Document ID: EPA-HQ-OPP-2014-0207-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-05-23T04:00Z

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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: [insert name and telephone number
with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Cheminova A/S]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Cheminova A/S], [1600 Wilson Blvd, Suite 700, Arlington, VA 22209-2510]
requesting, 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

	1. by establishing an import tolerance for residues of

	[Gamma-cyhalothrin] in or on the raw agricultural commodities [Fruit,
Citrus, Group 10-10] at [0.07] parts per million (ppm), [Citrus, dried
pulp] at [0.2] parts per million (ppm), and [Citrus, oil] at [3.5] parts
per million (ppm).  EPA has determined that the petition contains data
or information regarding the elements set forth in section 408 (d)(2) of
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. [No new plant metabolism data are being submitted
with this petition.  The relevant data to satisfy this data requirement
have been previously submitted to the Agency.  EPA has reviewed and
evaluated the metabolism studies in granting Section 3 approvals for a
variety of crops, for both lambda-cyhalothrin and gamma-cyhalothrin.]

	2. Analytical method. [An adequate analytical method for determining
lambda-cyhalothrin in plant matrices has been previously submitted and
accepted by EPA.  (Note:  the analytical enforcement methods for
lambda-cyhalothrin are applicable for determination of gamma-cyhalothrin
residues.)]

	3. Magnitude of residues. [Residue trials were conducted on oranges,
lemons, and grapefruits.  The application rate used two foliar
applications at 0.0134 lb a.i./A with a pre-harvest interval (PHI) of 7
days and a 15-day spray interval.  As part of the same residue study,
processing trials were also conducted.  Using the results of the residue
study, separate tolerances were calculated for oranges, grapefruits, and
lemons ranging from 0.03 ppm to 0.07 ppm.  Therefore, a tolerance of
0.07 ppm is proposed for the citrus crop group.  The results of the
processing study led to additional tolerances of 0.2 ppm and 3.5 ppm
being proposed for citrus, dried pulp and citrus, oil, respectively.]

B. Toxicological Profile

	No new toxicological data are being submitted with this package since
the toxicology database for gamma-cyhalothrin is complete.  EPA has
reviewed the entire database and, according to EPA’s June 2011
Lambda-cyhalothrin and Gamma-cyhalothrin Final Work Plan (FWP) for
Registration Review and EPA’s March 31, 2008 Gamma-Cyhalothrin risk
assessment (PC Code: 128807 and DP Barcodes: 333324, 346771, and
348227), and EPA’s March 18, 2004 Gamma Cyhalothrin Toxicology
Disciplinary Chapter for the Registration Support Document (PC Code:
128807, DP Barcode: D288053), no additional toxicology studies were
noted as being required.  

The only exception is for an immunotoxicity study and this requirement
was recently waived for all synthetic pyrethroids, including
gamma-cyhalothrin (please refer to EPA’s August 12, 2013 memorandum
regarding a July 25, 2013 HASPOC meeting for details).  Therefore, the
toxicology database currently at EPA can be considered complete.

	1. Acute toxicity.  [See above.]

	2. Genotoxicty. [See above.]

	3. Reproductive and developmental toxicity. [See above.]

4. Subchronic toxicity.  [See above.] 

	5. Chronic toxicity. [See above.]

	6. Animal metabolism: [No new animal metabolism data are being
submitted with this petition.  The relevant data to satisfy this data
requirement have been previously submitted to the Agency.  EPA has
reviewed and evaluated the metabolism studies in granting Section 3
approvals for a variety of crops, for both lambda-cyhalothrin and
gamma-cyhalothrin.]

	7. Endocrine disruption.  [As required under FFDCA section 408(p), EPA
has developed the Endocrine Disruptor Screening Program (EDSP) to
determine whether certain substances may have an effect in humans or
wildlife similar to an effect produced by a naturally occurring
estrogen.  EPA has issued test orders/data call-ins for the first 67
chemicals identified for the screening program.  Lambda- and
gamma-cyhalothrin are not among the 58 pesticide active ingredients on
the initial EDSP screening list.]   

C. Aggregate Exposure

	1. Dietary exposure. [Import tolerances are proposed for residues of
gamma-cyhalothrin on fruit, citrus, group (10-10); citrus, dried pulp;
and citrus, oil.  For the purposes of assessing the potential dietary
exposure, tolerances were calculated using the OECD MRL calculator for
the above crops.  As per EPA guidelines, the tolerances on processed
commodities were derived by multiplying the highest average citrus field
trial (HAFT) by the relevant processing factor and then rounding up. 
However, for the purposes of the risk assessment, since all analyzed
pulp samples for oranges, lemons, and grapefruits contained residues
less than the LOD of 0.003 ppm, a value of 0.0015 ppm (1/2 the LOD) was
used for all commodities except for citrus peel (for which the proposed
citrus group tolerance of 0.07 ppm was used) and citrus oil (for which
the proposed citrus, oil tolerance of 3.5 ppm was used).  To add
conservatism to the acute assessment, 100% of all citrus available for
consumption in the US was assumed to be treated.  For the chronic
assessment, percent import adjustments were incorporated.  These are
both conservative assumptions since only imported citrus could
potentially be treated (thereby bringing conservatism to the acute
assessment), and, furthermore, not all imported citrus would be treated
(thereby bringing conservatism to the chronic assessment).  The food
handling establishment (FHE) tolerance of 0.01 ppm is greater than the
anticipated pulp residue of 0.0015 ppm, so 0.01 ppm was used for the
non-oil and peel commodities in the chronic assessment.  Since FHE is
not incorporated into acute assessments, 0.0015 ppm was used for all
citrus commodities in the acute assessment except for citrus peel (0.07
ppm) and citrus oil (3.5 ppm).

The citrus residue values (as described above) were incorporated into
the March 12, 2007 dietary risk assessment for lambda-cyhalothrin (which
included gamma-cyhalothrin as well) conducted by EPA (PC Code: 128897;
DP Number: 334944; Decision Number: 361053).  In addition, a few minor
residue (chicory, eggplant, and okra) and percent crop treated (filbert
and walnuts) corrections were made to the EPA risk assessments.  The
assessment was conducted using the Dietary Exposure Evaluation
Model-Food Consumption Intake Database (DEEM-FCID) software, consumption
data derived from the 2003-2008 National Health and Nutrition
Examination Survey (NHANES), residue data derived from market basket
data, USDA’s Pesticide Data Program (PDP) data, field trial data, and
tolerance level residues.  Estimated potential residues in drinking
water were not modified because the proposed citrus use is for imported
citrus only.  Due to the low proposed import tolerance for the animal
feed item citrus, dried pulp at 0.20 ppm relative to other feed items,
the proposed citrus use is not anticipated to result in increases to any
of the currently established meat and milk tolerances for
gamma-cyhalothrin.] 

	i. Food. [Acute Dietary Exposure.  The acute population adjusted dose
(aPAD) of 0.005 mg/kg bw/day was used to characterize risk associated
with acute dietary exposure.  It is derived from a NOAEL of 0.5 mg/kg
bw/day from a chronic dog study (lambda-cyhalothrin) based on clinical
signs of neurotoxicity (ataxia) observed from Day 2, 3-7 hours
post-dosing at the LOAEL of 3.5 mg/kg/bw/day.  In the 2007
Lambda-cyhalothrin risk assessment, EPA determined that the appropriate
uncertainty factor was 100 and that the FQPA safety factor could be
reduced to 1.  Cheminova has conducted an acute dietary exposure
assessment with DEEM-FCID as discussed above.  The acute dietary
assessment was conducted for the overall US population and select
subpopulations (i.e., all infants <1 year old, children 1-2 years old,
children 3-5 years old, children 6-12 years old, youths 13-19 years old,
adults 20-49 years old, adults 50+ years old, and females 13-49 years
old).  The results of this acute analysis indicate that the most highly
exposed population is children 1-2 years old, with an estimated acute
dietary exposure of 0.002648 mg/kg bw/day, which corresponds to 53.0% of
the aPAD.  For the overall US population, the acute exposure is
calculated to be 0.001939 mg/kg bw/day, which corresponds to 38.8% of
the aPAD.  

ii. Chronic Dietary Exposure.  The chronic population adjusted dose
(cPAD) of

0.001 mg/kg bw/day was used to characterize risk associated with chronic
dietary exposures.  It is derived from a NOAEL of 0.1 mg/kg bw/day from
a chronic dog study (lambda-cyhalothrin) based on clinical signs of
neurotoxicity (abnormal gait) observed in the two dogs at the LOAEL of
0.5 mg/kg/bw/day.  In the 2007 Lambda-cyhalothrin risk assessment, EPA
determined that the appropriate uncertainty factor was 100 and that the
FQPA safety factor could be reduced to 1.  Cheminova has conducted a
chronic dietary exposure assessment with DEEM-FCID as discussed above. 
The chronic dietary assessment was conducted for the overall US
population and select subpopulations (i.e., all infants <1 year old,
children 1-2 years old, children 3-5 years old, children 6-12 years old,
youths 13-19 years old, adults 20-49 years old, adults 50+ years old,
and females 13-49 years old).  The results of this chronic analysis
indicate that the most highly exposed population is children 1-2 years
old, with an estimated chronic dietary exposure of
0.000516 mg/kg bw/day, which corresponds to 51.6% of the cPAD.  For
the overall US population, the chronic exposure is calculated to be
0.000159 mg/kg bw/day, which corresponds to 15.9% of the cPAD.  

2. Non-dietary exposure.  Gamma-cyhalothrin is currently registered for
use on residential non-food sites.  The addition of the proposed citrus
import tolerance will not impact the residential exposures.  After the
citrus commodities were included in the dietary risk assessment, the
resulting dietary exposures were similar to what they were previously,
so the impact on overall aggregate exposures is expected to be minimal.]

D. Cumulative Effects

	[Gamma-cyhalothrin is a pyrethroid insecticide that shares the same
general mode of action as other insecticides in this chemical class. 
EPA’s 2011 cumulative risk assessment for pyrethroids indicated that
exposures from the many current uses of pyrethrins and pyrethroid
insecticides do not pose risk concerns for children or adults.  Further,
the cumulative assessment supports consideration of registering
additional new uses (domestic or import) of these pesticides.]

E. Safety Determination

	1. U.S. population.  [Using the assumptions described above and based
on the completeness of the toxicity database, it can be concluded that
dietary exposure to gamma-cyhalothrin and lambda-cyhalothrin from all
uses (including the proposed import crop use) will be 38.8% of the aPAD
and 15.9% of the cPAD for the overall US population.  EPA generally has
no concern for exposures below 100% of the PAD because the PAD
represents the level at or below which daily aggregate (food plus water)
exposures will not pose appreciable risks to human health.  Thus, it can
be concluded that there is a reasonable certainty that no harm will
result from aggregate (food plus water) exposure to residues arising
from the proposed tolerances that are the subject of this petition.]

	2. Infants and children. [Using the assumptions described above and
based on the completeness of the toxicity database, it can be concluded
that dietary exposure to gamma-cyhalothrin and lambda-cyhalothrin from
all uses (including the proposed import crop use) will be 53% of the
aPAD and 51.6% of the cPAD for infants and children.  EPA generally has
no concern for exposures below 100% of the PAD because the PAD
represents the level at or below which daily aggregate (food plus water)
exposures will not pose appreciable risks to human health.  Thus, it can
be concluded that there is a reasonable certainty that no harm will
result from aggregate (food plus water) exposure to residues arising
from the proposed tolerances that are the subject of this petition.]

F. International Tolerances

	[There are established MRLs (maximum residue limits) for
gamma-cyhalothrin for Mexico, but not for Canada or Codex.]

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