[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Rules and Regulations]
[Page 60217-60221]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc05-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 710
[OPPT-2003-0075; FRL-7715-2]
RIN-2070 AC61
TSCA Inventory Update Reporting Partially Exempted Chemicals
List; Addition of 1,2,3-Propanetriol
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is taking direct final action to amend the Toxic
Substances Control Act (TSCA) section 8(a) Inventory Update Reporting
(IUR) regulations by adding 1,2,3-propanetriol (CASRN 56-81-5) to the
list of chemical substances in 40 CFR 710.46(b)(2)(iv) which are exempt
from reporting processing and use information required by 40 CFR
710.52(c)(4). EPA has determined that the IUR processing and use
information for this chemical is of low current interest. Manufacturers
and importers of the chemicals listed in 40 CFR 710.46(b)(2)(iv) must
continue to report manufacturing information.
DATES: This direct final rule is effective on December 16, 2005 without
further notice, unless EPA receives adverse comment by November 16,
2005. If, however, EPA receives adverse comment, EPA will publish a
Federal Register document to withdraw the direct final rule before the
effective date.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number OPPT-2005-0001, 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: 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-2003-0075. 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-2005-0001. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online 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
[[Page 60218]]
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
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
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: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; 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 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 Rule (IUR) 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 were processors of
chemical substances have not been required to comply with the
requirements of 40 CFR part 710. These amendments do not change the
status of processors under the regulations at 40 CFR part 710.
Potentially affected entities may include, but are not limited to:
Chemical manufacturers and importers subject to IUR reporting,
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 thisFederal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://
http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40
CFR part 710 is available at E-CFR Beta Site Two at http://
http://www.gpoaccess5.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through EDOCKET,
regulations.gov, or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives, and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. 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
[[Page 60219]]
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
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 (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. Minor corrections to the IUR were made in
July of 2004 (69 FR 40787, July 7, 2004) (FRL-7332-3).
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.
B. 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, 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 for a commercial
purpose during the reporting year in quantities of 25,000 pounds or
more at any single 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. Sites are required to report
information such as company name, 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 during the reporting year at
any 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
the processing and use information listed in 40 CFR 710.52(c)(4)).
After the 2006 reporting period, the partial exemption for inorganic
chemicals will no longer be applicable and submitters will report
processing and use information on inorganic chemical substances
manufactured (including imported at a site in volumes of 300,000 pounds
or more, unless partially exempted as described in Unit II.C. 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.
C. What is the ``Low Current Interest'' Partial Exemption and Petition
Process?
The 2003 Amendments established a partial exemption in 40 CFR
710.46(b)(2) for certain chemicals for which EPA has determined the IUR
processing and use information to be of ``low current interest.'' The
current list of chemical substances which are subject to the low
current interest exemption are identified at 40 CFR 710.46(b)(2)(iv).
Persons who manufacture or import chemical substances listed in 40 CFR
710.46(b)(2)(iv) are not required to report the processing and use
information specified in 40 CFR 710.52(c)(4), but are required to
comply with all other reporting obligations. The public may petition
EPA to add a substance to, or delete a substance from, the list of
chemicals partially exempt from reporting under 40 CFR 710.46(b)(2).
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 (see 40 CFR 710.46(b)(2)(ii)):
(A) Whether the chemical qualifies or has qualified in past IUR
collections for the reporting of the information described in Sec.
710.52(c)(4) (i.e., at least one site manufactures 300,000 pounds or
more of the chemical).
(B) The chemical substance's chemical and physical properties or
potential for persistence, bioaccumulation, health effects, or
environmental effects (considered independently or together).
(C) The information needs of EPA, other federal agencies,
tribes, states, and local governments, as well as members of the
public.
(D) The availability of other complementary risk screening
information.
(E) The availability of comparable processing and use
information.
(F) Whether the potential risks of the chemical substance are
adequately managed by EPA or another agency or authority.
It is important to note that the addition of a chemical substance
under this partial exemption will not necessarily be based on the
potential risks of the chemical, but 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.
A petition to amend the list of chemicals partially exempt from
reporting under 40 CFR 710.46(b)(2) (whether by adding or removing a
[[Page 60220]]
chemical to or from the list) must be in writing, must identify the
chemical in question, including a chemical identification number, and
should provide 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 interest.In an earlier Federal Register notice
(70 FR 3658, January 26, 2005) (FRL-7332-2), EPA proposed to further
amend the IUR regulations to clarify the petition requirements. In that
notice, EPA explained that a petition must include a written rationale
or justification to support the assertion that collecting processing
and use information for the chemical substance is of low current
interest. In addition, the proposal clarifies that the petition must be
accompanied by relevant documents, and include specific citations to
information in those documents. The proposed amendments also provide
that the petitioner's rationale must include sufficient information
upon which the Agency can assess the current need for IUR processing
and use information and can make a decision concerning the reporting of
that information for the subject chemical. Finally, the proposal
clarifies that the burden of proof is on the petitioner to demonstrate
why a given chemical substance should be considered of low current
interest. The proposed rule has not yet been finalized.
D. What Action is the Agency Taking?
Through this action, EPA is amending the list of chemical
substances that are partially exempt from reporting requirements under
the IUR. EPA received three petitions requesting the addition of 1,2,3-
propanetriol, CASRN 56-81-5, to the list of substances in 40 CFR
710.46(b)(2)(iv) (Refs. 1, 2, and 3). EPA considered the information
provided in the three petitions and determined that there is at least
one site manufacturing 300,000 pounds or more (see 40 CFR
710.46(b)(2)(ii)(A)); that there is sufficient current evidence of low
hazard (see 40 CFR 710.46(b)(2)(ii)(B)); and that EPA believes that
more information on 1,2,3-propanetriol (CASRN 56-81-5) would not
further our understanding of this chemical at this time (see 40 CFR
710.46(b)(2)(ii)(C)). Therefore, the IUR processing and use information
for 1,2,3-propanetriol (CASRN 56-81-5) is of low current interest (Ref.
4).
The petitions included sufficient information for EPA to identify a
low current interest in the processing and use information associated
with 1,2,3-propanetriol. One petition directed the Agency to specific
citations in documents supplied with the petition, enabling the Agency
to identify and review information pertinent to the decision.
EPA received 22 reports for 1,2,3-propanetriol with production
volumes of 300,000 lbs. or greater in the 2002 IUR submission period.
Removing the requirement to report processing and use information for
22 reports results in a cost savings of $119,483 to $128,960 in the
first reporting cycle and $95,586 to $103,168 in future reporting
cycles (Ref. 5).
The Agency acknowledges that additional, unidentified information
may exist. If you are in possession of information which is relevant to
the Agency's decision to partially exempt 1,2,3-propanetriol, please
provide comments following the procedure listed in ADDRESSES.
III. Direct Final Rule Procedures
EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial amendment and anticipates no
adverse comment. This final rule will be effective on December 16, 2005
without further notice unless the Agency receives adverse comment by
November 16, 2005. If EPA receives adverse comment on this rulemaking,
the Agency will publish a timely withdrawal in the Federal Register and
will publish a notice of proposed rulemaking in a future edition of the
Federal Register. The Agency will address the comments as part of that
proposed rulemaking.
IV. Materials in the Rulemaking Record
The public version of the official record for this rulemaking is
contained in three separate dockets that can be accessed as described
in the ADDRESSES unit. Docket ID number OPPT-2005-0001 contains the
main rulemaking record. Additionally, certain supporting records are
contained in docket ID numbers OPPT-2003-0059 and OPPT-2004-0071, as
identified in the listing contained in this unit. This record includes
the documents located in the docket as well as the documents that are
referenced in those documents.
1. Letter from Barbara J. Slatt, The Proctor & Gamble Company, to
OPPT Document Control Officer, EPA, April 3, 2003. Docket document
numbers OPPT-2003-0059-0002 through OPPT-2003-0059-0004.
2. Letter from Linda C. Burgert, The Dow Chemical Company, to OPPT
Document Control Officer, EPA, December 30, 2003. Docket document
number OPPT-2003-0059-0005.
3. Letter from Herbert Estreicher, Esq., and Martha E. Marrapese,
Esq., Keller and Heckman LLP, to OPPT Document Control Officer, EPA,
December 30, 2003. Docket document number OPPT-2004-0071-0002.
4. USEPA, ``Petition Review Report for CASRN 56-81-5,'' December
22, 2004.
5. USEPA, ``Cost Savings Estimate of Adding 1,2,3-Propanetriol to
the 40 CFR 710.46(b)(2) Chemical Substance List,'' OPPT, January 5,
2005.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This direct final rule implements one change to 40 CFR part 710,
resulting in a burden and cost reduction. Since this direct final rule
does not impose any new requirements, it is not subject to review by
the Office of Management and Budget (OMB) under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
This direct final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501et seq.
C. Regulatory Flexibility Act
Since this action makes one change to 40 CFR part 710, resulting in
a burden reduction, EPA certifies this action will not have a
significant economic impact on a substantial number of small entities.
There will be no adverse impact on small entities resulting from this
action.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
E. Executive Order 3132
The Agency has determined that this action 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). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism
[[Page 60221]]
implications.'' ``Policies that have federalism implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.'' This
action does not alter the relationships or distribution of power and
responsibilities established by Congress.
F. Executive Order 13175
The Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' This direct final rule will not 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. Thus, Executive Order 13175 does
not apply to this rule.
G. Executive Order 13045
This action does not require OMB review or any other Agency action
under Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997).
H. Executive Order 13211
Because this direct final rule is exempt from review under
Executive Order 12866 due to its lack of significance, this direct
final rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001).
I. National Technology Transfer Advancement Act
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 710
Environmental protection, Chemicals, Hazardous materials, 1,2,3-
Propanetriol, Reporting and recordkeeping requirements.
Dated: September 13, 2005.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 710 [AMENDED]
0
1. The authority citation for part 710 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
0
2. Section 710.46 is amended by adding the following entry in ascending
order to the table in paragraph (b)(2)(iv).
Sec. 710.46 Chemical substances for which information must be
reported.
* * * * *
(b) * * *
(2) * * *
(iv) * * *
CAS Numbers of Partially Exempt Chemical Substances Under Sec.
710.46(b)(2)
------------------------------------------------------------------------
CAS No. Chemical
------------------------------------------------------------------------
* * * * *
56-81-5................................... 1,2,3-Propanetriol
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-20711 Filed 10-14-05; 8:45 am]
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