[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]
[Page 54928-54933]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se06-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0617; FRL-8091-6]
Pantoea Agglomerans Strain E325; Exemption from the Requirement
of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Pantoea agglomerans strain E325 on
apples and pears when applied/used as a microbial pesticide. Northwest
Agricultural Products submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Pantoea
agglomerans strain E325.
DATES: This regulation is effective September 20, 2006. Objections and
requests for hearings must be received on or before November 20, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part
[[Page 54929]]
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-2006-0617. All documents in the
docket are listed in the index for the docket. 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 http://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: Leonard Cole, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5412; e-mail address: cole.leonard@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Document 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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0617 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 November 20, 2006.
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-2006-0617, by one of the following methods.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 26, 2006 (71 FR 42395) (FRL-8080-
6), 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 6F7086) by Northwest Agricultural Products, 821 South
Chestnut Ave., Pasco, Washington 99301. The petition requested that 40
CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of Pantoea agglomerans strain
E325. This notice included a summary of the petition prepared by the
petitioner Northwest Agricultural Products. There were no comments
received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other
[[Page 54930]]
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.
Pantoea agglomerans strain E325 was originally isolated from apple
blooms in Wenatchee, Washington. Pantoea agglomerans strain E325 was
isolated from an apple flower stigma by washing the flower in buffer
and plating dilutions on agar media. The Microbial Pest Control Agent
(MPCA) was selected from among more than 1,000 bacteria and yeast
isolates evaluated for potential use in the control of fire blight.
Screening assays were based on the ability of test organisms to
colonize the stigma and preemptively exclude the disease organism which
was introduced 24 hours after treatment with the test organism.
Pantoea agglomerans is ubiquitous in the environment, and is
recognized as an epiphyte of a wide variety of plants, such as
buckwheat, weeds, oilseed rape, sweet potato, rice, and trees of the
Rosaceae family. Pantoea agglomerans is found on a wide variety of
plant parts, including the rhizosphere, leaves, and seeds. The species
is also a heavy colonizer of cotton plants, grass and silage and is the
prominent species in organic dust. The organism has also been isolated
from soil and water. Recent reports have also identified P. agglomerans
on retail salad vegetables.
Pantoea agglomerans is a common organism of the gut microbiota of
mosquitos and locusts. In fecal pellets of the locust, the organism is
responsible for the release of guaiacol and phenol, essential
components of the locust cohesion pheromone. These components are not
produced in germ-free locusts. Pantoea agglomerans (Enterobacter
agglomerans) was also identified in association with sheep scab mites,
and as an intracellular symbiotic bacteria of the cereal weevil and the
apple maggot fly. It has been demonstrated that Enterobacter
agglomerans (in the gut of the fly) is able to detoxify the defense
chemical (phloridzin) of the apple tree, which would otherwise kill the
fly.
Fire blight is caused by the phytopathogenic bacterium Erwinia
amylovora which colonizes predominately on the stigmatic surfaces of
the apple or pear. The pathogen may enter the tree through the
blossoms, leaves, or stem wounds. Usually the disease is spread by
bacteria that over winter in holdover cankers in the main stem and
branches or infected twigs. In the spring, when the blossoms begin to
open, the cankers exude drops of bacterial ooze that are disseminated
to the blossoms and young leaves by rain, heavy dew, or windblown mist.
Fire blight may also be spread by pollinating insects such as bees,
sucking, chewing, or boring insects, and unsanitary pruning tools. Warm
temperatures (24-28[deg]C) and high humidity are the optimal conditions
for infection and disease development.
The disease becomes apparent in the spring, when infected blossoms
suddenly wilt and turn brown. Later, twigs and leaves also turn brown
and appear to be scorched by fire. The affected leaves usually remain
on the tree well into the winter. Young infected fruits become watery
or oily in appearance and exude droplets of clear, milky, or amber
colored ooze. They later become leathery and turn brown, dark brown, or
black, depending on the species. The shriveled fruit usually remains
attached to the tree.
Fire blight is considered one of the most destructive diseases of
fruit trees in North America. It occurs sporadically and unpredictably
and occasionally reaches epidemic levels. A severe outbreak can
seriously damage or kill mature pear, apple, or crab apple trees in one
season. Other ornamentals such as hawthorn, plum, chokecherry,
saskatoon, cotoneaster, and spirea may also be affected.
1. Acute oral toxicity/pathogenicity--rats (OPPTS 885.3050).
Nineteen male and 19 female Sprague-Dawley rats were dosed with the
test substance, Pantoea agglomerans strain E325, at a rate of 1.05 x
10\8\ colony forming unit (CFU) per animal. (Master Record
Identification Number (MRID) 464678-02) (Ref 1). Three animals were
sacrificed on day 3, 7, and 14. All rats survived to the scheduled
sacrifice. There was no change in organ weights (brain, blood, cecum
contents, kidneys, liver, lungs, lymph nodes, and spleen) of male and
female test animals from beginning of testing to sacrifice. The MPCA
was detected at high levels in the organs of all test animals.
Clearance of the MPCA from the blood and lymph node was achieved in all
test animals. Counts of the MPCA had fallen in the lungs and kidney of
test animals by day 7. Results from day 14 showed that the MPCA was
cleared from all organs in all test animals. No clinical manifestations
of treatment were noted. Gross necropsy revealed no indications of
treatment-related pathology or any unusual findings. It is concluded
that Pantoea agglomerans strain E325 is not acutely toxic to rats
following oral administration.
2. Acute pulmonary toxicity/pathogenicity--rat (OPPTS 885.3150).
Forty-eight male and 48 female Sprague-Dawley rats were dosed with the
test substance, Pantoea agglomerans strain E325 at a rate of 1.8 x
10\11\ CFU per animal. (MRID 464678-03) Ref 2. The test material was
determined to be below 100 CFU per animal at all time points tested.
The test organism (Pantoea agglomerans strain E325) was cleared from
the cecum contents by day 7 and from the lungs by day 14. The MPCA was
detected in the kidney and lymph nodes, spleen, and brain up to day 14,
but had cleared in all animals by day 21. Therefore, based on the
presented/submitted data, the test organism was not toxic nor
pathogenic to the test animals.
3. Acute dermal toxicity--rabbits (OPPTS 870.2500 and OPPTS
885.3100). The registrant has requested that the dermal irritation
study be waived. Pantoea agglomerans is found on a wide variety of
plant parts, including the rhizosphere, leaves, and seeds. The species
is also a heavy colonizer of cotton plants, grass, and silage, and is
the prominent species in organic dust. The organism has also been
isolated from soil and water. Recent reports have also identified P.
agglomerans on retail salad vegetables. There have been no adverse
dermal effects or dermal irritation reported in any cited literature
for Pantoea agglomerans strain E325. In light of the strong evidence
indicating no adverse effects due to dermal exposure to Pantoea
agglomerans, EPA has agreed to waive dermal toxicity testing. Further,
data show that exposure from ambient populations is sufficiently high
that it indicates there would be no adverse dermal effects from
pesticidal use no matter what the residue level is.
4. Primary eye irritation (OPPTS 870.2400). The registrant has
requested a waiver for the primary eye irritation study. Due to the
fact that Pantoea agglomerans is found in food and drinking water, and
there have been no adverse eye irritation effects reported, Pantoea
agglomerans is not considered to be an eye irritant. Additionally
Pantoea agglomerans is ubiquitous in the environment, and it is
recognized as an epiphyte of a wide variety of plants such as sweet
potato, rice, and organic
[[Page 54931]]
dust. No reports of eye irritation have been reported for this
organism.
5. Data waiver requests. Data waiver requests were made for the
following requirements for the Technical Grade of the Active
Ingredient/Manufacturing-use Product (TGAI/MP) and Experimental Product
(EP):
Acute Intravenous (IV), Intracerebral (IC),
Intraperitoneal (IP) injection Toxicity/Pathogenicity (OPPTS 885.3200).
Cell Culture (OPPTS 885.3500).
Immune Response (OPPTS 880.3800).
Hypersensitivity study.
Hypersensitivity Incidents (OPPTS 885.3400).
i. Acute inhalation toxicity/pathogenicity. The registrant cited
the acute pulmonary toxicity/pathogenicity study (see Unit III.?.3.) to
justify waiving the acute inhalation study. In the acute pulmonary
toxicity/pathogenicity study Pantoea agglomerans strain E325, was not
found in any organs or tissues which indicates that the active
ingredient cleared tissues and was not toxic, infective, or pathogenic
to rats when instilled intratracheally. Additionally, when this product
is applied, applicators will be required to wear the necessary
protective equipment to prevent inhalation, and this justifies granting
this request to waive acute-inhalation data requirements.
ii. Acute IV/IP/IC study. In an acute oral toxicity/pathogenicity
study (see Unit III.1. and 2.), no clinical signs of toxicity were
observed in rats and no Pantoea agglomerans strain E325 was recovered
from organs or tissues. These data show that Pantoea agglomerans strain
E325 was considered to clear rapidly from the test animal in that it
was never detected. The active ingredient Pantoea agglomerans strain
E325 is considered to be non-toxic. Based on the low toxicity potential
indicated by these observations, the request to waive the acute IP
study was granted.
iii. Cell culture. This study is required for a virus and is not
required for a bacterial active ingredient such as Pantoea agglomerans
strain E325.
iv. Immune response. The lack of pathogenicity seen in the acute
oral toxicity/pathogenicity study with the active ingredient indicates
the immune system was not adversely affected by Pantoea agglomerans
strain E325. Based on these considerations, the justifications to
support the request to waive data requirements for the immune response
studies for the TGAI/MP are acceptable.
v. Hypersensitivity study. No incidents of hypersensitivity have
occurred during the research, development, or testing of Pantoea
agglomerans strain E325 or the end use product, Bloomtime. A
hypersensitivity study is not required at this time, but may be
required in the future if there are reports of hypersensitivity
incidents associated with this active ingredient used in pesticides. If
a person is abnormally physiologically susceptible to a specific agent,
there are a number of symptoms that the individual will exhibit. This
organism has been in nature for many years, and there have been no
reports of any human or animal exhibiting any symptoms after having
been in contact with the organism.
vi. Hypersensitivity incidents (OPPTS 885.3400). The registrant
requested to waive reports of hypersensitivity incidents, because no
incidents of hypersensitivity associated with the TGAI or the EP have
been reported. However, the registrant agreed to report
hypersensitivity incidents, should they occur in the future. This
guideline requirement is satisfied at this time. In order to comply
with the Federal Insecticide, Fungicide, and Rotenticide Act (FIFRA)
requirements under section 6(a)(2), any incident of hypersensitivity
associated with the use of this pesticide must be reported to the
Agency. This data requirement has not been waived.
6. Subchronic, chronic toxicity and oncogenicity, and residue
data. Based on the data generated in accordance with the Tier I data
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III
data requirements were not triggered and, therefore, not required in
connection with this action. In addition, because the Tier II and Tier
III data requirements were not required, the residue data requirements
set forth in 40 CFR 158.740(b) also were not required.
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
Use of Pantoea agglomerans strain E325 is not expected to cause any
harm via consumption of food or feed treated with the microbial
pesticide, which is not applied directly to food as discussed in this
unit.
1. Food. Residues of Pantoea agglomerans strain E325 are not
expected on treated food commodities from the proposed use patterns.
The product, Bloomtime, containing Pantoea agglomerans strain E325, is
applied at bloom followed by a second application at first petal fall-
full bloom. After Bloomtime is applied, the pesticide becomes non-
viable very rapidly, which causes the need for more than one
application. The pesticide itself is not in direct contact with the
food commodities. This pesticide is applied prior to fruiting. There is
no post-harvest treatment directly to the food commodities.
Furthermore, the active ingredient is not a systemic pesticide. Thus,
detectable residues of Pantoea agglomerans strain E325 are not expected
on treated fruit trees or their food commodities. Furthermore, as
previously stated, Pantoea agglomerans strain E325 is found in soil,
water, and air. Data submissions to the Agency show that residues of
the Pantoea agglomerans strain E325 are not found on the food
commodities. Finally, as discussed previously in Unit III., the acute
oral tests demonstrate low toxicity potential via dietary exposure to
this Toxicity Category IV pesticide. Hence, even if the pesticide was
present in or on food commodities, exposure via the dietary route is
not expected to cause any harm. Therefore, the Agency has decided that
dietary exposure from the proposed uses of Pantoea agglomerans strain
E325 is not expected to adversely affect the U.S. adult population,
infants, and children.
2. Drinking water exposure. No drinking water exposure is
anticipated because of the use pattern and use sites. There are no
aquatic use sites permitted for this pesticide, so exposure to drinking
water is not expected. Further, there is no evidence of adverse effects
from exposure to this organism. Exposure from the proposed use of
Pantoea agglomerans strain E325 is not likely to pose any incremental
risk via consumption of drinking water to adult humans, infants and
children.
B. Other Non-Occupational Exposure
The proposed product is an end-use product to be commercially used
in apple and pear orchards. No non-occupational residential, school or
day care exposure is anticipated because of the use pattern of this
product. The use of Panteoa agglomerans strain E325 should result in
minimal to non-existent, non-occupational risk. No indoor residential,
school, or daycare uses are permitted on the label of this product.
[[Page 54932]]
1. Dermal exposure. The low toxicity potential observed in the
acute dermal studies discussed in Unit III., the low exposure potential
based on low application rates, and the lack of persistence of the
active ingredient, leads EPA to conclude that this pesticide poses
minimal risk to human populations via non-occupational dermal exposure.
Moreover, potential non-occupational dermal exposure to Panteoa
agglomerans strain E325 is unlikely because the use sites are
commercial and agricultural.
As previously discussed in Units III. and IV., a lack of
hypersensitivity incidents indicates Panteoa agglomerans strain E325
poses minimal risk to populations via non-occupational dermal exposure.
Thus, the Agency does not expect pesticides containing Panteoa
agglomerans strain E325 to pose a non-occupational dermal exposure
risk.
2. Inhalation exposure. Non-occupational inhalation exposure to the
active ingredient itself is not expected to pose an inhalation risk. No
treatment-related effects associated with the active ingredient were
observed in the pulmonary tests reported in Unit II. Based on the low
potential for non-occupational inhalation exposure, the Agency does not
expect Pantoea agglomerans strain E325 to pose an inhalation risk.
V. Cumulative Effects
The Agency has considered the potential for cumulative effects of
Pantoea agglomerans strain E325 and other substances in relation to a
common mechanism of toxicity. These considerations include the possible
cumulative effects of such residues on infants and children. As
demonstrated in the toxicity assessment, Pantoea agglomerans strain
E325 is non-toxic and non-pathogenic to mammals. Because no mechanism
of pathogenicity or toxicity in mammals has been identified for this
organism, no cumulative effects from the residues of this product with
other related microbial pesticides are anticipated.
VI. Determination of Safety for U.S. Population, Infants and Children
There is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposures to
residues of Pantoea agglomerans strain E325, as a result of its
proposed uses. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information. As discussed
previously, there appears to be no potential for harm, from this
bacterium in its use as a microbial pesticide in apple and pear
orchards. Furthermore, the organism is non-toxic and non-pathogenic to
animals and humans. The Agency has arrived at this conclusion based on
the very-low levels of mammalian toxicity for acute oral, pulmonary,
and dermal effects with no toxicity or infectivity at the doses tested
(see Unit III.). Moreover, potential non-occupational inhalation or
dermal exposure is not expected to pose any adverse effects to exposed
populations via aggregate and cumulative exposure.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of FFDCA, as amended by FQPA,
to develop a screening program to determine whether certain substances
(including all pesticide active and other ingredients) ``may have an
effect in humans that is similar to an effect produced by a naturally-
occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was scientific basis for including, as part
of the program, the androgen and thyroid systems, in addition to the
estrogen hormone system. EPA also adopted EDSTAC's recommendation that
the program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use FIFRA and, to the extent that effects
in wildlife may help determine whether a substance may have an effect
in humans, FFDCA authority, to require the wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). The Agency is not requiring information on the endocrine
effects of this active ingredient at this time. The Agency has
considered, among other relevant factors, available information
concerning whether the microorganism may have an effect in humans
similar to an effect produced by a naturally-occurring estrogen or
other endocrine effects.
There is no known metabolite produced by this bacterium that acts
as an endocrine disruptor. The submitted and cited toxicity/
pathogenicity studies in rodents indicate that following injection and
pulmonary routes of exposure, no test substance was found in organs or
tissues of test animals. This indicates that the body is able to
process and clear the active ingredient. The Agency concludes that
there will be no incremental adverse effects to the endocrine system.
B. Analytical Methods
The acute oral studies discussed in Unit II. demonstrate that the
active ingredient, Pantoea agglomerans strain E325 does not pose a
dietary risk. In addition, the active ingredient is not likely to come
into contact with food commodities. Since residues are not expected on
treated commodities, the Agency has concluded that an analytical method
to detect residues of this pesticide on treated food commodities for
enforcement purposes is not needed. Nevertheless, the Agency has
concluded that for analysis of the pesticide itself, microbiological
and biochemical methods exist and are acceptable for enforcement
purposes for product identity of Pantoea agglomerans strain E325. Other
appropriate methods are required for quality control to assure that
product characterization, the control of human pathogens and other
unintentional metabolites or ingredients are within regulatory limits,
and to ascertain storage stability and viability of the pesticidal
active ingredient.
C. CODEX Maximum Residue Level
There is no CODEX maximum residue level for residues of Pantoea
agglomerans strain E325.
VIII. Conclusions
The results of the studies discussed in Unit II. are sufficient to
comply with the requirements of FQPA. They support an exemption from
the requirement of a tolerance for residues of Pantoea agglomerans
strain E325 on apples and pears. In addition, the Agency is of the
opinion that, if the microbial active ingredient is used as labeled,
aggregate and cumulative exposures are not likely to pose any undue
risk. Submitted and cited data show that Pantoea agglomerans strain
E325 do not pose an incremental dietary and non-dietary risk to the
adult human U.S. population, children, and infants. Therefore, an
exemption from tolerance is granted in response to pesticide petition
6F7087.
MRID Citation References
1. 464678-02, Kuhn, J.O., Acute Oral Toxicity/Pathogenicity Study
in Rats With A Microbial Pest Control Agent (MPCA).
2. 464678-03, Kuhn, J.O., Acute Pulmonary Toxicity/Pathogenicity
Study In Rats With A Microbial Pest Control Agent (MPCA).
[[Page 54933]]
IX. Statutory and Executive Order Reviews
This final rule establishes an 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 rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this 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). 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., or 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). 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);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the 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. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. 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. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: September 11, 2006.
James J. Jones,
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 180.1272 is added to subpart D to read as follows:
Sec. 180.1272 Pantoea agglomerans strain E325; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Pantoea agglomerans strain E325 when used on apples and
pears.
[FR Doc. 06-8005 Filed 9-19-06; 8:45 am]
BILLING CODE 6560-50-S