Document ID: EPA-HQ-OPP-2006-0875-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-11-15T05:00Z

PP# 4E6867

Research Project #4 and Valent U.S.A Corporation

EPA has received a pesticide petition from the Interregional Research
Project #4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540 for Valent U.S.A.
Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, California
94596-8025, 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
180.466 by establishing tolerances for residues of fenpropathrin in or
on the raw agricultural commodities, fruit, stone, group 12 at 5.0 ppm;
nut, tree, group 14 at 0.10 ppm, pistachio at 0.10 ppm and almond hulls
at 5.0 ppm.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of the
FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.

Residue Chemistry

Plant and animal metabolism.  The qualitative nature of fenpropathrin
residues in plants and animals is adequately understood and was
previously published in the Federal Register of March 2, 2000 (65 FR
11234) (FRL-6492-6).

 Analytical method.  Adequate enforcement methods are available for
determination of fenpropathrin residues in plant commodities.  The
available analytical enforcement methodology was previously reviewed in
the Federal Register of March 2, 2000 (65 FR 11234) (FRL-6492-6).

Magnitude of residues.  Complete residue data for fenpropathrin on stone
fruit and tree nuts (including pistachio) has been submitted.  The
requested tolerances are adequately supported.

Toxicological Profile

The toxicological profile and endpoints of concern for Fenpropathrin,
which supports this petition to establish tolerances, were previously
reviewed in the Federal Register of March 2, 2000 (65 FR 11234)
(FRL-6492-6).

Aggregate Exposure

Dietary exposure.  Assessments were conducted to evaluate potential
risks due to acute and chronic dietary exposure of the general U.S.
population and various population subgroups to residues of
fenpropathrin.  These analyses include all registered crops, uses
pending with the Agency as well as all active and proposed Section 18
uses.  There are no residential uses for fenpropathrin; therefore
aggregate exposure consists entirely of dietary (food and drinking
water) exposures.  Toxicity endpoints of concern were identified by the
Agency’s Health Effects Division, HIARC on July 17, 1997 and revised
November 14, 1997.

Food.  Tier 3 acute and chronic dietary exposures and risk analyses were
conducted to assess potential dietary exposure to residues of
fenpropathrin. These risk analyses were conducted using the Cumulative
and Aggregate Risk Evaluation System (CARES) and are completely
consistent with the USEPA’s Tier 3 approach.  

Acute exposure.  Acute dietary exposure was calculated for the U.S.
population and 20 population subgroups.  At the 99.9th percentile of
exposure, the highest exposed population subgroup was children 1-2 years
old with an estimated exposure of 0.0238 mg/kg bwt/day, representing
39.7% of the acute population adjusted dose (aPAD) of 0.06 mg/kg bwt/day
and an MOE of 250.  

Chronic exposure.  Chronic dietary exposure was calculated for the U.S.
population and 12 population subgroups.  For the US population, the
chronic exposure for fenpropathrin was 0.00027 mg/kg bwt/day,
representing 1.08% of the cPAD, and an MOE of 9,250.

Chronic exposure was also calculated for 12 sub-populations.  For the
various sub-populations, the 100th percentile of chronic exposure was
highest among children 1-2 years old at 0.00145 mg/kg bwt/day,
representing 5.8% of the cPAD, and an MOE of 1,700.

Drinking water.  A worst-case estimate of potential fenpropathrin
drinking water acute and chronic exposure of 2.26 ppb was obtained from
the peak concentration from Tier I modeling using GENEEC 1.2.  Because
of mitigating factors such as dilution from rain or other water sources,
and soil binding, actual concentrations of fenpropathrin that might
occur in drinking water derived from surface water sources are likely to
be much lower than levels predicted by GENEEC. 

Acute drinking water risk.  Acute Drinking Water Levels of Concern
(aDWLOC) were calculated based on the aPAD, worst-case acute dietary
(food) exposure from the CARES analysis, and default assumptions about
drinking water consumption and body weight.  The aDWLOC value calculated
for non-nursing infants, the subpopulation with the greatest dietary
(food) exposure was 362 ppb.  Since the aDWLOC of 362 ppb is
considerably higher than the worst-case drinking water exposure of 2.26
ppb, the EPA should not have a concern for acute risk from drinking
water exposure. 

Chronic drinking water risk.  Chronic Drinking Water Levels of Concern
(cDWLOC) were calculated based on the cPAD, worst-case chronic dietary
(food) exposure from the CARES analysis, and default assumptions about
drinking water consumption and body weight.  The cDWLOC value calculated
for non-nursing infants, the subpopulation with the greatest dietary
(food) exposure was 236 ppb.  Since the cDWLOC of 236 ppb is
considerably higher than the worst-case drinking water exposure of 2.26
ppb, the EPA should not have a concern for chronic risk from drinking
water exposure. 

Non-dietary exposure.  Fenpropathrin is registered for professional
non-food use both indoors and outdoors on ornamentals and non-bearing
nursery fruit trees. Fenpropathrin has no animal health, homeowner,
turf, termite, indoor pest control, or industrial uses. Quantitative
information concerning human exposure from this ornamental use is not
available, but exposure to the general public from this use of
fenpropathrin is expected to be minimal.  No endpoints of concern were
identified by the Health Effects Division, Hazard Identification
Assessment Review Committee for occupational or residential, dermal or
inhalation exposures of any duration.  Thus, no additional risk
assessment is needed. 

Cumulative Effects

Section 408(b)(2)(D)(v) requires that the Agency must consider
"available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common
mechanism of toxicity." Available information in this context include
not only toxicity, chemistry, and exposure data, but also scientific
policies and methodologies for understanding common mechanisms of
toxicity and conducting cumulative risk assessments.  For most
pesticides, although the Agency has some information in its files that
may turn out to be helpful in eventually determining whether a pesticide
shares a common mechanism of toxicity with any other substances, EPA has
not at this time developed the methodologies to resolve the complex
scientific issues concerning common mechanism of toxicity.

There are numerous other pesticidal compounds, pyrethroids and natural
pyrethrins that are structurally related to fenpropathrin and may have
similar effects on animals.  In consideration of potential cumulative
effects of fenpropathrin and other substances that may have a common
mechanism of toxicity, there are currently no available data or other
reliable information indicating that any toxic effects produced by
fenpropathrin would be cumulative with those of other chemical
compounds.  Thus, only the potential risks of fenpropathrin have been
considered in this assessment of aggregate exposure and effects.

Valent will submit information for EPA to consider concerning potential
cumulative effects of fenpropathrin consistent with the schedule
established by EPA at 62 Federal Register 42020 (Aug. 4, 1997) and other
EPA publications pursuant to the Food Quality Protection Act.

Safety Determination

U.S. Population.  Valent concludes, based upon the information provided
above, that there is a reasonable certainty that no harm to the U.S.
population will result from aggregate acute or chronic dietary (food and
drinking water) exposure to fenpropathrin residues on stone fruits and
tree nuts (including pistachio) in addition to all currently registered
crops.  

Infants and children.  In assessing the potential for additional
sensitivity of infants and children to residues of fenpropathrin, FFDCA
section 408 provides that EPA shall apply an additional margin of
safety, up to ten-fold, for added protection for infants and children in
the case of threshold effects unless EPA determines that a different
margin of safety will be safe for infants and children. 

The toxicological data base for evaluating pre- and post-natal toxicity
for fenpropathrin is complete with respect to current data requirements.
 There are no special pre- or post-natal toxicity concerns for infants
and children, based on the results of the rat and rabbit developmental
toxicity studies or the reproductive toxicity study in rats.  EPA’s
HED Hazard ID Committee (Revised Memorandum, November 14, 1997) has
concluded that reliable data support use of the standard 100-fold
uncertainty factor and that an additional uncertainty factor is not
needed for fenpropathrin to be further protective of infants and
children.

Valent concludes, based upon the information provided above, that there
is reasonable certainty that no harm to infants and children will result
from aggregate acute or chronic dietary (food and drinking water)
exposure to fenpropathrin residues on stone fruits and tree nuts
(including pistachio) in addition to all currently registered crops.  

International Tolerances

Codex MRLs have been established for residues of fenpropathrin in/on
grapes (5.0 ppm), peppers, sweet (1.0 ppm), pome fruits (5.0 ppm),
tomato (1.0 ppm), gherkin (0.2 ppm), eggplant (0.2 ppm), cotton seed
(1.0 ppm), cotton seed oil, crude (3.0 ppm), cattle meat (0.5 ppm), milk
(0.1 ppm), edible offal (0.05 ppm), eggs (0.01 ppm), poultry meat (0.02
ppm), edible offal (0.01 ppm).

There are small differences between the Section 408 tolerances and the
Codex MRL values for secondary residues in animal products.  These minor
differences are mainly caused by differences in the methods used to
calculate animal feed dietary exposure.