
[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59901-59906]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24990]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0087; FRL-8889-8]


Isaria fumosorosea Apopka Strain 97; 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 Isaria fumosorosea (formerly known as 
Paecilomyces fumosoroseus) Apopka strain 97 in or on all food 
commodities when applied as an insecticide or miticide and used in 
accordance with good agricultural practices. Certis USA, LLC, submitted 
a petition to 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 Isaria fumosorosea Apopka strain 97 under the 
FFDCA.

DATES: This regulation is effective September 28, 2011. Objections and 
requests for hearings must be received on or before November 28, 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-2010-0087. 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: bacchus.shanaz@epa.gov.

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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

[[Page 59902]]

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-2010-0087 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 
November 28, 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-2010-0087, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line 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 March 10, 2010 (75 FR 11171) (FRL-8810-
8), 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 9F7665) by Certis USA, LLC, 9145 Guilford Rd., Suite 175, 
Columbia, MD 21046. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Paecilomyces fumosoroseus (now recognized as 
Isaria fumosorosea) Apopka strain 97. This notice referenced a summary 
of the petition prepared by the petitioner, Certis USA, LLC, which is 
available in the docket via http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the nomenclature of the active ingredient, which was recently 
reclassified as Isaria fumosorosea (Refs. 1, 2, and 3). The reason for 
this change is explained in Unit VII.C. 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 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 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 Isaria fumosorosea Apopka Strain 97

    In 1986, Paecilomyces fumosoroseus Apopka strain 97, an 
entomopathogenic fungus, was isolated from a mealy bug in a greenhouse 
in Apopka, Florida. It was recently reclassified, however, as Isaria 
fumosorosea Apopka strain 97 (Refs. 1, 2, and 3). Because of this 
history, in this and other EPA documents it is variously referred to as 
Isaria fumosorosea Apopka strain 97, Paecilomyces fumosoroseus Apopka 
strain 97, or PFR-97. The pure culture was identified in 1988 and 
deposited at the American Type Culture Collection (ATCC  
20874) in Manassas, Virginia. Conidia of the fungus attach to, and 
penetrate, the cuticle of the host insect or mite where they germinate 
and grow. This leads to pathogenesis and eventual death of the diseased 
insect or mite host.
    Isaria fumosorosea Apopka strain 97 is the active ingredient in two 
microbial pesticide products, which were registered under section 3 of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on 
April 22, 1998 to Thermo Trilogy:
    1. PFR-97TM MUP (EPA Reg. No. 70051-17); and
    2. PFR-97TM 20% WDG (EPA Reg. No. 70051-19).
    Later, Thermo Trilogy changed its name to Certis USA, LLC; Certis 
USA, LLC is both the petitioner and the current registrant of the 
aforementioned products. Since the registration of these pesticide 
products in 1998, they have been labeled specifically for non-food 
applications in greenhouses and nurseries to control various insects 
and mites (e.g., whiteflies, aphids, thrips and spider mites).
    After maintaining the registrations with non-food uses for 13 
years, Certis USA, LLC has now petitioned EPA to establish an exemption 
from the requirement of a tolerance for residues of Isaria fumosorosea 
Apopka strain 97 in or on all food commodities. Accordingly, EPA has 
reassessed the mammalian toxicology data that were submitted prior to 
1998 to support the initial applications for Isaria fumosorosea Apopka 
strain 97 pesticide products. The overall conclusions from these data, 
along with Toxicity Category classifications (as appropriate), are 
described in Unit III.B., while more in-depth synopses of the study 
results can be found in the 2011 Isaria fumosorosea (formerly 
Paecilomyces fumosoroseus) Apopka strain 97 Biopesticides Registration 
Action Document (BRAD) and a 2011 data evaluation record provided as 
references in Unit IX. (Refs.

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3 and 4). To learn more about the Toxicity Categories, please see 40 
CFR 156.62.

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 
Isaria fumosorosea Apopka strain 97 in or on all food commodities have 
been fulfilled with studies evaluated by EPA as acceptable (i.e., data 
that are scientifically sound and useful for risk assessment) or 
supplemental (i.e., data that provide some information useful for risk 
assessment).
    1. Acute oral toxicity/pathogenicity--rat (Harmonized Guideline 
885.3050; Master Record Identification Number (MRID No.) 431639-01). An 
acceptable acute oral toxicity/pathogenicity study demonstrated that 
Isaria fumosorosea Apopka strain 97 was not toxic, pathogenic, or 
infectious to test rodents. An oral dose of 1.7 x 10\6\ colony-forming 
units (cfu)/animal in a conidia spore suspension did not produce 
mortality or abnormal clinical effects. No signs of fungal 
contamination were reported for the brain, mesenteric lymph nodes, 
blood, kidney, spleen, liver, lung or cecum, and no infectivity or 
pathogenicity was recorded (Toxicity Category IV).
    2. Acute dermal toxicity--rabbit (Harmonized Guideline 885.3100; 
MRID No. 432255-01). An acceptable acute dermal toxicity test 
demonstrated that Isaria fumosorosea Apopka strain 97 was not toxic to 
rabbits when applied dermally. Two grams of test substance applied to 
the skin of rabbits produced a mild irritation at 72 hours post dosing, 
but dermal irritation was completely reversed by day 7. There were no 
deaths and no evidence of systemic toxicity. The acute dermal median 
lethal dose (LD50) (i.e., a statistically derived single 
dose that can be expected to cause death in 50% of test animals) was 
greater than 2,000 milligrams per kilogram (mg/kg) (Toxicity Category 
III).
    3. Acute pulmonary toxicity/pathogenicity--rat (Harmonized 
Guideline 885.3150; MRID No. 431398-02). An acceptable acute pulmonary 
toxicity/pathogenicity study demonstrated that Isaria fumosorosea 
Apopka strain 97 was not toxic, pathogenic, or infectious when a single 
dose (10\6\ conidia spores/animal) was intratrachaelly administered to 
rats. No deaths, signs of toxicity or infection, or colonization of the 
lungs were observed. Total clearance of the fungus was attained by day 
eight after treatment (Toxicity Category IV).
    4. Acute injection toxicity/pathogenicity (intraperitoneal)--rat 
(Harmonized Guideline 885.3200; MRID No. 431398-03). An acceptable 
acute injection toxicity/pathogenicity study demonstrated that single 
intraperitoneal doses of Isaria fumosorosea Apopka strain 97 
suspensions, containing 1.6 x 10\7\ conidia spores per animal, had no 
toxic or pathogenic effects. Moreover, the spores were cleared from the 
body within two days (Toxicity Category IV).
    5. Acute eye irritation--rabbit (Harmonized Guideline 870.2400; 
MRID No. 431462-01). An acceptable acute eye irritation study 
demonstrated that Isaria fumosorosea Apopka strain 97 produced slight 
eye irritation in rabbits. A dose of 0.1 milliliter of diluted test 
substance, containing >=10\7\ cfu, was instilled in the eye, which was 
examined 1 hour, 24 hours, 48 hours, 72 hours, 4 days, and 7 days after 
treatment (irritation symptoms reversed by day 4; Toxicity Category 
IV).
    6. Primary dermal irritation--rabbit (Harmonized Guideline 
870.2500; MRID No. 431462-02). An acceptable primary dermal irritation 
study demonstrated that Isaria fumosorosea Apopka strain 97 was 
slightly irritating to the skin of rabbits (irritation symptoms 
reversed by 48 hours; Toxicity Category IV).
    7. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600; 
MRID No. 431462-03). A supplemental dermal sensitization study 
demonstrated that Isaria fumosorosea Apopka strain 97 was not a dermal 
sensitizer to guinea pigs when induced and challenged at 3.0 x 10\7\ - 
5.3 x 10\9\ cfu.
    8. Hypersensitivity incidents (Harmonized Guideline 885.3400). No 
hypersensitivity incidents involving Isaria fumosorosea Apopka strain 
97 have been reported to EPA over the last 13 years, during which time 
the associated pesticide products have been both manufactured and used 
for non-food uses.

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 Isaria fumosorosea Apopka strain 97 
in or on all food commodities when used in accordance with good 
agricultural practices.
    1. Food exposure. For several reasons described in this unit, 
exposure to this microbial active ingredient through food is expected 
to be minimal. When applied in accordance with good agricultural 
practices, Isaria fumosorosea Apopka strain 97, a well-recognized 
pathogen of various insects and mites, is unlikely to persist on plants 
(Refs. 3 and 4). 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 
constantly fluctuating environmental factors such as rainfall, 
ultraviolet radiation, and temperature (Refs. 2, 3, 4, 5, and 6). For 
instance, using artificial sunlight, Fargues et al. (1997) investigated 
the effects of solar radiation on Paecilomyces fumosoroseus Apopka 
strain 97 conidia and found that both ultraviolet-B (280-320 nm) and 
ultraviolet-A (320-400 nm) light were most detrimental to the 
germinability, survival, and infectivity of the conidia (Ref. 6). In 
addition to certain environmental factors, washing, peeling, and/or 
other processing of food treated with Isaria fumosorosea Apopka strain 
97 should further remove, dilute, and/or inactivate pesticidal residues 
on food (to the extent they exist), particularly in light of the 
inability of this microbe to survive in water or at temperatures higher 
than 25[deg] C (Refs. 3, 4, and 5). In the remote likelihood that this 
microbial pesticide is present in or on food, the acute oral toxicity 
and pathogenicity data demonstrated no toxicity, infectivity, and/or 
pathogenicity is likely to occur with any such exposure to Isaria 
fumosorosea Apopka strain 97 (see additional discussion in Unit 
III.B.).
    2. Drinking water exposure. The potential for significant transfer 
of Isaria fumosorosea Apopka strain 97 to drinking water is minimal to 
non-existent, specifically given the three bases elaborated upon in 
this unit. First, there are no aquatic use sites permitted for 
pesticide products containing Isaria fumosoroseus Apopka strain 97, so 
exposure to surface water is not anticipated. Second, Isaria 
fumosorosea Apopka strain 97 is not known as an aquatic microorganism; 
therefore, even if Isaria fumosorosea Apopka strain 97 were to 
inadvertently come into contact with surface or ground waters, it is

[[Page 59904]]

unlikely to proliferate in water (Refs. 3 and 4). Finally, if Isaria 
fumosorosea Apopka strain 97 were to be transferred to surface water 
intended for eventual human consumption (e.g., through spray drift or 
runoff) and also managed to persist, it would not survive the 
conditions water is subjected to in wastewater treatment systems or 
drinking water facilities, including high temperatures, chlorination, 
pH adjustments and/or filtration (Refs. 7 and 8). In the remote 
likelihood that this microbial pesticide is present in drinking water, 
the acute oral toxicity and pathogenicity data demonstrated no 
toxicity, infectivity and/or pathogenicity is likely to occur with any 
such exposure to Isaria fumosorosea Apopka strain 97 (see additional 
discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Non-occupational dermal and inhalation exposure to Isaria 
fumosorosea Apopka strain 97 is expected to be minimal to non-existent, 
primarily because it will be applied to agricultural sites not in the 
proximity of residential areas where facilities with sensitive 
subpopulations (e.g., schools, nursing homes, and daycares) are most 
often situated. Even if non-occupational dermal and inhalation exposure 
were to occur inadvertently (e.g., through spray drift) or due to an 
eventual expansion of use sites, such exposure would not be of concern 
since testing indicates that Isaria fumosorosea Apopka strain 97 is not 
toxic, pathogenic, and/or infective (acute dermal toxicity and acute 
pulmonary toxicity/pathogenicity); is only slightly irritating (primary 
dermal irritation); and is not a sensitizer (dermal sensitization) (see 
additional discussion in Unit III.B.). In addition, this active 
ingredient has been in use for approximately 13 years without reported 
incidents.

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 exemption, EPA 
consider ``available information concerning the cumulative effects of 
[a particular pesticide's] * * * residues and other substances that 
have a common mechanism of toxicity.'' These considerations include the 
possible cumulative effects of such residues on infants and children. 
EPA has not found Isaria fumosorosea Apopka strain 97 to share a common 
mechanism of toxicity to mammals with any other substances, and Isaria 
fumosorosea Apopka strain 97 does not appear to produce a toxic 
metabolite produced by other substances that may be of toxicological 
concern to human health. For the purposes of this tolerance action, 
therefore, EPA has assumed that Isaria fumosorosea Apopka strain 97 
does not have a common mechanism of toxicity with other substances. 
Following from this, EPA concludes that no cumulative or incremental 
effects to humans, including infants and children, are anticipated in 
connection with the use of Isaria fumosorosea Apopka strain 97 when it 
is used in accordance with its label directions and good agricultural 
practices. 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 United States (U.S.) Population, 
Infants and Children

    In considering the establishment of a tolerance or tolerance 
exemption for a pesticide chemical residue, 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 (10X) 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 on toxicity and exposure unless EPA 
determines that a different margin of safety will be safe for infants 
and children. This additional margin of safety is commonly referred to 
as the Food Quality Protection Act Safety Factor. In applying this 
provision, EPA either retains the default value of 10X or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III.B., as well as use of Isaria fumosorosea Apopka strain 97 as a 
microbial pesticide for approximately 13 years without reported adverse 
effects to humans, EPA concludes that there are no threshold effects of 
concern to infants, children, or adults when Isaria fumosorosea Apopka 
strain 97 is used as labeled in accordance with good agricultural 
practices. As a result, the Agency concludes that no additional margin 
of exposure (safety) is necessary to protect infants and children, and 
that not adding any additional margin of exposure (safety) will be safe 
for infants and children.
    Moreover, based on the same data and EPA analysis as previewed in 
this unit, the Agency is able to conclude 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 Isaria 
fumosorosea Apopka strain 97 when it is used--as labeled and in 
accordance with good agricultural practices--as an insecticide or 
miticide. Such exposure includes all anticipated dietary exposures and 
all other exposures for which there is reliable information. EPA has 
arrived at this conclusion because, considered collectively, the data 
and information available on Isaria fumosorosea Apopka strain 97 do not 
demonstrate toxic, pathogenic, and/or infective potential to mammals, 
including infants and children.

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 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 Isaria fumosorosea Apopka 
strain 97.

C. Revisions to Petitioned-for Tolerance Exemption

    In the Federal Register of March 10, 2010, EPA announced Certis 
USA, LLC's filing of a pesticide petition that

[[Page 59905]]

proposed establishing an exemption from the requirement of a tolerance 
for residues of Paecilomyces fumosoroseus Apopka strain 97. Data 
submitted to EPA, as well as a review of current literature, 
demonstrate that the taxonomy of the microorganism has changed. 
Paecilomyces fumosoroseus Apopka strain 97 is now classified as Isaria 
fumosorosea Apopka strain 97 (Refs. 1, 2, and 3).

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 Isaria fumosorosea Apopka strain 
97. Therefore, an exemption from the requirement of a tolerance is 
established for residues of Isaria fumosorosea (formerly Paecilomyces 
fumosoroseus) Apopka strain 97 in or on all food commodities when 
applied as an insecticide or miticide and used in accordance with good 
agricultural practices.

IX. References

1. Agricultural Research Service Collection of Entomopathogenic 
Fungal (ARSEF) Cultures. January 24, 2011. Isaria, plus Paecilomyces 
and Evlachovea USDA-ARS Biological Integrated Pest Management 
Research, Robert W. Holley Center for Agriculture and Health. 538 
Tower Road, Ithaca, New York 14853-2901.
2. Zimmermann G. 2008. The entomopathogenic fungi Isaria farinosa 
(formerly Paecilomyces farinosus) and the Isaria fumosorosea species 
complex (formerly Paecilomyces fumosoroseus): biology, ecology and 
use in biological control. Biocontrol Science and Technology 18:865-
901.
3. U.S. EPA. 2011. Isaria fumosorosea (formerly Paecilomyces 
fumosoroseus) Apopka strain 97 Draft Biopesticides Registration 
Action Document (BRAD) dated August 10, 2011 (available as 
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2010-0088 at http://www.regulations.gov).
4. U.S. EPA. 2011. Request for Exemption from the Requirement of a 
Tolerance. Data evaluation record prepared by I. Barsoum, Ph.D. 
(available as ``Supporting & Related Material'' within docket ID 
number EPA-HQ-OPP-2010-0088 at http://www.regulations.gov).
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. Fargues J, Rougier M, Goujet R, Smits N, Coustere C, Itier B. 
1997. Inactivation of Conidia of Paecilomyces fumosoroseus by Near-
Ultraviolet (UVB and UVA) and Visible Radiation. Journal of 
Invertebrate Pathology 69:70-78.
7. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment 
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.
8. Centers for Disease Control and Prevention. 2009. Drinking 
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

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: September 20, 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 180.1306 is added to subpart D to read as follows:


Sec.  180.1306  Isaria fumosorosea (formerly Paecilomyces fumosoroseus) 
Apopka strain 97; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Isaria fumosorosea (formerly Paecilomyces fumosoroseus) 
Apopka strain 97 in or on all food commodities

[[Page 59906]]

when applied as an insecticide or miticide and used in accordance with 
good agricultural practices.

[FR Doc. 2011-24990 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P


