22460 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Rules and Regulations 

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 29, 2009. 

Meredith F. Laws, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In §180.910, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Calcium lactate 

pentahydrate (CAS 

Reg. No. 5743–47– 

5).

.......... Nutrient, 

stabilizer 

* * * * * 

[FR Doc. E9–10769 Filed 5–12–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0164; FRL–8412–9] 

Candida oleophila Strain O; 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 the microbial 

pesticide, Candida oleophila Strain O, 

on apples and pears when applied/used 

as a post-harvest biofungicide. BioNext 

sprl (in care of SynTech Global, 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 Candida oleophila Strain 

O. 

DATES: This regulation is effective May 

13, 2009. Objections and requests for 

hearings must be received on or before 

July 13, 2009, 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–2008–0164. 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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347-8920; e-mail address: 

kausch.jeannine@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2008–0164 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before July 13, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0164, by one of 

the following methods. 

Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Rules and Regulations 22461 

• 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. Background and Statutory Findings 

In the Federal Register of March 28, 

2008 (73 FR 16673) (FRL–8355–6), 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 7F7310) 

by BioNext sprl, Passage des deportes, 2, 

B-5030 Gembloux, Belgium (in care of 

SynTech Global, LLC, P.O. Box 640, 

Hockessin, DE 19707). The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Candida oleophila Strain O. 

This notice included a summary of the 

petition prepared by the petitioner, 

BioNext sprl (in care of SynTech Global, 

LLC). 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 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 the Agency 

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. 

Candida oleophila Strain O is a 

single-celled yeast in the phylum 

Ascomycota, the class Ascomycetes, and 

the family Saccharomycetaceae. Found 

naturally on plant tissues (fruits, 

flowers, and wood) and in water, it was 

originally isolated from Golden 

Delicious apples and is intended for use 

as an antagonist to control the fungal 

pathogens, grey mold (Botrytis cinerea) 

and blue mold (Penicillium expansum), 

that cause post-harvest decay on apples 

and pears. The mode of action for 

Candida oleophila Strain O is primarily 

through competition for nutrients and 

pre-colonization of plant wound sites. 

Submitted data also suggest that 

production of beta-1,3-glucanases (i.e., 

hydrolytic enzymes that can degrade 

fungal phytopathogen cell walls) may 

contribute to its antagonistic activity. 

According to reported testing, Candida 

oleophila Strain O does not grow above 

33°C, is sensitive to ultraviolet light, 

and is dependent on a carbon source for 

growth. Some species of Candida are 

reported as opportunistic pathogens to 

humans and/or animals. Candida 

oleophila, however, is an environmental 

microbe unable to grow at mammalian 

body temperatures and easily 

distinguished from the Candida species 

reported as clinical isolates. More 

importantly, no pathogenic effects or 

infections from Candida oleophila 

Strain O were seen in the submitted 

infectivity studies discussed below and 

there have been no clinical reports of 

Candida oleophila infection even 

though various strains of this species 

naturally occur on food commodities 

such as apples, olives, strawberries, 

fermenting grapes, and tomatoes. 

Additional information regarding 

Candida oleophila Strain O can be 

found in the Biopesticides Registration 

Action Document (BRAD) on the 

Biopesticides and Pollution Prevention 

Division (BPPD) website: http:// 

www.epa.gov/pesticides/biopesticides. 

Studies submitted to the Agency were 

issued Master Record Identification 

(MRID) Numbers and reviewed by BPPD 

scientists. These submissions were 

considered in light of the microbial 

pesticides data requirements, which 

became final on December 26, 2007 (72 

FR 61002). The following summaries of 

the toxicological profile of Candida 

oleophila Strain O are based on an 

Agency risk assessment memorandum 

and related data evaluation records 

dated November 13, 2008. 

A. Acute Oral Toxicity and 

Pathogenicity – Rat (Office of 

Prevention, Pesticides, and Toxic 

Substances [OPPTS] Guideline 

885.3050; MRID No. 473138-07) 

In an acute oral toxicity and 

pathogenicity study, groups of rats were 

given a single oral dose of Candida 

oleophila Strain O at a dose of 2.3–3.8 

x 108 colony-forming units (CFU)/ 

animal. The animals were observed for 

a period of up to 22 days with interim 

scheduled sacrifices on days 4, 8, and 

15. There were no treatment-related 

clinical signs, necropsy findings, or 

changes in body weight. No test 

organisms were recovered from the 

gastrointestinal contents, any organs, or 

blood of any animal or feces from 

treated animals sacrificed on day 22. 

Based on the results of this study, 

Candida oleophila Strain O does not 

appear to be toxic, infective, and/or 

pathogenic in rats. This study was rated 

‘‘ACCEPTABLE’’ for risk assessment 

purposes. 

B. Acute Subcutaneous Injection 

Toxicity and Pathogenicity – Rat 

(OPPTS Guideline 885.3200; MRID No. 

473138-08) 

In an acute subcutaneous injection 

toxicity and pathogenicity study, groups 

of rats were injected subcutaneously 

with Candida oleophila Strain O with a 

dose of 1.1–2.0 x 107 CFU/animal. The 

animals were observed for up to 22 

days. There were no treatment-related 

clinical signs, necropsy findings, or 

changes in body weight. No test 

22462 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Rules and Regulations 

organisms were recovered from the 

gastrointestinal contents, organs, blood, 

or the injection site of any animal. 

Based on the results of this study, 

Candida oleophila Strain O does not 

appear to be toxic, infective, and/or 

pathogenic in rats, when dosed at 1.1– 

2.0 x 107 CFU/animal. This study was 

rated ‘‘ACCEPTABLE’’ for risk 

assessment purposes. 

C. Acute Pulmonary Toxicity and 

Pathogenicity – Rat (OPPTS Guideline 

885.3150; MRID No. 473138-09) 

In an acute pulmonary toxicity and 

pathogenicity study, groups of rats were 

exposed by the intratracheal route to 

Candida oleophila Strain O at a dose of 

1.2–5.2 x 108 CFU/animal. The animals 

were observed for up to 22 days. There 

were no test substance-related clinical 

signs, necropsy findings, or changes in 

body weight. Test organisms were 

recovered in the lungs from the treated 

males and females sacrificed one hour 

post dosing with clearance by day 4. No 

test organisms were recovered from the 

gastrointestinal contents, organs, or 

blood of any animal or feces from 

treated animals sacrificed on day 22. 

Based on these results, Candida 

oleophila Strain O does not appear to be 

toxic, infective, and/or pathogenic to 

rats at 1.2–5.2 x 108 CFU/animal. This 

study was rated ‘‘ACCEPTABLE’’ for 

risk assessment purposes. 

D. Hypersensitivity Incidents (OPPTS 

Guideline 885.3400; MRID No. 473138- 

12) 

During a pilot-plant production trial 

using fermentation vessels and 

involving large amounts of Candida 

oleophila Strain O, 3 of 6 workers (all 

on the same work team) not wearing 

personal protective equipment (PPE) 

reported clinical symptoms of a 

respiratory reaction. No adverse dermal 

effects have been reported by workers. 

Respiratory and dermal sensitization to 

consumers is not anticipated, mainly 

due to the extremely high exposure to 

Candida oleophila Strain O encountered 

by workers during the fermentation 

process as opposed to the very low 

exposure anticipated on treated fruit 

intended for human consumption. Any 

future hypersensitivity reports must be 

reported per OPPTS Guideline 

885.3400. 

E. Bacterial Reverse Mutation Test 

(OPPTS Guideline 870.5100; MRID No. 

473138-13) and In Vitro Mammalian 

Cell Gene Mutation Test (OPPTS 

Guideline 870.5300; MRID No. 473138- 

14) 

Two mutagenicity tests were 

submitted, reviewed, and indicated that 

Candida oleophila Strain O did not 

have mutagenic potential. These studies 

were rated ‘‘SUPPLEMENTAL’’ for the 

purposes of risk assessment and they are 

not required studies for this active 

ingredient. 

IV. Aggregate Exposures 

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 Candida 

oleophila Strain O is likely to occur, 

mainly through food. However, the lack 

of acute oral toxicity/pathogenicity, 

based on the toxicology test on rats 

presented in Unit III., and the 

ubiquitous nature of the microbe on 

various food commodities support the 

establishment of an exemption from the 

requirement of a tolerance for Candida 

oleophila Strain O. Additionally, under 

40 CFR 180.1144, a similar active 

ingredient, Candida oleophila isolate I182, was assessed previously and 

granted an exemption from the 

requirement of a tolerance when used as 

a post-harvest biological fungicide in or 

on all raw agricultural commodities. 

1. Food. Candida oleophila Strain O 

is naturally present on apples as it was 

originally isolated in 1991 from the 

surface of Golden Delicious apples. 

Based on information submitted to the 

Agency, population densities of white 

yeasts are estimated to reach 1.5 x 103

CFU/square centimeter (cm2) on 

harvested apples, which includes the 

natural population of Candida 

oleophila. Background levels of 

Candida oleophila Strain O on apples 

are expected to be below 1.5 x 103 CFU/ 

cm2. Post-harvest treatment with 

Candida oleophila Strain O will 

probably lead to a temporary increased 

level of this yeast on apples. The mode 

of action of Candida oleophila Strain O 

is primarily based on competition for 

nutrients; therefore, sufficient 

colonization of apple surfaces has to be 

reached to ensure efficacy of the active 

ingredient. The recommended 

application rate of Candida oleophila 

Strain O leads to an expected residual 

Candida oleophila Strain O population 

of approximately 4 x 104 CFU/cm2 (105

CFU/apple). Standard practices of 

washing, peeling, cooking, or processing 

fruits further reduces residues of 

Candida oleophila Strain O and 

minimizes dietary exposure. Actual 

dietary exposure is expected to be 

several orders of magnitude lower than 

the dose used in the acute oral toxicity/ 

pathogenicity test referenced in Unit III., 

during which no toxic or pathogenic 

effects were observed in rats. The 

Agency concludes that there is a 

reasonable certainty that no harm will 

result from the aggregate exposure to the 

residues of Candida oleophila Strain O 

in food. 

2. Drinking water exposure. Exposure 

of humans to residues of Candida 

oleophila Strain O in drinking water is 

unlikely. The proposed use pattern, use 

sites, and application methods for 

Candida oleophila Strain O (i.e., dip or 

drench application to apples and pears 

after harvest and prior to storage) does 

not include direct application to aquatic 

environments. In the unlikely event that 

Candida oleophila Strain O was 

transferred to surface or ground water 

intended for eventual human 

consumption, the microbe would not 

survive the conditions water is 

subjected to in a drinking water 

treatment facility, including 

flocculation, chlorination, pH 

adjustments, and/or filtration. Even if 

oral exposure should occur through 

drinking water, the Agency concludes 

that there is a reasonable certainty that 

no harm will result from the exposure 

to the residues of Candida oleophila 

Strain O in all the anticipated drinking 

water exposures because of the lack of 

acute oral toxicity/pathogenicity to 

mammals and the ubiquitous nature of 

the microbe, as previously described. 

B. Other Non-Occupational Exposure 

Potential non-occupational dermal or 

inhalation exposure is considered 

unlikely for this distinctly agricultural 

use (i.e., post-harvest treatment of the 

harvested portions—pears and apples— 

of agricultural plants). 

1. Dermal exposure. Nonoccupational dermal exposure to 

Candida oleophila Strain O, when used 

as labeled, is expected to be negligible 

because it is limited to post-harvest 

agricultural treatment of apples and 

pears. However, should nonoccupational dermal exposure occur 

through treated food commodities, the 

risk posed by this low toxicity microbe 

is likely to be minimal based on the 

toxicity and pathogenicity tests 

described in Unit III. Furthermore, 

exposure would not be expected to 

exceed background as similar yeasts and 

those in the genus and species, Candida 

oleophila, are commonly associated 

with particular food commodities. 

Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Rules and Regulations 22463 

2. Inhalation exposure. Nonoccupational inhalation exposure to 

Candida oleophila Strain O, when used 

as labeled, is expected to be negligible 

because of the method of application 

(i.e., dipping and drenching of apples 

and pears), which then allows sufficient 

time for drying prior to distribution to 

consumers. Furthermore, most of the 

residual yeast on apples and pears is 

trapped in the cuticular wax and it is 

unlikely to be inhaled by consumers. 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the FFDCA 

requires the Agency to consider the 

cumulative effects of exposure to 

Candida oleophila Strain O and to other 

substances that have a common 

mechanism of toxicity. These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. As demonstrated 

in Unit III., Candida oleophila Strain O 

is not toxic or pathogenic to mammals 

via several routes of exposure. 

Additionally, there are no other 

Candida oleophila strains currently 

registered as pesticides with the 

Agency. Consequently, since this 

microbial pesticide has no demonstrated 

toxicity, there is no reason to anticipate 

cumulative effects from the residues of 

this product with other related 

microbial pesticides. 

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) also 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 assessment 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., 

EPA concludes that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to the United States 

population, including infants and 

children, to the residues of Candida 

oleophila Strain O. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. The Agency has 

arrived at this conclusion because the 

data available on Candida oleophila 

Strain O do not demonstrate toxic, 

pathogenic, or infective potential to 

mammals. Thus, there are no threshold 

effects of concern and, as a result, the 

provision requiring an additional 

margin of safety does not apply. Further, 

the considerations of consumption 

patterns, special susceptibility, and 

cumulative effects do not apply to 

pesticides without a demonstrated 

significant adverse effect. 

VII. Other Considerations 

A. Endocrine Disruptors 

EPA is required, under Section 408(p) 

of the FFDCA, to develop a screening 

program to determine whether certain 

substances (including all pesticide 

active and other ingredients) ‘‘may have 

an effect in humans that is similar to an 

effect produced by naturally-occurring 

estrogen, or other such endocrine effects 

as the Administrator may designate.’’ 

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there was a 

scientific basis for including, as part of 

its program, androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that the program include evaluations of 

potential effects on wildlife. 

The Agency has no knowledge of 

Candida oleophila Strain O being an 

endocrine disruptor, nor is this microbe 

related to any class of known endocrine 

disruptors. Following several routes of 

exposure in rodents, the Tier I 

toxicology data indicated that the 

immune system was still intact and able 

to process and clear Candida oleophila 

Strain O from a variety of organs or 

tissues. Additional data, specifically on 

the endocrine effects of this microbial 

pesticide, are not required at this time. 

Consequently, endocrine-related 

concerns did not impact the Agency’s 

safety finding for Candida oleophila 

Strain O. When the appropriate 

screening and/or testing protocols being 

considered under the Agency’s 

Endocrine Disruptor Screening Program 

(EDSP) have been developed and 

implemented, Candida oleophila Strain 

O may be subject to additional screening 

and/or testing to better characterize 

effects related to endocrine disruption. 

B. Analytical Method(s) 

The Agency proposes to establish an 

exemption from the requirement of a 

tolerance without any numerical 

limitation; therefore, the Agency has 

concluded that an analytical method is 

not required for enforcement purposes 

for Candida oleophila Strain O. 

C. Codex Maximum Residue Level 

No Codex maximum residue level 

exists for ECandida oleophila Strain O. 

VIII. Conclusions 

The results of the studies discussed in 

Unit III meet the safety requirements of 

the Food Quality Protection Act (FQPA) 

of 1996. They support an exemption 

from the requirement of a tolerance for 

the residues of the microbial pesticide, 

Candida oleophila Strain O, on apples 

and pears. In addition, the Agency is of 

the opinion that, if the microbial active 

ingredient is used as allowed, aggregate 

exposure and cumulative effects are not 

likely to harm the United States 

population, including infants and 

children. Therefore, in response to 

pesticide tolerance petition 7F7310, an 

exemption from the requirement of a 

tolerance is established for the residues 

of the microbial pesticide, Candida 

oleophila Strain O, on apples and pears 

when applied/used as a post-harvest 

biofungicide. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. 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). 

22464 Federal Register / Vol. 74, No. 91 / Wednesday, May 13, 2009 / Rules and Regulations 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance 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, 

nor does this action 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, 

the Agency 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, the Agency 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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

X. 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:May 1, 2009. 

Debra Edwards, 

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 180.1289 is added to 

subpart D to read as follows: 

§ 180.1289 Candida oleophila Strain O; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of the microbial pesticide, 

Candida oleophila Strain O, on apples 

and pears when applied/used as a postharvest biofungicide. 

[FR Doc. E9–10962 Filed 5–12–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0020; FRL–8410–3] 

Methoxyfenozide; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

the insecticide methoxyfenozide per se, 

in or on sorghum, forage; sorghum, 

grain; and sorghum, stover. This action 

is in response to a crisis exemption 

issued by the Louisiana Department of 

Agriculture under section 18 of the 

Federal Insecticide, Fungicide and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on grain sorghum. 

This regulation establishes a maximum 

permissible level for residues of 

methoxyfenozide in these feed 

commodities. The time-limited 

tolerances expire and will be revoked on 

December 31, 2012. 

DATES: This regulation is effective May 

13, 2009. Objections and requests for 

hearings must be received on or before 

July 13, 2009, 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–2009–0020. All documents in the 

docket are listed in the docket index 

available in 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: 

Stacey Groce, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–2505; e-mail address: 

groce.stacey@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.