Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59901 

Subpart P—Indiana 

■ 2. In § 52.770 the table in paragraph 

(c) is amended by revising the entries 

for ‘‘2–2–1’’ and ‘‘2–2–4’’ to read as 

follows: 

§ 52.770 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED INDIANA REGULATIONS

Indiana citation Subject Indiana effective date EPA approval date Notes 

*******

2–2–1 ........................................... Definitions .................................... 03/16/2011 9/28/2011, [Insert page 

number where the document begins].

* * * * * * * 

2–2–4 ........................................... Air quality analysis; requirements 03/16/2011 9/28/2011, [Insert page 

number where the document begins].

* * * * * * * 

* * * * * 

■ 3. In § 52.773, paragraph (k) is 

removed. 

[FR Doc. 2011–24790 Filed 9–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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/textidx?&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 


emcdonald on DSK5VPTVN1PROD with RULES
59902 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

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 indepth 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 × 106 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 (106 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 × 

107 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 ≥107 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 × 107 ¥ 5.3 × 109 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 nonfood 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 nonoccupational 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 wellrecognized 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°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 nonexistent, 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 


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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 


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Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1306 is added to 

subpart D to read as follows: 

§ 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 


emcdonald on DSK5VPTVN1PROD with RULES
59906 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 

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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0849; FRL–8889–1] 

Fluazifop-P-butyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and increases tolerances for residues of 

fluazifop-P-butyl in or on cotton, gin 

byproducts; cotton, refined oil; and 

cotton, undelinted seed. Syngenta Crop 

Protection requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (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–2010–0849. 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 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: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; e-mail 

address: montague.kathryn@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 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. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2010–0849 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–2010–0849, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(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. Summary of Petitioned-for Tolerance 

In the Federal Register of December 

15, 2010 (75 FR 78240) (FRL–8853–1), 

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 petition (PP 0F7768) by 

Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.411 

be amended by establishing tolerances 

for residues of the herbicide, fluazifopP-butyl, butyl(R)-2-[4-[[5- 

(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoate, and 

the free and conjugated forms of the 

resolved isomer of fluazifop, (R)-2-[4- 

[[5-(trifluoromethyl)-2- 

pyridinyl]oxy]phenoxy]propanoic acid, 

expressed as fluazifop, in or on cotton, 

undelinted seed at 0.9 ppm; and cotton, 

gin byproducts at 0.8 ppm. That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

the registrant, which is available in the 

docket, 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 made 

changes to the requested tolerances. 

First, EPA is raising the proposed 

cotton, gin byproducts tolerance from 

0.8 ppm to 1.5 ppm; second, raising the 

established cotton, refined oil tolerance 

from 0.2 ppm to 1.3 ppm; and finally, 


emcdonald on DSK5VPTVN1PROD with RULES