TSCA Inventory Update Reporting Revisions, 75059-75070 [05-24196]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 242 (Monday, December 19, 2005)]
[Rules and Regulations]
[Pages 75059-75070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24196]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2004-0106; FRL-7743-9]
RIN 2070-AC61


TSCA Inventory Update Reporting Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is amending the Toxic Substances Control Act (TSCA) 
section 8(a) Inventory Update Reporting (IUR) regulations. The IUR 
currently requires manufacturers (including importers) of certain 
chemical substances listed on the TSCA Chemical Substances Inventory to 
report data on chemical manufacturing, processing, and use every 4 
years. In this amendment, EPA is extending the reporting cycle, 
modifying the timing of the submission period, further clarifying the 
new partial exemption for specific chemicals for which certain IUR data 
are of low current interest, amending the petroleum refinery process 
streams partial exemption, amending the list of consumer and commercial 
product categories, revising the manner in which production volume 
would be reported, restricting reporting of processing and use 
information to domestic processing and use activities only, clarifying 
the polymer exemption definition, and removing a provision regarding 
the confidentiality of production volume within specified ranges.

DATES: This final rule is effective on January 18, 2006.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2004-0106. All documents in the 
docket are listed on the www.regulations.gov web site. (EDOCKET, EPA's 
electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced federal-wide electronic docket management and 
comment system located at https://www.regulations.gov/. Follow the on-
line instructions.) Although listed in the index, some information is 
not publicly available, i.e., confidential business information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, will not be placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center, EPA 
West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The 
Public Reading Room 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 the EPA Docket Center, is (202) 566-
0280.

FOR FURTHER INFORMATION CONTACT: For general information contact:
    Colby Lintner, Regulatory Coordinator, Environmental Assistance

[[Page 75060]]

Division (7408M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail 
address: TSCA-Hotline@epa.gov.
    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 20460-0001; telephone number: 
(202) 564-8789; e-mail address: sharkey.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
(defined by statute at 15 U.S.C. 2602(7) to include import) chemical 
substances, including inorganic chemical substances, subject to 
reporting under the TSCA Inventory Update Reporting (IUR) regulations 
at 40 CFR part 710. Any use of the term ``manufacture'' in this 
document will encompass ``import,'' unless otherwise stated. 
Potentially affected entities may include, but are not limited to:
    Chemical manufacturers and importers, including chemical 
manufacturers and importers of inorganic chemical substances (North 
American Industrial Classification System (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. The NAICS codes have been provided to assist you and others 
in determining whether this action might apply to certain entities. To 
determine whether you or your business may be affected by this action, 
you should carefully examine the applicability provisions at 40 CFR 
710.48. 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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 710 
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Background

A. What Action is the Agency Taking?

    Through this action, EPA is promulgating amendments to the IUR 
regulations that were proposed on January 26, 2005 (70 FR 3658) (FRL-
7332-2), taking into consideration comments received on the proposed 
rule. The amendments to the IUR regulation that are contained in this 
final rule pertain to 40 CFR Part 710, Subpart C--Inventory Update 
Reporting for 2006 and Beyond. The following is a brief listing of the 
changes made to the IUR regulations via this rule. These changes are 
described in more detail in Unit II.D., along with a summary of the 
comments received and the Agency's response to those comments.
    First, EPA is amending 40 CFR 710.43, 40 CFR 710.46, 40 CFR 710.48, 
and 40 CFR 710.52 to change the reporting cycle from 4 years to 5 
years.
    Second, EPA is amending 40 CFR 710.53 to adjust the dates of the 
submission period within which manufacturers and importers must report 
IUR data to EPA. For data required to be submitted in 2006, the 
submission period remains August 25 to December 23, 2006. Beginning in 
2010 and for each subsequent submission period, the submission period 
will begin June 1 and end September 30. EPA is also clarifying the 
recordkeeping requirements by identifying that the 5-year record 
retention period begins on the last day of the submission period.
    Third, EPA is clarifying the partial exemption for petroleum 
process streams and amending 40 CFR 710.46(b)(1) to add certain 
petroleum process streams to the listing.
    Fourth, EPA is amending 40 CFR 710.46(b)(2) to add an explanation 
that, for the partial exemption for chemicals for which the IUR 
processing and use information is of low current interest, petitions 
must include a written rationale for suggested additions of a chemical 
to or deletions of a chemical from the list of partially exempt 
chemical substances.
    Fifth, EPA is further amending 40 CFR 710.46 to remove the 
references to the 1985 edition of the TSCA Inventory from paragraphs 
(a)(1)(i) and (ii).
    Sixth, EPA is amending 40 CFR 710.52(c)(4)(ii)(A) to change the 
list of commercial and consumer product use categories by adding a new 
category.
    Seventh, EPA is amending 40 CFR 710.52(c)(3)(iv) to require 
separate reporting of manufacture and import volumes.
    Eighth, EPA is amending 40 CFR 710.52(c)(4) to limit the reporting 
of processing and use information to domestic processing and use 
activities only.
    Ninth, EPA is removing the provision regarding the confidentiality 
of production volume information within specified ranges (40 CFR 
710.52(c)(3)(v)).

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 
manufactured or processed in the United States. 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 regulation under TSCA section 8(a) at 40 CFR part 710 
(51 FR 21438, June 12, 1986) to facilitate the periodic updating of the 
TSCA Inventory and to support activities associated with the 
implementation of TSCA. In 2003, EPA promulgated extensive amendments 
to the IUR regulation (68 FR 848, January 7, 2003) (FRL-6767-4) (2003 
Amendments) to collect exposure-related information associated with the 
manufacturing, processing, and use of eligible chemical substances and 
to make certain other changes (Ref. 1).
    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. 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

[[Page 75061]]

manufacturer for purposes of 40 CFR part 710 generally is found at 40 
CFR 704.3. Processors are not currently subject to the regulations at 
40 CFR part 710.

C. What is the Inventory Update Reporting (IUR) Regulation?

    The data reported pursuant to the IUR regulations are used to 
update the information maintained on the TSCA Inventory. EPA uses the 
TSCA Inventory and data reported under the IUR regulation 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. The IUR regulations, as amended by the 2003 
Amendments (Ref. 1), require U.S. manufacturers (including importers) 
of chemicals listed on the TSCA Inventory to report to EPA every 4 
years the identity of chemical substances manufactured (including 
imported) during the reporting year in quantities of 25,000 pounds or 
more at any single site they own or control (see 40 CFR part 710, 
subpart C). The IUR regulation generally excludes several groups of 
chemical substances from its reporting requirements, i.e., polymers, 
microorganisms, naturally occurring chemical substances, and certain 
natural gas substances (40 CFR 710.46). Persons manufacturing or 
importing chemical substances are required to report information such 
as company name, site location and other identifying information, 
production volume of the reportable chemical substance, and exposure-
related information associated with the manufacture of each reportable 
chemical substance, including the physical form and maximum 
concentration of the chemical substance and the number of potentially 
exposed workers (40 CFR 710.52).
    Manufacturers (including importers) of chemicals in larger volumes 
(i.e., 300,000 lbs. or more manufactured (including imported) during 
the reporting year at any single site) are additionally required to 
report certain processing and use information (40 CFR 710.52(c)(4)). 
This information includes process or use category, NAICS code, 
industrial function category, percent production volume associated with 
each process or use category, number of use sites, number of 
potentially exposed workers, and consumer/commercial information such 
as use category, use in or on products intended for use by children, 
and maximum concentration.
    For the 2006 submission period, manufacturers (including importers) 
of inorganic chemical substances will be required to report for the 
first time. However, for the 2006 submission period only, manufacturers 
(including importers) of inorganic chemical substances will be 
partially exempt from reporting under IUR regulations, regardless of 
production volume. A partial exemption means that a submitter is exempt 
from the processing and use reporting requirements described in 40 CFR 
710.52(c)(4). After the 2006 submission period, the partial exemption 
for inorganic chemicals will no longer be applicable and submitters 
will fully report information on inorganic chemical substances, 
including information on processing and use (40 CFR 710.46(b)(3)). In 
addition, specifically listed petroleum process streams and other 
specifically listed chemical substances are partially exempt, and 
manufacturers of such substances are not required to report processing 
and use information during the 2006 or in any subsequent submission 
periods, for as long as the chemical substances remain on these partial 
exemption lists (40 CFR 710.46(b)(1) and (b)(2)).

D. What Changes are Being Made by the Agency to the IUR regulation?

    1. What changes are being made to the chemical substances covered 
by the IUR regulations?--a. Partially exempt petroleum process streams. 
Certain petroleum process streams listed in 40 CFR 710.46(b)(1) are 
exempted from additional reporting requirements under the IUR 
regulations for chemical substances manufactured in amounts of 300,000 
lbs. or more. EPA is adding chemicals to this list and is clarifying 
EPA's intention concerning the scope of this partial exemption. 
Additionally, EPA proposed changing the name of this partial exemption 
from ``petroleum process streams'' to ``petroleum refinery process 
streams'' to clarify the types of covered substances. EPA received 
comments which indicated that the proposed change was misunderstood; 
EPA, therefore, at this time, is retaining the name ``petroleum process 
streams.''
    EPA is amending the list of partially exempt substances by adding 
the following 25 petroleum refinery process streams, listed by CAS 
registry number: 67254-74-4, 67891-81-0, 67891-86-5, 68476-27-7, 68477-
98-5, 68477-99-6, 68478-31-9, 68513-03-1, 68514-39-6, 73138-65-5, 
92045-43-7, 92045-58-4, 92062-09-4, 98859-55-3, 98859-56-4, 101316-73-
8, 164907-78-2, 164907-79-3, 178603-63-9, 178603-64-0, 178603-65-1, 
178603-66-2, 212210-93-0, 221120-39-4, and 445411-73-4. EPA also is 
adding the following two petroleum process streams listed by CAS 
registry number: 68919-16-4 and 61789-60-4. They were inadvertently 
left off the initial partial exemption list established by the 2003 
Amendments
    The petroleum process stream partial exemption was established by 
the 2003 Amendments (Ref. 1). As described in the preamble to the 2003 
Amendments, EPA established the exemption based upon expected exposures 
and uses of the listed chemical substances. In the 2003 Amendment 
preamble, EPA explained that these 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. Also, 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 believed worker exposure to 
the chemicals termed ``petroleum process streams'' for purposes of IUR 
was diminished and thus IUR processing and use reporting was not 
considered to be warranted at the time the 2003 Amendments were 
promulgated. The initial listing of chemical substances in 40 CFR 
710.46(b)(1), was derived from the 1983 publication of the American 
Petroleum Institute (API) document entitled Petroleum Process Stream 
Terms Included in the Chemical Substances Inventory Under the Toxic 
Substances Control Act (TSCA) (API publication) (Ref. 2).
    In developing the proposed IUR Revisions rule, EPA considered 
adding potential petroleum process streams, identified by API as having 
been added to the TSCA Inventory since the 1983 publication was 
compiled, to the 40 CFR 710.46(b)(1) listing. As noted in the proposed 
rule, in order to determine which of these substances qualified as 
petroleum process streams, EPA applied the criteria embodied in the 
Agency's petroleum stream descriptions contained in EPA's January 1978 
Addendum I to the TSCA Candidate List of Chemical Substances, entitled 
Generic Terms Covering Petroleum Refinery Process Streams (Addendum I) 
(Ref. 3). Based on Addendum I, EPA described in the proposal the 
reasons why several of the suggested chemical substances were not 
considered to be petroleum process streams for IUR reporting purposes: 
(i) The chemical substance consists of a complex mixture of one class 
of hydrocarbons, e.g., all alkanes or all alkenes (with defined carbon 
number ranges) and aromatic hydrocarbons (without defined carbon number 
range), which do not specify petroleum as a source material in the 
chemical name; (ii) the chemical substance is a well defined

[[Page 75062]]

alkylbenzene, or is an alkylbenzene fractionation product or 
distillation residues. Alkylbenzenes are typical downstream 
petrochemical products that are made synthetically from benzene and 
paraffinic hydrocarbons in a chemical process that does not involve 
refinery processing; (iii) the chemical substance includes the chemical 
modification terms sulfated, bisulfited, sulfurized, sulfonated, 
esters, and reaction products etc., are not substances produced within 
the scope of petroleum refining operations, but rather they are 
considered to be products from other chemical manufacturing processes; 
or (iv) the chemical substance is derived using a chemical process (a 
Fischer-Tropsch process) from a non-petroleum source (Refs. 1 and 4).
    There is one point regarding the petroleum process stream exemption 
that EPA wishes to clarify. In the proposed rule, EPA stated that the 
decision criteria used to develop both the initial list in 40 CFR 
710.46(b)(1) and the then-proposed additions were applied in a 
consistent manner. The API document, used to compile the initial list, 
and EPA's Addendum I, used to compile today's additions, do vary in 
approach. The API document includes a number of substances that would 
not be included as petroleum process streams in Addendum I. For 
instance, the API publication contained individual light hydrocarbons 
and related gases (Class I substances) which were not identified in 
Addendum I. EPA intends to revisit the list in 40 CFR 710.46(b)(1) 
after the 2006 reporting cycle to ensure that all chemicals listed are 
consistent with Addendum I.
    The Agency received many comments on the proposed changes to the 
petroleum process streams partial exemption. In general, the commenters 
supported adding chemicals to the partial exemption chemical list. One 
commenter felt that EPA's proposed change in the name of the partial 
exemption to ``petroleum refinery process streams'' was constricting. 
Another commenter stated that the scope of the proposed change excludes 
a variety of substances that are in fact petroleum process streams 
produced in a refinery.
    EPA is not promulgating the name change and will retain ``petroleum 
process streams'' to describe the partial exemption. EPA's inclusion of 
the term ``refinery'' was intended to indicate that the streams were 
refining streams and to make the title consistent with terms used in 
EPA's Addendum I document. This name change was not intended to affect 
the scope of the partial exemption nor was it intended to restrict 
substances to only those produced at a refinery. Although EPA 
acknowledges that petroleum process streams can be manufactured outside 
of a refinery, the Agency also notes that some substances produced in a 
refinery are petrochemicals and do not qualify as petroleum process 
streams.
    Two commenters highlighted EPA's statement that ``Qualifying 
petroleum process streams are produced only in a petroleum refinery, 
are further refined at the same site, and are processed and used in 
closed equipment, or are used as fuel.'' 70 FR 3662. According to these 
commenters, limiting the scope of the partial exemption to petroleum 
refineries was inappropriate because certain chemicals are produced in 
closed systems at production facilities other than refineries, in a 
manner similar to their production at refineries. One of the commenters 
stated that denying the partial exemption to all except petroleum 
refineries violates the Paperwork Reduction Act (PRA) and offers a 
competitive advantage to refineries. One commenter requested that, if 
EPA implements its proposed definition of petroleum process stream as a 
substance produced only in a petroleum refinery, further refined at the 
same site, and processed and used in closed equipment or used as fuel, 
the Agency should acknowledge that the definition is not intended for 
any purpose other than for identifying partially exempt chemicals for 
the IUR regulation.
    The statement concerning qualifying petroleum process streams was 
included in the discussion describing the Agency's decision concerning 
whether or not to list certain substances suggested by the API. EPA did 
not intend the proposed change to alter the status of chemicals 
currently on the list nor did EPA intend to change the exemption to be 
based upon the location at which a substance is manufactured. A 
chemical substance listed by CAS Registry Number (CASRN) at 40 CFR 
710.46(b)(1) is exempt from reporting requirements of 40 CFR 
710.52(c)(4), unless the substance is ineligible because of exceptions 
noted in the introductory text of 40 CFR 710.46. For example, one of 
the commenters noted that calcined petroleum coke (CASRN 64743-05-1) 
can be manufactured either in a petroleum refinery or in another type 
of facility. This substance, since it is listed by CASRN at 40 CFR 
710.46(b)(1), is exempted from reporting IUR processing and use 
information regardless of where it is manufactured. Therefore, 
refineries are not receiving any competitive advantage over other 
manufacturers of these chemicals. As recognized by the commenters, EPA 
stated that qualifying petroleum process streams are produced only in a 
petroleum refinery. In light of the confusion identified by the 
comments, and to recognize that qualifying petroleum process streams 
may occur outside of a petroleum refinery, EPA is now stating that 
qualifying petroleum process streams to be added in 40 CFR 710.46(b)(1) 
are produced within the scope of petroleum refining operations. 
Additionally, while EPA did not define the term ``petroleum process 
stream'' in its proposal, the Agency agrees that the discussion 
included in the proposed revisions preamble is intended solely for 
reporting under the IUR regulations.
    b. ``Low current interest'' partial exemption. 40 CFR 710.46(b)(2) 
exempts manufacturers (including importers) of certain chemical 
substances from reporting processing and use information under 40 CFR 
710.52(c)(4) if EPA has determined that it has a ``low current 
interest'' in the IUR processing and use information for that chemical 
substance. The public may request EPA to add a substance to, or remove 
a substance from, the list of chemicals partially exempt from reporting 
by submitting a petition that addresses the considerations set forth in 
40 CFR 710.46(b)(2)(ii).
    In the proposed rule, the Agency sought to clarify the process for 
petitioning EPA to add a chemical to, or remove it from, the list at 40 
CFR 710.46(b)(2)(iv). The revisions were intended to more clearly state 
that the burden is on the petitioner to demonstrate that the collection 
of information on the production and use of the chemical substance is 
or is not of low current interest. The proposed rule also clarified 
that it is the petitioner's obligation to address the considerations 
set forth in Sec.  710.46(b)(2)(ii) by providing sufficient 
information, including documentation and relevant citations to 
supporting information. In addition, the proposed rule altered the 
consideration of whether a chemical substance was adequately managed by 
broadening it to include entities other than Federal agencies. (See 70 
FR 3658).
    Many persons commented that the proposed change would clarify the 
requirements for a petition for partial exemption under the IUR 
regulations and supported the change. In addition, one person commented 
that the proposed changes support the continued consideration of the 
totality of information available on a chemical in deciding to grant or 
deny a partial exemption. EPA is finalizing the

[[Page 75063]]

changes to this partial exemption as proposed.
    Several comments addressed issues beyond the Agency's proposed 
actions, advocating substantive changes to the partial exemption. For 
example, two persons believed that EPA should provide additional 
certainty to the exemption process. Another commented that, while a 
formal risk assessment was not needed, review of requests for partial 
exemption must be objective. This commenter supported a delisting 
process that incorporated the criteria used for exempting petroleum 
streams, described by the commenter as exempting intermediates 
processed in closed equipment or burned as fuels. Another commenter 
suggested adding additional criteria which promoted pollution 
prevention and resource recovery and ongoing programs of other offices 
within EPA. Finally, one commenter advocated removing the partial 
exemption process entirely. EPA intends to further consider these 
suggestions concerning the ``low current interest'' partial exemption. 
If change is warranted, EPA will initiate a separate rulemaking.
    2. How is this rule changing the data elements reported by all 
submitters?--a. Production volume reporting. EPA is requiring that 
domestic production volume data be reported separately from import 
volume data. Prior to the 2003 Amendments, submitters were required to 
report the domestically manufactured volume data separate from the 
imported volume data for each reportable substance. With the 2003 
Amendments, persons manufacturing and/or importing a reportable 
chemical substance were required to aggregate the amounts of a chemical 
imported and manufactured domestically and to report the total. In the 
proposed rule, EPA suggested a return to the previous method of 
reporting data on manufactured volumes separately from imported 
volumes. EPA explained that it is frequently useful to distinguish 
between the volume of a chemical manufactured in the United States and 
imported into this country to understand the nature of chemical 
production in the United States, characterize the markets for 
chemicals, and assess potential exposures during importation and 
domestic manufacture of chemical substances (See 70 FR 3658).
    Several persons who commented on the proposed rule agreed with the 
proposed change. One person noted that separate reporting of the 
manufactured and imported volumes for chemical substances will allow 
the Agency to separately evaluate manufacturing and import activities 
and assist the Agency in characterizing exposures to these chemical 
substances. EPA concurs with these observations and is promulgating the 
proposed change.
    b. Production volume range confidentiality claims. EPA is removing 
the requirement that submitters who claim production volume as TSCA 
confidential business information (CBI) must indicate whether they are 
also claiming a specified range within which the production volume 
falls as confidential (40 CFR 710.52 (c)(3)(v)).
    EPA received 11 comments on the proposed removal of the requirement 
that submitters indicate whether or not production volumes submitted in 
ranges should be treated as CBI. While one commenter supported this 
change, the others opposed it. Commenters that opposed the change 
expressed concern that such a change would decrease the protection of 
CBI, and several proposed that EPA simply adjust the ranges that it 
uses to publicly release aggregated production volume data to match 
those of the IUR regulation.
    EPA believes that many of the objections to this proposed change 
result from a misunderstanding of EPA's intent in removing this 
requirement. As a general matter, EPA releases IUR production volume 
range information for a chemical only after aggregating the data across 
all reporting sites. In the 2003 Amendments, EPA included a provision 
requiring each IUR submitter to report whether its production volume, 
when considered in a range specified in Sec.  710.52(c)(3)(v), should 
be treated as CBI. This amendment was included in the 2003 final rule 
as part of an effort to make available to the public site- and 
chemical-specific production volume range information from the IUR that 
was not claimed as CBI.
    Upon consideration of various public comments and internal 
discussion, the Agency has decided that a submitter may no longer claim 
as CBI a specified production volume range that corresponded to the 
submitter's site-specific production volume data. Submitters will be 
able to continue to claim their actual production volume as CBI. EPA's 
decision not to allow confidentiality claims for the standardized 
production volume ranges in 40 CFR 710.52(c)(3)(v) is based on several 
concerns, most importantly issues inherent in releasing both aggregated 
data and site-specific production volume ranges. Because of this 
difficulty, the Agency has determined that this provision regarding the 
confidentiality of production volume information within specified 
ranges is not likely to result in greater availability of production 
volume information to the public, which was the goal of this data 
element as expressed in the 2003 Amendments (Ref. 1). Additionally, 
several commenters suggested that EPA should not release these 
standardized production volume ranges. It is important to note that, by 
this change, EPA is not presuming consent to release these production 
volume ranges for site-specific production volume ranges or otherwise 
lessening any CBI protections. Any production volume information 
released to the public will be in the form of production volume data 
that is aggregated and ranged.
    3. How have the data elements reported only by larger production 
volume manufacturers changed?--a. Reporting processing and use 
information for domestic activities only. Persons manufacturing 300,000 
lbs. or more of a reportable chemical substance were required to report 
processing and use information for that chemical substance to the 
extent that the information is readily obtainable. EPA is restricting 
the processing and use information reported under 40 CFR 710.52(c)(4) 
to domestic processing and use activities for two reasons. First, EPA 
is primarily focused on exposures to chemical substances resulting from 
domestic processing and use of the chemicals. Second, EPA anticipates 
that restricting the processing and use information that must be 
reported by larger production volume manufacturers to that associated 
with domestic activities will reduce the burden associated with 
reporting this information. The Agency estimates that the average 
burden for reporting the IUR processing and use information is reduced 
by about 15%, resulting in a total savings of approximately $8 million 
per reporting period (Ref. 5).
    Many commenters supported limiting reported processing and use 
information to that associated with domestic activities. Those 
commenters supported this proposal as narrowly tailored to satisfy the 
Agency's data needs while reducing the burden on entities subject to 
reporting under the IUR regulations. They noted that chemicals sold in 
international commerce are frequently distributed through brokers and 
as a consequence the information on processing and use of exported 
chemicals is, in their view, not readily obtainable. In addition, the 
commenters stated that information from foreign sources may be less 
easily verified and therefore could reduce the accuracy of the data 
collected. One person commented that tracking the processing

[[Page 75064]]

and use of domestically manufactured volumes separately from exported 
volumes would require separate tracking systems and would increase the 
burden associated with larger production volume manufacturers' 
reporting under the IUR regulations. EPA anticipates that, for most 
submitters, limiting the reporting of processing and use information to 
that associated with domestic activities will decrease the burden 
associated with reporting under the IUR regulation. For these reasons, 
EPA is finalizing the proposal to restrict information reported in 
response to 40 CFR 710.52(c)(4) to domestic processing and use of 
chemical substances.
    b. Consumer and commercial product categories. Persons 
manufacturing 300,000 lbs. or more of a reportable chemical substance 
must report the commercial and consumer product category or categories 
that best describe the commercial and consumer products in which each 
reportable chemical substance is used (see 40 CFR 710.52(c)(4)(ii)(A)). 
EPA proposed the following changes to the list of categories:
    (i) Combine the categories for ``Soaps and Detergents'' and 
``Polishes and Sanitation Goods'' to form a new category called 
``Cleaning Products (non-pesticidal).''

These two categories are quite similar and this change was intended to 
assist submitters who might have difficulty differentiating between 
them. EPA believed that both categories relate, at least to a certain 
extent, to cleaning goods. EPA is not finalizing this proposed change.
    EPA received comments supporting the consolidation of these two 
categories, however no specific reasons were provided for their 
support. EPA also received a comment stating that combining these 
categories will result in a loss of information. The latter commenter, 
Environmental Defense, et.al., (ED) provided specific information on 
the ``Soaps and Detergents'' and ``Polishes and Sanitation Goods'' 
categories, noting that these categories have distinct six-digit North 
American Industry Classification System (NAICS) codes and showing that 
these categories are readily distinguishable from each other. EPA found 
the same information provided by ED at the following U.S. Census 
Bureau's web site: https://www.census.gov/epcd/naics02/def/
NDEF325.HTM#N3256. The website defines ``soaps and detergents'' and 
``polishes and sanitation goods'' by further breaking those categories 
into more distinct subcategories, demonstrating that there are real 
differences between those two categories. For instance, ``Soaps and 
Detergents'' contains bar soaps manufacturing; dentifrices 
manufacturing; dishwasher detergents manufacturing; hand soaps (e.g., 
hard, liquid, soft) manufacturing; toothpastes, gels, and tooth powders 
manufacturing; and other categories. ``Polishes and Sanitation Goods'' 
contains air fresheners manufacturing; ammonia, household-type, 
manufacturing; brass polishes manufacturing; floor polishes and waxes 
manufacturing; shoe polishes and cleaners manufacturing; wallpaper 
cleaners manufacturing; and other categories. Please note that, as 
described in the preamble to the 2003 Amendments, submitters under the 
IUR will not be required to report on non-TSCA downstream uses of the 
TSCA chemicals that they manufacture (See 68 FR 871, Unit III.B.3.b.).
    Additionally, ED stated that ``the two different types of uses may 
have significant implications for exposure patterns. For example, the 
former category primarily includes products that many people would use 
several times a day, while the latter includes products that most 
consumers would use considerably less frequently'' (Ref. 6). EPA more 
carefully considered the way in which it would utilize these categories 
in a screening-level exposure assessment. While there are products in 
the ``Polishes and Sanitation Goods'' category that could be used on a 
daily basis in similar quantities as products in the ``Soaps and 
Detergents'' category, there are also products with very different use 
scenarios. For instance, EPA has developed default scenarios in the 
Agency's screening level Consumer Exposure Module, which is embedded 
into the Agency's Exposure, Fate Assessment Screening Tool (E-FAST) 
(see https://www.epa.gov/opptintr/exposure/docs/efast.htm), for laundry 
detergent (in the ``Soap and Detergent'' category) and for solid air 
fresheners (in the ``Polishes and Sanitation Goods'' category). These 
use scenarios are different from each other and therefore would 
generate different potential exposure results. Therefore, based upon a 
further analysis of the NAICS Index Entries and EPA's screening models, 
EPA has decided not to combine the two categories and will maintain 
separate reporting categories for ``Soaps and Detergents'' and 
``Polishes and Sanitation Goods.''
    (ii) Add a category called ``Agricultural Products (non-
pesticidal).'' Comments addressing this addition were all favorable, 
and EPA is finalizing the addition of this category. Without this 
category, agricultural uses of chemicals would have been reported under 
the miscellaneous ``Other'' category.
    One commenter requested a definition for ``non-pesticidal,'' which 
is used in the ``Agricultural Products'' category as well as the 
existing ``Lawn and Garden Products (non-pesticidal)'' category. For 
guidance as to what substances are considered to be ``pesticides'' and 
information as to what uses are considered to be pesticidal uses, refer 
to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
definition of ``pesticide'' (7 U.S.C. 136(u) or FIFRA section 2(u)), 
which generally defines the term as ``(1) any substance or mixture of 
substances intended for preventing, destroying, repelling, or 
mitigating any pest, (2) any substance or mixture of substances 
intended for use as a plant regulator, defoliant, or desiccant, and (3) 
any nitrogen stabilizer. . .'' If the subject persons find that the 
agricultural or lawn and garden product on which they are reporting 
does not meet the definition under FIFRA section 2(u), their product 
will fall into the ``Agricultural Products (non-pesticidal)'' or the 
``Lawn and Garden Products (non-pesticidal) category.
    (iii) The Agency had also proposed removing the category 
``Photographic Chemicals,'' due to the expected decline in the 
traditional film photofinishing industry, which indicates that 
consumer/commercial exposure issues associated with photographic 
chemicals may be of diminished importance. Six commenters stated their 
general support of changes made to the commercial and consumer product 
categories, although no commenter specifically mentioned photographic 
chemicals or provided any specific reason for their support. One 
comment supported maintaining the ``Photographic Chemicals'' category, 
stating that any burden associated with the reporting of a category 
covering uses that are less prevalent over time ought to also decline, 
and that there are indications of a relatively stable remaining core of 
film users and therefore the associated chemicals will continue to be 
used. Upon further investigation, EPA has decided to maintain this 
category. According to several industry sources, despite the 
displacement of analog photography by digital imaging, U.S. consumption 
of film and paper chemicals is projected to remain relatively stable. 
Included in this category are many substances that have a role in 
digital as well as analog imaging. Also, toners and resins for copiers 
included in this category are continuing to increase in volume. Thus, 
while specific types of photographic

[[Page 75065]]

chemicals may decrease in use, it seems unlikely that use of chemical 
substances in the ``Photographic Chemicals'' category as a whole will 
drastically decrease, as EPA originally thought (Ref. 7).
    4. What other changes are being made?--a. Reporting frequency and 
recordkeeping. The IUR regulations require reporting every 4 years. The 
first submission period to occur after the 2003 Amendments will be in 
2006, at which time submitters will report information based on the 
2005 reporting year. EPA proposed to change the reporting frequency so 
that, after the 2006 submission period, the reporting frequency will be 
every 5 years instead of every 4 years. This means that the second 
submission period after the 2003 Amendments would be 2011 (i.e., 5 
years after 2006) and would then occur every 5 years thereafter. The 
reporting year would continue to occur in the calendar year immediately 
preceding the submission period, i.e., 2010, 2015, etc.
    EPA received a variety of comments on the proposed change to the 
IUR reporting cycle from every 4 years to every 5 years. Several 
companies and trade associations supported this extension to the 
reporting cycle. Those who supported the change generally recognized 
that the extended reporting cycle would result in burden reduction, 
particularly in the wake of the amended reporting requirements 
promulgated in 2003 (68 FR 848, January 7, 2003), while agreeing that 
the extended reporting cycle would still meet EPA's data needs. Certain 
commenters correctly understood that the extended cycle would allow 
inorganic chemical manufacturers to become familiar with IUR reporting 
(which will be required for inorganic chemical substances for the first 
time as of the 2006 submission period) before having to report 
processing and use information during submission periods after 2006. 
One company indicated that, although it was supportive of changing from 
a 4-year to a 5-year reporting cycle, such a change would not result in 
a reduced (or increased) burden to industry because the 4-year 
reporting cycle has been in effect for some time, and companies have 
this frequency integrated into their regulatory compliance calendars.
    Other commenters did not support the proposed change in reporting 
frequency. A group of organizations and individuals indicated that 
reporting every 5 years will not meet the Agency's and others' critical 
data needs. They suggested that the large fluctuation in the universe 
of high production volume chemicals from 1990-2002 indicates a need for 
more frequent, rather than less frequent, reporting, and they also 
provided an analysis of publicly available IUR information to bolster 
the assertion that the chemical industry is dynamic and that production 
volumes change dramatically over the 4 years between reporting cycles. 
These commenters suggested that annual reporting of production volume 
data would be more appropriate, but if EPA chose not to require annual 
reporting of this data, it should require the reporting of yearly 
production volume data every 5 years. They also recognized that EPA 
bases many of its actions on information reported under the IUR 
regulation, and contended that more accurate reporting will lead to 
better risk management at a lower cost.
    EPA intends to consider further the suggestion to adopt a provision 
requiring persons to report their annual production volumes for each of 
the 5 years preceding the submission period. If the reporting of annual 
volumes appears to be an appropriate change to the IUR regulations, EPA 
may initiate a separate rulemaking.
    EPA recognizes that more frequent reporting could track more 
closely the actual amounts of IUR reportable chemical substances 
manufactured (including imported) in the U.S. In this rule, the Agency 
is incorporating its proposed change to IUR reporting frequency in an 
effort to reduce burden to industry while still meeting the Agency's 
basic information needs. The Agency believes that reporting every 5 
years will meet EPA's most critical needs, particularly given that the 
information that will be reported under the newly amended IUR will be 
significantly more useful for exposure and risk screening purposes than 
the information that was reported under IUR in the past. EPA also 
agrees that the extended reporting cycle will allow increased time for 
industry (particularly inorganic chemical manufacturers) to learn how 
to comply with the amended IUR, and may result in submissions with 
fewer errors.
    EPA disagrees with the comment that the change from a 4-year 
reporting cycle to a 5-year reporting cycle does not affect industry 
burden. Over a 20-year period, a 5-year frequency results in 4 
submission periods while a 4-year frequency results in 5 submission 
periods. As a result of requiring one less submission period over the 
course of 20 years, EPA estimates that a 5-year frequency will save 
regulated entities from $59.3 to $75.7 million over 20 years at a 3% 
discount rate (about a 16% reduction), and from $41.2 to $52.6 million 
over 20 years at a 7% discount rate (Ref. 5), and would still meet 
EPA's most critical data needs.
    Currently, submitters are required to retain records relevant to 
reporting during a submission period for a period of 5 years beginning 
with the effective date of that submission period. EPA is clarifying 
this requirement by changing ``beginning with the effective date'' to 
``beginning on the last day'' of that submission period (i.e., for a 
submission period ending December 23, 2006, submitters would be 
required to retain records relevant to that submission until December 
23, 2011). EPA is also adding a sentence to the recordkeeping 
provisions to encourage submitters to retain records longer than 5 
years to ensure that past records are available as a reference when 
submitters are generating subsequent submissions.
    One commenter noted that, under the current IUR regulations, 
persons submitting their information at the beginning of the submission 
period rather than at the end will have to review their records twice, 
once in preparation for making the submission and then again for 
records retention purposes at the end of the submission period. The 
commenter stated that this could result in submitters who report early 
in the submission period keeping all IUR records from two submission 
periods for a period of time, even if the submitter determines the 
older records are not necessary to help guide subsequent reporting. The 
commenter suggests that to reduce burden and encourage early reporting, 
the required period for record retention be changed from 5 years from 
the last day of the submission period to ``5 years or until the date of 
their next IUR submission to EPA, whichever is less.'' In addition to 
the submitter having its past records to refer to, EPA proposed the 
change from ``beginning with the effective date'' to ``beginning on the 
last day'' of the submission period to clarify the records retention 
requirement. EPA is concerned that following the commenter's suggestion 
would result in a lack of clarity concerning what date is considered 
the date of submission or when the 5-year period begins. Additionally, 
EPA suspects that most submitters review past submissions well before 
submitting their information to EPA. A submitter can identify records 
it no longer finds useful at the time of review for the current 
submission and will easily be able to later identify those records. EPA 
does not require that a submitter destroy records by a certain date, 
and believes the method and timing of such an action is entirely up to 
the submitter, as long as the IUR

[[Page 75066]]

regulations record retention requirement is met.
    b. Submission period. Under the current IUR rule, submitters are 
required to report on a recurring basis every 4 years, and that report 
is required to be submitted to EPA during the period of August 25 
through December 23 in the year immediately following each reporting 
year. In today's action, for the submission period in 2006, EPA is 
retaining August 25 through December 23 as the submission period, but 
for future submission periods beginning in 2011 and thereafter, the 
submission period will be moved up to June 1 through September 30. This 
means that in the next submission period in 2011, submitters are 
required to submit reports between June 1 and September 30, 2011.
    In the proposed rule, EPA solicited comment on its proposal to move 
the submission period to January 1 through April 30 of the year 
following the reporting year. The 2003 amendment to the IUR regulation 
also changed the reporting year from the company's fiscal year to the 
calendar year beginning in 2005. Therefore, all of the information 
required to be submitted to EPA should be available early in 2006 for 
all companies. Moving the submission period to earlier in the calendar 
year would allow the Agency to obtain and process the information in a 
more timely manner, and therefore make the information available for 
use closer in time to the period in which it was generated.
    The Agency received many comments on its proposal to move the 
submission period to a point earlier in the year. The majority of 
commenters opposed the change to the submission period, stating:
    (1) The proposed submission period of January 1 to April 30 
coincides with the time when many other reports must be filed, and the 
current period (August 25 through December 23) works well allowing 
reporting companies time to generate accurate data. A trade group 
indicated that all of its members surveyed reported to the IUR in 
December.
    (2) It is unreasonable for EPA to shorten the submission period in 
light of the increased reporting requirements enacted by the 2003 
Amendments to the IUR. Inorganic chemical producers, who will be 
reporting for the first time under the IUR regulation in 2006, felt 
that adjusting to the reporting requirements would take considerable 
time. Most suggested that respondents will struggle to collect the 
required data in time. Firms reporting on a large number of chemicals 
were of the opinion that the complexity of their reporting would make 
meeting the April 30 deadline difficult due to obligations of other 
forms of regulatory compliance occurring early in the calendar year. 
Importers pointed out the complexity of their situation, especially 
because they will often have to rely on Customs Entry forms that can be 
delayed up to 30 days.
    (3) Numerous other EPA reporting programs require reporting in the 
first half of the year, such as the Toxics Release Inventory (TRI), as 
do other state and federal environmental programs. This would strain 
staff responsible for reporting, and lead to inaccuracy. Some 
commenters identified approximately 30 additional federal, state and 
local reporting programs that require their attention. Other commenters 
stated that they believe the coordination of these IUR and TRI 
reporting deadlines may encourage submitters to coordinate their data 
collection processes.
    (4) Several persons commenting on the proposal believed that 
delaying the reporting until later in calendar year 2006 would improve 
the accuracy of the information reported. These persons pointed out 
that import notifications are often delayed by up to 30 days after the 
chemical is imported thereby reducing the time available to incorporate 
this information into IUR reporting. In addition, those firms whose 
byproducts are either beneficially reused or disposed as wastes will 
need additional time to report because the determination of beneficial 
use may be made months after the byproducts are manufactured.
    (5) Requiring accelerated submissions based on ``timeliness'' of 
the data is inconsistent with EPA's proposal to extend the reporting 
cycle from 4 to 5 years because a delay of several additional months is 
insignificant when compared to the extension of the reporting cycle by 
an additional year. Some commenters pointed out that by waiting an 
extra few months, EPA would collect more accurate data. One commenter 
questioned EPA's rationale for moving up the submission period to 
better coincide with the change of the reporting year from the fiscal 
year to the calendar year. This commenter suggested that EPA's 
reasoning was erroneous because many businesses, in their experience, 
had fiscal years ending significantly before July and therefore, for 
those companies, the period to prepare and submit IUR reports has been 
reduced from approximately 1 year (for companies with a fiscal year 
coinciding with the calendar year) to only 4 months.
    (6) Almost all of the commenters objected to the change in the 
submission period for the 2006 reporting cycle. Based on the comments, 
EPA believes these objections are due to the commenter's unfamiliarity 
with the new requirements imposed by the amended IUR regulations. Many 
commenters mentioned that EPA guidance for the 2006 reporting period is 
not yet available (though several mentioned and appreciated that EPA 
was conducting IUR training), noted that EPA's electronic reporting 
program for 2002 was flawed, and questioned whether the 2006 materials 
would be ready in time to be adequately tested before reporting is 
required. Others stated that they were already planning IUR 
information-gathering activities around the August-December timeframe.
    Most commenters, while preferring that EPA retain the current 
submission period, suggested alternatives. These included deadlines of 
October 31, August 31, July 1 (to coincide with TRI reporting), and May 
1, and a submission period from July 1 through October 31.
    In response to the many objections to the proposed change to the 
submission period, EPA has reconsidered its proposal to move the 
submission period to January 1 through April 30. The proposed change 
was not intended to place additional burdens on industry, but to remove 
an unnecessary delay in collecting the IUR data. In light of the 
commenters' concerns about their ability to collect accurate data in a 
timely fashion and submit them during the proposed submission period, 
EPA will maintain the current submission period of August 25 through 
December 23 for the 2006 reporting cycle, and switch to a June 1 
through September 30 submission period for all future reporting cycles 
beginning in 2011. Recognizing that companies may have already begun 
planning data collection activities around the August to December 
submission period for the 2006 reporting cycle, and that the data 
collection will include new requirements resulting from the 2003 
Amendments, EPA recognizes that altering the 2006 IUR submission period 
at this time could be overly burdensome to some reporters. Beginning in 
2011, and for all future reporting cycles thereafter, EPA believes that 
the June 1 through September 30 submission period balances industry's 
needs in collecting the data with EPA's desire to begin analyzing the 
data in a timely manner.
    c. Polymer exemption. Chemical substances meeting the definition 
for polymers included in 40 CFR 710.46(a)(1) are fully exempt from 
reporting under the IUR regulations. EPA is changing the references 
included

[[Page 75067]]

in the polymer definition from the ``1985 edition of the Inventory or 
the Master Inventory File'' to the more general and current ``Master 
Inventory File'' by removing the reference to the 1985 edition of the 
Inventory. The Master Inventory File has been regularly updated since 
the 1985 edition of the Inventory was published, and is the more 
appropriate reference for use within the IUR polymer exemption. All who 
commented on this subject agreed with this change, and EPA is 
finalizing the definition as proposed.

III. Materials in the Rulemaking Record

    An official docket was established under docket ID number EPA-HQ-
OPPT-2004-0106. The official public docket includes information 
considered by EPA in developing this final rule, such as the documents 
specifically referenced in this action, any public comments received, 
and other information related to this action. In addition, interested 
parties should consult documents that are referenced in the documents 
that EPA has placed in the docket, regardless of whether these 
referenced documents are physically located in the docket. For 
assistance in locating documents that are referenced in documents that 
EPA has placed in the docket, but that are not physically located in 
the docket, please consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT. The official public docket is available 
for review as specified in ADDRESSES. The following is a listing of the 
documents referenced in this preamble that have been placed in the 
official docket for this final rule:
    1. USEPA, ``TSCA Inventory Update Rule Amendments'' (68 FR 848, 
January 7, 2003) (FRL-6767-4).
    2. 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.
    3. USEPA, ``Toxic Substances Control Act (TSCA) PL 94-469 Candidate 
List of Chemical Substances Addendum I Generic Terms Covering Petroleum 
Refinery Process Streams,'' January 1978.
    4. USEPA, ``Technical Support Document Inventory Update Reporting 
Rule Petroleum Process Stream Partial Exemption Added Petroleum Process 
Chemicals'' OPPT, April 17, 2004. Revised, July 6, 2005.
    5. USEPA, ``Economic Analysis of the IUR Revisions Final Rule,'' 
Office of Pollution Prevention and Toxics, July 2005.
    6. Comment from Denison, Richard A., Environmental Defense, on 
Comments on Proposed Rule, TSCA Inventory Update Reporting Revisions 
(70 FR 3658, 26 January 2005). Submitted via EDOCKET on 18 February, 
2005.
    7. USEPA, ``Summary of Information on Photographic Chemicals,'' 
Office of Pollution Prevention and Toxics, July 2005.

IV. Statutory 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 action is not a ``significant 
regulatory action'' subject to review by OMB because it does not meet 
the criteria in section 3(f) of the Executive Order.
    EPA has prepared an economic analysis of the potential impacts of 
this action, which is contained in a document entitled Economic 
Analysis of the IUR Revisions Final Rule (Ref. 1). This document is 
available as a part of the public version of the official record for 
this action and is briefly summarized here.
    These revisions will reduce IUR reporting costs. The quantified 
portions of the rule are estimated to save $6 million to $7 million per 
year when annualized over the next 20 years at a 3% or a 7% discount 
rate. Most of the savings of these revisions will accrue to the 
chemical industry in the form of decreased costs of complying with the 
IUR regulations. There will also be some savings to EPA in the form of 
decreased costs to administer the regulation and maintain the collected 
data.

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under the PRA, unless it has been approved by OMB and displays 
a currently valid OMB control number. The OMB control numbers for EPA's 
regulations, after initial display in the Federal Register and in 
addition to its display on any related collection instrument, are 
listed in 40 CFR part 9.
    The information collection requirements related to the IUR 
regulations have already been approved by OMB pursuant to the PRA under 
OMB control number 2070-0162. This action would not impose any burden 
requiring additional OMB approval. Instead, this action would reduce 
reporting burden by 113,000 to 123,000 hours in the 2006 reporting 
cycle and 112,000 to 121,000 hours in subsequent reporting cycles. This 
reduction is out of a total burden of 1,300,000 to 1,658,000 hours in 
the 2006 reporting cycle, and 1,189,000 to 1,516,000 in future 
reporting cycles.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division (2822), Office of Environmental 
Information, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this action 
will not have a significant adverse economic impact on a substantial 
number of small entities. The factual basis for the Agency's 
determination is summarized below.
    The term ``small entities'' includes small businesses, small not-
for profit organizations, and small governmental jurisdictions, but 
because not-for-profit organizations and governmental jurisdictions 
will not be affected by this rule, ``small entity'' in this analysis is 
synonymous with small business.
    Small manufacturers that fully meet the 40 CFR 704.3 definition are 
generally exempt from reporting under the IUR regulations, and thus are 
not significantly impacted by IUR reporting. Nevertheless, this 
rulemaking is expected to reduce IUR reporting costs for businesses of 
all sizes. Thus, EPA concludes that these revisions will not result in 
significant adverse effects on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4) (UMRA), 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. 
As described in Unit IV.A., the rule is expected to decrease 
expenditures by $6 million to $7 million per year. EPA has

[[Page 75068]]

also determined that the rule would not significantly or uniquely 
affect small governments and is not subject to the requirements of 
sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    This rule will not have a substantial direct effect on 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, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This rule will not have tribal implications because it is not 
expected to have substantial direct effects on tribal governments, on 
the relationship between the Federal Government and Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 6, 2000).

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expec