Pesticide Regulations; Technical Amendments, 75592-75600 [E8-29375]
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Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
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Approved: November 20, 2008.
M. Robb Hyde,
Commander, JAGC, U.S. Navy, Deputy
Assistant Judge Advocate, General (Admiralty
and Maritime Law).
[FR Doc. E8–29435 Filed 12–11–08; 8:45 am]
BILLING CODE 3810–FF–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Chapter I
[EPA–HQ–OPP–2008–0247; FRL–8146–6]
Pesticide Regulations; Technical
Amendments
I. Does this Action Apply to Me?
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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 https://
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 https://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
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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 (703) 305–5805.
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: (703) 305–
6304; fax number: (703) 305–5884; email address: boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
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
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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 plantincorporated protectants that are not
used in the regulatory text of part 152.
These definitions are duplicative of
definitions in part 174.
c. Reference in § 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 § 156.10(h) to
§ 156.62 and § 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
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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 allinclusive, 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 § 152.1 and § 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 § 152.10 and
§ 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
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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,
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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.
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40 CFR Part 160
§ 152.1
Environmental protection,
Laboratories, Pesticides and pest,
Reporting and recordkeeping
requirements.
(a) Part 152 sets forth procedures,
requirements and criteria concerning
the registration of pesticide products
under FIFRA section 3, including plantincorporated 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.
■ 3. In § 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:
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.
§ 152.3
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.
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Therefore, 40 CFR chapter I is
amended as follows:
PART 152—[AMENDED]
1. The authority citation for part 152
continues to read as follows:
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Authority: 7 U.S.C. 136 - 136y; Subpart U
is also issued under 31 U.S.C. 9701.
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Applicant means a person who
applies for a registration or amended
registration under FIFRA sec. 3.
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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;
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■ 4. In § 152.6 by revising paragraph
(a)(2) to read as follows:
§ 152.6 Substances excluded from
regulation by FIFRA.
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2. By revising § 152.1 to read as
follows:
Definitions.
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40 CFR Part 172
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Scope.
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(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.
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■ 5. By revising the section heading of
§ 152.10 to readas follows:
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§ 152.10 Products that are not pesticides
because they are not intended for a
pesticidal purpose.
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6. By revising the section heading of
§ 152.20 to readas follows:
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§ 152.20 Exemptions for pesticides
adequately regulated by another Federal
agency.
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7. Section 152.50 is amended by
revising paragraph (i), and by adding
paragraph (j) to read as follows:
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§ 152.50
Contents of application.
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(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.
■ 8. By revising § 152.80 to read as
follows:
§ 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
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§ 152.110
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.
§ 152.83
[Amended]
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.
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§ 152.86
[Amended]
§ 152.112 Approval of registration under
FIFRA sec. 3(c)(5)
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.
■ 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:
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§ 152.93 Citation of a previously submitted
valid study.
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(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:
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(iii) An offer to pay the person
compensation to the extent required by
FIFRA section 3(c)(1)(F);
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(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
§ 152.83(c).
§§ 152.94, 152.95, 152.98, and 152.99
[Amended]
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(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.
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§ 152.116 and § 152.135
[Amended]
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.
■ 16. Section 152.125 is revised to read
as follows:
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§ 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.
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]
19. The authority citation for part 155
is revised to read as follows:
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PART 154—[AMENDED]
Authority: 7 U.S.C. 136a and 136w.
17. The authority citation for part 154
is revised to read as follows:
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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 § 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.
■ 13. By revising § 152.110 to read as
follows:
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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.
■ 14. In § 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’’.
Authority: 7 U.S.C. 136a, d, and w.
18. Section 154.3 is revised to read as
follows:
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§ 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:
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20. By revising § 155.40(a) to read as
follows:
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§ 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
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FIFRA section 3(g), each pesticide is
required to be reviewed every 15 years.
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■ 21. By revising § 155.52(a) and (c), to
read as follows:
155.52
Stakeholder engagement.
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*
(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]
22. The authority citation for part 156
continues to read as follows:
■
Authority: 7 U.S.C. 136 - 136y.
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:
■
§ 156.10
Labeling requirements.
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*
*
*
*
*
(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 § 156.60(b))
(x) * * *
(D) For total release foggers as defined
in § 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
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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.
*
*
*
*
*
■ 24. Section 156.200 is amended by
revising paragraph (c) to read as follows:
§ 157.21
§ 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.
■ 25. Section 156.203 is amended by
revising the definition of ‘‘Restrictedentry interval’’ to read as follows:
§ 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.
■ 26. Section 156.204 is amended by
revising paragraph (b) to read as follows:
§ 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 §§ 156.206, 156.208, 156.210, or
156.212 must submit an application for
amended registration unless specifically
directed otherwise by the Agency.
§§ 156.206, 156.208, 156.210, and 156.212
[Amended]
27. Sections 156.206(e), 156.208(c)(1),
156.210(b)(1), and 156.212(d)(2) are
amended by revising the reference
‘‘§ 156.10(h)(l)’’ to read ‘‘§ 156.62’’,
wherever it occurs.
■
PART 157—[AMENDED]
28. The authority citation for part 157
continues to read as follows:
■
Authority: 7 U.S.C. 136w.
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[Amended]
29. Section 157.21 is amended by
removing the alpha paragraph
designations from the definitions.
■
PART 158—[AMENDED]
30. The authority citation for part 158
continues to read as follows:
■
Authority: 7 U.S.C. 136-136y; 21 U.S.C.
346a.
§ 158.220
[Amended]
31. In § 158.220, the title of the table
in paragraph (c) is revised to read
‘‘Table—Experimental Use Permit Data
Requirements for Product Performance’’.
§ 158.230
[Amended]
32. In § 158.230, the title of the table
in paragraph (c) is revised to read
‘‘Table—Experimental Use Permit
Toxicity Data Requirements.’’
■
§ 158.243
[Amended]
33. In § 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.’’
■
§ 158.260
[Amended]
34. In § 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]
35. The authority citation for part 159
continues to read as follows:
■
Authority: 7 U.S.C. 136 - 136y.
36. Section 159.153 is amended by
revising the introductory text of
paragraph (b) to read as follows:
■
§ 159.153
Definitions.
*
*
*
*
*
(b) For purposes of reporting
information pursuant to FIFRAsection
6(a)(2), the following definitions apply
only to this subpart:
*
*
*
*
*
■ 37. Section 159.160 is amended by
revising paragraph (b)(4) to read as
follows:
§ 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.
*
*
*
*
*
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§ 159.165
Authority: 7 U.S.C. l36v, 136w.
[Amended]
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]
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.
40. Section 160.1 is revised to read as
follows:
■
§ 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.
■ 41. In § 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:
§ 160.3
Definitions.
mstockstill on PROD1PC62 with RULES
*
*
*
*
*
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]
42. The authority citation for part 162
continues to read as follows:
■
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43. Section 162.151 is revised to read
as follows:
■
§ 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 § 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
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75597
to meet special local needs under
section 24(c) of the Act.
■ 44. Section 162.152 is amended by
revising paragraph (b)(1)(i) to read as
follows:
§ 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.
*
*
*
*
*
■ 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:
§ 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]
46. The authority citation for part 164
continues to read as follows:
■
Authority: 7 U.S.C. 136d.
47. Section 164.2 is amended by
revising paragraphs (l)(2) and (s) to read
as follows:
■
§ 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]
48. The authority citation for part 166
is revised to read as follows:
■
Authority: 7 U.S.C. 136p, and 136w.
49. Section 166.3 is revised to read as
follows:
■
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§ 166.3
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
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
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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 § 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.
§ 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 § 156.62
of this chapter.
*
*
*
*
*
PART 170—[AMENDED]
52. The authority citation for part 170
continues to read as follows:
■
Authority: 7 U.S.C. 136w.
§ 170.5
■
[Removed]
53. Section 170.5 is removed.
§ 170.104
[Amended]
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).
■
§ 170.112
[Amended]
PART 168—[AMENDED]
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.
■ 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:.
50. The authority citation for part 168
continues to read as follows:
§ 170.130
workers.
■
Authority: 7 U.S.C. 136 - 136y.
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.
■
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■
Pesticide safety training for
(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
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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 EPAapproved 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.
*
*
*
*
*
§ 170.204
[Amended]
57. Section 170.204 is amended by
removing paragraph (c).
■
PART 171—[AMENDED]
58. The authority citation for part 171
is revised to read as follows:
■
Authority: 7 U.S.C. 136i and 136w.
59. Section 171.2 is amended by
revising the introductory text of
paragraph (a) and by revising paragraph
(b)(4) to read as follows:
■
§ 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]
60. The authority citation for part 172
continues to read as follows:
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■
Authority: 7 U.S.C. 136c, 136w. Section
172.4 is also issued under 31 U.S.C. 9701.
61. Section 172.1 is revised to read as
follows
■
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§ 172.1
Definitions.
[Amended]
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.’’
■ 63. Section 172.4 is amended by
revising paragraph (b)(2)(i) and (ii) to
read as follows:
■
§ 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
*
*
*
*
*
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64. Section 172.21 is revised to read
as follows:
■
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.
§ 172.3
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§ 172.21
Definitions.
Terms used in this subpart shall have
the meaning set forth in FIFRA and in
§ 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.
■ 65. Section 172.24 is amended by
revising paragraphs (b)(3),(d)(1)(i) and
(d)(1)(ii) to read as follows:
§ 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
*
*
*
*
*
■ 66. Section 172.26 is amended by
revising paragraph (c)(1)(iii) to read as
follows:
§ 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
*
*
*
*
*
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[Amended]
§ 180.34 Tests on the amount of residue
remaining.
67. In the introductory text to
§ 172.46(c), revise ‘‘161.31’’ to read
‘‘161.32.’’.
■
*
PART 180—[AMENDED]
68. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
69. Part 180 is amended as follows:
a. By revising the part heading to read
‘‘Tolerances and Exemptions for
Pesticide Chemical Residues in Food.’’
■ b. By removing the center heading that
immediately follows the Subpart A
heading.
■ c. Removing the center heading that
immediately follows the Subpart B
heading.
■ d. By removing the two center
headings that immediately
precede§ 180.29.
■ 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:
■
■
§ 180.7 Petitions proposing tolerances or
exemptions for pesticide residues in or on
raw agricultural commodities or processed
foods.
mstockstill on PROD1PC62 with RULES
*
*
*
*
*
(b) * * *
(1) * * * The electronic copy should
be formatted according to the Office of
Pesticide Programs’ current standard for
electronic data submission as specified
at https://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 https://
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 https://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.* * *
*
*
*
*
*
■ 71. Section 180.34 is amended by
revising the introductory text of
paragraph (e) to read as follows:
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
*
*
*
*
(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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R10–OAR–2008–0166; FRL–8750–2]
Approval and Promulgation of
Implementation Plans; Alaska;
Interstate Transport of Pollution
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Correcting amendment.
SUMMARY: EPA issued a direct final rule
on October 15, 2008, entitled ‘‘Approval
and Promulgation of Implementation
Plans; Alaska; Interstate Transport of
Pollution.’’ This document makes a
minor correction to the October 15,
2008, action to correct a typographical
error in the regulatory text for the rule.
DATES: Effective Date: This document is
effective on December 15, 2008.
FOR FURTHER INFORMATION CONTACT: For
questions regarding this correction,
contact Donna Deneen, Office of Air,
Waste, and Toxics, Mail Code (AWT–
107), Environmental Protection Agency
Region 10, Seattle, WA 98121;
telephone number: (206) 553–6706; fax
number: (206) 553–0110; e-mail address:
deneen.donna@epa.gov.
SUPPLEMENTARY INFORMATION:
Background
The EPA issued ‘‘Approval and
Promulgation of Implementation Plans;
Alaska; Interstate Transport of
Pollution’’ as a direct final rule on
October 15, 2008, 73 FR 60955. This
direct final rule approved the State of
Alaska’s demonstration that its
emissions do not significantly
contribute to nonattainment or interfere
with maintenance of the NAAQS in
another state, or interfere with measures
required to be included in the SIP for
any other State to prevent significant
deterioration of air quality or to protect
visibility. For more information about
this action, please see the proposed and
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
final rulemaking actions which are
available at www.regulations.gov and
also in the Federal Register at 73 FR
60955 and 73 FR 60996.
Need for Correction
As published, the regulatory text in
the direct final regulation contains a
minor error that, if not corrected,
prevents publication of the regulatory
amendment in the Code of Federal
Regulations. EPA finds that there is
good cause to make this correction
without providing for notice and
comment because neither notice nor
comment is necessary and would not be
in the public interest due to the nature
of the correction which is minor,
technical and does not change the
obligations already existing in the rule.
EPA finds that the corrections are
merely correcting the numbering in the
amendatory language so that the
provision may be published in the Code
of Federal Regulations.
Corrections of Publication
In the regulatory text to the direct
final rule for ‘‘Approval and
Promulgation of Implementation Plans;
Alaska; Interstate Transport of
Pollution,’’ October 15, 2008, 73 FR
60955, EPA is correcting an inadvertent
minor error in instruction number 2.
Instruction number 2 reads ‘‘Section
52.97 is added to read as follows:’’, but
in the actual text just below that
statement the added section is
designated inadvertently as ‘‘Section
52.70.’’ EPA is correcting this
inadvertent minor error so that the
amendatory instruction number 2
continues to read ‘‘Section 52.97 is
added to read as follows:’’, but the
actual text just below that statement
‘‘§ 52.70’’ is changed to read ‘‘§ 52.97.’’
§ 52.97
[Corrected]
In FR Doc. E8–24279 published
October 15, 2008 (73 FR 60955), make
the following correction. On page
60957, in the center column, the section
heading following amendatory
instruction 2 is corrected to read as
follows:
§ 52.97 Interstate Transport for the 1997
8-hour ozone and PM2.5 NAAQS.
*
*
*
*
*
Dated: December 3, 2008.
Elin D. Miller,
Regional Administrator, Region 10.
[FR Doc. E8–29231 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\12DER1.SGM
12DER1
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Rules and Regulations]
[Pages 75592-75600]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29375]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
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 (703) 305-5805.
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: (703) 305-6304; fax number: (703) 305-5884; e-
mail address: boyle.kathryn@epa.gov.
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
[[Page 75593]]
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.
[[Page 75594]]
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
[[Page 75595]]
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
[[Page 75596]]
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.
* * * * *
[[Page 75597]]
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:
[[Page 75598]]
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
[[Page 75599]]
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
* * * * *
[[Page 75600]]
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 https://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 https://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 https://
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