[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Proposed Rules]
[Pages 3658-3666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1380]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 710
[OPPT-2004-0106; FRL-7332-2]
RIN 2070-AC61
TSCA Inventory Update Reporting Revisions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing amendments to the Toxic Substances Control
Act (TSCA) section 8(a) Inventory Update Reporting (IUR) regulations.
The IUR currently requires certain manufacturers (including importers)
of certain chemical substances on the TSCA Chemical Substances
Inventory to report data on chemical manufacturing, processing, and use
every 4 years. EPA is proposing to extend the reporting cycle, modify
the timing of the submission period, further clarify the new partial
exemption for specific chemicals of low current interest, amend the
petroleum refinery process streams partial exemption, amend the list of
consumer and commercial product categories, revise the manner in which
production volume would be reported, restrict reporting of processing
and use information to domestic processing and use activities only,
edit the polymer exemption definition, and remove the requirement to
determine confidentiality of production volume in ranges.
DATES: Comments, identified by docket identification (ID) number OPPT-
2004-0106, must be received on or before February 25, 2005.
ADDRESSES: Submit your comments, identified by docket ID number OPPT-
2004-0106, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/. Follow the
on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: epa.gov">oppt.ncic@epa.gov.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number OPPT-2004-0106. The DCO is open from 8 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
Instructions: Direct your comments to docket ID number OPPT-2004-
0106. EPA's policy is that all comments received will be included in
the public docket without change and may be made available on-line at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
[[Page 3659]]
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not 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/DC), EPA West, Rm.
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 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: TSCAHotline@
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: epa.gov">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 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. In the past, persons that
only processed chemical substances have not been required to comply
with the requirements of 40 CFR part 710. These proposed amendments do
not change the status of processors under the regulations at 40 CFR
part 710. Potentially affected entities may include, but are not
limited to:
Chemical manufacturers and importers, including 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. The North American Industrial Classification System (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 (http://www.epa.gov/edocket), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 710
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background
A. What Action is the Agency Taking?
The following is a brief listing of the proposed changes to the IUR
contained in this action, which are described in more detail in Unit
II.D. EPA is proposing to:
Change the reporting cycle from 4 years to 5 years.
Move the submission period from the end of the calendar
year (August 25 to December 23) to the beginning (January 1 to April
30).
Further explain the partial exemption for chemicals for
which the IUR processing and use information is of low current interest
by clarifying that petitions must include a written rationale for
changing the exemption chemical list.
Clarify the petroleum process stream partial exemption by
adding ``refinery'' to the name of the exemption and amend the partial
exemption by adding certain petroleum process streams.
Amend the list of commercial and consumer product use
categories by combining two categories into one, adding a category, and
deleting a category.
Require separate reporting of manufacture and import
volumes.
Restrict the reporting of processing and use information
to domestic processing and use activities only.
Edit the polymer exemption definition to refer solely to
chemical substance identification via the Master Inventory File, by
removing the reference to the 1985 edition of the Inventory.
Remove the requirement to determine confidentiality of
production volume in ranges.
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 under TSCA section 8(a) at 40 CFR part 710 (51 FR
21447, 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
[[Page 3660]]
the IUR (68 FR 848, January 7, 2003) (FRL-6767-4) (2003 Amendments) to
collect manufacturing, processing, and use exposure-related
information, and to make certain other changes.
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 manufacturer for purposes of 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.
C. What is the Inventory Update Reporting (IUR) Regulation?
The data reported under the IUR are used to update the information
maintained on the TSCA Inventory. 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.
The IUR, as amended by the 2003 Amendments in January 2003,
requires 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 during the reporting year in
quantities of 25,000 pounds or more at any plant site they own or
control. The IUR generally excludes several categories of substances
from its reporting requirements, i.e., polymers, microorganisms,
naturally occurring chemical substances, and certain natural gas
substances. Plant sites are required to report information such as
company name, plant site location and other identifying information,
identity and production volume of the reportable chemical substance,
manufacturing exposure-related information associated with each
reportable chemical substance, including the physical form and maximum
concentration of the chemical substance and the number of potentially
exposed workers.
Manufacturers (including importers) of larger volume chemicals
(i.e., 300,000 lbs. or more manufactured (including imported) during
the reporting year at any plant 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, inorganic chemicals, regardless of
production volume, are partially exempt (i.e., submitters do not report
processing and use information for inorganic chemicals). After the 2006
reporting period, the partial exemption for inorganic chemicals will no
longer be applicable and submitters will fully report information on
inorganic chemical substances. 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 submission period as well as subsequent submission periods.
D. What Changes is the Agency Proposing to Make?
Through this action, EPA is proposing to make further changes to
the IUR. The following discussion describes the proposed changes to the
IUR contained in this action.
1. Reporting frequency and recordkeeping. The IUR regulations
require reporting every 4 years. The first submission period since the
2003 Amendments will occur in 2006, at which time submitters will
report information generated during the 2005 reporting year. In this
action, EPA is proposing to change the reporting frequency after the
2005 reporting year from every 4 years to every 5 years. This means
that, instead of occurring in 2009, the second reporting year since the
2003 Amendments 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, i.e., 2011, 2016, etc.
EPA agreed to make the reporting frequency changes during
interagency review of the 2003 Amendments, in an effort to further
reduce the potential reporting burden. EPA estimates that a 5-year
frequency would 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, and would
still meet EPA's most critical data needs (Ref. 1).
Submitters currently are required to retain records related to and
including their IUR submissions for a period of 5 years, beginning with
the last day of the submission period (i.e., for a submission period
ending April 30, 2006, based on the submission period proposed in Unit
II.D.2., submitters would be required to retain records relevant to
that submission until April 30, 2011). EPA is not proposing to change
this requirement; however, the Agency encourages submitters to retain
records longer than 5 years to ensure that past records are available
as a reference when submitters are generating subsequent submissions.
2. Submission period. IUR submitters are required to report on a
recurring basis from August 25 to December 23 every 4 years (40 CFR
710.53). EPA is proposing to change the submission period to occur from
January 1 to April 30. This change is related to the reporting year
change in the 2003 Amendments 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 meant that these companies reported
their most current information as soon as possible after the end of the
reporting year (i.e., the year during which the information to be
reported was generated). However, under the amended regulations,
submitters will now report on a calendar year basis, making an earlier
submission period more appropriate because it would allow sites to
submit their information to EPA closer in time to the period during
which it was generated. This, in turn, would allow the Agency to obtain
and process the information in a more timely manner, and therefore make
the information available for use closer to the time period which the
information describes and therefore making the information more timely.
As the chemical industry is dynamic, information which is more timely
is most likely to better describe the industry than information which
is less timely.
[[Page 3661]]
EPA seeks comment on other possible submission periods and may
adopt a submission period in the final rule that differs from the
proposed January through April period. Suggested alternatives should be
accompanied by an explanation indicating why the alternative period
more appropriately meets submitters', the Agency's, and the public's
best interests than the proposed submission period.
The submission period occurs in the year following the reporting
year. As described in Unit II.D.1., EPA is proposing to change the
reporting frequency from every 4 years to every 5 years, which means
that the reporting year, and therefore the submission period, would
occur every 5 years (i.e., after the 2006 submission period, the next
submission period would occur in 2011).
3. ``Low current interest'' partial exemption. 40 CFR 710.46(b)(2)
contains the requirements for the exemption of certain chemicals for
which EPA has determined the IUR processing and use information to be
of ``low current interest'' from reporting requirements listed in 40
CFR 710.52(c)(4). The public may ask EPA to change the list of
chemicals partially exempt from reporting under 40 CFR 710.46(b)(2)
(whether by adding or removing a chemical to or from the list).
Currently, the request must be in writing, must identify the chemical
in question, including a chemical identification number, and should
include sufficient information for EPA to determine whether collection
of the information in 40 CFR 710.52(c)(4) for the chemical in question
is of low current interest.
In order to ensure that the public understands what requests need
to contain, and to allow the Agency to make decisions about the
listing/delisting of chemicals in the most expedient manner, EPA is
clarifying that a request for listing/delisting must provide written
rationale or justification for the request, accompanied by relevant
documents, and including specific cites to information in those
documents. The rationale needs to provide sufficient information upon
which the Agency can assess the current need for IUR processing and use
information and can make a decision concerning reporting of that
information for the subject chemical. It is a petitioner's burden to
demonstrate why a given chemical substance should be considered of low
current interest.
In determining whether the 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 information associated with one or more of the
following considerations listed in 40 CFR 710.46(b)(2)(ii).
Additionally, EPA is clarifying consideration 6 by proposing to delete
the phrase ``by EPA or another agency or authority.'' EPA is proposing
this deletion because the Agency did not intend to limit consideration
6 to Federal Government risk management actions. The amended
considerations are:
(i) Whether the chemical qualifies or has qualified in past IUR
collections for the reporting of the information described in 40 CFR
710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or
more of the chemical).
(ii) The chemical substance's chemical and physical properties or
potential for persistence, bioaccumulation, health effects, or
environmental effects (considered independently or together).
(iii) The information needs of EPA, other federal agencies, tribes,
states, and local governments, as well as members of the public.
(iv) The availability of other complementary risk screening
information.
(v) The availability of comparable processing and use information.
(vi) Whether the potential risks of the chemical substance are
adequately managed.
Petitioners should also include any additional information not
specifically covered by the listed considerations that would inform the
Agency's decision concerning current interest in the IUR processing and
use information. For instance, a chemical's physical/chemical
properties may be such that exposure is unlikely, and the IUR
processing and use information is likely to be of low interest. In its
review of the petition, the Agency will consider each petitioned
chemical substance individually, will conduct a limited search for
information not provided in the petition to see if there are additional
concerns or issues, and will make a decision based upon the totality of
information identified.
It is important to note that the addition of a chemical substance
under this partial exemption will not necessarily be based on the
potential risks of the chemical and that the Agency will not perform a
formal risk analysis as part of the petition review, but that EPA's
decision will be based on the Agency's current assessment of the need
for collecting IUR processing and use information for that chemical,
based upon the totality of information considered during the petition
review process. Additionally, interest in a chemical or a chemical's
processing and use information may increase in the future, at which
time EPA will reconsider the applicability of this partial exemption
for those chemicals.
EPA is making this clarification in reaction to the first round of
requests for consideration which were received by December 30, 2003. It
was always EPA's intent that the requests contain supporting rationale
associated with the request, and that the rationale specifically
address at least the considerations outlined in 40 CFR
710.46(b)(2)(ii). Instead, EPA has received a number of requests that
only cite the existence of another document, e.g., an Organization for
Economic Cooperation and Development (OECD) Screening Information Data
Set (SIDS) Initial Assessment Report (SIAR), as support, without any
discussion of the document's relevance to the considerations or why the
document supports a determination of low current interest. It is a
requester's burden to demonstrate in a clear, well supported manner,
why a given chemical substance should be considered of low current
interest. EPA is today proposing to clarify the required contents of a
petition for this exemption.
4. Partially exempt petroleum refinery process streams. Certain
listed petroleum refinery process streams are partially exempt from
reporting under IUR. Specifically, they are exempt from the downstream
processing and use reporting requirements described in 40 CFR
710.52(c)(4) (see 40 CFR 710.46(b)(1)). This list of substances was
derived from the 1983 publication of the American Petroleum Institute
(API) entitled ``Petroleum Process Stream Terms Included in the
Chemical Substances Inventory Under the Toxic Substances Control Act
(TSCA)'' (Ref. 2). In order to update the list in 40 CFR 710.46(b)(1),
and in response to suggestions from API (Ref. 3), EPA is proposing to
change the exemption name by adding the term ``refinery'' and to amend
the list to add certain petroleum process streams which have been added
to the TSCA Inventory since the 1983 publication was compiled.
Additionally, EPA is proposing to add two petroleum refinery process
streams that were inadvertently left off the initial partial exemption
list established by 68 FR 854 (CAS numbers: 68919-16-4 and 61789-60-4).
The two substances are listed in the 1983 publication and meet the
requirements for listing under this exemption.
EPA is proposing to change the name of the partial exemption to
``petroleum refinery process streams'' to clarify the
[[Page 3662]]
types of covered substances, which are restricted to petroleum refinery
process streams. This change is consistent with 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. 4). The decision criteria used to develop both the current
list in 40 CFR 710.46(b)(1) and the proposed additions to the list were
applied in a manner consistent with Addendum I.
API identified 125 potential petroleum refinery process streams
that were on the TSCA Inventory as of July 2003, but were not included
in the 1983 API publication. API stated that ``the 1983 document
comprised substances that were included in the original TSCA Inventory
(May 1979) or in the Cumulative Supplement II (May 1982). In the over
twenty years since then, petroleum refinery process streams have been
added to the TSCA Inventory when companies have submitted
premanufacture notifications (PMNs) and subsequent notices of
commencement (NOCs) for new chemical substances'' (Ref. 3).
EPA reviewed API's list of identified substances (Ref. 5), and
determined that three are already included in the partial exemption for
certain petroleum refinery process streams. The Chemical Abstract
Service (CAS) numbers for these chemicals are: 68187-60-0, 68918-98-9,
and 68921-09-5. The Agency has tentatively determined that the
following 25 substances are considered petroleum refinery process
streams for the purposes of reporting under IUR and is proposing to add
these substances to the partial exemption list in 40 CFR 710.46(b)(1):
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 determined that the following 14 substances are already
fully exempt from IUR reporting under the polymer exemption at 40 CFR
710.46(a)(1): 68911-05-7, 68938-55-6, 68952-09-0, 69430-34-8, 69430-35-
9, 71302-83-5, 74552-82-2, 88526-47-0, 93685-79-1, 100815-94-9, 106233-
12-9, 106233-13-0, 120928-15-6, and 163440-93-5.
The Agency has also tentatively determined that the remaining 83
substances are not considered petroleum refinery process streams for
purposes of reporting under IUR and are therefore not eligible for the
partial exemption under 40 CFR 710.46(b)(1) (Ref 5). In making this
determination, EPA would like to point out that petrochemicals are not
considered petroleum process streams for the purposes of reporting
under IUR. 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.
Petrochemicals often have names sounding similar to petroleum refinery
process streams, but can be made using a synthetic process such as a
chemical reaction. A petrochemical encompasses a wide variety of
chemical substances processed and used in a variety of venues, may be
processed and used in different manners in the venues with differing
likelihoods of exposure, and may be solids or otherwise not require
that the equipment in which they are processed be closed. The
petrochemical thereby may have a variety of uses and exposure
scenarios, and is not limited to being site-limited or used as a fuel,
as are the petroleum refinery process streams.
These 83 substances not being added to the petroleum refinery
process streams exemption are identified by CAS number and fit into one
or more of four categories (the substance is listed under the category
most appropriate):
(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, CAS numbers: 68333-90-4, 68409-73-4, 68551-15-5,
68551-16-6, 68551-17-7, 68551-18-8, 68551-19-9, 68551-20-2, 68603-35-0,
68989-41-3, 68990-23-8, 70024-92-9, 72162-34-6, 73138-29-1, 74664-93-0,
90622-46-1, 93762-80-2, 93924-07-3, 93924-10-8, 93924-11-9, 129813-66-
7, 129813-67-8, 131459-42-2, 289711-49-5, 289711-48-4, 329909-27-5,
426260-76-6.
(ii) The chemical substance is a well defined 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, CAS
numbers: 67774-74-7, 68855-24-3, 68936-98-1, 68936-99-2, 68987-40-6,
70356-32-0, 85117-41-5, 85117-43-7, 94094-93-6, 102783-85-7, 115733-08-
9, 125025-88-9, 129813-59-8, 129813-60-1,129813-61-2, 129813-62-3,
129813-63-4, 146865-37-4, 148520-81-4, 151911-58-9, 151911-60-3,
151911-59-0, 156105-29-2.
(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, CAS numbers:
68131-94-2, 68131-95-3, 68131-96-4, 68131-97-5, 68201-32-1, 68201-54-7,
68425-32-1, 68442-08-0, 68477-23-6, 68478-11-5, 68603-04-3, 68603-05-4,
68603-06-5, 68603-07-6, 68606-23-5, 68606-38-2, 68649-47-8, 68649-48-9,
68649-49-0, 68814-88-0, 68815-10-1, 68920-58-1, 68990-36-3, 71820-39-8,
73138-64-4, 73665-18-6, 96471-07-7, 102479-87-8, 108083-43-8, 108083-
44-9, 111163-74-7, 152699-00-8, 216977-01-4 (Ref. 5).
(iv) The chemical substance is derived using a chemical process (a
Fischer-Tropsch process) from a non-petroleum source, CAS number:
277316-99-1 (Ref. 5).
5. Consumer and commercial product categories. Certain 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 (see 40 CFR
710.52(c)(4)(iii)(A)). Following promulgation of the 2003 Amendments,
EPA had discussions with the American Chemistry Council, the Consumer
Specialty Products Association, and The Fertilizer Institute about
these categories. In light of these discussions and EPA's own research,
the Agency is proposing the following changes to the list of
categories:
(i) Combine the categories of ``Soaps and Detergents'' and
``Polishes and Sanitation Goods'' to form a new category called
``Cleaning Products (non-pesticidal).'' EPA further considered these
two categories, and believes that manufacturers might have difficulty
differentiating between downstream categories which are so similar.
Both categories relate to cleaning goods. Combining the categories does
not reduce the utility of the information to EPA, and it allows
manufacturers to avoid making difficult distinctions.
(ii) Remove the category ``Photographic chemicals.'' This deletion
is in recognition of the changing photography industry. The Photo
Marketing Association notes that traditional film photofinishing in the
U.S. peaked in 2000, and has been declining since. Declines of 5-10%
[[Page 3663]]
annually should continue through at least 2006 (Ref. 6). EPA believes
that this decline indicates that consumer/commercial exposure issues
associated with photographic chemicals may be of diminished importance,
and therefore proposes to eliminate ``Photographic chemicals'' as a
category. As a result of this revision, photosensitive chemicals will
be reported in the ``Other'' category, designated as U33. The Agency
will be able to distinguish these chemicals by the distinctive NAICS
numbers associated with use of these chemical substances.
(iii) Add a category called ``Agricultural products (non-
pesticidal).'' The Fertilizer Institute identified that a major use of
chemicals for consumer/commercial uses is in agriculture, an area not
covered by the consumer/commercial categories. EPA is proposing to add
a category for ``agricultural products (non-pesticidal)'' to ensure
that this end use would not be combined into the ``other'' category.
6. Production volume reporting. Submitters are currently required
to report the total production volume (i.e., the sum of manufactured
and imported volumes) for each reportable chemical substance (40 CFR
710.52(c)(3)(iv)) and a statement indicating whether the substance is
manufactured in the U.S., imported into the U.S., or both manufactured
and imported into the U.S. (40 CFR 710.52(c)(3)(ii)). Prior to the 2003
Amendments, submitters were required to report the manufactured volume
separately from the imported volume for each reportable chemical
substance. EPA often has need for either import or domestic manufacture
information on chemical substances, thus the Agency is proposing to
return to the previous method of reporting manufactured volume
separately from imported volume. As these volumes were previously
reported separately, EPA expects that these values are reasonably
ascertainable and that any increase in burden is negligible (Ref. 1).
Many chemicals are both manufactured domestically and imported at
the same site. The ability to differentiate between domestically
manufactured and imported volumes is important to understand the nature
of chemical production in the U.S. This information is used to
characterize the markets and structure of the chemical industry in the
U.S., providing context for decision makers as they consider
alternative policy choices. Additionally, the separation between
domestically manufactured and imported volumes is important for initial
exposure evaluations of a chemical and for assessing international
trade implications.
7. Reporting processing and use information for domestic activities
only. Submitters with production volumes of 300,000 lbs. or greater for
a reportable chemical substance are currently required to report
processing and use information (i.e., the information to be reported
under 40 CFR 710.52(c)(4)), without restrictions, to the extent the
information is readily obtainable. EPA is proposing to limit the
information to be reported under 40 CFR 710.52(c)(4) to domestic
processing and use activities only. Submitters would not report on
processing or use activities that occur outside the U.S. In other
words, the industrial processing or use operations (40 CFR
710.52(c)(4)(i)(A)) and commercial and consumer uses (40 CFR
710.52(c)(4)(ii)(A)) reported by submitters would be domestic
operations and uses. For example, if a manufacturer produces 350,000
lbs. of a reportable chemical substance, directly exports 100,000 lbs.,
and sells 250,000 lbs. within the U.S., the manufacturer would have to
report processing and use information for the 250,000 lbs. sold within
the U.S.
EPA is proposing to limit the reporting of information to domestic
processing and use activities only for two main reasons. First, the IUR
collection does not distinguish between domestic and foreign
activities; there is no way to identify if the information submitted
covers domestic or foreign activities. EPA generally has a stronger
interest in domestic processing and use information. Second, removing
the need to report on foreign processing and use activities reduces the
burden associated with reporting to the IUR (Ref. 1).
8. 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. EPA is proposing to change the references
included in the polymer definition from the ``1985 edition of the
Inventory or the Master Inventory File'' to solely 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.
9. Production volume range confidentiality claims. Submitters who
claim production volume as confidential are currently additionally
required to 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 added this provision in the 2003 Amendments in an
effort to promote the release of more general production volume
information for an individual plant site. EPA is now proposing to
remove this requirement. EPA currently releases aggregated, chemical-
specific, TSCA production volume information in ranges that are similar
to, but not the same as, the ranges specified in 40 CFR
710.52(c)(3)(v). The Agency has a concern that the existence of
competing sets of ranges, some with confidentiality claims and some
without, would complicate the release of aggregated production volume
information and reduce the amount of useful information available to
the public. As the intent in adding this provision in the 2003
Amendments was to increase the information available to the public, the
Agency is proposing to remove this requirement (although specific
production volumes could still be claimed as confidential). Information
claimed as CBI under 40 CFR 710.58 will not be disclosed by EPA except
in accordance with the procedures set forth at 40 CFR part 2.
III. Materials in the Rulemaking Record
1. USEPA, ``Economic Analysis of the IUR Revisions Proposed Rule,''
Office of Pollution Prevention and Toxics, September 2004.
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. E-mail from Glen Barrett, American Petroleum Institute, to Susan
Sharkey, EPA, ``Proposed Petroleum Refinery Process Streams to be Added
to Streams Listed in the IURA Rule (i.e., CFR 710.46(b)(1)),'' February
25, 2004.
4. 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.
5. USEPA, ``Technical Support Document Inventory Update Rule
Petroleum Refinery Process Stream Partial Exemption Added Refinery
Process Chemicals'' OPPT, April 17, 2004.
6. Photo Marketing Association International, ``Photo Industry
2004: Review and Forecast,'' February 2004, available at http://www.pmai.org/new_pma/Marketing_Research/Photo%20Industry%202004.pdf.
[[Page 3664]]
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
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 Proposed 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. 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 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 promulgation
of this action would 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 IUR, 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), 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 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 proposed rule, if finalized, would 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 proposed rule, if finalized, also would 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 expected to affect energy supply, distribution, or use.
I. National Technology Transfer Advancement Act
Since this action does not involve any technical standards, section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does
not apply to this action.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not involve special considerations of
environmental justice related issues as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
K. Executive Order 12988
In issuing this proposed rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize
[[Page 3665]]
potential litigation, and provide a clear legal standard for affected
conduct, as required by section 3 of Executive Order 12988, entitled
Civil Justice Reform (61 FR 4729, February 7, 1996).
List of Subjects in 40 CFR Part 710
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements.
Dated: January 6, 2005.
Susan B. Hazen.
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 710--[AMENDED]
1. The authority citation for part 710 would continue to read as
follows:
Authority: 15 U.S.C. 2607(a).
Sec. 710.43 [Amended]
2. Section 710.43 is amended by revising the phrase ``4-year
intervals'' to read ``5-year intervals'' in the definition for
``reporting year.''
3. Section 710.46 is amended as follows:
a. By removing the phrase ``the 1985 edition of the Inventory or
in'' in paragraph (a)(1)(i).
b. By removing the phrase ``the 1985 edition of the Inventory or''
in paragraph (a)(1)(ii).
c. By revising the paragraph heading for paragraph (b)(1).
d. By revising the table title to the table in paragraph (b)(1).
e. By relisting in ascending order the entries for 68514-36-3,
68514-37-4, 68514-38-5, 68814-87-9, and 68921-09-5 and adding entries
in ascending order to the table in paragraph (b)(1).
f. By revising paragraph (b)(2)(ii)(F).
g. By removing the third, fourth, and fifth sentences in paragraph
(b)(2)(iii)(A) and adding a new third sentence.
h. By revising the phrase ``4-year intervals'' to read ``5-year
intervals'' in paragraph (b)(2)(iii)(C).
Sec. 710.46 Chemical substances for which information must be
reported.
* * * * *
(b) * * *
(1) Petroleum refinery process streams. * * *
CAS Numbers of Partially Exempt Substances Termed ``Petroleum Refinery
Process Streams'' for Purposes of Inventory Update Reporting
------------------------------------------------------------------------
CAS No. Product
------------------------------------------------------------------------
61789-60-4................................ Pitch
* * * * *
67254-74-4................................ Naphthenic oils
* * * * *
67891-81-0................................ Distillates (petroleum),
oxidized light, potassium
salts
* * * * *
67891-86-5................................ Hydrocarbon waxes
(petroleum), oxidized,
compds. with
diisopropanolamine
* * * * *
68476-27-7................................ Fuel gases, amine system
residues
* * * * *
68477-98-5................................ Gases (petroleum),
hydrotreater blend oil
recycle, hydrogen-nitrogen
rich
68477-99-6................................ Gases (petroleum),
isomerized naphtha
fractionater, C4-rich,
hydrogen sulfide- free
* * * * *
68478-31-9................................ Tail gas (petroleum),
isomerized naphtha
fractionates, hydrogen
sulfide-free
* * * * *
68513-03-1................................ Naphtha (petroleum), light
catalytic reformed, arom.-
free
* * * * *
68514-39-6................................ Naphtha (petroleum), light
steam-cracked, isoprene-
rich
* * * * *
68919-16-4................................ Hydrocarbons, catalytic
alkylation, by-products, C3-
6
* * * * *
73138-65-5................................ Hydrocarbon waxes
(petroleum), oxidized,
magnesium salts
92045-43-7................................ Lubricating oils
(petroleum), hydrocracked
nonarom. solvent
deparaffined
92045-58-4................................ Naphtha (petroleum),
isomerization, C6-fraction
92062-09-4................................ Slack wax (petroleum),
hydrotreated
* * * * *
98859-55-3................................ Distillates (petroleum),
oxidized heavy, compds.
with diethanolamine
98859-56-4................................ Distillates (petroleum),
oxidized heavy, sodium
salts
101316-73-8............................... Lubricating oils
(petroleum), used,
noncatalytically refined
164907-78-2............................... Extracts (petroleum),
asphaltene-low vacuum
residue solvent
164907-79-3............................... Residues (petroleum),
vacuum, asphaltene-low
178603-63-9............................... Gas oils (petroleum),
vacuum, hydrocracked,
hydroisomerized,
hydrogenated, C10-25
178603-64-0............................... Gas oils (petroleum),
vacuum, hydrocracked,
hydroisomerized,
hydrogenated, C15-30,
branched and cyclic
178603-65-1............................... Gas oils (petroleum),
vacuum, hydrocracked,
hydroisomerized,
hydrogenated, C20-40,
branched and cyclic
178603-66-2............................... Gas oils (petroleum),
vacuum, hydrocracked,
hydroisomerized,
hydrogenated, C25-55,
branched and cyclic
212210-93-0............................... Solvent naphtha (petroleum),
heavy arom., distn.
residues
221120-39-4............................... Distillates (petroleum),
cracked steam-cracked, C5-
12 fraction
445411-73-4............................... Gas oils (petroleum),
vacuum, hydrocracked,
hydroisomerized,
hydrogenated, C10-25,
branched and cyclic
------------------------------------------------------------------------
* * * * *
(2) * * *
(ii) * * *
(F) Whether the potential risks of the chemical substance are
adequately managed.
(iii) * * *
(A) * * * Requests must identify the chemical in question, as well
as its CAS number or other chemical identification number as identified
in
[[Page 3666]]
Sec. 710.52(c)(3)(i), and must contain a written rationale for the
request that provides sufficient specific information, addressing the
considerations listed in Sec. 710.46(b)(2)(ii), including cites and
relevant documents, to demonstrate to EPA that the collection of the
information in Sec. 710.52(c)(4) for the chemical in question either
is or is not of low current interest. * * *
* * * * *
Sec. 710.48 [Amended]
4. Section 710.48 is amended by revising the phrase ``4-year
intervals'' to read ``5-year intervals'' in paragraph (a).
5. Section 710.52 is amended as follows:
a. By revising the phrase ``4-year intervals'' to read ``5-year
intervals'' in the first and last sentences of the introductory text,
and in the introductory text of paragraphs (c)(2), (c)(3), and (c)(4).
b. By revising paragraph (c)(3)(iv).
c. By removing paragraph (c)(3)(v) and redesignating existing
paragraphs (c)(3)(vi), (c)(3)(vii), (c)(3)(viii), and (c)(3)(ix) as
paragraphs (c)(3)(v), (c)(3)(vi), (c)(3)(vii), and (c)(3)(viii),
respectively.
d. By revising the phrase ``paragraph (c)(3)(viii)'' to read
``paragraph (c)(3)(vii)'' in newly designated paragraph (c)(3)(viii).
e. By adding a sentence after the third sentence in paragraph
(c)(4).
f. By revising the table in paragraph (c)(4)(ii)(A).
Sec. 710.52 Reporting information to EPA.
* * * * *
(c) * * *
(3) * * *
(iv) The total volume (in pounds) of each reportable chemical
substance manufactured and imported at each site. The total
manufactured volume (not including imported volume) and the total
imported volume must be separately reported. This amount must be
reported to two significant figures of accuracy provided that the
reported figures are within 10% of the actual volume.
* * * * *
(4) * * * Information reported in response to this paragraph is
limited to domestic (i.e., within the United States) processing and use
activities. * * *
* * * * *
(ii) * * *
(A) * * *
Codes for Reporting Commercial and Consumer Product Categories
------------------------------------------------------------------------
Codes Category
------------------------------------------------------------------------
C01....................................... Adhesives and sealants
C02....................................... Agricultural products (non-
pesticidal)
C03....................................... Artists' supplies
C04....................................... Automotive care products
C05....................................... Cleaning products (non-
pesticidal)
C06....................................... Electrical and electronic
products
C07....................................... Fabrics, textiles and
apparel
C08....................................... Glass and ceramic products
C09....................................... Lawn and garden products
(non-pesticidal)
C10....................................... Leather products
C11....................................... Lubricants, greases and fuel
additives
C12....................................... Metal products
C13....................................... Paints and coatings
C14....................................... Paper products
C15....................................... Rubber and plastic products
C16....................................... Transportation products
C17....................................... Wood and wood furniture
C18....................................... Other
------------------------------------------------------------------------
* * * * *
6. By revising Sec. 710.53 to read as follows:
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 January 1, 2006, to April 30, 2006.
Subsequent recurring submission periods are from January 1 to April 30
at 5-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'').
7. By revising Sec. 710.57 to read as follows:
Sec. 710.57 Reporting requirements.
Each person who is subject to the reporting requirements of this
subpart must retain 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 on the last day of the
submission period. Submitters are encouraged to retain their records
longer than 5 years to ensure that past records are available as a
reference when new submissions are being generated.
[FR Doc. 05-1380 Filed 1-25-05; 8:45 am]
BILLING CODE 6560-50-S