26194 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 

that the direct final approval will not 

take effect and we will address the 

comments in a subsequent final action 

based on the proposal. If we do not 

receive timely adverse comments, the 

direct final approval will be effective 

without further notice on July 5, 2011. 

This will incorporate these rules into 

the federally enforceable SIP. 

Please note that if EPA receives 

adverse comment on an amendment, 

paragraph, or section of this rule and if 

that provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. 

III. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

State choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this action merely 

approves State law as meeting Federal 

requirements and does not impose 

additional requirements beyond those 

imposed by State law. For that reason, 

this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act 

(5 U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address 

disproportionate human health or 

environmental effects with practical, 

appropriate, and legally permissible 

methods under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by July 5, 2011. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the Proposed Rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Particulate matter, Reporting 

and recordkeeping requirements, 

Volatile organic compounds. 

Dated: March 31, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, chapter I, title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

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

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraph (c)(385) to read as 

follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(385) New and amended regulations 

for the following APCDs were submitted 

on February 28, 2011. 

(i) Incorporation by Reference. 

(A) Mendocino County Air Quality 

Management District. 

(1) Rule 130, ‘‘Definitions,’’ amended 

February 15, 2011. 

(B) Northern Sonoma County Air 

Pollution Control District. 

(1) Rule 130, ‘‘Definitions,’’ amended 

December 14, 2010. 

[FR Doc. 2011–11038 Filed 5–4–11; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


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Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 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: 

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:// 

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 


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26196 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 

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 nonfood 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; TickEX 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 × 108 colonyforming 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 × 1010 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 × 

108 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 × 

107 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 × 108 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 × 

109 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 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 Metarhizium anisopliae 

strain F52. 


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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 soilborne 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 


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26198 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1303 is added to 

subpart D to read as follows: 

§ 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] 

BILLING CODE 6560–50–P 


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