[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Rules and Regulations]
[Pages 8467-8470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1508]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 710
[EPA-HQ-OPPT-2006-0025; FRL-7760-7]
RIN 2070-AC61
TSCA Inventory Update Reporting Partially Exempted Chemicals
List; Addition of Certain Vegetable-based Oils, Soybean Meal, and
Xylitol
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 the following four chemical substances to
the list of chemical substances in Sec. 710.46(b)(2)(iv) which are
exempt from reporting processing and use information required by Sec.
710.52(c)(4): Two vegetable-based oils (fats and glyceridic oils,
vegetable (CASRN 68956-68-3) and canola oil (CASRN 120962-03-0)),
soybean meal (CASRN 68308-36-1), and xylitol (CASRN 87-99-0). EPA has
determined that the IUR processing and use information for these
chemicals is of low current interest. Manufacturers and importers of
the chemicals listed in Sec. 710.46(b)(2)(iv) must continue to report
manufacturing information.
DATES: This direct final rule is effective on April 18, 2006 without
further notice, unless EPA receives adverse comment by March 20, 2006.
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 EPA-HQ-OPPT-2006-0025, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
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 EPA-HQ-OPPT-2006-0025. 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 EPA-HQ-OPPT-
2006-0025. EPA's policy is that all comments received will be included
in the public docket without change and may be made available in the
on-line docket athttp://www.regulations.gov, 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
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, 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 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.
Docket: All documents in the docket are listed in the docket index
at http://www.regulations.gov/. 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 the online docket at
http://www.regulations.gov/ 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: [email protected].
For technical information contact: Susan Sharkey, Project Manager,
Economics, Exposure and Technology Division (7406M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-8789; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you manufacture (defined by
statute 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.
Potentially affected persons may include, but are not limited to:
Chemical manufacturers and importers subject to IUR reporting,
including chemical manufacturers and importers of inorganic chemical
substances (The 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 persons likely to be affected by this
action. Other types of persons not listed in this unit could also be
affected. NAICS codes have been provided to assist you and others in
determining whether this action might apply to certain persons. 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 person, consult the technical
[[Page 8468]]
contact person listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
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. Additionally, 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.
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. This inventory is known
as the TSCA Chemical Substances Inventory (the TSCA Inventory). In
1986, EPA promulgated the initial IUR rule 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 the IUR rule (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.
Further revisions to the IUR rule were made in July of 2004 (69 FR
40787, July 7, 2004) (FRL-7332-3) and December of 2005 (70 FR 75059,
December 19, 2005) (FRL-7743-9) (2005 Revisions).
B. What is the Inventory Update Reporting (IUR) Rule?
The data reported under the IUR rule are used to update the
information maintained on the TSCA Inventory. EPA uses the TSCA
Inventory and data reported under the IUR rule 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 rule, as amended by the 2003 Amendments and the
2005 Revisions Rule, requires U.S. manufacturers (including importers)
of chemicals listed on the TSCA Inventory to report to EPA every 5
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 rule generally excludes several categories
of substances from its reporting requirements, i.e., polymers,
microorganisms, naturally occurring chemical substances, and certain
natural gas substances. Manufacturers (including importers) 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 plant site) are required to additionally report certain
processing and use information (40 CFR 710.52(c)(4)). This information
includes industrial information such as 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 are partially
exempt (i.e., submitters do not report the processing and use
information listed in 40 CFR 710.52(c)(4)), regardless of production
volume. The partial exemption for inorganic chemicals will no longer be
applicable in subsequent submission periods, when submitters will
report all information on inorganic chemical substances, based on site-
specific production volume. In addition, specifically listed petroleum
process streams and other specifically listed chemical substances are
partially exempt during the 2006 and 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
public may petition EPA to add or remove a chemical substance to or
from the list of chemical substances partially exempt from reporting
under 40 CFR 710.46(b)(2). The partial exemption was altered by the
2005 Revisions rule. However, because the petition for the four
chemical substances covered by this direct final action was received
prior to the 2005 Revisions rule, the petition was evaluated by EPA
under the criteria originally set forth by the 2003 Amendments. The
2003 Amendment criteria is as follows:
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)):
[[Page 8469]]
(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 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 its
potential risks, 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
chemical to or from the list) must be in writing. It 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 Sec. 710.52(c)(4) for the chemical in
question is of low current interest.
In the 2005 Revisions rule, EPA clarifies the standards for
submitting a petition by explaining that the information provided in a
petition must include a written rationale or justification for the
request, relevant documents, and specific cites to information in those
documents. The last of the considerations listed above was changed to
read ``[w]hether the potential risks of the chemicals substance are
adequately managed.'' The 2005 Revisions rule also required that the
supporting rationale provide sufficient information which the Agency
can use to assess the current need for IUR processing and use
information and make a decision concerning reporting of that
information for the subject chemical. Finally, the 2005 Revisions rule
clarifies that the burden is on the petitioner to demonstrate why a
given chemical substance should, or should not, be considered of low
current interest. These changes made by the 2005 Revisions rule will
apply prospectively to future petitions.
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 regulation. EPA received a petition requesting the addition of
xylitol (CASRN 87-99-0), soybean meal (CASRN 68308-36-1), fats and
glyceridic oils, vegetable (CASRN 68956-68-3), and canola oil (CASRN
120962-03-0) to the list of chemical substances in Sec.
710.46(b)(2)(iv) (Ref 1). The petitioner later supplemented their
petition with additional information (Ref 2). The Agency determined
that these four chemicals have been previously reported under IUR in
volumes of 300,000 pounds or more and would therefore be expected to
trigger the requirement to report IUR processing and use information.
Based on their past production volume, these four chemical substances
satisfy the first consideration identified in 40 CFR 710.46(b)(2)(ii)
(see Unit II.C.).
EPA reviewed the information provided by the petitioner and other
information as documented in the petition review report (Ref. 3) and
concluded that these four chemical substances generally present a low
risk of adverse human health or environmental effects. This conclusion
is further supported by the fact that none of the substances is
included on the various lists of concern maintained by EPA, state
governments, or others (such as the Toxics Release Inventory or the
Integrated Risk Information System). In addition, EPA did not identify
any information needs that were not being met. Therefore, EPA has
determined that, based on current knowledge, there is a low current
interest in the IUR processing and use information for the four
chemical substances (Ref. 3).
EPA received a total of five non-CBI reports for the four chemical
substances with production volumes of 300,000 pounds or greater in the
2002 IUR submission period. However, the non-CBI IUR reporting
represents only a portion of IUR reporting. For instance, while no
individual non-CBI reports were submitted for xylitol in 2002, the
total non-CBI volume was 10,000 to 500,000 pounds, indicating that one
or more CBI reports were received. On the basis of the number of non-
CBI previous reports and the production volumes for the four chemicals,
EPA estimated that seven reports in excess of 300,000 pounds would be
received for these four chemical substances. Eliminating the
requirement to report processing and use information for seven reports
results in a cost savings of $38,017 to $41,033 in the first reporting
cycle, and $30,414 to $32,826 in future reporting cycles (Ref 4).
The Agency acknowledges that additional, unidentified information
may exist. If you are in possession of information that may be relevant
to the Agency's decision to partially exempt any of the four chemical
substances listed in Unit II.D., please provide comments according to
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 EPA believes
public comment on this action is unnecessary. This final rule will be
effective on April 18, 2006 without further notice unless the Agency
receives adverse comment by March 20, 2006. 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 2 separate dockets which can be accessed as described in
the ADDRESSES unit. Docket ID number EPA-HQ-OPPT-2006-0025 contains the
main rulemaking record. In addition, certain supporting records are
contained in docket ID number EPA-HQ-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 Herbert Estreicher, Esq., and Martha E. Marrapese,
Esq., Keller and Heckman LLP, to OPPT Document Control Officer, EPA,
December 30, 2003. Docket document number EPA-HQ-OPPT-2004-0071-0002.
2. Letter from Herbert Estreicher, Keller and Heckman LLP, to Susan
Sharkey, Office of Pollution Prevention and Toxics, U. S. EPA, November
18, 2004. Docket document numbers EPA-
[[Page 8470]]
HQ-OPPT-2004-0071-0033 to EPA-HQ-OPPT-2004-0071-0036.
3. USEPA, ``Petition Review Report for CASRNs 87-99-0, 68308-36-1,
68956-68-3, and 120962-03-0),'' December 23, 2004.
4. USEPA, ``Cost Savings Estimate of Adding 4 Chemicals to the 40
CFR 710.46(B)(2) Chemical Substance List,'' Office of Pollution
Prevention and Toxics, November 4, 2005.
V. Statutory and Executive Order Reviews
A. Executive Order 12866
This direct final rule implements minor changes to 40 CFR part 710,
resulting in burden and cost reduction. Because 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. 3501 et seq.
C. Regulatory Flexibility Act
Because this action makes minor changes to 40 CFR part 710,
resulting in 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 13132
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 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 not considered to be a
significant action under Executive Order 12866 and is therefore exempt
from review under that Order, 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 amended by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally requires that before a rule may take effect, the Agency
promulgating the rule must submit a rule report, including 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, IUR
partial exemption, Reporting and recordkeeping requirements, Soybean
meal, Vegetable-based oils, Xylitol.
Dated: January 30, 2006.
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 entries in
ascending order to the table in paragraph (b)(2)(iv) to read as
follows:
Sec. 710.46 Chemical substances for which information is not
required.
* * * * *
(b) * * *
(2) * * *
(iv) * * *
CAS Numbers of Partially Exempt Chemical Substances Under Sec.
710.46(b)(2)
------------------------------------------------------------------------
CAS No. Chemical
------------------------------------------------------------------------
* * * * *
87-99-0 Xylitol
* * * * *
68308-36-1 Soybean meal
* * * * *
68956-68-3 Fats and glyceridic oils,
vegetable
* * * * *
120962-03-0 Canola oil
* * * * *
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[FR Doc. 06-1508 Filed 2-16-06; 8:45 am]
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