55268 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

Pesticide chemical CAS Reg. No. Limits 

*******

Lipase, triacylglycerol ................................................................ 9001–62–1 When ready for use, the end-use concentration is not to exceed 500 ppm. 

*******

* * * * * 

[FR Doc. 2011–22844 Filed 9–6–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0054; FRL–8887–4] 

Chromobacterium subtsugae Strain 

PRAA4–1T; 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 

Chromobacterium subtsugae strain 

PRAA4–1T in or on all food 

commodities when applied as an 

insecticide or miticide and used in 

accordance with good agricultural 

practices. Marrone Bio Innovations, Inc. 

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 Chromobacterium 

subtsugae strain PRAA4–1T under the 

FFDCA. 

DATES: This regulation is effective 

September 7, 2011. Objections and 

requests for hearings must be received 

on or before November 7, 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–2010–0054. 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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

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 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 

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–2010–0054 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 7, 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–2010–0054, 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. 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 55269 

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 9F7674) 

by Marrone Bio Innovations, Inc., 2121 

Second Street, Suite B–107, Davis, CA 

95618. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of Chromobacterium subtsugae strain 

PRAA4–1T. This notice referenced a 

summary of the petition prepared by the 

petitioner, Marrone Bio Innovations, 

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 

exposure to the pesticide chemical 

residue * * *’’ Additionally, section 

408(b)(2)(D) of FFDCA requires that the 

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 Chromobacterium 

subtsugae Strain PRAA4–1T

Chromobacterium subtsugae strain 

PRAA4–1T is a naturally occurring, 

gram-negative, violet-pigmented 

bacterium that was isolated from soil 

under an eastern hemlock (Tsuga 

canadensis) in the Catoctin Mountain 

region of central Maryland. The United 

States Department of Agriculture found 

this isolate of Chromobacterium 

subtsugae to be orally toxic to Colorado 

potato beetle (Leptinotarsa 

decemlineata) larvae, small hive beetle 

(Aethina tumida) larvae, southern corn 

rootworm (Diabrotica undecimpunctata) 

larvae and adults, and southern green 

stink bug (Nezara viridula) adults. 

Additional testing has shown that 

Chromobacterium subtsugae strain 

PRAA4–1T-treated diet resulted in 

reduced feeding in beet armyworm 

(Spodoptera exigua), cabbage looper 

(Trichoplusia ni), tobacco budworm 

(Heliothis virescens), diamondback 

moth (Plutella xylostella), and southern 

corn rootworm, suggesting this 

microbe’s insecticidal activity is due to 

reduction in weight or inhibition of 

feeding. In light of the demonstrated 

insecticidal and miticidal capabilities of 

Chromobacterium subtsugae strain 

PRAA4–1T, Marrone Bio Innovations, 

Inc. has proposed to register pesticide 

products that could be applied to 

agricultural and greenhouse crops, 

including vegetables, fruit, flowers, 

bedding plants, ornamentals, and turf, 

to control certain insect and mite pests. 

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 

Chromobacterium subtsugae strain 

PRAA4–1T in or on all food 

commodities have been fulfilled with 

data submitted by the petitioner or data 

waiver requests that have been granted 

by EPA. The toxicity tests (acute oral, 

dermal, and inhalation toxicity) and 

irritation tests (acute eye and primary 

dermal irritation), which addressed 

potential routes of exposure to the 

active ingredient, were all classified in 

Toxicity Category IV (see 40 CFR 

156.62). Moreover, an acute injection 

toxicity/pathogenicity test indicated 

that Chromobacterium subtsugae strain 

PRAA4–1T was not toxic, infective, and/ 

or pathogenic via the intravenous route 

of exposure, a worst-case scenario 

whereby the skin is bypassed as a 

barrier. Finally, Chromobacterium 

subtsugae strain PRAA4–1T is not 

recognized as a dermal sensitizer, and 

the petitioner has reported that no 

hypersensitivity incidents occurred 

during development and testing of this 

bacterium. The overall conclusions from 

all toxicological information submitted 

by the petitioner are described below, 

while more in-depth synopses of the 

study results can be found in the 

associated Biopesticides Registration 

Action Document provided as a 

reference in Unit IX. (Ref. 1). 

1. Acute oral toxicity—rat 

(Harmonized Guideline 870.1100; 

Master Record Identification Number 

(MRID No.) 479450–03). An acceptable 

acute oral toxicity study demonstrated 

that Chromobacterium subtsugae strain 

PRAA4–1T was not toxic to female rats 

when dosed at 5,000 milligrams per 

kilogram (mg/kg). The 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 5,000 mg/kg (Toxicity 

Category IV). 

2. Acute oral toxicity/pathogenicity 

(Harmonized Guideline 885.3050; MRID 

No. 479450–23). Upon consideration of 

results of other definitive toxicological 

data submitted by the petitioner, EPA 

waived acute oral toxicity/pathogenicity 

testing for Chromobacterium subtsugae 

strain PRAA4–1T. An acute oral toxicity 

study conducted on rats (MRID No. 

479450–03) demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic (LD50 greater 

than 5,000 mg/kg; Toxicity Category IV), 

while an acute injection toxicity/ 

pathogenicity study conducted on rats 

(MRID No. 479450–11) showed that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic, infective, and/ 

or pathogenic when the skin was 

bypassed as a barrier. EPA believes 

these data, when taken together, clearly 


jlentini on DSK4TPTVN1PROD with RULES
55270 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

indicate that this bacterium would not 

be toxic, infective, and/or pathogenic 

through the oral route of exposure and 

that further testing is not necessary. 

3. Acute inhalation toxicity—rat 

(Harmonized Guideline 870.1300; MRID 

No. 479450–05). An acceptable acute 

inhalation toxicity study demonstrated 

that Chromobacterium subtsugae strain 

PRAA4–1T was not toxic to male and 

female rats when exposed to 2.12 

milligrams per liter (mg/L). The median 

lethal concentration (LC50) (i.e., a 

statistically derived concentration of a 

substance that can be expected to cause 

death in 50% of test animals) was 

greater than 2.12 mg/L (Toxicity 

Category IV). 

4. Acute pulmonary toxicity/ 

pathogenicity (Harmonized Guideline 

885.3150; MRID No. 479450–23). Upon 

consideration of results of other 

definitive toxicological data submitted 

by the petitioner, EPA waived acute 

pulmonary toxicity/pathogenicity 

testing for Chromobacterium subtsugae 

strain PRAA4–1T. An acute inhalation 

toxicity study conducted on rats (MRID 

No. 479450–05) demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic (LC50 greater 

than 2.12 mg/L; Toxicity Category IV), 

while an acute injection toxicity/ 

pathogenicity study conducted on rats 

(MRID No. 479450–11) showed that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic, infective, and/ 

or pathogenic when the skin was 

bypassed as a barrier. EPA believes 

these data, when taken together, clearly 

indicate that this bacterium would not 

be toxic, infective, and/or pathogenic 

through the inhalation route of exposure 

and that further testing is not necessary. 

5. Acute injection toxicity/ 

pathogenicity (intravenous)—rat 

(Harmonized Guideline 885.3200; MRID 

No. 479450–11). An acceptable acute 

injection toxicity and pathogenicity 

(intravenous) demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic, infective, and/ 

or pathogenic to rats when dosed 

intravenously at 3.1 × 10 6 colonyforming units per animal. 

6. Acute dermal toxicity—rat 

(Harmonized Guideline 870.1200; MRID 

No. 479450–04). An acceptable acute 

dermal toxicity study demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was not toxic to rats when 

dosed at 5,050 mg/kg. The LD50 was 

greater than 5,050 mg/kg (Toxicity 

Category IV). 

7. Acute eye irritation—rabbit 

(Harmonized Guideline 870.2400; MRID 

No. 479450–06). An acceptable acute 

eye irritation study demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was minimally irritating to 

the eyes of rabbits (irritation symptoms 

cleared by 24 hours; Toxicity Category 

IV). 

8. Primary dermal irritation—rabbit 

(Harmonized Guideline 870.2500; MRID 

No. 479450–07). An acceptable primary 

dermal irritation study demonstrated 

that Chromobacterium subtsugae strain 

PRAA4–1T was slightly irritating to the 

skin of rabbits (irritation symptoms 

cleared by 24 hours; Toxicity Category 

IV). 

9. Dermal sensitization—guinea pig 

(Harmonized Guideline 870.2600; MRID 

No. 479450–08). An acceptable dermal 

sensitization study demonstrated that 

Chromobacterium subtsugae strain 

PRAA4–1T was not a dermal sensitizer 

to guinea pigs. 

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); 

however, the lack of acute oral toxicity, 

as exhibited in a toxicology test on rats, 

and the rationales justifying the waiver 

of acute oral toxicity/pathogenicity 

testing (see Unit III.B.), support the 

establishment of a tolerance exemption 

for residues of Chromobacterium 

subtsugae strain PRAA4–1T. 

1. Food exposure. Any exposure to 

this naturally occurring soil bacterium 

is anticipated to be negligible. Although 

Chromobacterium subtsugae strain 

PRAA4–1T may be applied directly to 

food, it is not expected to persist or 

accumulate in any reservoirs on plants 

or food commodities (the phyllosphere) 

because, as a soil microorganism, it is 

best adapted to more favorable 

conditions underground. Rather, after 

application, it likely will degrade due to 

predation by other biological organisms 

(e.g., protists) and exposure to particular 

environmental factors (e.g., sunlight and 

varying temperatures) (Refs. 2 and 3). 

Should this microbial pesticide be 

present on food, the acute oral toxicity 

and pathogenicity data/information 

demonstrated no toxicity, infectivity 

and/or pathogenicity is likely to occur 

with any exposure level of 

Chromobacterium subtsugae strain 

PRAA4–1T (see additional discussion in 

Unit III.B.). 

2. Drinking water exposure. Exposure 

of humans to residues of 

Chromobacterium subtsugae strain 

PRAA4–1T in consumed drinking water 

is unlikely. The proposed use patterns 

for Chromobacterium subtsugae strain 

PRAA4–1T do not include direct 

application to aquatic environments, 

thereby limiting contact with surface 

water. Furthermore, ground water is not 

expected to have significant exposure to 

Chromobacterium subtsugae strain 

PRAA4–1T since, like other 

microorganisms, this bacterium would 

likely be filtered out by the particulate 

nature of many soil types (Refs. 4, 5, and 

6) and is not known to survive in water 

or deep soil. If Chromobacterium 

subtsugae strain PRAA4–1T were to be 

transferred to surface or ground waters 

that are intended for eventual human 

consumption (e.g., through spray drift or 

runoff) and directed to wastewater 

treatment systems or drinking water 

facilities, it likely would not survive the 

conditions water is subjected to in such 

systems or 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 (e.g., in water not subject 

to treatment systems or facilities), the 

acute oral toxicity and pathogenicity 

data/information demonstrated no 

toxicity, infectivity and/or pathogenicity 

is likely to occur with any exposure 

level of Chromobacterium subtsugae 

strain PRAA4–1T (see additional 

discussion in Unit III.B.). 

B. Other Non-Occupational Exposure 

Dermal and inhalation nonoccupational exposure to 

Chromobacterium subtsugae strain 

PRAA4–1T is not expected as all 

proposed pesticide applications will 

take place in distinct agricultural 

settings. Even if dermal and inhalation 

non-occupational exposures were to 

occur, such exposures would not exceed 

EPA’s level of concern given testing that 

indicated that Chromobacterium 

subtsugae strain PRAA4–1T is not toxic 

(acute inhalation and dermal toxicity), 

is only slightly irritating (primary 

dermal irritation), is not a sensitizer 

(dermal sensitization), and is not 

pathogenic or infective (acute injection 

toxicity/pathogenicity) (see additional 

discussion in Unit III.B.). 

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 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 55271 

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.’’ 

EPA has not found Chromobacterium 

subtsugae strain PRAA4–1T to share a 

common mechanism of toxicity with 

any other substances, and 

Chromobacterium subtsugae strain 

PRAA4–1T does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that Chromobacterium 

subtsugae strain PRAA4–1T 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 Chromobacterium subtsugae strain 

PRAA4–1T 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 (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/information 

discussed in Unit III.B., 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 Chromobacterium subtsugae 

strain PRAA4–1T. 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 (e.g., 

lack of toxicity noted for oral, dermal, 

and inhalation routes of exposure) 

available on Chromobacterium 

subtsugae strain PRAA4–1T do not 

demonstrate toxic, pathogenic, and/or 

infective potential to sensitive 

populations from exposure to this 

microbial pest control agent. 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 

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 Chromobacterium subtsugae strain 

PRAA4–1T. 

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 

Chromobacterium subtsugae strain 

PRAA4–1T. Therefore, an exemption 

from the requirement of a tolerance is 

established for residues of 

Chromobacterium subtsugae strain 

PRAA4–1T in or on all food 

commodities when applied as an 

insecticide or miticide and used in 

accordance with good agricultural 

practices. 

IX. References 

1. U.S. EPA. 2011. Chromobacterium 

subtsugae strain PRAA4–1T

Biopesticides Registration Action 

Document dated July 2011 (available as 

‘‘Supporting & Related Material’’ within 

docket ID number EPA–HQ–OPP–2010– 

0058 at http://www.regulations.gov). 

2. 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. 

3. Lindow SE, Brandl MT. 2003. 

Microbiology of the phyllosphere. 

Applied and Environmental 

Microbiology 69:1875–1883. 

4. Pang L, McLeod M, Aislabie J, Sˇimu ̊nek J, 

Close M, Hector R. 2008. Modeling 

transport of microbes in ten undisturbed 

soils under effluent irrigation. Vadose 

Zone Journal 7:97–111. 

5. Aislabie J, Smith JJ, Fraser R, McLeod M. 

2001. Leaching of bacterial indicators of 

faecal contamination through four New 

Zealand soils. Australian Journal of Soil 

Research 39:1397–1406. 

6. DeFelice K, Wollenhaupt N, Buchholz D. 

1993. Aquifers and Soil Filter Effect. 

Available from http:// 

extension.missouri.edu/p/WQ24. 

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 


jlentini on DSK4TPTVN1PROD with RULES
55272 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

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: August 26, 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 180.1305 is added to 

subpart D to read as follows: 

§ 180.1305 Chromobacterium subtsugae 

strain PRAA4–1T; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Chromobacterium subtsugae strain 

PRAA4–1T in or on all food 

commodities when applied as an 

insecticide or miticide and used in 

accordance with good agricultural 

practices. 

[FR Doc. 2011–22868 Filed 9–6–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0099; FRL–8870–8] 

Flubendiamide; Pesticide Tolerances; 

Technical Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical 

amendment. 

SUMMARY: This document is being 

issued to correctly revise tolerance 

levels, for the pesticide, flubendiamide 

in or on the meat and meat byproducts 

of cattle, goat, hog, horse, and sheep. 

The tolerance levels were inadvertently 

transcribed incorrectly in a final rule 

printed in the Federal Register on 

March 23, 2011. 

DATES: This final rule is effective 

September 7, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0099. 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: 

Carmen Rodia, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; e-mail address: 

rodia.carmen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What does this technical amendment 

do? 

In the Federal Register of March 23, 

2011 (75 FR 16301) (FRL–8863–8), EPA 

issued a final rule establishing new 

tolerances and revising existing 

tolerances for residues of flubendiamide 

(40 CFR 180.639) on certain food and 

livestock commodities. Inadvertently, a 

few of the tolerance levels were 

transcribed incorrectly, and 

consequently, 40 CFR 180.639(a)(2) 

provides an incorrect tolerance value for 

the established tolerances for cattle, 

meat (0.60 ppm); cattle, meat 

byproducts (0.08 ppm); goat, meat (0.60 

ppm); goat, meat byproducts (0.08 ppm); 

hog, meat (0.15 ppm); hog, meat 

byproducts (0.03 ppm); horse, meat 

(0.60 ppm); horse, meat byproducts 

(0.08 ppm); sheep, meat (0.60 ppm); and 

sheep, meat byproducts (0.08 ppm). As 

supported by recalculated beef and 

dairy cattle, swine, and poultry dietary 

burdens, and re-evaluation of previously 

submitted animal feeding studies, these 

tolerance values should be revised to 

0.08 ppm; 0.60 ppm; 0.08 ppm; 0.60 


jlentini on DSK4TPTVN1PROD with RULES