Beauveria bassiana HF23; Amendment of Exemption from the Requirement of a Tolerance, 10186-10190 [2010-4544]
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10186
Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations
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. Section 808 allows
the issuing agency to make a rule
effective sooner than otherwise
provided by the CRA, if the agency
makes a good cause finding that notice
and public procedure is impracticable,
unnecessary or contrary to the public
interest. This determination must be
supported by a brief statement (5 U.S.C.
808(2)). As stated previously, EPA has
made such a good cause finding,
including the reasons therefore, and
established an effective date of March 5,
2010. The 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 the rule in
the Federal Register.
The EPA’s compliance with these
statutes and Executive Orders for the
underlying rule is discussed in the
December 3, 2009, Federal Register
notice containing the Area Source
Paints and Allied Products
Manufacturing final rule (74 FR 63504).
List of Subjects for 40 CFR Part 63
Environmental protection,
Administrative practice and procedure,
Air pollution control, Hazardous
substances, Intergovernmental relations,
Reporting and recordkeeping
requirements.
Dated: February 25, 2010.
Gina McCarthy,
Assistant Administrator, Office of Air and
Radiation.
For the reasons set out in the
preamble, title 40, chapter I, part 63, of
the Code of Federal Regulations is
amended as follows:
■
PART 63—[AMENDED]
1. The authority citation for part 63
continues to read as follows:
■
Authority: 42 U.S.C. 7401, et seq.
Subpart CCCCCCC—[Amended]
2. Section 63.11599 is amended by
revising paragraph (b)(1) to read as
follows:
■
§ 63.11599
Am I subject to this subpart?
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(b) * * *
(1) An affected source is existing if
you commenced construction or
reconstruction before June 1, 2009.
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3. Section 63.11601 is amended by:
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a. Revising paragraph (a) introductory
text;
■ b. Removing paragraph (a)(3);
■ c. Redesignating paragraphs (a)(4)
through (a)(7) as paragraphs (a)(3)
through (a)(6);
■ d. Revising newly designated
paragraph (a)(4)(i) to read as follows:
■
§ 63.11601 What are the standards for new
and existing paints and allied products
manufacturing facilities?
(a) For each new and existing affected
source, you must comply with the
requirements in paragraphs (a)(1)
through (5) of this section. These
requirements apply at all times.
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(4) You must:
(i) Capture particulate emissions and
route them to a particulate control
device meeting the requirements of
paragraph (a)(5) of this section during
the grinding and milling of materials
containing compounds of cadmium,
chromium, lead, or nickel; or
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3. Section 63.11602 is amended by:
a. In paragraph (a)(2)(iii) introductory
text by revising the last sentence:
■ b. In paragraph (a)(2)(iii)(A) by
revising the last sentence;
■ c. By revising paragraph (a)(2)(iii)(B).
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§ 63.11602 What are the performance test
and compliance requirements for new and
existing sources?
(a) * * *
(2) * * *
(iii) * * * If the Method 203C test
runs indicates an opacity greater than
the limitation in § 63.11601(a)(5), you
must comply with the requirements in
paragraphs (a)(2)(iii)(A) through (C) of
this section.
(A) * * * You must continue to take
corrective action and retest each 15 days
until a Method 203C test indicates an
opacity equal to or less than the
limitation in § 63.11601(a)(5).
(B) You must prepare a deviation
report in accordance with
§ 63.11603(b)(3) for each instance in
which the Method 203C opacity results
were greater than the limitation in
§ 63.11601(a)(5).
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4. Section 63.11603 is amended by:
a. Revising paragraph (c) introductory
text;
■ b. Redesignating paragraph (e) as
paragraph d).
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§ 63.11603 What are the notification,
reporting, and recordkeeping
requirements?
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(c) Records. You must maintain the
records specified I paragraphs (c)(1)
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through (4) of this section in accordance
with paragraphs (c)(5) through (6) of this
section, for five years after the date of
each recorded action.
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[FR Doc. 2010–4754 Filed 3–4–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0316; FRL–8814–6]
Beauveria bassiana HF23; Amendment
of Exemption from the Requirement of
a Tolerance
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends an
exemption from the requirement of a
tolerance for residues of the microbial
insecticide. Beauveria bassiana HF23
(40 CFR 180.1273) on all food
commodities when used to treat chicken
and livestock facilities, from which
manure will eventually be composted
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),
requesting this amendment of the
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
Beauveria bassiana HF23.
DATES: This regulation is effective
March 5, 2010. Objections and requests
for hearings must be received on or
before May 4, 2010, 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 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
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Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8097; e-mail address:
bacchus.shanaz@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. 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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B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr.
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
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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 May 4, 2010.
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: 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 March 16,
2009 (74 FR 11100) (FRL–8405–1), 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 8F7467)
by JABB of the Carolinas, P.O. Box 310,
Pine Level, NC 27568. The company’s
supporting documents for the notice of
filing of the petition incorrectly
assigned PP 5F6960 to this petition. The
petition requested that 40 CFR 180.1273
be amended by expanding the uses
covered by the existing exemption from
the requirement of a tolerance for
residues of Beauveria bassiana HF23.
This notice indicated that a summary of
the petition prepared by the petitioner
was included in the docket for this
action.
One anonymous public comment was
posted to the docket asserting that foods
should have zero pesticide residues and
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requested labeling for all foods with any
residue above the zero level. The
commenter also referred to the toxicity
of chemicals and their possible link to
cancer.
The Agency’s response to this
comment follows. This active
ingredient, Beauveria bassiana HF23,
occurs naturally in the environment and
the human population is potentially
exposed to it regardless of whether it is
registered as a pesticide or not. Thus, it
is not even possible to eliminate
exposure to this substance since it is a
naturally occurring ubiquitous soil
microbe.
EPA regulates pesticides according to
peer-reviewed and publicly available
guidelines that describe endpoints for
human health risk assessment. Tests are
conducted with the active ingredient or
end-use product in surrogate animals
through various routes of administration
(i.e., oral, dermal, pulmonary, etc.). Any
effects seen are reported to the Agency,
peer-reviewed, and evaluated to
determine whether the effects of the test
material demonstrate infectivity, acute
toxicity, or pathogenicity. Beauveria
bassiana HF23 has demonstrated a low
toxicity profile in such testing and did
not trigger the need for further testing
for carcinogenicity. Summaries of data
reviewed in support of this active
ingredient are available in the
Biopesticide Registration Action
Document (BRAD) on Beauveria
bassiana HF23 (www.epa.gov/pesticide/
biopesticides) and in the final rule
published for use of the active
ingredient for chicken manure treatment
in the Federal Register on January 10,
2007 (72 FR 1177) (FRL–8108–4).
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
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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.
Beauveria bassiana HF23 is a fungus
with insecticidal properties. It is a
naturally occurring, ubiquitous soil
microbe. This strain, and other strains of
Beauveria bassiana that are registered as
pesticides, demonstrate low toxicity
potential and are not likely to harm
human adults, infants, and children. An
exemption from tolerance has already
been established in 40 CFR 180.1273 for
residues of Beauveria bassiana HF23 on
all food/feed commodities, when the
pesticide is used to treat chicken
manure (72FR 1177, January 10, 2007).
The toxicological profile of this active
ingredient was published in that final
rule and summaries of the studies cited
in support of this tolerance exemption
amendment are available in the BRAD
on www.epa.gov/pesticides/
biopesticides. The registrant now cites
those data and provides additional
information to support expanding the
tolerance exemption to include residues
on food/feed commodities from
agricultural crops fertilized with
manure from livestock facilities, where
the manure was treated with Beauveria
bassiana HF23. Reference to those
studies are included in the following
discussion.
Based on the previously reviewed
data, the Agency classified the active
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ingredient as Toxicity Category IV for
acute oral and acute pulmonary effects
and Toxicity Category III for acute
dermal effects. These studies indicated
that the pesticide was not toxic,
infective or pathogenic via these routes
of exposure. Also, the test organism was
not toxic or pathogenic to rats via the
intraperitoneal route. Immunotoxicity
testing is not required for this active
ingredient because it does not contain
viruses that are known to interact in an
adverse manner with the mammalian
immune system.
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 Beauveria
bassiana HF23 must be reported to the
Agency, in accordance with the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) section 6(a)(2).
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
1. Food. The pesticide is intended for
the control of houseflies in livestock
and chicken facilities. In livestock
facilities, the pesticide is to be applied
as bait in stations that are not within
reach of livestock or as a spray to the
facilities. In chicken facilities, the
pesticide is applied directly onto the
chicken manure to control houseflies as
well as to the walls of the chicken
houses. The pesticide is not applied
directly either to chicken or livestock,
nor is it applied directly to food or feed.
In light of these uses in chicken and
livestock facilities, the Agency has
evaluated whether there is any potential
for residues of the pesticide to result in
or on meat, milk, poultry, eggs, or other
products derived from chickens or
livestock present in such facilities. In
addition, the Agency has considered
whether there is any potential for
residues to result in food or feed crops
as a result of the use of treated manure
as fertilizer for agricultural crops.
With respect to meat, milk, poultry,
eggs, or other products derived from
chickens or livestock, the Agency has
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considered the following. First, as
already explained in the aforementioned
BRAD and in the prior final rule
granting a tolerance exemption for
Beauveria bassiana HF23 (Unit III.A.
and B., 72 FR 1177, January 10, 2007),
the acute oral and dermal toxicity tests
in mammals resulted in the Agency
classifying the fungus as a low Toxicity
Category IV for acute oral effects and
Toxicity Category III for acute dermal
effects. Second, acute toxicology tests
involving dermally administered
Beauveria bassiana HF23 led to a
toxicity Category III acute dermal
classification for the fungus. Third,
there were no signs of infectivity in
tissues examined during the acute
intraperitoneal test in mammalian
rodents. Fourth, an acute oral toxicity
test conducted in chicken also
demonstrated that the active ingredient
is not toxic, infective or pathogenic to
chicken. Fifth, clearance was observed
in all tissues analyzed during these
avian and mammalian tests and they
were conducted with guideline levels of
the active ingredient, with no toxic,
infective or pathogenic effects to the
avian and mammalian test organisms.
Summaries of these tests can be found
in the prior final rule published on
January 10, 2007 (72 FR 1177, Unit III.
A, B, and E) and in the BRAD for
Beauveria bassiana HF23. Based on all
of this, the Agency concludes that
residues of the pesticide are not likely
to be transferred to meat, milk, eggs,
poultry or other products derived from
chicken and livestock as a result of
treating chicken and livestock facilities
with the pesticide.
Moreover, to the extent that there
could be negligible residues resulting in
meat, milk, eggs, poultry, or other
products derived from the chicken and
livestock from such facilities, it is
expected that they will not be greater
than naturally occurring background
levels to which humans already are
possibly exposed due to the fact that
this is a ubiquitous soil microbe. In
addition, to the extent that there were
any potential negligible residues of the
fungus Beauveria bassiana HF23
resulting in meat, milk, eggs, poultry, or
other products derived from the chicken
or livestock from treated facilities,
which, again, is unlikely and not
expected, it is expected that they would
be removed in connection with the steps
taken to prepare such products for
market and consumption. For example,
the shells of eggs are washed, and eggs
are cooked prior to human
consumption. The shells also can be
expected to prevent any residues of the
pesticide from getting into the edible
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portions of eggs. Feathers are removed
from chickens and hides from livestock
during dressing operations and meat
and poultry preparation. These
measures are expected to remove any
potential negligible residues prior to
human consumption. Similarly,
washing, cleaning and other processes
when preparing meat, as well as the
pasteurization of milk, would remove
any potential negligible residues from
meat and milk.
In connection with the use of treated
manure as fertilizer for agricultural
crops, the Agency has concluded that
while it is possible for extremely low or
negligible residues to result in or on
food and feed derived from those crops,
this, nonetheless, is unlikely for the
following reasons. First, prior to being
used on agricultural crops, chicken and
livestock manure is composted. This is
significant because Beauveria bassiana
HF23 does not survive temperatures
greater than 37 degrees Centigrade (the
average mammalian body temperature),
and thus, would not be expected to
survive the higher temperatures of
composting (40-50 degrees Centigrade
on average) (Master Records
Identification (MRID)) 46526011. In
addition, Beauveria bassiana HF23 does
not survive in Ultraviolet (UV) light, so
it is likely that any residues that
survived composting would be
destroyed by UV light once the treated
manure is applied to agricultural crops
in the field if the pesticide is used as
labeled.
On the basis of the foregoing
considerations, and mindful of the
previously mentioned studies that
indicate that Beauveria bassiana HF23
is not toxic, infective or pathogenic via
the tested routes of exposure, is not
toxic or pathogenic to rats via the
intraperitoneal route, and does not
contain viruses that are known to
interact in an adverse manner with the
mammalian immune system, the
Agency concludes that no harm is
expected to human adults, children, or
infants via consumption of any food
products derived from chicken or
livestock potentially exposed to the
pesticide as a result of its use (in
accordance with label directions) in
chicken and livestock facilities, or via
consumption of any food products
derived from agricultural crops to which
treated manure has been applied as a
fertilizer.
2. Drinking water exposure. No
drinking water exposure is anticipated
because of the use patterns, use sites,
and the nature of the active ingredient
at issue. The pesticide is to be used for
indoor treatment of chicken and
livestock facilities. It will be applied in
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either a suspension or a granular bait
formulation. Most notably, there are no
aquatic use sites permitted for this
pesticide. Thus, there is likely to be no
access to sources of drinking water as a
result of applications within such
facilities. Moreover, even if the
pesticide did somehow reach drinking
water as a result of the permitted indoor
uses, Beauveria bassiana HF23 is not
known to proliferate in aquatic
environments (BRAD Chapter III.C).
The Agency also does not expect any
residues in drinking water or ground
water as a result of application of
treated manure that is used as fertilizer
on agricultural crops. Beauveria
bassiana HF23 is a soil microbe. As
discussed in Unit IV.A.1, this microbe is
not likely to survive composting
temperatures or subsequent exposure to
UV light. In addition, because soil
microbes generally tend to seek their
nutrients and grow in the upper levels
of soil and do not, as a result, penetrate
lower soil levels that are more akin to
filtration beds, Beauveria bassiana HF23
is not expected to percolate into soil and
reach ground water (see BRAD Chapter
III.C.). Thus, transfer of this naturally
occurring, low toxicity, soil borne
microbe from soil to ground water is
unlikely.
Accordingly, the Agency concludes
that Beauveria bassiana HF23, when
used as labeled and in accordance with
good agricultural practices, is not likely
to pose any incremental dietary risk to
human adults, children, or infants via
consumption of drinking water (see
BRAD and 72 FR 1177, Jan. 10, 2007).
B. Other Non-Occupational Exposure
1. Dermal exposure. EPA has
concluded that there is unlikely to be
any non-occupational dermal exposure
because the use sites are commercial
and agricultural.
2. Inhalation exposure. Similarly,
non-occupational inhalation exposure to
Beauveria bassiana HF23 from its
proposed commercial and agricultural
use as a pesticide to treat chicken
manure or livestock facilities is not
anticipated.
In summary, the potential aggregate
exposure as a result of the use of the
pesticidal active ingredient Beauveria
bassiana HF23 is not likely to pose a
hazard via aggregate exposure. This
includes potential hazards derived from
(i.) dietary exposure from the treated
food/feed commodities, (ii.) drinking
water potentially exposed secondary to
treatment of sites with this pesticide;
and (iii.) dermal and inhalation nonoccupational exposure of populations
exposed to Beauveria bassiana HF23.
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10189
V. Cumulative Effects
Three other Beauveria bassiana
strains are registered. While they show
the same mechanism as
entomopathogens, they are involved in
treatments of specific target pests. In
this instance, Beauveria bassiana HF23
is directed against the public health
hazard, houseflies. Because Beauveria
bassiana HF23 does not operate via a
toxic mechanism, section 408(b)(2)(D)(v)
does not apply. In any event, since none
of the registered strains are toxic,
infective or pathogenic to humans and
other mammals or other non-target
organisms, cumulative adverse health or
environmental effects of Beauveria
bassiana HF23 are not expected.
VI. Determination of Safety for U.S.
Population, Infants and Children
The Agency has concluded that there
is a reasonable certainty that no harm
will result from aggregate exposures to
Beauveria bassiana HF23 in or on all
food commodities, when the pesticide is
used to treat manure in chicken and
livestock facilities, which manure will
in turn be used as fertilizer on
agricultural crops. The Agency bases
this conclusion on the data that
demonstrate this substance has little to
no toxicity or infectivity. Based on all
the available information, the Agency
concludes that the fungus, Beauveria
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 Beauveria 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 exposure
(safety) approach to assess the safety of
Beauveria bassiana HF23.
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, 72 FR 1177,
January 10, 2007.
B. Analytical Method(s)
See Federal Register, 72 FR 1177,
January 10, 2007.
C. Codex Maximum Residue Level
There is no Codex Maximum Residue
Level (MRL) for residues of Beauveria
bassiana HF23 on all food commodities.
VIII. Conclusions
In summary, the Agency has
determined that, based on available data
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erowe on DSK5CLS3C1PROD with RULES
and information, there is a reasonable
certainty of no harm from aggregate
exposure to Beauveria bassiana HF23
on all food commodities, resulting
either from its use (in accordance with
all label direction and good agricultural
practices) in chicken and livestock
facilities or as a result of the subsequent
use of treated manure from livestock
and chicken facilities as fertilizer on
agricultural crops. Thus, an exemption
from the requirement of a tolerance is
being granted for residues of Beauveria
bassiana HF23 on all food commodities
in response to pesticide petition PP
8F7467.
IX. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance exemption in this final
rule, do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
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
VerDate Nov<24>2008
14:25 Mar 04, 2010
Jkt 220001
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
X. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 25, 2010.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part
180.1273 continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In subpart D, revise §180.1273 to
read as follows:
■
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
§ 180.1273. Beauveria bassiana HF23;
exemption from the requirement of a
tolerance.
Residues of Beauveria bassiana HF23
are exempt from the requirement of a
tolerance on all food/feed commodities,
when the pesticide is used for the
treatment of chicken and livestock
facilities, including the treatment of
chicken and livestock manure.
[FR Doc. 2010–4544 Filed 3–4–10; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 217
Defense Federal Acquisition
Regulation Supplement; Payment of
Costs Prior to Definitization-Definition
of Contract Action (DFARS Case 2009–
D035)
AGENCY: Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Interim rule with request for
comments.
SUMMARY: DoD is issuing an interim rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to implement section 812 of
the National Defense Authorization Act
for Fiscal Year 2010 (Pub. L. 111–84,
enacted October 28, 2009).
DATES: Effective Date: March 5, 2010.
Comment date: Comments on the
interim rule should be submitted in
writing to the address shown below on
or before May 4, 2010, to be considered
in the formation of the final rule.
ADDRESSES: Submit comments
identified by DFARS Case 2009–D035,
using any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: dfars@osd.mil. Include
DFARS Case 2009–D035 in the subject
line of the message.
• Fax: 703–602–0350.
• Mail: Defense Acquisition
Regulations System, Attn: Ms. Meredith
Murphy, OUSD (AT&L) DPAP (DARS),
Room 3B855, 3060 Defense Pentagon,
Washington, DC 20301–3060.
• Hand Delivery/Courier: Defense
Acquisition Regulations System, Crystal
Square 4, Suite 200A, 241 18th Street,
Arlington, VA 22202–3402.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal information provided.
E:\FR\FM\05MRR1.SGM
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Agencies
[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Rules and Regulations]
[Pages 10186-10190]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4544]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0316; FRL-8814-6]
Beauveria bassiana HF23; Amendment of Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends an exemption from the requirement of a
tolerance for residues of the microbial insecticide. Beauveria bassiana
HF23 (40 CFR 180.1273) on all food commodities when used to treat
chicken and livestock facilities, from which manure will eventually be
composted 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), requesting this amendment of the exemption from
the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Beauveria
bassiana HF23.
DATES: This regulation is effective March 5, 2010. Objections and
requests for hearings must be received on or before May 4, 2010, 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 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
[[Page 10187]]
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8097; e-mail address: bacchus.shanaz@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.
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-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 May 4, 2010.
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: 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 March 16, 2009 (74 FR 11100) (FRL-8405-
1), 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 8F7467) by JABB of the Carolinas, P.O. Box 310, Pine
Level, NC 27568. The company's supporting documents for the notice of
filing of the petition incorrectly assigned PP 5F6960 to this petition.
The petition requested that 40 CFR 180.1273 be amended by expanding the
uses covered by the existing exemption from the requirement of a
tolerance for residues of Beauveria bassiana HF23. This notice
indicated that a summary of the petition prepared by the petitioner was
included in the docket for this action.
One anonymous public comment was posted to the docket asserting
that foods should have zero pesticide residues and requested labeling
for all foods with any residue above the zero level. The commenter also
referred to the toxicity of chemicals and their possible link to
cancer.
The Agency's response to this comment follows. This active
ingredient, Beauveria bassiana HF23, occurs naturally in the
environment and the human population is potentially exposed to it
regardless of whether it is registered as a pesticide or not. Thus, it
is not even possible to eliminate exposure to this substance since it
is a naturally occurring ubiquitous soil microbe.
EPA regulates pesticides according to peer-reviewed and publicly
available guidelines that describe endpoints for human health risk
assessment. Tests are conducted with the active ingredient or end-use
product in surrogate animals through various routes of administration
(i.e., oral, dermal, pulmonary, etc.). Any effects seen are reported to
the Agency, peer-reviewed, and evaluated to determine whether the
effects of the test material demonstrate infectivity, acute toxicity,
or pathogenicity. Beauveria bassiana HF23 has demonstrated a low
toxicity profile in such testing and did not trigger the need for
further testing for carcinogenicity. Summaries of data reviewed in
support of this active ingredient are available in the Biopesticide
Registration Action Document (BRAD) on Beauveria bassiana HF23
(www.epa.gov/pesticide/biopesticides) and in the final rule published
for use of the active ingredient for chicken manure treatment in the
Federal Register on January 10, 2007 (72 FR 1177) (FRL-8108-4).
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
[[Page 10188]]
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.
Beauveria bassiana HF23 is a fungus with insecticidal properties.
It is a naturally occurring, ubiquitous soil microbe. This strain, and
other strains of Beauveria bassiana that are registered as pesticides,
demonstrate low toxicity potential and are not likely to harm human
adults, infants, and children. An exemption from tolerance has already
been established in 40 CFR 180.1273 for residues of Beauveria bassiana
HF23 on all food/feed commodities, when the pesticide is used to treat
chicken manure (72FR 1177, January 10, 2007). The toxicological profile
of this active ingredient was published in that final rule and
summaries of the studies cited in support of this tolerance exemption
amendment are available in the BRAD on www.epa.gov/pesticides/biopesticides. The registrant now cites those data and provides
additional information to support expanding the tolerance exemption to
include residues on food/feed commodities from agricultural crops
fertilized with manure from livestock facilities, where the manure was
treated with Beauveria bassiana HF23. Reference to those studies are
included in the following discussion.
Based on the previously reviewed data, the Agency classified the
active ingredient as Toxicity Category IV for acute oral and acute
pulmonary effects and Toxicity Category III for acute dermal effects.
These studies indicated that the pesticide was not toxic, infective or
pathogenic via these routes of exposure. Also, the test organism was
not toxic or pathogenic to rats via the intraperitoneal route.
Immunotoxicity testing is not required for this active ingredient
because it does not contain viruses that are known to interact in an
adverse manner with the mammalian immune system.
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 Beauveria bassiana HF23 must be reported to the Agency, in
accordance with the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) section 6(a)(2).
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. The pesticide is intended for the control of houseflies in
livestock and chicken facilities. In livestock facilities, the
pesticide is to be applied as bait in stations that are not within
reach of livestock or as a spray to the facilities. In chicken
facilities, the pesticide is applied directly onto the chicken manure
to control houseflies as well as to the walls of the chicken houses.
The pesticide is not applied directly either to chicken or livestock,
nor is it applied directly to food or feed. In light of these uses in
chicken and livestock facilities, the Agency has evaluated whether
there is any potential for residues of the pesticide to result in or on
meat, milk, poultry, eggs, or other products derived from chickens or
livestock present in such facilities. In addition, the Agency has
considered whether there is any potential for residues to result in
food or feed crops as a result of the use of treated manure as
fertilizer for agricultural crops.
With respect to meat, milk, poultry, eggs, or other products
derived from chickens or livestock, the Agency has considered the
following. First, as already explained in the aforementioned BRAD and
in the prior final rule granting a tolerance exemption for Beauveria
bassiana HF23 (Unit III.A. and B., 72 FR 1177, January 10, 2007), the
acute oral and dermal toxicity tests in mammals resulted in the Agency
classifying the fungus as a low Toxicity Category IV for acute oral
effects and Toxicity Category III for acute dermal effects. Second,
acute toxicology tests involving dermally administered Beauveria
bassiana HF23 led to a toxicity Category III acute dermal
classification for the fungus. Third, there were no signs of
infectivity in tissues examined during the acute intraperitoneal test
in mammalian rodents. Fourth, an acute oral toxicity test conducted in
chicken also demonstrated that the active ingredient is not toxic,
infective or pathogenic to chicken. Fifth, clearance was observed in
all tissues analyzed during these avian and mammalian tests and they
were conducted with guideline levels of the active ingredient, with no
toxic, infective or pathogenic effects to the avian and mammalian test
organisms. Summaries of these tests can be found in the prior final
rule published on January 10, 2007 (72 FR 1177, Unit III. A, B, and E)
and in the BRAD for Beauveria bassiana HF23. Based on all of this, the
Agency concludes that residues of the pesticide are not likely to be
transferred to meat, milk, eggs, poultry or other products derived from
chicken and livestock as a result of treating chicken and livestock
facilities with the pesticide.
Moreover, to the extent that there could be negligible residues
resulting in meat, milk, eggs, poultry, or other products derived from
the chicken and livestock from such facilities, it is expected that
they will not be greater than naturally occurring background levels to
which humans already are possibly exposed due to the fact that this is
a ubiquitous soil microbe. In addition, to the extent that there were
any potential negligible residues of the fungus Beauveria bassiana HF23
resulting in meat, milk, eggs, poultry, or other products derived from
the chicken or livestock from treated facilities, which, again, is
unlikely and not expected, it is expected that they would be removed in
connection with the steps taken to prepare such products for market and
consumption. For example, the shells of eggs are washed, and eggs are
cooked prior to human consumption. The shells also can be expected to
prevent any residues of the pesticide from getting into the edible
[[Page 10189]]
portions of eggs. Feathers are removed from chickens and hides from
livestock during dressing operations and meat and poultry preparation.
These measures are expected to remove any potential negligible residues
prior to human consumption. Similarly, washing, cleaning and other
processes when preparing meat, as well as the pasteurization of milk,
would remove any potential negligible residues from meat and milk.
In connection with the use of treated manure as fertilizer for
agricultural crops, the Agency has concluded that while it is possible
for extremely low or negligible residues to result in or on food and
feed derived from those crops, this, nonetheless, is unlikely for the
following reasons. First, prior to being used on agricultural crops,
chicken and livestock manure is composted. This is significant because
Beauveria bassiana HF23 does not survive temperatures greater than 37
degrees Centigrade (the average mammalian body temperature), and thus,
would not be expected to survive the higher temperatures of composting
(40-50 degrees Centigrade on average) (Master Records Identification
(MRID)) 46526011. In addition, Beauveria bassiana HF23 does not survive
in Ultraviolet (UV) light, so it is likely that any residues that
survived composting would be destroyed by UV light once the treated
manure is applied to agricultural crops in the field if the pesticide
is used as labeled.
On the basis of the foregoing considerations, and mindful of the
previously mentioned studies that indicate that Beauveria bassiana HF23
is not toxic, infective or pathogenic via the tested routes of
exposure, is not toxic or pathogenic to rats via the intraperitoneal
route, and does not contain viruses that are known to interact in an
adverse manner with the mammalian immune system, the Agency concludes
that no harm is expected to human adults, children, or infants via
consumption of any food products derived from chicken or livestock
potentially exposed to the pesticide as a result of its use (in
accordance with label directions) in chicken and livestock facilities,
or via consumption of any food products derived from agricultural crops
to which treated manure has been applied as a fertilizer.
2. Drinking water exposure. No drinking water exposure is
anticipated because of the use patterns, use sites, and the nature of
the active ingredient at issue. The pesticide is to be used for indoor
treatment of chicken and livestock facilities. It will be applied in
either a suspension or a granular bait formulation. Most notably, there
are no aquatic use sites permitted for this pesticide. Thus, there is
likely to be no access to sources of drinking water as a result of
applications within such facilities. Moreover, even if the pesticide
did somehow reach drinking water as a result of the permitted indoor
uses, Beauveria bassiana HF23 is not known to proliferate in aquatic
environments (BRAD Chapter III.C).
The Agency also does not expect any residues in drinking water or
ground water as a result of application of treated manure that is used
as fertilizer on agricultural crops. Beauveria bassiana HF23 is a soil
microbe. As discussed in Unit IV.A.1, this microbe is not likely to
survive composting temperatures or subsequent exposure to UV light. In
addition, because soil microbes generally tend to seek their nutrients
and grow in the upper levels of soil and do not, as a result, penetrate
lower soil levels that are more akin to filtration beds, Beauveria
bassiana HF23 is not expected to percolate into soil and reach ground
water (see BRAD Chapter III.C.). Thus, transfer of this naturally
occurring, low toxicity, soil borne microbe from soil to ground water
is unlikely.
Accordingly, the Agency concludes that Beauveria bassiana HF23,
when used as labeled and in accordance with good agricultural
practices, is not likely to pose any incremental dietary risk to human
adults, children, or infants via consumption of drinking water (see
BRAD and 72 FR 1177, Jan. 10, 2007).
B. Other Non-Occupational Exposure
1. Dermal exposure. EPA has concluded that there is unlikely to be
any non-occupational dermal exposure because the use sites are
commercial and agricultural.
2. Inhalation exposure. Similarly, non-occupational inhalation
exposure to Beauveria bassiana HF23 from its proposed commercial and
agricultural use as a pesticide to treat chicken manure or livestock
facilities is not anticipated.
In summary, the potential aggregate exposure as a result of the use
of the pesticidal active ingredient Beauveria bassiana HF23 is not
likely to pose a hazard via aggregate exposure. This includes potential
hazards derived from (i.) dietary exposure from the treated food/feed
commodities, (ii.) drinking water potentially exposed secondary to
treatment of sites with this pesticide; and (iii.) dermal and
inhalation non-occupational exposure of populations exposed to
Beauveria bassiana HF23.
V. Cumulative Effects
Three other Beauveria bassiana strains are registered. While they
show the same mechanism as entomopathogens, they are involved in
treatments of specific target pests. In this instance, Beauveria
bassiana HF23 is directed against the public health hazard, houseflies.
Because Beauveria bassiana HF23 does not operate via a toxic mechanism,
section 408(b)(2)(D)(v) does not apply. In any event, since none of the
registered strains are toxic, infective or pathogenic to humans and
other mammals or other non-target organisms, cumulative adverse health
or environmental effects of Beauveria bassiana HF23 are not expected.
VI. Determination of Safety for U.S. Population, Infants and Children
The Agency has concluded that there is a reasonable certainty that
no harm will result from aggregate exposures to Beauveria bassiana HF23
in or on all food commodities, when the pesticide is used to treat
manure in chicken and livestock facilities, which manure will in turn
be used as fertilizer on agricultural crops. The Agency bases this
conclusion on the data that demonstrate this substance has little to no
toxicity or infectivity. Based on all the available information, the
Agency concludes that the fungus, Beauveria 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
Beauveria 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 exposure (safety) approach to
assess the safety of Beauveria bassiana HF23.
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, 72 FR 1177, January 10, 2007.
B. Analytical Method(s)
See Federal Register, 72 FR 1177, January 10, 2007.
C. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of
Beauveria bassiana HF23 on all food commodities.
VIII. Conclusions
In summary, the Agency has determined that, based on available data
[[Page 10190]]
and information, there is a reasonable certainty of no harm from
aggregate exposure to Beauveria bassiana HF23 on all food commodities,
resulting either from its use (in accordance with all label direction
and good agricultural practices) in chicken and livestock facilities or
as a result of the subsequent use of treated manure from livestock and
chicken facilities as fertilizer on agricultural crops. Thus, an
exemption from the requirement of a tolerance is being granted for
residues of Beauveria bassiana HF23 on all food commodities in response
to pesticide petition PP 8F7467.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 25, 2010.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180.1273 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In subpart D, revise Sec. 180.1273 to read as follows:
Sec. 180.1273. Beauveria bassiana HF23; exemption from the
requirement of a tolerance.
Residues of Beauveria bassiana HF23 are exempt from the requirement
of a tolerance on all food/feed commodities, when the pesticide is used
for the treatment of chicken and livestock facilities, including the
treatment of chicken and livestock manure.
[FR Doc. 2010-4544 Filed 3-4-10; 8:45 am]
BILLING CODE 6560-50-S