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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 lambdacyhalothrin in plant matrices has been previously submitted and accepted by EPA. (Note: 

the analytical enforcement methods for lambda-cyhalothrin are applicable for 
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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 Gammacyhalothrin 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 
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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 gammacyhalothrin 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 (lambdacyhalothrin) based on clinical signs of neurotoxicity (ataxia) observed from Day 2, 3-7 
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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
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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.]