Document ID: EPA-HQ-OPP-2006-0822-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-10-20T04:00Z

EPA Registration Division contact: Barbara Madden 703-305-6463

 

Interregional Research Project Number 4 and Dow AgroSciences

PP# 6E7086

	EPA has received a pesticide petition (6E7086) from Interregional
Research Project #4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.544 by establishing
a tolerance for residues of methoxyfenozide in or on the raw
agricultural commodities Vegetable, tuberous and corm, except potato,
subgroup 1D at 0.02 parts per million (ppm); Bushberries subgroup 13B at
3.0 ppm; Juneberry at 3.0 ppm; Lingonberry at 3.0 ppm, Salal at 3.0 ppm;
Aronia berry at 3.0 ppm;  Blueberry, lowbush at 3.0 ppm; Buffalo currant
at 3.0 ppm; Chilean guava at 3.0 ppm; European barberry at 3.0 ppm;
Highbush cranberry at 3.0 ppm; Honeysuckle at 3.0 ppm; Jostaberry at 3.0
ppm; Native currant at 3.0 ppm; Sea buckthorn at 3.0 ppm; Bean, dry,
seed at 0.15 ppm; Grass, forage, fodder and hay, group 17, forage at
18.0 ppm; Grass, forage, fodder and hay, group 17, hay at 30.0 ppm;
Peanut at 0.02 ppm;  Peanut, hay at 60 ppm; Peanut, oil at 0.09 ppm. EPA
has determined that the petition contains data or information regarding
the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data supports granting of the petition. Additional
data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The qualitative nature of methoxyfenozide residues
in plants and animals is adequately understood and was previously
published in the Federal Register of July 5, 2000 (65 FR 41355)
(FRL-6497-5).

	2. Analytical method. Adequate enforcement methods are available for
determination of methoxyfenozide residues in plant commodities.  The
available Analytical Enforcement Methodology was previously reviewed in
the Federal Register of September 20, 2002 (67 FR 59193).

	3. Magnitude of residues. Complete residue data for methoxyfenozide on
sweet potato; blueberry; dry bean; grasses; and peanut have been
submitted by IR-4.   The requested tolerances are adequately supported.

B. Toxicological Profile

	1. Acute toxicity.  The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.)

	2. Genotoxicty. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.).

	3. Reproductive and developmental toxicity. The toxicological profile
and endpoints for methoxyfenozide which supports this petition to
establish tolerances were previously published in the Federal Register
of August 31, 2005 (70 FRL-7732-3.).

	4. Subchronic toxicity. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.)

	5. Chronic toxicity. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.)

	6. Animal metabolism. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.)

	7. Metabolite toxicology. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.)

	8. Endocrine disruption. The toxicological profile and endpoints for
methoxyfenozide which supports this petition to establish tolerances
were previously published in the Federal Register of August 31, 2005 (70
FRL-7732-3.).

C. Aggregate Exposure

	1. Dietary exposure. Assessments were conducted to evaluate potential
risks due to chronic and acute dietary exposure of the U.S. population
subgroups to residues of methoxyfenozide.  These analyses cover all
registered crops, as well as, uses pending with the Agency, active and
proposed section 18 uses, and proposed IR-4 minor uses.  There are no
registered residential nonfood uses of methoxyfenozide.

	i. Food. a.  Acute risk.  No appropriate toxicological endpoint
attributable to a single exposure was identified in the available
toxicology studies on methoxyfenozide including the acute neurotoxicity
study in rats, the developmental toxicity study in rats and the
developmental toxicity study in rabbits.  Since no acute toxicological
endpoints were established, the acute aggregate risk is expected to be
negligible. 

 

b.  Chronic assessments were conducted to evaluate potential risks due
to chronic dietary exposure of the U.S. population and selected
population subgroups to residues of methoxyfenozide.  These analyses
cover all registered crops, uses pending with the EPA, active and
proposed Section 18 uses and new proposed IR-4 uses.  Dow AgroSciences
used the Dietary Exposure Evaluation Model™ (DEEM-FCID, ver. 2.03,
Exponent, Inc., Washington, DC-20036) software for conducting a chronic
dietary (food) risk analysis.  DEEM is a dietary exposure analysis
system that is used to estimate exposure to a pesticide chemical in
foods comprising the diets of the U.S. population, including population
subgroups.  DEEM contains food consumption data as reported by
respondents in the USDA Continuing Surveys of Food Intake by Individuals
(CSFII) conducted in 1994-1996 and 1998 and food translation to RACs, as
indicated by EPA/USDA FCID recipe set as of August, 2002.  Dow
AgroSciences assumed for a tier-I analysis that 100% of crops would be
treated and will contain methoxyfenozide residues at the tolerance
level.   

The dietary exposure analysis is proceeding from Intrepid® current and
proposed labels, assuming the worst case use patterns, summarized in
Section B – Amount, Frequency and Time of Application of
Methoxyfenozide, of the current NOF.   

 

Some of the currently proposed uses are involving crops commonly used as
feed for livestock: grass, forage and hay, and peanut hay.  Therefore,
an estimated animal dietary burden was conducted, in order to confirm
that the new uses proposed on grass and peanut will not trigger residue
levels above the current tolerances on meat and poultry food
commodities.  The methodology used by Dow AgroSciences followed EPA’s
OPPTS 860.1000 guidelines for residue chemistry test guidelines (ref. 5
).  A summary of the estimated dietary intake for beef and dairy cattle,
and also for poultry, is presented in Table 1.  

 Table 1.  Estimated Dietary Intake for Beef and Dairy Cattle and
Poultry from Methoxyfenozide’s Current and Proposed Uses on Feed-crops

 

 The maximum total intake estimated from all existing and proposed used
on field feed crops was compared with the doses tested in the feeding
study conducted by Rohm & Haas with methoxyfenozide on dairy cattle
(TR-34-98-95) and submitted previously to the agency.  Residue were
calculated in milk (cream and skim), muscle, fat, liver and kidney of
dairy cattle by extrapolating residues on dairy cattle from the dose
tested at 53.6 ppm and for beef cattle from the dose tested at 183 ppm. 
All residue levels in muscle, fat, liver, kidney and milk were found to
be below the current tolerances for all meat commodities.  A summary of
the residue estimated by this assessment in meat, fat, kidney and milk
of dairy and beef cattle is presented in Table 2. 

  

Table 2. Estimated Residue in Dairy and Beef Food Commodities from
Current and Proposed Uses of Methoxyfenozide on Feed-crops 

 

Feeding Study ( TR-34-98-95) 	 	 	 	 	 	 

 	 	 	 	 	 	 	 

Dairy Cattle 	  	  	 	 	 	 	 

 	MILK 	CREAM 	Skim milk 	Muscle 	* Kidney  	* Liver 	Fat 

 	 	 	 	 	 	 	 

Dose (ppm) 	mean 	mean 	mean 	mean 	mean 	mean 	mean 

0 	0 	0 	0 	0 	0 	0 	0 

16.5 	0.003 	 	 	ND 	ND 	0.02 	ND 

53.6 	0.004 	 	 	ND 	0.01 	0.066 	0.008 

183 	0.028 	0.12 	0.005 	0.007 	0.068 	0.276 	0.041 

 

74.5 

 

 

 	0.00556 	0 	0 	0.002 	0.014 	0.091735 	0.011 

118.6 	0.018 	0.078 	0.003 	0.005 	0.044 	0.178872 	0.027 

 	 	 	 	 	 	 	 

US – Tolerance 	0.1 	0.1 	0.1 	0.02 	0.1 	0.4 	0.5 

LOQ = 0.01 mg/kg 

LOD = 0.003 mg/kg 

Dairy Max. Estimated Residue < US Tolerances 

Beef Max. Estimated Residue < US Tolerances 

 

* Liver, kidney include parent + RH-1518 

 

Residue on poultry muscle, fat, liver and eggs, were also calculated
based on maximum intake from current and proposed treated feed and
findings of the feeding study conducted by Rohm & Haas on laying hens
(TR-34-00-33) and previously submitted to the agency. The calculation
extrapolated residue from the highest dose tested in the feeding study. 
A summary of the maximum expected residue in muscle, fat, liver and eggs
is presented in Table 3. 

 

Table 3. Estimated Residue in Poultry Food Commodities from Current and
Proposed Uses of Methoxyfenozide on Feed-crops 

Poultry Feeding  (TR-34-00-33) 	 	 	 	 	 	 

 	 	 	 	 	 	 	 

Hens 	  	  	 	 	 	 	 

 	eggs 	whole body 	l muscle 	d muscle 	ab fat 	sub fat 	liver * 

 	 	 	 	 	 	 	 

Dose (ppm) 	mean 	mean 	mean 	mean 	mean 	mean 	mean 

0 	0 	 	0 	0 	0 	0 	0 

2.37 	ND 	 	ND 	 	ND 	 	0.003 

7.58 	0.0057 	 	ND 	 	ND 	 	0.016 

23.49 	0.009 	 	ND 	 	ND 	 	0.031 

75.2 	0.029 	0 	0.005 	 	0.005 	 	0.098 

 

estimated max. intake) 

 

 

( 	 	 	 	 	 	 	 

 	 	 	 	 	 	 	 

US Tolerance 	0.02 	 	0.02 	 	0.02 	 	0.1 

LOQ = 0.01 mg/kg 

LOD = 0.003 mg/kg 

ND considered at 1/2 LOD 

Liver and eggs* includes parent + RH-1518 

 

The maximum level of residues were estimated to be below the current
tolerances for all poultry commodities, with the exception of eggs.
Considering the overly conservative assumptions of this tier-1
assessment, real exposure in eggs from treated feed, might still comply
with the current tolerance.  However, based on the findings of this
assessment the current tolerance on eggs is requested to be increased
from 0.02 ppm to 0.03 ppm.  

 

The actual dietary food exposure was calculated by the DEEM 2.03 model. 
It is a straight tier-I assessment considering residues at tolerance
levels for all current and proposed uses.  

Consumption patterns include results from CSFII 1994 and 1998 for
US-general population and subgroups by age groups from infants to
elderly.  The chronic tox-endpoint was the cRfD = 0.1 mg/kg-bw/day,
published in the Federal Register of August 31, 2005 (70 FRL-7732-3). 
The published FQPA SF = 1x for methoxyfenozide and therefore the cPAD =
0.1 mg/kg/day.  The tier-I exposure was found to occupy up to 24.9% of
the chronic population adjusted dose (PAD) for US-general population and
43.1% of PAD for the most highly exposed population subgroup, children 1
to 6 years old.  These results should be viewed as conservative (health
protective) risk estimates.  Refinements such as use of percent
crop-treated information and/or anticipated residue values would yield
lower estimates of chronic dietary exposure. A summary of the findings
of the tier-I dietary risk assessment is presented in Table 4.  

  

Table 4.  Chronic Dietary Risk for Methoxyfenozide Current and Proposed
Uses as Assessed by DEEM 2.03 (Tier I ) 

 

Population Subgroup 	Exposure milligram/kilogram/day (mg/kg/day) 
Percent of chronic Population Adjusted Dose   (% cPAD) 

U.S. population - (Total) 	0.0249 	24.9 

All infants (<1-year) 	0.0278 	27.8 

Nursing infants  	0.0141 	14.1 

Non-nursing infants 	0.0329 	32.9 

Children 1 to 6 years old 	0.0431 	43.1 

Children 7 to 12 years old 	0.0263 	26.3 

Females 13+ (nursing) 	0.0291 	29.1 

Non-Hispanic/non-White/non-Black 	0.0364 	36.5 

 

Percent chronic PAD - (Exposure divided by chronic cPAD) x 100%.  The
subgroups listed are: 

1. The U.S. population (total) 

2. Those for infants and children 

3. The most highly exposed of the females sub-groups, in this case
Females 13+ (nursing) 

4. The most highly exposed of the remaining subgroups, in this case
Non-Hispanic/non-white/non-black.

	ii. Drinking Water. There are no water-related exposure data from
monitoring to complete a quantitative drinking water exposure analysis
and risk assessment for methoxyfenozide.  Screening level exposure
levels to water were estimated from EPA’s water models (ref 6).  Index
Drinking Water Reservoir model (FIRST) was used to calculate estimated
the environmental concentrations (EECs) for surface water.  The
screening concentration in ground water was estimated by using the model
Screening Concentrations in GROund Water (SCI-GROW), an empirical model
based upon actual monitoring data collected for a number of pesticides
that serve as benchmarks.  These models take into account the use
patterns and the environmental profile of a pesticide, but do not
include consideration of the impact that processing raw water for
distribution as drinking water would likely have on the removal of
pesticides from the source water.  The primary use of these models at
this stage is to provide a coarse screen for assessing whether a
pesticide likely to be present in drinking water at concentrations which
would exceed human health levels of concern. 

 

A drinking water level of comparison (DWLOC) is the concentration of a
pesticide in drinking water that would be acceptable as a theoretical
upper limit in light of total aggregate exposure to that pesticide from
food, water, and residential uses.  HED uses DWLOCs internally in the
risk assessment process as a surrogate measure of potential exposure
associated with pesticide exposure through drinking water.  In the
absence of monitoring data for a pesticide, the DWLOC is used as a point
of comparison against the conservative EECs provided by computer
modeling (SCI-GROW, FIRST, GENEEC, PRZM/EXAMS).   

 

a.  Acute exposure and risk.  Because no acute dietary endpoint was
established, Dow AgroSciences concludes that there is a reasonable
certainty of no harm from acute exposure from drinking water. 

 

b.  Chronic exposure and risk.  Tier I screening-level exposure
assessments can be conducted using the simulation models SCI-GROW and
FIRST to generate EECs for ground and surface water, respectively.  The
modeling was conducted based on the environmental profile and the
maximum seasonal application rate proposed across current and proposed
labels for Intrepid®: 0.25 lb ai/acre, for maximum 4 applications per
season, with at least 7 days intervals.  FIRST was used to generate the
surface water EECs, because it is commonly used for tier-I risk
assessments. 

 

The EECs estimated in ground-water by Sci-Grow 2.3 for chronic
exposureis 2.2 parts per billion (ppb). A summary report as produced by
the Sci-Grow 2.3 model is included in Table 5. 

 

Table 5. Summary Report of EEC Estimated in Ground-water by SCI-GROW
2.3.  

SciGrow version 2.3  	 	Chemical:methoxyfenozide	 	5/19/2006  14:29:39 

Application  rate (lb/acre)    	Number of  applications 	Total Use  

(lb/acre/yr) 	Koc 

(ml/g)    	Soil Aerobic  metabolism (days) 

0.250           	      4.0          	1.000       	2.00E+02   	336.0 

 	 	groundwater screening cond (ppb) =   2.26E+00  	 	 

 

The concentration for chronic exposure from surface-water was estimated
by the screening model FIRST  as an EEC = 15.8 parts per billion (ppb)
(based on the FIRST, annual average concentration).  A summary report as
produced by FIRST model is presented in Table 6.  

 

Table 6. Summary Report of EEC Estimated in Surface-water by the FIRST
model.  

   RUN No.   1 FOR methoxyfenozide  ON   veggies, b    * INPUT VALUES * 

   -------------------------------------------------------------------- 

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP 

     ONE(MULT)    INTERVAL    Koc   (PPM )   (%DRIFT)     AREA    (IN) 

   -------------------------------------------------------------------- 

   .250(   .979)   4   7     200.0    3.3   AERIAL(16.0)  83.0    .0 

 

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)  

   -------------------------------------------------------------------- 

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED 

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.) 

   -------------------------------------------------------------------- 

    336.00        2          N/A     77.00- 9548.00   150.00    147.68 

 

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB))    Ver 1.0 AUG 1, 2001 

   -------------------------------------------------------------------- 

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)       

          CONCENTRATION             CONCENTRATION             

   -------------------------------------------------------------------- 

             63.970                     15.790 

 

The DWLOCs for assessing chronic aggregate dietary risk can be
back-calculated by subtracting from the cRfD the amount of the estimated
dietary exposure.  A summary of the DWLOC calculated for different
sub-population groups is presented in Table 7.  

 

Table 7.  DWLOC for Chronic Exposure from Methoxyfenozide’s Current
and Proposed Uses  

Population subgroup 	Chronic PAD (mg/kg/ day)  	Food exposure (mg/kg/
day) 	Maximum DW- water exposure (mg/kg/ day) 	DWLOC (mg /L) 	SCI-GROW
(mg/L) 	FIRST annual average (mg/L) 

U.S. population (total) 	0.1 	0.0249 	0.0751 	2.63 	0.002 	0.016 

Females 13+ (nursing) 	0.1 	0.0291 	0.0709 	2.13 	0.002 	0.016 

Non-nursing  < 1 year old 	0.1 	0.0329 	0.0671 	0.67 	0.002 	0.016 

Children 1-6 years old 	0.1 	0.043 	0.057 	0.57 	0.002 	0.016 

Children 7 - 12 years old 	0.1 	0.0263 	0.0737 	0.74 	0.002 	0.016 

 

Notes:  

Maximum water exposure (mg/kg/d) = chronic PAD (mg/kg/d) - chronic food
exposure (mg/kg/d).   

DWLOC (mg/L) = Maximum water exposure (mg/kg/d) x body weight (kg) /
water consumed daily (L/Day).   

Body weights (kg) for adults is 70, for females 13+ is 60 kg, and for
children is 10 kg.   

Drinking water consumption is 2 liters per day for adults and 1 liter
per day for children.] 

 

The range of the calculated DWLOC varies from 570 ppb for the most
highly exposed population subgroup (children 1-6 years old) to 2,630 ppb
for the U.S. population (48 contiguous States - all seasons). 
Therefore, DWLOC is at least 35 times higher than the EEC estimated in
drinking water by high screening level models. 

 

The SCI-GROW and FIRST chronic EECs are lower than the Agency’s level
of comparison (the DWLOC value for each population subgroup) for
methoxyfenozide residues in drinking water as a contribution to chronic
aggregate exposure.  Dow AgroSciences thus concludes with reasonable
certainty that residues of methoxyfenozide in drinking water will not
contribute significantly to the aggregate chronic human health risk and
that the chronic aggregate exposure from methoxyfenozide residues in
food and drinking water will not exceed the Agency’s level of concern
(100% of the chronic PAD) for chronic dietary aggregate exposure by any
population subgroup.  EPA generally has no concern for exposures below
100% of the chronic PAD, because it is a level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to the health and safety of any population subgroup.  This risk
assessment is considered high confidence, conservative, and very
protective of human health.]

	2. Non-dietary exposure. Methoxyfenozide is not currently registered
for use on any residential non-food sites.  Therefore, there is no
non-dietary acute, chronic, short- or intermediate-term exposure.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) 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.”   

 

EPA does not have, at this time, available data to determine whether
methoxyfenozide has a common mechanism of toxicity with other substances
or how to include this pesticide in a cumulative risk assessment. 
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, methoxyfenozide does
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, it is assumed that
methoxyfenozide does not have a common mechanism of toxicity with other
substances.

E. Safety Determination

	1. U.S. population. Using the DEEM exposure assumptions described in
this unit, Dow AgroSciences has concluded that the aggregate exposure to
methoxyfenozide from the current and proposed new tolerances will
utilize 24.9% of the chronic PAD for the U.S. population.  If potable
water is aggregated to the dietary exposure, at the maximum residue
level estimated by EPA’s model FIRST (0.016 ppm), the aggregate
exposure to US-population is slightly increasing from 24.9 to 25.3 %
PAD. EPA generally has no concern for exposures below 100% of the
chronic PAD because the chronic PAD represents the level at or below
which daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health.  Despite the potential for exposure
to methoxyfenozide in drinking water, the aggregate exposure is not
expected to exceed 100% of the chronic PAD.  Dow AgroSciences concludes
that there is a reasonable certainty that no harm will result to
US-general population from aggregate exposure to methoxyfenozide
residues.

	2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of methoxyfenozide, EPA
considered data from developmental toxicity studies in the rat and
rabbit and a 2-generation reproduction study in the rat.  The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from maternal pesticide exposure
during gestation.  Reproduction studies provide information relating to
effects from exposure to the pesticide on the reproductive capability of
mating animals and data on systemic toxicity.   

 

FFDCA section 408 provides that EPA shall apply an additional ten-fold
safety factor for infants and children in the case of threshold effects
to account for prenatal and postnatal toxicity and the completeness of
the database unless EPA determines 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 (MOE) analysis, or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans.  EPA believes that reliable data support using the standard
uncertainty factor (UF = 100 for combined interspecies and intraspecies
variability) and no additional safety factor is required for the
calculation of MOE for any of the population sub-groups.  

 

The toxicology data base available for methoxyfenozide included
acceptable developmental toxicity studies in both rats and rabbits as
well as a 2-generation reproductive toxicity study in rats.  The data
provided no indication of increased sensitivity of rats or rabbits to in
utero and/or postnatal exposure to methoxyfenozide.  There is a complete
toxicity data base for methoxyfenozide and the exposure data are
complete or are estimated based on data/assumptions that reasonably
accounts for potential exposures.  Based on the completeness of the data
base and the lack of prenatal and postnatal toxicity, EPA determined
that an additional safety factor was not needed for the protection of
infants and children (FQPA SF = 1x). 

 

Since no acute toxicological endpoints were established, the acute
aggregate risk is considered to be negligible.  Using the exposure
assumptions described in this report, Dow AgroSciences has concluded
that chronic dietary exposure to methoxyfenozide from the existing and
proposed new tolerances will utilize 43.1% of the cPAD for infants and
children.  If exposure from drinking water is aggregated to the dietary
exposure, at the maximum residue level estimated by EPA’s model FIRST
(0.016 ppm), the aggregate exposure to children 1-6 is slightly
increasing from 43.1 to 43.5 % PAD. EPA generally has no concern for
exposures below 100% of the cPAD because the cPAD represents the level
at or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health.  Despite the potential for
exposure to methoxyfenozide in drinking water, Dow AgroSciences does not
expect the aggregate exposure to exceed 100% of the cPAD.  Short and
intermediate term risks are judged to be negligible due to the lack of
significant toxicological effects observed.  Based on these risk
assessments, Dow AgroSciences concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to methoxyfenozide residues.

F. International Tolerances

	There are several countries around the globe that have established
tolerances/ MRLs for methoxyfenozide. The most extensive list has been
published by Codex (25 food commodities). Among others countries,
Canada, Australia, Brazil, United Kingdom, and several other European
countries have MRL’s established for residues of methoxyfenozide.  A
summary of the comparative MRLs from leading countries which establish
local MRLs is presented in Table 8. By comparing them, it is concluded
that the MRLs established by different agencies are incompatible.  The
difference may be originated by diverse good agricultural practices used
for efficacious pest control, different guidelines for conducting field
crop residue studies and different calculation methods to propose
tolerances.  Based on the current situation, the U.S. tolerance levels
cannot be re-considered in order to harmonize with MRLs from other
countries, and therefore the incompatibility will persist. 

 

Table 8. Comparative International and National MRL’s for
Methoxyfenozide as Reported by Homologa Database on 5-18-06.  

CTRY 	CROP_GROUP 	CROP 	AMOUNT 	UNIT 

BRA 	CEREALS 	CORN 	0.5000	PPM 

BRA 	OILSEEDS: SOYBEAN 	SOYBEANS 	0.0500	PPM 

BRA 	NON-FOOD: COTTON 	COTTON 	0.5000	PPM 

BRA 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	0.1000	PPM 

CAN 	FRUIT: POME-FRUIT 	LOQUAT/MEDLAR-JAPANESE 	1.5000	PPM 

CAN 	FRUIT: POME-FRUIT 	CRAB-APPLES 	1.5000	PPM 

CAN 	FRUIT: MISCELLENIUS 	MAYHAW 	1.5000	PPM 

CAN 	FRUIT: POME-FRUIT 	APPLES 	1.5000	PPM 

CAN 	FRUIT: POME-FRUIT 	PEARS 	1.5000	PPM 

CAN 	FRUIT: POME-FRUIT 	PYRUS-PYRIFOLIA/ORIENTAL-PEAR 	1.5000	PPM 

CAN 	FRUIT: POME-FRUIT 	QUINCE 	1.5000	PPM 

AUS 	OILSEEDS: OTHER 	COTTONSEED 	3.0000	PPM 

AUS 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	3.0000	PPM 

GBR 	CEREALS 	CORN 	0.1000	PPM 

GBR 	OILSEEDS: SOYBEAN 	SOYBEANS 	1.0000	PPM 

GBR 	OILSEEDS: OTHER 	COTTONSEED 	2.0000	PPM 

GBR 	FRUIT: POME-FRUIT 	APPLES 	2.0000	PPM 

GBR 	FRUIT: POME-FRUIT 	PEARS 	2.0000	PPM 

GBR 	FRUIT: STONE-FRUIT 	PEACHES/NECTARINES 	0.5000	PPM 

GBR 	FRUIT: MISCELLENIUS 	KIWI 	1.0000	PPM 

 



 

 

 

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2.0000	PPM 

CDX 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	2.0000	PPM 

CDX 	VEG: STALK&STEM 	CELERY 	15.0000	PPM 

CDX 	VEG: LEAFY&FRESH-HERBS 	LETTUCE-HEAD 	15.0000	PPM 

CDX 	VEG: LEAFY&FRESH-HERBS 	LETTUCE-LEAF 	30.0000	PPM 

CDX 	FRUIT: GRAPES-TABLE/VINE 	GRAPES: WINE 	1.0000	PPM 

  	  	  	  	  

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