Pasteuria usgae, 38970-38974 [E9-18472]
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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
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Inert Ingredients
Limits
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Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, Limited to no more than
68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1,
30% by weight in pes25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6,
ticide end-use products.
68442–09–1, 127646–44–0, 908356–18–3).
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4. In § 180.930, the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
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Limits
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Sodium alkyl naphthalenesulfonates (CAS Reg. Nos. 68909–83–1, 68909–84–2, Limited to no more than
68909–82–0, 27213–90–7, 26264–58–4, 27178–87–6, 111163–74–7, 908356–16–1,
30% by weight in pes25417–20–3, 25638–17–9, 145578–88–7, 1322–93–6, 1323–19–9, 7403–47–6,
ticide end-use products.
68442–09–1, 127646–44–0, 908356–18–3).
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DATES: This regulation is effective
August 5, 2009. Objections and requests
for hearings must be received on or
before October 5, 2009, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Pasteuria usgae; Temporary Exemption
From the Requirement of a Tolerance
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AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of the microbial pesticide, Pasteuria
usgae, on strawberries when applied/
used as a nematicide in accordance with
the terms of Experimental Use Permit
(EUP) 85004-EUP-1. MacIntosh and
Associates, Incorporated, 1203 Hartford
Avenue, Saint Paul, MN 55116–1622
(on behalf of Pasteuria Bioscience,
Incorporated, 12085 Research Drive,
Suite 185, Alachua, FL 32615)
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the temporary
tolerance exemption. This regulation
eliminates the need to establish a
maximum permissible level for residues
of Pasteuria usgae in or on strawberries.
The temporary tolerance exemption
expires on December 31, 2010.
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0881. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
ADDRESSES:
[EPA–HQ–OPP–2008–0881; FRL–8429–1]
Surfactants, related adjuvants of surfactants
§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Inert Ingredients
[FR Doc. E9–18702 Filed 8–4–09; 8:45 am]
Uses
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Uses
Surfactants, related adjuvants of surfactants
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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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go direcrly
to the guidelines at https://www.epa.gov/
opptsfrs/home/guidelin.htm.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. The EPA procedural
regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0881 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 October 5, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0881, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
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(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 January 8,
2009 (74 FR 808) (FRL–8394–2), 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 8G7471)
by MacIntosh and Associates,
Incorporated, 1203 Hartford Avenue,
Saint Paul, MN 55116–1622 (on behalf
of Pasteuria Bioscience, Incorporated,
12085 Research Drive, Suite 185,
Alachua, FL 32615). The petition
requested that 40 CFR part 180 be
amended by establishing a temporary
exemption from the requirement of a
tolerance for residues of Pasteuria usgae
in or on strawberries. This notice
included a summary of the petition
prepared by the petitioner MacIntosh
and Associates, Incorporated (on behalf
of Pasteuria Bioscience, Incorporated).
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 sections
408(b)(2)(C) and (D) 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.’’
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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.
Pasteuria, a genus of bacteria,
includes a number of species that have
shown potential in controlling plantparasitic nematodes. These bacteria are
obligate endoparasites, organisms that
grow internally in a limited range of
hosts. Pasteuria usgae, a recently
discovered species, is host-specific for
the sting nematode (Belonolaimus
longicaudatus). This species of
Pasteuria is pending recognition by the
Judicial Commission of the International
Committee for Systematic Bacteriology.
There is sufficient evidence from
morphology, host specificity, and
genomics to justify Pasteuria usgae as a
distinct species. In developing a product
for crop application, such as a use on
strawberries, the difficulty of growing
Pasteuria outside of a nematode host
has always been an obstacle. This host
specificity is at the core of EPA’s
conclusions that Pasteuria usgae may be
granted a temporary exemption from the
requirement of a tolerance. Additional
information regarding Pasteuria usgae
can be found in the biopesticides
registration action document (BRAD) on
the Biopesticides and Pollution
Prevention Division (BPPD) website:
https://www.epa.gov/pesticides/
biopesticides.
Studies submitted to the Agency were
issued master record identification
(MRID) numbers and reviewed by BPPD
scientists. The following summaries of
the toxicological profile of Pasteuria
usgae are based on an Agency risk
assessment memorandum and related
data evaluation records dated April 9,
2009.
1. Acute oral toxicity and
pathogenicity – rat, (OPPTS
Harmonized Guideline 885.3050; MRID
No. 474267–09). Pasteuria usgae does
not appear to be toxic and/or pathogenic
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in rats when dosed at 1 x 108 spores/
animal. There were no treatment-related
clinical signs or necropsy findings in
rats receiving a single oral dose of 1 x
108 Pasteuria usgae spores. Three males
in the microbial pest control agent
(MPCA)-treated group gained weight
through day 14 but lost weight by day
21. All other animals gained weight
prior to scheduled sacrifice. Microbial
enumeration was not performed because
the testing laboratory showed that the
test material would not grow on agar
media. Therefore, while no significant
adverse effects were seen, the typical
clearance of the microbe could not be
confirmed. However, because the spores
are highly specific to sting nematode,
infectivity is unlikely to be a concern.
This study was rated ‘‘Acceptable’’ and
Pasteuria usgae was classified as
Toxicity Category IV.
2. Acute injection toxicity and
pathogenicity – rat, (OPPTS
Harmonized Guideline 885.3200; MRID
No. 474267–11). There were no
treatment-related significant adverse
effects seen in the rats receiving a single
intravenous dose of 108 Pasteuria usgae
spores. One treated female lost weight
by day 7 but gained weight prior to
sacrifice on day 14. All other animals
gained weight throughout the study. All
animals survived and appeared normal
during the study. No abnormalities were
observed in any animal at necropsy or
in harvested organs. No significant
variations in organ weight were found
between different groups or sexes. The
acute intravenous LD50 of Pasteuria
usgae is greater than 1 x 108 spores/
animal in male and female rats.
Pasteuria usgae does not appear to be
toxic and/or pathogenic in rats when
dosed at 108 spores/animal. MRID No.
474267–09 reported that the microbial
enumeration was not done because the
test material would not grow on agar
media. Since microbial enumeration
was not performed, the infectivity was
uncertain. However, because the spores
are highly specific to sting nematode,
infectivity is unlikely to be a concern.
Pasteuria usgae was not pathogenic as
tested in this study. This study was
rated ‘‘Acceptable’’ and Pasteuria usgae
was classified as Toxicity Category IV.
3. Acute dermal toxicity – rat, (OPPTS
Harmonized Guideline 885.3100; MRID
No. 474267–12). Based on the results of
this study, Pasteuria usgae does not
appear to be toxic in rats when treated
with 2,000 milligrams/kilogram (mg/kg)
at 108 spores/milliliter (mL). Thus, the
acute dermal LD50 is greater than 2,000
mg/kg for 108 spores/mL in male and
female rats. There were no treatmentrelated significant adverse effects seen
in the dosed rats. Two males and one
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female had very slight erythema on day
1 with clearance by day 4. One male lost
weight slightly during the second week
and one male and two females lost
weight during the first week, but all
gained weight by the end of the study.
All other animals gained weight
throughout the study. This study was
rated ‘‘Acceptable’’ and Pasteuria usgae
was classified as Toxicity Category IV.
4. Acute pulmonary toxicity and
pathogenicity – rat, (OPPTS
Harmonized Guideline 885.3150; MRID
No. 474267–10). In an acute pulmonary
toxicity and pathogenicity assessment,
there were no test substance-related
significant adverse effects seen in rats
receiving a single dose of approximately
1–3 x 108 spores of Pasteuria usgae. One
dosed female exhibited pale lungs.
Additionally, one untreated control
female lost weight by day 21 and
another untreated control female lost
weight by day 14 but gained weight by
day 21. One MPCA-treated male did not
gain weight by day 7 but gained weight
thereafter. However, all other animals
gained weight throughout the study.
Based on these results, Pasteuria usgae
does not appear to be toxic and/or
pathogenic in rats when dosed at
approximately 1–3 x 108 spores/animal.
Microbial enumeration was not
performed because the testing laboratory
showed that the test material would not
grow on agar media. Therefore, while no
significant adverse effects were seen, the
typical clearance of the microbe could
not be confirmed. However, because the
spores are highly specific to sting
nematode, infectivity is unlikely to be a
concern. This study was rated
‘‘Acceptable’’ and Pasteuria usgae was
classified as Toxicity Category IV.
5. Hypersensitivity Incidents, (OPPTS
Harmonized Guideline 885.3400; MRID
No. 474350–02). No hypersensitivity
incidents—involving Pasteuria usgae
and occurring during fermentation,
processing, formulation, or research—
have been reported to the Agency. Any
future hypersensitivity incidents must
be reported per OPPTS Harmonized
Guideline 885.3400.
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).
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A. Dietary Exposure
Dietary exposure to Pasteuria usgae
may occur, mainly through food.
However, the lack of acute oral toxicity/
pathogenicity, based on the toxicology
test on rats presented in Unit III, along
with the inability of the microbe to grow
outside of a nematode host, support the
establishment of a temporary exemption
from the requirement of a tolerance for
Pasteuria usgae. Additionally, under 40
CFR 180.1135, a similar active
ingredient, Pasteuria penetrans, was
assessed previously and granted a
permanent exemption from the
requirement of a tolerance in or on all
raw agricultural commodities, except
roots and tubers, when used as a
nematicide in the production of fruits
and vegetables in greenhouses (59 FR
66740, December 28, 1994).
1. Food. The program description for
EUP 85004-EUP-1 details application
timing and methods, which indicate
strawberry exposure to Pasteuria usgae
is unlikely to occur (e.g., Pasteuria
usgae formulations are applied via
overhead spray or broadcast at bed
formation or prior to planting but only
via drip irrigation during plant growth).
Should exposure to Pasteuria usgae take
place during the course of EUP 85004EUP-1, standard practices of washing,
cooking, or processing fruits will reduce
residues of Pasteuria usgae and
minimize dietary exposure. Any actual
dietary exposure is expected to be
several orders of magnitude lower than
the dose used in the acute oral toxicity/
pathogenicity test referenced in Unit III,
during which no toxic or pathogenic
effects were observed in rats. The
Agency concludes that there is a
reasonable certainty that no harm will
result from the aggregate exposure to the
residues of Pasteuria usgae in food.
2. Drinking water exposure. Exposure
of humans to residues of Pasteuria
usgae in drinking water is unlikely. The
proposed use patterns, use sites, and
application methods associated with
EUP 85004-EUP-1 do not include direct
application to aquatic environments. In
the unlikely event that Pasteuria usgae
is transferred to surface or ground water
intended for eventual human
consumption, the microbe would not
survive the conditions water is
subjected to in a drinking water
treatment facility, including
flocculation, chlorination, pH
adjustments, and/or filtration. Even if
oral exposure should occur through
drinking water, the Agency concludes
that there is a reasonable certainty that
no harm will result from the exposure
to the residues of Pasteuria usgae in all
the anticipated drinking water
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exposures because of the lack of acute
oral toxicity/pathogenicity to mammals
and the host-specific nature of the
microbe, as previously described.
B. Other Non-Occupational Exposure
Potential non-occupational dermal or
inhalation exposure is considered
unlikely for this distinctly agricultural
use with specific application timing and
methods.
1. Dermal exposure. Nonoccupational dermal exposure to
Pasteuria usgae, when used as labeled
and according to the terms of EUP
85004-EUP-1, is expected to be
negligible because the use is limited to
agricultural settings. Additionally, the
methods and timing of application
explained in the program description for
EUP 85004-EUP-1 should make
strawberry exposure to Pasteuria usgae
unlikely. If non-occupational dermal
exposure were to occur through treated
food commodities, the risk posed by this
low toxicity microbe is likely to be
minimal based on the dermal toxicity
test described in Unit III.
2. Inhalation exposure. Nonoccupational inhalation exposure to
Pasteuria usgae, when used as labeled
and according to the terms of EUP
85004-EUP-1, is expected to be
negligible because the use is limited to
agricultural settings. Additionally, the
methods and timing of application
allow for sufficient drying of any treated
commodities (should exposure to
Pasteuria usgae even occur) prior to
distribution to consumers, which
further reduces the possibility for nonoccupational inhalation exposure. If
non-occupational inhalation exposure
were to occur through treated food
commodities, the risk posed by this low
toxicity microbe is likely to be minimal
based on the pulmonary toxicity and
pathogenicity test described in Unit III.
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V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA
requires the Agency to consider the
cumulative effects of exposure to
Pasteuria usgae 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. As
demonstrated in Unit III, Pasteuria
usgae is not toxic or pathogenic to
mammals via any of the routes of
exposure examined. Consequently,
since this microbial pesticide has no
demonstrated toxicity and is specific to
the sting nematode, there is no reason
to anticipate cumulative effects from the
residues of this product with other
related microbial pesticides.
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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 margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database unless
EPA determines that a different margin
of safety will be safe for infants and
children. Margins of exposure (safety),
which are often referred to as
uncertainty factors, are incorporated
into EPA risk assessments 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.
Based on the acute toxicity and
pathogenicity data discussed in Unit III,
EPA concludes that there is a reasonable
certainty that no harm will result from
aggregate exposure to the U.S.
population, including infants and
children, to the residues of Pasteuria
usgae. This includes all anticipated
dietary exposures and all other
exposures for which there is reliable
information. The Agency has arrived at
this conclusion because the data
available on Pasteuria usgae do not
demonstrate toxic, pathogenic, or
infective potential to mammals. Thus,
there are no threshold effects of concern
and, as a result, the provision requiring
an additional margin of safety does not
apply. Further, the considerations of
consumption patterns, special
susceptibility, and cumulative effects do
not apply to pesticides without a
demonstrated significant adverse effect.
VII. Other Considerations
A. Endocrine Disruptors
Section 408(p) of the FFDCA requires
EPA 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 such other endocrine effect
as the Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there were
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scientific bases for including, as part of
its program, androgen and thyroid
hormone systems, in addition to the
estrogen hormone system. EPA also
adopted EDSTAC’s recommendation
that the Program include evaluations of
potential effects on wildlife.
The Agency has no knowledge of
Pasteuria usgae being an endocrine
disruptor, nor is this microbe related to
any class of known endocrine
disruptors. Following several routes of
exposure in rodents, the Tier I
toxicology data indicated that the
immune system was still intact.
However, due to the difficulties in
recovering Pasteuria usgae, clearance
could not be determined; nevertheless,
there is no reason to believe that
additional data, specifically on the
endocrine effects of this microbial
pesticide, are required at this time.
Consequently, endocrine-related
concerns did not impact the Agency’s
safety finding for Pasteuria usgae. When
the appropriate screening and/or testing
protocols being considered under the
Agency’s Endocrine Disruptor Screening
Program (EDSP) have been developed
and vetted, Pasteuria usgae may be
subjected to additional screening and/or
testing to better characterize effects
related to endocrine disruption.
B. Analytical Method(s)
The Agency is establishing a
temporary exemption from the
requirement of a tolerance without any
numerical limitation; therefore, the
Agency has concluded that an analytical
method is not required for enforcement
purposes for Pasteuria usgae.
C. Codex Maximum Residue Level
No Codex maximum residue level
exists for Pasteuria usgae.
VIII. Statutory and Executive Order
Reviews
This final rule establishes a temporary
exemption from the requirement of a
tolerance under section 408(d) of
FFDCA in response to a petition
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations
srobinson on DSKHWCL6B1PROD with RULES
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 temporary exemption from the
requirement of a 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).
IX. 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
VerDate Nov<24>2008
16:20 Aug 04, 2009
Jkt 217001
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: July 22, 2009.
Debra Edwards,
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 180.1290 is added to
subpart D to read as follows:
■
§ 180.1290 Pasteuria usgae; temporary
exemption from the requirement of a
tolerance.
Pasteuria usgae is temporarily exempt
from the requirement of a tolerance
when applied/used as a nematicide on
strawberries in accordance with the
terms of EUP 85004-EUP-1. This
temporary exemption from the
requirement of a tolerance expires and
is revoked on December 31, 2010.
[FR Doc. E9–18472 Filed 8–4–09; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 599
[ Docket No. NHTSA–2009–0120]
RIN 2127–AK54; Notice 1
Requirements and Procedures for
Consumer Assistance To Recycle and
Save Program
AGENCY: National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Final rule.
SUMMARY: This final rule amends the
regulation implementing the Consumer
Assistance to Recycle and Save (CARS)
Program, published on July 29, 2009 in
the Federal Register, under the CARS
PO 00000
Frm 00088
Fmt 4700
Sfmt 4700
Act (Pub. L. 111–32). The rule clarifies
the insurance eligibility requirements
for trade-in vehicles under the CARS
program. The rule makes substantive
changes and a conforming amendment
related to the timing for disabling tradein vehicle engines. The rule also makes
a technical amendment to the
requirements and procedures for
identifying salvage auctions and
disposal facilities. Finally, we provide a
clarification related to the insurance
requirement under the CARS Act.
DATES: This final rule is effective August
5, 2009. Petitions: If you wish to petition
for reconsideration of this rule, your
petition must be received by September
21, 2009.
ADDRESSES: If you submit a petition for
reconsideration of this rule, you should
refer in your petition to the docket
number of this document and submit
your petition to: Administrator,
National Highway Traffic Safety
Administration, 1200 New Jersey
Avenue, SE., West Building,
Washington, DC 20590.
The petition will be placed in the
public docket. Anyone is able to search
the electronic form of all documents
received into any of our dockets by the
name of the individual submitting the
document (or signing the document, if
submitted on behalf of an association,
business, labor union, etc.). You may
review the complete User Notice and
Privacy Notice for Regulations.gov at
https://www.regulations.gov/search/
footer/privacyanduse.jsp.
FOR FURTHER INFORMATION CONTACT: For
questions, you may call David Bonelli,
NHTSA Office of Chief Counsel,
telephone (202) 366–5834.
SUPPLEMENTARY INFORMATION: This final
rule amends the regulation
implementing the Consumer Assistance
to Recycle and Save (CARS) Program,
published on July 29, 2009 (74 FR
37878), under the CARS Act (Pub. L.
111–32). The rule makes substantive
changes and a conforming amendment
related to the timing for disabling tradein vehicle engines. The rule also makes
a technical amendment to the
requirements and procedures for
identifying salvage auctions and
disposal facilities. Finally, the agency
clarifies the application of the insurance
requirement under the CARS Act.
a. Engine Disablement
The rule currently requires a dealer
that receives an eligible trade-in vehicle
under the CARS program to disable that
vehicle’s engine prior to submitting an
application for reimbursement and prior
to transferring the vehicle to a disposal
facility. That requirement is
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]]>Agencies
[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38970-38974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18472]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0881; FRL-8429-1]
Pasteuria usgae; Temporary Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the microbial pesticide,
Pasteuria usgae, on strawberries when applied/used as a nematicide in
accordance with the terms of Experimental Use Permit (EUP) 85004-EUP-1.
MacIntosh and Associates, Incorporated, 1203 Hartford Avenue, Saint
Paul, MN 55116-1622 (on behalf of Pasteuria Bioscience, Incorporated,
12085 Research Drive, Suite 185, Alachua, FL 32615) submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting the temporary tolerance exemption. This regulation
eliminates the need to establish a maximum permissible level for
residues of Pasteuria usgae in or on strawberries. The temporary
tolerance exemption expires on December 31, 2010.
DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0881. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: 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.
[[Page 38971]]
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this
document, go direcrly to the guidelines at https://www.epa.gov/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0881 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 October 5, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0881, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of January 8, 2009 (74 FR 808) (FRL-8394-
2), 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 8G7471) by MacIntosh and Associates, Incorporated, 1203
Hartford Avenue, Saint Paul, MN 55116-1622 (on behalf of Pasteuria
Bioscience, Incorporated, 12085 Research Drive, Suite 185, Alachua, FL
32615). The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of Pasteuria usgae in or on strawberries. This notice
included a summary of the petition prepared by the petitioner MacIntosh
and Associates, Incorporated (on behalf of Pasteuria Bioscience,
Incorporated). 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
sections 408(b)(2)(C) and (D) 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.
Pasteuria, a genus of bacteria, includes a number of species that
have shown potential in controlling plant-parasitic nematodes. These
bacteria are obligate endoparasites, organisms that grow internally in
a limited range of hosts. Pasteuria usgae, a recently discovered
species, is host-specific for the sting nematode (Belonolaimus
longicaudatus). This species of Pasteuria is pending recognition by the
Judicial Commission of the International Committee for Systematic
Bacteriology. There is sufficient evidence from morphology, host
specificity, and genomics to justify Pasteuria usgae as a distinct
species. In developing a product for crop application, such as a use on
strawberries, the difficulty of growing Pasteuria outside of a nematode
host has always been an obstacle. This host specificity is at the core
of EPA's conclusions that Pasteuria usgae may be granted a temporary
exemption from the requirement of a tolerance. Additional information
regarding Pasteuria usgae can be found in the biopesticides
registration action document (BRAD) on the Biopesticides and Pollution
Prevention Division (BPPD) website: https://www.epa.gov/pesticides/biopesticides.
Studies submitted to the Agency were issued master record
identification (MRID) numbers and reviewed by BPPD scientists. The
following summaries of the toxicological profile of Pasteuria usgae are
based on an Agency risk assessment memorandum and related data
evaluation records dated April 9, 2009.
1. Acute oral toxicity and pathogenicity - rat, (OPPTS Harmonized
Guideline 885.3050; MRID No. 474267-09). Pasteuria usgae does not
appear to be toxic and/or pathogenic
[[Page 38972]]
in rats when dosed at 1 x 108 spores/animal. There were no
treatment-related clinical signs or necropsy findings in rats receiving
a single oral dose of 1 x 108 Pasteuria usgae spores. Three
males in the microbial pest control agent (MPCA)-treated group gained
weight through day 14 but lost weight by day 21. All other animals
gained weight prior to scheduled sacrifice. Microbial enumeration was
not performed because the testing laboratory showed that the test
material would not grow on agar media. Therefore, while no significant
adverse effects were seen, the typical clearance of the microbe could
not be confirmed. However, because the spores are highly specific to
sting nematode, infectivity is unlikely to be a concern. This study was
rated ``Acceptable'' and Pasteuria usgae was classified as Toxicity
Category IV.
2. Acute injection toxicity and pathogenicity - rat, (OPPTS
Harmonized Guideline 885.3200; MRID No. 474267-11). There were no
treatment-related significant adverse effects seen in the rats
receiving a single intravenous dose of 108 Pasteuria usgae
spores. One treated female lost weight by day 7 but gained weight prior
to sacrifice on day 14. All other animals gained weight throughout the
study. All animals survived and appeared normal during the study. No
abnormalities were observed in any animal at necropsy or in harvested
organs. No significant variations in organ weight were found between
different groups or sexes. The acute intravenous LD50 of
Pasteuria usgae is greater than 1 x 108 spores/animal in
male and female rats. Pasteuria usgae does not appear to be toxic and/
or pathogenic in rats when dosed at 108 spores/animal. MRID
No. 474267-09 reported that the microbial enumeration was not done
because the test material would not grow on agar media. Since microbial
enumeration was not performed, the infectivity was uncertain. However,
because the spores are highly specific to sting nematode, infectivity
is unlikely to be a concern. Pasteuria usgae was not pathogenic as
tested in this study. This study was rated ``Acceptable'' and Pasteuria
usgae was classified as Toxicity Category IV.
3. Acute dermal toxicity - rat, (OPPTS Harmonized Guideline
885.3100; MRID No. 474267-12). Based on the results of this study,
Pasteuria usgae does not appear to be toxic in rats when treated with
2,000 milligrams/kilogram (mg/kg) at 108 spores/milliliter
(mL). Thus, the acute dermal LD50 is greater than 2,000 mg/
kg for 108 spores/mL in male and female rats. There were no
treatment-related significant adverse effects seen in the dosed rats.
Two males and one female had very slight erythema on day 1 with
clearance by day 4. One male lost weight slightly during the second
week and one male and two females lost weight during the first week,
but all gained weight by the end of the study. All other animals gained
weight throughout the study. This study was rated ``Acceptable'' and
Pasteuria usgae was classified as Toxicity Category IV.
4. Acute pulmonary toxicity and pathogenicity - rat, (OPPTS
Harmonized Guideline 885.3150; MRID No. 474267-10). In an acute
pulmonary toxicity and pathogenicity assessment, there were no test
substance-related significant adverse effects seen in rats receiving a
single dose of approximately 1-3 x 108 spores of Pasteuria
usgae. One dosed female exhibited pale lungs. Additionally, one
untreated control female lost weight by day 21 and another untreated
control female lost weight by day 14 but gained weight by day 21. One
MPCA-treated male did not gain weight by day 7 but gained weight
thereafter. However, all other animals gained weight throughout the
study. Based on these results, Pasteuria usgae does not appear to be
toxic and/or pathogenic in rats when dosed at approximately 1-3 x
108 spores/animal. Microbial enumeration was not performed
because the testing laboratory showed that the test material would not
grow on agar media. Therefore, while no significant adverse effects
were seen, the typical clearance of the microbe could not be confirmed.
However, because the spores are highly specific to sting nematode,
infectivity is unlikely to be a concern. This study was rated
``Acceptable'' and Pasteuria usgae was classified as Toxicity Category
IV.
5. Hypersensitivity Incidents, (OPPTS Harmonized Guideline
885.3400; MRID No. 474350-02). No hypersensitivity incidents--involving
Pasteuria usgae and occurring during fermentation, processing,
formulation, or research--have been reported to the Agency. Any future
hypersensitivity incidents must be reported per OPPTS Harmonized
Guideline 885.3400.
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
Dietary exposure to Pasteuria usgae may occur, mainly through food.
However, the lack of acute oral toxicity/pathogenicity, based on the
toxicology test on rats presented in Unit III, along with the inability
of the microbe to grow outside of a nematode host, support the
establishment of a temporary exemption from the requirement of a
tolerance for Pasteuria usgae. Additionally, under 40 CFR 180.1135, a
similar active ingredient, Pasteuria penetrans, was assessed previously
and granted a permanent exemption from the requirement of a tolerance
in or on all raw agricultural commodities, except roots and tubers,
when used as a nematicide in the production of fruits and vegetables in
greenhouses (59 FR 66740, December 28, 1994).
1. Food. The program description for EUP 85004-EUP-1 details
application timing and methods, which indicate strawberry exposure to
Pasteuria usgae is unlikely to occur (e.g., Pasteuria usgae
formulations are applied via overhead spray or broadcast at bed
formation or prior to planting but only via drip irrigation during
plant growth). Should exposure to Pasteuria usgae take place during the
course of EUP 85004-EUP-1, standard practices of washing, cooking, or
processing fruits will reduce residues of Pasteuria usgae and minimize
dietary exposure. Any actual dietary exposure is expected to be several
orders of magnitude lower than the dose used in the acute oral
toxicity/pathogenicity test referenced in Unit III, during which no
toxic or pathogenic effects were observed in rats. The Agency concludes
that there is a reasonable certainty that no harm will result from the
aggregate exposure to the residues of Pasteuria usgae in food.
2. Drinking water exposure. Exposure of humans to residues of
Pasteuria usgae in drinking water is unlikely. The proposed use
patterns, use sites, and application methods associated with EUP 85004-
EUP-1 do not include direct application to aquatic environments. In the
unlikely event that Pasteuria usgae is transferred to surface or ground
water intended for eventual human consumption, the microbe would not
survive the conditions water is subjected to in a drinking water
treatment facility, including flocculation, chlorination, pH
adjustments, and/or filtration. Even if oral exposure should occur
through drinking water, the Agency concludes that there is a reasonable
certainty that no harm will result from the exposure to the residues of
Pasteuria usgae in all the anticipated drinking water
[[Page 38973]]
exposures because of the lack of acute oral toxicity/pathogenicity to
mammals and the host-specific nature of the microbe, as previously
described.
B. Other Non-Occupational Exposure
Potential non-occupational dermal or inhalation exposure is
considered unlikely for this distinctly agricultural use with specific
application timing and methods.
1. Dermal exposure. Non-occupational dermal exposure to Pasteuria
usgae, when used as labeled and according to the terms of EUP 85004-
EUP-1, is expected to be negligible because the use is limited to
agricultural settings. Additionally, the methods and timing of
application explained in the program description for EUP 85004-EUP-1
should make strawberry exposure to Pasteuria usgae unlikely. If non-
occupational dermal exposure were to occur through treated food
commodities, the risk posed by this low toxicity microbe is likely to
be minimal based on the dermal toxicity test described in Unit III.
2. Inhalation exposure. Non-occupational inhalation exposure to
Pasteuria usgae, when used as labeled and according to the terms of EUP
85004-EUP-1, is expected to be negligible because the use is limited to
agricultural settings. Additionally, the methods and timing of
application allow for sufficient drying of any treated commodities
(should exposure to Pasteuria usgae even occur) prior to distribution
to consumers, which further reduces the possibility for non-
occupational inhalation exposure. If non-occupational inhalation
exposure were to occur through treated food commodities, the risk posed
by this low toxicity microbe is likely to be minimal based on the
pulmonary toxicity and pathogenicity test described in Unit III.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effects of exposure to Pasteuria usgae 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. As demonstrated in Unit III, Pasteuria usgae
is not toxic or pathogenic to mammals via any of the routes of exposure
examined. Consequently, since this microbial pesticide has no
demonstrated toxicity and is specific to the sting nematode, there is
no reason to anticipate cumulative effects from the residues of this
product with other related microbial pesticides.
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 margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
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.
Based on the acute toxicity and pathogenicity data discussed in
Unit III, EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to the U.S. population,
including infants and children, to the residues of Pasteuria usgae.
This includes all anticipated dietary exposures and all other exposures
for which there is reliable information. The Agency has arrived at this
conclusion because the data available on Pasteuria usgae do not
demonstrate toxic, pathogenic, or infective potential to mammals. Thus,
there are no threshold effects of concern and, as a result, the
provision requiring an additional margin of safety does not apply.
Further, the considerations of consumption patterns, special
susceptibility, and cumulative effects do not apply to pesticides
without a demonstrated significant adverse effect.
VII. Other Considerations
A. Endocrine Disruptors
Section 408(p) of the FFDCA requires EPA 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 such other endocrine effect as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of its program,
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that the
Program include evaluations of potential effects on wildlife.
The Agency has no knowledge of Pasteuria usgae being an endocrine
disruptor, nor is this microbe related to any class of known endocrine
disruptors. Following several routes of exposure in rodents, the Tier I
toxicology data indicated that the immune system was still intact.
However, due to the difficulties in recovering Pasteuria usgae,
clearance could not be determined; nevertheless, there is no reason to
believe that additional data, specifically on the endocrine effects of
this microbial pesticide, are required at this time. Consequently,
endocrine-related concerns did not impact the Agency's safety finding
for Pasteuria usgae. When the appropriate screening and/or testing
protocols being considered under the Agency's Endocrine Disruptor
Screening Program (EDSP) have been developed and vetted, Pasteuria
usgae may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
B. Analytical Method(s)
The Agency is establishing a temporary exemption from the
requirement of a tolerance without any numerical limitation; therefore,
the Agency has concluded that an analytical method is not required for
enforcement purposes for Pasteuria usgae.
C. Codex Maximum Residue Level
No Codex maximum residue level exists for Pasteuria usgae.
VIII. Statutory and Executive Order Reviews
This final rule establishes a temporary exemption from the
requirement of a tolerance under section 408(d) of FFDCA in response to
a petition submitted to the Agency. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety
[[Page 38974]]
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 temporary
exemption from the requirement of a 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).
IX. 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: July 22, 2009.
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 180.1290 is added to subpart D to read as follows:
Sec. 180.1290 Pasteuria usgae; temporary exemption from the
requirement of a tolerance.
Pasteuria usgae is temporarily exempt from the requirement of a
tolerance when applied/used as a nematicide on strawberries in
accordance with the terms of EUP 85004-EUP-1. This temporary exemption
from the requirement of a tolerance expires and is revoked on December
31, 2010.
[FR Doc. E9-18472 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S?>
