Methoxyfenozide; Pesticide Tolerance, 32849-32853 [E6-8828]
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Federal Register / Vol. 71, No. 109 / Wednesday, June 7, 2006 / Rules and 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.
Commodity
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0.1
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SUPPLEMENTARY INFORMATION:
BILLING CODE 6560–50–S
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0404; FRL–8069–5]
Methoxyfenozide; Pesticide Tolerance
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).
AGENCY:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 24, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.361 is amended by
alphabetically adding a commodity to
the table in paragraph (a) to read as
follows:
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I
§ 180.361 Pendimethalin; tolerances for
residues.
(a) * * *
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FOR FURTHER INFORMATION CONTACT:
Mark Suarez, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–0120; e-mail
address:suarez.mark@epa.gov.
[FR Doc. E6–8830 Filed 6–6–06; 8:45 am]
VII. Congressional Review Act
List of Subjects in 40 CFR Part 180
32849
Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
tolerance for residues of
methoxyfenozide in or on soybean
aspirated grain fractions, soybean
forage, soybean hay, soybean hulls, and
soybean seed. Dow AgroSciences
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective June
7, 2006. Objections and requests for
hearings must be received on or before
August 7, 2006, 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–2006–0404. 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
athttps://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.
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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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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 underFOR 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 https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings
athttps://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 https://
www.gpoaccess.gov/ecfr.
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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–2006–0404 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 August 7, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0404, 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 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.
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II. Background and Statutory Findings
In the Federal Register of August 13,
2004 (69 FR 50192) (FRL–7364–9), 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 petition (PP 3F6794) by
DowAgroSciences, 9330 Zionsville Road
308–2E225, Indianapolis, IN 46268–
1054. The petition requested that 40
CFR 180.544 be amended by
establishing a tolerance for residues of
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the insecticide methoxyfenozide per se;
benzoic acid, 3-methoxy-2-methyl-, 2(3,5-dimethylbenzoyl)-2-(1,1dimethylethyl) hydrazide, in or on
soybean aspirated grain at 200 parts per
million (ppm), soybean forage at 45
ppm, soybean hay at 65 ppm, soybean
hulls at 3.0 ppm, soybean meal at 0.1
ppm, soybean oil at 1.0 ppm, and
soybean seed at 2.0 ppm. That notice
included a summary of the petition
prepared by Dow AgroSciences, the
registrant. There were no comments
received in response to the notice of
filing.
The registrant subsequently revised
Section F of the petition to concur with
the tolerances found to be supported by
the Agency based on the available data
used for the risk assessment. In the
revised Section F, Dow AgroSciences
requested that 40 CFR 180.544 be
amended by establishing a tolerance for
residues of the insecticide
methoxyfenozide per se; benzoic acid,
3-methoxy-2-methyl-, 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)
hydrazide, in or on soybean aspirated
grain at 160 ppm, soybean forage at 30
ppm, soybean hay at 80 ppm, soybean
hulls at 2.0 ppm, and soybean seed at
1.0 ppm.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(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. Section
408(b)(2)(C) of FFDCA requires 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. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of FFDCA
and a complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
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III. Aggregate Risk Assessment and
Determination of Safety
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. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
methoxyfenozide on soybean aspirated
grain at 160 ppm, soybean forage at 30
ppm, soybean hay at 80 ppm, soybean
hulls at 2.0 ppm, and soybean seed at
1.0 ppm. EPA’s assessment of exposures
and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies 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. Specific
informationon the studies received and
the nature of the toxic effects caused by
methoxyfenozide as well as the no
observed adverse effect level (NOAEL)
and the lowest observed adverse effect
level (LOAEL) from the toxicity studies
can be found at https://www.epa.gov/
EPA-PEST/2002/September/Day-20/
p23996.htm.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
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additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for methoxyfenozide used for
human risk assessment is shown in
Table 1 of this unit:
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR METHOXYFENOZIDE FOR USE IN HUMAN RISK
ASSESSMENT
Exposure/Scenario
Dose (mg/kg/day)
Acute dietary
None
Endpoint
Study
No appropriate endpoint was identified
in the oral toxicity studies including
the acute neurotoxicity study in rats
and thedevelopmental toxicity studies
in rats and rabbits
UF = N/A
None
Acute RfD = Not Applicable
Chronic dietary (Non cancer)
NOAEL = 10.2 mg/kg/day
Hematological changes (decreased
RBC, hemoglobin and/or hematocrit),
liver toxicity (increased weights, hypertrophy), histopathological changes
in thyroid (increased follicular cell hypertrophy, altered colloid), possible
adrenal toxicity (increased weights).
All population subgroups
UF =100 FQPA = 1X
Chronic RfD = 0.10 mg/kg/day Chronic Population Adjusted Dose
(cPAD) = 0.10 mg/kg/day This cPAD applies to All population subgroups.
Short-Term, Intermediate- Term,
and Long-Term (Dermal)
None
No systemic toxicity was seen at the
limit dose following repeated dermal
application to rats
None
Short-Term,
Intermediate-Term,
and Long-Term (Inhalation)
None
Based on low vapor pressure, the low
acute toxicity of both the technical
and formulated products as well as
the application rate and application
method, there is minimal concern for
inhalation exposure.
None
Cancer
None
Methoxyfenozide has been classified as
‘‘not likely to be a human carcinogen.’’ The classification is based
on the lack of evidence of carcinogenicity in male and female rats as
well as in male and female mice and
on the lack of genotoxicity in an acceptable battery of mutagenicity studies
None
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.544) for the
residues of methoxyfenozide, in or on a
variety of raw agricultural commodities,
animal (cattle, goat, hog, horse, poultry,
and sheep) meats and fats, and milk.
Risk assessments were conducted by
EPA to assess dietary exposures from
methoxyfenozide in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure. No appropriate endpoint was
identified in the oral toxicity studies
including the acute neurotoxicity study
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in rats and the developmental toxicity
studies in rats and rabbits. Therefore,
acute dietary exposure assessments
were not conducted.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), which incorporates
food consumption data as reported by
respondents in the USDA 1994–1996
and 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to
the chemical for each commodity. The
following assumptions were made for
the chronic exposure assessments:
Drinking water will contain the highest
estimate drinking water concentration
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2—Year combined
chronic feeding/carcinogenicity, rats
(EDWC), 100% of all existing and
proposed crops are treated, and all
resulting residues are at tolerance levels.
iii. Cancer. Because methoxyfenozide
has been classified as ‘‘not likely to be
a human carcenogen,’’ an exposure
assessment for the purpose of assessing
cancer risk is not needed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
methoxyfenozide in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
methoxyfenozide. Further information
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regarding EPA drinking water models
used in pesticide exposure assessment
is discussed in Unit III.C.2 of the final
rule previously published in the Federal
Register of July 5, 2000 (65 FR 41355)
(FRL–6496–5).
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System and Screening Concentrations in
Groundwater models, the estimated
environmental concentrations (EECs) of
methoxyfenozide for acute exposures
are estimated to be 43 parts per billion
(ppb) for surface water and 3.5 ppb for
ground water. The EECs for chronic
exposures are estimated to be 30 ppb,
based on surface water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Methoxyfenozide is not registered for
use on any sites that would result in
residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
methoxyfenozide and any other
substances and methoxyfenozide does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
methoxyfenozide has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website athttps://www.epa.gov/
pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
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additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a margin of exposure analysis or
through using uncertainty (safety)
factors in calculating a dose level that
poses no appreciable risk to humans. In
applying this provision, EPA either
retains the default value of 10X when
reliable data do not support the choice
of a different factor, or, if reliable data
are available, EPA uses a different
additional safety factor value based on
the use of traditional uncertainty factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There is no evidence of prenatal or
postnatal sensitivity, as discussed in
Unit IV.C. of the final rule previously
published in the Federal Register of
August 31, 2005 (70 FR 51597) (FRL–
7732–3).
3. Conclusion. There is a complete
toxicity data base formethoxyfenozide
and exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. The
Agency has determined that the FQPA
Safety Factor can be reduced to 1X in
assessing the risk posed by this
chemical. The basis for this
determination is discussed in Unit
IV.C.5 of the final rule previously
published in the Federal Register of
August 31, 2005.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. No appropriate
endpoint was identified in the oral
toxicity studies including the acute
neurotoxicity study in rats and the
developmental toxicity studies in rats
and rabbits. Therefore, no acute dietary
risk is expected.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to methoxyfenozide from
food and drinking water will utilize
23% of the cPAD for the U.S.
population, 32% of the cPAD for all
infants <1-year old, and 56% of the
cPAD for children 1-2 years old, the
highest exposed subgroup. There are no
residential uses for methoxyfenozide
that result in chronic residential
exposure to methoxyfenozide.
3. Short-term and Intermediate-term
risk. Short-term and intermediate-term
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aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Methoxyfenozide is not registered for
use on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which does not exceed
the Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. Methoxyfenozide has been
classified as ‘‘not likely’’ to be a human
carcinogen. The classification is based
on the lack of evidence of
carcinogenicity in male and female rats
as well as in male and female mice and
on the lack of genotoxicity in an
acceptable battery of mutagenicity
studies. Therefore, methoxyfenozide is
not expected to pose a cancer risk.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to
methoxyfenozide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(TR 34–00–28) was previously
developed by Rohm and Haas; high
performance liquid chromatography
(HPLC) with positive ion electrospray
(E.I.) tandem mass spectrometry (LC/
MS/MS)) is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed
Codex, Canadian, or Mexican limits for
residues of methoxyfenozide in or on
plant or animal commodities. Therefore,
no compatibility issues exist regarding
the proposed U.S. tolerances.
V. Conclusion
Therefore, the tolerance is established
for residues of methoxyfenozide per se;
benzoic acid, 3-methoxy-2-methyl-2(3,5- dimethylbenzoyl)-2-(1,1dimethylethyl)hydrazide, in or on
soybean aspirated grain at 160 ppm,
soybean forage at 30 ppm, soybean hay
at 80 ppm, soybean hulls at 2.0 ppm,
and soybean seeds at 1.0 ppm. The
original petition (PP 3F6794) and notice
of filing (Docket identification number
OPP–2004–0184) contained additional
proposed tolerances for soybean, oil and
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soybean, meal. Dow AgroSciences the
registrant submitted a revised Section F
of the petition for the removal of
soybean, oil and soybean, meal from the
tolerance expression.
VI. 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 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 FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
VerDate Aug<31>2005
19:09 Jun 06, 2006
Jkt 208001
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. 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
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
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: May 22, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.544 is amended by
alphabetically adding commodities to
the table in paragraph (a)(1) to read as
follows:
I
§ 180.544 Methoxyfenozide; tolerances for
residues.
(a) General. (1) *
*
*
Parts per
million
Commodity
*
*
*
*
Soybean, aspirated grain fractions .......................................
Soybean, forage .......................
Soybean, hay ............................
Soybean, hulls ..........................
Soybean, seed ..........................
*
*
*
*
*
*
*
*
*
160
30
80
2.0
1.0
*
*
[FR Doc. E6–8828 Filed 6–6–06; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 06–1051; MB Docket No. 05–108; RM–
11178]
Radio Broadcasting Services; Andover
and Haverhill, MA
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: The Audio Division, at the
request of Beanpot Broadcasting Corp.,
licensee of Station WXRV(FM), Channel
223B, Haverhill, Massachusetts, deletes
Channel 223B at Haverhill,
E:\FR\FM\07JNR1.SGM
07JNR1
Agencies
[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Rules and Regulations]
[Pages 32849-32853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8828]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0404; FRL-8069-5]
Methoxyfenozide; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
methoxyfenozide in or on soybean aspirated grain fractions, soybean
forage, soybean hay, soybean hulls, and soybean seed. Dow AgroSciences
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective June 7, 2006. Objections and
requests for hearings must be received on or before August 7, 2006, 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-2006-0404. 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 athttps://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: Mark Suarez, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-0120; e-mail address:suarez.mark@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 underFOR 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 https://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings athttps://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 https://
www.gpoaccess.gov/ecfr.
[[Page 32850]]
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-2006-0404 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 August 7, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0404, 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
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 August 13, 2004 (69 FR 50192) (FRL-7364-
9), 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 petition (PP
3F6794) by DowAgroSciences, 9330 Zionsville Road 308-2E225,
Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.544
be amended by establishing a tolerance for residues of the insecticide
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean
aspirated grain at 200 parts per million (ppm), soybean forage at 45
ppm, soybean hay at 65 ppm, soybean hulls at 3.0 ppm, soybean meal at
0.1 ppm, soybean oil at 1.0 ppm, and soybean seed at 2.0 ppm. That
notice included a summary of the petition prepared by Dow AgroSciences,
the registrant. There were no comments received in response to the
notice of filing.
The registrant subsequently revised Section F of the petition to
concur with the tolerances found to be supported by the Agency based on
the available data used for the risk assessment. In the revised Section
F, Dow AgroSciences requested that 40 CFR 180.544 be amended by
establishing a tolerance for residues of the insecticide
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean
aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80
ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires 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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
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. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of methoxyfenozide on
soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean
hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific informationon the studies received and the nature of
the toxic effects caused by methoxyfenozide as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at https://
www.epa.gov/EPA-PEST/2002/September/Day-20/p23996.htm.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of
[[Page 32851]]
additional cancer cases. More information can be found on the general
principles EPA uses in risk characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological endpoints for methoxyfenozide used
for human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Methoxyfenozide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Exposure/Scenario Dose (mg/kg/day) Endpoint Study
----------------------------------------------------------------------------------------------------------------
Acute dietary None No appropriate endpoint None
was identified in the
oral toxicity studies
including the acute
neurotoxicity study in
rats and
thedevelopmental
toxicity studies in
rats and rabbits
--------------------------------------------------------------------------
UF = N/A Acute RfD = Not Applicable
----------------------------------------------------------------------------------------------------------------
Chronic dietary (Non cancer) NOAEL = 10.2 mg/kg/day Hematological changes 2--Year combined
(decreased RBC, chronic feeding/
hemoglobin and/or carcinogenicity, rats
hematocrit), liver
toxicity (increased
weights, hypertrophy),
histopathological
changes in thyroid
(increased follicular
cell hypertrophy,
altered colloid),
possible adrenal
toxicity (increased
weights).
--------------------------------------------------------------------------
All population subgroups UF =100 FQPA = 1X Chronic RfD = 0.10 mg/kg/day Chronic Population
Adjusted Dose (cPAD) = 0.10 mg/kg/day This cPAD
applies to All population subgroups.
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate- Term, and None No systemic toxicity None
Long-Term (Dermal) was seen at the limit
dose following
repeated dermal
application to rats
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term, and None Based on low vapor None
Long-Term (Inhalation) pressure, the low
acute toxicity of both
the technical and
formulated products as
well as the
application rate and
application method,
there is minimal
concern for inhalation
exposure.
----------------------------------------------------------------------------------------------------------------
Cancer None Methoxyfenozide has None
been classified as
``not likely to be a
human carcinogen.''
The classification is
based on the lack of
evidence of
carcinogenicity in
male and female rats
as well as in male and
female mice and on the
lack of genotoxicity
in an acceptable
battery of
mutagenicity studies
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.544) for the residues of methoxyfenozide, in or
on a variety of raw agricultural commodities, animal (cattle, goat,
hog, horse, poultry, and sheep) meats and fats, and milk. Risk
assessments were conducted by EPA to assess dietary exposures from
methoxyfenozide in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No appropriate endpoint was
identified in the oral toxicity studies including the acute
neurotoxicity study in rats and the developmental toxicity studies in
rats and rabbits. Therefore, acute dietary exposure assessments were
not conducted.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: Drinking water will contain the highest estimate drinking
water concentration (EDWC), 100% of all existing and proposed crops are
treated, and all resulting residues are at tolerance levels.
iii. Cancer. Because methoxyfenozide has been classified as ``not
likely to be a human carcenogen,'' an exposure assessment for the
purpose of assessing cancer risk is not needed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for methoxyfenozide in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of methoxyfenozide. Further information
[[Page 32852]]
regarding EPA drinking water models used in pesticide exposure
assessment is discussed in Unit III.C.2 of the final rule previously
published in the Federal Register of July 5, 2000 (65 FR 41355) (FRL-
6496-5).
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System and Screening Concentrations in Groundwater models, the
estimated environmental concentrations (EECs) of methoxyfenozide for
acute exposures are estimated to be 43 parts per billion (ppb) for
surface water and 3.5 ppb for ground water. The EECs for chronic
exposures are estimated to be 30 ppb, based on surface water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Methoxyfenozide is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to methoxyfenozide and any
other substances and methoxyfenozide does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that methoxyfenozide
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website athttps://www.epa.gov/pesticides/
cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence of
prenatal or postnatal sensitivity, as discussed in Unit IV.C. of the
final rule previously published in the Federal Register of August 31,
2005 (70 FR 51597) (FRL-7732-3).
3. Conclusion. There is a complete toxicity data base
formethoxyfenozide and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. The
Agency has determined that the FQPA Safety Factor can be reduced to 1X
in assessing the risk posed by this chemical. The basis for this
determination is discussed in Unit IV.C.5 of the final rule previously
published in the Federal Register of August 31, 2005.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No appropriate endpoint was identified in the oral
toxicity studies including the acute neurotoxicity study in rats and
the developmental toxicity studies in rats and rabbits. Therefore, no
acute dietary risk is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
methoxyfenozide from food and drinking water will utilize 23% of the
cPAD for the U.S. population, 32% of the cPAD for all infants <1-year
old, and 56% of the cPAD for children 1-2 years old, the highest
exposed subgroup. There are no residential uses for methoxyfenozide
that result in chronic residential exposure to methoxyfenozide.
3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Methoxyfenozide is not registered for use
on any sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which does
not exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Methoxyfenozide has
been classified as ``not likely'' to be a human carcinogen. The
classification is based on the lack of evidence of carcinogenicity in
male and female rats as well as in male and female mice and on the lack
of genotoxicity in an acceptable battery of mutagenicity studies.
Therefore, methoxyfenozide is not expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to methoxyfenozide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (TR 34-00-28) was previously
developed by Rohm and Haas; high performance liquid chromatography
(HPLC) with positive ion electrospray (E.I.) tandem mass spectrometry
(LC/MS/MS)) is available to enforce the tolerance expression. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex, Canadian, or Mexican
limits for residues of methoxyfenozide in or on plant or animal
commodities. Therefore, no compatibility issues exist regarding the
proposed U.S. tolerances.
V. Conclusion
Therefore, the tolerance is established for residues of
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on soybean
aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80
ppm, soybean hulls at 2.0 ppm, and soybean seeds at 1.0 ppm. The
original petition (PP 3F6794) and notice of filing (Docket
identification number OPP-2004-0184) contained additional proposed
tolerances for soybean, oil and
[[Page 32853]]
soybean, meal. Dow AgroSciences the registrant submitted a revised
Section F of the petition for the removal of soybean, oil and soybean,
meal from the tolerance expression.
VI. 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 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 FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. 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: May 22, 2006.
Lois Rossi,
Director, Registration 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 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.544 is amended by alphabetically adding commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.544 Methoxyfenozide; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Soybean, aspirated grain fractions......................... 160
Soybean, forage............................................ 30
Soybean, hay............................................... 80
Soybean, hulls............................................. 2.0
Soybean, seed.............................................. 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-8828 Filed 6-6-06; 8:45 am]
BILLING CODE 6560-50-S