Document ID: EPA-HQ-OPPT-2006-0025-0001
Agency: epa
Document Type: Rule
Title: TSCA Inventory Update Reporting Partially Exempted Chemicals List; Addition of Certain Vegetable-based Oils, Soybean Meal, and Xylitol
Posted Date: 2006-02-17T13:08:18Z

[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Rules and Regulations]               
[Page 8467-8470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe06-15]                         

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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.

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

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: 
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.
    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
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 06-1508 Filed 2-16-06; 8:45 am]

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