[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Rules and Regulations]
[Pages 26194-26198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11030]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0194; FRL-8872-3]
Metarhizium anisopliae Strain F52; Exemption From the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Metarhizium anisopliae strain F52 in or
on all food commodities when applied as an insecticide, miticide, or
ixodicide and used in accordance with good agricultural practices.
Novozymes Biologicals, Inc. submitted a petition to
[[Page 26195]]
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Metarhizium anisopliae strain F52 under the FFDCA.
DATES: This regulation is effective May 6, 2011. Objections and
requests for hearings must be received on or before July 5, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0194. All documents in the
docket are listed in the docket index available at http://www.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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open 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: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0194 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0194, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 8, 2009 (74 FR 15969) (FRL-8407-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F7508) by Novozymes Biologicals, Inc., 5400 Corporate
Circle, Salem, VA 24153. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Metarhizium anisopliae strain F52. This
notice referenced a summary of the petition prepared by the petitioner,
Novozymes Biologicals, Inc., which is available in the docket, via
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate
[[Page 26196]]
exposure to the pesticide chemical residue. * * *'' Additionally,
section 408(b)(2)(D) of FFDCA requires that EPA consider ``available
information concerning the cumulative effects of [a particular
pesticide's] residues and other substances that have a common mechanism
of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and has considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
A. Overview of Metarhizium Anisopliae Strain F52
Metarhizium anisopliae strain F52 (called MetF52), a
deuteromycetous and entomopathogenic fungus that is found worldwide,
infects numerous insect (primarily Coleoptera of the families
Elateridae and Curculionidae), mite, and tick species that are
contacted by it. Once spores of Metarhizium anisopliae strain F52
attach to the surface of the target pest, they germinate, grow,
penetrate the target pest's exoskeleton, continue to grow in the target
pest, and eventually cause death. Susceptible insects, mites, or ticks
that come into contact with other insects, mites, or ticks that have
been infected with Metarhizium anisopliae strain F52 also become
infected with the fungus, thus continuing this microbe's pesticidal
effect.
Given this distinct capability and efficiency in controlling
various insects, mites, and ticks, Metarhizium anisopliae strain F52 is
currently recognized as the active ingredient in several microbial
pesticide products, which were conditionally registered under section 3
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in
June 2003 to Earth BioSciences, Inc. Since the registration of these
pesticide products in 2003, they have been labeled specifically for
non-food applications in urban and suburban (residential) areas to
control various insects (e.g., thrips and root weevils), mites, and
ticks. In 2006, the Metarhizium anisopliae strain F52-containing
registrations were transferred from Earth BioSciences, Inc. to
Novozymes Biologicals, Inc. (TAE-001 Technical Bioinsecticide, EPA Reg.
No. 70127-7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127-8;
Tick-EX G, EPA Reg. No. 70127-9; Tick-EX EC, EPA Reg. No. 70127-10).
After maintaining the registrations with non-food uses for several
years, Novozymes Biologicals, Inc. has now petitioned EPA to establish
an exemption from the requirement of a tolerance for residues of
Metarhizium anisopliae strain F52 in or on all food commodities.
Accordingly, EPA has reevaluated an assessment of the mammalian
toxicology data that were submitted prior to 2003 to support the
initial applications for Metarhizium anisopliae strain F52 pesticide
products. The overall conclusions from these data are described in Unit
III.B., while more in-depth synopses of the study results can be found
in a 2001 risk assessment, the 2003 Metarhizium anisopliae strain F52
Biopesticides Registration Action Document (BRAD), and the 2011
Addendum to the Metarhizium anisopliae strain F52 BRAD provided as
references in Unit IX. (Refs. 1, 2, and 3).
B. Microbial Pesticide Toxicology Data Requirements
All mammalian toxicology data requirements supporting the request
for an exemption from the requirement of a tolerance for residues of
Metarhizium anisopliae strain F52 in or on all food commodities have
been fulfilled with acceptable studies.
1. Acute oral toxicity and pathogenicity--rat (Harmonized Guideline
885.3050; Master Record Identification Number (MRID No.) 448447-09). An
acceptable acute oral toxicity and pathogenicity study demonstrated
that Metarhizium anisopliae strain F52 was not toxic and/or pathogenic
to rats when dosed at approximately 1.04 x 10\8\ colony-forming units
(cfu)/animal.
2. Acute dermal toxicity--rabbit (Harmonized Guideline 885.3100;
MRID No. 448447-10). An acceptable acute dermal toxicity study
demonstrated that Metarhizium anisopliae strain F52 was not toxic to
rabbits when dosed at 3.63-4.42 x 10\10\ cfu/animal (median lethal dose
(LD50) > 2,000 milligrams per kilogram (mg/kg); Toxicity
Category III).
3. Acute pulmonary toxicity and pathogenicity--rat (Harmonized
Guideline 885.3150; MRID No. 448447-11). An acceptable acute pulmonary
toxicity and pathogenicity study demonstrated that Metarhizium
anisopliae strain F52 was not toxic and/or pathogenic to rats when
dosed intratracheally at approximately 1.17 x 10\8\ cfu/animal.
4. Acute injection toxicity and pathogenicity--rat (Harmonized
Guideline 885.3200; MRID No. 448447-12). An acceptable acute injection
toxicity and pathogenicity study demonstrated that Metarhizium
anisopliae strain F52 was not toxic and/or pathogenic to rats when
dosed intraperitoneally at approximately 1 x 10\7\ cfu/animal.
5. Acute eye irritation--rabbit (Harmonized Guideline 870.2400;
MRID No. 448447-13). An acceptable acute eye irritation study
demonstrated that Metarhizium anisopliae strain F52 was moderately
irritating (i.e., the test substance caused corneal opacity, iritis,
and conjunctival irritation with resolution by day 4) to rabbits when
dosed at 6.3 x 10\8\ cfu/eye/animal (Toxicity Category III).
6. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 448447-15). An acceptable dermal sensitization study
demonstrated that Metarhizium anisopliae strain F52 was not a dermal
sensitizer to guinea pigs when induced and challenged at 2.37 x 10\9\
cfu.
7. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID
No. 448447-14). No hypersensitivity incidents involving Metarhizium
anisopliae strain F52 and occurring during fermentation, processing,
formulation, research, or application have been reported to EPA.
IV. Aggregate Exposure
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Dietary exposure to this microbial pesticide may occur (more likely
through food than drinking water), but the lack of acute oral toxicity,
infectivity, and/or pathogenicity, as exhibited in a toxicology test on
rats presented in Unit III.B., supports the establishment of a
tolerance exemption for residues of Metarhizium anisopliae strain F52.
[[Page 26197]]
1. Food. Exposure to this microbial active ingredient through food
is expected to be minimal. When applied in accordance with good
agricultural practices, Metarhizium anisopliae strain F52, a known
pathogen of various insects, mites, and ticks, is unlikely to persist
on plants. Any spores on plants due to pesticide application would
presumably decrease over time, similar to other fungal entomopathogens
and microbial pest control agents, because of environmental factors
such as rainfall, ultraviolet radiation, and temperature (Refs. 4 and
5). For example, several studies, designed to evaluate the
susceptibility of Metarhizium spores to sunlight, showed that
ultraviolet radiation (UV-A and UV-B) quickly causes inactivation of
these spores, both with and without the use of substances intended to
act as sunscreens (Ref. 6). In the unlikely event that the applied
fungus grew on the edible portions of treated crops, the results of the
toxicology testing demonstrated that no toxicity, infectivity, and/or
pathogenicity in treated animals occurred, even when dosed with high
levels of Metarhizium anisopliae strain F52 by the oral route of
exposure (see additional discussion in Unit III.B.). In conclusion,
there are no concerns for Metarhizium anisopliae strain F52 exposure
through food.
2. Drinking water exposure. Much like dietary exposure, drinking
water exposure is expected to be negligible, albeit for slightly
different reasons. Given the terrestrial use sites, the application
methods with reduced chance for offsite movement of Metarhizium
anisopliae strain F52 (e.g., soil incorporation), and low application
rates, it is not likely that use of Metarhizium anisopliae strain F52
products, when good agricultural practices are followed, will result in
significant increase in fungal spore exposure in drinking water. With
regard to percolation through the soil, Zimmerman (2007) suggests that
Metarhizium anisopliae is a typical soil-borne fungus as it has mostly
been isolated from the upper soil layer. Further, Zimmerman (2007) also
goes on to describe field tests in which many sprayed Metarhizium
anisopliae spores were found in upper layers of loamy soil and humus,
thereby supporting the soil adhesion theory and the absence of
significant spore percolation down to ground water. In the unlikely
event of exposure to Metarhizium anisopliae strain F52 spores through
drinking water, the results of the oral toxicology testing, as
described in Unit III.B., demonstrated that no toxicity, infectivity,
and/or pathogenicity in treated animals occurred. As was concluded for
food exposure, there are no concerns for Metarhizium anisopliae strain
F52 exposure through drinking water.
B. Other Non-Occupational Exposure
Deuteromycetous fungi, such as Metarhizium anisopliae strain F52,
are naturally occurring and found worldwide. As a pesticidal active
ingredient, Metarhizium anisopliae strain F52 has historically been
applied in residential areas. Because of the use patterns and low
application rates, there will not likely be a significant increase in
exposure over the background levels of Metarhizium anisopliae strain
F52 in these residential areas. Furthermore, there is no evidence of
any concern for inhalation or dermal toxicity at exposure levels
several orders of magnitude higher than would be expected to be
encountered by a typical residential end user (see Unit III.B.).
Finally, given that this deuteromycetous fungi affects only certain
species of insects, mites, and ticks, and that no recognized
relationships exist between the Metarhizium genus and any pathogen of
humans and animals, no adverse effects to humans from inhalation or
dermal exposure to this widespread fungus have been reported or are
anticipated.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, EPA consider
``available information concerning the cumulative effects of [a
particular pesticide's] residues and other substances that have a
common mechanism of toxicity.''
EPA has not found Metarhizium anisopliae strain F52 to share a
common mechanism of toxicity with any other substances, and Metarhizium
anisopliae strain F52 does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that Metarhizium anisopliae strain
F52 does not have a common mechanism of toxicity with other substances.
Following from this, therefore, EPA concludes that there are no
cumulative effects associated with Metarhizium anisopliae strain F52
that need to be considered. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http:// www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments,
either directly, or through the use of a margin of exposure analysis,
or by using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk.
Based on the acute toxicity and pathogenicity data discussed in
Unit III.B., as well as use of Metarhizium anisopliae strain F52 as a
microbial pesticide for approximately eight years without reported
adverse effects to humans, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Metarhizium anisopliae strain F52. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion because the data and
information available on Metarhizium anisopliae strain F52 do not
demonstrate toxic, pathogenic, and/or infective potential to mammals.
Thus, there are no threshold effects of concern and, as a result, an
additional margin of safety is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
EPA is establishing an exemption from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever
[[Page 26198]]
possible, consistent with U.S. food safety standards and agricultural
practices. In this context, EPA considers the international maximum
residue limits (MRLs) established by the Codex Alimentarius Commission
(Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius
is a joint U.N. Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
The Codex has not established a MRL for Metarhizium anisopliae
strain F52.
VIII. Conclusions
EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Metarhizium anisopliae strain
F52. Therefore, an exemption is established for residues of Metarhizium
anisopliae strain F52 in or on all food commodities when applied as an
insecticide, miticide, or ixodicide and used in accordance with good
agricultural practices.
IX. References
1. U.S. EPA. 2011. Addendum to Metarhizium anisopliae strain F52
Biopesticides Registration Action Document dated March 2011
(available as ``Supporting & Related Materials'' within docket ID
number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
2. U.S. EPA. 2003. Metarhizium anisopliae strain F52 Biopesticides
Registration Action Document.
3. U.S. EPA. 2001. Review of Toxicology Data for Metarhizium
anisopliae F52 in Support of a Section Three Registration for
Metarhizium anisopliae F52 from Taensa, Inc., Fairfield, CT.
Memorandum from C.A. Wozniak, PhD and J.L. Kough, PhD to L. Cole
dated December 11, 2001 (available as ``Supporting & Related
Materials'' within docket ID number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
4. Jaronski ST. 2010. Ecological factors in the inundative use of
fungal entomopathogens. Biocontrol 55:159-185.
5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background
for Residue Analysis of Microbial Pest Control Agents (OPPTS
885.2000). Available from: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
6. Zimmermann G. 2007. Review of safety of the entomopathogenic
fungus Metarhizium anisopliae. Biocontrol Sci Techn 17(9):879-920.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to EPA. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require EPA consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
XI. 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 to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 28, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1303 is added to subpart D to read as follows:
Sec. 180.1303 Metarhizium anisopliae strain F52; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Metarhizium anisopliae strain F52 in or on all food
commodities when applied as an insecticide, miticide, or ixodicide and
used in accordance with good agricultural practices.
[FR Doc. 2011-11030 Filed 5-5-11; 8:45 am]
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