EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [P.V. Shah 703-308-1846]

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:

[ Oro-Agri Inc ]

[OA 1]

EPA has received a pesticide petition (OA 1]) from [Oro-Agri Inc], [990 Trophy 

Club Drive, Trophy Club TX, 76262] 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.

to establish an exemption from the requirement of a tolerance for

[Sweet Orange Peel Tincture, CAS# 8028-48-6, under 40CFR 180.910 for pre 

and post harvest crops when used as a surfactant and fragrance when contained at 

concentrations up to 10% in pesticide formulations and applied to agricultural 

crops, preplant through post harvest]. 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 [This information is not available, nor required for the 

establishment of a tolerance exemption.]

1. Plant metabolism. [omit -per above, not needed.]

2. Analytical method. [omit -per above, not needed.]

3. Magnitude of residues. [omit -per above, not needed.]
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B. Toxicological Profile

[Sweet Orange Peel Tincture is a cold press extract of orange peel, comprised of 

greater than 95% D-Limonene (CAS# 5989-27-5) and other minor (<1%) 

components. Given the trace levels of these other components compared to Dlimonene there is no expectation of contribution to the toxicological profile from 

them. Pure D-limonene is exempt from requirement of a tolerance when used as an 

inert ingredient in pesticide formulations on food (40 CFR 180.910). The EPA has 

conducted a thorough toxicological profile for D-Limonene for use as an active 

ingredient as a vertebrate repellent. Since Sweet Orange Peel Tincture is 95% or 

more D-Limonene, this profile represents Sweet Orange Peel Tincture.]

1. Acute toxicity. [The oral toxicity of limonene is relatively low. An oral 

lethal dose for humans has been estimated at 1 oz. - 1 pint. Limonene has been 

administered therapeutically to humans at doses of 20 g to dissolve gallstones. 

Systemic toxicity from dermal exposure is anticipated to be lower than oral toxicity 

because dermal penetration is expected to be less than 100% and since local dermal 

irritation would occur at high exposure levels, causing discontinuation of exposure.]

2. Genotoxicity. [Limonene is not mutagenic in numerous assays. Renal 

adenomas/ carcinomas in male rats administered limonene for 2 years (National 

Toxicology Program study) are considered to be related to alpha 2u-globulininduced nephropathy and therefore are not considered relevant to human risk 

assessment (Risk Assessment Forum document on alpha -globulin nephropathy).]

3. Reproductive and developmental toxicity. [Limonene is not a developmental 

toxicant. Delayed ossification in bone development may be observed at high doses 

that also cause maternal toxicity. Several developmental toxicity studies were cited 

in the literature review of the NTP study. No developmental effects were observed in 

rabbits administered limonene up to 1,000 mg/kg.]

4. Subchronic toxicity. [In a National Toxicology Program study, toxicity of Dlimonene administered by gavage in corn oil was assessed in CD rats and in B6C3F1 

mice in 16-day, 13-week and 2-year studies. In the 16-day study, no effects were 

observed in males at or below 825 mg/kg/day or in females at or below 1,650 

mg/kg/day. Decreased body weights were observed in males at 1,650 mg/kg/day and 

in females at 3,300 mg/kg/day. Deaths occurred at 3,300 and 6,600 mg/kg/day 

among both males and females. In the 13-week study, no effects were observed in 

females at or below 600 mg/kg/day. At 1,200 and 2,400 mg/kg/day clinical signs 

(lethargy, salivation) were observed in males and females. Decreased body weight 

was observed in males at 1,200 mg/kg/day and females at 2,400 mg/kg/day. 

Lacrimation, rough coat and lethargy were noted at 1,200 mg/kg/day. Nephropathy 

related to alpha - 2u globin accumulation was observed in male rats at all doses (150 

mg/kg/day above).
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Mortality was increased in males and females at 2,400 mg/kg/day (highest dose

tested).]

5. Chronic toxicity. [In a 2-year study, male rats were given 75 or 150 

mg/kg/day and females 300 or 600 mg/kg/day limonene. At 150 mg/kg/day males 

had slightly decreased body weight but at both doses developed alpha -globulin 

nephrotoxicity and renal 2u adenoma/adenocarcinoma. Females showed no effects 

at 300 mg/kg/day but at 600 mg/kg/day had slightly decreased body weight and 

increased mortality.

Mice given limonene at the same doses in the 16-day and 13-week studies also 

showed limited evidence of toxicity at high doses, although some body weight 

decrease in males was observed at all doses. Mice were given 250 or 500 mg/kg/day 

(males) or 500 or 1000 mg/kg/day (females) in the 2-year study.

Females at 1000 mg/kg/day had decreased body weight. No treatment-related 

nephropathy or renal adenomas/carcinomas were observed in either sex in the 2-

year study.]

6. Animal metabolism. [NA-Remove]

7. Metabolite toxicology. [NA-Remove]

8. Endocrine disruption. [The Agency has no information that suggests Sweet 

Orange Peel Tincture in general will have an effect on the immune or endocrine 

system. ]

C. Aggregate Exposure

1. Dietary exposure. [Dietary exposure to sweet orange peel tincture is 

possible through ingestion of citrus fruit (oranges). D-Limonene, the constituent 

which comprises 95% of sweet orange peel tincture, is naturally occurring in fruits, 

vegetables, meats and spices.]

i. Food. [D-Limonene occurs naturally in fruits (especially citrus fruits, 

vegetables, meats, and spices). As an additive it is found in a variety of foods and 

beverages. According to the National Toxicology Program report of 1992, 

approximately 254,000 kg are consumed annually. All of the orange peel tincture 

constituents are found in common foods. The exposures from residues of orange 

peel tincture applied to crops as an inert ingredient will constitute a negligible 

addition to diet. ] 

ii. Drinking water. [The peel extract are nonsoluble oils and terpenes. The 

contamination of drinking water is highly improbable.]

2. Non-dietary exposure. [The primary route of exposure to these chemicals 
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from their use as inert ingredients in pesticide products would most likely be 

through consumption of food to which pesticide products containing them have 

been applied. Dermal and inhalation exposures are also possible for workers from 

use of pesticide products containing this inert ingredient. However, the quantitative 

exposure assessment via inhalation and dermal routes of exposure has not been 

determined but is not expected to be of significance. ]

D. Cumulative Effects

[Unlike other pesticide ingredients for which EPA has followed a 

cumulative risk approach based on a common mechanism of toxicity, EPA has not 

made a common mechanism of toxicity finding as to Sweet Orange Peel Tincture 

and any other substances. For the purposes of this tolerance action, therefore, 

EPA has not assumed that Sweet Orange Peel Tincture has a common mechanism 

of toxicity with other substances.]

E. Safety Determination

1. U.S. population. [D-Limonene occurs naturally in fruits (especially citrus 

fruits, vegetables, meats, and spices). As an additive it is found in a variety of foods 

and beverages. According to the National Toxicology Program report of 1992, 

approximately 254,000 kg are consumed annually. All of the orange peel tincture 

constituents are found in common foods. The exposures from residues of orange 

peel tincture applied to crops as an inert ingredient will constitute a negligible 

addition to diet.] 

2. Infants and children. 

[EPA concluded that the FQPA safety factor can be set to 1X for Sweet 

Orange Peel Tincture for the following reasons:

There is sufficient data to assess the toxicity of sweet orange peel tincture. 

The data presented in the assessment on D-Limonene, the primary constituent, 

constituting greater than 95% of the product, are adequate to characterize the 

expected behavior of the subject extract. Studies have shown that this natural terpene 

does not pose a teratogenic, developmental or mutagenic effect. All of the peel extract 

components can be found in food (fruit) commonly consumed by children. The 

incidental residues possible from application of this product are significantly less 

than the natural exposure of infants and children through ingestion of fruit 

(especially citrus fruit).]

F. International Tolerances

[There are no CODEX or international tolerance exemptions established for the subject 

inert ingredient at this time.]