Bacillus Subtilis Strain CX-9060; Exemption From the Requirement of a Tolerance, 1633-1637 [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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 https://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
https://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,
SUMMARY:
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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 https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the harmonized
test guidelines referenced in this
document electronically, please go to
https://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
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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:
https://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, https://
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 postharvest uses, the removal on December
8, 2010 of 40 CFR 180.1(h) (75 FR
76284, FRL–8853–8) eliminates the
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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
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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
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(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 × 108 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 × 108
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 × 107 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 × 1010 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 posttreatment, 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
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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 nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
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
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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
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occur since Bacillus subtilis is
ubiquitous in the environment. The
potential for non-dietary, nonoccupational 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 highdose 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 nonoccupation 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
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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 https://
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.
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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 https://
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
E:\FR\FM\11JAR1.SGM
11JAR1
Federal Register / Vol. 77, No. 7 / Wednesday, January 11, 2012 / Rules and Regulations
pmangrum on DSK3VPTVN1PROD with RULES
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
VerDate Mar<15>2010
12:38 Jan 10, 2012
Jkt 226001
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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1309 is added to
subpart D to read as follows:
■
§ 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
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 20 and 54
[WC Docket Nos. 10–90, 07–135, 05–337,
03–109; GN Docket No. 09–51; CC Docket
Nos. 01–92, 96–45; WT Docket No. 10–208;
FCC 11–189]
Connect America Fund; Developing an
Unified Intercarrier Compensation
Regime; Lifeline and Link Up
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this document, the
Commission amends rules regarding the
attributes of ‘‘voice telephony service’’
to be supported by the Federal universal
service support mechanisms. This
action is necessary to reflect the
evolution of the marketplace and to
limit supported services. The
Commission also waives certain
effective dates so that intercarrier
compensation for non-access traffic
exchanged between Local Exchange
SUMMARY:
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
1637
Carriers (LEC) and Commercial Mobile
Radio Service (CMRS) providers
pursuant to an interconnection
agreement in effect as of December 23,
2011, will be subject to a default billand-keep methodology on July 1, 2012,
rather than on December 29, 2011. This
action is necessary to limit marketplace
disruption by delaying bill-and-keep
until carriers are eligible to receive
recovery as part of the transitional
revenue recovery mechanism for this
type of traffic.
DATES: Effective January 11, 2012.
FOR FURTHER INFORMATION CONTACT:
Amy Bender, Wireline Competition
Bureau, (202) 418–1469, or Victoria
Goldberg, Wireline Competition Bureau,
(202) 418–7353, or TTY: (202) 418–
0484.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order on
Reconsideration (Order) in WC Docket
Nos. 10–90, 07–135, 05–337, 03–109,
GN Docket No. 09–51, CC Docket Nos.
01–92, 96–45, WT Docket No. 10–208,
FCC 11–189, released on December 23,
2011. The full text of this document is
available for public inspection during
regular business hours in the FCC
Reference Center, Room CY–A257, 445
12th Street SW., Washington, DC 20554.
1. In this Order, the Commission
modifies on its own motion two aspects
of the USF/ICC Transformation Order,
76 FR 73830, November 18, 2011.
2. In the USF/ICC Transformation
Order, the Commission eliminated its
former list of nine supported services
and amended § 54.101 of the
Commission’s rules to specify that
‘‘voice telephony service’’ is supported
by federal universal service support
mechanisms. The Commission found
this to be a more technologically neutral
approach that focuses on the
functionality offered instead of the
technologies used, while allowing
services to be provided over any
platform. This approach also recognizes
that many of the services enumerated in
the previous rule are universal today
and that the importance of operator
services and directory assistance, in
particular, has declined with changes in
the marketplace. A number of parties
have raised questions about how the
amended rule should be understood to
affect Lifeline-only ETCs and their
compliance with section 214(e)(1)(A) of
the Act, which requires a carrier to
provide supported services using its
own facilities, in whole or in part, in
order to be eligible to receive support.
Several parties have urged the
Commission to take action to ensure
that there is no disruption to the
services currently being provided to
E:\FR\FM\11JAR1.SGM
11JAR1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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 https://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: https://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, https://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 https://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 https://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