Federal Register / Vol. 76, No. 164 / Wednesday, August 24, 2011 / Rules and Regulations 52871 

* * * * * 

[FR Doc. 2011–21362 Filed 8–23–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0087; FRL–8884–6] 

Pseudomonas fluorescens Strain 

CL145A; 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 Pseudomonas 

fluorescens strain CL145A in or on all 

food commodities when applied as a 

molluscicide. Marrone Bio Innovations, 

Inc. (formerly Marrone Organic 

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 

Pseudomonas fluorescens strain 

CL145A under the FFDCA. 

DATES: This regulation is effective 

August 24, 2011. Objections and 

requests for hearings must be received 

on or before October 24, 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–2009–0087. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: Ann 

Sibold, Biopesticides and Pollution 

Prevention Division (7511P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 305– 

6502; e-mail address: 

sibold.ann@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, pesticide 

manufacturer, hydroelectric power 

facility operator or water supply system 

operator. 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). 

• Hydroelectric power generation 

(NAICS code 221111). 

• Water supply and irrigation systems 

(NAICS code 221310). 

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–2009–0087 in the subject 

line on the first page of your 

submission. All objections and requests 

for a hearing must be in writing, and 

must be received by the Hearing Clerk 

on or before October 24, 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–2009–0087, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: OPP Regulatory Public Docket 

(7502P), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of March 16, 

2009 (74 FR 11100) (FRL–8405–1), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 9F7511) 

by Marrone Bio Innovations, Inc. 

(formerly Marrone Organic 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 Pseudomonas fluorescens strain 

CL145A in or on all food commodities 

when applied as a molluscicide. This 

notice referenced a summary of the 

petition prepared by the petitioner, 


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52872 Federal Register / Vol. 76, No. 164 / Wednesday, August 24, 2011 / Rules and Regulations 

Marrone Bio Innovations, Inc. (formerly 

Marrone Organic Innovations, Inc.), 

which is available in the docket via 

http://www.regulations.gov. One 

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit VII.C. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance exemption and 

to ‘‘ensure that there is a reasonable 

certainty that no harm will result to 

infants and children from aggregate 

exposure to the pesticide chemical 

residue. * * *’’ Additionally, section 

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

fluorescens and Pseudomonas 

fluorescens Strain CL145A 

Pseudomonas fluorescens is 

ubiquitous in soil and water and is 

commonly associated with plants, 

including those food plants consumed 

raw. The Manual of Clinical 

Microbiology (8th edition) states the 

following: ‘‘Pseudomonas spp. have a 

worldwide distribution with a 

predilection for moist environments. 

They are found in water and soil and on 

plants, including fruits and vegetables’’ 

(Ref. 1). Although Pseudomonas 

fluorescens is of low virulence and 

usually not clinically significant, it has 

been associated with opportunistic 

infections in compromised patients 

when Pseudomonas fluorescenscontaminated blood product was used 

for transfusions. 

In the past, EPA has registered several 

pesticide products, each containing a 

different isolate of Pseudomonas 

fluorescens as an active ingredient: 

1. Pseudomonas fluorescens strain 

NCIB 12089—used as a mushroom 

blotch control agent and exempted from 

the requirement of a tolerance (40 CFR 

180.1129) in the Federal Register of 

August 24, 1994 (59 FR 43490) (FRL– 

4899–5); 

2. Pseudomonas fluorescens A506 

and Pseudomonas fluorescens 1629RS— 

used for reduction of frost and frost 

damage on various food crops and 

exempted from the requirement of a 

tolerance (40 CFR 180.1114) in the 

Federal Register of September 16, 1992 

(57 FR 42700) (FRL–4161–1); and 

3. Pseudomonas fluorescens EG– 

1053—used for control of the PythiumRhizoctonia seedling disease complex of 

cotton and exempted from the 

requirement of a tolerance (40 CFR 

180.1088) in the Federal Register of 

March 10, 1988 (53 FR 7740) (FRL– 

3339–2). 

Out of these isolates, only 

Pseudomonas fluorescens A506 is still 

contained in an actively registered 

pesticide product. 

Pseudomonas fluorescens strain 

CL145A is a naturally occurring 

bacterial species that was isolated from 

a river mud sample in the northeastern 

United States. This isolate is being 

registered as a biocontrol agent for zebra 

mussels (Dreissena polymorpha) and 

quagga mussels (Dreissena bugensis) 

that infest enclosed and other confined 

static or flowing water infrastructures 

(e.g., water storage chambers and tanks, 

pipes, general plumbing and equipment, 

and other water conveyance structures 

associated with civil infrastructure). 

When a zebra or quagga mussel ingests 

artificially high densities of 

Pseudomonas fluorescens strain 

CL145A, a toxin within this bacterium’s 

cells destroys the digestive system of the 

mussel. 

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 Pseudomonas 

fluorescens strain CL145A 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. Acceptable (i.e., data 

that are scientifically sound and useful 

for risk assessment) acute oral toxicity, 

acute inhalation toxicity, and acute 

pulmonary toxicity/pathogenicity data, 

which addressed potential routes of 

exposure to the active ingredient and 

which tested doses significantly higher 

than or comparable to the labeled 

application rates, were classified in 

Toxicity Categories IV or III (toxicity 

studies) (see 40 CFR 156.62) or 

indicated that Pseudomonas fluorescens 

CL145A was not toxic, infective and/or 

pathogenic (toxicity/pathogenicity 

study). The overall conclusions from all 

toxicological information submitted by 

the petitioner is 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. 2). 

1. Acute oral toxicity—rat 

(Harmonized Guideline 870.1100; 

Master Record Identification Number 

(MRID No.) 476402–02). An acceptable 

acute oral toxicity study demonstrated 

that Pseudomonas fluorescens strain 

CL145A was not toxic to rats when 

dosed at 5,000 milligrams per kilogram 

(mg/kg) (or 2.35 × 1010 colony-forming 

units per kilogram (CFU/kg)). The no 

observed adverse effect level (NOAEL) 

and median lethal dose (LD50) (i.e., a 

statistically derived single dose that can 

be expected to cause death in 50% of 

test animals) were greater than 5,000 

mg/kg (or greater than 2.35 × 1010 CFU/ 

kg) (Toxicity Category IV). 

2. Acute oral toxicity/pathogenicity 

(Harmonized Guideline 885.3050; MRID 

No). 477494–03). The rationale provided 

in support of a data waiver request for 

acute oral toxicity/pathogenicity stated 

that Pseudomonas fluorescens is 

considered an ubiquitous inhabitant of 

soil and water and is found on the 

surface and roots of a variety of plant 

types, including food plants consumed 

raw. Pseudomonads and, in particular, 

Pseudomonas fluorescens are 

considered a benign part of the regular 


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human diet commonly occurring on the 

surface of leafy green vegetables and 

other food stuffs (Refs. 1, 3, and 4). 

Additionally, an acute oral toxicity 

study conducted on rats (MRID No. 

476402–02) found the NOAEL and LD50

were greater than 5,000 mg/kg, 

corresponding to greater than 2.35 × 

1010 CFU/kg (Toxicity Category IV). 

Based on this rationale, oral infectivity, 

clearance, and pathogenicity testing for 

Pseudomonas fluorescens strain 

CL145A was waived. It should be noted 

that this is a different data requirement 

from the acute oral toxicity test 

(Harmonized Guideline 870.1100; MRID 

No. 476402–02), which only evaluated 

toxicity, but not pathogenicity and 

infectivity potential, of the microbial 

pest control agent. 

3. Acute inhalation toxicity—rat 

(Harmonized Guideline 870.1300; MRID 

No. 476402–04). An acceptable acute 

inhalation toxicity study demonstrated 

that Pseudomonas fluorescens strain 

CL145A was not toxic to rats when 

exposed to approximately 0.225 

milligrams per liter (mg/L) (or 1.1 × 106

colony-forming units per liter (CFU/L)). 

The NOAEL and median lethal 

concentration (LC50) were greater than 

0.225 mg/L (or greater than 1.1 × 106

CFU/L) (Toxicity Category II but 

upgraded to Toxicity Category III with 

the results of MRID No. 482767–02. The 

dose used in the acute pulmonary 

toxicity/pathogenicity study (MRID No. 

482767–02), which looked at the same 

route of exposure and did not show any 

toxicity, pathogenicity, and/or 

infectivity, was greater than the dose 

used in the study described in this unit. 

Thus, this allowed the Toxicity 

Category, as initially established in this 

study, to be upgraded from II to III.). 

4. Acute pulmonary toxicity/ 

pathogenicity—rat (Harmonized 

Guideline 885.3150; MRID No. 482767– 

02). An acceptable acute pulmonary 

toxicity and pathogenicity study 

demonstrated that Pseudomonas 

fluorescens strain CL145A was not 

toxic, infective, and/or pathogenic to 

rats when dosed intratrachaelly at 3.4 × 

108 colony-forming units (CFU)/rat. As 

detailed in the acute inhalation toxicity 

study summary in this unit, this study 

upgraded the Toxicity Category for 

MRID No. 476402–04 from II to III. 

5. Acute dermal toxicity—rat 

(Harmonized Guideline 870.1200; MRID 

No. 476402–03). An acceptable acute 

dermal toxicity study demonstrated that 

Pseudomonas fluorescens strain 

CL145A was not toxic to rats when 

dosed at 5,050 mg/kg (or 2.38 × 1010

CFU/kg). The LD50 was greater than 

5,050 mg/kg (or greater than 2.38 × 1010

CFU/kg) (Toxicity Category IV). 

6. Acute eye irritation—rabbit 

(Harmonized Guideline 870.2400; MRID 

No. 476402–05). An acceptable acute 

eye irritation study demonstrated that 

Pseudomonas fluorescens strain 

CL145A was practically non-irritating to 

rabbits (irritation symptoms cleared by 

48 hours; Toxicity Category IV). 

7. Primary dermal irritation—rabbit 

(Harmonized Guideline 870.2500; MRID 

No. 476402–06). An acceptable primary 

dermal irritation study demonstrated 

that Pseudomonas fluorescens strain 

CL145A was practically non-irritating to 

rabbits (irritation symptoms cleared by 

24 hours; Toxicity Category IV). 

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 

Pseudomonas fluorescens strain 

CL145A end-use products are not 

labeled for direct application to food 

crops. Any potential food exposures 

would be as a result of its presence in 

water. Thus, minimal dietary exposure 

to this microbial pesticide may occur 

through irrigation water, wash water or 

drinking water (see discussions of food 

and drinking water exposures in this 

unit); 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 Pseudomonas 

fluorescens strain CL145A. 

1. Food. Exposure to this microbial 

active ingredient through food is 

expected to be minimal. Pseudomonas 

fluorescens strain CL145A end-use 

products are not labeled for direct 

application to food crops. Rather, 

Pseudomonas fluorescens strain 

CL145A will be applied to water in 

enclosed and other confined static or 

flowing water infrastructures to control 

zebra and quagga mussels. The 

treatment areas are limited to 

completely enclosed pipe or water 

conveyance systems or concrete 

chambers with defined inlets or outlets. 

Nevertheless, water drawn downstream 

from points of application (e.g., pump 

stations and irrigation systems) and 

used to irrigate or wash food crops may 

contain Pseudomonas fluorescens strain 

CL145A. Concentrations of 

Pseudomonas fluorescens will be 

diluted as water flows past points of 

application and thus will rapidly 

decrease. Also, natural degradation (e.g., 

environmental factors such as 

ultraviolet light, nutrient depletion and 

bacterial grazing/predation by protists 

and others) and manmade filtering 

operations are expected to greatly lower 

the overall level of the pesticide after 

application (Refs. 5 and 6). Furthermore, 

Pseudomonas fluorescens is considered 

ubiquitous in soil and water and is 

commonly associated with plants, 

including food plants consumed raw; 

thus, this microorganism is already part 

of the normal human diet (Refs. 1, 3, 

and 4). Exposure to Pseudomonas 

fluorescens strain CL145A through food 

that has come into contact with treated 

irrigation or wash waters is not expected 

to exceed background levels of similar 

Pseudomonads already present in the 

human diet (Refs. 1, 3, and 4). 

Nonetheless, in the unlikely event that 

this microbial pesticide is 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 

Pseudomonas fluorescens strain 

CL145A (see additional discussion in 

Unit III.B.). 

2. Drinking water exposure. Much like 

food exposure, drinking water exposure 

is expected to be negligible for similar 

reasons: 

i. Concentrations of Pseudomonas 

fluorescens strain CL145A will be 

diluted as water flows past points of 

application; 

ii. Natural degradation (e.g., 

environmental factors such as 

ultraviolet light, nutrient depletion and 

bacterial grazing/predation by protists 

and others) of the microbial active 

ingredient will occur; and 

iii. Flocculation and filtering at water 

treatment plants will further inactivate 

and decrease levels of Pseudomonas 

fluorescens strain CL145A (Refs. 5 and 

6). Additionally, Pseudomonas 

fluorescens is already present naturally 

in soil, in water, and on plants, thereby 

making it a part of the normal human 

diet (Refs. 1, 3, and 4). Exposure to 

Pseudomonas fluorescens strain 

CL145A through drinking water is not 

expected to exceed background levels of 

similar Pseudomonads already present 

in the human diet (Refs. 1, 3, and 4). 

Nonetheless, in the unlikely event that 

this microbial pesticide is present in 

drinking water, the acute oral toxicity 

and pathogenicity data/information 

demonstrated no toxicity, infectivity 

and/or pathogenicity is likely to occur 


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with any exposure level of 

Pseudomonas fluorescens strain 

CL145A (see additional discussion in 

Unit III.B.). 

B. Other Non-Occupational Exposure 

Dermal and inhalation nonoccupational exposure to Pseudomonas 

fluorescens strain CL145A is expected 

to be minimal to non-existent. 

Pseudomonas fluorescens strain 

CL145A end-use products are labeled 

for application to use sites—enclosed 

and other confined static or flowing 

water infrastructures infested with zebra 

and/or quagga mussels—that are not 

considered residential areas. 

1. Dermal exposure. Although dermal 

exposure to Pseudomonas fluorescens 

strain CL145A may occur when water 

from a treated dam or industrial facility 

is discharged to surface water and is 

subsequently used by a community 

water system in a residential area, such 

exposure is expected to be minimal due 

to dilution, natural degradation, and 

filtering at water treatment plants (Refs. 

5 and 6). Moreover, acute dermal 

toxicity and primary dermal irritation 

tests demonstrated that Pseudomonas 

fluorescens strain CL145A is not toxic 

and is practically non-irritating via the 

dermal route of exposure (see additional 

discussion in Unit III.B.). 

2. Inhalation exposure. Inhalation 

exposure to Pseudomonas fluorescens 

strain CL145A is not anticipated with 

the labeled (i.e., water-based) 

molluscicide use. If inhalation exposure 

to Pseudomonas fluorescens strain 

CL145A were to occur in gardens, 

lawns, or buildings (i.e., residential 

areas), such exposure would not exceed 

EPA’s level of concern given the acute 

inhalation toxicity and acute pulmonary 

toxicity/pathogenicity tests that 

demonstrated Pseudomonas fluorescens 

strain CL145A’s lack of toxicity, 

pathogenicity and/or infectivity (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 

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 Pseudomonas 

fluorescens strain CL145A to share a 

common mechanism of toxicity with 

any other substances. Pseudomonas 

fluorescens strain CL145A affects gut 

function in the target molluscs and does 

not produce a similar toxic response in 

the other species tested. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

Pseudomonas fluorescens strain 

CL145A 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 

Pseudomonas fluorescens strain 

CL145A 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 website 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 Pseudomonas fluorescens 

strain CL145A. 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 Pseudomonas fluorescens strain 

CL145A 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 Pseudomonas fluorescens strain 

CL145A. 

C. Response to Comments 

In response to the Notice of Filing, 

EPA received one comment, protesting 

the presence of this product in food, the 

proposed exemption from the 

requirement of a tolerance, and the 

toxicity of the product. In response, EPA 

again emphasizes that Pseudomonas 

fluorescens strain CL145A is present 

naturally in soil and water (Refs. 1, 3, 

and 4), is not toxic, pathogenic, and/or 

infective for dietary considerations (see 

additional discussion in Unit III.B.), 

and, in any event, is expected to 

degrade quickly in the environment 

(Ref. 6). Biological materials from dead 

cells would be consumed by degradative 

microflora in treatment areas, and the 

few live cells diluted in treated waters 

would likely not approach the levels of 

Pseudomonas fluorescens already 

present in water, in soil, and on foods 

(Refs. 1, 3, 4, and 6). EPA has concluded 

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 

Pseudomonas fluorescens strain 

CL145A in or on all food commodities 

(see Unit VIII.). Thus, under the 


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Federal Register / Vol. 76, No. 164 / Wednesday, August 24, 2011 / Rules and Regulations 52875 

standard in FFDCA section 408(c)(2), a 

tolerance exemption is appropriate. 

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 Pseudomonas 

fluorescens strain CL145A. Therefore, 

an exemption from the requirement of a 

tolerance is established for residues of 

Pseudomonas fluorescens strain 

CL145A in or on all food commodities 

when applied as a molluscicide. 

IX. References 

1. Murray PR, Baron E, Jorgensen JH, Pfaller 

MA, Yolken RH, editors. 2003. Manual of 

Clinical Biology. 8th ed. Washington 

(DC): ASM Press. 

2. U.S. EPA. 2011. Pseudomonas fluorescens 

strain CL145A Biopesticides Registration 

Action Document dated July 2011 

(available as ‘‘Supporting & Related 

Material’’ within docket ID number 

EPA–HQ–OPP–2011–0568 at http:// 

www.regulations.gov). 

3. Garrity GM, Bell JA, Lilburn T, editors. 

2005. ‘‘Pseudomonadales’’ in Bergey’s 

Manual of Systematic Bacteriology. 2nd 

ed. New York (NY): Springer. 

4. Organisation for Economic Co-operation 

and Development. 1997. Consensus 

Document on Information Used in the 

Assessment of Environmental 

Applications Involving Pseudomonas. 

Available from http://www.rebecanet.de/downloads/

OECD%20Consensus%20document%

20pseudomonas.pdf. 

5. U.S. EPA. 2004. Primer for Municipal 

Wastewater Treatment Systems. EPA 

832–R–04–001. 

6. 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. 

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: July 29, 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 180.1304 is added to 

subpart D to read as follows: 

§ 180.1304 Pseudomonas fluorescens 

strain CL145A; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Pseudomonas fluorescens strain 

CL145A in or on all food commodities 

when applied as a molluscicide. 

[FR Doc. 2011–21249 Filed 8–23–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0430; FRL–8881–5] 

2-Propenoic Acid, Polymer With 

Ethenylbenzene and (1-methylethenyl) 

Benzene, Sodium Salt; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-Propenoic 

acid, polymer with ethenylbenzene and 

(1-methylethenyl) benzene, sodium salt 

when used as an inert ingredient in a 

pesticide chemical formulation under 

40 CFR 180.960. BASF Corporation 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 


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