Novaluron; Pesticide Tolerance, 17009-17014 [06-3261]
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Federal Register / Vol. 71, No. 65 / Wednesday, April 5, 2006 / Rules and Regulations
(i) Sulfur dioxide (SO2) in all PM2.5
nonattainment and maintenance areas,
(ii) Nitrogen oxides in all PM2.5
nonattainment and maintenance areas
unless both the State and EPA
determine that it is not a significant
precursor, and
(iii) Volatile organic compounds
(VOC) and ammonia (NH3) only in PM2.5
nonattainment or maintenance areas
where either the State or EPA
determines that they are significant
precursors.
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*
*
*
*
I 6. Section 93.153 is amended by
revising paragraph (b) to read as follows:
§ 93.153
Applicability analysis.
*
*
*
*
*
(b) For Federal actions not covered by
paragraph (a) of this section, a
conformity determination is required for
each criteria pollutant or precursor
where the total of direct and indirect
emissions of the criteria pollutant or
precursor in a nonattainment or
maintenance area caused by a Federal
action would equal or exceed any of the
rates in paragraphs (b)(1) or (2) of this
section.
(1) For purposes of paragraph (b) of
this section, the following rates apply in
nonattainment areas (NAA’s):
Tons/
year
Ozone (VOC’s or NOX):
Serious NAA’s ...............................
Severe NAA’s ................................
Extreme NAA’s ..............................
Other ozone NAA’s outside an
ozone transport region ..............
Other ozone NAA’s inside an ozone
transport region:
VOC ..............................................
NOX ...............................................
Carbon monoxide: All NAA’s ............
SO2 or NO2: All NAA’s .....................
PM–10:
Moderate NAA’s ............................
Serious NAA’s ...............................
PM2.5:
Direct emissions ............................
SO2 ................................................
NOX (unless determined not to be
significant precursors) ...............
VOC or ammonia (if determined to
be significant precursors) ..........
Pb: All NAA’s ....................................
50
25
10
100
50
100
100
100
100
70
100
100
100
100
25
*
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*
*
(2) For purposes of paragraph (b) of
this section, the following rates apply in
maintenance areas:
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*
Tons/
year
Ozone (NOX, SO2 or NO2): All Maintenance Areas ...............................
Ozone (VOC’s):
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100
Tons/
year
Maintenance areas inside an
ozone transport region ..............
Maintenance areas outside an
ozone transport region ..............
Carbon monoxide: All Maintenance
Areas .............................................
PM–10: All Maintenance Areas ........
PM2.5:
Direct emissions ............................
SO2 ................................................
NOX (unless determined not to be
significant precursors) ...............
VOC or ammonia (if determined to
be significant precursors) ..........
Pb: All Maintenance Areas ...............
*
*
*
*
50
100
100
100
100
100
100
100
25
*
[FR Doc. 06–3311 Filed 4–4–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0525; FRL–7756–8]
Novaluron; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of novaluron in or
on brassica, head and stem, subgroup
5A. Interregional Research Project
Number 4 (IR-4) 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 April
5, 2006. Objections and requests for
hearings must be received on or before
June 5, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
OPP–2005–0525. All documents are
listed on the www.regulations.gov web
site. (EDOCKET, EPA’s electronic public
docket and comment system was
replaced on November 25, 2005, by an
enhanced federal-wide electronic docket
management and comment system
located at https://www.regulations.gov/.
Follow the on-line
instructions.)Although listed in the
index, some information is not publicly
available, i.e., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
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17009
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in
EDOCKET or in hard copy at the Public
Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1801 S. Bell St., Arlington, VA. This
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:
Shaja R. Brothers, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–3194; e-mail
address:brothers.shaja@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 under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET https://
www.epa.gov/edocket/, you may access
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Federal Register / Vol. 71, No. 65 / Wednesday, April 5, 2006 / Rules and Regulations
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two athttps://
www.gpoaccess.gov/ecfr/.
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II. Background and Statutory Findings
In the Federal Register of January 18,
2006 (71 FR 2927) (FRL–7756–8), 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 4E6834) by IR-4,
681 U.S. Highway #1 South, North
Brunswick, NJ 08902–3390. The petition
requested that 40 CFR 180.598 be
amended by establishing a tolerance for
residues of the insecticide novaluron,
[(N [[[3-chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide), in or on brassica,
head and stem, subgroup 5A at 0.50
parts per million (ppm). That notice
included a summary of the petition
prepared by Makhteshim-Agan of North
America, Inc., the registrant. There were
no comments received in response to
the notice of filing.
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 the
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
novaluron on brassica, head and stem,
subgroup 5A at 0.50 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
information on the studies received and
the nature of the toxic effects caused by
novaluron 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/EPAPEST/2004/June/Day-02/p12316.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
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
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characterization athttps://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for novaluron used for human
risk assessment is discussed in Unit
III.B. of the final rule published in
theFederal Register of June 2, 2004 (69
FR 31013) (FRL–7359–2).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.598) for the
residues of novaluron, in or on the
following raw agricultural commodities:
Apple, wet pomace at 8.0; cattle, fat at
11 ppm; cattle, kidney at 1.0 ppm;
cattle, liver at 1.0 ppm; cattle, meat at
0.60 ppm; cattle, meat byproducts,
except liver and kidney at 0.60 ppm;
cotton, gin byproducts at 30 ppm;
cotton, undelinted seed at 0.60 ppm;
eggs at 0.05 ppm; fruit, pome, group 11
at 2.0 ppm; goat, fat at 11 ppm; goat,
kidney at 1.0 ppm; goat, liver at 1.0
ppm; goat, meat at 0.60 ppm; goat, meat
byproducts except liver and kidney at
0.60 ppm; hog, fat at 0.05 ppm; hog,
meat at 0.01 ppm; hog, meat byproducts
at 0.01 ppm; horse, fat at 11 ppm; horse,
kidney at 1.0 ppm; horse, liver at 1.0
ppm; horse, meat at 0.60 ppm; horse,
meat byproducts, except liver and
kidney at 0.60 ppm; milk at 1.0 ppm;
milk, fat at 20 ppm; poultry, fat at 0.40
ppm; poultry, meat at 0.03 ppm;
poultry, meat byproducts at 0.04 ppm;
sheep, fat at 11 ppm; sheep, kidney at
1.0 ppm; sheep, liver at 1.0 ppm; sheep,
meat at 0.60 ppm; sheep, meat
byproducts, except liver and kidney at
0.60 ppm, and vegetables, tuberous and
corn, subgroup 1C at 0.05 ppm. Risk
assessments were conducted by EPA to
assess dietary exposures from novaluron
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 such effects were identified in the
toxicological studies for novaluron;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
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 United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
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exposure to the chemical for each
commodity. The following assumptions
were made for the chronic exposure
assessments: 100% crops treated for all
commodities; average field trial
residues; empirical processing factors
for apple juice (translated to pear juice);
and DEEMTM (ver 7.76) default
processing factors for the remaining
processed commodities. Furthermore,
anticipated residues (ARs) were
calculated for meat and milk
commodities and the recommended
tolerances were used for poultry
commodities (partially refined, Tier II
analysis).
iii. Cancer. A cancer dietary exposure
assessment was not conducted because
novaluron was classified as ‘‘not likely
to be carcinogenic to humans.’’
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of the FFDCA authorizes
EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide chemicals
that have been measured in food. If EPA
relies on such information, EPA must
pursuant to section 408(f)(1) require that
data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. Following the initial data
submission, EPA is authorized to
require similar data on a time frame it
deems appropriate. For the present
action, EPA will issue such Data CallIns for information relating to
anticipated residues as are required by
FFDCA section 408(b)(2)(E) and
authorized under FFDCA section
408(f)(1). Such Data Call-Ins will be
required to be submitted no later than
5 years from the date of issuance of this
tolerance.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
novaluron 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
novaluron. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found athttps://www.epa.gov/
oppefed1/models/water/index.htm.
Tier 2 Pesticide Root Zone Model/
Exposure Analysis Modeling System
(PRZM/EXAMS) modeling was
performed to estimate drinking water
concentrations for surface water for
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novaluron per se. The scenarios were
selected to provide high-end drinking
water concentrations for each crop and
represent the geographic locations
where the specific crops are grown in
large quantities.
The most-conservative estimates were
obtained for airblast applications to
Pennsylvania apples at the maximum
annual application rate of 0.96 pound
active ingredient/acre (lb a.i./acre),
applied three times at 0.32 lb a.i./acre
with an interval between applications of
10 days.
For surface water, the 1-in-10 year
annual mean estimated drinking water
concern (EDWC) for the parent
novaluron is 1.8 micrograms/Liter (µg/L)
(ppb).
A Tier I drinking water analysis was
performed for the chlorophenyl urea
and chloroaniline degradates. The
FQPA Index Reservoir Screening Tool
(FIRST) model was used to obtain
surface water estimates. As a
conservative assumption, the model
assumed chlorophenyl urea was directly
applied, i.e., as granular, to the field,
assuming no spray drift and no foliar
interception. The FIRST model
estimates a peak and an annual average
value based on the Index Reservoir
scenario.
For surface water, the annual average
EDWC for chlorophenyl urea is 0.86 µg/
L (ppb) and the annual average EDWC
for chloroaniline is 2.6 µg/L (ppb). Both
of these estimates are based upon the
maximum application rate in apples.
For ground water, the screening
concentration in ground water (SCIGROW) model was used to predict a
ground water concentration for
novaluron at the annual application rate
of 0.96 lb a.i./acre (i.e., three
applications of 0.32 lb a.i./acre). The
estimate for the parent novaluron is 5.5
x 10-3 µg/L in drinking water from
shallow ground water sources. For the
chlorophenyl urea degradate, the
predicted ground water concentration is
4.5 x 10-3 µg/L, and for the chloroaniline
degradate the concentration is 9.0 x 10-3
µg/L. These concentrations were
estimated with the same assumptions
used for surface water modeling, and
may be considered as both the peak and
annual average upper bound exposures.
These EDWC values are meant to
represent upper-bound estimates of the
concentrations that might be found in
surface water and ground water based
upon existing and proposed uses. Of the
three EDWC values, chronic estimates
for the terminal metabolite,
chloroaniline are the highest (100%
conversion from parent to aniline was
assumed). This is consistent with the
expected degradation pattern for
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novaluron. Therefore, the EDWC value
for the chloroaniline degradate (2.6 ppb)
was used to assess chronic aggregate
risk.
Based on the FIRST, PRZM/EXAMS,
and SCI-GROW models, the estimated
environmental concentrations (EECs) of
novaluron for acute exposures are
estimated to be 1.8 parts per billion
(ppb) for novaluron, and 2.6 ppb for the
chloroaniline degradate for surface
water, respectively. The EECs for
chronic exposures are estimated to be
2.6 ppb surface water and 0.009 ppb
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM). For chronic dietary risk
assessment, the annual average
concentration of 2.6 ppb was used to
access the contribution to drinking
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).
Novaluron 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
novaluron and any other substances,
and novaluron 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 novaluron 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/.
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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 MOE 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 quantitative or qualitative
evidence of increased susceptibility of
rat and rabbit fetuses to in utero
exposure to novaluron in developmental
toxicity studies. There is no quantitative
or qualitative evidence of increased
susceptibility to novaluron following
prenatal/postnatal exposure in a 2generation reproduction study.
EPA determined that the 10X SF to
protect infants and children should be
reduced to 1X because of the following
reasons:
• There is no concern for
developmental neurotoxicity resulting
from exposure to novaluron. A
developmental neurotoxicity study
(DNT) study is not required.
• The toxicological database is
complete for FQPA assessment.
• Dietary assessments are estimated
based on data that reasonably accounts
for potential exposures. The chronic
dietary food exposure assessment uses
the conservative assumption that 100%
crops treated for all commodities.
• The dietary drinking water
assessment utilizes water concentration
values generated by model and
associated modeling parameters which
are designed to provide conservative,
health protective, high-end estimates of
water concentrations which will not
likely be exceeded.
• There are no proposed or existing
uses for novaluron which result in
residential exposure.
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E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
pesticide from food, drinking water, and
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
EDWCs. The DWLOC values are not
regulatory standards for drinking water,
but are theoretical upper limits on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food and residential
uses. In calculating a DWLOC, the
Agency determines how much of the
acceptable exposure (i.e., the population
adjusted dose (PAD)) is available for
exposure through drinking water e.g.,
allowable chronic water exposure
milligrams/kilogram/day (mg/kg/day) =
chronic PAD - (average food +
residential exposure). This allowable
exposure through drinking water is used
to calculate a DWLOC.
A DWLOC will vary depending on the
toxic endpoint, drinking water
consumption, and body weights. Default
body weights and consumption values
as used by the EPA’s Office of Water are
used to calculate DWLOCs: 2 liter(L)/70
kg (adult male), 2L/60 kg (adult female),
and 1L/10 kg (child). Different
populations will have different
DWLOCs. Generally, a DWLOC is
calculated for each type of risk
assessment used: Acute, short-term,
intermediate-term, chronic, and cancer.
When EDWCs for surface water and
ground water are less than the
calculated DWOCs, EPA can conclude
with reasonable certainty that exposures
to the pesticide in drinking water (when
considered along with other sources of
exposures for which EPA has reliable
data) would not result in unacceptable
levels of aggregate human health risk at
this time. Because EPA considers the
aggregate risk resulting from multiple
exposure pathways associated with a
pesticide’s uses, levels of comparison in
drinking water may vary as those uses
change. When new uses are added, EPA
reassesses the potential impacts of
residues of the pesticide in drinking
water as a part of the aggregate
assessment process.
More recently the Agency has used
another approach to estimate aggregate
exposure through food, residential and
drinking water pathways. In this
approach, modeled surface water and
ground water EDWCs are directly
incorporated into the dietary exposure
analysis, along with food. This provides
a more realistic estimate of exposure
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because actual body weights and water
consumption from the CSFII are used.
The combined food and water exposures
are then added to estimated exposure
from residential sources to calculate
aggregate risks. The resulting exposure
and risk estimates are still considered to
be high end, due to the assumptions
used in developing drinking water
modeling inputs.
1. Acute risk. 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 such effects were identified in the
toxicological studies for novaluron;
therefore, novaluron is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to novaluron from food
plus water will utilize 20% of the cPAD
for the U.S. population, 33% of the
cPAD for infants < 1 year old, and 71%
of the cPAD for children 1-2 years old.
There are no residential uses for
novaluron. Therefore, EPA does not
expect the aggregate exposure to exceed
100% of the cPAD.
3. Short-term risk/intermediate-term
risk.Short and intermediate-term
aggregate exposures take into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Novaluron 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 do not exceed the
Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. Novaluron is classified as
‘‘not likely to be carcinogenic to
humans’’ based on the lack of evidence
for carcinogenicity in mice and rats.
Therefore, novaluron 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 novaluron
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
Gas Chromatography/Electron Capture
Detection (GC/EDC) is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
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Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established
Codex, Canadian, or Mexican maximum
residue limits (MRLs) for novaluron.
V. Conclusion
Therefore, the tolerance is established
for residues of novaluron, [(N [[[3chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6difluorobenzamide), in or on brassica,
head and stem, subgroup 5A at 0.50
ppm.
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VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of FFDCA provides
essentially the same process for persons
to ‘‘object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0525 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 June 5, 2006.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issue(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
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evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit VI.A., you should also send a copy
of your request to the PIRIB for its
inclusion in the official record that is
described inADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0525, to: Public Information
and Records Integrity Branch,
Information Technology and Resource
Management Division (7502C), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001. In person or by courier, bring a
copy to the location of the PIRIB
described in ADDRESSES. You may also
send an electronic copy of your request
via e-mail to:opp-docket@epa.gov.
Please use an ASCII file format and
avoid the use of special characters and
any form of encryption. Copies of
electronic objections and hearing
requests will also be accepted on disks
in WordPerfect 6.1/8.0 or ASCII file
format. Do not include any CBI in your
electronic copy. You may also submit an
electronic copy of your request at many
Federal Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
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17013
uncontested claims or facts to the
contrary; and resolution of the factual
issue(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
VII. 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, entitledFederal 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,
entitledFederalism (64 FR 43255,
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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.
VIII. 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
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Jkt 208001
the Comptroller General of the United
States prior to publication of this final
rule in theFederal 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: March 27, 2006.
Losi Rossi,
Director, Registration Division, Office of
Pesticide Programs.
This final rule also increases the
tolerances for almond, hulls; pea and
bean, dried shelled, except soybean,
subgroup 6C; and strawberry. BASF
Corporation requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA).
This regulation is effective April
5, 2006. Objections and requests for
hearings must be received on or before
June 5, 2006.
DATES:
To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
I Therefore, 40 CFR chapter I is
INFORMATION. EPA has established a
amended as follows:
docket for this action under docket
PART 180—[AMENDED]
identification (ID) number EPA–HQ–
OPP–2004–0292. All documents in the
I 1. The authority citation for part 180
docket are listed on the regulations.gov
continues to read as follows:
website. (EDOCKET, EPA’s electronic
Authority: 21 U.S.C. 321(q), 346a and 371.
public docket and comment system was
replaced on November 25, 2005, by an
I 2. Section 180.598 is amended by
enhanced Federal-wide electronic
alphabetically adding the following
docket management and comment
commodity to the table in paragraph (a)
system located at https://
to read as follows:
www.regulations.gov. Follow the on-line
§ 180.598 Novaluron; tolerances for
instructions.) Although listed in the
residues.
index, some information is not publicly
(a) * * *
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Commodity
Parts per million
Certain other material, such as
copyrighted material, is not placed on
*
*
*
*
*
the Internet and will be publicly
Brassica, head and stem,
subgroup 5A
0.50 available only in hard copy form.
Publicly available docket materials are
*
*
*
*
*
available either electronically through
regulations.gov or in hard copy at the
[FR Doc. 06–3261 Filed 4–4–06; 8:45 am]
Public Information and Records
BILLING CODE 6560–50–S
Integrity Branch(PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This Docket Facility is
ENVIRONMENTAL PROTECTION
open from 8:30 a.m. to 4 p.m., Monday
AGENCY
through Friday, excluding legal
40 CFR Part 180
holidays. The Docket telephone number
is (703) 305–5805.
[EPA–HQ–OPP–2004–0292; FRL–7772–8]
Pyraclostrobin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
pyraclostrobin (carbamic acid, [2-[[[1-(4chlorophenyl)-1H-pyrazol-3yl]oxy]methyl]phenyl]methoxy-, methyl
ester) and its desmethoxy metabolite
(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3yl]oxy]methyl]phenylcarbamate),
expressed as parent compound, in or on
bean, succulent, shelled; legume
vegetables group, foliage, in crop group
7; mango (import); and papaya (import).
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ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Tony Kish, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9443; e-mail address:
kish.tony@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:
E:\FR\FM\05APR1.SGM
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Agencies
[Federal Register Volume 71, Number 65 (Wednesday, April 5, 2006)]
[Rules and Regulations]
[Pages 17009-17014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3261]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0525; FRL-7756-8]
Novaluron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
novaluron in or on brassica, head and stem, subgroup 5A. Interregional
Research Project Number 4 (IR-4) 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 April 5, 2006. Objections and
requests for hearings must be received on or before June 5, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0525. All documents are
listed on the www.regulations.gov web site. (EDOCKET, EPA's electronic
public docket and comment system was replaced on November 25, 2005, by
an enhanced federal-wide electronic docket management and comment
system located at https://www.regulations.gov/. Follow the on-line
instructions.)Although listed in the index, some information is not
publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail
address:brothers.shaja@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 under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET https://www.epa.gov/edocket/, you may
access
[[Page 17010]]
this Federal Register document electronically through the EPA Internet
under the ``Federal Register'' listings at https://www.epa.gov/fedrgstr/
. A frequently updated electronic version of 40 CFR part 180 is
available at E-CFR Beta Site Two athttps://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of January 18, 2006 (71 FR 2927) (FRL-7756-
8), 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
4E6834) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ
08902-3390. The petition requested that 40 CFR 180.598 be amended by
establishing a tolerance for residues of the insecticide novaluron, [(N
[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6-difluorobenzamide), in or on brassica, head
and stem, subgroup 5A at 0.50 parts per million (ppm). That notice
included a summary of the petition prepared by Makhteshim-Agan of North
America, Inc., the registrant. There were no comments received in
response to the notice of filing.
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 the 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 novaluron on
brassica, head and stem, subgroup 5A at 0.50 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 information on the studies received and the nature
of the toxic effects caused by novaluron 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/2004/June/Day-02/p12316.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 additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization athttps://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for novaluron used for
human risk assessment is discussed in Unit III.B. of the final rule
published in theFederal Register of June 2, 2004 (69 FR 31013) (FRL-
7359-2).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.598) for the residues of novaluron, in or on
the following raw agricultural commodities: Apple, wet pomace at 8.0;
cattle, fat at 11 ppm; cattle, kidney at 1.0 ppm; cattle, liver at 1.0
ppm; cattle, meat at 0.60 ppm; cattle, meat byproducts, except liver
and kidney at 0.60 ppm; cotton, gin byproducts at 30 ppm; cotton,
undelinted seed at 0.60 ppm; eggs at 0.05 ppm; fruit, pome, group 11 at
2.0 ppm; goat, fat at 11 ppm; goat, kidney at 1.0 ppm; goat, liver at
1.0 ppm; goat, meat at 0.60 ppm; goat, meat byproducts except liver and
kidney at 0.60 ppm; hog, fat at 0.05 ppm; hog, meat at 0.01 ppm; hog,
meat byproducts at 0.01 ppm; horse, fat at 11 ppm; horse, kidney at 1.0
ppm; horse, liver at 1.0 ppm; horse, meat at 0.60 ppm; horse, meat
byproducts, except liver and kidney at 0.60 ppm; milk at 1.0 ppm; milk,
fat at 20 ppm; poultry, fat at 0.40 ppm; poultry, meat at 0.03 ppm;
poultry, meat byproducts at 0.04 ppm; sheep, fat at 11 ppm; sheep,
kidney at 1.0 ppm; sheep, liver at 1.0 ppm; sheep, meat at 0.60 ppm;
sheep, meat byproducts, except liver and kidney at 0.60 ppm, and
vegetables, tuberous and corn, subgroup 1C at 0.05 ppm. Risk
assessments were conducted by EPA to assess dietary exposures from
novaluron 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 such effects were identified in the toxicological studies for
novaluron; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
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 United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated
[[Page 17011]]
exposure to the chemical for each commodity. The following assumptions
were made for the chronic exposure assessments: 100% crops treated for
all commodities; average field trial residues; empirical processing
factors for apple juice (translated to pear juice); and DEEM\TM\ (ver
7.76) default processing factors for the remaining processed
commodities. Furthermore, anticipated residues (ARs) were calculated
for meat and milk commodities and the recommended tolerances were used
for poultry commodities (partially refined, Tier II analysis).
iii. Cancer. A cancer dietary exposure assessment was not conducted
because novaluron was classified as ``not likely to be carcinogenic to
humans.''
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such Data Call-Ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such Data Call-Ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for novaluron 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 novaluron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found athttps://www.epa.gov/oppefed1/models/water/index.htm.
Tier 2 Pesticide Root Zone Model/Exposure Analysis Modeling System
(PRZM/EXAMS) modeling was performed to estimate drinking water
concentrations for surface water for novaluron per se. The scenarios
were selected to provide high-end drinking water concentrations for
each crop and represent the geographic locations where the specific
crops are grown in large quantities.
The most-conservative estimates were obtained for airblast
applications to Pennsylvania apples at the maximum annual application
rate of 0.96 pound active ingredient/acre (lb a.i./acre), applied three
times at 0.32 lb a.i./acre with an interval between applications of 10
days.
For surface water, the 1-in-10 year annual mean estimated drinking
water concern (EDWC) for the parent novaluron is 1.8 micrograms/Liter
([mu]g/L) (ppb).
A Tier I drinking water analysis was performed for the chlorophenyl
urea and chloroaniline degradates. The FQPA Index Reservoir Screening
Tool (FIRST) model was used to obtain surface water estimates. As a
conservative assumption, the model assumed chlorophenyl urea was
directly applied, i.e., as granular, to the field, assuming no spray
drift and no foliar interception. The FIRST model estimates a peak and
an annual average value based on the Index Reservoir scenario.
For surface water, the annual average EDWC for chlorophenyl urea is
0.86 [mu]g/L (ppb) and the annual average EDWC for chloroaniline is 2.6
[mu]g/L (ppb). Both of these estimates are based upon the maximum
application rate in apples.
For ground water, the screening concentration in ground water (SCI-
GROW) model was used to predict a ground water concentration for
novaluron at the annual application rate of 0.96 lb a.i./acre (i.e.,
three applications of 0.32 lb a.i./acre). The estimate for the parent
novaluron is 5.5 x 10-\3\ [mu]g/L in drinking water from
shallow ground water sources. For the chlorophenyl urea degradate, the
predicted ground water concentration is 4.5 x 10-\3\ [mu]g/
L, and for the chloroaniline degradate the concentration is 9.0 x
10-\3\ [mu]g/L. These concentrations were estimated with the
same assumptions used for surface water modeling, and may be considered
as both the peak and annual average upper bound exposures.
These EDWC values are meant to represent upper-bound estimates of
the concentrations that might be found in surface water and ground
water based upon existing and proposed uses. Of the three EDWC values,
chronic estimates for the terminal metabolite, chloroaniline are the
highest (100% conversion from parent to aniline was assumed). This is
consistent with the expected degradation pattern for novaluron.
Therefore, the EDWC value for the chloroaniline degradate (2.6 ppb) was
used to assess chronic aggregate risk.
Based on the FIRST, PRZM/EXAMS, and SCI-GROW models, the estimated
environmental concentrations (EECs) of novaluron for acute exposures
are estimated to be 1.8 parts per billion (ppb) for novaluron, and 2.6
ppb for the chloroaniline degradate for surface water, respectively.
The EECs for chronic exposures are estimated to be 2.6 ppb surface
water and 0.009 ppb ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For chronic
dietary risk assessment, the annual average concentration of 2.6 ppb
was used to access the contribution to drinking 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).
Novaluron 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 novaluron and any other
substances, and novaluron 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 novaluron 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/.
[[Page 17012]]
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
MOE 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 quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure to novaluron in developmental toxicity
studies. There is no quantitative or qualitative evidence of increased
susceptibility to novaluron following prenatal/postnatal exposure in a
2-generation reproduction study.
EPA determined that the 10X SF to protect infants and children
should be reduced to 1X because of the following reasons:
There is no concern for developmental neurotoxicity
resulting from exposure to novaluron. A developmental neurotoxicity
study (DNT) study is not required.
The toxicological database is complete for FQPA
assessment.
Dietary assessments are estimated based on data that
reasonably accounts for potential exposures. The chronic dietary food
exposure assessment uses the conservative assumption that 100% crops
treated for all commodities.
The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
There are no proposed or existing uses for novaluron which
result in residential exposure.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EDWCs. The DWLOC values are not
regulatory standards for drinking water, but are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the population adjusted dose (PAD)) is
available for exposure through drinking water e.g., allowable chronic
water exposure milligrams/kilogram/day (mg/kg/day) = chronic PAD -
(average food + residential exposure). This allowable exposure through
drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter(L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/
10 kg (child). Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EDWCs for surface water and ground water are less than the
calculated DWOCs, EPA can conclude with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. When new
uses are added, EPA reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This provides a more realistic estimate of exposure
because actual body weights and water consumption from the CSFII are
used. The combined food and water exposures are then added to estimated
exposure from residential sources to calculate aggregate risks. The
resulting exposure and risk estimates are still considered to be high
end, due to the assumptions used in developing drinking water modeling
inputs.
1. Acute risk. 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 such effects were identified in the toxicological studies for
novaluron; therefore, novaluron is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to novaluron
from food plus water will utilize 20% of the cPAD for the U.S.
population, 33% of the cPAD for infants < 1 year old, and 71% of the
cPAD for children 1-2 years old. There are no residential uses for
novaluron. Therefore, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD.
3. Short-term risk/intermediate-term risk.Short and intermediate-
term aggregate exposures take into account residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level). Novaluron 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 do not exceed the
Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Novaluron is
classified as ``not likely to be carcinogenic to humans'' based on the
lack of evidence for carcinogenicity in mice and rats. Therefore,
novaluron 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 novaluron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology Gas Chromatography/Electron
Capture Detection (GC/EDC) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch,
[[Page 17013]]
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 currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for novaluron.
V. Conclusion
Therefore, the tolerance is established for residues of novaluron,
[(N [[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6-difluorobenzamide), in or on brassica, head
and stem, subgroup 5A at 0.50 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0525 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 June 5,
2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described inADDRESSES. Mail your copies,
identified by docket ID number OPP-2005-0525, to: Public Information
and Records Integrity Branch, Information Technology and Resource
Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to:opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. 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, entitledFederal 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, entitledFederalism
(64 FR 43255,
[[Page 17014]]
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.
VIII. 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 theFederal 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: March 27, 2006.
Losi 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 180.598 is amended by alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.598 Novaluron; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Brassica, head and stem, subgroup 5A 0.50
* * * * *
------------------------------------------------------------------------
[FR Doc. 06-3261 Filed 4-4-06; 8:45 am]
BILLING CODE 6560-50-S