Document ID: EPA-HQ-OPP-2009-0087-0004
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Pseudomonas Fluorescens Strain CL145A
Posted Date: 2011-08-24T04:00Z

[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Rules and Regulations]
[Pages 52871-52875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21249]

-----------------------------------------------------------------------

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/text-idx?&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,

[[Page 52872]]

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 fluorescens-contaminated 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 
Pythium-Rhizoctonia 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 x 10\10\ 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 x 10\10\ 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

[[Page 52873]]

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 x 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 x 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 x 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 x 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 x 1010 CFU/kg). The 
LD50 was greater than 5,050 mg/kg (or greater than 2.38 x 
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 non-occupational 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

[[Page 52874]]

with any exposure level of Pseudomonas fluorescens strain CL145A (see 
additional discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Dermal and inhalation non-occupational 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

[[Page 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.rebeca-net.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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1304 is added to subpart D to read as follows:

Sec.  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