for more information) 
require that, as part of the 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 of 
their chemicals. EPA recognizes that submitters may not always have 
detailed information about how the chemical(s) they make are used. As a 
result, submitters will only be required to report this information to 
the 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 as the information 
that will be reported under the IURA. These data are believed to be of 
sufficient reliability for use by the Agency and others for purposes 
such as screening level risk assessments and prioritization.
    EPA also requires much of the IURA information to be 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 the burdens associated with data collection. Second, 
information reported in discrete numeric values can indicate a level of 
accuracy that is not necessarily present. EPA believes that a higher 
level of confidence in data accuracy can be achieved by specifying 
ranges.
    Commenters suggested that EPA use other methods 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. For example, the UEIP was undertaken by EPA in 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 of the forms received for those 48 chemicals were not 
completely filled out, and only a subset of manufacturers submitted 
data. Thus, while the information that EPA received was quite useful, 
it was insufficiently complete for the purposes to which IURA 
information will be put. EPA's experience with UEIP is an indicator 
that exposure data collected under a voluntary effort are likely to be 
uneven and fall short of meeting EPA's needs.
    iii. Validity of the data. Another commenter had specific concerns 
about the validity of the worker exposure data and felt that an 
auditing program would be necessary to generally ensure an acceptable 
level of quality for data collected under IURA.
    EPA agrees that validated exposure data are the most useful for the 
full range of Agency risk assessment activities. However, EPA's 
experience with similar data collection efforts such as TSCA's New 
Chemicals Program demonstrates that the type of data 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 on industry and the Agency that 
would 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 and types of exposures from 
which chemicals need further review.
    b. Will the Agency use the data in a timely manner? Many commenters 
questioned whether EPA would be able to make effective and timely use 
of IURA processing and use information, stating that the large amount 
of data submitted would overwhelm the Agency. EPA acknowledges that 
IURA will generate a significant quantity of new data that EPA has not 
handled under past IUR data collections. However, EPA has carefully 
designed

[[Page 868]]

the data collection to facilitate efficient data management and use. 
Data collected through IURA will be put into a relational data base 
format, which can be easily searched, compared, and used. The 
collection of data organized by codes, rather than narrative 
information presented in an unstructured manner, lends itself to such a 
data base format. In addition, providing for electronic IURA 
submissions allows data to be entered into the data base more 
accurately and expeditiously, resulting in a quick turnaround between 
the submission of the data to the Agency and the availability of the 
data for use. The Agency anticipates that approximately 95% of all 
reports will be submitted electronically or on 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't EPA use other available sources of data or 
mechanisms to collect the data sought under IURA? EPA requested 
comments on specific mechanisms or data sources it could use to obtain 
needed exposure-related information with greater ease and less burden 
to industry. Commenters responded with a variety of sources, ranging 
from current data collection mechanisms within EPA (such as TSCA 8(a) 
PAIR, UEIP, and cooperative approaches) to public data sources such as 
the Hazardous Substances Data Bank (HSDB) (HSDB is a toxicology data 
file on the National Library of Medicine's (NLM) Toxicology Data 
Network (TOXNET)). In addition, many commenters stated that EPA has not 
made effective use of the exposure-related 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 that under the voluntary 
UEIP, EPA was furnished exposure-related data on 60 HPV chemicals 
(actually only 48), but only two reached the initial risk assessment 
stage.
    The alternate data sources commenters described were generally 
sources that EPA had already evaluated in its analysis for the proposed 
rule or with which EPA was otherwise familiar. EPA explored a wide 
variety of public data sources, as demonstrated 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 of Existing Exposure-
Related Data Sources and Approaches to Screening Chemicals: A Response 
to CMA'' (Ref. 27) (see also Unit V.B.5. of the 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 that EPA proposed to 
collect under IURA. After considering the information provided, EPA 
believes 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 as part of its 
consideration of a 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 and up-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 sought under IURA is not currently 
accessible to EPA. Although some useful exposure-related data exist in 
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, if EPA were to have specific concerns about 
information collection for substances or categories of substances, the 
selective use of TSCA section 8(a) PAIR (40 CFR part 712) reporting 
would be more cost effective than requiring all manufacturers exceeding 
a production trigger to report manufacturing, processing, and use 
information. EPA disagrees with the 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 of chemicals on the TSCA 
Inventory. PAIR is a very useful data collection tool when one or a 
small group of chemicals is targeted for risk assessment; however, PAIR 
is limited when collecting information on a large number of chemicals. 
Additionally, the PAIR rule has fewer, less definitive data elements 
than IURA, is a one-time collection versus the recurring collection of 
IURA, and will not provide data sufficient to meet the goals of IURA. 
Use of PAIR rather than IURA would force EPA to set risk 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: A Response 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 data previously collected under PAIR, 
CAIR, and the UEIP in a variety of ways, such as to support TSCA 
section 4 test rule analyses, to provide analyses for the Agency's 
efforts under the OECD SIDS program, and in support of international 
efforts (Refs. 18 and 27). However, the existing sources are generally 
best used when conducting a more detailed risk assessment of a specific 
chemical of concern, rather than preliminary risk screening of a 
relatively large set of chemicals. The IURA submissions will provide a 
consistent set of screening level exposure data that will allow EPA to 
better identify on a relative basis the chemicals of highest priority 
for further risk evaluation. EPA will use IURA data to identify those 
specific chemicals which are of potential concern and need 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 (or 
group of chemicals) has sufficient potential for exposure or risk to 
warrant further assessment, the Agency will use the other information 
sources and data gathering tools as appropriate.
    4. Can TSCA information be used for right-to-know purposes? Some of 
the commenters stated that TSCA does not authorize EPA to promulgate 
IURA based in part on EPA's goal of providing ``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 of the principles embodied in the right-to-know 
concept. For instance, 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

[[Page 869]]

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 of health, 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 of the Toxic Substances Control Act, at 414 
(1976) (``Present authorities for protecting against and regulating 
hazardous chemicals are fragmented and inadequate . . . Most 
significant among the deficiencies are . . . (3) No authority exists 
for collection of data to determine the totality of human and 
environmental exposure to chemicals.''). TSCA was seen as a way of 
providing federal agencies and the public with access to health, 
safety, and exposure data so that the risks of chemical substances 
could be more fully evaluated and understood. See, Statement of Sen. 
Hartke, Cong. Rec., March 26, 1976 [S4397- 4432], reprinted in 
Legislative History of the Toxic Substances Control Act, at 218 (1976) 
(``[T]he essential element of this legislation is that it has 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 of the chemicals is concerned.``). Congress envisioned TSCA as 
a tool for providing the public and others with health, safety, and 
exposure information about chemical substances.
     Finally, TSCA does not limit the use or disclosure of data (except 
if data 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 of government. These sections again demonstrate 
TSCA's role as a tool for gathering and disseminating information about 
chemicals.

B. Comments on Specific Data Elements

    1. Manufacturing information--a. Physical form. EPA requested 
comment on its proposed requirement that submitters report the physical 
form of a chemical as it leaves the site of manufacture. Several 
commenters suggested variations on the specifics of physical form 
reporting, but generally agreed with reporting the physical form as the 
chemical leaves the site of manufacture. For instance, one commenter 
suggested expanding the types of physical forms that can be reported. 
EPA has determined that the six categories as proposed (see Sec.  
710.52(c)(3)(viii) of the regulatory text) will be adequate for risk 
screening purposes, and is not adding additional physical form 
categories at this time. Experience with the same six physical form 
categories as part of EPA's exposure screening assessment of over 
20,000 chemicals in its New Chemicals Program indicates that the 
categories of physical forms that EPA is using 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 site in more than one physical form. EPA agrees 
with this comment and is requiring in this final rule that submitters 
report all physical forms of a substance when the substance is sent 
off-site. Reporting on all physical forms in IURA will lead to a better 
assessment of exposure to a chemical substance. For example, processing 
a fine, nonagglomerating powder could result in occupational exposure 
by inhalation of chemical dust. Processing the same chemical as a 
liquid solution would eliminate, or at 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 of a chemical substance, its production volume, and the fraction 
directed to each industrial processing or use activity, a screening 
estimate of the potential exposure associated with manufacturing or 
processing of a chemical substance can be derived. The resulting 
exposure assessment will be more representative and less conservative 
than if the physical form(s) were unknown. For these reasons, EPA is 
requiring the reporting of all 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 of each reportable chemical 
substance at the time the substance is sent off-site. A number of 
commenters felt that 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 or maximum concentration of an individual chemical across these 
formulations; such information does not reside in any currently 
available data bases and would need to be generated for IURA reporting 
(which would be particularly difficult with respect to average 
concentration information); and average and maximum concentrations may 
vary in product formulations during different IURA reporting cycles. 
Commenters suggested that maximum concentration information will be 
misleading if only a small amount of the reportable chemical substance 
is made available commercially at that concentration, while the bulk of 
the 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 or by the weighted average 
of each product, and each of the 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 less likely to 
present a risk to human health or the environment. Average 
concentration information cannot be used to make such a determination.
    EPA recognizes that the concentration of an 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 
select for IUR reporting. Instead, EPA is simply requiring that 
submitters select a range of concentrations from a list of given 
ranges. The ranges from which 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 it 
would 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

[[Page 870]]

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 of the chemical substance. 
EPA recognizes that concentration data may vary from product to product 
and from shipment to shipment, and may be difficult to report in some 
instances, particularly in product formulations. EPA is not requiring 
the reporting of concentrations in all products and formulations but 
rather only one maximum concentration, regardless of the 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 should be 
known to or reasonably ascertainable by most 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 to report 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 of the MSDS.
    2. Industrial processing and use. The Agency received three 
comments regarding the IFCs to be reported by submitters that have 
plant sites at which 300,000 lbs. or more of a reportable chemical 
substance are manufactured. The first comment questioned how the IFCs 
would apply to chemicals with multiple industrial uses. The second 
comment suggested that the Agency provide submitters with a ``free 
response'' option if their 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 of 
processing or use categories, IFCs, and NAICS codes (see Sec.  
710.52(c)(4)(i)(A), (c)(4)(i)(B), and (c)(4)(i)(C) of the regulatory 
text). In making their selection from among the IFC codes, submitters 
must determine which IFC best represents the specific industrial use of 
the reportable chemical within a given NAICS code/processing and use 
category. The Agency will provide examples of how to select which code 
``best represents'' an industrial use in the instruction manual that 
will be available to all submitters (see Sec.  710.59 of the regulatory 
text). Submitters may report multiple IFCs for the same NAICS code, and 
multiple NAICS codes may be paired with the same IFC. Unit II.F.7. 
provides further information on reporting industrial processing and use 
information.
    The set of IFCs adopted by EPA at Sec.  710.52(c)(4)(i)(C) 
encompasses the vast majority of uses 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 and believes 
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 should be matched. If none of the 
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 of the production of each 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 if the Agency, rather than the submitter, attempted to 
aggregate uses other than those identified in the prescribed list of 
IFCs.
    3. Commercial and consumer use--a. Commercial and consumer product 
categories. In the proposed rule, the Agency requested comment on the 
appropriateness of the commercial and consumer product categories. 
Commenters had a range of opinions about the proposed categories. One 
commenter felt that EPA should adopt the use categories used by the 
European Commission (EC) (Ref. 28). Another commenter stated that the 
categories appeared to be adequate. A third commenter suggested that 
the ``C-19 Other'' category be deleted and that 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. EPA has evaluated the EC's set of use categories and 
has determined that these categories blend functional use information 
with end use information. They therefore constitute a more complex 
identification system than the one that will be used under IURA. For 
the screening level purposes of IURA data, EPA currently believes that 
focusing on end use information alone for commercial and consumer uses 
provides the necessary level of detail for its screening level reviews. 
EPA is concerned that the use of EC'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 on the 
relationship between EC and IURA categories can be found in the 
instruction manual for IURA (see Sec.  710.59 of the 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 a propellant would be listed under the category ``aerosol 
propellants'' using the EC system. Such a listing would not provide the 
Agency with the information it needs about the type of commercial/
consumer product in which 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 will provide examples of the types 
of products that fit into its commercial and consumer product 
categories in the instruction manual that will be made available to all 
submitters (see Sec.  710.59 of the regulatory text).
    EPA considered requiring submitters to identify the specific use of 
the 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 Sec.  
710.52(c)(4)(ii)(A) of the regulatory text in order to encourage 
manufacturers to more carefully consider the listed categories, as 
opposed to being 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

[[Page 871]]

consumer category their product use best fits. By aggregating similar 
product categories, EPA will more effectively characterize the risk 
associated with the totality of the use of each 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 end uses. Three commenters requested that EPA not only 
continue to exempt chemicals that are manufactured only for non-TSCA 
purposes (such as pesticides, drugs, cosmetics, etc.) from all IURA 
reporting, but also exempt manufacturers of IURA-reportable TSCA 
chemicals from the requirement that non-TSCA downstream uses be 
reported (such as use of a TSCA chemical by a downstream processor in 
making a pesticide, etc.). These commenters assert that EPA does not 
have authority under TSCA to implement requirements of this sort.
    EPA agrees that substances that are manufactured only for 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 of manufacture to 
be used for non-TSCA purposes (e.g., as a pesticide, as a drug) do not 
have to be reported.
    The Agency also agrees that submitters under IURA will not be 
required to report on the non-TSCA downstream uses of the TSCA 
chemicals that they manufacture. It is important to note that EPA was 
able to reach this conclusion without reaching the issue of whether it 
has the authority to require such reporting. Descriptions of IFCs (see 
Sec.  710.52(c)(4)(i)(C) of the regulatory text) have been clarified to 
reflect the fact that they only include TSCA uses. For example, one of 
the IFCs is called ``Agricultural chemicals (non-pesticidal).'' The 
consumer and commercial product categories (see Sec.  
710.52(c)(4)(ii)(A) of the regulatory text) are also restricted to TSCA 
uses. An example of one of these categories is ``Lawn and garden 
products (non-pesticidal).'' 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 may be regulated under TSCA, (e.g., surfactants).
    c. Exempt reporting of use information for chemicals in articles. 
Two commenters believed that to the extent a submitter's reportable 
chemical is used in an article, the submitter should be exempt from the 
reporting of consumer and commercial end-use information (i.e., Sec.  
710.32(c)(5) of the proposed regulatory text). The commenters stated 
that there is no reason to believe that consumer exposure will result 
from chemicals in articles.
    EPA does not agree that manufacturers of chemicals 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 data and maximum concentration 
data. A commenter felt that in the case of consumer products in 
particular, it is unclear whether the percent production data and 
maximum concentration data required under Sec.  710.32(c)(5)(i)(B) and 
(c)(5)(i)(C) of the proposed regulatory text would add any material 
information to the production volume information already required under 
the existing IUR. The commenter stated that the volumes of chemicals 
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 at the 
manufacturing site is 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 of products, or the chemical will be used multiple times 
before reaching the consumer/commercial product. For instance, a 
manufacturer may report that a chemical is used in three different 
commercial and consumer product categories--20% of the 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 (say 90%), a final product may have a different 
concentration. For instance, the final product may contain only 5% of 
the chemical. The resulting potential exposure scenario associated with 
such a product would be very different from a scenario where the 
concentration in the final product is 90%. The Agency, therefore, is 
retaining the commercial and consumer percent production volume and 
maximum concentration data elements.
     4. General data elements comments--a. Workers who are ``reasonably 
likely to be exposed'' to a reportable chemical. EPA requested comment 
on alternative definitions of ``potentially exposed worker'' and 
``reasonably likely to be exposed.'' Specifically, EPA requested 
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 or in foreseeable emergencies. Workers such as 
office workers or bank tellers who encounter hazardous chemicals only 
in non-routine, isolated instances are not covered. OSHA's hazard 
communication standard also defines ``exposure'' or ``exposed'' as the 
exposure of an employee to a hazardous chemical in the course of 
employment through any route of entry (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 likely to be exposed to 
chemical substances. This commenter stated that the Agency should 
broaden the definition of exposure in IURA to include potential 
(accidental or possible) exposures to chemical substances which workers 
may experience in the course of their employment. This commenter also 
stated that this is what worker exposure entails in the real world and 
to exclude some portion of those worker exposures, as EPA proposed, is 
inappropriate. A second commenter felt that persons who could be 
exposed to a chemical substance in foreseeable emergencies should be 
included in EPA's new definition for persons who are reasonably likely 
to be exposed to a reportable substance.

[[Page 872]]

    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 of the 
potential hazards of that chemical, EPA is seeking to specifically 
identify those persons routinely exposed to chemical substances and for 
whom engineering controls and personal 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 protective equipment. EPA requested comment on whether 
the Agency should collect information on the use of PPE during the 
manufacture of chemicals reported under IURA. Several commenters stated 
that EPA should not collect PPE information for the purposes of risk 
screening. After reviewing these comments, EPA agrees that collecting 
information on the availability of PPE would not enhance the initial 
risk screening process, and has determined that this data element 
should not be added to the IUR as part of this 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 of a chemical substance is initially assessed by EPA 
in the absence of PPE information. The IURA is designed primarily to 
collect only screening level information. Inclusion of PPE in risk 
assessment would require collection and integration of location-
specific information on physical conditions and the PPE used, and would 
greatly complicate the risk assessment. This type of information is 
more 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 EPA use 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 of workers 
reasonably likely to be exposed. Because the reporting of PPE 
information would not contribute to the initial risk screening process 
and would impose an additional burden on persons reporting under IUR, 
EPA is not including information on PPE in the reporting requirements 
for this rule.
    c. Metric system reporting. Under IUR, data are currently reported 
using the U.S. customary system of measurement 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 at 
least give submitters the option of using either metric or U.S. 
customary units. One commenter requested that EPA continue to require 
the use of U.S. customary units or give submitters the option of 
reporting in either metric or U.S. customary units. EPA has decided to 
continue to require the use of the U.S. customary system because at 
least in the short term, this allows the IUR data base to remain 
compatible with other Agency data bases, 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 of units 
would create confusion and increase reporting and administrative error. 
EPA may revisit this issue in future IUR amendments.

C. Reporting Universe Comments

    EPA received a variety of comments concerning which chemicals and 
sites should be subject to reporting and recordkeeping requirements.
    1. Chemical categories undergoing changes in reporting status. In 
the IURA proposal, EPA created exemptions from reporting for several 
groups of chemicals that would otherwise be IUR-reportable. 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 of the existing full exemption; (2) 
creating a partial reporting exemption for chemical substances termed 
``petroleum process streams'' for purposes of reporting under IURA; 
and, (3) creating a full exemption for certain forms of natural gas. 
EPA also requested comment on the creation of additional exemptions, 
but asked that commenters provide a clear supporting rationale for 
creating such exemptions.
    a. Inorganic chemicals - Many commenters submitted comments about 
the removal of the full exemption for inorganic chemicals.
    EPA originally created the inorganic chemical exemption because it 
believed that the hazard potential of many inorganics was ``relatively 
well-established'' (50 FR 9944, 9947, March 12, 1985) and that hazard 
information alone was sufficient for prioritization within inorganic 
chemical substance risk assessments. EPA now intends to increase the 
consideration given to exposure, another component of risk, in 
screening chemicals and in setting priorities for risk assessment and 
risk management activities. The Agency no longer believes that chemical 
hazard information alone provides a sufficient basis for prioritization 
for these purposes. As a result, the former basis for this exemption is 
no longer applicable.
    i. Why does the Agency need basic IUR information on inorganic 
chemical substances? During interagency review prior to proposal it was 
suggested that EPA first collect the IUR information in Sec. Sec.  
710.52(c)(1), (c)(2), (c)(3), and 710.58 of the regulatory text (Parts 
I and II of the revised Form U) on inorganic substances before 
collecting the processing and use information in Sec.  710.52(c)(4) of 
the regulatory text (Part III of the revised Form U). It was thought 
that partial reporting would allow EPA to become generally familiar 
with the production volumes of inorganic chemicals, and would permit 
manufacturers of these 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 that EPA 
had not demonstrated the practical utility of collecting basic 
information on inorganic substances. Other commenters felt the Agency 
should collect these data and that inorganic chemicals should not have 
had an exemption under IUR.
     EPA uses basic IUR information in a wide variety of ways (as 
described in Units II.C. and E.) and expects the basic IUR information 
on inorganic chemicals to be used in similar ways. For example, EPA 
used IUR information in the HPV Challenge Program (see http://www.epa.gov/opptintr/chemrtk/volchall.htm) to identify chemicals 
produced in aggregate national volumes of one million pounds or more. 
The HPV Challenge Program has not been able to include inorganic 
chemicals as EPA did not have 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

[[Page 873]]

of even the most basic IUR data for these chemicals (Ref. 30).
    ii. Why is EPA phasing in reporting for inorganic chemical 
substances? EPA requested comment on completely removing the inorganic 
chemicals exemption, requiring reporting of all of IURA information, 
including the information described in Sec.  710.52(c)(4) of the 
regulatory text on inorganic chemicals manufactured in volumes of 
300,000 lbs. or more at a site. Some commenters supported phased-in 
reporting of this information, where EPA would maintain a partial 
exemption (i.e., requiring the reporting of all of IURA information 
except the information in Sec.  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, and provides basic production information in the 
first submission period. Requiring full reporting for inorganic 
chemicals in subsequent submission periods provides EPA with the 
processing and use exposure-related information needed to continue 
efforts begun with the first reporting year information.
    EPA's primary use of both the basic 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 of both hazard and exposure information. The absence of 
exposure-related data for inorganic chemicals, beyond even the basic 
production data collected during the first submission period under 
IURA, would severely limit the usefulness of IURA data for risk 
screening. See Unit III.A.1. for further discussion of additional uses 
of IURA exposure-related data.
    While some commenters supported the phasing-in approach, other 
commenters suggested that EPA review the information collected on 
inorganic chemicals under the partial exemption and collect additional 
information on these chemicals through a future rulemaking. Commenters 
suggested a variety of ways to collect this additional information, 
including specifically listing chemicals that would be subject to 
future IUR collections or using 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't EPA use already available information on inorganic 
chemical substances? Commenters stated that the inorganic chemicals 
data that EPA needs 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 by the Agency for Toxic Substances and Disease Registry, 
studies by OSHA, the TRI compiled by EPA, and literature published by 
trade 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 of the suggested data sources pertain to naturally occurring 
substances which are exempted from reporting by a provision in IUR that 
EPA has not proposed to change, i.e., 40 CFR 710.26(a)(3), which is 
codified as Sec.  710.46(a)(3) for IURA. Many of the remaining data 
sources identified by commenters pertain to metallic alloys or studies 
of a single metal species and do not include information on the 
multiplicity of pigments, flocculating agents, oxidants, photochromic 
salts, flame retardants, catalysts, and other inorganic compounds for 
which data are sought through 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 to time, do not identify the chemicals with 
sufficient specificity, do not identify the manufacturing site or a 
technical contact, and/or do not provide information on the use of the 
inorganic chemical. In sum, the data sources identified by commenters 
and by EPA are not sufficient to provide the information sought through 
IURA. EPA has consulted with USGS to investigate whether the USGS 
annual survey of approximately 80 minerals could be amended to better 
serve as a source for use and exposure data that could be used in place 
of IURA for those minerals (Ref. 31). EPA plans 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 of information for individual 
chemicals. EPA is 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 or 
revised information collections to ensure that the Agency's 
informational needs are met with the minimal burden possible. Although 
none of the 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. EPA is 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 of the applicability of available data 
sources is found in ``Summary of EPA'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 of Information Suggested by Commenters to the Proposed 
Inventory Update Rule Amendments'' (Ref. 32).
    b. Partial exemption for petroleum process streams. EPA proposed a 
partial exemption from IURA reporting for certain chemical substances 
that the Agency is calling ``petroleum process streams'' for purposes 
of IURA and requested comment on duplication of reporting under the 
information collections conducted by DOE's Energy Information 
Administration (EIA) through EIA forms EIA 810, EIA 816, and EIA 64A. 
Operators of all operating and idle petroleum refineries, blending 
plants, or blending terminals must complete form EIA 810 to provide a 
monthly refinery report on their 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 
form EIA 816 to provide a monthly natural gas liquids report to DOE. 
Operators of domestic natural gas processing plants must complete form 
EIA 64A to provide an annual report of the geographical location and 
geological formation of natural 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 of DOE's information collections in fulfilling EPA's 
statutory obligations under TSCA.

[[Page 874]]

    One commenter stated that EPA could use the DOE data along with 
other supplemental information sources to generate the type of 
petroleum process stream information that IURA proposed to collect. 
Several commenters also stated that the proposed IURA reporting would 
be duplicative of DOE reporting for certain chemicals, particularly 
fuel oil 2 and kerosene, and that EPA should therefore 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, and has determined 
that chemical substances are not sufficiently identified for EPA's 
purposes in the DOE reports. For example, many of the chemical 
substances in the DOE reports are identified by nomenclature other than 
the CAS nomenclature used by EPA for TSCA purposes, are identified in 
broad categories, or are not identified by CAS number. Many of the 
chemical names used by DOE are either generic or represent groups of 
chemicals. For example, distillate fuel oil, reported on EIA Form 810, 
may refer to several chemicals on the TSCA Inventory, such as fuel oil 
2, fuel oil 4, or fuel oil 6. This lack of 
specific identifier information means that EPA and others cannot 
distinguish which information collected by DOE is attributable to which 
chemical. More specific identification is needed 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 of workers reasonably likely to be exposed to a chemical or the 
maximum concentration of the chemical. In addition, it may be difficult 
to discern from the DOE data if a petroleum process stream is used as a 
solvent in a consumer product or as a combustible fuel. This is an 
important distinction because 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 limit worker exposure. 
Discussed in more detail in Unit II.F.1.b.
    c. Exemption for certain forms of natural gas. EPA proposed that 
six natural gas substances be fully exempt from reporting under IURA. 
In addition, EPA requested comment on whether 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 of the six 
natural gas streams listed in the proposed IURA. These commenters also 
recommended adding fuel oil 2, kerosene, methane, ethane, 
propane, butane, pentane, and hexane, and liquefied natural gas to the 
full exemption list. The commenters stated that an exemption is 
warranted for these chemicals because: (1) DOE already requires annual 
and monthly 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 of data is available for these chemicals as for 
the six chemicals EPA proposed to exempt; and, (5) a similar number of 
TSCA reports are filed for these chemicals as for the six chemicals EPA 
proposed to exempt.
    EPA has retained the exemption for certain forms of natural gas as 
proposed. Adequate IUR information has been collected on the six 
chemical substances to fulfill EPA's and other IUR information users' 
current needs. EPA will take action to revoke this exemption if 
circumstances warrant in the future.
    Liquefied natural gas, which is a form of natural gas (CAS No. 
8006-61-9), is covered under the natural gas exemption. EPA did not 
include ethane, methane, propane, butane, other paraffinic 
hydrocarbons, fuel oil 2, or kerosene in the list of 
substances included in the natural gas exemption because they are not 
just isolated components of natural gas but are also chemical 
substances which can be 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 of ethane/propane mixtures to produce ethylene, and vapor-
phase oxidation of n-butane to produce maleic anhydride. At present, 
there is not a sufficient basis to conclude that data on all 
significant uses of these alkanes are adequate.
    EPA did not rely on the data contained in the DOE reports discussed 
in Unit III.C.1.b. in its creation of the new exemption for certain 
forms of natural gas. While some useful information for these chemicals 
is included in the DOE reports, it is insufficient for exposure or risk 
screening (see Unit III.C.1.b.). Downstream processing and use exposure 
information collected through IURA for these chemicals will not 
duplicate information collected by DOE.
    2. Exemption of additional groups of chemicals from IURA reporting 
or from the reporting of specific data elements. EPA requested comment 
in the proposed rule on the selection of chemicals that might be 
exempted from reporting under IURA and on specific criteria to 
distinguish these chemicals from those that remain subject to 
reporting. EPA received many industry comments in favor of creating 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, in response to these comments 
and comments received during interagency review, EPA created a partial 
exemption (i.e., an exemption from the reporting of information 
required under regulatory text Sec.  710.52(c)(4)) for certain 
chemicals for which the collection of processing and use information is 
currently of ``low interest.'' This new partial exemption is intended 
to improve IURA's efficiency and effectiveness. EPA has established a 
process by which future changes to the chemicals included in the 
partial exemption can be made after careful examination of the totality 
of information available for the chemical substance, including but not 
limited to the considerations provided in Sec.  710.46(b)(2) and 
discussed in Unit II.F.1.d. This partial exemption also provides 
additional benefits in reducing the potential reporting burden of IURA 
for certain manufacturers of these chemicals. The inclusion of a 
chemical substance under this partial exemption does not address 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. See Unit 
II.F.1.d for a discussion of the exemption and the process to add or 
remove chemical substances from the exemption.
    In addition, commenters suggested classes of chemicals for 
exemption. EPA has determined that none of these suggested exemptions 
can be implemented at this time, as described in the remainder of this 
section.
    a. HPV chemicals. A number of commenters stated that industry is 
already providing EPA with sufficient hazard data via the HPV Challenge

[[Page 875]]

Program (see http://www.epa.gov/opptintr/chemrtk/volchall.htm), as well 
as exposure data through other voluntary programs (e.g., International 
Council of Chemical 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 a variety of voluntary and regulatory 
efforts to collect hazard 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 of which will also be IURA-reportable chemicals. 
The IURA focus is on gathering 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 limit its 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 of that 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 (as reported to IUR). 
Production volumes can vary significantly over a 4-year reporting 
cycle, and it is not uncommon for chemicals to rise above or fall below 
the HPV threshold each reporting cycle. For instance, EPA used 1990 IUR 
reporting to identify approximately 2,800 HPV substances. An additional 
500 substances which were not HPV chemicals in 1990 were identified as 
being HPV via the 1994 IUR production volume data. The IURA collection 
could be limited to the HPV Challenge Program chemicals (i.e., the 
baseline set of chemicals for the program, consisting of chemicals that 
were HPV according to 1990 IUR information). However, that restricts 
IURA's ability to supply screening level exposure information to only 
those HPV chemicals. This would severely limit the usefulness of IURA 
over time, as the universe of chemicals that were HPV in 1990 will not 
be the same universe of chemicals that are HPV in future years, and 
would compromise the Agency's broader responsibility for risk 
screening.
    b. Existing Chemicals Program ``low concern'' chemicals. Commenters 
recommended that the chemicals previously determined by EPA to be 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 by the Existing 
Chemicals Program, but was unable to develop standard criteria for such 
an exemption (See Ref. 33 and Unit IX.3. of the 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 of low current 
interest for purposes of IURA processing and use information reporting, 
based on considerations described in Unit II.F.1.d., and identified an 
initial list of chemicals currently covered by the partial exemption 
(Ref. 5).
    c. Organization for Economic Cooperation and Development (OECD) 
chemicals. Commenters recommended that the chemicals for which EPA has 
a minimum set of hazard 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 of Chemical 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 to replace IURA 
information. Data collection efforts under the auspices of OECD and 
ICCA concentrate on the development of hazard assessments and generally 
provide only a small fraction of the exposure-related data called for 
under IURA. A goal of the ICCA Program is to process chemical cases 
through OECD's HPV SIDS Program, which develops hazard information for 
the program chemicals. As hazard 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 and 
preliminary assessments. Exposure information, as collected under IURA, 
will vary from reporting year to reporting year and therefore needs to 
be collected on a continuing basis. While the OECD HPV SIDS Program 
does not specifically disallow the collection of exposure information, 
the program does leave such collection to the discretion of the sponsor 
country (Ref. 34). Exposure information available via SIDS is therefore 
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 IURA reporting. Several commenters asserted that 
providing 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 present in 
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 other routes such as inhalation or 
ingestion). Additionally, a commenter stated that 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 form in 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 as the USGS, 
or because specific metals, such as copper and zinc, are beneficial to 
human health and therefore should be of no exposure concern.
    Metals present some unique issues regarding exposure potential, and 
the information that will be collected under IURA on metals will do 
much to improve EPA's and others' knowledge about the uses and 
exposures associated with these chemicals. Not all metal-containing 
products are pure metal. For example, metal powders used in fine arts, 
metal pastes used in repairs, and commercial metallic paints contain 
varying percentages of metals. 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 can be present in a variety of 
physical forms, different routes of exposure are possible. Chronic 
exposure to solutions

[[Page 876]]

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 
of fumes containing chromium resulted in an elevated incidence of 
bronchial carcinoma among workers in the U.S. chromate industry before 
the source of the exposure was recognized and corrected. Exposure by 
ingestion is of concern for metals that may enter water sources 
following improper disposal of used materials, for example. The use of 
cadmium in batteries for portable electronic devices, including 
computers, is increasing; long-term exposure to cadmium has a potential 
to cause kidney, liver, bone, and blood 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 of an article (see 40 CFR 710.30(b) and Sec.  710.50(b) of the 
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 that provide 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 of the major 
commercial metals, is not comparable to the national scale and domestic 
exposures data that will be 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 and use will benefit many EPA offices and programs.
    As indicated previously, EPA will be reconsidering individual 
chemicals for applicability under the new partial exemption, and plans 
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. Other chemical groups. Commenters suggested EPA exempt a variety 
of additional 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 a 
polymer matrix; pesticides; and certain chemicals outside the scope of 
TSCA 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 as DOE, 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 sound manner'' 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 of little concern, due to low exposure 
potentials for the encapsulated chemicals, as implied by the Agency's 
treatment of such substances under Significant New Use Rules (SNURs); 
the commenter believed that, when chemicals are secured within a 
polymer matrix, the SNUR requirements no longer apply. Commenters also 
stated that pesticides and other chemicals not subject to TSCA should 
be fully exempt from reporting.
    Comments specific to these different groups of chemicals are 
addressed below.
    i. Fossil fuel combustion byproducts. 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 OSW had adequately reviewed data on these 
substances to allow their use as solid waste in situations where 
exposures were possible, such as in the case of soil 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 actions under TSCA, and suggested that 
continued reporting on these chemicals would be particularly 
burdensome.
    EPA disagrees with these comments. Review of the recent OSW Report 
to Congress on the subject of fossil fuel combustion byproducts (Ref. 
35) indicates that these products can be hazardous to human health and 
the environment when mismanaged. These products not only typically 
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 OSW was not able to identify damage 
cases or significant risks to human health or the environment 
associated with these types of beneficial 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, EPA in general needs information to be able to screen these 
chemicals for potential concerns outside of the OSW purview. Review of 
such contemporary data, as shared between OPPT and OSW, will allow EPA 
to make well-informed risk management decisions by constructing 
realistic screening level exposure profiles for these substances. These 
profiles could be adjusted as the production dynamics change between 
IURA reporting cycles. EPA believes 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 
of commenters emphasized that, in general, fertilizers are chemicals 
whose risks have already have been well-characterized. According to the 
commenters, ample recent hazard 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 on urea, a common fertilizer, 
described the chemical to be ``of low 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 they believe the 
constituents are not harmful to human health or the environment, 
fertilizers should be exempt from downstream use and exposure reporting 
under IURA (i.e., a partial exemption from IURA reporting). Other 
commenters stated that fertilizers should be granted a full exemption 
from

[[Page 877]]

IURA reporting, or that EPA 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 of the 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 ``non-nutritive'' components in fertilizers as adequate 
justification for classifying fertilizers as ``safe,'' and therefore 
eligible for exemption. The OSW report addresses trace quantities of 
metal contaminants in those fertilizers (i.e., the non-nutritive 
elements), not the fertilizers themselves. A review of basic 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, and urea, can cause both reversible and irreversible adverse 
health effects ranging from acute to chronic. The availability of IURA 
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 of risks to workers, 
consumers, and the general population. The Agency therefore believes it 
is appropriate to require reporting for fertilizers under IURA.
    iii. Encapsulated substances. A commenter stated that the import 
volumes of IUR reportable components contained within compounded 
imported polymers should be exempt from IURA reporting. The commenter 
indicated that volumes of these 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 a polymer 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 a polymer 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 do not 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 
a polymer matrix from IURA is not warranted. Not all polymers are 
inviolable. Additives such as colorants and lubricants, which can be 
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 to the 
surface of the polymeric material and be released over time from the 
polymer. Under IURA, each non-exempted mixture component is reportable 
if imported above the stated thresholds. Reasonably ascertainable 
information can be used to estimate these import quantities.
    iv. Pesticides. Some commenters stated that the Agency should 
exempt pesticide chemicals from reporting under the IURA, and also 
should exempt those substances outside the scope of TSCA, including 
drugs and cosmetics.
    The original IUR did not require reporting for chemicals 
manufactured for non-TSCA purposes. Similarly, in IURA, amounts of an 
otherwise IUR-reportable substance that are intended at the time of 
manufacture to be used for non-TSCA purposes (e.g., as a pesticide, as 
a drug) do not have to be reported. For example, if a company were to 
manufacture 300,000 lbs. of an IUR-reportable substance, 170,000 lbs. 
of which were intended at the time of manufacture to be sold as a drug 
precursor, and 130,000 lbs. of which were intended at the time of 
manufacture to be used for a TSCA purpose, only 130,000 lbs. of the 
substance would have to be reported under IUR. The company would not 
have to report the processing and use information described in Sec.  
710.52(c)(4) of the regulatory text for that chemical at that plant 
site, since the company did not manufacture a total of at least 300,000 
lbs. of the chemical at the site for TSCA purposes. Many substances, 
such as the 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. Food additives. Commenters stated that low hazard chemicals, 
such as food additives, should be 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 of 
a 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's purposes are those that are added directly to 
food, and could inadvertently contact and be incorporated into food 
because of use in packaging material or in food processing. FDA does 
not evaluate chemicals for environmental effects--only for human health 
effects. The chemicals subject to FDA rules are not inherently low 
hazard in many cases. For example, substances such as plasticizers, 
lubricants, release agents, acids (e.g., hydrochloric acid), boiler 
water additives, and solvents (e.g., acetone and hexane) are included 
as food use substances. Furthermore, even direct (i.e., listed) GRAS 
chemicals can be of concern 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 and the 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 extent that they are intended at the time 
of manufacture to be used for TSCA purposes.
    3. Thresholds. EPA requested comment on the 300,000 lbs. threshold 
for reporting industrial processing and use, and consumer and 
commercial use information (required under Sec.  710.52(c)(4) of the 
regulatory text). Commenters generally were supportive of having a 
second, higher reporting threshold for this exposure-related 
information. However, one commenter stated that the 300,000 lbs. 
threshold is too low, and that it should be set at one million pounds 
to coincide with the HPV Challenge Program threshold.
    EPA considered chemicals with aggregate, nationwide U.S. production 
and importation volumes of one million pounds or more (based on 1990 
IUR data) for the HPV Challenge Program. That is, if one million pounds 
of a

[[Page 878]]

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 of 
the HPV Challenge Program. The 300,000 lbs. IURA threshold captures at 
least one report for more than 95% of the HPV chemicals reported to the 
1990 IUR.
    The production volume that defines chemicals as HPV should not be 
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 at a single site and is not an 
aggregate, industry-wide production number. EPA is implementing the 
300,000 lbs. per year reporting threshold for individual IUR submitters 
because it limits the increase in burden associated with the new IURA 
processing and use reporting requirements and it limits the number of 
chemicals for which exposure-related data will be reported to 
approximately 4,000. This number is consistent with the ``several 
thousand chemicals'' suggested by GAO 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 (defined by national aggregate production). 
Increasing the 300,000 lbs. threshold to one million lbs. would 
drastically undermine the Agency's collection of processing 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 of the 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 of chemicals. Those groups include: (1) A set of HPV 
chemicals that submitters identify as being produced nationwide in 
amounts of one 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 of 
processing 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 HPV threshold in a given 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 if processing and use data 
reporting were limited to HPV chemicals.
    Many commenters favored use of the set of HPV chemicals in lieu of 
the 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 that relevant information is being provided 
already through other programs. Nor did they offer possible solutions 
to the problem of reliably aggregating production volumes.
    EPA does not believe that submitters will be able to effectively 
aggregate nationwide production volumes. Aggregation is especially 
difficult in light of continual, market-driven changes in production 
and many submitters' interest in protecting individual plant site 
production volume information as CBI. Additionally, for a nationally 
aggregated one million lbs. threshold to be effective, it must be able 
to accommodate the frequency with which individual chemicals may rise 
above or fall below the HPV threshold criteria of a U.S. aggregate 
production volume of one million lbs. or more per year. For example, 
17% of the chemicals which were HPVs according to data submitted under 
the 1990 IUR were not HPVs according to data submitted under the 1994 
IUR.

D. Definitions and Clarification Requests

    1. Is mining considered manufacturing? Commenters asked whether 
mining is considered ``manufacturing'' under TSCA. Under TSCA, the term 
``manufacture'' includes production or importation of a 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 of metal ore from reuse or 
other storage piles, wastes, or rock dumps, or from mill tailings 
derived from the mining, cleaning, or concentration of metal 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 by manual, 
mechanical, or gravitational means (see 40 CFR 710.4(b)(1)) are 
currently excluded from IUR reporting 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 Sec.  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 other than as specified in Sec.  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 on the 
TSCA Inventory because at least some of the time they are produced by 
other than 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 Sec.  710.4(b). It also 
exempts any other chemical substance derived or separated from the 
substance originally removed from nature, provided such derivation 
involved only the means specified in Sec.  710.4(b). For example, when 
using manual, mechanical, or gravitational processes to separate one or 
more substances from a naturally-occurring mixture, these isolated 
component substances are also considered naturally-occurring and 
excluded from reporting. However, any substance manufactured from a 
naturally occurring precursor substance via a chemical reaction is not 
considered naturally occurring and, therefore, not excluded from 
reporting under Sec.  710.46(a)(3).
    2. What is the difference between ``reasonably ascertainable'' 
information and ``readily obtainable'' information? A number of 
commenters raised concerns about the meaning of ``readily obtainable'' 
and ``reasonably

[[Page 879]]

ascertainable,'' what level of effort is required for each, and the 
difference in the level of effort required. Commenters also stated that 
the expectation that submitters will provide data on users outside 
their control seems to be an unworkable and unrealistic mandate. The 
reporting standard of TSCA 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 of the 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 
all information 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 Sec.  710.52(c)(1), (c)(2), and (c)(3) of the regulatory text.
    ``Readily obtainable'' is a lesser standard EPA is applying to the 
reporting of information concerning the processing and use of chemicals 
subject to IURA (Sec.  710.52(c)(4) of the regulatory text). The 
readily obtainable standard is limited to information known by 
management and supervisory employees of the submitter, and does not 
require additional effort to collect information on processing or use 
of chemicals by others not under the control of the submitter. Although 
the Agency is requiring submitters to provide only information that it 
knows, EPA believes that in many cases submitters will possess some 
knowledge concerning use of chemicals sold by the submitter to their 
customers, even though the submitter does not control its customers' 
sites. For example, when a company markets the substances for certain 
end uses. EPA's experience with over 30,000 TSCA section 5 PMNs 
demonstrates that companies generally do know 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 of chemicals that are beyond his or her control. 
The standard for reporting information on processing and use of 
chemical substances under IURA is the same as the standard adopted in 
the PAIR, which was also promulgated under the authority of TSCA 
section 8(a). (See 40 CFR 712.7)

E. Confidential Business Information

    The Agency's intent under these regulations is to achieve balance 
and ensure that the submitter only claims as confidential that 
information which is legally entitled to confidential treatment. EPA 
believes that these amendments will discourage the assertion of invalid 
CBI claims by focusing submitter's attention more closely on their 
decision to make certain claims.
    1. General CBI.--a. Reducing the amount of CBI claims. EPA 
solicited suggestions from commenters on what could be done to the IUR 
reporting process and data elements to reduce CBI claims, thereby 
allowing better public access to the data. Some commenters suggested 
that EPA 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 can be expected to result in a 
significant increase in the number of legitimate CBI claims.
    EPA agrees that submitters will make CBI claims for the new data 
elements that are being added by these amendments, most likely 
resulting in a greater number of CBI claims overall. However, EPA is 
requiring reporting for most of the new data elements in ranges, a 
reporting method EPA believes will result in fewer CBI claims compared 
to reporting discrete numbers. Additionally, EPA is amending the IUR to 
encourage the assertion of only legally valid CBI claims, and to ensure 
that CBI claims are well thought out by the submitter. The IURA 
includes a new requirement to provide upfront substantiation of CBI 
claims for site identity. This requirement will minimize claims by 
prompting submitters to perform an initial evaluation of the need for 
and validity of a 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 clarify that it is not attempting to discourage 
legitimate confidentiality claims; rather, the Agency intends only to 
discourage inappropriate claims. This allows the Agency to protect 
legitimate CBI while also increasing the amount of information 
available for public use.
    EPA has information indicating the existence of inappropriate or no 
longer valid CBI claims. For instance, when EPA has selectively 
challenged CBI claims in the past, many of these claims have been 
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 or no longer valid CBI claims exist. For instance, 
the Georgia Department of Natural Resources reported in a 1996 CBI Data 
Review that IUR data 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 of data 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 site-specific 
information by the individual sites is the best way to collect the 
information needed. EPA will continue to perform the aggregating 
function when providing the public with information that is subject to 
a site-specific CBI claim. Collecting only national aggregate values 
would drastically reduce the usefulness of the information to the 
Agency, even though it may reduce the number of CBI claims. The IUR is 
used to address both national needs and local issues. For example, IUR 
production volume information was used to identify the national list of 
High Production Volume (HPV) chemicals for the Agency's HPV Challenge 
Program (see http://www.epa.gov/opptintr/chemrtk/volchall.htm). 
Moreover, site-specific IUR information is used to secure a better 
overall understanding of activities at individual sites. This 
information is used for site-specific risk assessments for the use of 
federal, state and local entities.
    b. Protection of CBI. Some commenters expressed concern about the 
Agency's ability to protect against the inappropriate release of CBI 
and stated that, under section 14 of TSCA, EPA has a statutory 
obligation to protect information properly claimed as CBI. These 
commenters are concerned about past releases of information claimed as 
confidential, and would like to see the Agency take steps to guarantee 
greater protection of CBI data.
    EPA agrees that it has a statutory obligation to protect 
information

[[Page 880]]

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 that protection under the established legal standards. 
The new IURA requirements will help assure that EPA's system of 
information protection is limited to valid claims.
     c. Production volume ranges. EPA requested comment on the use of 
production volume ranges as a mechanism to reduce the number of 
confidentiality claims by allowing characterizations of site-specific 
chemical and specific production volume information without releasing 
CBI. In general, commenters felt that the use of the ranges would not 
necessarily result in reduced CBI claims. Commenters cited a few 
examples where production volume would still be 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 (EPA made adjustments to the 
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 CBI claims 
for both the specific and the ranged production volume information. 
However, EPA believes that in many cases submitters will allow the 
release of ranged production volume information. This belief is 
supported by some industry organizations. For example, in a 1993 
letter, a company suggested the use of the original Inventory 
production volume ranges for non-confidential reporting. While the 
company did state that ``conceivably, a submitter could be able to 
justify 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 by EPA's experience with the 
original TSCA Inventory, where only 35% of production volume values 
reported were claimed CBI, compared to the typical claim level of 65% 
for production volumes under IUR.
    d. Disclosing customer confidential information. A commenter 
expressed concern that, as a producer of chemical feedstocks, they 
might inadvertently report customer data and not claim the data as CBI, 
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 or how much 
their individual customers produce. In addition, CBI claims can be made 
as necessary for any information provided on Form U.
    2. Upfront substantiation.--a. Authority for substantiation. A 
commenter stated that 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 stated that substantiation should 
only be required if and when a request for public disclosure is made, 
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 such manner as the 
Administrator may prescribe.'' EPA is continuing to require that those 
reporting under IURA substantiate their chemical identity CBI claims, 
and is requiring under these amendments that submitters also 
substantiate any plant site identity CBI claims. Section 710.58 of the 
regulatory text requires submitters to substantiate these claims 
submitted under IUR by providing answers to specified questions. EPA 
has long required upfront substantiation for specified CBI claims under 
the authority specified in TSCA (see, e.g., 40 CFR 710.38(c) of the 
current regulatory text) and will continue to require upfront 
substantiation where appropriate.
    The Agency is adding upfront substantiation requirements for plant 
site identity information because EPA has observed that, on occasion, 
plant site information has been claimed as confidential even though, 
for example, it was revealed in filings required under sections 311, 
312, and 313 of the Emergency Planning and Community Right-to-Know Act 
(EPCRA), 42 U.S.C. sections 11021 to 11023. EPA believes that many of 
these CBI claims are inappropriate and that the new substantiation 
requirement will reduce the occurrence of inappropriate claims. A 
decrease in the number of CBI claims under the new substantiation 
requirement would facilitate 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 of CBI 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 of reporting all 
elements of plant site identity information. The burden of upfront 
substantiation for plant site identity CBI claims is included in this 
estimate.
    b. Alternate substantiation questions. One commenter suggested a 
simplified set of substantiation questions, consisting of two 
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 list of substantiation 
questions in Sec.  710.58 of the regulatory text is necessary to ensure 
that information submitted for confidential protection qualifies for 
that protection. The commenter's proposed questions, while providing 
the opportunity for a submitter to express its business reasons and 
preferences regarding the information, do not provide all of the 
necessary information to definitively evaluate the eligibility of the 
information for confidential treatment.
    3. Reassertion. EPA received a number of comments regarding the 
proposed new CBI reassertion provisions. All of these 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 of voluminous old 
records. Others felt the proposed standards would violate the Agency's 
obligation under TSCA to protect confidential information and that EPA 
would exceed its authority if it required the reassertion of CBI 
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 of CBI is justified as 
a practical measure to ensure that information withheld meets the legal 
criteria and that the expressions of concern relating to burden 
associated with reassertion, appear to be the result of a 
misunderstanding of the practical aspects of the proposed reassertion 
requirement, the Agency is not finalizing the proposed reassertion

[[Page 881]]

requirement. EPA has made this decision in an effort to reduce the 
overall burden of these amendments.

F. Administrative Comments

    1. Frequency of reporting. Several commenters stated that one-time 
reporting of IURA 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.). A 
few commenters stated that there is insufficient change in the chemical 
industry to warrant recurring reporting of IURA information, especially 
for higher volume chemicals.
    EPA's experience with past IUR reporting demonstrates that the 
chemical industry is dynamic, with a 30% change in the number of 
chemicals reported from one submission period to the next. The specific 
chemicals that are reported or not reported in any single submission 
period change at a variety of production volumes; this change is by no 
means limited to lower production volume chemicals.
    Although a chemical's hazards may be fully characterized, EPA needs 
up-to-date exposure information to stay current with developments and 
adequately screen chemicals for possible risks to human 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 time be minor, but 
as uses change from industrial applications to consumer uses, or as 
production volumes increase, exposures also tend to increase. Because 
exposures and uses can and do change over time as technologies develop 
or innovations arise, updated exposure information is needed to 
maintain an adequate understanding of current exposures. EPA did 
consider one-time reporting for IURA processing and use data, but the 
information would quickly become out of date.
    A primary goal of IURA is to provide a data base of exposure-
related information which can be used for screening level purposes to 
identify chemicals for further assessment, as well as chemicals of 
lesser concern (see Unit III.A.1.). EPA intends to use other data 
sources and collection tools, as appropriate, once a chemical has been 
identified as a candidate for further assessment.
    2. Calendar year reporting. One commenter stated that the 
requirement to report data on a calendar 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 (by creating the need for a second tracking system), 
while adding no additional value or accuracy in the reporting of 
manufacturing data. This commenter pointed out that because the most 
that companies' fiscal years can differ from a calendar year is 6 
months and IUR reporting occurs every 4 years (instead of every year), 
there can be little difference in the data with a maximum 6-month time 
frame shift. Other commenters supported the change to a calendar year 
basis, supporting the idea of having a consistent 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 data bases such as the 
TRI. This compatibility increases the usefulness of the IURA collection 
by allowing IURA data to be combined with data from other collections. 
Generally, companies should be sufficiently familiar with their 
production that this provision should not present special challenges 
that are unaccounted for in the burden estimates provided by survey 
respondents, as described in the economic analysis.

G. Economic Impact Estimates

     Commenters raised a number of concerns about the economic 
analysis. In response, EPA has made a number of changes to make the 
analysis a more readable document and to incorporate changes made to 
the final IURA requirements.
    1. General burden comments. Commenters raised a variety of concerns 
about the size of the burden associated with the amendments, and EPA's 
estimates of that burden. In general, commenters felt that the Agency's 
burden estimates were too low. However, few commenters provided 
evidence as to why they felt EPA underestimated the burden, and none 
provided any specific analytical basis for amending the estimates. Some 
commenters claimed that the revised form represents a 5-, 10-, or 30-
fold increase in burden, at least partly based upon the fact that the 
original Form U was only 1 page and the sample revised Form U provided 
in the proposed rule was 3 pages.
    In response to these comments, EPA reviewed the burden analysis 
and, although the estimated burden was adjusted, determined that the 
comments do not warrant modifications to the Agency's general approach 
to the analysis. EPA based much of the burden analysis on a survey of 
78 industry respondents (Ref. 7). In addition, EPA considered the 
burden associated with such programs as the UEIP (described in Unit 
III.A.1.), a voluntary project in which EPA collected information 
similar in some ways to IURA information. UEIP respondents provided 
estimates of the amount of time they used to complete the survey forms 
(Ref. 7). However, EPA did reassess the results of the burden survey 
and did make some changes to the analysis. The burden from the analysis 
associated with the proposed rule was $36 to $51 million in the first 
year, and $27 million to $41 million in future reporting years. Changes 
in the rule and methodology raised estimated costs of the final rule to 
between $72 and $87 million in the first reporting cycle, and $64 to 
$77 million in 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, and 
updating the number of report submissions to incorporate the 1998 IUR 
data collection. These changes are discussed further in ``Revised 
Economic Analysis for the Amended Inventory Update Rule'' (Ref. 7).
    a. Burden over time. Commenters raised concerns about specific 
burden issues. Several commenters felt that burden associated with IURA 
will not decrease over time because of the 4-year time lapse between 
submission periods. Those commenters believe that the 4-year period 
between submission periods will result in changes to product lines and 
personnel such that a complete reintroduction to IUR reporting will be 
necessary in each reporting cycle. EPA disagrees, and expects rule 
familiarization to require the most effort in the first year of 
reporting. EPA believes that there will be some similarity in the 
information reported from one submission period to the next, especially 
for Parts I and II of the revised Form U. Subsequent reporting will be 
facilitated by the site's maintenance of its previous submission 
period's records.
    b. Characterization of burden reduction. Commenters asserted that 
the economic analysis for the proposed rule was misleading in its 
characterization of

[[Page 882]]

the actions that constitute burden reduction and cost savings. 
Specifically, commenters referred to EPA's claim of a burden reduction 
and cost savings associated with the 300,000 lbs. threshold for 
reporting of Form U, Part III information on industrial processing and 
use, and consumer and commercial use. EPA simply meant that providing a 
partial exemption for chemicals below the 300,000 lbs. threshold is a 
concession to the burden that the rule imposes on reporting sites, and 
that the Agency has no other basis for this exemption other than to 
mitigate the increase in burden. 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 put into 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 (versus reporting on an unlimited number of NAICS codes), given 
that identifying these top 10 could take considerable effort. EPA 
continues to believe that reporting only the top 10 NAICS codes will be 
less burdensome than reporting all NAICS codes associated with 
industrial processing or use operations.
    2. Cost comments. Two commenters asserted that compliance costs for 
chemicals manufactured in amounts below the 25,000 lbs. threshold are 
not zero and that, as production volume for a chemical approaches the 
threshold, tracking costs will accrue to determine if production will 
cross the threshold.
    Compliance determination (the act of determining the need to comply 
with a regulation) occurs on a per-site basis. This means that all 
sites that report under IURA are assumed to incur the same average cost 
for determining compliance, regardless of the number of chemicals 
reported. Some small number of firms that are not required to report 
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 of the volumes it produces. The 
existence of voluntary submitters does not imply that below-threshold 
compliance costs are non-zero; it simply indicates that some firms 
choose to respond to IUR when 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 of reports will be eliminated by 
raising the reporting threshold.
    3. Benefits comments. Commenters stated that EPA has overestimated 
the benefits of this rule and should quantify the benefits. However, 
given that IURA is an information rule and its benefits are therefore 
indirect, it is currently not possible to quantify the benefits of the 
rule. Only by collecting the information required under the IURA can 
EPA begin to assess thoroughly the risks from a portion of the more 
than 76,000 chemicals in commerce. The actions that result from EPA 
review of the IURA data will have direct health and environmental 
benefits, benefits that typically can be quantified. Commenters offered 
no alternate assessment, quantitative or otherwise, of the benefits 
from IURA. In the absence of quantified benefit figures, it is 
impossible to make simple comparisons to estimates of reporting costs. 
Thus, EPA must balance the needs of the Agency for data with which to 
address important environmental and health risks, with the burdens of 
obtaining such data. In doing so, the uses of and need for the data are 
carefully addressed both within the Agency, and during interagency 
review. EPA has made every attempt to collect only the information 
necessary to meet Agency goals for obtaining screening level exposure-
related information.
    4. Small business impact comments. Several commenters argued that 
EPA's analysis of the impacts of IURA on small businesses is 
insufficient to meet the requirements of the Regulatory Flexibility Act 
(RFA), as amended by the Small Business Regulatory Enforcement Fairness 
Act (SBREFA) of 1996. EPA's analysis of small 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 
of the RFA. The analysis for the final rule can be found in the 
``Revised Economic Analysis for the Amended Inventory Update Rule'' 
(Ref. 7). For both the proposed and final 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 found 
in Unit V.B.
    5. Non-regulatory alternatives. Commenters also stated that EPA did 
not identify any non-regulatory alternatives and failed to assess the 
relative costs and benefits of an alternative approach. In the 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 Unit III.A.3. The Agency found that the information to be 
collected through IURA was not publicly available and therefore this 
was not a viable 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 a 
voluntary program may lack consistency, may not be sufficiently 
comprehensive, or may not occur on a recurring basis, and therefore 
would not fully serve the purposes of IURA information. Therefore, a 
voluntary approach was not a viable option.

IV. Materials in the Rulemaking Record

    The public version of the official record for this rulemaking has 
been established as described in Unit I.B.1. under docket ID number 
OPPT-2002-0054. This record includes the documents located in the 
docket as well as the documents that are referenced in those documents. 
The following is a listing of the documents that are specifically 
referenced in this final rule. These documents, and the documents 
referenced therein, are also included in the public version of the 
official record. Please note that some referenced documents are already 
publicly available and this list includes 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 of Public 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 3 of the

[[Page 883]]

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 of Chemicals 
for the Inventory Update Rule Amendments (IURA) `Low Current Interest' 
Partial Reporting Exemption,'' OPPT, July 24, 2002.
    6. USEPA, ``EPA Needs Exposure-Related Data: A Discussion of the 
Justification for Collecting Exposure-Related 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 of Likelihood of Confidential Business Information 
Claims for Production Volume Information,'' OPPT, August 26, 1996.
     11. Letter from Mark N. Duvall, Union Carbide, to EPA, 
``Additional Comments of Union 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 and Health 
Administration, to Wardner G. Penberthy, EPA, October 15, 1996.
    13. Letter from Paul A. Schulte, Ph.D., National Institute for 
Occupational Safety and Health, to Wardner 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 of 
Workers/Production Quantity Analysis,'' OPPT, September 26, 1996.
    17. Standard Consumer Safety Inspection ASTM F963-96A (sec. 3.1-
3.3).
    18. USEPA, ``Summary of EPA'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, to Wardner 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 Strategy Needed 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 of Existing Exposure-Related Data Sources and 
Approaches to Screening Chemicals: A Response to CMA,'' OPPT, March 
1999.
    28. European Commission, ``Technical Guidance Document in Support 
of Commission Directive 93/67/EEC on Risk Assessment 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 of Consumer 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 of Information 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 
of Management and Budget, May 21, 1999.
    34. OECD, ``Guidance for Collection and Transmission of Exposure 
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 of 
Fossil Fuels (EPA Docket F-2000-FF2F-FFFFF) 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 Data Review, 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 Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this is a ``significant regulatory 
action'' under section 3(f) of the Executive Order, because it raises 
``novel legal or policy issues arising out of legal 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 that review have been documented in the public record.
    In addition, EPA has prepared an economic analysis of the potential 
impacts of this action, which is contained in a document entitled 
Economic Analysis for the Amended Inventory Update Rule (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 used by the decision-makers to help in the selection of the 
final rule requirements presented in this document. This document is 
available as a part of the public version of the official record for 
this action and is briefly summarized here.
    EPA estimates that these amendments will cost between $72 and $87 
million in the first reporting cycle, and $64 to

[[Page 884]]

$77 million in future reporting cycles, resulting in an annualized cost 
of $17 to $21 million over the next 20 years 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 during the first submission period. In 
the first submission period, approximately 9,800 of those submissions 
(providing information on about 4,000 chemicals) will be full reports 
which include information found in Part III of revised reporting Form 
U. The remainder will report only company, site and chemical 
identification and manufacturing information (Parts I and II of revised 
Form U). In future submission periods with the addition of full 
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 only the top 10 NAICS codes be accounted for 
when reporting industrial processing and use information, and that only 
readily obtainable information in Part III of revised Form U be 
reported.
     EPA analyzed the effects of a number of different alternatives for 
the rule, including variations in exemptions, different thresholds for 
both partial- (i.e., Parts I and II of revised Form U) and full-form 
(i.e., all parts of revised Form U) reporting, and various frequencies 
of collection. 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 a full exemption for site-
limited petroleum streams. EPA examined the effects of keeping 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.
     EPA believes that this 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 of that 
mission, to provide information needed by other agencies (OSHA, NIOSH, 
CPSC, etc.).
    The costs of these 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 attempt to balance data needs with 
collection costs and burden. Wherever possible, EPA has used exemptions 
or partial exemptions to reduce the number of reports that would 
potentially be filed by industry. EPA has provided a second threshold 
for reporting use information required in Part III of revised 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 of the information that will be required in three ways: 
(1) By requiring the reporting of only readily obtainable information 
for the processing and use exposure-related data; (2) by requiring that 
submitters report much of the information in ranges, reducing the need 
to generate specific estimates; and, (3) by requiring processing and 
use exposure-related information on only the top 10 uses/NAICS codes/
IFCs, as determined by percent of the chemical's volume. These steps 
limit the amount of information required, reducing the time and effort 
spent by the 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 to the extent that the information being reported 
remains somewhat constant from one submission period to the next. 
Projected costs to 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. of the 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 of 
this final rule can be found in the public version of the 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 of low 
current interest, and deleting the proposed CBI reassertion 
requirement. Changes made to the cost methodology include increasing 
burden estimates for reporting processing and use data. The increase in 
burden estimate was initiated in response to industry comment, and 
stemmed from differences in the survey instrument used to estimate 
costs of IURA 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 U required EPA to 
aggregate certain responses. After reading the comments, EPA is using 
more conservative assumptions in this process. Therefore, it is more 
likely that EPA cost estimates overestimate, rather than underestimate, 
actual costs.

B. Paperwork Reduction Act

    The OMB has approved the information collection requirements 
contained in this rule under the provisions of the Paperwork Reduction 
Act (PRA), 44 U.S.C. 3501 et seq., 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 as EPA ICR No. 1884.02), which is also included in the 
public docket that is described in Unit I.B.1.
    The information that will be reported under IURA will better enable 
EPA to screen thousands of chemical substances for potential risk. Risk 
screening is necessary in order to conserve limited Agency and industry 
resources by focusing risk assessment work on chemical substances for 
which some level of potential risk has been indicated. The new 
information that will be 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 may be 
made for all or part of the information that will be reported under 
IURA. This action includes new substantiation procedures for CBI claims 
regarding plant site identity (See Sec.  710.58(d) in the regulatory 
text).
    As a result of IURA, reporting sites will submit either a full 
report for a

[[Page 885]]

chemical (which includes site identification, manufacturing information 
and processing and use data) or a partial report (which does not 
include processing and use data). For the first reporting cycle, 
inorganic chemical manufacturers will only submit partial reports while 
organic chemical manufacturers will submit a mix of partial and full 
reports. The IURA increases the average reporting burden for both 
partial and full reports compared to previous IUR reporting.
    Companies will continue to report under IURA once every 4 years, so 
the average annual IURA reporting burden and cost is calculated in the 
ICR as one quarter of the 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 in 
burden due to IURA, while the ICR calculates the total reporting and 
recordkeeping burden for IURA (i.e., the sum of the incremental IURA 
burden and the baseline IUR burden). Companies may continue to report 
for multiple chemicals on a single Form U (as revised). Companies 
generally submit one Form U per site, so the burden per Form U is 
approximately equivalent to the burden per site.
    For the first reporting cycle, the annual average burden 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 of 5.1 
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 of 
8.3 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 of information; and transmit 
or otherwise disclose the information. The actual burden on any 
specific site may be different from this estimate depending on the 
complexity of the site, the number of IURA reportable chemicals at the 
site, and the profile of the site's operations. There will be 
approximately 2,500 submitters for organic chemicals (including 
petroleum 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 
cost of $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 or provide information to or for a Federal agency. This 
includes the time needed to: Review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, 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 or otherwise disclose the 
information.
    As part of the PRA approval renewal process, which occurs every 3 
years 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 ICR renewal document that details the 
chemicals evaluated under the exemption process, the exemption requests 
received, and the Agency's decisions made, as well 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 of information 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 list the OMB approval number for the information collection 
requirements contained in this final rule. This listing of the OMB 
control numbers and their subsequent codification in the CFR satisfies 
the display requirements of the PRA and OMB's implementing regulations 
at 5 CFR part 1320. This ICR was previously subject to public notice 
and comment prior to OMB approval. Due to the technical nature of the 
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) 
of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), to amend this 
table without further notice and comment.

C. Regulatory Flexibility Act

     Pursuant to section 605(b) of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), 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 of the 
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 (5 U.S.C. 601(6)). 
Because not-for-profit organizations and governmental jurisdictions 
will not be affected by this rule, ``small entity'' for purposes of 
this final rule is synonymous with ``small business.'' Section 601(3) 
of the RFA establishes as the default definition of small business the 
definition used in section 3 of the Small Business Act (15 U.S.C. 632) 
under which the Small Business Administration (SBA) establishes small 
business size standards (13 CFR 121.201). The RFA recognizes, however, 
that it may be appropriate at times for Federal agencies to use an 
alternate definition of small business. As a result, RFA section 601(3) 
provides that an Agency may establish a different definition of small 
business after consultation with the SBA Office of Advocacy and after 
notice and an opportunity for public comment. EPA established a 
different definition of small business, 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 small business are generally 
exempted from IUR reporting in 40 CFR 710.29. This exemption is 
retained under these amendments in Sec.  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 and human health protection goals of the statute and the 
Agency.
    Despite the fact that small manufacturers that fully meet the 40 
CFR 704.3 definition are generally exempt from reporting under IUR, and 
thus are not significantly impacted by IURA, EPA conducted an analysis 
of the potential impact for submitters that meet only part of the 40 
CFR 704.3 definition. Specifically, an analysis of the potential impact 
was conducted only for those submitters that meet the first criterion 
in the 40 CFR 704.3 definition of ``small manufacturer or importer,'' 
i.e., total annual sales of less than $40 million, but that do not meet 
the second criterion, i.e., production or import volume of less than 
100,000 pounds at all sites.

[[Page 886]]

    For small manufacturers of organic chemicals subject to reporting, 
the Agency estimates the impact to be 0.15% to 0.18% of sales. For 
small manufacturers of inorganic chemicals subject to reporting, the 
Agency estimates the impact to be 0.07% to 0.20% of sales.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4), EPA has determined that this regulatory action does 
not contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or for the private sector in any 1 year. The analysis of the 
costs associated with this action are described in Unit V.A. In 
addition, EPA has determined that this rule does not significantly or 
uniquely affect small governments. Accordingly, this rule is not 
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    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 on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132. Thus, Executive 
Order 13132 does not apply to this rule.

F. Executive Orders 13084 and 13175

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian 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 costs incurred by the tribal governments, or EPA 
consults with those governments.
    If EPA complies by consulting, Executive Order 13084 requires EPA 
to provide to OMB, in a separately identified section of the preamble 
to the rule, a description of the extent of EPA's prior consultation 
with representatives of affected tribal governments, a summary of the 
nature of their 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 of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that significantly or uniquely 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) of Executive Order 13084 do not apply to this rule.
    On November 6, 2000, the President issued Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249). Executive Order 13175 took effect on January 6, 2001, 
and revokes Executive Order 13084 as of that date. EPA developed this 
rule, however, during the period when Executive Order 13084 was in 
effect; thus, EPA addressed tribal considerations under Executive Order 
13084.

G. Executive Order 13211

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) because it is not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. This final rule 
modifies the existing IUR reporting and recordkeeping requirements that 
apply to chemical manufacturers and importers. As such, we have 
concluded that this rule is not likely to have adverse energy effects.

H. Executive Order 13045

    This rulemaking does not require special consideration pursuant to 
the terms of Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997), because it is not likely to have an annual effect on the 
economy of $100 million or more 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 on potential exposures to 
children. This information will allow the Agency and others to 
determine which chemical substances have potential risks, allowing the 
Agency and others to take appropriate action to investigate and 
mitigate those risks.

I. National Technology Transfer and Amendment Act

    This regulatory action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 
U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be 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 adopted by voluntary consensus 
standards bodies. The NTTAA requires EPA to provide Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.

J. Executive Order 12898

    Pursuant to Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-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 on the environmental and health conditions in 
minority and low-income populations. The Agency believes that the 
information collected under this rule will assist EPA 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 by being better able to 
prioritize chemical substances of concern.

K. Executive Order 12630

     EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with

[[Page 887]]

Constitutionally Protected Property 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 of Risk and Avoidance of Unanticipated Takings'' issued 
under the Executive Order.

L. Executive Order 12988

    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, titled Civil Justice Reform (61 FR 
4729, February 7, 1996).

VI. Submission to Congress and the 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 a rule report, which includes a copy of the rule, 
to each House of the 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 of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 710

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

List of Subjects in 40 CFR Part 723

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


    Dated: December 18, 2002.
Stephen L. Johnson,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
    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 Sec.  9.1, the table is amended by revising the heading 
``Inventory Reporting Regulations'' to read ``TSCA Chemical Inventory 
Regulations''; removing the existing entry under the heading; and 
adding the following entries to read as follows:


Sec.  9.1   OMB approvals under the Paperwork Reduction Act.

* * * * *

 
------------------------------------------------------------------------
             40 CFR citation                      OMB Control No.
------------------------------------------------------------------------
                               * * * * *
                   TSCA Chemical Inventory Regulations
 
------------------------------------------------------------------------
Part 710, Subpart B......................  2070-0070
Part 710, Subpart C......................  2070-0162
                                * * * * *
------------------------------------------------------------------------

* * * * *
    2. Part 710 is amended as follows:

PART 710--[AMENDED]

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

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

    b. Revise the part heading and table of contents 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 of the inventory.

Subpart B--2002 Inventory Update Reporting

710.23 Definitions.
710.25 Chemical substances for which information must be reported.
710.26 Chemical substances for which information is not 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 to report.
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 not required.
710.48 Persons who must report.
710.49 Persons not subject to this subpart.
710.50 Activities for which 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 of reporting form and instructions.
    c. Sections 710.1 through 710.4 are designated as subpart A and the 
subpart heading is added to read as follows:

Subpart A--General Provisions

    d. Revise Sec.  710.1 to read as follows:


Sec.  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) of the 
Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a) 
authorizes the Administrator to require reporting of information 
necessary for administration of the Act and requires EPA to issue 
regulations for the purpose of compiling and keeping current an 
inventory of chemical substances manufactured or processed for a 
commercial purpose, as required by section 8(b) of the Act. Following 
an initial reporting period, EPA published an initial inventory of 
chemical 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 and reported under section 5(a)(1) of 
the Act. EPA also revises the categories of chemical substances and 
makes other amendments as appropriate.
    (b) The regulations in this part apply to the activities associated 
with the compilation of the TSCA Chemical Inventory and the update of 
information on a subset of the chemical substances included on the 
Inventory. The Inventory Update regulations were

[[Page 888]]

amended in 2002; however, these amendments apply to updates 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 and revised 
requirements that apply to updates after 2002 appear in subpart C. 
Prior to January 1, 2003, the regulations in subpart B of this part are 
effective for purposes of Inventory update activities. As of January 1, 
2003, subpart C is effective for purposes of Inventory update 
activities. The Agency intends to remove subpart B from the CFR once 
the 2002 update is complete.
    (c) Section 15(3) of TSCA 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 to the United States for a civil 
penalty and may be criminally prosecuted. Pursuant to section 17, the 
Government may seek judicial relief to 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.

Sec.  710.2 [Removed]

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


Sec.  710.3   Definitions.

    In addition to the definitions in Sec.  704.3 of this 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 et seq., and the 
regulations issued under such Act: Cosmetic, device, drug, food, and 
food additive. In addition, the term food includes poultry and poultry 
products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 
453 et seq.; meats and meat food products, as defined in the Federal 
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, 
as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
    (b) The term pesticide will have the meaning contained in the 
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et 
seq., and the regulations issued thereunder.
    (c) The following terms will have the meaning contained in the 
Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations 
issued thereunder: Byproduct material, source material, and special 
nuclear material.
    (d) The following definitions also apply to this part:
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    Administrator means the Administrator of the U.S. Environmental 
Protection Agency, any employee or authorized representative of the 
Agency to whom the Administrator may either herein or by order delegate 
his/her authority to carry out his/her functions, or any other person 
who will by operation of law be authorized to carry out such functions.
    An article is a manufactured item:
    (1) Which is formed to a specific shape or design during 
manufacture,
    (2) Which has end use 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 during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article and that may occur as 
described in Sec.  710.4(d)(5); except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without separate 
commercial intent during the manufacture or processing of another 
chemical substance(s) or mixture(s).
    Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical; except that ``chemical substance'' does not include:
    (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.
    Commerce means 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) of this definition.
    Distribute in commerce and distribution in commerce, when used to 
describe an action taken with respect to a chemical substance or 
mixture or article containing a substance or mixture, mean to sell or 
the sale of the substance, mixture, or article in commerce; to 
introduce or deliver for introduction into commerce, or the 
introduction or delivery for introduction into commerce of the 
substance, mixture, or article; or to hold or the holding of the 
substance, mixture, or article after its introduction into commerce.
    EPA means the U.S. Environmental Protection Agency.
    Importer means any person who imports any chemical substance or any 
chemical substance as part of a 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/her behalf (as defined in 19 
CFR 1.11).
    Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    Intermediate means any chemical substance:
    (1) Which is intentionally removed from the equipment in which it 
is manufactured, and
    (2) Which either is consumed in whole or in part in chemical 
reaction(s) used for 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 equipment in which it was manufactured includes the 
reaction vessel in which the chemical substance was manufactured and 
other equipment which is strictly ancillary to the reaction vessel, 
and any other equipment through which the chemical substance may 
flow during a continuous flow process, but does not include tanks or 
other vessels in which the chemical substance is stored after its 
manufacture.

    Manufacture means to manufacture, produce, or import for commercial 
purposes.
    Manufacture or import ``for commercial purposes'' means to 
manufacture, produce, or import with the purpose of obtaining an 
immediate or eventual commercial advantage, and includes, for example, 
the manufacture

[[Page 889]]

or import of any amount of a chemical substance or mixture:
    (1) For commercial distribution, including for test marketing, or
    (2) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that ``mixture'' does 
include:
    (1) Any combination which occurs, in whole or in part, as a result 
of a chemical reaction if the 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 of the chemical substances comprising the combination is a new 
chemical substance, and
    (2) Hydrates of a chemical substance or hydrated ions formed by 
association of a chemical substance with water.
    New chemical substance means any chemical substance which is not 
included in the inventory compiled and published under section 8(b) of 
the Act.
    Person means any natural or juridical 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 of the Federal 
Government.
    Process means the preparation of a 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 or mixture, or
    (2) As part of a mixture or article containing the chemical 
substance or mixture.
    Process ``for commercial purposes'' means to process:
    (1) For distribution in commerce, including for test marketing 
purposes, or
    (2) For use as an intermediate.
    Processor means any person who processes a chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way will be considered one site. There may be more than 
one manufacturing plant on a single site. For the purposes of imported 
chemical substances, the site will be the business address of the 
importer.
    Small quantities for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including any such research or analysis for the 
development of a product (hereinafter sometimes shortened to small 
quantities for research and development) means quantities of a chemical 
substance manufactured, imported, or processed or proposed to be 
manufactured, imported, or processed that:
    (1) Are no greater than reasonably necessary for such purposes, and
    (2) After the publication of the revised inventory, are used by, or 
directly under the supervision of, a technically qualified 
individual(s).
    Note: Any chemical substances manufactured, imported, or 
processed in quantities less than 1,000 lbs. (454 kg) annually will 
be presumed to be manufactured, imported, or processed for research 
and development purposes. No person may report for the inventory any 
chemical substance in such quantities unless that person can certify 
that the substance was not manufactured, imported, or processed 
solely in small quantities for research and development, as defined 
in this section.

    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
the Canal Zone, American Samoa, the Northern Mariana Islands, or any 
other territory or possession of the United States.
    Technically qualified individual means a person:
    (1) Who because of his/her education, training, or experience, or a 
combination of these factors, is capable of appreciating the health and 
environmental risks associated with the chemical substance which is 
used under his/her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or chemical research 
in order to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the chemical 
substance as may be appropriate or required within the scope of 
conducting the research and development activity. The responsibilities 
in this paragraph may be delegated to another individual, or other 
individuals, as long as each meets the criteria in paragraph (1) of 
this definition.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture, or article in commerce.
    United States, when used in the geographic sense, means all of the 
States, territories, and possessions of the United States.

Sec.  710.4 [Amended]

    g. Section 710.4 is amended as follows:
    i. In paragraphs (a), (c)(1), (c)(2), (c)(3), and the Note at the 
end of paragraph (d)(8), change the references to ``Sec.  710.2'', 
``Sec.  710.2(h)'', ``Sec.  710.2(q)'', ``Sec.  710.2(y)'', and ``Sec.  
710.2(n)'', respectively to ``Sec.  710.3(d)''.
    ii. In paragraph (b)(2), change ``shall'' to ``will''.
    iii. In the Note to paragraph (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 and 
the subpart heading is added to read as follows:

Subpart B--2002 Inventory Update Reporting

    i. Add Sec.  710.23 to subpart B to read as follows:


Sec.  710.23   Definitions.

    In addition to the definitions in Sec.  704.3 of this chapter and 
Sec.  710.3, the following definitions also apply to subpart B of this 
part.
    Master Inventory File means EPA's comprehensive list of chemical 
substances which constitute the Chemical Substances Inventory compiled 
under section 8(b) of the Act. It includes substances reported under 
subpart A of this part and substances reported under part 720 of this 
chapter for which a Notice of Commencement of Manufacture or Import has 
been received under Sec.  720.120 of this chapter.
    Non-isolated intermediate means 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 through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture.

[[Page 890]]

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

Sec.  710.39 [Amended]

    j. Section 710.39 is amended as follows:
    i. Revise the section heading 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 of the 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 to read as follows:

Subpart C--Inventory Update Reporting for 2006 and Beyond


Sec.  710.43   Definitions.

    In addition to the definitions in Sec.  704.3 of this chapter and 
Sec.  710.3, the following definitions also apply to subpart C of this 
part:
    Commercial use means the use of a chemical substance or mixture in 
a commercial enterprise providing saleable goods or services (e.g., dry 
cleaning establishment, painting contractor).
    Consumer use means the use of a chemical substance that is 
directly, or as part of a mixture, sold to or made available to 
consumers for their use in or around a permanent or temporary household 
or residence, in or around a school, or in or around recreational 
areas.
    Industrial use means use at a site at which one or more chemical 
substances or mixtures are manufactured (including imported) or 
processed.
    Intended for use by children means the chemical substance or 
mixture is used in or on a product that is specifically intended for 
use by children age 14 or younger. A chemical substance or mixture is 
intended for use by children when the submitter answers ``yes'' to at 
least one of the following questions for the product into which the 
submitter's chemical substance or mixture is incorporated:
    (1) Is the product commonly recognized (i.e., by a reasonable 
person) as being intended for children age 14 or younger?
    (2) Does the manufacturer of the product state through product 
labeling or other written materials that the product is intended for or 
will be used by children age 14 or younger?
    (3) Is the advertising, promotion, or marketing of the product 
aimed at children age 14 or younger?
    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Master Inventory File means EPA's comprehensive list of chemical 
substances which constitute the Chemical Substances Inventory compiled 
under section 8(b) of the Act. It includes substances reported under 
subpart A of this part and substances reported under part 720 of this 
chapter for which a Notice of Commencement of Manufacture or Import has 
been received under Sec.  720.120 of this chapter.
    Non-isolated intermediate means 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 through 
which the substance passes during a continuous flow process, but not 
including tanks or other vessels in which the substance is stored after 
its manufacture.
    Readily obtainable information means information which is known by 
management and supervisory employees of the submitter company who are 
responsible for manufacturing, processing, distributing, technical 
services, and marketing of the reportable chemical substance. Extensive 
file searches are not required.
    Reasonably likely to be exposed means an exposure to a chemical 
substance which, under foreseeable conditions of manufacture (including 
import), processing, distribution in commerce, or use of the chemical 
substance, is more 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 of entry (inhalation, ingestion, skin contact, absorption, etc.), 
but excludes accidental or theoretical exposures.
    Repackaging means the physical transfer of a chemical substance or 
mixture, as is, from one container to another container or containers 
in preparation for distribution of the chemical substance or mixture in 
commerce.
    Reportable chemical substance means a chemical substance described 
in Sec.  710.45.
    Reporting year means 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-limited means a chemical substance is manufactured and 
processed only within a site and is not distributed for commercial 
purposes as a substance or as part of a 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.
    Submission period means the period in which the information 
generated during the reporting year is submitted to EPA.
    Use means any utilization of a chemical substance or mixture that 
is not otherwise covered by the terms manufacture or process. 
Relabeling or redistributing a container holding a chemical substance 
or mixture where no repackaging of the chemical substance or mixture 
occurs does not constitute use or processing of the chemical substance 
or mixture.


Sec.  710.45  Chemical substances for which information must be 
reported.

    Any chemical substance which is in the Master Inventory File at the 
beginning of a submission period described in Sec.  710.53, unless the 
chemical substance is specifically excluded by Sec.  710.46.


Sec.  710.46   Chemical substances for which information is not 
required.

    The following groups or categories of chemical substances are 
exempted from some or all of the reporting requirements of this 
subpart, with the following exception: A chemical substance described 
in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not 
exempted from any of the reporting requirements of this subpart if that 
substance is the subject of a rule

[[Page 891]]

proposed or promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the 
Act, or is the subject of an order issued under section 5(e) or 5(f) of 
the Act, or is the subject of relief that has been granted under a 
civil action under section 5 or 7 of the Act.
    (a) Full exemptions. The following categories of chemical 
substances are exempted from the reporting requirements of this 
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 of the 1985 edition of the Inventory or in 
the Master Inventory File, where the asterisk (*) indicates that any 
sets of characters may precede, or follow, the character string 
defined.
    (ii) Any chemical substance which is identified in the 1985 edition 
of the Inventory or the Master Inventory File as siloxane and silicone, 
silsesquioxane, a protein (albumin, casein, gelatin, gluten, 
hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum), 
rubber, or lignin.
    (iii) This exclusion does not apply to a polymeric substance that 
has 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 of chemical substances that is 
a living organism, and that meets the definition of ``microorganism'' 
at Sec.  725.3 of this chapter. Any chemical substance produced from a 
living microorganism is reportable under this subpart unless otherwise 
excluded.
    (3) Naturally occurring chemical substances. Any naturally 
occurring chemical substance, as described in Sec.  710.4(b). The 
applicability of this exclusion is determined in each case by the 
specific activities of the person who manufactures the substance in 
question. Some chemical substances can be manufactured both as 
described in Sec.  710.4(b) and by means other than those described in 
Sec.  710.4(b). If a person described in Sec.  710.48 manufactures a 
chemical substance by means other than those described in Sec.  
710.4(b), the person must report regardless of whether the substance 
also could have been produced as described in Sec.  710.4(b). Any 
chemical substance that is produced from such a naturally occurring 
chemical substance described in Sec.  710.4(b) is reportable unless 
otherwise excluded.
    (4) Certain forms of natural gas. Chemical substances with the 
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 of chemical substances 
are partially exempted from the reporting requirements of this subpart 
(i.e., the information described in Sec.  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. A 
chemical substance described in paragraph (b)(3) of this section 
qualifies for a partial reporting exemption during the 2006 submission 
period; in subsequent submission periods, the chemical substances 
described in paragraph (b)(3) of this section will be subject to full 
reporting under this subpart (i.e., all of the information described in 
this subpart must be reported), unless otherwise exempted.
    (1) Petroleum process streams. 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.                              Product
------------------------------------------------------------------------
7732-18-5.........................  Water
8002-05-9.........................  Petroleum
8002-74-2.........................  Paraffin waxes and hydrocarbon waxes
8006-20-0.........................  Fuel gases, low and medium B.T.U.
8008-20-6.........................  Kerosine (petroleum)
8009-03-8.........................  Petrolatum
8012-95-1.........................  Paraffin oils
8030-30-6.........................  Naphtha
8032-32-4.........................  Ligroine
8042-47-5.........................  White mineral oil (petroleum)
8052-41-3.........................  Stoddard solvent
8052-42-4.........................  Asphalt
63231-60-7........................  Paraffin waxes and hydrocarbon
                                     waxes, microcryst.
64741-41-9........................  Naphtha (petroleum), heavy straight-
                                     run
64741-42-0........................  Naphtha (petroleum), full-range
                                     straight-run
64741-43-1........................  Gas oils (petroleum), straight-run
64741-44-2........................  Distillates (petroleum), straight-
                                     run middle
64741-45-3........................  Residues (petroleum), atm. tower
64741-46-4........................  Naphtha (petroleum), light straight-
                                     run
64741-47-5........................  Natural gas condensates (petroleum)
64741-49-7........................  Condensates (petroleum), vacuum
                                     tower
64741-50-0........................  Distillates (petroleum), light
                                     paraffinic
64741-51-1........................  Distillates (petroleum), heavy
                                     paraffinic
64741-52-2........................  Distillates (petroleum), light
                                     naphthenic
64741-53-3........................  Distillates (petroleum), heavy
                                     naphthenic
64741-54-4........................  Naphtha (petroleum), heavy catalytic
                                     cracked
64741-55-5........................  Naphtha (petroleum), light catalytic
                                     cracked
64741-56-6........................  Residues (petroleum), vacuum
64741-57-7........................  Gas oils (petroleum), heavy vacuum
64741-58-8........................  Gas oils (petroleum), light vacuum
64741-59-9........................  Distillates (petroleum), light
                                     catalytic cracked

[[Page 892]]

 
64741-60-2........................  Distillates (petroleum),
                                     intermediate catalytic cracked
64741-61-3........................  Distillates (petroleum), heavy
                                     catalytic cracked
64741-62-4........................  Clarified oils (petroleum),
                                     catalytic cracked
64741-63-5........................  Naphtha (petroleum), light catalytic
                                     reformed
64741-64-6........................  Naphtha (petroleum), full-range
                                     alkylate
64741-65-7........................  Naphtha (petroleum), heavy alkylate
64741-66-8........................  Naphtha (petroleum), light alkylate
64741-67-9........................  Residues (petroleum), catalytic
                                     reformer fractionator
64741-68-0........................  Naphtha (petroleum), heavy catalytic
                                     reformed
64741-69-1........................  Naphtha (petroleum), light
                                     hydrocracked
64741-70-4........................  Naphtha (petroleum), isomerization
64741-73-7........................  Distillates (petroleum), alkylate
64741-74-8........................  Naphtha (petroleum), light thermal
                                     cracked
64741-75-9........................  Residues (petroleum), hydrocracked
64741-76-0........................  Distillates (petroleum), heavy
                                     hydrocracked
64741-77-1........................  Distillates (petroleum), light
                                     hydrocracked
64741-78-2........................  Naphtha (petroleum), heavy
                                     hydrocracked
64741-79-3........................  Coke (petroleum)
64741-80-6........................  Residues (petroleum), thermal
                                     cracked
64741-81-7........................  Distillates (petroleum), heavy
                                     thermal cracked
64741-82-8........................  Distillates (petroleum), light
                                     thermal cracked
64741-83-9........................  Naphtha (petroleum), heavy thermal
                                     cracked
64741-84-0........................  Naphtha (petroleum), solvent-refined
                                     light
64741-85-1........................  Raffinates (petroleum), sorption
                                     process
64741-86-2........................  Distillates (petroleum), sweetened
                                     middle
64741-87-3........................  Naphtha (petroleum), sweetened
64741-88-4........................  Distillates (petroleum), solvent-
                                     refined heavy paraffinic
64741-89-5........................  Distillates (petroleum), solvent-
                                     refined light paraffinic
64741-90-8........................  Gas oils (petroleum), solvent-
                                     refined
64741-91-9........................  Distillates (petroleum), solvent-
                                     refined middle
64741-92-0........................  Naphtha (petroleum), solvent-refined
                                     heavy
64741-95-3........................  Residual oils (petroleum), solvent
                                     deasphalted
64741-96-4........................  Distillates (petroleum), solvent-
                                     refined heavy naphthenic
64741-97-5........................  Distillates (petroleum), solvent-
                                     refined light naphthenic
64741-98-6........................  Extracts (petroleum), heavy naphtha
                                     solvent
64741-99-7........................  Extracts (petroleum), light naphtha
                                     solvent
64742-01-4........................  Residual oils (petroleum), solvent-
                                     refined
64742-03-6........................  Extracts (petroleum), light
                                     naphthenic distillate solvent
64742-04-7........................  Extracts (petroleum), heavy
                                     paraffinic distillate solvent
64742-05-8........................  Extracts (petroleum), light
                                     paraffinic distillate solvent
64742-06-9........................  Extracts (petroleum), middle
                                     distillate solvent
64742-07-0........................  Raffinates (petroleum), residual oil
                                     decarbonization
64742-08-1........................  Raffinates (petroleum), heavy
                                     naphthenic distillate
                                     decarbonization
64742-09-2........................  Raffinates (petroleum), heavy
                                     paraffinic distillate
                                     decarbonization
64742-10-5........................  Extracts (petroleum), residual oil
                                     solvent
64742-11-6........................  Extracts (petroleum), heavy
                                     naphthenic distillate solvent
64742-12-7........................  Gas oils (petroleum), acid-treated
64742-13-8........................  Distillates (petroleum), acid-
                                     treated middle
64742-14-9........................  Distillates (petroleum), acid-
                                     treated light
64742-15-0........................  Naphtha (petroleum), acid-treated
64742-16-1........................  Petroleum resins
64742-18-3........................  Distillates (petroleum), acid-
                                     treated heavy naphthenic
64742-19-4........................  Distillates (petroleum), acid-
                                     treated light naphthenic
64742-20-7........................  Distillates (petroleum), acid-
                                     treated heavy paraffinic
64742-21-8........................  Distillates (petroleum), acid-
                                     treated light paraffinic
64742-22-9........................  Naphtha (petroleum), chemically
                                     neutralized heavy
64742-23-0........................  Naphtha (petroleum), chemically
                                     neutralized light
64742-24-1........................  Sludges (petroleum), acid
64742-25-2........................  Lubricating oils (petroleum), acid-
                                     treated spent
64742-26-3........................  Hydrocarbon waxes (petroleum), acid-
                                     treated
64742-27-4........................  Distillates (petroleum), chemically
                                     neutralized heavy paraffinic
64742-28-5........................  Distillates (petroleum), chemically
                                     neutralized light paraffinic
64742-29-6........................  Gas oils (petroleum), chemically
                                     neutralized
64742-30-9........................  Distillates (petroleum), chemically
                                     neutralized middle
64742-31-0........................  Distillates (petroleum), chemically
                                     neutralized light
64742-32-1........................  Lubricating oils (petroleum),
                                     chemically neutralized spent
64742-33-2........................  Hydrocarbon waxes (petroleum),
                                     chemically neutralized
64742-34-3........................  Distillates (petroleum), chemically
                                     neutralized heavy naphthenic
64742-35-4........................  Distillates (petroleum), chemically
                                     neutralized light naphthenic
64742-36-5........................  Distillates (petroleum), clay-
                                     treated heavy paraffinic
64742-37-6........................  Distillates (petroleum), clay-
                                     treated light paraffinic

[[Page 893]]

 
64742-38-7........................  Distillates (petroleum), clay-
                                     treated middle
64742-39-8........................  Neutralizing agents (petroleum),
                                     spent sodium carbonate
64742-40-1........................  Neutralizing agents (petroleum),
                                     spent sodium hydroxide
64742-41-2........................  Residual oils (petroleum), clay-
                                     treated
64742-42-3........................  Hydrocarbon waxes (petroleum), clay-
                                     treated microcryst.
64742-43-4........................  Paraffin waxes (petroleum), clay-
                                     treated
64742-44-5........................  Distillates (petroleum), clay-
                                     treated heavy naphthenic
64742-45-6........................  Distillates (petroleum), clay-
                                     treated light naphthenic
64742-46-7........................  Distillates (petroleum),
                                     hydrotreated middle
64742-47-8........................  Distillates (petroleum),
                                     hydrotreated light
64742-48-9........................  Naphtha (petroleum), hydrotreated
                                     heavy
64742-49-0........................  Naphtha (petroleum), hydrotreated
                                     light
64742-50-3........................  Lubricating oils (petroleum), clay-
                                     treated spent
64742-51-4........................  Paraffin waxes (petroleum),
                                     hydrotreated
64742-52-5........................  Distillates (petroleum),
                                     hydrotreated heavy naphthenic
64742-53-6........................  Distillates (petroleum),
                                     hydrotreated light naphthenic
64742-54-7........................  Distillates (petroleum),
                                     hydrotreated heavy paraffinic
64742-55-8........................  Distillates (petroleum),
                                     hydrotreated light paraffinic
64742-56-9........................  Distillates (petroleum), solvent-
                                     dewaxed light paraffinic
64742-57-0........................  Residual oils (petroleum),
                                     hydrotreated
64742-58-1........................  Lubricating oils (petroleum),
                                     hydrotreated spent
64742-59-2........................  Gas oils (petroleum), hydrotreated
                                     vacuum
64742-60-5........................  Hydrocarbon waxes (petroleum),
                                     hydrotreated microcryst.
64742-61-6........................  Slack wax (petroleum)
64742-62-7........................  Residual oils (petroleum), solvent-
                                     dewaxed
64742-63-8........................  Distillates (petroleum), solvent-
                                     dewaxed heavy naphthenic
64742-64-9........................  Distillates (petroleum), solvent-
                                     dewaxed light naphthenic
64742-65-0........................  Distillates (petroleum), solvent-
                                     dewaxed heavy paraffinic
64742-67-2........................  Foots oil (petroleum)
64742-68-3........................  Naphthenic oils (petroleum),
                                     catalytic dewaxed heavy
64742-69-4........................  Naphthenic oils (petroleum),
                                     catalytic dewaxed light
64742-70-7........................  Paraffin oils (petroleum), catalytic
                                     dewaxed heavy
64742-71-8........................  Paraffin oils (petroleum), catalytic
                                     dewaxed light
64742-72-9........................  Distillates (petroleum), catalytic
                                     dewaxed middle
64742-73-0........................  Naphtha (petroleum),
                                     hydrodesulfurized light
64742-75-2........................  Naphthenic oils (petroleum), complex
                                     dewaxed heavy
64742-76-3........................  Naphthenic oils (petroleum), complex
                                     dewaxed light
64742-78-5........................  Residues (petroleum),
                                     hydrodesulfurized atmospheric tower
64742-79-6........................  Gas oils (petroleum),
                                     hydrodesulfurized
64742-80-9........................  Distillates (petroleum),
                                     hydrodesulfurized middle
64742-81-0........................  Kerosine (petroleum),
                                     hydrodesulfurized
64742-82-1........................  Naphtha (petroleum),
                                     hydrodesulfurized heavy
64742-83-2........................  Naphtha (petroleum), light steam-
                                     cracked
64742-85-4........................  Residues (petroleum),
                                     hydrodesulfurized vacuum
64742-86-5........................  Gas oils (petroleum),
                                     hydrodesulfurized heavy vacuum
64742-87-6........................  Gas oils (petroleum),
                                     hydrodesulfurized light vacuum
64742-88-7........................  Solvent naphtha (petroleum), medium
                                     aliph.
64742-89-8........................  Solvent naphtha (petroleum), light
                                     aliph.
64742-90-1........................  Residues (petroleum), steam-cracked
64742-91-2........................  Distillates (petroleum), steam-
                                     cracked
64742-92-3........................  Petroleum resins, oxidized
64742-93-4........................  Asphalt, oxidized
64742-94-5........................  Solvent naphtha (petroleum), heavy
                                     arom.
64742-95-6........................  Solvent naphtha (petroleum), light
                                     arom.
64742-96-7........................  Solvent naphtha (petroleum), heavy
                                     aliph.
64742-97-8........................  Distillates (petroleum), oxidized
                                     heavy
64742-98-9........................  Distillates (petroleum), oxidized
                                     light
64742-99-0........................  Residual oils (petroleum), oxidized
64743-00-6........................  Hydrocarbon waxes (petroleum),
                                     oxidized
64743-01-7........................  Petrolatum (petroleum), oxidized
64743-02-8........................  Alkenes, C10 .alpha.-
64743-03-9........................  Phenols (petroleum)
64743-04-0........................  Coke (petroleum), recovery
64743-05-1........................  Coke (petroleum), calcined
64743-06-2........................  Extracts (petroleum), gas oil
                                     solvent
64743-07-3........................  Sludges (petroleum), chemically
                                     neutralized
64754-89-8........................  Naphthenic acids (petroleum), crude
64771-71-7........................  Paraffins (petroleum), normal C10
64771-72-8........................  Paraffins (petroleum), normal C5-20
67674-12-8........................  Residual oils (petroleum), oxidized,
                                     compounds with triethanolamine
67674-13-9........................  Petrolatum (petroleum), oxidized,
                                     partially deacidified

[[Page 894]]

 
67674-15-1........................  Petrolatum (petroleum), oxidized, Me
                                     ester
67674-16-2........................  Hydrocarbon waxes (petroleum),
                                     oxidized, partially deacidified
67674-17-3........................  Distillates (petroleum), oxidized
                                     light, compounds with
                                     triethanolamine
67674-18-4........................  Distillates (petroleum), oxidized
                                     light, Bu esters
67891-79-6........................  Distillates (petroleum), heavy arom.
67891-80-9........................  Distillates (petroleum), light arom.
67891-82-1........................  Hydrocarbon waxes (petroleum),
                                     oxidized, compounds with
                                     ethanolamine
67891-83-2........................  Hydrocarbon waxes (petroleum),
                                     oxidized, compounds with
                                     isopropanolamine
67891-85-4........................  Hydrocarbon waxes (petroleum),
                                     oxidized, compounds with
                                     triisopropanolamine
68131-05-5........................  Hydrocarbon oils, process blends
68131-49-7........................  Aromatic hydrocarbons, C6-10, acid-
                                     treated, neutralized
68131-75-9........................  Gases (petroleum), C3-4
68153-22-0........................  Paraffin waxes and Hydrocarbon
                                     waxes, oxidized
68187-57-5........................  Pitch, coal tar-petroleum
68187-58-6........................  Pitch, petroleum, arom.
68187-60-0........................  Hydrocarbons, C4, ethane-propane-
                                     cracked
68307-98-2........................  Tail gas (petroleum), catalytic
                                     cracked distillate and catalytic
                                     cracked naphtha fractionation
                                     absorber
68307-99-3........................  Tail gas (petroleum), catalytic
                                     polymn. naphtha fractionation
                                     stabilizer
68308-00-9........................  Tail gas (petroleum), catalytic
                                     reformed naphtha fractionation
                                     stabilizer, hydrogen sulfide-free
68308-01-0........................  Tail gas (petroleum), cracked
                                     distillate hydrotreater stripper
68308-02-1........................  Tail gas (petroleum), distn.,
                                     hydrogen sulfide-free
68308-03-2........................  Tail gas (petroleum), gas oil
                                     catalytic cracking absorber
68308-04-3........................  Tail gas (petroleum), gas recovery
                                     plant
68308-05-4........................  Tail gas (petroleum), gas recovery
                                     plant deethanizer
68308-06-5........................  Tail gas (petroleum),
                                     hydrodesulfurized distillate and
                                     hydrodesulfurized naphtha
                                     fractionator, acid-free
68308-07-6........................  Tail gas (petroleum),
                                     hydrodesulfurized vacuum gas oil
                                     stripper, hydrogen sulfide-free
68308-08-7........................  Tail gas (petroleum), isomerized
                                     naphtha fractionation stabilizer
68308-09-8........................  Tail gas (petroleum), light straight-
                                     run naphtha stabilizer, hydrogen
                                     sulfide-free
68308-10-1........................  Tail gas (petroleum), straight-run
                                     distillate hydrodesulfurizer,
                                     hydrogen sulfide-free
68308-11-2........................  Tail gas (petroleum), propane-
                                     propylene alkylation feed prep
                                     deethanizer
68308-12-3........................  Tail gas (petroleum), vacuum gas oil
                                     hydrodesulfurizer, hydrogen sulfide-
                                     free
68308-27-0........................  Fuel gases, refinery
68333-22-2........................  Residues (petroleum), atmospheric
68333-23-3........................  Naphtha (petroleum), heavy coker
68333-24-4........................  Hydrocarbon waxes (petroleum),
                                     oxidized, compds. with
                                     triethanolamine
68333-25-5........................  Distillates (petroleum),
                                     hydrodesulfurized light catalytic
                                     cracked
68333-26-6........................  Clarified oils (petroleum),
                                     hydrodesulfurized catalytic cracked
68333-27-7........................  Distillates (petroleum),
                                     hydrodesulfurized intermediate
                                     catalytic cracked
68333-28-8........................  Distillates (petroleum),
                                     hydrodesulfurized heavy catalytic
                                     cracked
68333-29-9........................  Residues (petroleum), light naphtha
                                     solvent extracts
68333-30-2........................  Distillates (petroleum), oxidized
                                     heavy thermal cracked
68333-81-3........................  Alkanes, C4-12
68333-88-0........................  Aromatic hydrocarbons, C9-17
68334-30-5........................  Fuels, diesel
68409-99-4........................  Gases (petroleum), catalytic cracked
                                     overheads
68410-00-4........................  Distillates (petroleum), crude oil
68410-05-9........................  Distillates (petroleum), straight-
                                     run light
68410-12-8........................  Distillates (petroleum), steam-
                                     cracked, C5-10 fraction, high-temp.
                                     stripping products with light steam-
                                     cracked petroleum naphtha C5
                                     fraction polymers
68410-71-9........................  Raffinates (petroleum), catalytic
                                     reformer ethylene glycol-water
                                     countercurrent exts.
68410-96-8........................  Distillates (petroleum),
                                     hydrotreated middle, intermediate
                                     boiling
68410-97-9........................  Distillates (petroleum), light
                                     distillate hydrotreating process,
                                     low-boiling
68410-98-0........................  Distillates (petroleum),
                                     hydrotreated heavy naphtha,
                                     deisohexanizer overheads
68411-00-7........................  Alkenes, C8
68425-29-6........................  Distillates (petroleum), naphtha-
                                     raffinate pyrolyzate-derived,
                                     gasoline-blending
68425-33-2........................  Petrolatum (petroleum), oxidized,
                                     barium salt
68425-34-3........................  Petrolatum (petroleum), oxidized,
                                     calcium salt
68425-35-4........................  Raffinates (petroleum), reformer,
                                     Lurgi unit-sepd.
68425-39-8........................  Alkenes, C10 .alpha.-,
                                     oxidized
68441-09-8........................  Hydrocarbon waxes (petroleum), clay-
                                     treated microcryst., contg.
                                     polyethylene, oxidized
68459-78-9........................  Alkenes, C18-24 .alpha.-, dimers
68475-57-0........................  Alkanes, C1-2
68475-58-1........................  Alkanes, C2-3
68475-59-2........................  Alkanes, C3-4
68475-60-5........................  Alkanes, C4-5
68475-61-6........................  Alkenes, C5, naphtha-raffinate
                                     pyrolyzate-derived
68475-70-7........................  Aromatic hydrocarbons, C6-8, naphtha-
                                     raffinate pyrolyzate-derived
68475-79-6........................  Distillates (petroleum), catalytic
                                     reformed depentanizer
68475-80-9........................  Distillates (petroleum), light steam-
                                     cracked naphtha
68476-26-6........................  Fuel gases
68476-28-8........................  Fuel gases, C6-8 catalytic reformer

[[Page 895]]

 
68476-29-9........................  Fuel gases, crude oil distillates
68476-30-2........................  Fuel oil, no. 2
68476-31-3........................  Fuel oil, no. 4
68476-32-4........................  Fuel oil, residues-straight-run gas
                                     oils, high-sulfur
68476-33-5........................  Fuel oil, residual
68476-34-6........................  Fuels, diesel, no. 2
68476-39-1........................  Hydrocarbons, aliph.-arom.-C4-5-
                                     olefinic
68476-40-4........................  Hydrocarbons, C3-4
68476-42-6........................  Hydrocarbons, C4-5
68476-43-7........................  Hydrocarbons, C4-6, C5-rich
68476-44-8........................  Hydrocarbons, C3
68476-45-9........................  Hydrocarbons, C5-10 arom. conc.,
                                     ethylene-manuf.-by-product
68476-46-0........................  Hydrocarbons, C3-11, catalytic
                                     cracker distillates
68476-47-1........................  Hydrocarbons, C2-6, C6-8 catalytic
                                     reformer
68476-49-3........................  Hydrocarbons, C2-4, C3-rich
68476-50-6........................  Hydrocarbons, C>=5, C5-6-rich
68476-52-8........................  Hydrocarbons, C4, ethylene-manuf.-by-
                                     product
68476-53-9........................  Hydrocarbons, C>=20, petroleum
                                     wastes
68476-54-0........................  Hydrocarbons, C3-5, polymn. unit
                                     feed
68476-55-1........................  Hydrocarbons, C5-rich
68476-56-2........................  Hydrocarbons, cyclic C5 and C6
68476-77-7........................  Lubricating oils, refined used
68476-81-3........................  Paraffin waxes and Hydrocarbon
                                     waxes, oxidized, calcium salts
68476-84-6........................  Petroleum products, gases, inorg.
68476-85-7........................  Petroleum gases, liquefied
68476-86-8........................  Petroleum gases, liquefied,
                                     sweetened
68477-25-8........................  Waste gases, vent gas, C1-6
68477-26-9........................  Wastes, petroleum
68477-29-2........................  Distillates (petroleum), catalytic
                                     reformer fractionator residue, high-
                                     boiling
68477-30-5........................  Distillates (petroleum), catalytic
                                     reformer fractionator residue,
                                     intermediate-boiling
68477-31-6........................  Distillates (petroleum), catalytic
                                     reformer fractionator residue, low-
                                     boiling
68477-33-8........................  Gases (petroleum), C3-4, isobutane-
                                     rich
68477-34-9........................  Distillates (petroleum), C3-5, 2-
                                     methyl-2-butene-rich
68477-35-0........................  Distillates (petroleum), C3-6,
                                     piperylene-rich
68477-36-1........................  Distillates (petroleum), cracked
                                     steam-cracked, C5-18 fraction
68477-38-3........................  Distillates (petroleum), cracked
                                     steam-cracked petroleum distillates
68477-39-4........................  Distillates (petroleum), cracked
                                     stripped steam-cracked petroleum
                                     distillates, C8-10 fraction
68477-40-7........................  Distillates (petroleum), cracked
                                     stripped steam-cracked petroleum
                                     distillates, C10-12 fraction
68477-41-8........................  Gases (petroleum), extractive, C3-5,
                                     butadiene-butene-rich
68477-42-9........................  Gases (petroleum), extractive, C3-5,
                                     butene-isobutylene-rich
68477-44-1........................  Distillates (petroleum), heavy
                                     naphthenic, mixed with steam-
                                     cracked petroleum distillates C5-12
                                     fraction
68477-47-4........................  Distillates (petroleum), mixed heavy
                                     olefin vacuum, heart-cut
68477-48-5........................  Distillates (petroleum), mixed heavy
                                     olefin vacuum, low-boiling
68477-53-2........................  Distillates (petroleum), steam-
                                     cracked, C5-12 fraction
68477-54-3........................  Distillates (petroleum), steam-
                                     cracked, C8-12 fraction
68477-55-4........................  Distillates (petroleum), steam-
                                     cracked, C5-10 fraction, mixed with
                                     light steam-cracked petroleum
                                     naphtha C5 fraction
68477-58-7........................  Distillates (petroleum), steam-
                                     cracked petroleum distillates, C5-
                                     18 fraction
68477-59-8........................  Distillates (petroleum), steam-
                                     cracked petroleum distillates
                                     cyclopentadiene conc.
68477-60-1........................  Extracts (petroleum), cold-acid
68477-61-2........................  Extracts (petroleum), cold-acid, C4-
                                     6
68477-62-3........................  Extracts (petroleum), cold-acid, C3-
                                     5, butene-rich
68477-63-4........................  Extracts (petroleum), reformer
                                     recycle
68477-64-5........................  Gases (petroleum), acetylene manuf.
                                     off
68477-65-6........................  Gases (petroleum), amine system feed
68477-66-7........................  Gases (petroleum), benzene unit
                                     hydrodesulfurizer off
68477-67-8........................  Gases (petroleum), benzene unit
                                     recycle, hydrogen-rich
68477-68-9........................  Gases (petroleum), blend oil,
                                     hydrogen-nitrogen-rich
68477-69-0........................  Gases (petroleum), butane splitter
                                     overheads
68477-70-3........................  Gases (petroleum), C2-3
68477-71-4........................  Gases (petroleum), catalytic-cracked
                                     gas oil depropanizer bottoms, C4-
                                     rich acid-free
68477-72-5........................  Gases (petroleum), catalytic-cracked
                                     naphtha debutanizer bottoms, C3-5-
                                     rich
68477-73-6........................  Gases (petroleum), catalytic cracked
                                     naphtha depropanizer overhead, C3-
                                     rich acid-free
68477-74-7........................  Gases (petroleum), catalytic cracker
68477-75-8........................  Gases (petroleum), catalytic
                                     cracker, C1-5-rich
68477-76-9........................  Gases (petroleum), catalytic polymd.
                                     naphtha stabilizer overhead, C2-4-
                                     rich
68477-77-0........................  Gases (petroleum), catalytic
                                     reformed naphtha stripper overheads
68477-79-2........................  Gases (petroleum), catalytic
                                     reformer, C1-4-rich
68477-80-5........................  Gases (petroleum), C6-8 catalytic
                                     reformer recycle
68477-81-6........................  Gases (petroleum), C6-8 catalytic
                                     reformer
68477-82-7........................  Gases (petroleum), C6-8 catalytic
                                     reformer recycle, hydrogen-rich

[[Page 896]]

 
68477-83-8........................  Gases (petroleum), C3-5 olefinic-
                                     paraffinic alkylation feed
68477-84-9........................  Gases (petroleum), C2-return stream
68477-85-0........................  Gases (petroleum), C4-rich
68477-86-1........................  Gases (petroleum), deethanizer
                                     overheads
68477-87-2........................  Gases (petroleum), deisobutanizer
                                     tower overheads
68477-88-3........................  Gases (petroleum), deethanizer
                                     overheads, C3-rich
68477-89-4........................  Distillates (petroleum),
                                     depentanizer overheads
68477-90-7........................  Gases (petroleum), depropanizer dry,
                                     propene-rich
68477-91-8........................  Gases (petroleum), depropanizer
                                     overheads
68477-92-9........................  Gases (petroleum), dry sour, gas-
                                     concn.-unit-off
68477-93-0........................  Gases (petroleum), gas concn.
                                     reabsorber distn.
68477-94-1........................  Gases (petroleum), gas recovery
                                     plant depropanizer overheads
68477-95-2........................  Gases (petroleum), Girbatol unit
                                     feed
68477-96-3........................  Gases (petroleum), hydrogen absorber
                                     off
68477-97-4........................  Gases (petroleum), hydrogen-rich
68478-00-2........................  Gases (petroleum), recycle, hydrogen-
                                     rich
68478-01-3........................  Gases (petroleum), reformer make-up,
                                     hydrogen-rich
68478-02-4........................  Gases (petroleum), reforming
                                     hydrotreater
68478-03-5........................  Gases (petroleum), reforming
                                     hydrotreater, hydrogen-methane-rich
68478-04-6........................  Gases (petroleum), reforming
                                     hydrotreater make-up, hydrogen-rich
68478-05-7........................  Gases (petroleum), thermal cracking
                                     distn.
68478-08-0........................  Naphtha (petroleum), light steam-
                                     cracked, C5-fraction, oligomer
                                     conc.
68478-10-4........................  Naphtha (petroleum), light steam-
                                     cracked, debenzenized, C8-16-
                                     cycloalkadiene conc.
68478-12-6........................  Residues (petroleum), butane
                                     splitter bottoms
68478-13-7........................  Residues (petroleum), catalytic
                                     reformer fractionator residue
                                     distn.
68478-15-9........................  Residues (petroleum), C6-8 catalytic
                                     reformer
68478-16-0........................  Residual oils (petroleum),
                                     deisobutanizer tower
68478-17-1........................  Residues (petroleum), heavy coker
                                     gas oil and vacuum gas oil
68478-18-2........................  Residues (petroleum), heavy olefin
                                     vacuum
68478-19-3........................  Residual oils (petroleum), propene
                                     purifn. splitter
68478-20-6........................  Residues (petroleum), steam-cracked
                                     petroleum distillates
                                     cyclopentadiene conc., C4-
                                     cyclopentadiene-free
68478-22-8........................  Tail gas (petroleum), catalytic
                                     cracked naphtha stabilization
                                     absorber
68478-24-0........................  Tail gas (petroleum), catalytic
                                     cracker, catalytic reformer and
                                     hydrodesulfurizer combined
                                     fractionater
68478-25-1........................  Tail gas (petroleum), catalytic
                                     cracker refractionation absorber
68478-26-2........................  Tail gas (petroleum), catalytic
                                     reformed naphtha fractionation
                                     stabilizer
68478-27-3........................  Tail gas (petroleum), catalytic
                                     reformed naphtha separator
68478-28-4........................  Tail gas (petroleum), catalytic
                                     reformed naphtha stabilizer
68478-29-5........................  Tail gas (petroleum), cracked
                                     distillate hydrotreater separator
68478-30-8........................  Tail gas (petroleum),
                                     hydrodesulfurized straight-run
                                     naphtha separator
68478-32-0........................  Tail gas (petroleum), saturate gas
                                     plant mixed stream, C4-rich
68478-33-1........................  Tail gas (petroleum), saturate gas
                                     recovery plant, C1-2-rich
68478-34-2........................  Tail gas (petroleum), vacuum
                                     residues thermal cracker
68512-61-8........................  Residues (petroleum), heavy coker
                                     and light vacuum
68512-62-9........................  Residues (petroleum), light vacuum
68512-78-7........................  Solvent naphtha (petroleum), light
                                     arom., hydrotreated
68512-91-4........................  Hydrocarbons, C3-4-rich, petroleum
                                     distillates
68513-02-0........................  Naphtha (petroleum), full-range
                                     coker
68513-11-1........................  Fuel gases, hydrotreater
                                     fractionation, scrubbed
68513-12-2........................  Fuel gases, saturate gas unit
                                     fractionater-absorber overheads
68513-13-3........................  Fuel gases, thermal cracked
                                     catalytic cracking residue
68513-14-4........................  Gases (petroleum), catalytic
                                     reformed straight-run naphtha
                                     stabilizer overheads
68513-15-5........................  Gases (petroleum), full-range
                                     straight-run naphtha dehexanizer
                                     off
68513-16-6........................  Gases (petroleum), hydrocracking
                                     depropanizer off, hydrocarbon-rich
68513-17-7........................  Gases (petroleum), light straight-
                                     run naphtha stabilizer off
68513-18-8........................  Gases (petroleum), reformer effluent
                                     high-pressure flash drum off
68513-19-9........................  Gases (petroleum), reformer effluent
                                     low-pressure flash drum off
68513-62-2........................  Disulfides, C5-12-alkyl
68513-63-3........................  Distillates (petroleum), catalytic
                                     reformed straight-run naphtha
                                     overheads
68513-65-5........................  Butane, branched and linear
68513-66-6........................  Residues (petroleum), alkylation
                                     splitter, C4-rich
68513-67-7........................  Residues (petroleum), cyclooctadiene
                                     bottoms
68513-68-8........................  Residues (petroleum), deethanizer
                                     tower
68513-69-9........................  Residues (petroleum), steam-cracked
                                     light
68513-74-6........................  Waste gases, ethylene oxide absorber-
                                     reactor
68514-15-8........................  Gasoline, vapor-recovery
68514-29-4........................  Hydrocarbons, amylene feed
                                     debutanizer overheads
                                     nonextractable raffinates
68514-31-8........................  Hydrocarbons, C1-4
68514-32-9........................  Hydrocarbons, C10 and C12, olefin-
                                     rich
68514-33-0........................  Hydrocarbons, C12 and C14, olefin-
                                     rich
68514-34-1........................  Hydrocarbons, C9-14, ethylene-manuf.-
                                     by-product

[[Page 897]]

 
68514-35-2........................  Hydrocarbons, C14-30, olefin-rich
68514-38-5........................  Hydrocarbons, C4-10-unsatd.
68514-36-3........................  Hydrocarbons, C1-4, sweetened
68514-37-4........................  Hydrocarbons, C4-5-unsatd.
68514-79-4........................  Petroleum products, hydrofiner-
                                     powerformer reformates
68515-25-3........................  Benzene, C1-9-alkyl derivs.
68515-26-4........................  Benzene, di-C12-14-alkyl derivs.
68515-27-5........................  Benzene, di-C10-14-alkyl derivs.,
                                     fractionation overheads, heavy ends
68515-28-6........................  Benzene, di-C10-14-alkyl derivs.,
                                     fractionation overheads, light ends
68515-29-7........................  Benzene, di-C10-14-alkyl derivs.,
                                     fractionation overheads, middle cut
68515-30-0........................  Benzene, mono-C20-48-alkyl derivs.
68515-32-2........................  Benzene, mono-C12-14-alkyl derivs.,
                                     fractionation bottoms
68515-33-3........................  Benzene, mono-C10-12-alkyl derivs.,
                                     fractionation bottoms, heavy ends
68515-34-4........................  Benzene, mono-C12-14-alkyl derivs.,
                                     fractionation bottoms, heavy ends
68515-35-5........................  Benzene, mono-C10-12-alkyl derivs.,
                                     fractionation bottoms, light ends
68515-36-6........................  Benzene, mono-C12-14-alkyl derivs.,
                                     fractionation bottoms, light ends
68516-20-1........................  Naphtha (petroleum), steam-cracked
                                     middle arom.
68526-52-3........................  Alkenes, C6
68526-53-4........................  Alkenes, C6-8, C7-rich
68526-54-5........................  Alkenes, C7-9, C8-rich
68526-55-6........................  Alkenes, C8-10, C9-rich
68526-56-7........................  Alkenes, C9-11, C10-rich
68526-57-8........................  Alkenes, C10-12, C11-rich
68526-58-9........................  Alkenes, C11-13, C12-rich
68526-77-2........................  Aromatic hydrocarbons, ethane
                                     cracking scrubber effluent and
                                     flare drum
68526-99-8........................  Alkenes, C6-9 .alpha.-
68527-00-4........................  Alkenes, C8-9 .alpha.-
68527-11-7........................  Alkenes, C5
68527-13-9........................  Gases (petroleum), acid,
                                     ethanolamine scrubber
68527-14-0........................  Gases (petroleum), methane-rich off
68527-15-1........................  Gases (petroleum), oil refinery gas
                                     distn. off
68527-16-2........................  Hydrocarbons, C1-3
68527-18-4........................  Gas oils (petroleum), steam-cracked
68527-19-5........................  Hydrocarbons, C1-4, debutanizer
                                     fraction
68527-21-9........................  Naphtha (petroleum), clay-treated
                                     full-range straight-run
68527-22-0........................  Naphtha (petroleum), clay-treated
                                     light straight-run
68527-23-1........................  Naphtha (petroleum), light steam-
                                     cracked arom.
68527-26-4........................  Naphtha (petroleum), light steam-
                                     cracked, debenzenized
68527-27-5........................  Naphtha (petroleum), full-range
                                     alkylate, butane-contg.
68553-00-4........................  Fuel oil, no. 6
68553-14-0........................  Hydrocarbons, C8-11
68602-79-9........................  Distillates (petroleum), benzene
                                     unit hydrotreater dipentanizer
                                     overheads
68602-81-3........................  Distillates, hydrocarbon resin
                                     prodn. higher boiling
68602-82-4........................  Gases (petroleum), benzene unit
                                     hydrotreater depentenizer overheads
68602-83-5........................  Gases (petroleum), C1-5, wet
68602-84-6........................  Gases (petroleum), secondary
                                     absorber off, fluidized catalytic
                                     cracker overheads fractionater
68602-96-0........................  Distillates (petroleum), oxidized
                                     light, strong acid components,
                                     compds. with diethanolamine
68602-97-1........................  Distillates (petroleum), oxidized
                                     light, strong acid components,
                                     sodium salts
68602-98-2........................  Distillates (petroleum), oxidized
                                     light, strong acid components
68602-99-3........................  Distillates (petroleum), oxidized
                                     light, strong acid-free
68603-00-9........................  Distillates (petroleum), thermal
                                     cracked naphtha and gas oil
68603-01-0........................  Distillates (petroleum), thermal
                                     cracked naphtha and gas oil, C5-
                                     dimer-contg.
68603-02-1........................  Distillates (petroleum), thermal
                                     cracked naphtha and gas oil,
                                     dimerized
68603-03-2........................  Distillates (petroleum), thermal
                                     cracked naphtha and gas oil,
                                     extractive
68603-08-7........................  Naphtha (petroleum), arom.-contg.
68603-09-8........................  Hydrocarbon waxes (petroleum),
                                     oxidized, calcium salts
68603-10-1........................  Hydrocarbon waxes (petroleum),
                                     oxidized, Me esters, barium salts
68603-11-2........................  Hydrocarbon waxes (petroleum),
                                     oxidized, Me esters, calcium salts
68603-12-3........................  Hydrocarbon waxes (petroleum),
                                     oxidized, Me esters, sodium salts
68603-13-4........................  Petrolatum (petroleum), oxidized,
                                     ester with sorbitol
68603-14-5........................  Residual oils (petroleum), oxidized,
                                     calcium salts
68603-31-6........................  Alkenes, C10, tert-amylene
                                     concentrator by-product
68603-32-7........................  Alkenes, C15-20 .alpha.-, isomerized
68606-09-7........................  Fuel gases, expander off
68606-10-0........................  Gasoline, pyrolysis, debutanizer
                                     bottoms
68606-11-1........................  Gasoline, straight-run, topping-
                                     plant
68606-24-6........................  Hydrocarbons, C4, butene
                                     concentrator by-product
68606-25-7........................  Hydrocarbons, C2-4
68606-26-8........................  Hydrocarbons, C3
68606-27-9........................  Gases (petroleum), alkylation feed
68606-28-0........................  Hydrocarbons, C5 and C10-aliph. and
                                     C6-8-arom.

[[Page 898]]

 
68606-31-5........................  Hydrocarbons, C3-5, butadiene
                                     purifn. by-product
68606-34-8........................  Gases (petroleum), depropanizer
                                     bottoms fractionation off
68606-36-0........................  Hydrocarbons, C5-unsatd. rich,
                                     isoprene purifn. by-product
68607-11-4........................  Petroleum products, refinery gases
68607-30-7........................  Residues (petroleum), topping plant,
                                     low-sulfur
68608-56-0........................  Waste gases, from carbon black
                                     manuf.
68647-60-9........................  Hydrocarbons, C4
68647-61-0........................  Hydrocarbons, C4-5, tert-amylene
                                     concentrator by-product
68647-62-1........................  Hydrocarbons, C4-5, butene
                                     concentrator by-product, sour
68650-36-2........................  Aromatic hydrocarbons, C8, o-xylene-
                                     lean
68650-37-3........................  Paraffin waxes (petroleum),
                                     oxidized, sodium salts
68782-97-8........................  Distillates (petroleum), hydrofined
                                     lubricating-oil
68782-98-9........................  Extracts (petroleum), clarified oil
                                     solvent, condensed-ring-arom.-
                                     contg.
68782-99-0........................  Extracts (petroleum), heavy
                                     clarified oil solvent, condensed-
                                     ring-arom.-contg.
68783-00-6........................  Extracts (petroleum), heavy
                                     naphthenic distillate solvent,
                                     arom. conc.
68783-01-7........................  Extracts (petroleum), heavy
                                     naphthenic distillate solvent,
                                     paraffinic conc.
68783-02-8........................  Extracts (petroleum), intermediate
                                     clarified oil solvent, condensed-
                                     ring-arom.-contg.
68783-04-0........................  Extracts (petroleum), solvent-
                                     refined heavy paraffinic distillate
                                     solvent
68783-05-1........................  Gases (petroleum), ammonia-hydrogen
                                     sulfide, water-satd.
68783-06-2........................  Gases (petroleum), hydrocracking low-
                                     pressure separator
68783-07-3........................  Gases (petroleum), refinery blend
68783-08-4........................  Gas oils (petroleum), heavy
                                     atmospheric
68783-09-5........................  Naphtha (petroleum), catalytic
                                     cracked light distd.
68783-12-0........................  Naphtha (petroleum), unsweetened
68783-13-1........................  Residues (petroleum), coker
                                     scrubber, condensed-ring-arom.-
                                     contg.
68783-15-3........................  Alkenes, C6-7 .alpha.-
68783-61-9........................  Fuel gases, refinery, sweetened
68783-62-0........................  Fuel gases, refinery, unsweetened
68783-64-2........................  Gases (petroleum), catalytic
                                     cracking
68783-65-3........................  Gases (petroleum), C2-4, sweetened
68783-66-4........................  Naphtha (petroleum), light,
                                     sweetened
68814-47-1........................  Waste gases, refinery vent
68814-67-5........................  Gases (petroleum), refinery
68814-89-1........................  Extracts (petroleum), heavy
                                     paraffinic distillates, solvent-
                                     deasphalted
68814-87-9........................  Distillates (petroleum), full-range
                                     straight-run middle
68814-90-4........................  Gases (petroleum), platformer
                                     products separator off
68814-91-5........................  Alkenes, C5-9 .alpha.-
68855-57-2........................  Alkenes, C6-12 .alpha.-
68855-58-3........................  Alkenes, C10-16 .alpha.-
68855-59-4........................  Alkenes, C14-18 .alpha.-
68855-60-7........................  Alkenes, C14-20 .alpha.-
68911-58-0........................  Gases (petroleum), hydrotreated sour
                                     kerosine depentanizer stabilizer
                                     off
68911-59-1........................  Gases (petroleum), hydrotreated sour
                                     kerosine flash drum
68915-96-8........................  Distillates (petroleum), heavy
                                     straight-run
68915-97-9........................  Gas oils (petroleum), straight-run,
                                     high-boiling
68918-69-4........................  Petrolatum (petroleum), oxidized,
                                     zinc salt
68918-73-0........................  Residues (petroleum), clay-treating
                                     filter wash
68918-93-4........................  Paraffin waxes and Hydrocarbon
                                     waxes, oxidized, alkali metal salts
68918-98-9........................  Fuel gases, refinery, hydrogen
                                     sulfide-free
68918-99-0........................  Gases (petroleum), crude oil
                                     fractionation off
68919-00-6........................  Gases (petroleum), dehexanizer off
68919-01-7........................  Gases (petroleum), distillate
                                     unifiner desulfurization stripper
                                     off
68919-02-8........................  Gases (petroleum), fluidized
                                     catalytic cracker fractionation off
68919-03-9........................  Gases (petroleum), fluidized
                                     catalytic cracker scrubbing
                                     secondary absorber off
68919-04-0........................  Gases (petroleum), heavy distillate
                                     hydrotreater desulfurization
                                     stripper off
68919-05-1........................  Gases (petroleum), light straight
                                     run gasoline fractionation
                                     stabilizer off
68919-06-2........................  Gases (petroleum), naphtha unifiner
                                     desulfurization stripper off
68919-07-3........................  Gases (petroleum), platformer
                                     stabilizer off, light ends
                                     fractionation
68919-08-4........................  Gases (petroleum), preflash tower
                                     off, crude distn.
68919-09-5........................  Gases (petroleum), straight-run
                                     naphtha catalytic reforming off
68919-10-8........................  Gases (petroleum), straight-run
                                     stabilizer off
68919-11-9........................  Gases (petroleum), tar stripper off
68919-12-0........................  Gases (petroleum), unifiner stripper
                                     off
68919-15-3........................  Hydrocarbons, C6-12, benzene-
                                     recovery
68919-17-5........................  Hydrocarbons, C12-20, catalytic
                                     alkylation by-products
68919-19-7........................  Gases (petroleum), fluidized
                                     catalytic cracker splitter residues
68919-20-0........................  Gases (petroleum), fluidized
                                     catalytic cracker splitter
                                     overheads
68919-37-9........................  Naphtha (petroleum), full-range
                                     reformed
68920-06-9........................  Hydrocarbons, C7-9
68920-07-0........................  Hydrocarbons, C<10-linear
68920-64-9........................  Disulfides, di-C1-2-alkyl

[[Page 899]]

 
68921-07-3........................  Distillates (petroleum),
                                     hydrotreated light catalytic
                                     cracked
68921-09-5........................  Distillates (petroleum), naphtha
                                     unifiner stripper
68921-08-4........................  Distillates (petroleum), light
                                     straight-run gasoline fractionation
                                     stabilizer overheads
68921-67-5........................  Hydrocarbons, ethylene-manuf.-by-
                                     product distn. residues
68952-76-1........................  Gases (petroleum), catalytic cracked
                                     naphtha debutanizer
68952-77-2........................  Tail gas (petroleum), catalytic
                                     cracked distillate and naphtha
                                     stabilizer
68952-78-3........................  Tail gas (petroleum), catalytic
                                     hydrodesulfurized distillate
                                     fractionation stabilizer, hydrogen
                                     sulfide-free
68952-79-4........................  Tail gas (petroleum), catalytic
                                     hydrodesulfurized naphtha separator
68952-80-7........................  Tail gas (petroleum), straight-run
                                     naphtha hydrodesulfurizer
68952-81-8........................  Tail gas (petroleum), thermal-
                                     cracked distillate, gas oil and
                                     naphtha absorber
68952-82-9........................  Tail gas (petroleum), thermal
                                     cracked hydrocarbon fractionation
                                     stabilizer, petroleum coking
68953-80-0........................  Benzene, mixed with toluene,
                                     dealkylation product
68955-27-1........................  Distillates (petroleum), petroleum
                                     residues vacuum
68955-28-2........................  Gases (petroleum), light steam-
                                     cracked, butadiene conc.
68955-31-7........................  Gases (petroleum), butadiene
                                     process, inorg.
68955-32-8........................  Natural gas, substitute, steam-
                                     reformed desulfurized naphtha
68955-33-9........................  Gases (petroleum), sponge absorber
                                     off, fluidized catalytic cracker
                                     and gas oil desulfurizer overhead
                                     fractionation
68955-34-0........................  Gases (petroleum), straight-run
                                     naphtha catalytic reformer
                                     stabilizer overhead
68955-35-1........................  Naphtha (petroleum), catalytic
                                     reformed
68955-36-2........................  Residues (petroleum), steam-cracked,
                                     resinous
68955-76-0........................  Aromatic hydrocarbons, C9-16,
                                     biphenyl deriv.-rich
68955-96-4........................  Disulfides, dialkyl and di-Ph,
                                     naphtha sweetening
68956-47-8........................  Fuel oil, isoprene reject absorption
68956-48-9........................  Fuel oil, residual, wastewater
                                     skimmings
68956-52-5........................  Hydrocarbons, C4-8
68956-54-7........................  Hydrocarbons, C4-unsatd.
68956-55-8........................  Hydrocarbons, C5-unsatd.
68956-70-7........................  Petroleum products, C5-12,
                                     reclaimed, wastewater treatment
68988-79-4........................  Benzene, C10-12-alkyl derivs.,
                                     distn. residues
68988-99-8........................  Phenols, sodium salts, mixed with
                                     sulfur compounds, gasoline alk.
                                     scrubber residues
68989-88-8........................  Gases (petroleum), crude distn. and
                                     catalytic cracking
68990-35-2........................  Distillates (petroleum), arom.,
                                     hydrotreated, dicyclopentadiene-
                                     rich
68991-49-1........................  Alkanes, C10-13, arom.-free
                                     desulfurized
68991-50-4........................  Alkanes, C14-17, arom.-free
                                     desulfurized
68991-51-5........................  Alkanes, C10-13, desulfurized
68991-52-6........................  Alkenes, C10-16
69013-21-4........................  Fuel oil, pyrolysis
69029-75-0........................  Oils, reclaimed
69430-33-7........................  Hydrocarbons, C6-30
70024-88-3........................  Ethene, thermal cracking products
70528-71-1........................  Distillates (petroleum), heavy
                                     distillate solvent ext. heart-cut
70528-72-2........................  Distillates (petroleum), heavy
                                     distillate solvent ext. vacuum
                                     overheads
70528-73-3........................  Residues (petroleum), heavy
                                     distillate solvent ext. vacuum
70592-76-6........................  Distillates (petroleum),
                                     intermediate vacuum
70592-77-7........................  Distillates (petroleum), light
                                     vacuum
70592-78-8........................  Distillates (petroleum), vacuum
70592-79-9........................  Residues (petroleum), atm. tower,
                                     light
70693-00-4........................  Hydrocarbon waxes (petroleum),
                                     oxidized, sodium salts
70693-06-0........................  Aromatic hydrocarbons, C9-11
70913-85-8........................  Residues (petroleum), solvent-extd.
                                     vacuum distilled atm. residuum
70913-86-9........................  Alkanes, C18-70
70955-08-7........................  Alkanes, C4-6
70955-09-8........................  Alkenes, C13-14 .alpha.-
70955-10-1........................  Alkenes, C15-18 .alpha.-
70955-17-8........................  Aromatic hydrocarbons, C12-20
71243-66-8........................  Hydrocarbon waxes (petroleum), clay-
                                     treated, microcryst., oxidized,
                                     potassium salts
71302-82-4........................  Hydrocarbons, C5-8, Houdry butadiene
                                     manuf. by-product
71329-37-8........................  Residues (petroleum), catalytic
                                     cracking depropanizer, C4-rich
71808-30-5........................  Tail gas (petroleum), thermal
                                     cracking absorber
72230-71-8........................  Distillates (petroleum), cracked
                                     steam-cracked, C5-17 fraction
72623-83-7........................  Lubricating oils (petroleum), C25, hydrotreated bright
                                     stock-based
72623-84-8........................  Lubricating oils (petroleum), C15-
                                     30, hydrotreated neutral oil-based,
                                     contg. solvent deasphalted residual
                                     oil
72623-85-9........................  Lubricating oils (petroleum), C20-
                                     50, hydrotreated neutral oil-based,
                                     high-viscosity
72623-86-0........................  Lubricating oils (petroleum), C15-
                                     30, hydrotreated neutral oil-based
72623-87-1........................  Lubricating oils (petroleum), C20-
                                     50, hydrotreated neutral oil-based
93762-80-2........................  Alkenes, C15-18
------------------------------------------------------------------------


[[Page 900]]

    (2) Specific exempted chemical substances--(i) Exemption. EPA has 
determined that, at this time, the information in Sec.  710.52(c)(4) 
associated with the chemicals listed in paragraph (b)(2)(iv) of this 
section is of low current interest.
    (ii) Considerations. In making its determination of whether this 
partial exemption should apply to a particular chemical substance, EPA 
will consider the totality of information available for the chemical 
substance in question, including but not limited to, one or more of the 
following considerations:
    (A) Whether the chemical qualifies or has qualified in past IUR 
collections for the reporting of the information described in Sec.  
710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or 
more of the 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 of EPA, other federal agencies, tribes, 
states, and local governments, as well as members of the public.
    (D) The availability of other complementary risk screening 
information.
    (E) The availability of comparable processing and use information.
    (F) Whether the potential risks of the chemical substance are 
adequately managed by EPA or another agency or authority.
    (iii) Amendments. EPA may amend the chemical list in paragraph 
(b)(2)(iv) of this section on its own initiative or in response to a 
request from the public based on EPA's determination of whether the 
information in Sec.  710.52(c)(4) is of low interest.
    (A) Any person may request that EPA amend the chemical list in 
paragraph (b)(2)(iv) of this section. Your request must be in writing 
and must be submitted to the address provided in Sec.  710.59(d). 
Requests must identify the chemical in question, as well as its CAS 
Number or other chemical identification number as identified in Sec.  
710.52(c)(3)(i). Your request should provide sufficient information for 
EPA to determine whether collection of the information in Sec.  
710.52(c)(4) for the chemical in question is of low interest. In 
preparing your request, please refer to the considerations outlined in 
paragraph (b)(2)(ii) of this section. If a request 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 a written response to each request within 120 days of 
receipt of the request, and will maintain copies of these 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 in paragraph (b)(2)(iv) of this section.
    (C) To assist EPA in reaching a decision regarding a particular 
request prior to a given reporting year, requests must be submitted to 
EPA no later than 12 months prior to the start of the reporting year, 
i.e., by January 1, 2004, or by each January 1 at 4-year intervals 
thereafter.
    (iv) List of chemical substances. 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 Sec.
                              710.46(b)(2)
------------------------------------------------------------------------
              CAS No.                             Chemical
------------------------------------------------------------------------
50-70-4...........................  D-Glucitol
50-81-7...........................  L-Ascorbic acid
50-99-7...........................  D-Glucose
56-87-1...........................  L-Lysine
57-50-1...........................  .alpha.-D-Glucopyranoside, .beta.-D-
                                     fructofuranosyl
58-95-7...........................  2H-1-Benzopyran-6-ol, 3,4-dihydro-
                                     2,5,7,8-tetramethyl-2-[(4R,8R)-
                                     4,8,12- trimethyltridecyl]-,
                                     acetate, (2R)-
59-02-9...........................  2H-1-Benzopyran-6-ol, 3,4-dihydro-
                                     2,5,7,8-tetramethyl-2-[(4R,8R)-
                                     4,8,12- trimethyltridecyl]-, (2R)-
59-51-8...........................  Methionine
69-65-8...........................  D-Mannitol
87-79-6...........................  L-Sorbose
123-94-4..........................  Octadecanoic acid, 2,3-
                                     dihydroxypropyl ester
124-38-9..........................  Carbon dioxide
137-08-6..........................  .beta.-Alanine, N-[(2R)-2,4-
                                     dihydroxy-3,3-dimethyl-1-oxobutyl]-
                                     , calcium alt (2:1)
142-47-2..........................  L-Glutamic acid, monosodium salt
150-30-1..........................  Phenylalanine
1317-65-3.........................  Limestone
1333-74-0.........................  Hydrogen
1592-23-0.........................  Octadecanoic acid, calcium salt
7440-37-1.........................  Argon
7440-44-0.........................  Carbon
7727-37-9.........................  Nitrogen
7782-42-5.........................  Graphite
7782-44-7.........................  Oxygen
8001-21-6.........................  Sunflower oil
8001-22-7.........................  Soybean oil
8001-23-8.........................  Safflower oil
8001-26-1.........................  Linseed oil
8001-29-4.........................  Cottonseed oil
8001-30-7.........................  Corn oil
8001-31-8.........................  Coconut oil
8001-78-3.........................  Castor oil, hydrogenated
8001-79-4.........................  Castor oil
8002-03-7.........................  Peanut oil
8002-13-9.........................  Rape oil
8002-43-5.........................  Lecithins
8002-75-3.........................  Palm oil

[[Page 901]]

 
8006-54-0.........................  Lanolin
8016-28-2.........................  Lard, oil
8016-70-4.........................  Soybean oil, hydrogenated
8021-99-6.........................  Charcoal, bone
8029-43-4.........................  Syrups, hydrolyzed starch
9004-53-9.........................  Dextrin
9005-25-8.........................  Starch
9050-36-6.........................  Maltodextrin
11103-57-4........................  Vitamin A
16291-96-6........................  Charcoal
26836-47-5........................  D-Glucitol, monooctadecanoate
61789-44-4........................  Fatty acids, castor-oil
61789-97-7........................  Tallow
61789-99-9........................  Lard
64147-40-6........................  Castor oil, dehydrated
64755-01-7........................  Fatty acids, tallow, calcium salts
65996-63-6........................  Starch, acid-hydrolyzed
65996-64-7........................  Starch, enzyme-hydrolyzed
67701-01-3........................  Fatty acids, C12-18
68002-85-7........................  Fatty acids, C14-22 and C16-22-
                                     unsatd.
68131-37-3........................  Syrups, hydrolyzed starch,
                                     dehydrated
68188-81-8........................  Grease, poultry
68308-54-3........................  Glycerides, tallow mono-, di- and
                                     tri-, hydrogenated
68334-00-9........................  Cottonseed oil, hydrogenated
68334-28-1........................  Fats and glyceridic oils, vegetable,
                                     hydrogenated
68409-76-7........................  Bone meal, steamed
68424-45-3........................  Fatty acids, linseed-oil
68424-61-3........................  Glycerides, C16-18 and C18-unsatd.
                                     mono- and di-
68425-17-2........................  Syrups, hydrolyzed starch,
                                     hydrogenated
68439-86-1........................  Bone, ash
68442-69-3........................  Benzene, mono-C10-14-alkyl derivs.
68476-78-8........................  Molasses
68514-27-2........................  Grease, catch basin
68514-74-9........................  Palm oil, hydrogenated
68525-87-1........................  Corn oil, hydrogenated
68648-86-2........................  Benzene, C14-16-alkyl derivs.
68648-87-3........................  Benzene, C10-16-alkyl derivs.
68918-42-3........................  Soaps, stocks, soya
68952-94-3........................  Soaps, stocks, vegetable-oil
68989-98-0........................  Fats and glyceridic oils, vegetable,
                                     residues
73138-67-7........................  Lard, hydrogenated
129813-58-7.......................  Benzene, mono-C10-13-alkyl derivs.
129813-59-8.......................  Benzene, mono-C12-14-alkyl derivs.
129813-60-1.......................  Benzene, mono-C14-16-alkyl derivs.
------------------------------------------------------------------------

    (3) Inorganic chemical substances. For purposes of this subpart, an 
inorganic chemical substance is any chemical substance which does not 
contain carbon or contains carbon only in the form of carbonato [=CO3], 
cyano [--CN], cyanato [--OCN], isocyano [--NC], or isocyanato [--NCO] 
groups or the chalcogen analogues of such groups. During the 2006 
submission period, manufacturers are excluded only from the reporting 
requirements under Sec.  710.52(c)(4) for inorganic chemical 
substances. During the 2006 submission period, manufacturers of 
inorganic chemical substances are not excluded from the other reporting 
requirements under this part. During submission periods following the 
2006 submission period, manufacturers of inorganic chemical substances 
are subject to all of the reporting requirements in this subpart.


Sec.  710.48   Persons who must report.

    Except as provided in Sec.  Sec.  710.49 and 710.50, the following 
persons are subject to the requirements of this 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) Persons subject to recurring reporting. Any person who 
manufactured (including imported) for commercial purposes 25,000 lbs. 
(11,340 kg) or more of a chemical substance described in Sec.  710.45 
at any single site owned or controlled by that person at any time 
during calendar year 2005 or during the calendar year at 4-year 
intervals thereafter is subject to reporting.
    (b) Special provisions for importers. For purposes of this section, 
the site for a person who imports a chemical substance described in 
Sec.  710.45 is the site of the operating unit within the person's 
organization which is directly responsible for importing the substance 
and which controls the import transaction. The import site may in some 
cases be the organization's headquarters in the United States (see also 
Sec.  710.55(b)).


Sec.  710.49  Persons not subject to this subpart.

    A person described in Sec.  710.48 is not subject to the 
requirements of this subpart if that person qualifies as a small 
manufacturer as that term is defined in Sec.  704.3 of this chapter. 
Notwithstanding this exclusion, a

[[Page 902]]

person who qualifies as a small manufacturer is subject to this subpart 
with respect to any chemical substance that is the subject of a rule 
proposed or promulgated under section 4, 5(b)(4), or 6 of the Act, or 
is the subject of an order in effect under section 5(e) of the Act, or 
is the subject of relief that has been granted under a civil action 
under section 5 or 7 of the Act.


Sec.  710.50  Activities for which reporting is not required.

    A person described in Sec.  710.48 is not subject to the 
requirements of this subpart with respect to any chemical substance 
described in Sec.  710.45 that the person solely manufactured or 
imported under the following circumstances:
    (a) The person manufactured or imported the chemical substance 
described in Sec.  710.45 solely in small quantities for research and 
development.
    (b) The person imported the chemical substance described in Sec.  
710.45 as part of an article.
    (c) The person manufactured the chemical substance described in 
Sec.  710.45 in a manner described in Sec.  720.30(g) or (h) of this 
chapter.


Sec.  710.52   Reporting information to EPA.

    Any person who must report under this subpart, as described in 
Sec.  710.48, must submit the information described in this section for 
each chemical substance described in Sec.  710.45 that the person 
manufactured (including imported) for commercial purposes in an amount 
of 25,000 lbs. (11,340 kg) or more at any one site during calendar year 
2005 or during the calendar year at 4-year intervals thereafter. (See 
Sec.  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 of information under this 
subpart must report information as described in paragraphs (c)(1), 
(c)(2), and (c)(3) of this section to the extent that such information 
is known to or reasonably ascertainable by that person whereas a 
submitter must report information as described in paragraph (c)(4) of 
this section only to the extent that such information is readily 
obtainable by that person. A submitter under this subpart must report 
information that applies to the calendar year for which the person is 
required to report (i.e., calendar year 2005 and the calendar year at 
4-year intervals thereafter).
    (a) Reporting in 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 Sec.  710.59. The 
form must include all information described in paragraph (c) of this 
section. Persons reporting in writing must submit a separate form for 
each site for which the person is required to report.
    (b) Reporting by magnetic media. Any person who chooses to report 
information to EPA by means of magnetic media must submit the 
information described in paragraph (c) of this section. Magnetic media 
submitted in response to this subpart must meet EPA specifications, as 
described in the instruction booklet available from EPA at the address 
set forth in Sec.  710.59.
    (c) Information to be reported. Manufacturers (including importers) 
of a reportable chemical substance in an amount of 25,000 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 a reportable chemical 
substance in an amount of 300,000 lbs. (136,077 kg) or more at a site 
during a reporting year must report the information described in 
paragraph (c)(4) of this section in addition to the information 
described in paragraphs (c)(1), (c)(2), and (c)(3) of this section. As 
described in Sec.  710.46(b)(3), manufacturers of certain inorganic 
chemical substances are not required to report the information 
described in paragraph (c)(4) of this section during the 2006 
submission period, but are required to report this information during 
subsequent submission periods. As described in Sec.  710.46(b)(1) and 
(b)(2), manufacturers of certain chemicals are not required to report 
the information described in paragraph (c)(4) of this section.
    (1) A certification statement signed and dated by an authorized 
official of the submitter company. Persons reporting by means of 
magnetic media must submit this information on the reporting form 
available as described in Sec.  710.59.
    (2) Company and plant site information. The following company and 
plant site information must be reported for each site at which at least 
25,000 lbs. (11,340 kg) of a reportable chemical substance is 
manufactured (including imported) during calendar year 2005 or during 
the calendar year at 4-year intervals thereafter (see Sec.  710.48(b) 
for the ``site'' for importers):
    (i) The name of a person who will serve as technical contact for 
the submitter company, and who will be able to answer questions about 
the information submitted by the 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 of each site. A submitter 
under this subpart must include the appropriate Dun and Bradstreet 
Number for each plant site reported, and the county or parish (or other 
jurisdictional indicator) in which the plant site is located.
    (3) Specific information for chemicals manufactured in amounts of 
25,000 lbs. or more. The following chemical-specific information must 
be reported for each reportable chemical substance manufactured at 
(including imported into) each site in amounts of 25,000 lbs. (11,340 
kg) or more during calendar year 2005 or during the calendar year at 4-
year intervals thereafter:
    (i) The specific chemical name and CAS Number of each reportable 
chemical substance at each site. A submitter under this subpart may use 
an EPA-designated Accession Number for confidential substances, or a 
premanufacture notice (PMN) case number (see Sec.  720.65 of this 
chapter) in lieu of a CAS Number when a CAS Number is not known to or 
reasonably ascertainable by the submitter. In addition to reporting the 
number itself, submitters must specify the type of number they are 
reporting by selecting from among the following codes:

          Codes to Specify Type of Chemical Identifying Number
------------------------------------------------------------------------
                   Codes                             Number Type
------------------------------------------------------------------------
A.........................................  Accession Number
C.........................................  CAS Registry Number
P.........................................  PMN Number
------------------------------------------------------------------------

    (ii) A statement indicating, for each reportable chemical substance 
at each site, whether the substance is manufactured in the United 
States, imported into the United States, or both manufactured in the 
United States and imported into the United States.
    (iii) A designation indicating, for each reportable chemical 
substance at each site, whether the substance is site-limited.
    (iv) The total volume (in pounds) of each reportable chemical 
substance manufactured (including imported) at each site. This amount 
must be reported to two significant figures of accuracy provided that 
the reported figures are within plus or minus 10% of the actual volume.
    (v) Any person claiming that the volume reported under paragraph 
(c)(3)(iv) of this section is confidential

[[Page 903]]

business information under Sec.  710.58 must indicate, for each 
reportable chemical substance at each site, whether the total volume 
range (in pounds) which corresponds with the specific volume figure 
reported in response to paragraph (c)(3)(iv) of this 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 of workers reasonably likely to be exposed to 
each reportable chemical substance at each site. For each reportable 
substance at each site, the submitter must select from among the ranges 
of workers listed in the following table and report 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 less than 25
                                             workers
W3........................................  At least 25 but less than 50
                                             workers
W4........................................  At least 50 but less than
                                             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 less than
                                             10,000 workers
W8........................................  At least 10,000 workers
------------------------------------------------------------------------

    (vii) The maximum concentration, measured by percentage of weight, 
of each reportable chemical substance at the time it is sent off-site 
from each site. If the chemical is site-limited, you must report the 
maximum concentration, measured by percentage of weight, of the 
reportable chemical substance at the time it is reacted on-site to 
produce a different chemical substance. This information must be 
reported regardless of the physical form(s) in which the substance is 
sent off-site/reacted on-site. For each substance at each site, select 
the maximum concentration of the 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
------------------------------------------------------------------------
                                               Concentration Range (%
                   Codes                               weight)
------------------------------------------------------------------------
M1........................................  Less than 1% by weight
M2........................................  From 1 to 30% by weight
M3........................................  From 31 to 60% by weight
M4........................................  From 61 to 90% by weight
M5........................................  Greater than 90% by weight
------------------------------------------------------------------------

    (viii) The physical form(s) of the reportable chemical substance as 
it is sent off-site from each site. If the chemical is site-limited, 
you must report the physical form(s) of the reportable chemical 
substance at the time it is reacted on-site to produce a different 
chemical substance. For each substance at each site, the submitter must 
report as many physical forms as apply from among the 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 off to the 
closest 10%, of total production volume of the 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) of this 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. or more. In addition to the information 
required under paragraphs (c)(1), (c)(2), and (c)(3) of this section, 
the following information must be reported for each reportable chemical 
substance manufactured (including imported) in an amount of 300,000 
lbs. (136,077 kg) or more at any one site during calendar year 2005 or 
during the calendar year at 4-year intervals thereafter. Persons 
subject to paragraph (c)(4) of this section must report the information 
described in paragraphs (c)(4)(i) and (c)(4)(ii) of this section for 
each reportable chemical substance at sites under their control and at 
sites that receive a reportable chemical substance from the submitter 
directly or indirectly (including through a broker/distributor, from a 
customer of the submitter, etc.). Information reported in response to 
this paragraph must be reported only to the extent that it is readily 
obtainable by the submitter. If information responsive to a given data 
requirement under this paragraph, including information in the form of 
an estimate, is not readily obtainable, the submitter is not required 
to respond to the requirement.
    (i) Industrial processing and use information.
    (A) A designation indicating the type of industrial processing or 
use operation(s) at each site that receives a reportable substance from 
the submitter site directly or indirectly (whether the recipient 
site(s) are controlled by the submitter site or not). 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, to the extent that a submitter reports more 
than one NAICS code (under paragraph (c)(4)(i)(B) of this section) that 
applies to a given designation under this paragraph.

 
------------------------------------------------------------------------
                Designation                           Operation
------------------------------------------------------------------------
PC........................................  Processing as a reactant
PF........................................  Processing - incorporation
                                             into formulation, mixture
                                             or reaction product
PA........................................  Processing - incorporation
                                             into article
PK........................................  Processing - repackaging
U.........................................  Use - non-incorporative
                                             activities
------------------------------------------------------------------------

    (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) of this section. Information about how to find 
these codes is provided in the instruction booklet available from EPA 
at the address set forth in Sec.  710.59. A particular NAICS code may 
need to be reported more than once, to the extent that a submitter 
reports more than one industrial function code (under paragraph 
(c)(4)(i)(C) of this section) that applies to a given NAICS code under 
this paragraph.
    (C) For each NAICS code reported under paragraph (c)(4)(i)(B) of 
this section, code(s) from the following list must be selected to 
designate the industrial function category(ies) that best represents 
the specific manner in which the chemical substance is used. A 
particular 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

[[Page 904]]

combination (under paragraphs (c)(4)(i)(A) and (c)(4)(i)(B) of this 
section) that applies to a given industrial function category under 
this paragraph. If more than 10 unique combinations of industrial 
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 of the submitter's production volume 
for that chemical, measured by weight.

           Codes for Reporting Industrial Function Categories
------------------------------------------------------------------------
                   Codes                              Category
------------------------------------------------------------------------
U01.......................................  Adsorbents and absorbents
U02.......................................  Adhesives and binding agents
U03.......................................  Aerosol propellants
U04.......................................  Agricultural chemicals (non-
                                             pesticidal)
U05.......................................  Anti-adhesive agents
U06.......................................  Bleaching agents
U07.......................................  Coloring agents, dyes
U08.......................................  Coloring agents, pigments
U09.......................................  Corrosion inhibitors and
                                             anti-scaling agents
U10.......................................  Fillers
U11.......................................  Fixing agents
U12.......................................  Flame retardants
U13.......................................  Flotation agents
U14.......................................  Fuels
U15.......................................  Functional fluids
U16.......................................  Intermediates
U17.......................................  Lubricants
U18.......................................  Odor agents
U19.......................................  Oxidizing agents
U20.......................................  pH-regulating agents
U21.......................................  Photosensitive chemicals
U22.......................................  Plating agents and metal
                                             surface treating agents
U23.......................................  Processing aid, not
                                             otherwise listed
U24.......................................  Process regulators, used in
                                             vulcanization or
                                             polymerization processes
U25.......................................  Process regulators, other
                                             than polymerization or
                                             vulcanization processes
U26.......................................  Reducing agents
U27.......................................  Solvents (for cleaning or
                                             degreasing)
U28.......................................  Solvents (which become part
                                             of product formulation or
                                             mixture)
U29.......................................  Solvents (for chemical
                                             manufacture and processing
                                             and are not part of product
                                             at greater than one percent
                                             by weight)
U30.......................................  Stabilizers
U31.......................................  Surface active agents
U32.......................................  Viscosity adjustors
U33.......................................  Other
------------------------------------------------------------------------

    (D) The estimated percentage, rounded off to the closest 10%, of 
total production volume of the reportable chemical substance associated 
with each combination of industrial processing or use operation, NAICS 
code and industrial function category. Where a particular combination 
of industrial processing or use operation, NAICS code and industrial 
function category accounts for 5% or less of the submitter's site's 
total production volume of a reportable chemical substance, the 
percentage must not be rounded off to zero % if the production volume 
attributable to that industrial processing or use operation, NAICS code 
and industrial function category combination is 300,000 lbs. (136,077 
kg) or more during the reporting year. Instead, in such a case, 
submitters must report the percentage, rounded off to the closest 1%, 
of the submitter's site's total production volume of the reportable 
chemical substance associated with the particular combination of 
industrial processing or use operation, NAICS code and industrial 
function category.
    (E) For each combination of industrial processing or use operation, 
NAICS code and industrial function category, the submitter must 
estimate the number of sites 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 of 
sites 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 of industrial processing or use operation, 
NAICS code and industrial function category, the submitter must 
estimate the number of workers reasonably likely to be exposed to each 
reportable chemical substance. For each combination associated with 
each substance, the submitter must select from among the worker ranges 
listed in paragraph (c)(3)(vi) of this section and report the 
corresponding code (i.e., W1 though W8).
    (ii) Commercial and consumer use information.
    (A) Using the codes listed in this paragraph, submitters must 
designate the commercial and consumer product category or categories 
that best describe the commercial and consumer products in which each 
reportable chemical substance is used (whether the recipient site(s) 
are controlled by the submitter site or not). If more 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 of the 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) of this 
section, whether any amount of each reportable chemical substance 
manufactured (including imported) by the submitter is present in (for 
example, a plasticizer 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 of 14, regardless of the 
concentration of the 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 off to the closest 10%, of 
the submitter's site's total production volume of the reportable 
chemical substance associated with each commercial and consumer product

[[Page 905]]

category. Where a particular commercial and consumer product category 
accounts for 5% or less of the total production volume of a reportable 
chemical substance, the percentage must not be rounded off to zero % if 
the 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 off to the closest 1%, of the submitter's site's 
total production volume of the 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 by weight, of the chemical substance in each commercial and 
consumer product category reported under paragraph (c)(4)(ii)(A) of 
this section. For each substance in each commercial and consumer 
product category reported under paragraph (c)(4)(ii)(A) of this 
section, submitters must select from among the ranges of concentrations 
listed in the table in paragraph (c)(3)(vii) of this section and report 
the corresponding code (i.e., M1 through M5).


Sec.  710.53   When to report.

    All information reported to EPA in response to the requirements of 
this 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 Sec.  710.48(a) must report during each submission 
period for each chemical substance described in Sec.  710.45 that the 
person manufactured (including imported) during the preceding calendar 
year (i.e., the ``reporting year'').


Sec.  710.55   Duplicative reporting.

    (a) With regard to section 8(a) rules. Any person subject to the 
requirements of this part who previously has complied with reporting 
requirements of a rule under section 8(a) of the Act by submitting the 
information described in Sec.  710.52 for a chemical substance 
described in Sec.  710.45 to EPA, and has done so within 1 year of the 
start of a submission period described in Sec.  710.53, is not required 
to report again on the manufacture of that substance at that site 
during that submission period.
    (b) With regard to importers. This part requires that only one 
report be submitted on each import transaction involving a chemical 
substance described in Sec.  710.45. When two or more persons are 
involved in a particular import transaction and each person meets the 
Agency's definition of ``importer'' as set forth in Sec.  Sec.  710.3 
and 704.3 of this chapter, they may determine among themselves who 
should submit the required report; if no report is submitted as 
required under this part, EPA will hold each such person liable for 
failure to report.


Sec.  710.57   Recordkeeping requirements.

    Each person who is subject to the reporting requirements of this 
subpart must maintain records that document any information reported to 
EPA. Records relevant to reporting during a submission period must be 
retained for a period of 5 years beginning with the effective date of 
that submission period.


Sec.  710.58   Confidentiality.

    (a) Any person submitting information under this subpart may assert 
a business confidentiality claim for the information at the time it is 
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 during the next 
submission period. Guidance for asserting confidentiality claims is 
provided in the instruction booklet identified in Sec.  710.59. 
Information claimed as confidential in accordance with this section 
will be treated and disclosed in accordance with the procedures in part 
2 of this chapter.
    (b) Chemical identity. A person may assert a claim of 
confidentiality for the chemical identity of a specific chemical 
substance only if the identity of that substance is treated as 
confidential in the Master Inventory File as of the time the report is 
submitted for that substance under this subpart. The following steps 
must be taken to assert a claim of confidentiality for the identity of 
a reportable chemical substance:
    (1) The submitter must submit with the report detailed written 
answers to the following questions signed and dated by an authorized 
official.
    (i) What harmful effects to your competitive position, if any, do 
you think would result from the identity of the chemical substance 
being disclosed in connection with reporting 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 and the harmful effects?
    (ii) How long should confidential treatment be given? Until a 
specific date, the occurrence of a 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? If the chemical substance has been patented and 
therefore disclosed through the patent, why should it be treated as 
confidential?
    (iv) Has the identity of the chemical substance been kept 
confidential to the extent that your competitors do not know it is 
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 have been taken to prevent undesired disclosure 
of the fact that the chemical substance is being manufactured 
(including imported) for a commercial purpose?
    (vii) To what extent has the fact that this chemical substance is 
manufactured (including imported) for commercial purposes been revealed 
to others? What precautions have been taken regarding these 
disclosures? Have there been public disclosures or disclosures to 
competitors?
    (viii) Does this particular chemical substance leave the site of 
manufacture (including import) in any form, e.g., as product, effluent, 
emission? If so, what measures have been taken to guard against the 
discovery of its identity?
    (ix) If the chemical substance leaves the site in a product that is 
available to the public or your competitors, can the substance be 
identified by analysis of the product?
    (x) For what purpose do you manufacture (including import) the 
substance?
    (xi) Has EPA, another Federal agency, or any Federal court made any 
pertinent confidentiality determinations regarding this chemical 
substance? If so, please attach copies of such determinations.
    (2) If any of the information contained in the answers to the 
questions listed in paragraph (b)(1) of this section is 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 a label such as ``confidential 
business information,'' ``proprietary,'' or ``trade secret.''

[[Page 906]]

    (c) Site identity. A submitter may assert a claim of 
confidentiality for a site only if the linkage of the site with a 
reportable chemical is confidential and not publicly available. The 
following steps must be 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 under the Emergency 
Planning and Community Right-to-Know Act (EPCRA) section 311, namely 
through a Material Safety Data Sheet (MSDS)? If so, identify all such 
schemes. Was the linkage claimed as confidential in any of these 
instances?
    (ii) What harmful effect, if any, to your competitive position do 
you think would result from the identity of the site and the chemical 
substance being disclosed in connection with reporting 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 and the harmful effects?
    (2) If any of the information contained in the answers to the 
questions listed in paragraph (c)(1) of this section is 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 a label such as ``confidential 
business information,'' ``proprietary,'' or ``trade secret.''
    (d) If no claim of confidentiality is indicated on the reporting 
form submitted to EPA under this subpart, or if confidentiality 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.


Sec.  710.59   Availability of reporting form and instructions.

    (a) Use the proper EPA form. You must use the EPA form identified 
as ``Form U'' to submit written information in response to the 
requirements of this subpart. Copies of 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.
    (b) Follow the reporting instructions. Guidance for completing the 
reporting form and preparing an electronic (magnetic media) report will 
be made available prior to each submission period.
    (c) Obtain the reporting package and copies of the form. EPA will 
send a reporting package (consisting of a copy of Form U and a copy of 
the reporting instructions) to those submitters that reported in the 
IUR submission period that occurred immediately prior to the current 
submission period. Failure to receive a reporting package does not 
obviate or otherwise affect the requirement to submit a timely report. 
If you did not receive a reporting package, but are required to report, 
you may obtain a copy of the 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) By e-mail. Send an e-mail request for this information to the 
EPA TSCA Hotline at [email protected].
    (3) By mail. Send a written request for this information to the 
following address: TSCA Hotline, Mailcode 7408M, ATTN: Inventory Update 
Rule, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    (4) By Internet. To download a copy of the form and/or instructions 
go to: http://www.epa.gov/oppt/iur.
    (d) Submit the completed reports. You must submit your completed 
reporting form(s) and/or magnetic media to EPA at the following 
address: OPPT Document Control Officer (DCO), Mailcode 7407M, ATTN: 
Inventory Update Rule, Office of Pollution 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 Sec.  723.175, revise paragraph (b)(3) to read as follows:


Sec.  723.175  Premanufacture Notification Exemptions

* * * * *
    (b) Definitions. * * *
    (3) The terms byproduct, EPA, impurities, person, and site have the 
same meanings as in Sec.  710.3 of this chapter.
* * * * *
[FR Doc. 02-32909 Filed 12-31-02; 9:56 am]
BILLING CODE 6560-50-S