Chromobacterium subtsugae Strain PRAA4-1T, 55268-55272 [2011-22868]
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Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations
Pesticide chemical
CAS Reg. No.
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0054; FRL–8887–4]
Chromobacterium subtsugae Strain
PRAA4–1T; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of
Chromobacterium subtsugae strain
PRAA4–1T in or on all food
commodities when applied as an
insecticide or miticide and used in
accordance with good agricultural
practices. Marrone Bio Innovations, Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Chromobacterium
subtsugae strain PRAA4–1T under the
FFDCA.
DATES: This regulation is effective
September 7, 2011. Objections and
requests for hearings must be received
on or before November 7, 2011, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0054. All documents in the
docket are listed in the docket index
available at 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
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the harmonized
test guidelines referenced in this
document electronically, please go to
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P
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When ready for use, the end-use concentration is not to exceed 500 ppm.
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 Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
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[FR Doc. 2011–22844 Filed 9–6–11; 8:45 am]
SUMMARY:
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9001–62–1
Limits
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–0054 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 7, 2011. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0054, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: OPP Regulatory Public Docket
(7502P), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8920; e-mail address:
kausch.jeannine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
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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.
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.
II. Background and Statutory Findings
In the Federal Register of March 10,
2010 (75 FR 11171) (FRL–8810–8), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 9F7674)
by Marrone Bio Innovations, Inc., 2121
Second Street, Suite B–107, Davis, CA
95618. The petition requested that 40
CFR part 180 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of Chromobacterium subtsugae strain
PRAA4–1T. This notice referenced a
summary of the petition prepared by the
petitioner, Marrone Bio Innovations,
Inc., which is available in the docket via
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which require
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance exemption and
to ‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue * * *’’ Additionally, section
408(b)(2)(D) of FFDCA requires that the
EPA consider ‘‘available information
concerning the cumulative effects of [a
particular pesticide’s] * * * residues
and other substances that have a
common mechanism of toxicity.’’
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.
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A. Overview of Chromobacterium
subtsugae Strain PRAA4–1T
Chromobacterium subtsugae strain
PRAA4–1T is a naturally occurring,
gram-negative, violet-pigmented
bacterium that was isolated from soil
under an eastern hemlock (Tsuga
canadensis) in the Catoctin Mountain
region of central Maryland. The United
States Department of Agriculture found
this isolate of Chromobacterium
subtsugae to be orally toxic to Colorado
potato beetle (Leptinotarsa
decemlineata) larvae, small hive beetle
(Aethina tumida) larvae, southern corn
rootworm (Diabrotica undecimpunctata)
larvae and adults, and southern green
stink bug (Nezara viridula) adults.
Additional testing has shown that
Chromobacterium subtsugae strain
PRAA4–1T-treated diet resulted in
reduced feeding in beet armyworm
(Spodoptera exigua), cabbage looper
(Trichoplusia ni), tobacco budworm
(Heliothis virescens), diamondback
moth (Plutella xylostella), and southern
corn rootworm, suggesting this
microbe’s insecticidal activity is due to
reduction in weight or inhibition of
feeding. In light of the demonstrated
insecticidal and miticidal capabilities of
Chromobacterium subtsugae strain
PRAA4–1T, Marrone Bio Innovations,
Inc. has proposed to register pesticide
products that could be applied to
agricultural and greenhouse crops,
including vegetables, fruit, flowers,
bedding plants, ornamentals, and turf,
to control certain insect and mite pests.
B. Microbial Pesticide Toxicology Data
Requirements
All mammalian toxicology data
requirements supporting the request for
an exemption from the requirement of a
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tolerance for residues of
Chromobacterium subtsugae strain
PRAA4–1T in or on all food
commodities have been fulfilled with
data submitted by the petitioner or data
waiver requests that have been granted
by EPA. The toxicity tests (acute oral,
dermal, and inhalation toxicity) and
irritation tests (acute eye and primary
dermal irritation), which addressed
potential routes of exposure to the
active ingredient, were all classified in
Toxicity Category IV (see 40 CFR
156.62). Moreover, an acute injection
toxicity/pathogenicity test indicated
that Chromobacterium subtsugae strain
PRAA4–1T was not toxic, infective, and/
or pathogenic via the intravenous route
of exposure, a worst-case scenario
whereby the skin is bypassed as a
barrier. Finally, Chromobacterium
subtsugae strain PRAA4–1T is not
recognized as a dermal sensitizer, and
the petitioner has reported that no
hypersensitivity incidents occurred
during development and testing of this
bacterium. The overall conclusions from
all toxicological information submitted
by the petitioner are described below,
while more in-depth synopses of the
study results can be found in the
associated Biopesticides Registration
Action Document provided as a
reference in Unit IX. (Ref. 1).
1. Acute oral toxicity—rat
(Harmonized Guideline 870.1100;
Master Record Identification Number
(MRID No.) 479450–03). An acceptable
acute oral toxicity study demonstrated
that Chromobacterium subtsugae strain
PRAA4–1T was not toxic to female rats
when dosed at 5,000 milligrams per
kilogram (mg/kg). The median lethal
dose (LD50) (i.e., a statistically derived
single dose that can be expected to
cause death in 50% of test animals) was
greater than 5,000 mg/kg (Toxicity
Category IV).
2. Acute oral toxicity/pathogenicity
(Harmonized Guideline 885.3050; MRID
No. 479450–23). Upon consideration of
results of other definitive toxicological
data submitted by the petitioner, EPA
waived acute oral toxicity/pathogenicity
testing for Chromobacterium subtsugae
strain PRAA4–1T. An acute oral toxicity
study conducted on rats (MRID No.
479450–03) demonstrated that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic (LD50 greater
than 5,000 mg/kg; Toxicity Category IV),
while an acute injection toxicity/
pathogenicity study conducted on rats
(MRID No. 479450–11) showed that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic, infective, and/
or pathogenic when the skin was
bypassed as a barrier. EPA believes
these data, when taken together, clearly
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indicate that this bacterium would not
be toxic, infective, and/or pathogenic
through the oral route of exposure and
that further testing is not necessary.
3. Acute inhalation toxicity—rat
(Harmonized Guideline 870.1300; MRID
No. 479450–05). An acceptable acute
inhalation toxicity study demonstrated
that Chromobacterium subtsugae strain
PRAA4–1T was not toxic to male and
female rats when exposed to 2.12
milligrams per liter (mg/L). The median
lethal concentration (LC50) (i.e., a
statistically derived concentration of a
substance that can be expected to cause
death in 50% of test animals) was
greater than 2.12 mg/L (Toxicity
Category IV).
4. Acute pulmonary toxicity/
pathogenicity (Harmonized Guideline
885.3150; MRID No. 479450–23). Upon
consideration of results of other
definitive toxicological data submitted
by the petitioner, EPA waived acute
pulmonary toxicity/pathogenicity
testing for Chromobacterium subtsugae
strain PRAA4–1T. An acute inhalation
toxicity study conducted on rats (MRID
No. 479450–05) demonstrated that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic (LC50 greater
than 2.12 mg/L; Toxicity Category IV),
while an acute injection toxicity/
pathogenicity study conducted on rats
(MRID No. 479450–11) showed that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic, infective, and/
or pathogenic when the skin was
bypassed as a barrier. EPA believes
these data, when taken together, clearly
indicate that this bacterium would not
be toxic, infective, and/or pathogenic
through the inhalation route of exposure
and that further testing is not necessary.
5. Acute injection toxicity/
pathogenicity (intravenous)—rat
(Harmonized Guideline 885.3200; MRID
No. 479450–11). An acceptable acute
injection toxicity and pathogenicity
(intravenous) demonstrated that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic, infective, and/
or pathogenic to rats when dosed
intravenously at 3.1 × 10 6 colonyforming units per animal.
6. Acute dermal toxicity—rat
(Harmonized Guideline 870.1200; MRID
No. 479450–04). An acceptable acute
dermal toxicity study demonstrated that
Chromobacterium subtsugae strain
PRAA4–1T was not toxic to rats when
dosed at 5,050 mg/kg. The LD50 was
greater than 5,050 mg/kg (Toxicity
Category IV).
7. Acute eye irritation—rabbit
(Harmonized Guideline 870.2400; MRID
No. 479450–06). An acceptable acute
eye irritation study demonstrated that
Chromobacterium subtsugae strain
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PRAA4–1T was minimally irritating to
the eyes of rabbits (irritation symptoms
cleared by 24 hours; Toxicity Category
IV).
8. Primary dermal irritation—rabbit
(Harmonized Guideline 870.2500; MRID
No. 479450–07). An acceptable primary
dermal irritation study demonstrated
that Chromobacterium subtsugae strain
PRAA4–1T was slightly irritating to the
skin of rabbits (irritation symptoms
cleared by 24 hours; Toxicity Category
IV).
9. Dermal sensitization—guinea pig
(Harmonized Guideline 870.2600; MRID
No. 479450–08). An acceptable dermal
sensitization study demonstrated that
Chromobacterium subtsugae strain
PRAA4–1T was not a dermal sensitizer
to guinea pigs.
IV. Aggregate Exposure
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other 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
Dietary exposure to this microbial
pesticide may occur (more likely
through food than drinking water);
however, the lack of acute oral toxicity,
as exhibited in a toxicology test on rats,
and the rationales justifying the waiver
of acute oral toxicity/pathogenicity
testing (see Unit III.B.), support the
establishment of a tolerance exemption
for residues of Chromobacterium
subtsugae strain PRAA4–1T.
1. Food exposure. Any exposure to
this naturally occurring soil bacterium
is anticipated to be negligible. Although
Chromobacterium subtsugae strain
PRAA4–1T may be applied directly to
food, it is not expected to persist or
accumulate in any reservoirs on plants
or food commodities (the phyllosphere)
because, as a soil microorganism, it is
best adapted to more favorable
conditions underground. Rather, after
application, it likely will degrade due to
predation by other biological organisms
(e.g., protists) and exposure to particular
environmental factors (e.g., sunlight and
varying temperatures) (Refs. 2 and 3).
Should this microbial pesticide be
present on food, the acute oral toxicity
and pathogenicity data/information
demonstrated no toxicity, infectivity
and/or pathogenicity is likely to occur
with any exposure level of
Chromobacterium subtsugae strain
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PRAA4–1T (see additional discussion in
Unit III.B.).
2. Drinking water exposure. Exposure
of humans to residues of
Chromobacterium subtsugae strain
PRAA4–1T in consumed drinking water
is unlikely. The proposed use patterns
for Chromobacterium subtsugae strain
PRAA4–1T do not include direct
application to aquatic environments,
thereby limiting contact with surface
water. Furthermore, ground water is not
expected to have significant exposure to
Chromobacterium subtsugae strain
PRAA4–1T since, like other
microorganisms, this bacterium would
likely be filtered out by the particulate
nature of many soil types (Refs. 4, 5, and
6) and is not known to survive in water
or deep soil. If Chromobacterium
subtsugae strain PRAA4–1T were to be
transferred to surface or ground waters
that are intended for eventual human
consumption (e.g., through spray drift or
runoff) and directed to wastewater
treatment systems or drinking water
facilities, it likely would not survive the
conditions water is subjected to in such
systems or facilities, including high
temperatures, chlorination, pH
adjustments, and/or filtration (Refs. 7
and 8). In the remote likelihood that this
microbial pesticide is present in
drinking water (e.g., in water not subject
to treatment systems or facilities), the
acute oral toxicity and pathogenicity
data/information demonstrated no
toxicity, infectivity and/or pathogenicity
is likely to occur with any exposure
level of Chromobacterium subtsugae
strain PRAA4–1T (see additional
discussion in Unit III.B.).
B. Other Non-Occupational Exposure
Dermal and inhalation nonoccupational exposure to
Chromobacterium subtsugae strain
PRAA4–1T is not expected as all
proposed pesticide applications will
take place in distinct agricultural
settings. Even if dermal and inhalation
non-occupational exposures were to
occur, such exposures would not exceed
EPA’s level of concern given testing that
indicated that Chromobacterium
subtsugae strain PRAA4–1T is not toxic
(acute inhalation and dermal toxicity),
is only slightly irritating (primary
dermal irritation), is not a sensitizer
(dermal sensitization), and is not
pathogenic or infective (acute injection
toxicity/pathogenicity) (see additional
discussion in Unit III.B.).
V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
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tolerance exemption, EPA consider
‘‘available information concerning the
cumulative effects of [a particular
pesticide’s] * * * residues and other
substances that have a common
mechanism of toxicity.’’
EPA has not found Chromobacterium
subtsugae strain PRAA4–1T to share a
common mechanism of toxicity with
any other substances, and
Chromobacterium subtsugae strain
PRAA4–1T does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that Chromobacterium
subtsugae strain PRAA4–1T does not
have a common mechanism of toxicity
with other substances. Following from
this, therefore, EPA concludes that there
are no cumulative effects associated
with Chromobacterium subtsugae strain
PRAA4–1T that need to be considered.
For information regarding EPA’s efforts
to determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
VI. Determination of Safety for U.S.
Population, Infants and Children
FFDCA section 408(b)(2)(C) provides
that EPA shall assess the available
information about consumption patterns
among infants and children, special
susceptibility of infants and children to
pesticide chemical residues, and the
cumulative effects on infants and
children of the residues and other
substances with a common mechanism
of toxicity. In addition, FFDCA section
408(b)(2)(C) provides that EPA shall
apply an additional tenfold (10X)
margin of safety for infants and children
in the case of threshold effects to
account for prenatal and postnatal
toxicity and the completeness of the
database on toxicity and exposure
unless EPA determines that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor. In applying this provision, EPA
either retains the default value of 10X or
uses a different additional safety factor
when reliable data available to EPA
support the choice of a different factor.
Based on the acute toxicity and
pathogenicity data/information
discussed in Unit III.B., EPA concludes
that there is a reasonable certainty that
no harm will result to the U.S.
population, including infants and
children, from aggregate exposure to the
residues of Chromobacterium subtsugae
strain PRAA4–1T. Such exposure
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includes all anticipated dietary
exposures and all other exposures for
which there is reliable information. EPA
has arrived at this conclusion because,
considered collectively, the data (e.g.,
lack of toxicity noted for oral, dermal,
and inhalation routes of exposure)
available on Chromobacterium
subtsugae strain PRAA4–1T do not
demonstrate toxic, pathogenic, and/or
infective potential to sensitive
populations from exposure to this
microbial pest control agent. Thus, there
are no threshold effects of concern and,
as a result, an additional margin of
safety is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since EPA is
establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. In this context, EPA considers
the international maximum residue
limits (MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for Chromobacterium subtsugae strain
PRAA4–1T.
VIII. Conclusions
EPA concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of
Chromobacterium subtsugae strain
PRAA4–1T. Therefore, an exemption
from the requirement of a tolerance is
established for residues of
Chromobacterium subtsugae strain
PRAA4–1T in or on all food
commodities when applied as an
insecticide or miticide and used in
accordance with good agricultural
practices.
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IX. References
1. U.S. EPA. 2011. Chromobacterium
subtsugae strain PRAA4–1T
Biopesticides Registration Action
Document dated July 2011 (available as
‘‘Supporting & Related Material’’ within
docket ID number EPA–HQ–OPP–2010–
0058 at https://www.regulations.gov).
2. U.S. EPA. 1996. Microbial Pesticide Test
Guidelines—Background for Residue
Analysis of Microbial Pest Control
Agents (OPPTS 885.2000). Available
from https://www.epa.gov/ocspp/pubs/
frs/publications/Test_Guidelines/
series885.htm.
3. Lindow SE, Brandl MT. 2003.
Microbiology of the phyllosphere.
Applied and Environmental
Microbiology 69:1875–1883.
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4. Pang L, McLeod M, Aislabie J, Simunek J,
Close M, Hector R. 2008. Modeling
transport of microbes in ten undisturbed
soils under effluent irrigation. Vadose
Zone Journal 7:97–111.
5. Aislabie J, Smith JJ, Fraser R, McLeod M.
2001. Leaching of bacterial indicators of
faecal contamination through four New
Zealand soils. Australian Journal of Soil
Research 39:1397–1406.
6. DeFelice K, Wollenhaupt N, Buchholz D.
1993. Aquifers and Soil Filter Effect.
Available from https://
extension.missouri.edu/p/WQ24.
7. U.S. EPA. 2004. Primer for Municipal
Wastewater Treatment Systems. EPA
832–R–04–001. Available from https://
www.epa.gov/npdes/pubs/primer.pdf.
8. Centers for Disease Control and
Prevention. 2009. Drinking Water—
Water Treatment. Available from https://
www.cdc.gov/healthywater/drinking/
public/water_treatment.html.
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
exemption under section 408(d) of
FFDCA in response to a petition
submitted to EPA. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
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Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance exemption in this final
rule, do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes.
As a result, this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
EPA has determined that this action will
not have a substantial direct effect on
States or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, EPA has determined that
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
EPA consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
jlentini on DSK4TPTVN1PROD with RULES
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).
16:02 Sep 06, 2011
Jkt 223001
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 26, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1305 is added to
subpart D to read as follows:
■
§ 180.1305 Chromobacterium subtsugae
strain PRAA4–1T; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Chromobacterium subtsugae strain
PRAA4–1T in or on all food
commodities when applied as an
insecticide or miticide and used in
accordance with good agricultural
practices.
[FR Doc. 2011–22868 Filed 9–6–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0099; FRL–8870–8]
Flubendiamide; Pesticide Tolerances;
Technical Amendment
Environmental Protection
Agency (EPA).
ACTION: Final rule; technical
amendment.
AGENCY:
This document is being
issued to correctly revise tolerance
levels, for the pesticide, flubendiamide
in or on the meat and meat byproducts
of cattle, goat, hog, horse, and sheep.
The tolerance levels were inadvertently
transcribed incorrectly in a final rule
printed in the Federal Register on
March 23, 2011.
DATES: This final rule is effective
September 7, 2011.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0099. All documents in the
docket are listed in the docket index
available in https://www.regulations.gov.
Although listed in the index, some
SUMMARY:
XI. Congressional Review Act
VerDate Mar<15>2010
List of Subjects in 40 CFR Part 180
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
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:
Carmen Rodia, Registration Division
(7504P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460–0001; telephone
number: (703) 306–0327; fax number:
(703) 308–0029; e-mail address:
rodia.carmen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
The Agency included in the final rule
a list of those who may be potentially
affected by this action. If you have
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
II. What does this technical amendment
do?
In the Federal Register of March 23,
2011 (75 FR 16301) (FRL–8863–8), EPA
issued a final rule establishing new
tolerances and revising existing
tolerances for residues of flubendiamide
(40 CFR 180.639) on certain food and
livestock commodities. Inadvertently, a
few of the tolerance levels were
transcribed incorrectly, and
consequently, 40 CFR 180.639(a)(2)
provides an incorrect tolerance value for
the established tolerances for cattle,
meat (0.60 ppm); cattle, meat
byproducts (0.08 ppm); goat, meat (0.60
ppm); goat, meat byproducts (0.08 ppm);
hog, meat (0.15 ppm); hog, meat
byproducts (0.03 ppm); horse, meat
(0.60 ppm); horse, meat byproducts
(0.08 ppm); sheep, meat (0.60 ppm); and
sheep, meat byproducts (0.08 ppm). As
supported by recalculated beef and
dairy cattle, swine, and poultry dietary
burdens, and re-evaluation of previously
submitted animal feeding studies, these
tolerance values should be revised to
0.08 ppm; 0.60 ppm; 0.08 ppm; 0.60
E:\FR\FM\07SER1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55268-55272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22868]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0054; FRL-8887-4]
Chromobacterium subtsugae Strain PRAA4-1\T\; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ in or on all food commodities when applied as an insecticide or
miticide and used in accordance with good agricultural practices.
Marrone Bio Innovations, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of
Chromobacterium subtsugae strain PRAA4-1\T\ under the FFDCA.
DATES: This regulation is effective September 7, 2011. Objections and
requests for hearings must be received on or before November 7, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0054. All documents in the
docket are listed in the docket index available at 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 Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 347-8920; e-mail
address: kausch.jeannine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to https://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0054 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 7, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0054, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S.
[[Page 55269]]
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays). Special arrangements
should be made for deliveries of boxed information. The Docket Facility
telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F7674) by Marrone Bio Innovations, Inc., 2121 Second
Street, Suite B-107, Davis, CA 95618. The petition requested that 40
CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of Chromobacterium subtsugae
strain PRAA4-1\T\. This notice referenced a summary of the petition
prepared by the petitioner, Marrone Bio Innovations, Inc., which is
available in the docket via https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue * * *'' Additionally, section 408(b)(2)(D) of FFDCA requires
that the EPA consider ``available information concerning the cumulative
effects of [a particular pesticide's] * * * residues and other
substances that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
A. Overview of Chromobacterium subtsugae Strain PRAA4-1\T\
Chromobacterium subtsugae strain PRAA4-1\T\ is a naturally
occurring, gram-negative, violet-pigmented bacterium that was isolated
from soil under an eastern hemlock (Tsuga canadensis) in the Catoctin
Mountain region of central Maryland. The United States Department of
Agriculture found this isolate of Chromobacterium subtsugae to be
orally toxic to Colorado potato beetle (Leptinotarsa decemlineata)
larvae, small hive beetle (Aethina tumida) larvae, southern corn
rootworm (Diabrotica undecimpunctata) larvae and adults, and southern
green stink bug (Nezara viridula) adults. Additional testing has shown
that Chromobacterium subtsugae strain PRAA4-1\T\-treated diet resulted
in reduced feeding in beet armyworm (Spodoptera exigua), cabbage looper
(Trichoplusia ni), tobacco budworm (Heliothis virescens), diamondback
moth (Plutella xylostella), and southern corn rootworm, suggesting this
microbe's insecticidal activity is due to reduction in weight or
inhibition of feeding. In light of the demonstrated insecticidal and
miticidal capabilities of Chromobacterium subtsugae strain PRAA4-1\T\,
Marrone Bio Innovations, Inc. has proposed to register pesticide
products that could be applied to agricultural and greenhouse crops,
including vegetables, fruit, flowers, bedding plants, ornamentals, and
turf, to control certain insect and mite pests.
B. Microbial Pesticide Toxicology Data Requirements
All mammalian toxicology data requirements supporting the request
for an exemption from the requirement of a tolerance for residues of
Chromobacterium subtsugae strain PRAA4-1\T\ in or on all food
commodities have been fulfilled with data submitted by the petitioner
or data waiver requests that have been granted by EPA. The toxicity
tests (acute oral, dermal, and inhalation toxicity) and irritation
tests (acute eye and primary dermal irritation), which addressed
potential routes of exposure to the active ingredient, were all
classified in Toxicity Category IV (see 40 CFR 156.62). Moreover, an
acute injection toxicity/pathogenicity test indicated that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic, infective,
and/or pathogenic via the intravenous route of exposure, a worst-case
scenario whereby the skin is bypassed as a barrier. Finally,
Chromobacterium subtsugae strain PRAA4-1\T\ is not recognized as a
dermal sensitizer, and the petitioner has reported that no
hypersensitivity incidents occurred during development and testing of
this bacterium. The overall conclusions from all toxicological
information submitted by the petitioner are described below, while more
in-depth synopses of the study results can be found in the associated
Biopesticides Registration Action Document provided as a reference in
Unit IX. (Ref. 1).
1. Acute oral toxicity--rat (Harmonized Guideline 870.1100; Master
Record Identification Number (MRID No.) 479450-03). An acceptable acute
oral toxicity study demonstrated that Chromobacterium subtsugae strain
PRAA4-1\T\ was not toxic to female rats when dosed at 5,000 milligrams
per kilogram (mg/kg). The median lethal dose (LD50) (i.e., a
statistically derived single dose that can be expected to cause death
in 50% of test animals) was greater than 5,000 mg/kg (Toxicity Category
IV).
2. Acute oral toxicity/pathogenicity (Harmonized Guideline
885.3050; MRID No. 479450-23). Upon consideration of results of other
definitive toxicological data submitted by the petitioner, EPA waived
acute oral toxicity/pathogenicity testing for Chromobacterium subtsugae
strain PRAA4-1\T\. An acute oral toxicity study conducted on rats (MRID
No. 479450-03) demonstrated that Chromobacterium subtsugae strain
PRAA4-1\T\ was not toxic (LD50 greater than 5,000 mg/kg;
Toxicity Category IV), while an acute injection toxicity/pathogenicity
study conducted on rats (MRID No. 479450-11) showed that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic, infective,
and/or pathogenic when the skin was bypassed as a barrier. EPA believes
these data, when taken together, clearly
[[Page 55270]]
indicate that this bacterium would not be toxic, infective, and/or
pathogenic through the oral route of exposure and that further testing
is not necessary.
3. Acute inhalation toxicity--rat (Harmonized Guideline 870.1300;
MRID No. 479450-05). An acceptable acute inhalation toxicity study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was not
toxic to male and female rats when exposed to 2.12 milligrams per liter
(mg/L). The median lethal concentration (LC50) (i.e., a
statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals) was greater than 2.12 mg/L
(Toxicity Category IV).
4. Acute pulmonary toxicity/pathogenicity (Harmonized Guideline
885.3150; MRID No. 479450-23). Upon consideration of results of other
definitive toxicological data submitted by the petitioner, EPA waived
acute pulmonary toxicity/pathogenicity testing for Chromobacterium
subtsugae strain PRAA4-1\T\. An acute inhalation toxicity study
conducted on rats (MRID No. 479450-05) demonstrated that
Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic
(LC50 greater than 2.12 mg/L; Toxicity Category IV), while
an acute injection toxicity/pathogenicity study conducted on rats (MRID
No. 479450-11) showed that Chromobacterium subtsugae strain PRAA4-1\T\
was not toxic, infective, and/or pathogenic when the skin was bypassed
as a barrier. EPA believes these data, when taken together, clearly
indicate that this bacterium would not be toxic, infective, and/or
pathogenic through the inhalation route of exposure and that further
testing is not necessary.
5. Acute injection toxicity/pathogenicity (intravenous)--rat
(Harmonized Guideline 885.3200; MRID No. 479450-11). An acceptable
acute injection toxicity and pathogenicity (intravenous) demonstrated
that Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic,
infective, and/or pathogenic to rats when dosed intravenously at 3.1 x
10 \6\ colony-forming units per animal.
6. Acute dermal toxicity--rat (Harmonized Guideline 870.1200; MRID
No. 479450-04). An acceptable acute dermal toxicity study demonstrated
that Chromobacterium subtsugae strain PRAA4-1\T\ was not toxic to rats
when dosed at 5,050 mg/kg. The LD50 was greater than 5,050
mg/kg (Toxicity Category IV).
7. Acute eye irritation--rabbit (Harmonized Guideline 870.2400;
MRID No. 479450-06). An acceptable acute eye irritation study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was
minimally irritating to the eyes of rabbits (irritation symptoms
cleared by 24 hours; Toxicity Category IV).
8. Primary dermal irritation--rabbit (Harmonized Guideline
870.2500; MRID No. 479450-07). An acceptable primary dermal irritation
study demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was
slightly irritating to the skin of rabbits (irritation symptoms cleared
by 24 hours; Toxicity Category IV).
9. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 479450-08). An acceptable dermal sensitization study
demonstrated that Chromobacterium subtsugae strain PRAA4-1\T\ was not a
dermal sensitizer to guinea pigs.
IV. Aggregate Exposure
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Dietary exposure to this microbial pesticide may occur (more likely
through food than drinking water); however, the lack of acute oral
toxicity, as exhibited in a toxicology test on rats, and the rationales
justifying the waiver of acute oral toxicity/pathogenicity testing (see
Unit III.B.), support the establishment of a tolerance exemption for
residues of Chromobacterium subtsugae strain PRAA4-1\T\.
1. Food exposure. Any exposure to this naturally occurring soil
bacterium is anticipated to be negligible. Although Chromobacterium
subtsugae strain PRAA4-1\T\ may be applied directly to food, it is not
expected to persist or accumulate in any reservoirs on plants or food
commodities (the phyllosphere) because, as a soil microorganism, it is
best adapted to more favorable conditions underground. Rather, after
application, it likely will degrade due to predation by other
biological organisms (e.g., protists) and exposure to particular
environmental factors (e.g., sunlight and varying temperatures) (Refs.
2 and 3). Should this microbial pesticide be present on food, the acute
oral toxicity and pathogenicity data/information demonstrated no
toxicity, infectivity and/or pathogenicity is likely to occur with any
exposure level of Chromobacterium subtsugae strain PRAA4-1\T\ (see
additional discussion in Unit III.B.).
2. Drinking water exposure. Exposure of humans to residues of
Chromobacterium subtsugae strain PRAA4-1\T\ in consumed drinking water
is unlikely. The proposed use patterns for Chromobacterium subtsugae
strain PRAA4-1\T\ do not include direct application to aquatic
environments, thereby limiting contact with surface water. Furthermore,
ground water is not expected to have significant exposure to
Chromobacterium subtsugae strain PRAA4-1\T\ since, like other
microorganisms, this bacterium would likely be filtered out by the
particulate nature of many soil types (Refs. 4, 5, and 6) and is not
known to survive in water or deep soil. If Chromobacterium subtsugae
strain PRAA4-1\T\ were to be transferred to surface or ground waters
that are intended for eventual human consumption (e.g., through spray
drift or runoff) and directed to wastewater treatment systems or
drinking water facilities, it likely would not survive the conditions
water is subjected to in such systems or facilities, including high
temperatures, chlorination, pH adjustments, and/or filtration (Refs. 7
and 8). In the remote likelihood that this microbial pesticide is
present in drinking water (e.g., in water not subject to treatment
systems or facilities), the acute oral toxicity and pathogenicity data/
information demonstrated no toxicity, infectivity and/or pathogenicity
is likely to occur with any exposure level of Chromobacterium subtsugae
strain PRAA4-1\T\ (see additional discussion in Unit III.B.).
B. Other Non-Occupational Exposure
Dermal and inhalation non-occupational exposure to Chromobacterium
subtsugae strain PRAA4-1\T\ is not expected as all proposed pesticide
applications will take place in distinct agricultural settings. Even if
dermal and inhalation non-occupational exposures were to occur, such
exposures would not exceed EPA's level of concern given testing that
indicated that Chromobacterium subtsugae strain PRAA4-1\T\ is not toxic
(acute inhalation and dermal toxicity), is only slightly irritating
(primary dermal irritation), is not a sensitizer (dermal
sensitization), and is not pathogenic or infective (acute injection
toxicity/pathogenicity) (see additional discussion in Unit III.B.).
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a
[[Page 55271]]
tolerance exemption, EPA consider ``available information concerning
the cumulative effects of [a particular pesticide's] * * * residues and
other substances that have a common mechanism of toxicity.''
EPA has not found Chromobacterium subtsugae strain PRAA4-1\T\ to
share a common mechanism of toxicity with any other substances, and
Chromobacterium subtsugae strain PRAA4-1\T\ does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has assumed that Chromobacterium
subtsugae strain PRAA4-1\T\ does not have a common mechanism of
toxicity with other substances. Following from this, therefore, EPA
concludes that there are no cumulative effects associated with
Chromobacterium subtsugae strain PRAA4-1\T\ that need to be considered.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the Food Quality Protection Act Safety
Factor. In applying this provision, EPA either retains the default
value of 10X or uses a different additional safety factor when reliable
data available to EPA support the choice of a different factor.
Based on the acute toxicity and pathogenicity data/information
discussed in Unit III.B., EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Chromobacterium subtsugae strain PRAA4-1\T\. Such exposure includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. EPA has arrived at this conclusion because,
considered collectively, the data (e.g., lack of toxicity noted for
oral, dermal, and inhalation routes of exposure) available on
Chromobacterium subtsugae strain PRAA4-1\T\ do not demonstrate toxic,
pathogenic, and/or infective potential to sensitive populations from
exposure to this microbial pest control agent. Thus, there are no
threshold effects of concern and, as a result, an additional margin of
safety is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
EPA is establishing an exemption from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. In this
context, EPA considers the international maximum residue limits (MRLs)
established by the Codex Alimentarius Commission (Codex), as required
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for Chromobacterium subtsugae
strain PRAA4-1\T\.
VIII. Conclusions
EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Chromobacterium subtsugae strain
PRAA4-1\T\. Therefore, an exemption from the requirement of a tolerance
is established for residues of Chromobacterium subtsugae strain PRAA4-
1\T\ in or on all food commodities when applied as an insecticide or
miticide and used in accordance with good agricultural practices.
IX. References
1. U.S. EPA. 2011. Chromobacterium subtsugae strain PRAA4-1\T\
Biopesticides Registration Action Document dated July 2011
(available as ``Supporting & Related Material'' within docket ID
number EPA-HQ-OPP-2010-0058 at https://www.regulations.gov).
2. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background
for Residue Analysis of Microbial Pest Control Agents (OPPTS
885.2000). Available from https://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
3. Lindow SE, Brandl MT. 2003. Microbiology of the phyllosphere.
Applied and Environmental Microbiology 69:1875-1883.
4. Pang L, McLeod M, Aislabie J, [Scaron]im[uring]nek J, Close M,
Hector R. 2008. Modeling transport of microbes in ten undisturbed
soils under effluent irrigation. Vadose Zone Journal 7:97-111.
5. Aislabie J, Smith JJ, Fraser R, McLeod M. 2001. Leaching of
bacterial indicators of faecal contamination through four New
Zealand soils. Australian Journal of Soil Research 39:1397-1406.
6. DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil
Filter Effect. Available from https://extension.missouri.edu/p/WQ24.
7. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment
Systems. EPA 832-R-04-001. Available from https://www.epa.gov/npdes/pubs/primer.pdf.
8. Centers for Disease Control and Prevention. 2009. Drinking
Water--Water Treatment. Available from https://www.cdc.gov/healthywater/drinking/public/water_treatment.html.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to EPA. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in
[[Page 55272]]
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require EPA consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 26, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1305 is added to subpart D to read as follows:
Sec. 180.1305 Chromobacterium subtsugae strain PRAA4-1\T\; exemption
from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Chromobacterium subtsugae strain PRAA4-1\T\ in or on all
food commodities when applied as an insecticide or miticide and used in
accordance with good agricultural practices.
[FR Doc. 2011-22868 Filed 9-6-11; 8:45 am]
BILLING CODE 6560-50-P
