[Federal Register: January 10, 2007 (Volume 72, Number 6)]
[Rules and Regulations]
[Page 1177-1183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja07-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0316; FRL-8108-4]
Beauveria Bassiana HF23; 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 microbial active ingredient
Beauveria bassiana HF23 (B. bassiana HF23) on all food and feed
commodities when applied/used to
[[Page 1178]]
treat chicken manure which will eventually be processed and used as
fertilizer on agricultural crops. Jabb of the Carolinas 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 B. bassiana HF23.
DATES: This regulation is effective January 10, 2007. Objections and
requests for hearings must be received on or before March 12, 2007, 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-2005-0316. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8097; e-mail address: bacchus.shanaz@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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.
To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the 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-2005-0316 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 March 12, 2007.
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-2005-0316, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 7, 2005 (70 FR 72831) (FRL-
7748-4), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 5F6960) by the consultant, SHB Scientific, P.O.
Box 321, Chandler, AZ 85224-0321 on behalf of Jabb of the Carolinas,
456 E. Main Street, Pine Level, NC 27568. The petition requested that
40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of B. bassiana HF23 on all food
commodities. This notice included a summary of the petition prepared by
the petitioner SHB Scientific on behalf of Jabb of the Carolinas. One
comment was received in response to this publication. The commenter
inquired if Diquat was included in this pesticide. The Agency's
response is that Diquat is not included in the formulation.
Section 408(c)(2)(A)(i) of the 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 the 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
[[Page 1179]]
section 408(c)(2)(B), 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), 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 the 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.
B. bassiana HF23 is a naturally occurring ubiquitous fungus in the
environment that has insecticidal properties. This strain, and other
strains of B. bassiana that are registered as pesticides, demonstrate
low toxicity potential and are not likely to harm human adults,
infants, and children. The applicant has submitted an application to
the Agency to register the active ingredient, B. bassiana HF23, as a
manufacturing use product (MP) for formulation into insecticidal end-
use products (EPs) and an application for an EP to control house flies
in chicken manure.
This exemption from the requirement for a tolerance only applies to
the proposed use of the active ingredient for chicken manure treatment.
Such use would not result in direct pesticidal contact with any food or
animal feed commodities. Chicken manure, treated with a pesticide
containing B. bassiana HF23, is composted and then used on agricultural
crops as a fertilizer. The fungal active ingredient does not survive
temperatures greater than 37 [deg]C (the average mammalian body
temperature), and thus, would not be expected to survive the higher
temperatures of composting (40-50 [deg]C on average). See further
discussion in Unit IV.A.1. Therefore, potential residues of B. bassiana
HF23, from its use as a pesticide to control house flies in chicken
manure, are not expected to exceed or be distinguishable from the
naturally occurring background levels of the fungus.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the 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.
The following summaries are taken from the Biopesticide and
Pollution Prevention Division (BPPD) Data Evaluation Records (DERs),
which are reviews performed by Agency scientists of the data submitted
by the registrant for this tolerance exemption.
A. Acute Oral Toxicity (OPPTS 885.3050 Test Guideline)
A study was reviewed by the Agency to ascertain acute oral toxicity
and pathogenic effects of the Technical Grade Active Ingredient (TGAI)
B. bassiana HF23 on rats (Master Record Identification Number (MRID)
46526003; DER dated 1/31/06). Laboratory rats were treated by oral
gavage with B. bassiana HF23 at guideline recommended doses: Males were
treated with 2.10-4.20 x 10\4\ colony forming units of B. bassiana HF23
per gram (cfu/g) of body weight; females were treated with 1.60-3.60 x
10\4\ cfu/g. Untreated rats of both sexes served as controls. All of
the rats, treated and untreated, survived, exhibited normal weight
gain, and appeared normal throughout the study.
B. bassiana HF23 was detected in the feces of all treated animals
collected on the day of dosing. The fungus was not detected in the
feces, tissues, blood, and cecum contents of these animals collected 3
and 7 days later. No test organisms were detected in any of the
untreated (control) animals. The data presented did not indicate any
significant clinical signs in rats. At the end of the study, B.
bassiana HF23 was not found in the following organs: Kidney, brain,
liver, lungs, spleen, and cervical and mesenteric lymph nodes.
Therefore, based on the presented/submitted data, the Agency has
determined that the test organism is not acutely toxic, infective, or
pathogenic to rats at the levels tested in this study. The active
ingredient is classified as Toxicity Category IV for acute oral
toxicity/pathogenicity effects in mammals.
B. Acute Dermal Toxicity Study (OPPTS 885. 3100 Test Guideline) and
Primary Dermal Irritation (OPPTS 870.2500 Test Guideline)
A study was reviewed by the Agency to ascertain acute dermal
toxicity and pathogenic effects of the Technical Grade Active
Ingredient (TGAI) B. bassiana HF23 in rabbits (MRID 46526004; DER dated
2/1/06).
B. bassiana HF23 (2,000 mg/kg body weight) was applied to the
shaved skin on the backs of New Zealand white rabbits (5 per sex) for
24 hours. The animals were observed twice daily for 14 days for signs
of irritation and toxicity. All of the rabbits survived, and exhibited
normal body weight gain. The test organism produced no adverse reaction
on the skin of the rabbits. The dermal LD50 for B. bassiana
HF23 in rabbits was greater than 2,000 mg/kg. B. bassiana HF23 is
classified in Toxicity Category III.
Based on the lack of irritation to the skin of rabbits in this
study, and the nature of the inert ingredients in the products being
registered by the petitioner, the Agency waived the requirement of a
primary dermal irritation study for their products.
C. Acute Pulmonary Toxicity/Pathogenicity (OPPTS 885.3150 Test
Guideline)
A study was reviewed by the Agency to ascertain acute pulmonary
toxicity and pathogenic effects of the Technical Grade Active
Ingredient (TGAI) B. bassiana HF23 in rats (MRID 46526005; DER dated 1/
31/06).
In this study, single doses of the test material were administered
to laboratory rats by intratracheal instillation at a concentration of
1.06 x 10\7\ cfu/0.1 ml (purified water). The animals were observed for
signs of toxicity, clinical signs, morbidity, and mortality twice daily
until the end of the study.
One male and one female rat died on the day of dosing, with the
cause of death likely due to anesthesia. All other rats survived,
appeared normal, and exhibited normal weight gains until scheduled
sacrifice. Reduced feces were observed in one female each from the
untreated (control) groups for one day, but since these animals were
not exposed to B. bassiana HF23, the effect was not attributed to the
test material.
Lungs, kidney, brain, liver, lungs, spleen, cervical and mesenteric
lymph nodes, cecum contents and blood samples were collected from
treated and control animals. B. bassiana HF23 was detected in the lungs
of all treated animals collected on the day of dosing
[[Page 1180]]
(males: 2.10-3.70 x 10\4\ cfu/g lung tissue; females: 4.70-7.60 x 10\4\
cfu/g lung tissue).
No test organisms were detected in the tissues, blood, and cecum
contents collected from the treated animals on days 3 and 7, and no
test organisms were detected in any of the untreated animals during the
study. The presented data show no clinical signs in treated rats. B.
bassiana HF23 was detected only in lungs immediately following dosing,
but this cleared by day 3 after dosing. Therefore, based upon the
results of this study, B. bassiana HF23 is not toxic, infective, nor
pathogenic to rats via the pulmonary route of administration, and thus
is considered Toxicity Category IV.
D. Acute Inhalation (Data Waiver Request; OPPTS 870.1300 Test
Guideline)
The registration requirement for an acute inhalation study for the
proposed use as a treatment for chicken manure was waived by the
Agency, based upon the nature of the inert ingredients of the proposed
pesticide EP and the low toxicity potential of the active ingredient
demonstrated in the acute pulmonary toxicity/pathogenicity study
discussed in Unit III.C. The inert ingredients in the proposed EP
consist of a solid state matrix with particles which are not
respirable. Based on the acute pulmonary test and the nature of the
inert ingredients, the MP is considered Toxicity Category IV.
E. Acute Intraperitoneal Injection (OPPTS 885.3200 Test Guideline)
A study was reviewed by the Agency to ascertain acute
intraperitoneal toxicity and pathogenic effects of the Technical Grade
Active Ingredient (TGAI) B. bassiana HF23 in rats (MRID 46526006; DER
dated 1/31/06).
In this study, laboratory rats were dosed with 1 ml of a suspension
of B. bassiana HF23 in purified water (3.97 x 10\8\ cfu (hemacytometer
count) or 2.8 x 10\7\ cfu/animal) by intraperitoneal injection. There
were no clinically significant signs in any of the rats. All animals
gained weight and survived to the end of the study. One treated male
and one treated female developed a lump under the skin in the ventral
abdomen at the injection site. The test organism was not recovered from
those lesions. One treated male had mottled kidneys and one treated
female had red lungs. One untreated female and four treated females had
red/enlarged ovaries/uterus. No lesions or other signs of infectivity
were observed in the affected kidneys, lungs, ovaries, and uteri. Based
on the presented/submitted data, the test organism was not toxic or
pathogenic to rats via the intraperitoneal route.
F. Hypersensitivity Study
Since no incidents of hypersensitivity have been reported at this
time for B. bassiana HF23, the Agency has determined that the active
ingredient is not expected to initiate a hypersensitive response in
humans. Footnote (iii) of 40 CFR 158.740(c) states that this guideline
is required if commonly recognized practices will result in repeated
human contact by inhalation and dermal routes, and based upon the
proposed uses of B. bassiana HF23 as an insecticide in chicken manure,
repeated human exposure by these routes are not expected.
In order to mitigate the potential for B. bassiana HF23 to cause
hypersensitivity in humans, the Agency will require appropriate
protective clothing to avoid repeated contact with skin and respiratory
tract when the active ingredient is used as a pesticide.
G. Hypersensitivity Incidents (OPPTS 885.3400 Test Guideline)
No incidents of hypersensitivity associated with the TGAI or
proposed components of the EP have been reported or are found in the
scientific literature to date. However, as with all pesticides, any
incidents of hypersensitivity or other adverse effects associated with
the use of B. bassiana HF23 must be reported to the Agency, in
accordance with the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) section 6(a)(2).
H. Immune Response (OPPTS 880.3800 Test Guideline)
The Agency has waived the registration requirements for an immune
response study based on the following: B. bassiana HF23 is a well-known
entomopathogenic (pathogenic to insects) fungus, that is ubiquitous in
nature. As no incidents of hypersensitivity have been reported, B.
bassiana HF23 is not expected to initiate a hypersensitive response in
humans. Based upon the proposed uses of B. bassiana HF23 as an
insecticide in chicken manure, repeated human exposure by these routes
are not expected.
In its decision to waive this required study, the Agency considered
the results of the acute dermal study, in which no adverse dermal
reaction to a 24-hour exposure to the active ingredient, as previously
discussed. The Agency also considered the results of the acute
toxicity/pathogenicity oral, dermal, pulmonary, and intraperitoneal
tests. These studies demonstrated that the active ingredient is neither
acutely toxic nor pathogenic when it is administered to test animals
via intraperitoneal, oral, dermal, or respiratory routes. The results
from these tests indicate that mammalian immune systems can clear the
organism, since none were found in any organs or tissues involved in
immunity (spleen, lymph node, blood).
In order to mitigate the potential for B. bassiana HF23 to cause
hypersensitivity in humans, the Agency will require appropriate
protective clothing to avoid repeated contact with skin and respiratory
tract when the active ingredient is used as a pesticide.
I. Subchronic, Chronic Toxicity and Oncogenicity, and Residue Data
The summaries of the data discussed in this Unit comply with the
Tier I data requirements set forth in 40 CFR 158.740(c), and do not
trigger the Tier II and Tier III data requirements, which, therefore,
are 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 the 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
The microbial pesticide containing the active ingredient, B.
bassiana HF23, is not applied directly to food as discussed previously.
Food or animal feed commodities could potentially be exposed to
inadvertent residues of B. bassiana HF23 as a result of treated chicken
manure being used as fertilizer to agricultural crops.
1. Food. B. bassiana HF23 is sensitive to warm temperatures (MRID
46526011) and UV light. The treated chicken manure is processed by
composting into fertilizer for use on agricultural crops. The high
temperatures of composting are very likely to destroy any potential
residual B. bassiana HF23 or other potential microbial contaminants.
Thus, the amount of viable B. bassiana HF23 spores that may have
remained after composting treated chicken manure would greatly diminish
once the manure is spread as a fertilizer and the
[[Page 1181]]
spores exposed to sunlight. However, data show that viable B. bassiana
HF23 spores will leave poultry production houses upon disposal of
manure and litter (MRID 46786401; BPPD DER 6/20/06). At the time of
application of the treated chicken manure, B. bassiana HF23 colonies
have declined to levels which are no greater than those observed of the
naturally occurring microbe (MRID 46786401; BPPD DER 6/20/06).
There is no direct post-harvest treatment of food commodities with
B. bassiana HF23. Thus, detectable residues of B. bassiana HF23 are not
expected on agricultural crops or food commodities as a result of the
proposed use of this active ingredient. Moreover, washing, peeling and
processing of foods and feed commodities before consumption would
further mitigate any potential exposure and risk via dietary exposure.
The active ingredient occurs naturally and is ubiquitous in the
environment. The toxicological profile discussed in Unit III. indicates
no acute oral toxicity/pathogenicity effects of this active ingredient.
In addition, a study conducted for ecological effects, used chickens
for avian oral toxicology tests. No adverse effects were observed for
20 day old chickens dosed at acceptable guideline levels. Transfer to
meat, milk, poultry, and eggs is expected to be negligible to non-
existent, as noted in these discussions of submitted toxicology
studies. Thus, no harm is expected to human adults, children or infants
via consumption of food or feed exposed to chicken manure which has
been treated with B. bassiana HF23.
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. Thus, transfer of B.
bassiana HF23 from soil to groundwater is unlikely. Even if such a
transfer were to occur, the fungus would not survive the conditions of
drinking water treatment, such as chlorination, pH adjustments, and
other water processing conditions. Further, there is no evidence of
adverse effects from exposure to this ubiquitous organism. Exposure
from the proposed use of B. bassiana HF23 is not likely to pose any
incremental risk to adult humans, infants, and children via consumption
of drinking water.
B. Other Non-Occupational Exposure
The proposed products are an MP for formulation into pesticide EPs
and an EP that is intended to be used commercially for treatment of
chicken manure in poultry houses to control house flies. Non-
occupational residential, school, or day care exposure is not
anticipated because of the use pattern of this product. The use of B.
bassiana HF23 should result in minimal to non-existent, non-
occupational risk. No indoor residential, school, or daycare uses are
currently permitted for this active ingredient.
1. Dermal exposure. EPA has concluded that this pesticide poses
minimal risk to human populations via non-occupational dermal exposure.
This conclusion is based on the low toxicity potential observed in the
acute dermal studies discussed in Unit III., and the low exposure
potential based on non-viability of the active ingredient after treated
chicken manure is used as a fertilizer on agricultural crops. Moreover,
potential non-occupational dermal exposure to B. bassiana HF23 is
unlikely because the use sites are commercial and agricultural.
As previously discussed, no hypersensitivity incidents associated
with B. bassiana HF23 have been reported to date. Therefore, the Agency
does not expect pesticides containing B. bassiana HF23 to pose a non-
occupational dermal exposure risk.
2. Inhalation exposure. Non-occupational inhalation exposure to B.
bassiana HF23 from its proposed agricultural use as a pesticide to
treat chicken manure is not anticipated. In the pulmonary study
described in Unit III.C., no treatment-related effects associated with
the active ingredient were observed in laboratory rats. In the unlikely
event that an individual is exposed to the active ingredient by the
inhalation route, such exposure is not expected to pose an inhalation
risk.
In summary, the potential aggregate exposure as a result of the use
of the pesticidal active ingredient B. bassiana HF23 is not likely to
pose a hazard via aggregate exposure. This includes hazards derived
from (a) dietary exposure from the treated food/feed commodities, (b)
drinking water potentially exposed secondary to treatment of sites with
this pesticide; and (c) dermal and inhalation non-occupational exposure
of populations exposed to B. bassiana HF23.
V. Cumulative Effects
The Agency has considered the potential for cumulative effects of
B. bassiana HF23 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, B. bassiana HF23 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 B. bassiana HF23, 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 fungus in its use as an
insecticide via dietary exposure since 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, dermal, and intraperitoneal 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 (see Units IV. and V.)
FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional ten-fold margin of exposure (safety) for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base on toxicity
and exposure, unless EPA determines that a different margin of exposure
(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 assessment either directly, or through the
use of a margin of exposure analysis, or by using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk. In
this instance, based on all the available information (as discussed in
Unit III.), the Agency concludes that the fungus, B. bassiana HF23, is
non-toxic to mammals, including infants and children. Because there are
no threshold effects of concern to infants, children, and adults when
B. bassiana HF23 is used as a pesticidal active ingredient, the Agency
has determined that the additional margin of safety is not necessary to
protect infants and children, and that not adding any additional margin
of safety will be safe for infants and children. As a result, EPA has
not used a margin of
[[Page 1182]]
exposure (safety) approach to assess the safety of B. bassiana HF23.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was 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).
At this time, the Agency is not requiring information on the
endocrine effects of this active ingredient, B. bassiana HF23. 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 that acts as
an ``endocrine disruptor'' produced by this microorganism. The
submitted toxicity/infectivity or pathogenicity studies in the rodent
(required for microbial pesticides) indicate that, following oral,
pulmonary, dermal, and intraperitoneal routes of exposure, the immune
system is still intact and able to process and clear the active
ingredient (see Unit III.). In addition, based on the low potential
exposure level associated with the proposed uses of the pesticide, the
Agency expects no adverse effects to the endocrine or immune systems.
Thus, there is no impact via endocrine-related effects on the Agency's
safety finding set forth in this final rule for B. bassiana HF23.
B. Analytical Method(s)
The acute oral studies discussed in Unit III. demonstrate that the
active ingredient does not pose a dietary risk. In addition, the active
ingredient is not likely to come into contact with the treated food
commodities. Furthermore, the low application rate and non-persistence
on food during applications suggests very low exposure potential via
the dietary route. Since residues are not expected on treated
commodities, the Agency has concluded that an analytical method to
detect residues of this pesticide on treated food commodities for
enforcement purposes is not needed.
Nevertheless, the Agency has concluded that for analysis of the
pesticide itself, microbiological and biochemical methods exist and are
acceptable for enforcement purposes for product identity of B. bassiana
HF23. 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 B. bassiana
HF23.
VIII. Conclusions
The results of the studies discussed are sufficient to comply with
the requirements of the FQPA. They support an exemption from the
requirement of a tolerance for residues of B. bassiana HF23, on treated
food or feed commodities. In addition, the Agency is of the opinion
that, if the microbial active ingredient is used as allowed, aggregate
and cumulative exposures are not likely to pose any undue hazard to the
adult human U.S. population, children, and infants. Therefore, an
exemption from the requirement of a tolerance is granted in response to
pesticide petition 5F6960.
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of the 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, 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 the 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. The Agency
hereby certifies that this rule will not have significant negative
economic impact on a substantial number of small entities. 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
[[Page 1183]]
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 the
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: December 22, 2006.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR part 180 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 180.1273 is added to subpart D to read as follows:
Sec. 180.1273 Beauveria bassiana HF23; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established on
all food/feed commodities, for residues of Beauveria bassiana HF23 when
the pesticide is used for chicken manure treatment.
[FR Doc. E7-170 Filed 1-9-07; 8:45 am]
BILLING CODE 6560-50-S