Bacillus subtilis MBI 600; Exemption from the Requirement of a Tolerance, 15865-15869 [E9-7172]
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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations
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Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
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Dated: February 12, 2009.
George Pavlou,
Acting Regional Administrator, Region 2.
Part 52, chapter I, title 40 of the Code
of Federal Regulations is amended as
follows:
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PART 52—[AMENDED]
1. The authority citation for part 52
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Authority: 42 U.S.C. 7401 et seq.
Subpart FF—New Jersey
2. Section 52.1582 is amended by
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■
§ 52.1582 Control strategy and
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*
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*
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(l) Attainment determination. EPA
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[FR Doc. E9–7683 Filed 4–7–09; 8:45 am]
BILLING CODE
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0762; FRL–8408–7]
Bacillus subtilis MBI 600; Exemption
from the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the
biofungicide, Bacillus subtilis MBI 600,
in or on all food commodities, including
residues resulting from post-harvest
uses, when applied/used in accordance
with good agricultural practices. Becker
Underwood, Inc. submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an
amendment to expand the existing
exemption from the requirement of a
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15865
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of Bacillus
subtilis MBI 600 in or on all food
commodities.
DATES: This regulation is effective April
8, 2009. Objections and requests for
hearings must be received on or before
June 8, 2009, 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–2008–0762. 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),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8263; e-mail 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
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Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations
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.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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. The EPA procedural
regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2008–0762 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before June 8, 2009.
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 that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0762, 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
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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 November
14, 2008 (73 FR 67512) (FRL–8388–3),
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 8F7368)
by Becker Underwood, Inc., 801 Dayton
Ave., P. O. Box 667, Ames, IA 50010.
The petition requested that 40 CFR
180.1128 be amended by expanding the
existing exemption from the
requirement of a tolerance for the
biofungicide Bacillus subtilis MBI 600
to cover residues in or on all food
commodities, including residues
resulting from post-harvest uses. The
notice included a summary of the
petition prepared by the petitioner
Becker Underwood, Inc.
Previously, on June 8, 1994 (59 FR
29543) (FRL–4865–8), EPA issued a
final rule granting an exemption from
the requirement of a tolerance for
residues of Bacillus subtilis MBI 600 in
or on all raw agricultural commodities
when applied as a seed treatment on
seeds used for growing agricultural
crops. In submitting this current
petition (i.e., 8F7368), Becker
Underwood, Inc. is relying on the data
previously submitted by another
company, Gustafson, Inc., in support of
the existing tolerance exemption for
Bacillus subtilis MBI 600. These data
were previously summarized by EPA in
the June 8, 1994, final rule. On July 18,
2002, EPA issued a Tolerance
Reassessment Decision in which it
found that the existing tolerance
exemption for Bacillus subtilis MBI 600
continues to meet the FQPA safety
standard. This determination in 2002
was based on EPA’s review of the data
on which Becker Underwood, Inc., is
now relying in connection with this
action.
There was one comment received in
response to the notice of filing. The
commenter expressed dissatisfaction
with the level of safety EPA provides to
Americans. Pursuant to its authority
under the FFDCA, EPA conducted a
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comprehensive assessment of Bacillus
subtilis MBI 600, including a review of
studies addressing acute oral,
pulmonary and intravenous injection
toxicity/pathogenicity; acute dermal
toxicity; primary eye irritation: and skin
sensitization. EPA review of these
studies indicated that the active
ingredient is not toxic to test animals
when administered via the oral,
pulmonary, intravenous or dermal
routes of exposure. In addition, the
active ingredient was not infective or
pathogenic to test animals when
administered via the oral, pulmonary or
intravenous routes. Moreover, no
reports of hypersensitivity have been
recorded in personnel working with this
organism. Based on these data, the
Agency has concluded that there is a
reasonable certainty that no harm will
result from dietary exposure to residues
of Bacillus subtilis MBI 600 in or on all
food commodities, including residues
resulting from post-harvest uses. Thus,
under the standard in FFDCA section
408(c)(2), an exemption from the
requirement of a tolerance is
appropriate.
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
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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.
Toxicological data on the active
ingredient were previously submitted to
support the existing exemption from the
requirement of a tolerance for residues
of Bacillus subtilis MBI 600 resulting
from its use in the treatment of seeds
used for growing agricultural crops, and
to support various pesticide product
registrations held by the petitioner. The
previously submitted studies on the
active ingredient include the following:
An acceptable acute oral toxicity/
pathogenicity study performed in rats
(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 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 x 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 x 107 CFU of the test
material. Although the microbe was
detected in every organ tested, the test
material displayed a distinct pattern of
clearance. The study resulted in a
classification of Toxicity Category IV for
this strain of Bacillus subtilis.
An acceptable acute dermal toxicity
study in rabbits (MRID 419074–03)
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demonstrated that Bacillus subtilis MBI
600 was not toxic to rabbits when a
single 5 x 1010 dose was administered
dermally. The study resulted in a
classification of Toxicity Category IV for
this strain of Bacillus subtilis.
An acceptable primary eye irritation
study in rabbits (MRID 419074–06)
demonstrated that Bacillus subtilis MBI
600 produced a slight ocular irritation
when a single 0.1 gram ocular dose was
administered. Ocular irritation
dissipated by day 4. The study resulted
in a classification of Toxicity Category
IV for this strain of Bacillus subtilis.
A supplemental skin sensitization test
resulted in an overall moderate reaction
in guinea pigs 24 to 78 hours posttreatment. However, an acceptable
dermal sensitization study, conducted
with an end use formulation,
demonstrated no irritation 2 weeks after
sensitization and treatment using 400
milligrams of test material. As a result,
the product was determined to not be a
dermal sensitizer. Furthermore, in the
nearly 15 years since its initial
registration as an active ingredient,
there have been no hypersensitivity
reports associated with Bacillus subtilis
MBI 600 pesticide products.
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
Bacillus subtilis MBI 600 is
ubiquitous in the environment,
especially in soils and agricultural
environments (indeed, strain MBI 600 of
Bacillus subtilis is a naturally-occurring
isolate of the genus Bacillus, originally
isolated from faba beans grown at
Nottingham University School of
Agriculture in the United Kingdom). As
a result, dietary exposure to background
levels of the naturally occurring microbe
likely is already occurring and likely
will continue to occur. Because of its
ubiquitous presence in the environment,
the Agency expects there to be no
increase in exposure to Bacillus subtilis
MBI 600 resulting from the existing and
proposed pesticidal uses when
compared to existing exposure to
background levels of Bacillus subtilis
MBI 600.
1. Food. As discussed above, dietary
exposure to the naturally occurring
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microbe likely is already occurring and
likely will continue to occur. Notably,
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 MBI 600, at issue
in this action) in food-borne illness do
not describe any pathogen or toxin
production, but rather simple spoilage
from Bacillus subtilis growth in dough.
Such low-quality dough would not be
suitable for bread production by
commercial bakeries and so the Agency
considers this particular food exposure
scenario to be unlikely and the risk to
be negligible. The risk posed to adults,
infants and children from food-related
exposures to Bacillus subtilis MBI 600 is
minimal due to the demonstrated lack of
acute oral toxicity/pathogenicity
associated with the microbial pesticide.
Based on the evaluation of the
submitted data, there are no dietary
risks that exceed the Agency’s level of
concern.
2. Drinking water exposure. Because
Bacillus subtilis MBI 600 is ubiquitous
in the environment, exposure to the
microbe through drinking water may
already be occurring and likely will
continue to occur. While the proposed
and existing use sites do not include
direct application to aquatic
environments, the intended use of
Bacillus subtilis MBI 600 is treatment of
growing crops or seed for the control of
plant disease. If such uses were to result
in pesticide spray drift or runoff that
were to reach surface or ground waters,
there is the potential for human
exposure to Bacillus subtilis MBI 600
residues, albeit greatly diluted, in
drinking water. Municipal drinking
water treatment processes and deep
water wells, however, would both
further reduce any such residues. More
importantly, even if oral exposure to
this ubiquitous microbe should occur
through drinking water, due to its
demonstrated 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
MBI 600, both those currently allowed
and the additional ones being
established by this rule, are limited to
commercial agricultural and
horticultural settings. There are no
residential uses. Nonetheless, because
Bacillus subtilis MBI 600 is naturally
occurring and ubiquitous in the
environment, the potential for nondietary, non-occupational exposure to
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its 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 the microbe. However, neither
such common human exposures to
Bacillus subtilis MBI 600 naturally
present in soils, waters and plants, nor
exposures associated with similar
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 reported only in
otherwise-compromised individuals),
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 resulted in the
assignment of Toxicity Category IV
(least toxic), and 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 Level of Concern (LOC).
Therefore, the Agency has determined
that any additional exposure to the
microbe resulting from residues
attributable to Bacillus subtilis MBI 600
pesticide use will not result in
additional aggregate non-occupational
risk from dermal and inhalation
exposures. This conclusion, based
solely on non-occupational exposures,
is consistent with EPA’s determination
that no occupational risks exceed the
Agency’s LOC, meaning that even
regular occupational exposures
associated with this active ingredient
pose negligible risk.
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V. Cumulative Effects
No mechanism of toxicity in
mammals has been identified for
Bacillus subtilis MBI 600. Therefore, no
cumulative effect with other related
organisms is anticipated. Because the
available data demonstrate a lack of
toxicity/pathogenicity potential for the
active ingredient, adverse dietary effects
are unlikely.
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
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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
United States population, including
infants and children, from aggregate
exposure to residues of Bacillus subtilis
MBI 600. 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 MBI 600
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. Endocrine Disruptors
Bacillus subtilis MBI 600 is a
ubiquitous organism in the environment
that is non-toxic to mammals. To date,
there is no evidence to suggest that
Bacillus subtilis MBI 600 affects the
immune system, functions in a manner
similar to any known hormone, or that
it acts as an endocrine disruptor.
Indeed, the submitted toxicity/
pathogenicity studies in rodents
indicate that, following several routes of
exposure, the immune system is intact
and able to process and clear the active
ingredient. Therefore, it is unlikely that
this organism will have estrogenic or
endocrine effects.
B. Analytical Method
The Agency is establishing an
exemption from the requirement of a
tolerance for residues of Bacillus subtilis
MBI 600 in or on all food commodities,
including residues resulting from postharvest uses, for the reasons stated
above. Therefore, the Agency has
concluded that an analytical method is
not required for enforcement purposes
for detecting Bacillus subtilis MBI 600
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residues resulting from its use as a
pesticide.
C. Codex Maximum Residue Level
No Codex maximum residue level
(MRL) exists for Bacillus subtilis MBI
600.
VIII. Conclusions
Based on the toxicity information for
Bacillus subtilis MBI 600 that was
previously submitted and reviewed,
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
Bacillus subtilis MBI 600 under
reasonably foreseeable circumstances
when used as a microbial pesticide in
accordance with its label and good
agricultural practices. This includes all
anticipated dietary exposures and all
other exposures for which there is
reliable information. As a result,
pursuant to FFDCA sections 408(c) and
(d) EPA is establishing an exemption
from the requirement of a tolerance for
residues of the biofungicide 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.
IX. 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
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
E:\FR\FM\08APR1.SGM
08APR1
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Rules and Regulations
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) (Public Law 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).
X. 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).
rwilkins on PROD1PC63 with RULES
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
VerDate Nov<24>2008
16:13 Apr 07, 2009
Jkt 217001
Dated: March 20, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, 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 180.1128 is revised to read
as follows:
■
§ 180.1128 Bacillus subtilis MBI 600;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the biofungicide Bacillus subtilis MBI
600 in or on all food commodities,
including residues resulting from postharvest uses, when applied or used in
accordance with good agricultural
practices.
[FR Doc. E9–7172 Filed 4–7–09; 8:45 am]
BILLING CODE 6560–50–S
40 CFR Part 180
[EPA–HQ–OPP–2008–0167; FRL–8407–8]
Thiamethoxam; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for combined residues of
thiamethoxam and its metabolite CGA322704 in or on citrus fruits, citrus
pulp, tree nuts, almond hulls, and
pistachios. Syngenta Crop Protection,
Inc., requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective April
8, 2009. Objections and requests for
hearings must be received on or before
June 8, 2009, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0167. 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,
ADDRESSES:
Frm 00039
Fmt 4700
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: Julie
Chao, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8735; e-mail address:
chao.julie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
PO 00000
15869
Sfmt 4700
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 those engaged in the
following activities:
• 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 to provide 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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
E:\FR\FM\08APR1.SGM
08APR1
]]>Agencies
[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Rules and Regulations]
[Pages 15865-15869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7172]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0762; FRL-8408-7]
Bacillus subtilis MBI 600; 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 biofungicide, Bacillus subtilis MBI
600, in or on all food commodities, including residues resulting from
post-harvest uses, when applied/used in accordance with good
agricultural practices. Becker Underwood, Inc. submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an amendment to expand the existing exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Bacillus subtilis MBI 600 in or on
all food commodities.
DATES: This regulation is effective April 8, 2009. Objections and
requests for hearings must be received on or before June 8, 2009, 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-2008-0762. 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), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8263; e-mail 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
[[Page 15866]]
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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2008-0762 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before June 8, 2009.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0762, 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 November 14, 2008 (73 FR 67512) (FRL-
8388-3), 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 8F7368) by Becker Underwood, Inc., 801 Dayton Ave., P. O.
Box 667, Ames, IA 50010. The petition requested that 40 CFR 180.1128 be
amended by expanding the existing exemption from the requirement of a
tolerance for the biofungicide Bacillus subtilis MBI 600 to cover
residues in or on all food commodities, including residues resulting
from post-harvest uses. The notice included a summary of the petition
prepared by the petitioner Becker Underwood, Inc.
Previously, on June 8, 1994 (59 FR 29543) (FRL-4865-8), EPA issued
a final rule granting an exemption from the requirement of a tolerance
for residues of Bacillus subtilis MBI 600 in or on all raw agricultural
commodities when applied as a seed treatment on seeds used for growing
agricultural crops. In submitting this current petition (i.e., 8F7368),
Becker Underwood, Inc. is relying on the data previously submitted by
another company, Gustafson, Inc., in support of the existing tolerance
exemption for Bacillus subtilis MBI 600. These data were previously
summarized by EPA in the June 8, 1994, final rule. On July 18, 2002,
EPA issued a Tolerance Reassessment Decision in which it found that the
existing tolerance exemption for Bacillus subtilis MBI 600 continues to
meet the FQPA safety standard. This determination in 2002 was based on
EPA's review of the data on which Becker Underwood, Inc., is now
relying in connection with this action.
There was one comment received in response to the notice of filing.
The commenter expressed dissatisfaction with the level of safety EPA
provides to Americans. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of Bacillus subtilis MBI 600,
including a review of studies addressing acute oral, pulmonary and
intravenous injection toxicity/pathogenicity; acute dermal toxicity;
primary eye irritation: and skin sensitization. EPA review of these
studies indicated that the active ingredient is not toxic to test
animals when administered via the oral, pulmonary, intravenous or
dermal routes of exposure. In addition, the active ingredient was not
infective or pathogenic to test animals when administered via the oral,
pulmonary or intravenous routes. Moreover, no reports of
hypersensitivity have been recorded in personnel working with this
organism. Based on these data, the Agency has concluded that there is a
reasonable certainty that no harm will result from dietary exposure to
residues of Bacillus subtilis MBI 600 in or on all food commodities,
including residues resulting from post-harvest uses. Thus, under the
standard in FFDCA section 408(c)(2), an exemption from the requirement
of a tolerance is appropriate.
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
[[Page 15867]]
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.
Toxicological data on the active ingredient were previously
submitted to support the existing exemption from the requirement of a
tolerance for residues of Bacillus subtilis MBI 600 resulting from its
use in the treatment of seeds used for growing agricultural crops, and
to support various pesticide product registrations held by the
petitioner. The previously submitted studies on the active ingredient
include the following:
An acceptable acute oral toxicity/pathogenicity study performed in
rats (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 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 x 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 x 107 CFU of the test
material. Although the microbe was detected in every organ tested, the
test material displayed a distinct pattern of clearance. The study
resulted in a classification of Toxicity Category IV for this strain of
Bacillus subtilis.
An acceptable acute dermal toxicity study in rabbits (MRID 419074-
03) demonstrated that Bacillus subtilis MBI 600 was not toxic to
rabbits when a single 5 x 1010 dose was administered
dermally. The study resulted in a classification of Toxicity Category
IV for this strain of Bacillus subtilis.
An acceptable primary eye irritation study in rabbits (MRID 419074-
06) demonstrated that Bacillus subtilis MBI 600 produced a slight
ocular irritation when a single 0.1 gram ocular dose was administered.
Ocular irritation dissipated by day 4. The study resulted in a
classification of Toxicity Category IV for this strain of Bacillus
subtilis.
A supplemental skin sensitization test resulted in an overall
moderate reaction in guinea pigs 24 to 78 hours post-treatment.
However, an acceptable dermal sensitization study, conducted with an
end use formulation, demonstrated no irritation 2 weeks after
sensitization and treatment using 400 milligrams of test material. As a
result, the product was determined to not be a dermal sensitizer.
Furthermore, in the nearly 15 years since its initial registration as
an active ingredient, there have been no hypersensitivity reports
associated with Bacillus subtilis MBI 600 pesticide products.
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
Bacillus subtilis MBI 600 is ubiquitous in the environment,
especially in soils and agricultural environments (indeed, strain MBI
600 of Bacillus subtilis is a naturally-occurring isolate of the genus
Bacillus, originally isolated from faba beans grown at Nottingham
University School of Agriculture in the United Kingdom). As a result,
dietary exposure to background levels of the naturally occurring
microbe likely is already occurring and likely will continue to occur.
Because of its ubiquitous presence in the environment, the Agency
expects there to be no increase in exposure to Bacillus subtilis MBI
600 resulting from the existing and proposed pesticidal uses when
compared to existing exposure to background levels of Bacillus subtilis
MBI 600.
1. Food. As discussed above, dietary exposure to the naturally
occurring microbe likely is already occurring and likely will continue
to occur. Notably, 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 MBI 600, at issue in this action) in food-
borne illness do not describe any pathogen or toxin production, but
rather simple spoilage from Bacillus subtilis growth in dough. Such
low-quality dough would not be suitable for bread production by
commercial bakeries and so the Agency considers this particular food
exposure scenario to be unlikely and the risk to be negligible. The
risk posed to adults, infants and children from food-related exposures
to Bacillus subtilis MBI 600 is minimal due to the demonstrated lack of
acute oral toxicity/pathogenicity associated with the microbial
pesticide. Based on the evaluation of the submitted data, there are no
dietary risks that exceed the Agency's level of concern.
2. Drinking water exposure. Because Bacillus subtilis MBI 600 is
ubiquitous in the environment, exposure to the microbe through drinking
water may already be occurring and likely will continue to occur. While
the proposed and existing use sites do not include direct application
to aquatic environments, the intended use of Bacillus subtilis MBI 600
is treatment of growing crops or seed for the control of plant disease.
If such uses were to result in pesticide spray drift or runoff that
were to reach surface or ground waters, there is the potential for
human exposure to Bacillus subtilis MBI 600 residues, albeit greatly
diluted, in drinking water. Municipal drinking water treatment
processes and deep water wells, however, would both further reduce any
such residues. More importantly, even if oral exposure to this
ubiquitous microbe should occur through drinking water, due to its
demonstrated 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 MBI 600, both those
currently allowed and the additional ones being established by this
rule, are limited to commercial agricultural and horticultural
settings. There are no residential uses. Nonetheless, because Bacillus
subtilis MBI 600 is naturally occurring and ubiquitous in the
environment, the potential for non-dietary, non-occupational exposure
to
[[Page 15868]]
its 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 the microbe. However, neither such common human exposures to
Bacillus subtilis MBI 600 naturally present in soils, waters and
plants, nor exposures associated with similar 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 reported only in otherwise-
compromised individuals), 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 resulted in the assignment of Toxicity Category
IV (least toxic), and 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 Level of Concern (LOC). Therefore, the Agency has determined
that any additional exposure to the microbe resulting from residues
attributable to Bacillus subtilis MBI 600 pesticide use will not result
in additional aggregate non-occupational risk from dermal and
inhalation exposures. This conclusion, based solely on non-occupational
exposures, is consistent with EPA's determination that no occupational
risks exceed the Agency's LOC, meaning that even regular occupational
exposures associated with this active ingredient pose negligible risk.
V. Cumulative Effects
No mechanism of toxicity in mammals has been identified for
Bacillus subtilis MBI 600. Therefore, no cumulative effect with other
related organisms is anticipated. Because the available data
demonstrate a lack of toxicity/pathogenicity potential for the active
ingredient, adverse dietary effects are unlikely.
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 United States population, including infants and children, from
aggregate exposure to residues of Bacillus subtilis MBI 600. 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 MBI 600
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. Endocrine Disruptors
Bacillus subtilis MBI 600 is a ubiquitous organism in the
environment that is non-toxic to mammals. To date, there is no evidence
to suggest that Bacillus subtilis MBI 600 affects the immune system,
functions in a manner similar to any known hormone, or that it acts as
an endocrine disruptor. Indeed, the submitted toxicity/pathogenicity
studies in rodents indicate that, following several routes of exposure,
the immune system is intact and able to process and clear the active
ingredient. Therefore, it is unlikely that this organism will have
estrogenic or endocrine effects.
B. Analytical Method
The Agency is establishing an exemption from the requirement of a
tolerance for residues of Bacillus subtilis MBI 600 in or on all food
commodities, including residues resulting from post-harvest uses, for
the reasons stated above. Therefore, the Agency has concluded that an
analytical method is not required for enforcement purposes for
detecting Bacillus subtilis MBI 600 residues resulting from its use as
a pesticide.
C. Codex Maximum Residue Level
No Codex maximum residue level (MRL) exists for Bacillus subtilis
MBI 600.
VIII. Conclusions
Based on the toxicity information for Bacillus subtilis MBI 600
that was previously submitted and reviewed, 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 Bacillus
subtilis MBI 600 under reasonably foreseeable circumstances when used
as a microbial pesticide in accordance with its label and good
agricultural practices. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. As a
result, pursuant to FFDCA sections 408(c) and (d) EPA is establishing
an exemption from the requirement of a tolerance for residues of the
biofungicide 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.
IX. 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 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
[[Page 15869]]
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) (Public Law 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).
X. 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: March 20, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
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 180.1128 is revised to read as follows:
Sec. 180.1128 Bacillus subtilis MBI 600; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biofungicide 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.
[FR Doc. E9-7172 Filed 4-7-09; 8:45 am]
BILLING CODE 6560-50-S
