[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Rules and Regulations]
[Pages 61025-61029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20827]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152, 156, 159, 160, 168 and 172

[EPA-HQ-OPP-2004-0387; FRL-8114-1]


Pesticide Data Requirements; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This document makes technical changes and revises cross 
references in the Code of Federal Regulations (CFR) to reflect changes 
in pesticide data requirements being promulgated elsewhere in today's 
Federal Register. These technical changes are solely to conform other 
parts of the CFR to the new rules, and have no substantive impact on 
any requirements. This regulation is a technical amendment which 
requires no opportunity for comment or public participation.

DATES: This final rule is effective December 26, 2007.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2004-0387. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP 
Public Docket, in Rm. S-4400, One Potomac Yard (South Building), 2777 
S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jean Frane, Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 305-5944; fax 
number: (703) 305-5884; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me

    You may be potentially affected by this action if you are a 
producer or registrant of a pesticide product. This action may also 
affect any person or company who might petition the Agency for new 
tolerances, hold a pesticide registration with existing tolerances, or 
any person or company

[[Page 61026]]

who is interested in obtaining or retaining a tolerance in the absence 
of a registration, that is, an import tolerance. Potentially affected 
entities may include, but are not limited to:
     Pesticide Producers (NAICS code 32532), e.g., pesticide 
manufacturers or formulators of pesticide products, importers or any 
person or company who seeks to register a pesticide or to obtain a 
tolerance for a pesticide.
    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) 
code has been provided to assist you and others in determining whether 
this action might apply to certain entities. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the persons listed under FOR FURTHER INFORMATION CONTACT.

II. Background

    In the Federal Register of March 11, 2005 [70 FR 12276] and March 
8, 2006 [71 FR 12072], EPA proposed to amend pesticide data 
requirements in 40 CFR part 158 for conventional pesticides and for 
biochemical and microbial pesticides, respectively. EPA is today 
issuing final rules for both proposals. In order to preserve existing 
data requirements for antimicrobial pesticides, that were contained in 
part 158, but not proposed for revision, EPA issued a final rule on 
October 24, 2007, transferring the bulk of current part 158 to new part 
161. Together part 158 and part 161 contain the entirety of pesticide 
data requirements previously contained only in part 158.
    This final rule makes certain technical changes and corrects cross-
references elsewhere in pesticide regulations to conform to new parts 
161 and 158. By issuing a separate technical changes rule, EPA intends 
that the promulgation of the substantive revisions for conventional, 
biochemical and microbial pesticide data requirements will be 
straightforward without confusing technical changes. The key changes 
are:
    1. Formulators' Exemption. EPA has consolidated requirements and 
policies for the formulators' exemption into part 152. EPA has combined 
existing material from Sec.  152.85 and Sec.  158.50 in one location 
(Sec.  152.85) and made minor conforming changes to reflect the 
consolidation. The consolidation is discussed in detail in the final 
rule for conventional pesticides.
    2. Cross-reference changes. Cross-references in parts 152, 156, 
159, 160, 168 and 172 are being revised to reflect the new data 
requirements structure of part 158 and part 161. The majority of these 
changes reflect the addition of new part 161 for antimicrobial 
pesticides. Others are revised to reflect the new definition of 
biochemical or microbial pesticide.

III. Why are these Technical Revisions Issued as a Final Rule?

    Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 
553(b)(B), provides that, when an Agency for good cause finds that 
notice and public procedure are impracticable, unnecessary or contrary 
to the public interest, the Agency may issue a final rule without 
providing notice and an opportunity for public comment. EPA has 
determined that it is unnecessary to make today's rule final without 
prior proposal and opportunity for comment, because EPA is simply 
making corrections to cross-references for accuracy. EPA finds that 
this constitutes good cause under 5 U.S.C. 553(b)(B).

IV. Regulatory Assessment Requirements

    This rule makes technical changes and cross-reference corrections 
in the EPA regulations governing pesticides. The amendments are 
administrative in nature and, for the most part, amend the CFR so that 
it is consistent with regulations concerning data requirements being 
promulgated elsewhere in this issue of the Federal Register. Other than 
making EPA regulations more accurate, these amendments are not expected 
to have any impact on regulated parties or the public.
    Accordingly, these amendments are not subject to review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993), as a significant regulatory action. Because 
this rule has been exempted from review under Executive Order 12866 due 
to its lack of significance, this 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). This 
rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or 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). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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). Since this action is not subject to notice and 
comment requirements under the Administrative Procedure Act or any 
other statute, it is not subject to the regulatory flexibility 
provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq).
    In addition, 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 rule is directed at pesticide manufacturers and 
others who seek to register, amend or maintain a registration or to 
establish, modify, or revoke pesticide tolerances or exemptions, not 
States. For these same reasons, 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.'' ``Policies that 
have tribal implications'' is defined in the

[[Page 61027]]

Executive Order to include regulations that have ``substantial direct 
effects on one or more Indian tribes, on the relationship between the 
Federal Government and the Indian tribes, or on the distribution of 
power and responsibilities between the Federal Government and Indian 
tribes.'' This 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.

V. 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 152

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 156

    Environmental protection, Labeling, Pesticides and pests, Reporting 
and recordkeeping requirements.

List of Subjects in 40 CFR Part 159

    Environmental protection, Pesticides and pests, Reporting and 
recordkeeping requirements.

List of Subjects in 40 CFR Part 160

    Environmental protection, Laboratories, Pesticides and pests, 
Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 168

    Environmental protection, Administrative practice and procedure, 
Advertising, Exports, Labeling, Pesticides and pests, Reporting and 
recordkeeping requirements.

List of Subjects in 40 CFR Part 172

    Environmental protection, Intergovernmental relations, Labeling, 
Pesticides and pests, Reporting and recordkeeping requirements, 
Research.


    Dated: October 11, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides, and Toxic 
Substances.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 152--[AMENDED]

0
1. The authority citation for part 152 continues to read as follows:

    Authority: 7 U.S.C. 136-136y. Subpart U is also issued under 31 
U.S.C. 9701.


0
2. Section 152.20 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  152.20  Exemptions for pesticides regulated by another Federal 
agency.

* * * * *
    (a) * * *
    (3) The following biological control agents are not exempt from 
FIFRA requirements:
    (i) A eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (ii) A procaryotic microorganism including, but not limited to, 
Eubacteria and Archaebacteria; or
    (iii) A parasitically-replicating microscopic element, including, 
but not limited to, viruses.
* * * * *
0
3. Section 152.43 is amended by revising paragraph (b)(4) to read as 
follows:


Sec.  152.43  Alternative formulations.

* * * * *
    (b) * * *
    (4) The analytical method required under Sec.  158.355 of this 
chapter must be suitable for use on both the basic formulation and the 
alternate formulation.
* * * * *

0
4. Amend Sec.  152.50 in paragraph (f)(1) by revising the reference to 
``FIFRA sec. 3(c)(1)(D)'' to read ``FIFRA sec. 3(c)(1)(F)'', and by 
revising paragraph (c) and paragraph (f)(2) to read as follows:


Sec.  152.50  Contents of application.

* * * * *
    (c) Summary of the application. Each application must include a 
list of the data submitted with the application, together with a brief 
description of the results of the studies. The list of data submitted 
may be the same as the list required by Sec.  158.32 or Sec.  161.32, 
as applicable, of this chapter. The summary must state that it is 
releasable to the public after registration in accordance with Sec.  
152.119.
* * * * *
    (f) * * *
    (2) An applicant must furnish any data specified in part 158 or 
part 161 of this chapter, as applicable, of this chapter which are 
required by the Agency to determine that the product meets the 
registration standards of FIFRA sec. 3(c)(5) or (7). Each study must 
comply with:
    (i) Section 158.32 of this chapter, with respect to format of data 
submission.
    (ii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made.
    (iii) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects.
    (iv) Section 160.12 of this chapter, with respect to a statement 
whether studies were conducted in accordance with Good Laboratory 
Practices of part 160.
* * * * *

0
5. Revise Sec.  152.85 to read as follows:


Sec.  152.85  Formulators' exemption.

    (a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an 
applicant from the requirement to submit or cite data pertaining to any 
pesticide contained in his product that is derived solely from one or 
more EPA-registered products which the applicant purchases from another 
person. This provision is commonly referred to as the formulators' 
exemption.
    (b) Applicability of the formulators' exemption. (1) The 
formulators' exemption applies only to data concerning the purchased 
product or its ingredients. These data may include, but are not limited 
to, product chemistry, toxicology, residue chemistry, exposure, 
environmental fate, and ecological effects.
    (2) The data to which the formulators' exemption applies usually 
will concern the safety of one or more of the product's active 
ingredients, specifically, those active ingredients which are contained 
in the purchased product. In general, data for which the required test 
substance is the technical grade of the active ingredient, the pure 
active ingredient, the radiolabeled pure active ingredient, or a 
typical end-use product are eligible for the formulators' exemption.
    (3) The formulators' exemption generally does not apply to data on 
the applicant's product itself, including the

[[Page 61028]]

safety or efficacy of the product, unless the composition of the 
product is identical to the purchased product. In general, data for 
which the required test substance is the product proposed for 
registration are not eligible for the formulators' exemption.
    (c) Limitation of the formulators' exemption. EPA interprets FIFRA 
section 3(c)(2)(D) as allowing an applicant to use the formulators' 
exemption with respect to data concerning an ingredient of his product 
only if:
    (1) The application indicates that the ingredient's presence in the 
product is attributable solely to the purchase from another person of 
an identified, registered product containing that ingredient and the 
use of the purchased product in formulating the product; and
    (2) The purchased product is a registered manufacturing-use product 
whose label does not prohibit its use for making an end-use product 
labeled for any use for which the applicant's product will be labeled; 
or
    (3) The purchased product is a registered end-use product labeled 
for each use for which the applicant's product will be labeled.
    (d) Claiming eligibility for the exemption. (1) If the product 
contains one or more ingredients eligible for the formulators' 
exemption, the applicant need not comply with the requirements of 
Sec. Sec.  152.90 through 152.96 with respect to any data requirement 
pertaining to such ingredient, provided that he submits to the Agency a 
certification statement containing the following information (a form 
for this purpose is available from the Agency):
    (i) Identification of the applicant, and of the product by EPA 
registration number or file symbol.
    (ii) Identification of each ingredient in the pesticide that is 
eligible for the formulators' exemption, and the EPA registration 
number of the product that is the source of that ingredient.
    (iii) A statement that the listed ingredients meet the requirements 
for the formulators' exemption.
    (iv) A statement that the applicant has submitted (either 
previously or with the current application) a complete, accurate and 
current Confidential Statement of Formula.
    (v) The name, title and signature of the applicant or his 
authorized representative and the date of signature.
    (2) An applicant for amended registration is not required to submit 
a new formulators' exemption statement, if the current statement in 
Agency files is complete and accurate.
    (e) Approval of registration. Notwithstanding FIFRA section 
3(c)(2)(D), EPA will not approve an application unless there are 
available to EPA for its review all data that are necessary to make the 
required risk/benefit finding under FIFRA section 3(c)(5) or section 
3(c)(7).

0
6. Revise Sec.  152.90(a)(2) to read as follows:


Sec.  152.90  The selective method.

* * * * *
    (a) * * *
    (2) If a Registration Standard has not been issued, or if an issued 
Registration Standard does not cover all data requirements for products 
containing the active ingredient in question, the applicant must list 
the applicable requirements as prescribed by 40 CFR part 158 or part 
161, as applicable. All required (R) studies, and any studies that 
could be conditionally required (CR) based upon composition, use 
pattern, or the results of required studies, are to be listed. The 
applicant may demonstrate via the data gap procedures in Sec.  152.96 
that a conditional requirement need not be satisfied by the submission 
or citation of data at the time of application.
* * * * *


Sec.  152.91  [Amended]

0
7. In Sec.  152.91(b) revise the reference ``40 CFR 158.45'' to read 
``40 CFR 158.45 or 40 CFR 161.45''.

0
8. Revise Sec.  152.97(a)(2)(iii) to read as follows:


Sec.  152.97  Rights and obligations of data submitters.

    (a) * * *
    (2) * * *
    (iii) For each such active ingredient, the type(s) of study he has 
previously submitted (corresponding to Guidelines reference numbers 
given in tables in 40 CFR part 158 or part 161, as applicable), the 
date of submission, and the EPA registration number, file symbol, or 
other identifying reference for which it was submitted.
* * * * *

0
9. Revise Sec.  152.104 to read as follows:


Sec.  152.104  Completeness of applications.

    The applicant is responsible for the accuracy and completeness of 
all information submitted in connection with the application. The 
Agency will review each application to determine whether it is 
complete. An application is incomplete if any pertinent item specified 
in Sec.  152.50 has not been submitted, or has been incorrectly 
submitted (for example, data required by part 158, or part 161 of this 
chapter, as applicable, and not submitted in accordance with the 
requirements for format, claims of confidential business information, 
or flagging).


Sec.  152.107  [Amended]

0
10. In Sec.  152.107(b)(3) revise the reference ``Sec.  158.34 of this 
chapter'' to read ``Sec.  158.34 or Sec.  161.34 of this chapter''.

0
11. Revise Sec.  152.112(d) to read as follows:


Sec.  152.112  Approval of registration under FIFRA sec. 3(c)(5).

* * * * *
    (d) The Agency has determined that the composition of the product 
is such as to warrant the proposed efficacy claims for it, if efficacy 
data are required to be submitted by part 158 or part 161, as 
applicable, of this chapter for the product.
* * * * *

0
12. Revise Sec.  152.403(b) to read as follows:


Sec.  152.403  Definitions of fee categories.

* * * * *
    (b) New biochemical and microbial registration review means review 
of an application for registration of a biochemical or microbial 
pesticide product containing a biochemical or microbial active 
ingredient not contained in any other pesticide product that is 
registered under FIFRA at the time the application is made. For 
purposes of this subpart, the definitions of biochemical and microbial 
pesticides contained in Sec.  158.2000 and Sec.  158.2100, 
respectively, shall apply.
* * * * *

PART 156--[AMENDED]

0
13. The authority citation for part 156 continues to read as follows:

    Authority: 7 U.S.C. 136-136y.

Sec.  156.208  [Amended]

0
14. In Sec.  156.208(e)(1) revise the reference to ``Sec.  158.390'' to 
read ``Sec.  158.1070 or Sec.  161.390''.

PART 159--[AMENDED]

0
15. The authority citation for part 159 continues to read as follows:

    Authority: 7 U.S.C. 136-136y.

Sec.  159.156  [Amended]

0
16. Section 159.156 is amended as follows:
0
a. In paragraph (e) revise the reference to ``Sec.  158.32 of this 
chapter'' to read ``Sec.  158.32 or Sec.  161.32 of this chapter, as 
applicable''.

[[Page 61029]]

0
b. In paragraph (g) revise the reference to ``Sec.  158.33 of this 
chapter'' to read ``Sec.  158.33 or Sec.  161.33 of this chapter, as 
applicable''.
0
c. In paragraph (h) revise the reference to ``Sec.  158.34 of this 
chapter'' to read ``Sec.  158.34 or Sec.  161.34 of this chapter, as 
applicable''.

0
17. Revise Sec.  159.188(a)(2) to read as follows:


Sec.  159.188  Failure of performance information.

    (a) * * *
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims made by the registrant regarding 
uses intended for control of microorganisms tha may pose a risk to 
human health, including any of the public health antimicrobials 
identified in part 161 of this chapter.
* * * * *

PART 160--[AMENDED]

0
18. The authority citation for part 160 continues to read as follows:

    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136v, 136w; 21 
U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.


0
19. In Sec.  160.3, revise the definition for the term ``Study'' to 
read as follows:


Sec.  160.3  Definitions.

* * * * *
    Study means any experiment at one of more test sites, in which a 
test substance is studied in a test system under laboratory conditions 
or in the environment to determine or help predict its effects, 
metabolism, product performance (efficacy studies only as required by 
40 CFR 158.400 or 161.640, as applicable), environmental and chemical 
fate, persistence and residue, or other characteristics in humans, 
other living organisms, or media. The term ``study''does not include 
basic exploratory studies carried out to determine whether a test 
substance or a test method has any potential utility.
* * * * *

PART 168--[AMENDED]

0
20. The authority citation for part 168 continues to read as follows:

    Authority: 7 U.S.C. 136-136y.


0
21. Section 168.75 is amended by revising the reference in paragraph 
(b)(4)(ii) to ``Sec.  158.640 of this chapter'' to read ``Sec.  158.400 
or Sec.  161.640 of this chapter, as applicable'', and by revising 
paragraph (b)(3)(ii) to read as set follows:


Sec.  168.75  Procedures for exporting unregistered pesticides--
purchaser acknowledgement statements.

* * * * *
    (b) * * *
    (3) * * *
    (ii) An exporter who is also the manufacturer of a U.S. registered 
pesticide may add new uses to the label of that product for export 
purposes, without triggering the requirements of section 17(a)(2), as 
long as the new uses are within the same general use patterns as those 
for the registered product. The general pesticide use patterns are: 
terrestrial food crop and terrestrial non-food crop; greenhouse food 
crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood 
crop' indoor use' and forestry use. Adding new uses to the label which 
change the use pattern, such as changes from nonfood to food use, 
outdoor to indoor use, or terrestrial to aquatic use, render the 
product unregistered and subject to the requirements of section 17 for 
unregistered products. If the new use added to the label is a food or 
feed use, a tolerance must already be established for the use of that 
pesticide in or on that commodity.
* * * * *

PART 172--[AMENDED]

0
22. The Authority citation for part 172 continues to read as follows:

    Authority: 7 U.S.C. 136c, 136w. Section 172.4 is also issued 
under 31 U.S.C. 9701.


0
23. In Sec.  172.43 revise the definition for ``microbial pesticide'' 
to read as follows:


Sec.  172.43  Definitions.

* * * * *
    Microbial pesticide means a microbial agent intended for 
preventing, destroying, repelling, or mitigating any pest, or intended 
for use as a plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
Eubacteria and Archaebacteria; or
    (3) Is a parasitically replicating microscopic element, including, 
but not limited to, viruses.
* * * * *


Sec.  172.46  [Amended]

0
24. In Sec.  172.46(c) introductory text, revise the phrases 
``Sec. Sec.  158.32 and 158.33 of this chapter'' to read ``Sec. Sec.  
158.32 and 158.33 or 161.31 and 161.33 of this chapter''
[FR Doc. E7-20827 Filed 10-25-07; 8:45 am]
BILLING CODE 6560-50-S