[Federal Register Volume 72, Number 205 (Wednesday, October 24, 2007)]
[Rules and Regulations]
[Pages 60251-60255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20836]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 161

[EPA-HQ-OPP-2004-0387; FRL-8116-2]


Pesticides: Redesignation of part 158; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is redesignating certain pesticide data requirements 
currently located in 40 CFR part 158 into a new part 161. The data 
requirements being transferred apply to antimicrobial pesticides. EPA 
is also making conforming changes and cross-reference revisions to the 
newly redesignated material. The redesignation is intended to preserve 
regulatory data requirements for antimicrobial pesticides, while 
preparing for the promulgation of final rules pertaining to data 
requirements for conventional pesticides, biochemical, and microbial 
pesticides.

DATES: This final rule is effective December 24, 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, Field and External Affairs 
Division 7506P), Office of Pesticide Programs, Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-0001; 
telephone number: (703) 305-5944; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a 
producer or registrant of an antimicrobial pesticide product, including 
wood preservatives and antifouling products. 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 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:
     Producers of cleaning preparations that include an 
antimicrobial pesticide (NAICS code 3256).
     Pesticide manufacturers or formulators of paints or 
coatings that contain an antimicrobial pesticide (NAICS code 32551).
    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.

[[Page 60252]]

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using regulations.gov, you may access this Federal 
Register document electronically through the EPA Internet under the 
``Federal Register'' listings at http://www.epa.gov/fedrgstr.

II. What Does this Redesignation Do?

    In the Federal Register of March 11, 2005 (70 FR 12276), EPA issued 
a proposed rule to revise its pesticide data requirements for 
conventional pesticides. Those data requirements, currently located in 
40 CFR part 158, cover all pesticides. EPA's purpose in developing data 
requirements devoted to conventional pesticides (and subsequently for 
biochemical and microbial pesticides) was to tailor data requirements 
for different types of pesticides to make them more transparent and 
flexible. As part of that effort, EPA intends in the future to issue a 
proposed rule updating data requirements for antimicrobial pesticides, 
including wood preservatives and antifoulants.
    EPA is shortly issuing final rules for conventional pesticides, 
biochemical and microbial pesticides. Those rules would supersede 
current part 158 data requirements in their entirety. Unless EPA acts 
to preserve the data requirements applicable to antimicrobial 
pesticides, the promulgation of the final rules would eliminate any 
regulatory data requirements for antimicrobial pesticides.
    Accordingly, EPA is issuing a final rule that would preserve the 
current data requirements for antimicrobial pesticides until such time 
as a final rule can be promulgated and made effective.
    To accomplish this, EPA is moving those portions of current part 
158 that apply to antimicrobial pesticides into new part 161, and 
making technical corrections to accommodate the change. Specifically, 
the following changes are being made:
    1. EPA is removing sections of part 158 that relate only to 
biochemical and microbial pesticides, including Sec. Sec.  158.65, 
158.690 and 158.740. These sections had, and would not have, any 
bearing on antimicrobial data requirements.
    2. EPA is also removing Sec.  158.50 pertaining to the formulators' 
exemption because this material will be consolidated in Sec.  152.85 
when final rules for conventional pesticides and biochemical and 
microbial pesticides are promulgated.
    3. EPA is making internal cross-reference changes from ``158'' to 
``161'' throughout the redesignated material.
    4. In new Sec.  161.108, EPA has updated the Guidelines information 
to reflect the current order numbers from the National Technical 
Information Service.

III. Why is this Redesignation 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 there is good cause for making today's rule final 
without prior proposal and opportunity for comment, because EPA is 
acting to preserve existing data requirements that would otherwise be 
removed from the Code of Federal Regulations by promulgation of an 
impending final rule. Redesignating the material in advance of 
promulgation will also avoid potential errors in accomplishing a 
complex transition in the Code of Federal Regulations. EPA finds that 
this constitutes good cause under 5 U.S.C. 553(b)(B).

IV. Do Any of the Statutory and Executive Order Reviews Apply to this 
Action?

    This rule redesignates, makes technical changes and cross-reference 
corrections in the EPA regulations governing pesticides. The amendments 
are administrative in nature. Other than making EPA regulations clearer 
and more transparent, 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 
the Agency has made a ``good cause''finding that this action is not 
subject to notice-and-comment requirements under the Administrative 
Procedure Act or any other statute. this rule has been exempted from 
review under Executive Order 12866. Moreover, for the same reason, 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, as 
detailed above, these amendments will have no detrimental impact on 
regulated parties or the public, EPA certifies under the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) that the amendments will 
not have a significant impact on a substantial number of small 
entities.
    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 a 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

[[Page 60253]]

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 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 to 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 this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 158

    Environmental protection, Confidential business information, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements

40 CFR Part 161

    Environmental protection, Pesticides and pests, Reporting and 
recordkeeping requirements


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

PART 158--[AMENDED]

0
1. The authority citation for part 158 continues to read as follows:

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

Sec. Sec.  158.50, 158.65, 158.690 and 158.740  [Removed]

0
2. Sections 158.50, 158.65, 158.690, and 158.740 are removed.

PART 158--[REDESIGNATED AS PART 161 AND AMENDED]

0
3. The remainder of part 158, consisting of subparts A, B, C, and D are 
redesginated as part 161, subparts A, B, C, and D as shown in the 
Redesignation table below:

------------------------------------------------------------------------
    Old part, subpart or section         New part, subpart or section
------------------------------------------------------------------------
Part 158--Data Requirements for      Part 161--Data Requirements for
 Registration                         Registration of Antimircobial
                                      Pesticides
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Subpart A                            Subpart A
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158.20                               161.20
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158.25                               161.25
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158.30                               161.30
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158.32                               161.32
------------------------------------------------------------------------
158.33                               161.33
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158.34                               161.34
------------------------------------------------------------------------
158.35                               161.35
------------------------------------------------------------------------
158.40                               161.40
------------------------------------------------------------------------
158.45                               161.45
------------------------------------------------------------------------
158.55                               161.55
------------------------------------------------------------------------
158.60                               161.60
------------------------------------------------------------------------
158.70                               161.70
------------------------------------------------------------------------
158.75                               161.75
------------------------------------------------------------------------
158.80                               161.80
------------------------------------------------------------------------
158.85                               161.85
------------------------------------------------------------------------
Subpart B                            Subpart B
------------------------------------------------------------------------
158.100                              161.100
------------------------------------------------------------------------
158.101                              161.101
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[[Page 60254]]

 
158.102                              161.102
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158.108                              161.108
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Subpart C                            Subpart C
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158.150                              161.150
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158.153                              161.153
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158.155                              161.155
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158.160                              161.160
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158.162                              161.162
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158.165                              161.165
------------------------------------------------------------------------
158.167                              161.167
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158.170                              161.170
------------------------------------------------------------------------
158.175                              161.175
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158.180                              161.180
------------------------------------------------------------------------
158.190                              161.190
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Subpart D                            Subpart D
------------------------------------------------------------------------
158.202                              161.202
------------------------------------------------------------------------
158.240                              161.240
------------------------------------------------------------------------
158.290                              161.290
------------------------------------------------------------------------
158.340                              161.340
------------------------------------------------------------------------
158.390                              161.390
------------------------------------------------------------------------
158.440                              161.440
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158.490                              161.490
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158.540                              161.540
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158.590                              161.590
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158.640                              161.640
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Appendix A To Part 158--Data         Appendix A To Part 161--Data
 Requirements For Registration: Use   Requirements For Registration: Use
 Pattern Index                        Pattern Index
------------------------------------------------------------------------

Sec.  161.25  [Amended]

0
4. In newly redesignated Sec.  161.25, references to ``Sec.  158.35,'' 
``Sec.  158.40,'' ``Sec.  158.45,'' ``Sec.  158.60,'' ``Sec.  158.100'' 
and ``Sec.  158.101'' are revised to read ``Sec.  161.35,'' ``Sec.  
161.40,'' ``Sec.  161.45,'' ``Sec.  161.60,'' ``Sec.  161.100,'' and 
``Sec.  161.101,'' respectively, wherever they occur.


Sec.  161.30  [Amended]

0
5. In newly redesignated Sec.  161.30, references to ``part 158,'' 
``Sec.  158.75,'' and ``Sec.  158.160'' are revised to read ``part 
161,'' ``Sec.  161.75,'' and ``Sec.  161.160,'' respectively, wherever 
they occur.


Sec.  161.32  [Amended]

0
6. In newly redesignated Sec.  161.32, references to ``Sec.  158.33,'' 
and ``Sec.  158.34(b)'' are revised to read ``Sec.  161.33,'' and 
``Sec.  161.34(b),'' respectively, wherever they occur.


Sec.  161.34  [Amended]

0
7. In newly redesignated Sec.  161.34, in paragraph (b), the reference 
to ``Sec.  158.34(c)'' is revised to read ``paragraph (c) of this 
section'' and in paragraphs (c)(1) and (c)(2) the reference to ``40 CFR 
158.34'' is revised to read to read ``40 CFR 161.34,''.


Sec.  161.35  [Amended]

0
8. In newly redesignated Sec.  161.35, references to ``Sec.  
158.20(b),'' ``Sec.  158.40,'' ``Sec.  158.45,'' ``Sec.  158.60,'' 
``Sec.  158.75'' and ``Sec.  158.80'' are revised to read ``Sec.  
161.20(b),'' ``Sec.  161.40,'' ``Sec.  161.45,'' ``Sec.  161.60,'' 
``Sec.  161.75,'' and ``Sec.  161.80,'' respectively.


Sec.  161.70  [Amended]

0
9. In newly redesignated Sec.  161.70, reference to ``Sec.  158.20(d)'' 
is revised to read ``Sec.  161.20(d).''


Sec.  161.75  [Amended]

0
10. In newly redesignated Sec.  161.75(a), reference to ``part 158'' is 
revised to read ``part 161''.

[[Page 60255]]

Sec.  161.100  [Amended]

0
11. In newly redesignated Sec.  161.100, reference to``Sec. Sec.  
158.150 through 158.740'', is revised to read ``Sec. Sec.  161.150 
through 161.640'' and the reference to ``Sec.  158.108'' is revised to 
read ``Sec.  161.108''.


Sec.  161.101  [Amended]

0
12. In newly redesignated Sec.  161.101, reference to ``Sec.  158.45'' 
is revised to read ``Sec.  161.45,'' wherever it occurs.

0
13. Newly redesignated Sec.  161.108 is revised to read as follows:


Sec.  161.108  Relationship of Pesticide Assessment Guidelines to data 
requirements.

    The Pesticide Assessment Guidelines contain the standards for 
conducting acceptable tests, guidance on evaluation and reporting of 
data, definition of terms, further guidance on when data are required, 
and examples of acceptable protocols. They are available through the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161 (703-605-6000). The following Subdivisions of the 
Pesticide Assessment Guidelines, referenced to the appropriate sections 
of this part, are currently available:

----------------------------------------------------------------------------------------------------------------
                                                                                        Corresponding section(s)
             Subdivision                       Title                NTIS order no.            in this part
----------------------------------------------------------------------------------------------------------------
D                                     Product Chemistry        PB83-153890                    161.150 - 161.190
----------------------------------------------------------------------------------------------------------------
E                                     Hazard Evaluation:       PB83-153908                              161.490
                                       Wildlife and Aquatic
                                       Organisms
----------------------------------------------------------------------------------------------------------------
F                                     Hazard Evaluation:       PB83-153916                              161.340
                                       Humans and Domestic
                                       Animals
----------------------------------------------------------------------------------------------------------------
G                                     Product Performance      PB83-153924                              161.640
----------------------------------------------------------------------------------------------------------------
I                                     Experimental Use         PB83-153932                     161.20 - 161.640
                                       Permits
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J                                     Hazard Evaluation:       PB83-153940                              161.540
                                       Nontarget Plants
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K                                     Reentry Protection       PB85-120962                              161.390
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L                                     Hazard Evaulation:       PB83-153957                              161.590
                                       Nontarget Insect
----------------------------------------------------------------------------------------------------------------
N                                     Environmental Fate       PB83-153973                              161.290
----------------------------------------------------------------------------------------------------------------
O                                     Residue Chemistry        PB83-153961                              161.240
----------------------------------------------------------------------------------------------------------------
R                                     Spray Drift Evaluation   PB84-189216                              161.440
----------------------------------------------------------------------------------------------------------------

Sec.  161.150  [Amended]

0
14. In newly redesignated Sec.  161.150, references to ``Sec. Sec.  
158.175,'' and ``Sec.  158.155,'' are revised to read ``Sec.  161.175'' 
and ``Sec.  161.155,'' respectively, wherever they occur.


Sec.  161.155  [Amended]

0
15. In newly redesignated Sec.  161.155, reference to ``Sec.  158.175'' 
is revised to read ``Sec.  161.175,'' whereever it occurs.


Sec.  161.162  [Amended]

0
16. In newly redesignated Sec.  161.162, reference to ``Sec.  158.165'' 
is revised to read ``Sec.  161.165.''


Sec.  161.165  [Amended]

0
17. In newly redesignated Sec.  161.165, reference to ``Sec.  158.162'' 
is revised to read ``Sec.  161.162'', whereever it occurs.


Sec. Sec.  161.190, 161.240, 161.290, 161.340, 161.390, 161.440, 
161.490, 161.540, 161.590, and 161.640  [Amended]

0
18. In newly redesignated Sec. Sec.  161.190, 161.240, 161.290, 
161.340, 161.390, 161.440, 161.490, 161.540, 161.590, and 161.640, 
reference to the phrase ``Sections 158.50 and 158.100 through 158.102'' 
is revised to read ``Sections 161.100 through 161.102''.


Sec.  161.340  [Amended]

0
19. Newly redesignated Sec.  161.340 is further amended in paragraph 
(b)(22)(i) by revising the reference to ``Sec.  158.202'' to read 
``Sec.  161.202.''


Appendix A  [Amended]

0
20. Appendix A to newly redesignated part 161 is amended under the 
topic ``How to use this Index,'' in paragraph 4, by revising the phrase 
``in Sec. Sec.  158.120 through 153.170'' to read ``in Sec. Sec.  
161.155 through 161.640''.
[FR Doc. E7-20836 Filed 10-23-07; 8:45 am]
BILLING CODE 6560-50-S