Bacillus firmus isolate 1582; Exemption from the Requirement of a Tolerance, 25524-25528 [E8-10121]
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Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations
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[FR Doc. E8–9950 Filed 5–6–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0159; FRL–8362–7]
Bacillus firmus isolate 1582;
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 Bacillus
firmus isolate 1582 or Bacillus firmus I1582 on all food/feed commodities
when applied/used as soil applications
and seed treatments. AgroGreen
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA),
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Bacillus firmus I-1582.
DATES: This regulation is effective May
7, 2008. Objections and requests for
hearings must be received on or before
July 7, 2008, 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–2007–0159. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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
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ADDRESSES:
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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:
Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8097; e-mail address:
bacchus.shanaz@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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicable provisions. 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 an electronic
copy of this Federal Register document
through the electronic docket 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
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Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, 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–2007–0159 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 July 7, 2008.
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–2007–0159, 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’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 21,
2007 (72 FR 13277) (FRL–8117–4), 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 6F7111)
by AgroGreen, Biological Division,
Minrav Infrastructures (1993) Ltd., 3
Habossem Str, P.O. Box 153, Ashdod
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Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations
77101, Israel. The petition requested
that 40 CFR part 180 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of Bacillus firmus isolate I-1582 when
used as a soil application or seed
treatment. This notice included a
summary of the petition prepared by the
petitioner RegWest Company, LLC,
30856 Rocky Road, Greeley, CO 80631–
9375, United States Department of
Agriculture (USDA) and submitted on
behalf of AgroGreen. The current
representative for AgroGreen is SciReg,
Inc. 12733 Director’s Loop, Woodbridge,
VA 22192, USA. There were no
comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which require
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance 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
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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 firmus isolate 1582 (called B.
firmus I-1582) (U.S. Patent No.
6,406,690) is a Microbial Pesticide
Control Agent (MPCA). It is intended to
be used as a biological nematode
suppressant on fruits, vegetables, field
crops, and on such non-food crops as
turf, and ornamentals. Further
information regarding this MPCA can be
found in the Biopesticide Registration
Action Document (BRAD) on the
Biopesticides and Pollution and
Prevention Division website https://
www.epa.gov/pesticides/biopesticides.
Studies submitted to the agency were
issued Master Record Identification
numbers (MRIDs) and then reviewed by
the Biopesticides and Pollution
Prevention Division (BPPD). The
Agency also considered these
submissions in light of the new
microbial pesticides data requirements,
which became final on December 26,
2007 (72 FR 61002). The following
summaries of the toxicological profile of
Bacillus firmus isolate I-1582 are based
on Agency reviews or Data Evaluation
Records (DERs) dated March 05, 2008.
These reviews include the following
acute toxicity/pathogenicity studies;
oral, dermal, pulmonary and injection.
a. Acute oral toxicity/pathogenicity rats (OPPTS 885.3050; MRID
#46933007; DER 03/05/2008). Nineteen
male and 19 female Sprague-Dawley rats
were each treated by a single oral gavage
dose of 0.1 mL per animal (>108 colony
forming unit (cfu) animal) of Bacillus
firmus I-1582 spores. The presented
data showed no clinical signs and no
weight loss related to test substance in
rats. Bacillus firmus I-1582 was detected
in brain, blood, cecum content, kidneys,
lungs, lymph nodes, and spleen of the
treated animals with clearance from the
blood by day 7 and from all other organs
by day 14. Necropsy was not conducted.
Based on the presented/submitted data,
Bacillus firmus I-1582 does not appear
to be toxic, infective, and/or pathogenic
in rats, when dosed orally at >108 cfu/
animal. This study was classified as
‘‘acceptable’’ and the pesticide
considered Toxicity Category IV for
acute oral effects.
b. Acute dermal toxicity/
pathogenicity - rabbits (OPPTS
885.3100; MRID #46933008; DER 03/05/
2008). Five male and five female New
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Zealand White rabbits were each treated
with 5,050 milligrams/kilogram/
bodyweight (mg/kg/bwt) Bacillus firmus
I-1582 spore suspension applied to the
clipped dorsal trunk in an area of
approximately 10% of the body surface
in a dermal occlusion test according to
standard laboratory procedures.
Animals were observed for dermal
irritation 60 minutes after patch
removal. The test animals were
observed for mortality and clinical signs
of toxicity at least three times on the day
of treatment and once daily thereafter
for 14 days. The rabbits were euthanized
on day 14 and necropsies were
performed. With the exception of one
female that lost weight during the first
week, all animals had normal body
weight gain. All rabbits appeared
normal during the study and all
survived the study. Very slight to well
defined erythema was observed on day
1 with clearance by day 4. No
observable abnormalities were noted at
necropsy. The dermal LD50 for males,
females, and combined was greater than
5,050 mg/kg. Thus, Bacillus firmus I1582 is not toxic, infective, or
pathogenic via the dermal route of
exposure, and the active ingredient is
placed in Toxicity Category IV for acute
dermal effects.
c. Acute pulmonary toxicity/
pathogenicity - rats (OPPTS 885.3150;
MRID #46933009; DER 03/05/2008).
Thirty male and 30 female SpragueDawley rats received 0.1 mL per animal
(>108 cfu/animal) Bacillus firmus I-1582
by intratracheal instillation. The
presented data show no adverse
abnormal clinical signs in rats. No test
organisms were detected in any sample
from the control rats. All six animals
sacrificed on day 3 had significant cfus
(686 to 30,731 cfu/g) in their lungs. The
test organism was detected in brain,
blood, cecum content, kidneys, lungs,
lymph nodes, and spleen of the treated
animals. Clearance was observed from
the blood, kidneys, and liver by day 7
and from all other organs by day 14.
Necropsy studies were not conducted.
Based on the presented/submitted data,
the test organisms were not toxic,
infective and/or pathogenic to rats and
the active ingredient was placed in
Toxicity Category IV for acute
pulmonary effects.
d. Acute inhalation toxicity (OPPTS
870.1300; MRID # 46933009; DER 03/
05/2008). An acute inhalation study was
not required for this non-volatile active
ingredient. The Agency also considered
the acute pulmonary study in Unit III.c.,
the nature of the inert ingredients, the
label requirements for Personal
Protective Equipment for workers, and
the potential low exposure associated
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with the proposed application methods.
Based on its non-volatile nature, if the
pesticide is used as labeled, it will pose
minimal to non-existent risk to nonoccupationally-exposed populations via
inhalation.
e. Acute injection toxicity/
pathogenicity - rats (OPPTS 885.3200;
MRID # 46933010; DER 03/05/2008).
Twenty six male and 26 female SpragueDawley rats each received a dose of 0.1
mL per animal (>107 cfu/animal), by
injection into the tail vein. The
presented data showed no observable
clinical signs in treated rats. No test
organisms were recovered in any
samples from the control rats. The test
organism was detected in the blood,
kidneys, liver, lungs, lymph nodes, and
spleen of the treated rats. Clearance
from the brain, blood, kidneys, lymph
nodes, and spleen was established by
day 21 after dosing. Clearance from the
cecum and liver was established by day
14 after dosing. Necropsy studies
showed no abnormal findings. Bacillus
firmus spores did not appear to be toxic,
infective, and/or pathogenic in rats,
when dosed at >107 cfu/animal. The
submission is classified as acceptable.
f. Cell culture (OPPTS 885.3500). This
data requirement is only required for
active ingredients that are viruses and
not for this type of bacterial pesticide.
g. Waiver request: Hypersensitivity
incidents technical-grade active
ingredient (TGAI) (OPPTS 885.3400;
DER 03/05/2008). In addition to the
rationales in Unit III.h., the applicant
requested that hypersensitivity
incidents be waived based on there
being no adverse effects of Bacillus
firmus or its metabolites to humans or
mammals in literature searches. The
request to waive this requirement is not
granted. As required for all pesticides,
the Agency requires that
hypersensitivity incidents, should
adverse effects occur, must be reported
to comply with section 6(a)(2)
40CFR159.152.
h. Waiver requests for Tiers II and
Tier III (OPPTS 885.3550); MRID #s
46933011; 47024806; DER 03/05/2008).
The registrant requested that the Agency
waive the requirement for submission of
data to support Tier II and Tier III
requirements for the TGAI.
The following rationales were
provided to support requests to waive
submission of the studies
1. The active ingredient, Bacillus
firmus strain I-1582, is a naturally
occurring microorganism.
2. No reports of adverse effects of
Bacillus firmus or its metabolites to
humans or mammals were found in
literature searches.
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3. The proposed uses of the proposed
End-use Product (EP) are not expected
to result in increased exposure or
adverse effects to humans or mammals.
4. The bacteria count falls to subeffective levels in the environment
within 90 days of treatment.
5. The submitted studies, MRIDs
46933007, 46933008, 46933009, and
46933010, did not show pathogenicity
to animals treated by oral gavage,
dermal application, pulmonary
instillation, or intravenous injection.
6. Bacillus firmus was not found on
any of eleven lists of pathogens
searched.
Based on these acceptable rationales
and there being no toxicological,
infectivity or pathogenicity concerns in
the Tier I mammalian toxicity data
submitted, the Agency granted the
request to waive studies required for
Tier II and Tier III testing.
i. Waiver requests: EP and
hypersensitivity incidents (OPPTS
885.3400; DER 03/05/2008). The
applicant has submitted rationales to
waive data for acute oral toxicity/
pathogenicity, acute pulmonary
toxicity/pathogenicity, acute dermal,
primary eye, hypersensitivity study,
acute inhalation, and primary dermal,
primary eye studies. These rationales
were based on the results of tests for the
TGAI discussed in the toxicological
profile in Unit III of this document. In
addition to the rationales in Unit III.h.,
the applicant reiterated that there were
no reports of adverse effects of Bacillus
firmus or its metabolites to humans or
mammals in literature searches.
The request to waive toxicity testing
for the EP was based on acceptable data
reviews of the TGAI and the nature of
the inert ingredients which are exempt
from the requirement of a tolerance. The
Agency decided to grant the request to
waive the test for primary eye irritation
based on the acceptable low acute
dermal toxicity category IV
classification of the pesticide. Any
potential primary eye irritation to this
low toxcity pesticide can be mitigated
by goggles or personal protective eye
equipment. In addition the application
rate and types of soil application and
seed treatments indicate minimal to
non-existent risk via eye exposure. The
request to waive the requirement for
hypersensitivity incidents for the EP is
not granted. As required for all
pesticides, the Agency requires that
hypersensitivity incidents, should
adverse effects occur, must be reported
to comply with section 6(a)(2) (40 CFR
159.152).
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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
1. Food. Dietary exposure to the
microbial pesticide is likely to occur to
this ubiquitous microbe. The lack of
acute oral toxicity/pathogenicity, based
on the toxicology test in rats, supports
the exemption from the requirement of
a tolerance for this active ingredient.
The pesticide is intended to be applied
to the soil or to be used as seed
treatments, mainly for control of
nematodes. It is not systemic. Thus,
dietary exposure by direct contact with
food is not expected. The acute oral
study described in Unit III indicates that
the active ingredient is not toxic,
infective or pathogenic when
administered to mammals (rats) via the
oral route. In addition to this acute oral
study, other toxicology studies
indicated that the microbe cleared all
organs within the time allotted for the
studies.
There is no direct post-harvest
treatment of food commodities with
Bacillus firmus I-1582. Thus, detectable
residues of Bacillus firmus I-1582 are
not expected on agricultural crops or
food commodities as a result of the
proposed use of this active ingredient.
All inerts in the proposed EP are exempt
from the requirement of a tolerance.
Based on these observations, the Agency
concluded that dietary exposure to
Bacillus firmus I-1582 is not expected to
cause harm to human adults, infants
and children.
2. Drinking water exposure. Drinking
water is not being screened for Bacillus
firmus I-1582 as a potential indicator of
microbial contamination. The pesticide
is not intended for application to
aquatic agricultural crops. In the
unlikely event that Bacillus firmus I1582 was transferred to ground water,
the microbe would not survive the
conditions of drinking water treatment,
such as chlorination, pH adjustments,
and other water processing conditions.
However, because of the lack of
mammalian toxicity, even if negligible
oral exposure should occur through
drinking water, the Agency concludes
that such exposure would present no
risk.
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B. Other Non-Occupational Exposure
The Agency expects non-occupational
dermal and inhalation exposure to pose
no harm if the pesticide is used as
labeled. The proposed product is anEP
that is intended to be used
commercially for seed and soil
treatments of agricultural crops. Other
homeowner and residential uses are also
for soil applications outdoors at very
low rates. No indoor residential, school,
or daycare uses are currently permitted
for this active ingredient. Even if there
is non-occupational residential, school
or day care exposure from the proposed
uses of Bacillus firmus I-1582, the risk
posed by this low toxicity microbe is
likely to be minimal.
1. Dermal exposure. As discussed in
Unit III. Bacillus firmus I-1582 is not
toxic, infective, or pathogenic via the
dermal route of exposure, and the active
ingredient is placed in Toxicity
Category IV for acute dermal effects. The
pesticide is proposed for use as soil and
seed treatments to agricultural crops.
For these exposure scenarios, nonoccupational dermal exposure is not
expected. The potential for nonoccupational exposure exists for
residential and home and garden use.
However, low application rates, soil
applications and the low toxicity
potential of the active ingredient
indicate that non-occupational exposure
through these uses is not likely to cause
harm to the exposed population if the
pesticide is used as labeled.
2. Inhalation exposure. A similar
rationale supports the Agency’s
conclusion that non-occupational
inhalation exposure is not likely to
cause harm to the exposed population if
the pesticide is used as labeled. The
active ingredient is placed in Toxicity
Category IV on the basis of the acute
pulmonary study (see Unit III.) and is
non-volatile.
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V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA
requires the Agency to consider the
cumulative effect of exposure to
Bacillus firmus I-1582 and to other
substances that have a common
mechanism of toxicity. These
considerations include the possible
cumulative effects of such residues on
infants and children. Bacillus firmus I1582 is not toxic or pathogenic to
mammals via several routes of exposure
(Unit III.) There are no other Bacillus
firmus strains registered. Consequently,
no cumulative effects from the residues
of this product with other related
microbial pesticides are anticipated.
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VI. Determination of Safety for U.S.
Population, Infants and Children
See Unit III. for acute toxicological
evaluations of Bacillus firmus I-1582.
Further, FFDCA section 408(b)(2)(C)
provides that EPA shall apply an
additional tenfold margin of exposure
(safety) for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure, unless EPA determines
that a different margin of exposure
(MOE) (safety) will be safe for infants
and children. Margins of exposure
(safety), which often are referred to as
uncertainty factors, are incorporated
into EPA risk assessment either directly
or through the use of a margin of
exposure analysis or by using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk. Actual exposures to
adults and children through diet are
expected to be several orders of
magnitude less than the doses used in
the toxicity and pathogenicity tests
referenced in Unit III. Thus, the Agency
has determined that an additional
margin of safety for infants and children
is unnecessary.
VII. Other Considerations
A. Endocrine Immunotoxicity
EPA is required under section 408(p)
of the FFDCA, as amended by FQPA, to
develop a screening program to
determine whether certain substances
(including all pesticide active and other
ingredients) ‘‘may have an effect in
humans that is similar to an effect
produced by a naturally-occurring
estrogen, or other such endocrine effects
as the Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there was a
scientific basis for including, as part of
the program, androgen and thyroid
hormone systems, in addition to the
estrogen hormone system. EPA also
adopted EDSTAC’s recommendation
that it include evaluations of potential
effects in wildlife.
The Agency has no knowledge of
Bacillus firmus I-1582 being an
endocrine disruptor, nor if this microbe
is related to any class of known
endocrine disruptors. Consequently,
endocrine-related concerns did not
impact the Agency’s safety finding for
these Bacillus firmus I-1582 strains.
Additional data specifically on the
endocrine effects of this microbial
pesticide are not required at this time.
When the appropriate screening and/or
testing protocols being considered
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under the Agency’s Endocrine Disrupter
Screening Program (EDSP) have been
developed and implemented, Bacillus
firmus I-1582 may be subject to
additional screening and/or testing to
better characterize effects related to
endocrine disruption.
As discussed in this document in Unit
III. Tier I toxicology data evaluated for
this active ingredient showed clearance
in a variety of tissues and did not trigger
Tier III data requirements for
immunotoxicity testing.
B. Analytical Methods
The acute oral studies discussed in
Unit III. demonstrate that the active
ingredient does not pose a dietary risk.
In addition, the active ingredient is not
likely to come into contact with the
treated food commodities. Furthermore,
the low application rate and nonpersistence on food during applications
suggests very low exposure potential via
the dietary route. Since residues are not
expected on treated commodities, the
Agency has concluded that an analytical
method to detect residues of this
pesticide on treated food commodities
for enforcement purposes is not needed.
Nevertheless, the Agency has
concluded that for analysis of the
pesticide itself, microbiological and
biochemical methods exist and are
acceptable for enforcement purposes for
product identity of Bacillus firmus I1582. Other appropriate methods are
required for quality control to assure
that product characterization, the
control of human pathogens and other
unintentional metabolites or ingredients
are within regulatory limits, and to
ascertain storage stability and viability
of the pesticidal active ingredient.
C. Codex Maximum Residue Level
There is no Codex maximum residue
level for residues of Bacillus firmus I1582.
VIII. Conclusions
The results of the studies discussed in
Unit III. meet the safety standards of the
1996 FQPA. They support an exemption
from the requirement of a tolerance for
residues of Bacillus firmus I-1582, on
treated food or feed commodities. In
addition, the Agency is of the opinion
that, if the microbial active ingredient is
used as allowed, aggregate and
cumulative exposures are not likely to
harm the adult human U.S. population,
children and infants. Therefore, an
exemption from tolerance is granted for
residues of Bacillus firmus I-1582 when
used as soil and seed treatments in/on
all food/feed commodities in response
to pesticide petition 6F7111.
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jlentini on PROD1PC65 with RULES
25528
Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Rules and Regulations
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,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance 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
VerDate Aug<31>2005
16:44 May 06, 2008
Jkt 214001
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).
ENVIRONMENTAL PROTECTION
AGENCY
X. Congressional Review Act
SUMMARY: This regulation establishes
tolerances for residues of pyridalyl in or
on vegetables, leafy, except Brassica,
group 4; Brassica, head and stem,
subgroup 5A; vegetables, fruiting, group
8; mustard greens; and turnip greens.
Valent U.S.A. Corporation and the
International Research Project Number 4
(IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective May
7, 2008. Objections and requests for
hearings must be received on or before
July 7, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
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: April 23, 2008.
Debra Edwards,
Director, Office of Pesticide Programs
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1282 is added to read
as follows:
I
§ 180.1282 Bacillus firmus I-1582;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established in/on all
food/feed commodities, for residues of
Bacillus firmus I-1582 when used as a
soil application or seed treatment.
[FR Doc. E8–10121 Filed 5–6–08; 8:45 am]
BILLING CODE 6560–50–S
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
40 CFR Part 180
[EPA–HQ–OPP–2004–0306; FRL–8361–4]
Pyridalyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2004–0306. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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: Olga
Odiott, Registration Division (7505P),
ADDRESSES:
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[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Rules and Regulations]
[Pages 25524-25528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10121]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0159; FRL-8362-7]
Bacillus firmus isolate 1582; 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 Bacillus firmus isolate 1582 or
Bacillus firmus I-1582 on all food/feed commodities when applied/used
as soil applications and seed treatments. AgroGreen submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Bacillus firmus I-1582.
DATES: This regulation is effective May 7, 2008. Objections and
requests for hearings must be received on or before July 7, 2008, 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-2007-0159. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8097; e-mail address: bacchus.shanaz@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicable provisions. 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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, 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-2007-0159 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 July 7, 2008.
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-2007-0159, 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'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 21, 2007 (72 FR 13277) (FRL-8117-
4), 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 6F7111) by AgroGreen, Biological Division, Minrav
Infrastructures (1993) Ltd., 3 Habossem Str, P.O. Box 153, Ashdod
[[Page 25525]]
77101, Israel. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of Bacillus firmus isolate I-1582 when used as a soil
application or seed treatment. This notice included a summary of the
petition prepared by the petitioner RegWest Company, LLC, 30856 Rocky
Road, Greeley, CO 80631-9375, United States Department of Agriculture
(USDA) and submitted on behalf of AgroGreen. The current representative
for AgroGreen is SciReg, Inc. 12733 Director's Loop, Woodbridge, VA
22192, USA. There were no comments received in response to the notice
of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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 firmus isolate 1582 (called B. firmus I-1582) (U.S. Patent
No. 6,406,690) is a Microbial Pesticide Control Agent (MPCA). It is
intended to be used as a biological nematode suppressant on fruits,
vegetables, field crops, and on such non-food crops as turf, and
ornamentals. Further information regarding this MPCA can be found in
the Biopesticide Registration Action Document (BRAD) on the
Biopesticides and Pollution and Prevention Division website https://
www.epa.gov/pesticides/biopesticides.
Studies submitted to the agency were issued Master Record
Identification numbers (MRIDs) and then reviewed by the Biopesticides
and Pollution Prevention Division (BPPD). The Agency also considered
these submissions in light of the new microbial pesticides data
requirements, which became final on December 26, 2007 (72 FR 61002).
The following summaries of the toxicological profile of Bacillus firmus
isolate I-1582 are based on Agency reviews or Data Evaluation Records
(DERs) dated March 05, 2008. These reviews include the following acute
toxicity/pathogenicity studies; oral, dermal, pulmonary and injection.
a. Acute oral toxicity/pathogenicity - rats (OPPTS 885.3050; MRID
#46933007; DER 03/05/2008). Nineteen male and 19 female Sprague-Dawley
rats were each treated by a single oral gavage dose of 0.1 mL per
animal (>108 colony forming unit (cfu) animal) of Bacillus
firmus I-1582 spores. The presented data showed no clinical signs and
no weight loss related to test substance in rats. Bacillus firmus I-
1582 was detected in brain, blood, cecum content, kidneys, lungs, lymph
nodes, and spleen of the treated animals with clearance from the blood
by day 7 and from all other organs by day 14. Necropsy was not
conducted. Based on the presented/submitted data, Bacillus firmus I-
1582 does not appear to be toxic, infective, and/or pathogenic in rats,
when dosed orally at >108 cfu/animal. This study was
classified as ``acceptable'' and the pesticide considered Toxicity
Category IV for acute oral effects.
b. Acute dermal toxicity/pathogenicity - rabbits (OPPTS 885.3100;
MRID #46933008; DER 03/05/2008). Five male and five female New Zealand
White rabbits were each treated with 5,050 milligrams/kilogram/
bodyweight (mg/kg/bwt) Bacillus firmus I-1582 spore suspension applied
to the clipped dorsal trunk in an area of approximately 10% of the body
surface in a dermal occlusion test according to standard laboratory
procedures. Animals were observed for dermal irritation 60 minutes
after patch removal. The test animals were observed for mortality and
clinical signs of toxicity at least three times on the day of treatment
and once daily thereafter for 14 days. The rabbits were euthanized on
day 14 and necropsies were performed. With the exception of one female
that lost weight during the first week, all animals had normal body
weight gain. All rabbits appeared normal during the study and all
survived the study. Very slight to well defined erythema was observed
on day 1 with clearance by day 4. No observable abnormalities were
noted at necropsy. The dermal LD50 for males, females, and
combined was greater than 5,050 mg/kg. Thus, Bacillus firmus I-1582 is
not toxic, infective, or pathogenic via the dermal route of exposure,
and the active ingredient is placed in Toxicity Category IV for acute
dermal effects.
c. Acute pulmonary toxicity/pathogenicity - rats (OPPTS 885.3150;
MRID #46933009; DER 03/05/2008). Thirty male and 30 female Sprague-
Dawley rats received 0.1 mL per animal (>108 cfu/animal)
Bacillus firmus I-1582 by intratracheal instillation. The presented
data show no adverse abnormal clinical signs in rats. No test organisms
were detected in any sample from the control rats. All six animals
sacrificed on day 3 had significant cfus (686 to 30,731 cfu/g) in their
lungs. The test organism was detected in brain, blood, cecum content,
kidneys, lungs, lymph nodes, and spleen of the treated animals.
Clearance was observed from the blood, kidneys, and liver by day 7 and
from all other organs by day 14. Necropsy studies were not conducted.
Based on the presented/submitted data, the test organisms were not
toxic, infective and/or pathogenic to rats and the active ingredient
was placed in Toxicity Category IV for acute pulmonary effects.
d. Acute inhalation toxicity (OPPTS 870.1300; MRID # 46933009; DER
03/05/2008). An acute inhalation study was not required for this non-
volatile active ingredient. The Agency also considered the acute
pulmonary study in Unit III.c., the nature of the inert ingredients,
the label requirements for Personal Protective Equipment for workers,
and the potential low exposure associated
[[Page 25526]]
with the proposed application methods. Based on its non-volatile
nature, if the pesticide is used as labeled, it will pose minimal to
non-existent risk to non-occupationally-exposed populations via
inhalation.
e. Acute injection toxicity/pathogenicity - rats (OPPTS 885.3200;
MRID # 46933010; DER 03/05/2008). Twenty six male and 26 female
Sprague-Dawley rats each received a dose of 0.1 mL per animal
(>107 cfu/animal), by injection into the tail vein. The
presented data showed no observable clinical signs in treated rats. No
test organisms were recovered in any samples from the control rats. The
test organism was detected in the blood, kidneys, liver, lungs, lymph
nodes, and spleen of the treated rats. Clearance from the brain, blood,
kidneys, lymph nodes, and spleen was established by day 21 after
dosing. Clearance from the cecum and liver was established by day 14
after dosing. Necropsy studies showed no abnormal findings. Bacillus
firmus spores did not appear to be toxic, infective, and/or pathogenic
in rats, when dosed at >107 cfu/animal. The submission is classified as
acceptable.
f. Cell culture (OPPTS 885.3500). This data requirement is only
required for active ingredients that are viruses and not for this type
of bacterial pesticide.
g. Waiver request: Hypersensitivity incidents technical-grade
active ingredient (TGAI) (OPPTS 885.3400; DER 03/05/2008). In addition
to the rationales in Unit III.h., the applicant requested that
hypersensitivity incidents be waived based on there being no adverse
effects of Bacillus firmus or its metabolites to humans or mammals in
literature searches. The request to waive this requirement is not
granted. As required for all pesticides, the Agency requires that
hypersensitivity incidents, should adverse effects occur, must be
reported to comply with section 6(a)(2) 40CFR159.152.
h. Waiver requests for Tiers II and Tier III (OPPTS 885.3550); MRID
#s 46933011; 47024806; DER 03/05/2008). The registrant requested that
the Agency waive the requirement for submission of data to support Tier
II and Tier III requirements for the TGAI.
The following rationales were provided to support requests to waive
submission of the studies
1. The active ingredient, Bacillus firmus strain I-1582, is a
naturally occurring microorganism.
2. No reports of adverse effects of Bacillus firmus or its
metabolites to humans or mammals were found in literature searches.
3. The proposed uses of the proposed End-use Product (EP) are not
expected to result in increased exposure or adverse effects to humans
or mammals.
4. The bacteria count falls to sub-effective levels in the
environment within 90 days of treatment.
5. The submitted studies, MRIDs 46933007, 46933008, 46933009, and
46933010, did not show pathogenicity to animals treated by oral gavage,
dermal application, pulmonary instillation, or intravenous injection.
6. Bacillus firmus was not found on any of eleven lists of
pathogens searched.
Based on these acceptable rationales and there being no
toxicological, infectivity or pathogenicity concerns in the Tier I
mammalian toxicity data submitted, the Agency granted the request to
waive studies required for Tier II and Tier III testing.
i. Waiver requests: EP and hypersensitivity incidents (OPPTS
885.3400; DER 03/05/2008). The applicant has submitted rationales to
waive data for acute oral toxicity/pathogenicity, acute pulmonary
toxicity/pathogenicity, acute dermal, primary eye, hypersensitivity
study, acute inhalation, and primary dermal, primary eye studies. These
rationales were based on the results of tests for the TGAI discussed in
the toxicological profile in Unit III of this document. In addition to
the rationales in Unit III.h., the applicant reiterated that there were
no reports of adverse effects of Bacillus firmus or its metabolites to
humans or mammals in literature searches.
The request to waive toxicity testing for the EP was based on
acceptable data reviews of the TGAI and the nature of the inert
ingredients which are exempt from the requirement of a tolerance. The
Agency decided to grant the request to waive the test for primary eye
irritation based on the acceptable low acute dermal toxicity category
IV classification of the pesticide. Any potential primary eye
irritation to this low toxcity pesticide can be mitigated by goggles or
personal protective eye equipment. In addition the application rate and
types of soil application and seed treatments indicate minimal to non-
existent risk via eye exposure. The request to waive the requirement
for hypersensitivity incidents for the EP is not granted. As required
for all pesticides, the Agency requires that hypersensitivity
incidents, should adverse effects occur, must be reported to comply
with section 6(a)(2) (40 CFR 159.152).
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
1. Food. Dietary exposure to the microbial pesticide is likely to
occur to this ubiquitous microbe. The lack of acute oral toxicity/
pathogenicity, based on the toxicology test in rats, supports the
exemption from the requirement of a tolerance for this active
ingredient. The pesticide is intended to be applied to the soil or to
be used as seed treatments, mainly for control of nematodes. It is not
systemic. Thus, dietary exposure by direct contact with food is not
expected. The acute oral study described in Unit III indicates that the
active ingredient is not toxic, infective or pathogenic when
administered to mammals (rats) via the oral route. In addition to this
acute oral study, other toxicology studies indicated that the microbe
cleared all organs within the time allotted for the studies.
There is no direct post-harvest treatment of food commodities with
Bacillus firmus I-1582. Thus, detectable residues of Bacillus firmus I-
1582 are not expected on agricultural crops or food commodities as a
result of the proposed use of this active ingredient. All inerts in the
proposed EP are exempt from the requirement of a tolerance. Based on
these observations, the Agency concluded that dietary exposure to
Bacillus firmus I-1582 is not expected to cause harm to human adults,
infants and children.
2. Drinking water exposure. Drinking water is not being screened
for Bacillus firmus I-1582 as a potential indicator of microbial
contamination. The pesticide is not intended for application to aquatic
agricultural crops. In the unlikely event that Bacillus firmus I-1582
was transferred to ground water, the microbe would not survive the
conditions of drinking water treatment, such as chlorination, pH
adjustments, and other water processing conditions. However, because of
the lack of mammalian toxicity, even if negligible oral exposure should
occur through drinking water, the Agency concludes that such exposure
would present no risk.
[[Page 25527]]
B. Other Non-Occupational Exposure
The Agency expects non-occupational dermal and inhalation exposure
to pose no harm if the pesticide is used as labeled. The proposed
product is anEP that is intended to be used commercially for seed and
soil treatments of agricultural crops. Other homeowner and residential
uses are also for soil applications outdoors at very low rates. No
indoor residential, school, or daycare uses are currently permitted for
this active ingredient. Even if there is non-occupational residential,
school or day care exposure from the proposed uses of Bacillus firmus
I-1582, the risk posed by this low toxicity microbe is likely to be
minimal.
1. Dermal exposure. As discussed in Unit III. Bacillus firmus I-
1582 is not toxic, infective, or pathogenic via the dermal route of
exposure, and the active ingredient is placed in Toxicity Category IV
for acute dermal effects. The pesticide is proposed for use as soil and
seed treatments to agricultural crops. For these exposure scenarios,
non-occupational dermal exposure is not expected. The potential for
non-occupational exposure exists for residential and home and garden
use. However, low application rates, soil applications and the low
toxicity potential of the active ingredient indicate that non-
occupational exposure through these uses is not likely to cause harm to
the exposed population if the pesticide is used as labeled.
2. Inhalation exposure. A similar rationale supports the Agency's
conclusion that non-occupational inhalation exposure is not likely to
cause harm to the exposed population if the pesticide is used as
labeled. The active ingredient is placed in Toxicity Category IV on the
basis of the acute pulmonary study (see Unit III.) and is non-volatile.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Bacillus firmus I-1582
and to other substances that have a common mechanism of toxicity. These
considerations include the possible cumulative effects of such residues
on infants and children. Bacillus firmus I-1582 is not toxic or
pathogenic to mammals via several routes of exposure (Unit III.) There
are no other Bacillus firmus strains registered. Consequently, no
cumulative effects from the residues of this product with other related
microbial pesticides are anticipated.
VI. Determination of Safety for U.S. Population, Infants and Children
See Unit III. for acute toxicological evaluations of Bacillus
firmus I-1582. Further, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of exposure (safety) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the database on
toxicity and exposure, unless EPA determines that a different margin of
exposure (MOE) (safety) will be safe for infants and children. Margins
of exposure (safety), which often are referred to as uncertainty
factors, are incorporated into EPA risk assessment either directly or
through the use of a margin of exposure analysis or by using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk. Actual exposures to adults and children through diet
are expected to be several orders of magnitude less than the doses used
in the toxicity and pathogenicity tests referenced in Unit III. Thus,
the Agency has determined that an additional margin of safety for
infants and children is unnecessary.
VII. Other Considerations
A. Endocrine Immunotoxicity
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was a scientific basis for including, as part
of the program, androgen and thyroid hormone systems, in addition to
the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that it include evaluations of potential effects in wildlife.
The Agency has no knowledge of Bacillus firmus I-1582 being an
endocrine disruptor, nor if this microbe is related to any class of
known endocrine disruptors. Consequently, endocrine-related concerns
did not impact the Agency's safety finding for these Bacillus firmus I-
1582 strains. Additional data specifically on the endocrine effects of
this microbial pesticide are not required at this time. When the
appropriate screening and/or testing protocols being considered under
the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and implemented, Bacillus firmus I-1582 may be subject to
additional screening and/or testing to better characterize effects
related to endocrine disruption.
As discussed in this document in Unit III. Tier I toxicology data
evaluated for this active ingredient showed clearance in a variety of
tissues and did not trigger Tier III data requirements for
immunotoxicity testing.
B. Analytical Methods
The acute oral studies discussed in Unit III. demonstrate that the
active ingredient does not pose a dietary risk. In addition, the active
ingredient is not likely to come into contact with the treated food
commodities. Furthermore, the low application rate and non-persistence
on food during applications suggests very low exposure potential via
the dietary route. Since residues are not expected on treated
commodities, the Agency has concluded that an analytical method to
detect residues of this pesticide on treated food commodities for
enforcement purposes is not needed.
Nevertheless, the Agency has concluded that for analysis of the
pesticide itself, microbiological and biochemical methods exist and are
acceptable for enforcement purposes for product identity of Bacillus
firmus I-1582. Other appropriate methods are required for quality
control to assure that product characterization, the control of human
pathogens and other unintentional metabolites or ingredients are within
regulatory limits, and to ascertain storage stability and viability of
the pesticidal active ingredient.
C. Codex Maximum Residue Level
There is no Codex maximum residue level for residues of Bacillus
firmus I-1582.
VIII. Conclusions
The results of the studies discussed in Unit III. meet the safety
standards of the 1996 FQPA. They support an exemption from the
requirement of a tolerance for residues of Bacillus firmus I-1582, on
treated food or feed commodities. In addition, the Agency is of the
opinion that, if the microbial active ingredient is used as allowed,
aggregate and cumulative exposures are not likely to harm the adult
human U.S. population, children and infants. Therefore, an exemption
from tolerance is granted for residues of Bacillus firmus I-1582 when
used as soil and seed treatments in/on all food/feed commodities in
response to pesticide petition 6F7111.
[[Page 25528]]
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, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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: April 23, 2008.
Debra Edwards,
Director, 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 180.1282 is added to read as follows:
Sec. 180.1282 Bacillus firmus I-1582; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established in/
on all food/feed commodities, for residues of Bacillus firmus I-1582
when used as a soil application or seed treatment.
[FR Doc. E8-10121 Filed 5-6-08; 8:45 am]
BILLING CODE 6560-50-S
