Document ID: EPA-HQ-OPP-2010-0104-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Bacillus subtilis strain CX-9060
Posted Date: 2012-01-11T05:00Z

[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Rules and Regulations]
[Pages 1633-1637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-228]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0104; FRL-9330-9]

Bacillus Subtilis Strain CX-9060; 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 the microbial pesticide Bacillus 
subtilis strain CX-9060 in or on all food commodities when applied/used 
in accordance with good agricultural practices. Certis U.S.A., L.L.C. 
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 Bacillus subtilis strain CX-9060.

DATES: This regulation is effective January 11, 2012. Objections and 
requests for hearings must be received on or before March 12, 2012, 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-2010-0104. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8263; email 
address: greenway.denise@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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, 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-2010-0104 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

[[Page 1634]]

received by the Hearing Clerk on or before March 12, 2012. 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-2010-0104, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 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 9F7643) by Certis U.S.A., L.L.C., 9145 Guilford Road, 
Suite 175, Columbia, MD 21046. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of the microbial pesticide, Bacillus subtilis 
strain CX-9060. This notice referenced a summary of the petition 
prepared by the petitioner, Certis U.S.A., L.L.C., which is available 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    Although the Certis U.S.A., L.L.C. pesticide tolerance petition (PP 
9F7643) specified that the requested exemption include residues 
resulting from post-harvest uses, the removal on December 8, 2010 of 40 
CFR 180.1(h) (75 FR 76284, FRL-8853-8) eliminates the option for the 
expression of tolerances or exemptions from the requirement of a 
tolerance to include any reference to post-harvest use patterns. 
Therefore, the exemption established today by this rule does not 
specify post-harvest applications. Incidentally, there currently are no 
post-harvest uses proposed for the product containing Bacillus subtilis 
strain CX-9060. The addition of such uses to a Bacillus subtilis strain 
CX-9060 product label should be sought by amendment of the pesticide 
product under the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA).
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.'' Additionally, section 408(b)(2)(D) of FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.'' EPA performs a number of 
analyses to determine the risks from aggregate exposure to pesticide 
residues. First, EPA determines the toxicity of pesticides. Second, EPA 
examines exposure to the pesticide through food, drinking water, and 
through other exposures that occur as a result of pesticide use in 
residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. Bacillus subtilis is a rod-shaped, gram-positive, 
aerobic, flagellar bacterium, which is ubiquitous in nature and has 
been recovered from water, soil, air, and decomposing plant residues 
(Ref. 1). The bacterium produces an endospore that allows it to endure 
extreme conditions of heat and desiccation in the environment (Ref. 1). 
Bacillus subtilis is not considered toxic or pathogenic to humans, 
animals, or plants (Ref. 2). Several strains of Bacillus subtilis are 
used predominantly as fungicidal active ingredients in various 
pesticides registered with the Agency.
    A new strain, Bacillus subtilis strain CX-9060, proposed as a 
microbial pesticide by Certis U.S.A., L.L.C., is the subject of this 
final rule. Bacillus subtilis strain CX-9060 was isolated from a peat 
medium containing a naturally occurring strain of the Bacillus subtilis 
bacterium. The progenitor strain, Bacillus subtilis MBI 600, is a 
currently registered pesticide. Data and information, submitted by 
Certis U.S.A., L.L.C. and reviewed by the Agency, indicate that both 
Bacillus subtilis strain CX-9060 and Bacillus subtilis MBI 600 are in 
the B. subtilis/amyloliquifaciens group, and are closely related. The 
established level of equivalency is such that citation of existing data 
on the progenitor strain supports the Bacillus subtilis strain CX-9060 
petition for an exemption from the requirement of a tolerance.
    The toxicological data on Bacillus subtilis MBI 600 cited by Certis 
U.S.A., L.L.C. were previously submitted to support an exemption from 
the requirement of a tolerance for residues of that active ingredient 
in or on all raw agricultural commodities resulting from its use in the 
treatment of seeds used for growing agricultural crops (June 8, 1994; 
59 FR 29543; FRL-4865-8), and later to support an amendment that 
established a broader exemption for use of Bacillus subtilis MBI 600 in 
or on all food commodities, including residues resulting from post-
harvest uses, when applied or used in accordance with good agricultural 
practices (April 8, 2009; 74 FR 15865; FRL-8408-7). The previously 
submitted studies on Bacillus subtilis MBI 600 include the following:
     An acceptable acute oral toxicity/pathogenicity study 
performed in rats

[[Page 1635]]

(MRID 419074-02) demonstrated the lack of mammalian toxicity at high 
levels of exposure to Bacillus subtilis MBI 600. In this study, 
Bacillus subtilis MBI 600 was not toxic, infective nor pathogenic to 
rats given an oral dose of 2 x 10\8\ colony forming units (CFU) per 
animal. The study resulted in a classification of Toxicity Category IV 
for this strain of Bacillus subtilis.
     An acceptable acute pulmonary toxicity/pathogenicity study 
in rats (MRID 419074-04) demonstrated that Bacillus subtilis MBI 600 
was neither toxic, pathogenic nor infective to rats dosed 
intratracheally with 3.4 x 10\8\ CFU of the test material. The study 
resulted in a classification of Toxicity Category IV for this strain of 
Bacillus subtilis.
     An acceptable acute intravenous injection toxicity/
pathogenicity study in rats (MRID 419074-05) demonstrated that Bacillus 
subtilis MBI 600 was neither toxic, pathogenic nor infective to rats 
dosed intravenously with approximately 4 x 10\7\ CFU of the test 
material. Although the microbe was detected in every organ tested, the 
test material displayed a distinct pattern of clearance from all 
organs. The study resulted in a classification of Toxicity Category IV 
for this strain of Bacillus subtilis.
    New studies submitted by Certis U.S.A., L.L.C., and conducted with 
a formulation containing 25.0% Bacillus subtilis strain CX-9060 (at a 
concentration of 5 x 10\10\ spores per gram), include the following:
     An acceptable acute eye irritation study in rabbits (MRID 
478203-05) demonstrated that the undiluted test article was mildly 
irritating when a single 0.1 mL ocular dose was administered. At one 
hour post-treatment, one animal showed signs of corneal opacity, which 
cleared by 24 hours. Chemosis exhibited by one animal at 1 and 24 hours 
post-treatment cleared at 48 hours. The study resulted in a 
classification of Toxicity Category III.
     An acceptable primary dermal irritation study in rabbits 
(MRID 478203-04) resulted in an observation of slight erythema in a 
single animal at 24 hours, which resolved by 48 hours. The study 
resulted in a classification of Toxicity Category IV.
    Consistent with test note five, 40 CFR 158.2140, waiver of the 
acute oral, acute dermal, and acute inhalation toxicity tests, which 
provide data on the end-use pesticide product, was requested by the 
petitioner. The justification supporting a waiver of these tests (MRID 
478203-06) was adequate as the petitioner demonstrated that the 
combination of inert ingredients is not likely to pose any significant 
human health risks. Furthermore, the Agency has assigned Toxicity 
Category IV for all three routes of exposure: Acute oral toxicity 
(based upon the results of the cited acute oral toxicity/pathogenicity 
study (MRID 419074-02)); acute dermal toxicity (based upon the low 
toxicity of the inert ingredients and observed slight dermal irritation 
(MRID 478203-04)); and acute inhalation toxicity (based upon the 
results of the cited acute pulmonary toxicity/pathogenicity study (MRID 
419074-04)).
    There have been no reports of hypersensitivity in over 15 years of 
registered uses of the progenitor strain, nor have incidents associated 
with the testing or production of Bacillus subtilis strain CX-9060 been 
reported. Any future hypersensitivity incidents must be reported per 
OCSPP Guideline 885.3400.
    Consistent with test note four, 40 CFR 158.2140, no cell culture 
OCSPP Guideline 885.3500) data submission is required because Bacillus 
subtilis strain CX-9060 is not a virus.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other 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

    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).
    1. Food. Bacillus subtilis is ubiquitous in the environment (Ref. 
1), especially in soils (Ref. 3) and agricultural environments (Ref. 
4). Strain CX-9060 of Bacillus subtilis is derived from a naturally 
occurring isolate of the genus Bacillus, which was originally isolated 
from faba bean plants grown at the Nottingham University School of 
Agriculture in the United Kingdom. As a result, human dietary exposure 
to background levels of the microbe is likely occurring and will likely 
continue. Due to the ubiquitous presence of Bacillus subtilis in the 
environment, the Agency expects human exposure to Bacillus subtilis 
strain CX-9060 resulting from the proposed pesticidal uses will be no 
greater than existing human exposure to background levels of Bacillus 
subtilis.
    Similar Bacillus subtilis strains are used internationally in the 
production of food grade products and in fermented foods in Japan and 
Thailand. Reports in the literature, implicating Bacillus subtilis (as 
distinguished from the specific strain, Bacillus subtilis strain CX-
9060, at issue in this action) in food-borne illness, do not describe 
any pathogen or toxin production, only simple food spoilage from 
Bacillus subtilis growth in dough. This, in combination with test 
results (stated above) showing a lack of acute oral toxicity/
pathogenicity, indicates the risk posed to adults, infants, and 
children from food-related exposures to Bacillus subtilis strain CX-
9060 is expected to be minimal. Based on the Agency's evaluation of the 
submitted and cited data, there are no dietary risks that exceed the 
Agency's Level of Concern (LOC).
    2. Drinking water exposure. Because Bacillus subtilis is ubiquitous 
in the environment, exposure to the microbe through drinking water may 
already be occurring and likely will continue. The proposed use sites 
do not include direct application to aquatic environments: the intended 
use of Bacillus subtilis strain CX-9060 is to treat growing crops 
(including roots and cuttings) for the control of plant disease. If the 
uses resulted in pesticide residues in spray drift or runoff that were 
to reach surface or ground waters, there is the potential for human 
exposure to Bacillus subtilis strain CX-9060 residues in drinking 
water, albeit likely greatly diluted. Municipal drinking water 
treatment processes and deep water wells, however, should further 
reduce any such residues. More importantly, even if oral exposure to 
this ubiquitous microbe should occur through drinking water, due to its 
expected lack of acute oral toxicity/pathogenicity, the Agency 
concludes that there is a reasonable certainty that no harm will result 
from such exposure.

B. Other Non-Occupational Exposure

    The pesticide uses of Bacillus subtilis strain CX-9060 are limited 
to commercial agricultural and horticultural settings. There are no 
residential uses; it is not intended to be used in and around the home, 
or in schools, day care facilities or other such settings. Nonetheless, 
residential and other non-occupational exposure may

[[Page 1636]]

occur since Bacillus subtilis is ubiquitous in the environment. The 
potential for non-dietary, non-occupational exposure to Bacillus 
subtilis strain CX-9060 residues for the general population, including 
infants and children, is likely since populations have probably been 
previously exposed (and likely will continue to be exposed) to 
background levels of Bacillus subtilis. Neither such common human 
exposures to similar Bacillus subtilis strains naturally present in 
soils, waters and plants, nor exposures associated with those Bacillus 
subtilis strains used internationally in producing food-grade products 
and fermented foods, have resulted in reports of disease or other 
effects. Finally, while the literature includes accounts of Bacillus 
subtilis infections in humans (which consistently are bacteremias 
associated with immunosuppression, surgical intervention, neoplastic 
disease, and trauma), those reports are most notable for their rare and 
exceptional nature. EPA's evaluation of the required high-dose Tier I 
acute toxicity and pathogenicity tests, which were cited in support of 
this petition, resulted in the assignment of Toxicity Category IV 
(least toxic), as well as determinations of not infective and not 
pathogenic, for all exposure routes. No toxicological end points of 
concern were identified. There are no dietary endpoints that exceed the 
Agency's LOC. Therefore, the Agency has determined that any additional 
exposure to the microbe resulting from residues attributable to 
Bacillus subtilis strain CX-9060 pesticide use will not result in 
additional aggregate non-occupational risk from dermal and inhalation 
exposures. Because even regular occupational exposures associated with 
this active ingredient pose negligible risk, no risk is expected from 
non-occupation exposures.

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, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has not found Bacillus subtilis strain CX-9060 to share a 
common mechanism of toxicity with any other substances, and Bacillus 
subtilis strain CX-9060 does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that Bacillus subtilis strain CX-
9060 does not have a common mechanism of toxicity with other 
substances. 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), as amended by the Food Quality 
Protection Act (FQPA) of 1996, 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 (b)(2)(C) also provides that EPA 
shall apply an additional tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database, unless EPA 
determines that a different margin of safety will be safe for infants 
and children.
    Based on the acute toxicity information discussed in Unit III., 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 Bacillus subtilis strain CX-9060. This includes 
all anticipated dietary exposures and all other exposures for which 
there is reliable information. The Agency has arrived at this 
conclusion because the data available on Bacillus subtilis strain CX-
9060 demonstrate a lack of toxicity/pathogenicity potential. Thus, 
there are no threshold effects of concern and, as a result, the Agency 
has concluded that the additional tenfold margin of safety for infants 
and children is unnecessary in this instance. Further, the need to 
consider consumption patterns, special susceptibility, and cumulative 
effects does not arise when dealing with pesticides with no 
demonstrated significant adverse effects.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency 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. 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 Bacillus subtilis strain 
CX-9060.

VIII. Conclusions

    Therefore, an exemption is established for residues of Bacillus 
subtilis strain CX-9060 in or on all food commodities.

IX. References

1. U.S. EPA. 2010. Bacillus subtilis Final Registration Review 
Decision. Case 6012. March 2010.
2. U.S. EPA. 1997. Bacillus subtilis Final Risk Assessment. 
Available from http://www.epa.gov/oppt/biotech/pubs/fra/fra009.htm.
3. Bergey. 2009. Bergey's Manual of Systematic Bacteriology, Volume 
3; 2nd Ed. Springer. New York.
4. U.S. EPA. 2008. Memorandum (J. V. Gagliardi to D. Greenway). 
December 23, 2008. Bacillus subtilis MBI 600.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB

[[Page 1637]]

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 in this final rule, do not require the issuance 
of a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

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: December 15, 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 180.1309 is added to subpart D to read as follows:

Sec.  180.1309  Bacillus subtilis strain CX-9060; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus subtilis strain CX-9060, 
in or on all food commodities, when applied or used in accordance with 
good agricultural practices.

[FR Doc. 2012-228 Filed 1-10-12; 8:45 am]
BILLING CODE 6560-50-P