[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Rules and Regulations]
[Page 75592-75600]
[DOCID:fr12de08-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPP-2008-0247; FRL-8146-6]

Pesticide Regulations; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA has reviewed its pesticide regulations contained in 40 CFR
Parts 150-180, and is making technical changes in a number of areas.
These technical changes will correct errors and cross-references,
improve presentation and format, and conform the regulations to current
CFR practice. These changes have no substantive impact on any
requirements. As such, notice and public comment procedures are
unnecesary, and EPA finds that this constitutes good cause under the
Administrative Procedure Act.

DATES: This final rule is effective February 10, 2009.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0247. 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 website 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 Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you produce or
register pesticide products, or petition the Agency to establish or
modify a pesticide tolerance. Potentially affected entities may
include, but are not limited to Pesticide Producers (NAICS 32532),
e.g., pesticide manufacturers or formulators of pesticide products or
importers of pesticide products.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

II. Background

    Under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA), the Agency
regulates the sale, distribution and use of pesticides. EPA regulations
covering activities under these statutes are contained in 40 CFR parts
150 - 180. Many of these regulations were promulgated or last revised
in the 1970s and 1980s and have not been significantly updated.
    Over the past year, EPA has conducted a detailed review of its
pesticide regulations, contained in 40 CFR parts 150 - 180. EPA
believes that improvements in these regulations are warranted. Today's
final rule makes ``housekeeping'' or non-substantive technical changes
to a series of regulations. Future rulemakings implementing substantive
changes will be issued as proposed rules with opportunity for comment.
The types of changes being made today involve error correction,
conforming changes, and general non-substantive improvements in
presentation and format.

III. Today's final rule

    In today's final rule EPA is making the following key types
ofchanges to the regulations in 40 CFR parts 150 - 180.
    1. EPA is removing compliance and effective dates that have
passed.These involve certain provisions concerning:
    a. Data compensation (part 152, subpart E);
    b. Worker protection interim provisions and exceptions (part 170).
    2. EPA is removing unnecessary or obsolete references, including:
    a. References to the Pesticide Assessment Guidelines that are
notneeded in regulatory text (part 172);
    b. Definitions related solely to plant-incorporated protectants
that are not used in the regulatory text of part 152. These definitions
are duplicative of definitions in part 174.
    c. Reference in Sec.  180.34 to the certification of usefulness, a
provision eliminated by the Food Quality Protection Act (FQPA) in 1996.
    3. EPA is removing most references to section 409 of the FFDCA.
Prior to 1996, EPA established tolerances for raw agricultural
commodities under section 408 and food additive regulations for certain
pesticide residues in processed foods under section 409, which pertains
to food additives. As part of the FQPA, Congress combined EPA's
authority to regulate all pesticide chemical residues in food under
section 408 of the FFDCA (leaving the Food and Drug Administration the
sole authority under section 409 to regulate food additives). As it no
longer has any regulatory authority under section 409, EPA is
eliminating most references to FFDCA section 409 from its regulations.
Those retained are needed for continued enforcement of pre-FQPA
provisions.
    4. EPA is correcting other statutory and regulatory cross-
references.
    a. EPA is correcting the references to data compensation provisions
in FIFRA sec. 3(c)(1)(D), which is now 3(c)(1)(F).
    b. EPA is correcting the references to FIFRA sec. 4, which is now
FIFRA sec. 11.
    c. EPA is correcting the regulatory cross-references from Sec.
156.10(h) to Sec.  156.62 and Sec.  162.11 to part 154. These
regulations were restructured a number of years ago, but the cross-
references were not.
    5. EPA is correcting part 155, subpart C, Registration Review
Procedures, to include the mandatory 15-year

registration review and minor changes to docket procedures required
under the Pesticide Regulatory Improvement Renewal Act.
    6. EPA is updating organizational and docket references in the
regulations. For example, EPA is revising a reference to the U.S.
Bureau of Mines to refer to the National Institute for Occupational
Safety and Health. EPA is revising the URL for the location of EPA's
electronic dockets to www.regulations.gov.
    7. EPA is revising the regulations to conform with current CFR
practice.
    a. EPA is revising the structure used to present definitions.
Current CFR practice is to list definitions alphabetically without
numeric or alpha paragraph designations. EPA is revising various
definitions sections to provide for greater consistency in presentation
by removing numeric and alpha paragraph designations from parts 154,
157, 162, 166, and 172. In addition, EPA is standardizing the
introductory material and, in a few cases, revising a definition from
``term includes'' or ``term refers to'' to ``term means.'' In each
instance where EPA is making this revision the existing definition
contains language that makes the definition all-inclusive, so that the
term ``includes'' in actuality means ``means.''
    b. EPA is removing the topic headings in part 180, which are no
longerused in regulations.
    8. EPA is reformatting certain material without substantive change
for greater clarity and understanding.
    a. EPA is restructuring the opening paragraphs of Sec.  152.1 and
Sec.  160.1
    b. EPA is revising certain table titles in part 158 to clearly
identify experimental use permit versus registration data requirements.
    9. EPA is revising section titles to reflect statutory
language.Specifically, EPA is revising the titles of Sec.  152.10 and
Sec.  152.20 to accurately reflect the underlying statutory language.

IV. Good Cause Exemption

    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 issuing today's rule final
without prior proposal and opportunity for comment because notice and
public comment are unnecessary. EPA is making only technical changes
that have no substantive effect on any requirement, while improving the
clarity and usefulness of its regulations. EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(B).

V. FIFRA Review Requirements

    In accordance with FIFRA sec. 25(a), a draft of this final rule was
submitted to the Secretary of Agriculture, the FIFRA SAP, and
appropriate Congressional Committees. The FIFRA SAP and the Secretary
of Agriculture waived review of the final rule.

VI. Statutory and Executive Order Reviews

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB) under Executive Order 12866, nor does this
rule contain any information collections subject to OMB approval under
the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
    Because the Agency has made a ``good cause'' finding that this
action is not subject to notice-and-comment requirements under the APA
or any other statute (see Unit IV.), it is not subject to the
regulatory flexibility provisions of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does this action significantly or uniquely affect small governments or
impose a significant intergovernmental mandate, as described in
sections 203 and 204 of UMRA.
    This rule will not 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, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999), nor will this rule have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000).
    This rule does not require any special considerations, 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). Nor will this rule have any affect on energy
supply, distribution or use as described in Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001).
    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, Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
The rule also does not involve special consideration of environmental
justice related issues under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (55 FR 7629, February 16, 1994).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report 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

40 CFR Parts 152 and 154

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

40 CFR Part 155

    Environmental protection, Administrative practice and procedure,
Confidential business information, Pesticides and pest, Reporting and
recordkeeping requirements.

40 CFR Part 156

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

40 CFR Part 157

    Environmental protection, Administrative practice and procedure,
Infants and children, Packaging and containers, Pesticides and pest,
Reporting and recordkeeping requirements.

40 CFR Parts 158 and 159

    Environmental protection, Confidential business information,
Pesticides and pest, Reporting and recordkeeping requirements.

40 CFR Part 160

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

40 CFR Part 162

    Environmental protection, Administrative practice and procedure,
Intergovernmental relations, Laboratories, Pesticides and pest.

40 CFR Part 164

    Environmental protection, Administrative practice and procedure,
Pesticides and pest.

40 CFR Part 166

    Environmental protection, Administrative practice and procedure,
Intergovernmental relations, Laboratories, Pesticides and pest.

40 CFR Part 168

    Environmental protection, Administrative practice and procedure,
Advertising, Pesticides and pest.

40 CFR Part 170

    Environmental protection, Intergovernmental relations, Labeling,
Occupational safety and health, Pesticides and pest.

40 CFR Part 171

    Environmental protection, Indian lands, Intergovernmental
relations, Laboratories, Pesticides and pest, Reporting and
recordkeeping requirements.

40 CFR Part 172

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

40 CFR Part 180

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

    Dated: December 2, 2008.
James B. Gulliford,
Assistant Administrator for 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. By revising Sec.  152.1 to read as follows:

Sec.  152.1  Scope.

    (a) Part 152 sets forth procedures, requirements and criteria
concerning the registration of pesticide products under FIFRA section
3, including plant-incorporated protectants (PIPs). Unless specifically
superseded by part 174, the regulations in part 152 apply to PIPs.
    (b) Part 152 also describes associated regulatory activities
affecting registration, as described in this paragraph.
    (1) Data compensation and exclusive use of data in support of
registration. Refer to subpart E of this part.
    (2) Rights and obligations of registrants. Refer to subpart G of
this part.
    (3) Classification of pesticide uses. Refer to subpart I of this
part.
    (4) Fees. Refer to subpart U of this part.
    (5) Requirements pertaining to pesticide devices. Refer to subpart
Z of this part.

0
3. In Sec.  152.3 by removing the definitions of ``Genetic material
necessary for the production,'' ``In a living plant,'' ``Noncoding,
nonexpressed nucleotide sequences,'' ``Pesticidal substance,''
``Produce thereof,'' and ``Regulatory region'', and by revising the
definitions of ``Applicant,'' and subparagraph (1) under the definition
for ``New use'' to read as follows:

Sec.  152.3  Definitions.

* * * * *
    Applicant means a person who applies for a registration or amended
registration under FIFRA sec. 3.
* * * * *
    New use * * *
    (1) Any proposed use pattern that would require the establishment
of, the increase in, or the exemption from the requirement of a
tolerance or food additive regulation under section 408 of the Federal
Food, Drug and Cosmetic Act;
* * * * *

0
4. In Sec.  152.6 by revising paragraph (a)(2) to read as follows:

Sec.  152.6  Substances excluded from regulation by FIFRA.

* * * * *
    (a) * * *
    (2) Claims. The product must bear a sterilant claim, or a sterilant
plus subordinate level disinfection claim. Products that bear
antimicrobial claims solely at a level less than ``sterilant'' are not
excluded and are jointly regulated by EPA and FDA.
* * * * *

0
5. By revising the section heading of Sec.  152.10 to readas follows:

Sec.  152.10  Products that are not pesticides because they are not
intended for a pesticidal purpose.

* * * * *

0
6. By revising the section heading of Sec.  152.20 to readas follows:

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

* * * * *

0
7. Section 152.50 is amended by revising paragraph (i), and by adding
paragraph (j) to read as follows:

Sec.  152.50  Contents of application.

* * * * *
    (i) Statement concerning tolerances. (1) If the proposed labeling
bears instructions for use of the pesticide on food or feed crops, or
if the intended use of the pesticide results or may be expected to
result, directly or indirectly, in pesticide chemical residues in or on
food or feed (including residues of any active ingredient, inert
ingredient, metabolite, or degradation product), the applicant must
submit a statement indicating whether such residues are authorized by a
tolerance or exemption from the requirement of a tolerance issued under
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA).
    (2) If such residues have not been authorized, the application must
be accompanied by a petition for establishment of appropriate
tolerances or exemptions from the requirement of a tolerance, in
accordance with part 180 of this chapter.
    (j) Fees. (1) The applicant shall identify the appropriate fee
category in the schedule provided for by FIFRA sec. 33, and shall
submit the fee for that category as prescribed by the latest EPA notice
of section 33 fees.
    (2) If FIFRA sec. 33 is not in effect, the applicant shall submit
any fees required by subpart U of this part, if applicable.

0
8. By revising Sec.  152.80 to read as follows:

Sec.  152.80  General.

    This subpart E describes the information that an applicant must
submit with his application for registration or amended registration to
comply (and for the Agency to determine compliance) with the provisions
of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by
which data submitters may challenge registration actions which
allegedly failed to comply with these procedures. If the Agency
determines that an applicant has failed to comply with the requirements
and procedures in this subpart, the application may be denied. If the
Agency determines, after

registration has been issued, that an applicant failed to comply with
these procedures and requirements, the Agency may issue a notice of
intent to cancel the product's registration.

Sec.  152.83  [Amended]

0
9. Section 152.83 is amended by removing the alpha paragraph
designations from the definitions, and revising the reference to
``FIFRA section 3(c)(1)(D)'' to read ``FIFRA section 3(c)(1)(F)'',
wherever it appears.

Sec.  152.86  [Amended]

0
10. Section 152.86 is amended by revising the reference ``FIFRA section
3(c)(1)(D)'' to read ``FIFRA section 3(c)(1)(F)'' wherever it appears.

0
11. Section 152.93 is amended by revising the introductory text of
paragraph (b)(2), paragraphs (b)(2)(iii) and (b)(3) to read as follows:

Sec.  152.93  Citation of a previously submitted valid study.

* * * * *
    (b) * * *
    (2) Citation with offer to pay compensation to the original data
submitter. The applicant may cite any valid study that is not subject
to the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without
written authorization from the original data submitter if the applicant
certifies to the Agency that he has furnished to the original data
submitter:
* * * * *
    (iii) An offer to pay the person compensation to the extent
required by FIFRA section 3(c)(1)(F);
* * * * *
    (3) Citation without authorization or offer to pay. The applicant
may cite any valid study without written authorization from, or offer
to pay to, the original data submitter if the study was originally
submitted to the Agency on or before the date that is 15 years before
the date of the application for which it is cited, and the study is not
an exclusive use study, as defined in Sec.  152.83(c).

Sec. Sec.  152.94, 152.95, 152.98, and 152.99  [Amended]

0
12. Sections 152.94, 152.95, 152.98, are amended by revising the
reference ``FIFRA section 3(c)(1)(D)'' to read ``FIFRA section
3(c)(1)(F)'' and Sec.  152.99 is amended by revising the reference
``FIFRA section 3(c)(1)(D)(ii)'' to read ``FIFRA section
3(c)(1)(F)(ii)'' whichever occurs and wherever it occurs.

0
13. By revising Sec.  152.110 to read as follows:

Sec.  152.110  Time for agency review.

    The Agency will complete its review of applications as
expeditiously as possible. Applications subject to specific timeframes
under the fee schedule established by FIFRA section 33 will be reviewed
within the timeframes established for the application or action type.

0
14. In Sec.  152.112 by revising paragraph (d) to read as follows, and
in paragraph (g), by revising the phrase ``under FFDCA sec. 408, sec.
409 or both; and'' to read ``under FFDCA sec. 408, and''.

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 for the product by part 158 or part
161 of this chapter, as applicable.
* * * * *

Sec.  152.116 and Sec.  152.135  [Amended]

0
15. Section 152.116 and 152.135 are amended by revising the reference
``FIFRA sec. 3(c)(1)(D)(i)'' to read ``FIFRA sec. 3(c)(1)(F)(i)'' or by
revising the reference ``FIFRA sec. 3(c)(1)(D)'' to read ``FIFRA
section 3(c)(1)(F)'', whichever occurs and wherever it occurs.

0
16. Section 152.125 is revised to read as follows:

Sec.  152.125  Submission of information pertaining to adverse effects.

    If at any time the registrant receives or becomes aware of any
factual information regarding unreasonable adverse effects of the
pesticide on the environment that has not previously been submitted to
the Agency, the registrant shall, in accordance with FIFRA section
6(a)(2) and the requirements of part 159, subpart D of this chapter,
provide such information to the Agency, clearly identified as FIFRA
6(a)(2) data.

PART 154--[AMENDED]

0
17. The authority citation for part 154 is revised to read as follows:

    Authority: 7 U.S.C. 136a, d, and w.

0
18. Section 154.3 is revised to read as follows:

Sec.  154.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In
addition, as used in this part, the following terms shall apply:
    Act or FIFRA means the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended.
    Administrator means the Administrator of the Environmental
Protection Agency or any officer or employee thereof to whom authority
has been delegated to act for the Administrator.
    Confidential business information means trade secrets or
confidential commercial or financial information under FIFRA section
10(b) or 5 U.S.C. 552(b)(3) or (4).
    Other significant evidence means factually significant information
that relates to the uses of the pesticide and its adverse risk to man
or to the environment but does not include evidence based only on
misuse of the pesticide unless such misuse is widespread and commonly
recognized practice.
    Person means an applicant, registrant, manufacturer, pesticide
user, environmental group, labor union, or other individual or group of
individuals interested in pesticide regulation.
    Pesticide use means a use of a pesticide (described in terms of the
application site and other applicable identifying factors) that is
included in the labeling of a pesticide product which is registered, or
for which an application for registration is pending, and the terms and
conditions (or proposed terms and conditions) of registration for the
use.
    Terms and conditions of registration means the terms and conditions
governing lawful sale, distribution, and use approved in conjunction
with registration, including labeling, use classification, composition,
and packaging.
    Validated test means a test determined by the Agency to have been
conducted and evaluated in a manner consistent with accepted scientific
procedures.

PART 155--[AMENDED]

0
19. The authority citation for part 155 is revised to read as follows:

    Authority: 7 U.S.C. 136a and 136w.

0
20. By revising Sec.  155.40(a) to read as follows:

Sec.  155.40  General.

    (a) Purpose. These regulations establish procedures for the
registration review program required in FIFRA section 3(g).
Registration review is the periodic review of a pesticide's
registration to ensure that each pesticide registration continues to
satisfy the FIFRA standard for registration. Under

FIFRA section 3(g), each pesticide is required to be reviewed every 15
years.
* * * * *

0
21. By revising Sec.  155.52(a) and (c), to read as follows:

155.52  Stakeholder engagement.

* * * * *
    (a) Minutes of meetings with persons outside of government. Subject
to paragraph (c) of this section, if the Agency meets with one or more
individuals that are not government employees to discuss matters
relating to a registration review, the Agency will place in the docket
a list of meeting attendees, minutes of the meeting, and any documents
exchanged at the meeting, not later than the earlier of:
    (1) 45 days after the meeting; or
    (2) The date of issuance of the registration review decision.
* * * * *
    (c) Confidential business information. The Agency will identify,
but not include in the docket, any confidential business information
whose disclosure is prohibited by FIFRA section 10.

PART 156--[AMENDED]

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

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

0
23. Section 156.10 is amended by revising paragraphs (i)(2)(ix), and
(i)(2)(x)(D), and the introductory text of paragraph (j) to read as
follows:

Sec.  156.10  Labeling requirements.

* * * * *
    (i) * * *
    (2) * * *
    (ix) Specific directions concerning the storage, residue removal
and disposal of the pesticide and its container, in accordance with
subpart H of this part. These instructions must be grouped and appear
under the heading,``Storage and Disposal.'' This heading must be set in
type of the same minimum sizes as required for the child hazard
warning. (See table in Sec.  156.60(b))
    (x) * * *
    (D) For total release foggers as defined in Sec.  156.78(d)(1), the
following statements must be included in the ``Directions for Use.''
* * * * *
    (j) Statement of use classification. Any pesticide product for
which some uses are classified for general use and others for
restricted use shall be separately labeled according to the labeling
standards set forth in this subsection, and shall be marketed as
separate products with different registration numbers, one bearing
directions only for general use(s) and the other bearing directions for
restricted use(s) except that, if a product has both restricted use(s)
and general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the provisions of
paragraph (j)(2) of this section.
* * * * *

0
24. Section 156.200 is amended by revising paragraph (c) to read as
follows:

Sec.  156.200  Scope and applicability.

* * * * *
    (c) Effective dates. No product to which this subpart applies shall
be distributed or sold without amended labeling by any registrant after
April 21, 1994, or by any person after October 23, 1995.

0
25. Section 156.203 is amended by revising the definition of
``Restricted-entry interval'' to read as follows:

Sec.  156.203  Definitions.

* * * * *
    Restricted-entry interval or REI means the time after the end of a
pesticide application during which entry to the treated area is
restricted.

0
26. Section 156.204 is amended by revising paragraph (b) to read as
follows:

Sec.  156.204  Modification and waiver of requirements.

* * * * *
    (b) Other modifications. The Agency, pursuant to this subpart and
authorities granted in FIFRA sections 3, 6, and 12, may, on its
initiative or based on data submitted by any person, modify or waive
the requirements of this subpart, or permit or require alternative
labeling statements. Supporting data may be either data conducted
according to Subdivisions U or K of the Pesticide Assessments
guidelines or data from medical, epidemiological, or health effects
studies. A registrant who wishes to modify any of the statements
required in Sec. Sec.  156.206, 156.208, 156.210, or 156.212 must
submit an application for amended registration unless specifically
directed otherwise by the Agency.

Sec. Sec.  156.206, 156.208, 156.210, and 156.212  [Amended]

0
27. Sections 156.206(e), 156.208(c)(1), 156.210(b)(1), and
156.212(d)(2) are amended by revising the reference ``Sec.
156.10(h)(l)'' to read ``Sec.  156.62'', wherever it occurs.

PART 157--[AMENDED]

0
28. The authority citation for part 157 continues to read as follows:

    Authority: 7 U.S.C. 136w.

Sec.  157.21  [Amended]

0
29. Section 157.21 is amended by removing the alpha paragraph
designations from the definitions.

PART 158--[AMENDED]

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

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

Sec.  158.220  [Amended]

0
31. In Sec.  158.220, the title of the table in paragraph (c) is
revised to read ``Table--Experimental Use Permit Data Requirements for
Product Performance''.

Sec.  158.230  [Amended]

0
32. In Sec.  158.230, the title of the table in paragraph (c) is
revised to read ``Table--Experimental Use Permit Toxicity Data
Requirements.''

Sec.  158.243  [Amended]

0
33. In Sec.  158.243, the title of the table in paragraph (c) is
revised to read ``Table--Experimental Use Permit Terrestrial and
Aquatic Nontarget Organism Data Requirements.''

Sec.  158.260  [Amended]

0
34. In Sec.  158.260, the title of the table in paragraph (c) is
revised to read ``Table--Experimental Use Permit Environmental Fate
Data Requirements.''

PART 159--[AMENDED]

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

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

0
36. Section 159.153 is amended by revising the introductory text of
paragraph (b) to read as follows:

Sec.  159.153  Definitions.

* * * * *
    (b) For purposes of reporting information pursuant to FIFRAsection
6(a)(2), the following definitions apply only to this subpart:
* * * * *

0
37. Section 159.160 is amended by revising paragraph (b)(4) to read as
follows:

Sec.  159.160  Obligations of former registrants.

* * * * *
    (b) * * *
    (4) The information pertains solely to a formerly registered
product that no longer meets the definition of ``pesticide'' in section
2(u) of FIFRA.
* * * * *

Sec.  159.165  [Amended]

0
38. Section 159.165 is amended in paragraph (a)(2) by revising the
reference ``40 CFR 156.10(h)'' to read ``40 CFR 156.62'' and in the
introductory text of paragraph (d)(2) by revising the phrase ``90
calendar days or less,'' to read ``more than 90 calendar days.''

PART 160--[AMENDED]

0
39. The authority citation for part 160 is revised to read as follows:

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

0
40. Section 160.1 is revised to read as follows:

Sec.  160.1  Scope and applicability.

    (a) This part prescribes good laboratory practices for conducting
studies that support or are intended to support applications for
research or marketing permits for pesticide products regulated by the
EPA. This part is intended to assure the quality and integrity of data
submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act, as amended, and section
408 or 409 of the Federal Food, Drug and Cosmetic Act.
    (b) This part applies to any study described by paragraph (a) of
this section which any person conducts, initiates, or supports on or
after October 16, 1989.

0
41. In Sec.  160.3 revise the introductory text of the definition for
Application for research or marketing permit, and in the same
definition, revise paragraph (5), and revise the definition for
``person'' to read as follows:

Sec.  160.3  Definitions.

* * * * *
    Application for research or marketing permit means any of the
following:
* * * * *
    (5) A petition or other request for establishment or modification
of a food additive regulation or other clearance by EPA under FFDCA
section 409 that was submitted prior to August 3, 1996.
* * * * *
    Person means an individual, partnership, corporation, association,
scientific or academic establishment, government agency or
organizational unit thereof, or any other legal entity.
* * * * *

PART 162--[AMENDED]

0
42. The authority citation for part 162 continues to read as follows:

    Authority: 7 U.S.C. l36v, 136w.

0
43. Section 162.151 is revised to read as follows:

Sec.  162.151  Definitions.

    Terms used in this part have the same meaning as in the Act and
part 152 of this chapter. In addition, as used in this subpart, the
following terms shall apply:
    Federally registered means currently registered under section 3 of
the Act, after having been initially registered under the Federal
Insecticide, Fungicide, and Rodenticide Act of 1947 by the Secretary of
Agriculture or under FIFRA by the Administrator.
    Manufacturing-use product means any pesticide product other than a
product to be labeled with directions for end use. This term includes
any product intended for use as a pesticide after reformulation or
repackaging.
    New product means a pesticide product which is not a federally
registered product.
    Pest problem means:
    (1) A pest infestation and its consequences, or
    (2) Any condition for which the use of plant regulators,
defoliants, or desiccants would be appropriate.
    Product or pesticide product means a pesticide offered for
distribution and use, and includes any labeled container and any
supplemental labeling.
    Similar composition means a pesticide product which contains only
the same active ingredient(s), or combinations of active ingredients,
and which is in the same toxicity category, as defined in Sec.  156.62
of this chapter, as a federally registered pesticide product.
    Similar product means a pesticide product which, when compared to a
federally registered product, has a similar composition and a similar
use pattern.
    Similar use pattern means a use of a pesticide product which, when
compared to a federally registered use of a product with a similar
composition, does not require a change in precautionary labeling under
part 156 of this chapter, and which is substantially the same as the
federally registered use. Registrations involving changed use patterns
are not included in this term.
    Special local need means an existing or imminent pest problem
within a State for which the State lead agency, based upon satisfactory
supporting information, has determined that an appropriate federally
registered pesticide product is not sufficiently available.
    State or State lead agency means the State agency designated by the
State to be responsible for registering pesticides to meet special
local needs under section 24(c) of the Act.

0
44. Section 162.152 is amended by revising paragraph (b)(1)(i) to read
as follows:

Sec.  162.152  State registration authority.

* * * * *
    (b) * * *
    (1) * * *
    (i)Subject to the provisions of paragraphs (a) and (b)(1)(ii)
through (iv) of this section, States may register any new use of a
federally registered pesticide product.
* * * * *

0
45. Section 162.153 is amended by redesignating paragraph (a)(6) as
paragraph (j), and by revising the last sentence of paragraph (c)(2) to
read as follows:

Sec.  162.153  State registration procedures.

* * * * *
    (c) * * *
    (2) * * * Such determinations may also involve consideration of the
effect of the anticipated classification of the product or use under
paragraph (g) of this section.
* * * * *

PART 164--[AMENDED]

0
46. The authority citation for part 164 continues to read as follows:

    Authority: 7 U.S.C. 136d.

0
47. Section 164.2 is amended by revising paragraphs (l)(2) and (s) to
read as follows:

Sec.  164.2  Definitions.

* * * * *
    (l) * * *
    (2) Qualification. A judicial officer shall be a permanent or
temporary employee or officer of the Agency who may perform other
duties for the Agency. Such judicial officer shall not be employed by
the Office of Prevention, Pesticides, and Toxic Substances or have any
connection with the preparation or presentation of evidence for a
hearing.
* * * * *
    (s) The term Respondent means the Assistant Administrator of the
Office of Prevention, Pesticides, and Toxic Substances.
* * * * *

PART 166--[AMENDED]

0
48. The authority citation for part 166 is revised to read as follows:

    Authority: 7 U.S.C. 136p, and 136w.

0
49. Section 166.3 is revised to read as follows:

Sec.  166.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act,
as amended.
    Agency and EPA mean the U. S. Environmental Protection Agency.
    Beneficial organism means any pollinating insect, or any pest
predator, parasite, pathogen or other biological control agent which
functions naturally or as part of an integrated pest management program
to control another pest.
    Emergency condition means an urgent, non-routine situation that
requires the use of a pesticide(s) and shall be deemed to exist when:
    (1) No effective pesticides are available under the Act that have
labeled uses registered for control of the pest under the conditions of
the emergency; and
    (2) No economically or environmentally feasible alternative
practices which provide adequate control are available; and
    (3) The situation:
    (i) Involves the introduction or dissemination of an invasive
species or a pesticide new to or not theretofore known to be widely
prevalent or distributed within or throughout the United States and its
territories; or
    (ii) Will present significant risks to human health; or
    (iii) Will present significant risks to threatened or endangered
species, beneficial organisms, or the environment; or
    (iv) Will cause significant economic loss due to:
    (A) An outbreak or an expected outbreak of a pest; or
    (B) A change in plant growth or development caused by unusual
environmental conditions where such change can be rectified by the use
of a pesticide(s).
    First food use means the use of a pesticide on a food or in a
manner which otherwise would be expected to result in residues in a
food, if no tolerance or exemption from the requirements of a tolerance
for residues of the pesticide on any food has been established for the
pesticide under section 408 of the Federal Food, Drug, and Cosmetic
Act.
    Food means any article used for food or drink for man or animals.
    Invasive species means, with respect to a particular ecosystem, any
species that is not native to that ecosystem, and whose introduction
does or is likely to cause economic or environmental harm or harm to
human health.
    IR-4 means the Interregional Research Project No. 4, a cooperative
effort of the state land grant universities, the U.S. Department of
Agriculture and EPA, to address the chronic shortage of pest control
options for minor crops, which are generally of too small an acreage to
provide economic incentive for registration by the crop protection
industry.
    New chemical means an active ingredient not contained in any
currently registered pesticide.
    Significant economic loss means that, compared to the situation
without the pest emergency and despite the best efforts of the affected
persons, the emergency conditions at the specific use site identified
in the application are reasonably expected to cause losses meeting any
of the following criteria:
    (1) For pest activity that primarily affects the current crop or
other output, one or more of the following:
    (i) Yield loss greater than or equal to 20%.
    (ii) Economic loss, including revenue losses and cost increases,
greater than or equal to 20% of gross revenues.
    (iii) Economic loss, including revenue losses and cost increases
greater than or equal to 50% of net revenues.
    (2) For any pest activity where EPA determines that the criteria in
paragraph (1) of this definition would not adequately describe the
expected loss, substantial loss or impairment of capital assets, or a
loss that would affect the long-term financial viability expected from
the productive activity.
    Special Review means any interim administrative review of the risks
and benefits of the use of a pesticide conducted pursuant to the
provisions of part 154 of this chapter, or Sec.  162.11 of this chapter
prior to November 27, 1985, or any subsequent version of those rules.
    Unreasonable adverse effects on the environment means any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide.

PART 168--[AMENDED]

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

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

0
51. Section 168.65 is amended by revising the last sentence of
paragraph (b)(1)(ii), and paragraph (b)(1)(vii), to read as set forth
below.

Sec.  168.65  Pesticide export label and labeling requirements.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * * Where the U.S. warning or caution statement, as
translated, is obviously inappropriate to protect residents of the
importing country (for example, where a statement calls for a gas mask
meeting the specifications of the National Institute of Occupational
Safety and Health), an equivalent caution must be substituted.
* * * * *
    (vii) Additional warning for highly toxic pesticides. If the
pesticide, device or active ingredient is highly toxic to humans, the
skull and crossbones, the word ``Poison,'' and a first aid statement
must appear on the label. The word ``Poison'' and the first aid
statement shall be in English and in the appropriate foreign languages,
as described in paragraph (b)(4) of this section. The skull and
crossbones may be in red or black. For criteria on what pesticides are
highly toxic, see Sec.  156.62 of this chapter.
* * * * *

PART 170--[AMENDED]

0
52. The authority citation for part 170 continues to read as follows:

    Authority: 7 U.S.C. 136w.

Sec.  170.5  [Removed]

0
53. Section 170.5 is removed.

Sec.  170.104  [Amended]

0
54. Section 170.104 is amended by revising the acronym ``PPE'' in
paragraph (b)(2)(iii) to read ``personal protective equipment'' and by
removing paragraph (c).

Sec.  170.112  [Amended]

0
55. Section 170.112 is amended by removing paragraphs (e)(7)(i) and
(e)(7)(iv), and by redesignating paragraphs (e)(7)(ii) and (e)(7)(iii)
as paragraphs (e)(7)(i) and (e)(7)(ii), respectively.

0
56. Section 170.130 is amended by revising paragraph (a)(3)(i) to read
as follows, by removing paragraph (a)(3)(iii) and by revising paragraph
(d)(3) to read as follows:.

Sec.  170.130  Pesticide safety training for workers.

    (a) * * *
    (3) * * * (i) Information before entry. Except as provided in
paragraph (a)(2) of this section, before a worker enters any areas on
the agricultural establishment where, within the last 30

days a pesticide to which this subpart applies has been applied or the
restricted-entry interval for such pesticide has been in effect, the
agricultural employer shall assure that the worker has been provided
the pesticide safety information specified in paragraph (c) of this
section, in a manner that agricultural workers can understand, such as
by providing written materials or oral communication or by other means.
The agricultural employer must be able to verify compliance with this
requirement.
* * * * *
    (d) * * *
    (3) Any person who issues an EPA-approved Worker Protection
Standard worker training certificate must assure that the worker who
receives the training certificate has been trained in accordance with
paragraph (d)(4) of this section.
* * * * *

Sec.  170.204  [Amended]

0
57. Section 170.204 is amended by removing paragraph (c).

PART 171--[AMENDED]

0
58. The authority citation for part 171 is revised to read as follows:

    Authority: 7 U.S.C. 136i and 136w.

0
59. Section 171.2 is amended by revising the introductory text of
paragraph (a) and by revising paragraph (b)(4) to read as follows:

Sec.  171.2  Definitions.

    (a) Terms used in this subpart have the same meaning as in the Act.
In addition, the following definitions are applicable to all aspects of
the certification of pesticide applicator program in this part:
* * * * *
    (b) * * *
    (4) The term uncertified person means any person who is not holding
a currently valid certification document indicating that he is
certified under section 11 of FIFRA in the category of the restricted
use pesticide made available for use.
* * * * *

PART 172--[AMENDED]

0
60. 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
61. Section 172.1 is revised to read as follows

Sec.  172.1  Definitions.

    Terms used in this part have the same meaning as in the Act. In
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide and Rodenticide Act,
as amended.
    Applicant means any person who applies for an experimental use
permit pursuant to section 5 of the Act.
    Cooperator means any person who grants permission to a permittee or
a permittee's designated participant for the use of an experimental use
pesticide at an application site owned or controlled by the cooperator.
    Experimental animals means individual animals or groups of animals,
regardless of species, intended for use and used solely for research
purposes. The term does not include animals intended to be used for any
food purposes
    Participant means any person acting as a representative of the
permittee and responsible for making available for use, or supervising
the use or evaluation of, an experimental use pesticide to be applied
at a specific application site.
    Permittee means any applicant to whom an experimental use permit
has been granted.
    Value for pesticide purposes means that characteristic of a
substance or mixture of substances which produces an efficacious action
on a pest.

Sec.  172.3  [Amended]

0
62. Section 172.3(d) is amended by removing the third sentence which
reads ``Subdivision I of the Pesticide Assessment Guidelines provides
guidance on the procedures, data requirements, and general aspects
pertaining to the issuance and use of EUPs.''

0
63. Section 172.4 is amended by revising paragraph (b)(2)(i) and (ii)
to read as follows:

Sec.  172.4  Applications.

* * * * *
    (b) * * *
    (2) * * *
    (i) Submit evidence that a tolerance or exemption from the
requirement of a tolerance has been established for residues of the
pesticide in or on such food or feed under section 408 of the Federal
Food, Drug, and Cosmetic Act; or
    (ii) Submit a petition proposing establishment of a tolerance or an
exemption from the requirement of a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act; or
* * * * *

0
64. Section 172.21 is revised to read as follows:

Sec.  172.21  Definitions.

    Terms used in this subpart shall have the meaning set forth in
FIFRA and in Sec.  172.1.
    Designated State Agency means the State agency designated by State
law or other authority to be responsible for registering pesticides to
meet special local needs.
    Public or Private Agricultural Research Agency or Educational
Institution means any organization engaged in research pertaining to
the agricultural use of pesticides, or any educational institution
engaged in pesticide research. Any research agency or educational
institution whose principal function is to promote, or whose principal
source of income is directly derived from, the sale or distribution of
pesticides (or their active ingredients) does not come within the
meaning of this term.

0
65. Section 172.24 is amended by revising paragraphs (b)(3),(d)(1)(i)
and (d)(1)(ii) to read as follows:

Sec.  172.24  State issuance of permits.

* * * * *
    (b) * * *
    (3) For use of a restricted use pesticide only if the pesticide is
to be used by, or under the direct supervision of, an applicator
certified in accordance with section 11 of FIFRA.
* * * * *
    (d) * * *
    (1) * * *
    (i) A tolerance or exemption from the requirement of a tolerance
has been established for residues of the pesticide in or on such food
or feed under section 408 of the Federal Food, Drug and Cosmetic Act;
and
    (ii) The proposed program would not reasonably be expected to
result in residues of the pesticide in or on such food or feed in
excess of that authorized under section 408 of the Federal Food, Drug
and Cosmetic Act; and
* * * * *

0
66. Section 172.26 is amended by revising paragraph (c)(1)(iii) to read
as follows:

Sec.  172.26  EPA review of permits.

* * * * *
    (c) * * *
    (1) * * *
    (iii) That new evidence demonstrates that any tolerance upon which
the permit is based will be inadequate to protect the public health, or
that any exemption from the requirement for a tolerance is no longer
appropriate; or
* * * * *

Sec.  172.46  [Amended]

0
67. In the introductory text to Sec.  172.46(c), revise ``161.31'' to
read ``161.32.''.

PART 180--[AMENDED]

0
68. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
69. Part 180 is amended as follows:
0
a. By revising the part heading to read ``Tolerances and Exemptions for
Pesticide Chemical Residues in Food.''
0
b. By removing the center heading that immediately follows the Subpart
A heading.
0
c. Removing the center heading that immediately follows the Subpart B
heading.
0
d. By removing the two center headings that immediately precedeSec.
180.29.

0
70. Section 180.7 is amended by revising the last sentence in paragraph
(b)(1), the last sentence in paragraph (d) and by revising the next to
the last sentence in paragraph (f) to read as follows:

Sec.  180.7  Petitions proposing tolerances or exemptions for pesticide
residues in or on raw agricultural commodities or processed foods.

* * * * *
    (b) * * *
    (1) * * * The electronic copy should be formatted according to the
Office of Pesticide Programs' current standard for electronic data
submission as specified at http://www.epa.gov/pesticides/regulating/
registering/submissions/index.htm.
* * * * *
    (d) * * * The Administrator shall make the full text of the summary
referenced in paragraph (b)(1) of this section available to the public
in the public docket at http://www.regulations.gov no later than
publication in the Federal Register of the notice of the petition
filing.
* * * * *
    (f) * * * The notice shall explicitly reference the specific docket
identification number in the public docket at http://
www.regulations.gov where the full text of the summary required in
paragraph (b) of this section is located, and refer interested parties
to this document for further information on the petition.* * *
* * * * *

0
71. Section 180.34 is amended by revising the introductory text of
paragraph (e) to read as follows:

Sec.  180.34  Tests on the amount of residue remaining.

* * * * *
    (e) Each of the following groups of crops lists raw agricultural
commodities that are considered to be related for the purpose of
paragraph (d) of this section. Commodities not listed in this paragraph
are not considered to be related for the purpose of paragraph (d) of
this section.
* * * * *

[FR Doc. E8-29375 Filed 12-11-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: June 6, 2008 (Volume 73, Number 110)]
[Rules and Regulations]
[Page 32238-32240]
[DOCID:fr06jn08-6]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0097; FRL-8576-4]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Section 110(a)(1) 8-Hour Ozone Maintenance Plan and 2002
Base-Year Inventory for the Wayne County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania. The Pennsylvania
Department of Environmental Protection (PADEP) submitted a SIP revision
consisting of a maintenance plan that provides for continued attainment
of the 8-hour ozone national ambient air quality standard (NAAQS) for
at least 10 years after the April 30, 2004, designations, as well as, a
2002 base-year inventory for the Wayne County Area. EPA is approving
the maintenance plan and the 2002 base-year inventory for the Wayne
County Area as revisions to the Pennsylvania SIP in accordance with the
requirements of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on July 7, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2008-0097. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., 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 electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environment
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Background

    On April 14, 2008 (73 FR 20002), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed
approval of Pennsylvania's SIP revision that establishes a maintenance
plan for the Wayne County Area that provides for continued attainment
of the 8-hour ozone NAAQS for at least 10 years after designation, and
a 2002 base-year emissions inventory. The formal SIP revisions were
submitted by PADEP on December 17, 2007. Other specific requirements of
Pennsylvania's SIP revision and the rationales for EPA's proposed
actions are explained in the NPR and will not be restated here. No
public comments were received on the NPR.

II. Final Action

    EPA is approving the maintenance plan and the 2002 base-year
inventory for the Wayne County Area, submitted on December 17, 2007, as
revisions to the Pennsylvania SIP. EPA is approving the maintenance
plan and 2002 base-year inventory for the Wayne County Area because it
meets the requirements of section 110(a)(1) of the CAA.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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 action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 5, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action.
    This action approving the maintenance plan and the 2002 base-year
inventory for the Wayne County Area may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: May 28, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

     Authority: 42 U.S.C. 7401 et seq.

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
an entry for the 8-Hour Ozone Maintenance Plan and 2002 Base-Year
Inventory for Wayne County at the end of the table to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
   Name of non-regulatory SIP        Applicable        State submittal                            Additional
            revision               geographic area           date          EPA approval date      explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan    Wayne County......  12/17/2007.........  June 6, 2008
 and 2002 Base-Year Inventory.                                             [Insert page
                                                                           number where the
                                                                           document begins].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E8-12589 Filed 6-5-08; 8:45 am]

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