EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [PV Shah; (703) 308-1846]

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from [Drexel 

Chemical Company (Drexel; EPA Company Number 19713), P.O. Box 13327, Memphis, 

TN 38113-03227] 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 by establishing a 

tolerance for residues of [Dichlormid] in or on the raw agricultural commodities [listed 

in Table 1] at [0.05 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 

FFDCA; 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.

[Table 1: Commodities for which Drexel is requesting tolerances for Dichlormid

Commodity

Tolerance Level 

(parts per million)

Almond hulls 0.05

Animal feed, nongrass, group 18 0.05

Asparagus 0.05

Barley, grain 0.05

Barley, hay 0.05

Barley, straw 0.05

Beet, garden, leaves 0.05

Beet, sugar, molasses 0.05

Beet, sugar, roots 0.05

Beet, sugar, tops 0.05

Brassica, head and stem, subgroup 5A 0.05

Brassica, leafy greens, subgroup 5B 0.05

Buckwheat, grain 0.05

Bushberry subgroup 13-07B 0.05

Caneberry, subgroup 13-07A 0.05

Carrots, roots 0.05

Cattle, fat 0.05

Cattle, kidney 0.05

Cattle, liver 0.05

Cattle, meat 0.05

Cattle, meat byproducts, except kidney and liver 0.05

Cilantro, leaves 0.05

Coriander, seed 0.05

Cotton, gin byproducts 0.05
2

Commodity

Tolerance Level 

(parts per million)

Cotton, undelinted seed 0.05

Cucumber 0.05

Dillweed 0.05

Egg 0.05

Grain, aspirate fractions 0.05

Goat, fat 0.05

Goat, kidney 0.05

Goat, liver 0.05

Goat, meat 0.05

Goat, meat byproducts, except kidney and liver 0.05

Grass, forage 0.05

Grass, hay 0.05

Horse, fat 0.05

Horse, kidney 0.05

Horse, liver 0.05

Horse, meat 0.05

Horse, meat byproducts, except kidney and liver 0.05

Leaf petioles, subgroup 4B 0.05

Melon, subgroup 9A 0.05

Milk 0.05

Millet, forage 0.05

Millet, grain 0.05

Millet, hay 0.05

Millet, straw 0.05

Nut, tree, group 14 0.05

Oat, forage 0.05

Oat, grain 0.05

Oat, hay 0.05

Oat, straw 0.05

Okra 0.05

Onion, bulb, subgroup 3-07A 0.05

Onion, green, subgroup 3-07B 0.05

Peanut 0.05

Peanut, hay 0.05

Peanut, meal 0.05

Potato 0.05

Poultry, fat 0.05

Poultry, meat 0.05

Poultry, meat byproducts 0.05

Pumpkin 0.05

Rice, grain 0.05

Rye, forage 0.05

Rye, grain 0.05
3

Commodity

Tolerance Level 

(parts per million)

Rye, straw 0.05

Safflower, seed 0.05

Sesame, seed 0.05

Sheep, fat 0.05

Sheep, kidney 0.05

Sheep, liver 0.05

Sheep, meat 0.05

Sheep, meat byproducts, except kidney and liver 0.05

Sorghum, grain, forage 0.05

Sorghum, grain, grain 0.05

Sorghum, grain, stover 0.05

Sorghum, sweet, stalk 0.05

Soybean, forage 0.05

Soybean, hay 0.05

Soybean, seed 0.05

Spinach 0.05

Squash, winter 0.05

Sunflower, seed 0.05

Sunflower, meal 0.05

Tomato 0.05

Tomato, paste 0.05

Turnip, greens 0.05

Vegetable, foliage of legume, subgroup 7A, except soybean 0.05

Vegetable, fruiting, Group 8, except tabasco pepper 0.05

Vegetable, legume, group 6 0.05

Vegetable, root, except sugar beet, subgroup 1B, except carrot 0.05

Vegetable, tuberous and corm, subgroup 1C 0.05

Wheat, forage 0.05

Wheat, grain 0.05

Wheat, hay 0.05

Wheat, straw 0.05

Section 18 emergency exemptions: Tolerances with regional registrations

Pepper, nonbell 0.50

Pepper, tabasco 0.50
4

A. Residue Chemistry

[Nature of the residue (NOR) and magnitude of the residue (MOR) studies have been 

conducted in support of the existing dichlormid permanent tolerances on corn 

commodities. For this petition, Drexel has submitted a white paper detailing the rationale 

for not conducting any additional NOR or MOR residue studies to support the additional 

requested tolerances listed in Table 1.]

1. Plant metabolism. [An NOR study was conducted in corn at a nominal rate of 5 lb 

ai/A on pre-emergence soil, or post-emergence foliar application. The residues 

were readily extractable from forage and stover but there was poor extractability 

for grain. The overall results of the study indicated that the metabolism of 

dichlormid was qualitatively similar in all corn matrices. The total radioactive 

residue was low. EPA determined that the study was adequate to support 

permanent tolerances and that the residue of concern was the parent dichlormid. 

Based on the results of this and other residue studies (summarized below), EPA 

determined that the tolerance expression for dichlormid includes potential 

metabolites and degradates of dichlormid, and compliance with the tolerance is 

measurement of dichlormid only.]

2. Analytical method. [The original analytical method (limit of quantitation (LOQ) 

of 0.05 ppm) for dichlormid is well defined and has been validated by EPA, 

supporting the 0.05 ppm tolerance level. A revised method, lowering the LOQ to 

0.01 has also been reviewed and approved by EPA.]

3. Magnitude of residues. [Eight MOR trials on corn were conducted with 

dichlormid applied post-emergence to 5-9 inch plants at a rate of 0.5 lb 

dichlormid/A. Eight additional trials were also conducted with dichlormid applied 

to 9-12 inch plants at a rate of 0.48 lb dichlormid/A. The highest average field 

trial (HAFT) values were below analytical LOQ of either 0.003 ppm or 0.01 ppm 

dichlormid (depending on the trial) in all samples of forage, grain and stover.]

B. Toxicological Profile

[The toxicology database for dichlormid is complete and has previously been reviewed 

by EPA for prior tolerance approvals.]

1. Acute toxicity. [The acute toxicity of dichlormid is low to moderate depending on 

the route of exposure. Oral and dermal exposure studies results show moderate 

toxicity, while inhalation toxicity and eye irritation are low.]

2. Genotoxicty. [Five of the six genotoxicity studies conducted with dichlormid 

showed no evidence of genotoxic potential. In one study, an in vitro mouse 

lymphoma cell study, the study results indicated that dichlormid was mutagenic in 

the cells tested with and without S9 activation, but these results were seen at dose 

levels that were cytotoxic. Even with one positive result at cytotoxic levels, the 
5

battery of studies indicate that dichlormid is not mutagenic.]

3. Reproductive and developmental toxicity. [Reproductive and developmental 

studies were conducted on rats and rabbits. 

a. Rat developmental toxicity: In the rat study, the doses tested were 0, 

10, 40, 160 mg/kg/day. The maternal NOAEL was 10 mg/kg/day and 

the maternal LOAEL was 40 mg/kg/day, based on decreased mean 

absolute body weight, body weight gains, and food consumption. The 

developmental NOAEL in the rat study was 40 mg/kg/day and the 

developmental LOAEL was 160 mg/kg/day based on a marginal 

increase in skeletal abnormalities.

b. Rabbit developmental toxicity: In the rabbit study, the doses tested

were 0, 5, 30, 180 mg/kg/day. The maternal NOAEL was 30 

mg/kg/day and the maternal LOAEL was 180 mg/kg/day, based on 

increased incidence of alopecia, decreased mean maternal body weight 

gain, and decreased food consumption. The developmental NOAEL 

was 30 mg/kg/day and the developmental LOAEL was 180 mg/kg/day 

based on an increase in post-implantation loss and increased number of 

early and late resorptions/doe, decreased number of live fetuses/litter, 

and a slight decrease in mean fetal body weight.

c. Rat reproduction toxicity: In the rat reproduction study the doses 

tested were M0: 0, 1.5, 7.4, 48.5 mg/kg/day; M1: 0, 1.8, 8.9, 59.4 

mg/kg/day; F0: 0, 1.6, 8.0, 52.1 mg/kg/day; and F1: 0, 1.9, 9.4, 63.0 

mg/kg/day. The parental/systemic NOAELs were 7.4 mg/kg/day 

(male), and 8.0 mg/kg/day (female) and the parental/systemic 

LOAELs were 48.5 mg/kg/day (male) and 52.1 mg/kg/day (female) 

based on minimal increased liver weight, minimal decreased weight 

gain, and a minimal decrease in food consumption. The reproductive 

NOAELs were 48.5 mg/kg/day (male) and 52.1 mg/kg/day (female), 

and the reproductive LOAELs was not determined. The offspring 

NOAELs were 7.4 mg/kg/day (male) and 8.0 mg/kg/day (female) and 

the offspring LOAELs were 48.5 mg/kg/day (male) and 52.1 

mg/kg/day (female) based on increased liver weight.]

4. Subchronic toxicity. [Subchronic studies have been conducted on the rat and the 

dog by oral and inhalation routes. A subchronic neurotoxicity study has also been 

conducted in the rat. No 90-day dermal study was conducted so EPA assumes 

100% as a default value for dermal absorption. 

a. Rat subchronic oral toxicity: In the rat study, the doses tested were 0, 

1.4, 14, 140 mg/kg/day (male) and 0, 1.6, 16, 150 mg/kg/day (female). 

The NOAELs were 1.4 mg/kg/day (male) and 14 mg/kg/day (female)

and the LOAELs were 14 mg/kg/day (male) and 16 mg/kg/day 

(female) based on a minor decrease in body weight gain and food 

efficiency in females, and increased liver weights and non-statistically 

significant liver lipidosis in males.
6

b. Dog subchronic oral toxicity: In the dog study, doses tested were 0, 1, 

5, 25, 50 mg/kg/day. The NOAEL was 5 mg/kg/day (male and female)

and the LOAEL was 25 mg/kg/day (male and female) based on 

decreased body weight gain, hematological and clinical chemistry 

alterations, liver toxicity, and voluntary muscle pathological changes.

c. Rat subchronic inhalation toxicity: In the rat study, doses tested were

0, 2, 19.2, 192.5 mg/L/day. The NOAEL was 2 mg/L/day (male and 

female) and the LOAEL was 19.9 mg/L/day (male and female) based 

on clinical signs, gross pathology, ophthalmology, liver and kidney 

weights and non-neoplastic histology.

d. Rat subchronic neurotoxicity: In the 2011 dichlormid EPA Human 

Health Risk Assessment (Dichlormid: Human Health Risk Assessment 

for the Purpose of Making Time-Limited Tolerances of Field Corn 

Commodities Permanent; DP Barcode D385691; January 13, 2011) 

EPA noted that although the study was not acceptable, no additional 

study was required to be conducted.]

5. Chronic toxicity. [Chronic studies have been conducted in the rat, mouse and dog, 

No information on the chronic dog study details or results is available in EPA risk 

assessment documents so it is not summarized here or in the petition.

a. Rat carcinogenicity: In the rat study, doses tested were 0, 1.3, 6.5, 32.8 

mg/kg/day (male) and 0, 1.5, 7.5, 37.1 mg/kg/day (female). The 

NOAELs were 6.5 mg/kg/day (male) and 7.5 mg/kg/day (female) and 

the LOAELs were 32.8 mg/kg/day (male) and 37.1 mg/kg/day 

(female) based on decreased body weight gain, increased liver weight, 

and liver histopathology. Dichlormid was not carcinogenic. 

b. Mouse carcinogenicity: In the mouse study, doses tested were 0, 1.4, 

7.0, 70.7 mg/kg/day (male) and 0, 1.8, 9.2, 92.4 mg/kg/day (female). 

The NOAELs were 7.0 mg/kg/day (male) and 9.2 mg/kg/day (female) 

and the LOAELs 70.7 mg/kg/day (male) and 92.4 mg/kg/day (female) 

based on changes in reproductive organs and kidney changes in 

males.]

6. Animal metabolism. [In a rat study, dichlormid was well absorbed, extensively 

metabolized and excreted primarily in the urine within 24 hours. Up to 11% of the 

dose was exhaled as CO2. In an NOR study in the goat, very low measured 

residues were found in goat tissues (<0.001-0.023 ppm) when dosed at 

approximately 200X of 0.05 ppm tolerance level. EPA concluded that no animal 

tolerances were required for dichlormid based on the results of the goat study. In 

an NOR study in the hen, very little dichlormid was detected in tissues, and a very 

small fraction of the total radioactive residues was identified in each matrix 

analyzed.]
7

7. Metabolite toxicology. [Not Applicable/Not required]

8. Endocrine disruption. [A study to assess the endocrine disruption potential of 

dichlormid has not been conducted. The database of studies conducted with 

dichlormid do not indicate any adverse effects associated with endocrine

disruption. Furthermore, dichlormid was not included on EPA’s July 2015 list of 

Tier 1 screening assays for the first 52 chemicals assessed in the Endocrine 

Disruptor Screening Program.]

C. Aggregate Exposure

[To examine aggregate exposure, available information concerning exposures from the 

pesticide residue in food and all other non-occupational exposures, including drinking 

water from groundwater or surface water and exposure through pesticide use in gardens, 

lawns, or buildings (residential and other indoor uses) is considered. 

On the basis of dichlormid data, the proposed use patterns (which do not include 

residential uses) and the results of a conservative dietary exposure and risk assessment it 

is unlikely that humans (adults and children) would be exposed to significant residues of 

dichlormid via foods and in drinking water. A previous EPA risk assessment (Human 

Health Risk Assessment for Dichlormid. Petition Number 4F6950. DP Barcode 

D321927, November 15, 2005) indicated that acute and chronic aggregate risk were 

below the level of concern, and short and intermediate term aggregate risk assessments 

were not conducted because of the lack of residential uses.]

1. Dietary exposure. [As the request for expansion of tolerances for dichlormid 

includes a more extensive list of crops than were previously evaluated, Drexel 

conducted updated acute and chronic dietary (including drinking water) exposure and 

risk assessments. These conservative Tier 1 assessments incorporated all current 

tolerances and all the proposed additional crops. Tolerance level residues of 0.05 ppm, 

default processing factors, and 100% crop treated were used in the acute and chronic 

risk assessments. The acute and chronic risks are below 100% of their respective acute 

and chronic reference doses (aRfD = 0.1 mg/kg bw/day; cRfD = 0.065 mg/kg bw/day). 

In 2011, EPA reduced all FQPA factors for this compound to 1X, these results meet the 

reasonable certainty of no harm standard.]

i. Food. [The available data demonstrate that the chronic dietary (food and 

drinking water) exposures for dichlormid are well below EPA’s established level of 

concern for all U.S. subpopulations.]

ii. Drinking water. [Drinking water is included in the assessment conducted with 

the tolerance petition. Exposure to dichlormid from drinking water is expected to be 

negligible.]

2. Non-dietary exposure. [None]
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D. Cumulative Effects

[No data are available to determine whether dichlormid has a common mechanism of 

toxicity with other substances. Because of this lack of data and the absence of the ability 

to include it in a cumulative risk assessment, EPA has assumed for previous tolerance 

reviews and approvals that there is no common mechanism of toxicity with other 

substances. Drexel believes that, in the continued absence of additional information, EPA 

should continue to make the assumption for the risk assessments associated with this 

tolerance amendment petition that no common mechanisms exist.] 

E. Safety Determination

1. U.S. population. [A dietary exposure assessment for dichlormid was conducted. 

Based on the conservative dietary exposure estimates, there is a reasonable certainty 

that no harm will result to the US population from the aggregate exposure to 

dichlormid.]

2. Infants and children. [The FQPA Safety Factor for dichlormid is 1X because there 

are no uncertainties in the database of studies. The dietary exposure risk assessment 

(including drinking water), includes analysis of the %RfD for the entire US 

population and all subpopulations (including infants and children). The risk 

assessment shows that, for infants and children, there is a reasonable certainty that no 

harm will result from the aggregate exposure to dichlormid.]

F. International Tolerances

[There are no known international tolerances for dichlormid.]