[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55268-55272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22868]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0054; FRL-8887-4]


Chromobacterium subtsugae Strain PRAA4-1\T\; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ 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 PRAA4-1\T\ 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: [email protected].

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/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-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.

[[Page 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 PRAA4-1\T\. 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 PRAA4-1\T\

    Chromobacterium subtsugae strain PRAA4-1\T\ 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 PRAA4-1\T\-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 PRAA4-1\T\, 
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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 
PRAA4-1\T\ 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 PRAA4-1\T\. An acute oral toxicity study conducted on rats (MRID 
No. 479450-03) demonstrated that Chromobacterium subtsugae strain 
PRAA4-1\T\ 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 PRAA4-1\T\ was not toxic, infective, 
and/or pathogenic when the skin was bypassed as a barrier. EPA believes 
these data, when taken together, clearly

[[Page 55270]]

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 PRAA4-1\T\ 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 PRAA4-1\T\. An acute inhalation toxicity study 
conducted on rats (MRID No. 479450-05) demonstrated that 
Chromobacterium subtsugae strain PRAA4-1\T\ 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 PRAA4-1\T\ 
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 PRAA4-1\T\ was not toxic, 
infective, and/or pathogenic to rats when dosed intravenously at 3.1 x 
10 \6\ colony-forming 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 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

    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 PRAA4-1\T\.
    1. Food exposure. Any exposure to this naturally occurring soil 
bacterium is anticipated to be negligible. Although Chromobacterium 
subtsugae strain PRAA4-1\T\ 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 PRAA4-1\T\ (see 
additional discussion in Unit III.B.).
    2. Drinking water exposure. Exposure of humans to residues of 
Chromobacterium subtsugae strain PRAA4-1\T\ in consumed drinking water 
is unlikely. The proposed use patterns for Chromobacterium subtsugae 
strain PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ (see additional discussion in Unit III.B.).

B. Other Non-Occupational Exposure

    Dermal and inhalation non-occupational exposure to Chromobacterium 
subtsugae strain PRAA4-1\T\ 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 PRAA4-1\T\ 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

[[Page 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 PRAA4-1\T\ to 
share a common mechanism of toxicity with any other substances, and 
Chromobacterium subtsugae strain PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\ 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 PRAA4-1\T\. 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 PRAA4-1\T\ 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 PRAA4-1\T\.

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 
PRAA4-1\T\. Therefore, an exemption from the requirement of a tolerance 
is established for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ 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 PRAA4-1\T\ 
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, [Scaron]im[uring]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

[[Page 55272]]

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]

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 180.1305 is added to subpart D to read as follows:


Sec.  180.1305  Chromobacterium subtsugae strain PRAA4-1\T\; exemption 
from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Chromobacterium subtsugae strain PRAA4-1\T\ 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