2-Phenethyl Propionate Petition to Establish a Tolerance Exemption – March 1, 2012

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Petition for an exemption from the requirement of a tolerance 

for residues of products containing the active ingredient “2-

Phenethyl Propionate” and its degradates “Phenethyl 

Alcohol” and “Propionic Acid” in and on all food 

commodities

Submitted for: EcoSMART Technologies, Inc.

20 Mansell Court, Suite 375

Roswell, GA 30076

Submitted by: Technology Sciences Group Inc.

712 Fifth Street, Suite A

Davis, CA 95616
2-Phenethyl Propionate Petition to Establish a Tolerance Exemption – March 1, 2012

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SECTION A Product name and proposed use practice

Product Name: 2-PEP Technical (TGAI)

EcoPCO® ACU (EP); EPA Reg. No. 67425-14

Proposed Use Practice: EcoSMART Technologies, Inc. uses 2-PEP as a minimum risk 

pesticide active ingredient in a variety of exempt 25(b) products and 

as a broad spectrum contact insecticide/miticide for application in 

commercial, industrial and residential areas. With the establishment 

of an exemption from the requirement of a tolerance for residues of 

this active ingredient, EcoSMART Technologies, Inc. proposes to 

expand the use of its products to include crack and crevice 

treatments in food and feed handling and processing facilities for the 

control of insect pests. This is an indoor use pattern that does not 

involve direct application to food crops.

SECTION B Product identity/chemistry

Active Ingredient: 2-Phenethyl Propionate (CAS No. 122-70-3).

Information regarding the name, identity and chemical composition 

has been submitted to EPA and can be found in MRID No. 487536-

02.

2-Phenethyl Propionate (2-PEP) degrades after twenty-four (24) 

hours into Phenethyl Alcohol (PEA) (CAS No. 60-12-8) and Propionic 

Acid (CAS No. 79-09-4). It also degrades rapidly in water and soil. 

2-PEP also hydrolyzes in the gut to PEA. (MRID Nos. 487536-05 and 

487536-06). Therefore, this tolerance exemption covers 2-PEP and 

its degradates.

2-PEP is classified as a minimum risk pesticide per 40 CFR 152.25(f) 

and is exempt from federal registration requirements under section 

25(b) of the Federal Insecticide Fungicide Rodenticide Act (FIFRA). 

It is also found in registered products, as a biochemical active 

ingredient, when combined with other non-exempt active ingredients 

or with inert ingredients that do not meet the criteria of 40 CFR 

152.25(f). Historically, 2-PEP has been used to attract Japanese 

Beetles to traps and as an insecticide/miticide on a wide variety of 

insects, mites, ticks, spiders, etc. (EPA, Floral Attractants, 

Repellents and Insecticides Fact Sheet, 11/04). 

2-PEP is a naturally occurring plant volatile ingredient derived from 

peanut oil. In addition to its use as a pesticide active ingredient, it is 
2-Phenethyl Propionate Petition to Establish a Tolerance Exemption – March 1, 2012

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listed as GRAS and approved as a direct food additive by the FDA 

(21 CFR 172.515) as a flavoring agent. 2-PEP is widely used as an 

additive in the food and flavor industry, and occurs naturally in the 

human diet. It is an ester formed from PEA and Propionic Acid, and 

is often in natural sources with those two compounds.

PEA is a degradate of 2-PEP. PEA has been identified as a volatile 

component in various raw and processed foods. PEA is commonly

used as a flavoring agent in food and as a fragrance in cosmetics, 

household and laundry cleaning products and air fresheners. PEA is 

cleared by the FDA for use as a synthetic flavoring substance in food 

per 21 CFR 172.515. EPA has conducted an extensive review of the 

toxicity and fate of PEA (MRID No. 487536-06).

Propionic Acid is a degradate of 2-PEP. Propionic Acid is used 

widely as a preservative and flavoring agent in packaged foods such 

as baked goods and cheese. Propionic Acid occurs naturally in dairy

products and is a normal component of human metabolism. 

Propionic Acid is exempt from the requirement of a tolerance for 

residues when used as an active or an inert ingredient on all food 

crops per 40 CFR 180.1023(c). Propionic Acid is affirmed GRAS as 

a direct human food ingredient per 21 CFR 184.1081.

Mode of Action: When used as an insecticide/miticide, 2-PEP has a unique mode of 

action that targets and blocks a key neurotransmitter receptor site 

called octopamine, which is found in all invertebrates, but not 

mammals. Octopamine regulates an insect’s heart rate, movement 

and metabolism. Interrupting the function of octopamine results in a 

total breakdown of the insect’s nervous system. 2-PEP degrades 

after 24 hours into PEA and Propionic Acid. 2-PEP and its

degradates dissipate rapidly leaving low concentrations for short 

periods of time, likely due to their ready volatility (MRID No. 487536-

05).

Magnitude of residues and

method to determine: An analytical method for residues is not applicable. It is expected 

that, when used as proposed, 2-PEP, and its degradates PEA and 

Propionic Acid, would not result in residues that are of toxicological 

concern.
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SECTION C Toxicological Profile

Toxicity of 2-PEP:

1) Acute Toxicity of 2-PEP. 2-Phenethyl Propionate is of low acute oral and dermal toxicity, 

with two oral LD50s in rats reported at 4,000 mg/kg and 3980 mg/kg (Toxicity Category III), 

and a dermal LD50 in rabbits reported at greater than 5,000 mg/kg (Toxicity Category IV). 

Low acute inhalation toxicity was demonstrated in a study on the active ingredient on rats 

that resulted in an LC50 of greater than 2.06 mg/L (Toxicity Category IV). 2-Phenethyl 

Propionate is a moderate irritant in an eye irritation study (Toxicity Category III) and a slight 

irritant in skin irritation study (Toxicity Category IV). Finally, 2-PEP was shown to not be a 

dermal sensitizer.

2) Subchronic Toxicity, Teratogenicity and Genotoxicity of 2-PEP. EcoSMART 

Technologies, Inc. has requested that existing data be considered to satisfy these data 

requirements based on the results of toxicity testing available in published literature, studies 

on persistence and dissipation of 2-PEP in the environment, the results of toxicity testing on 

appropriate degradates available in published literature, the ingredient’s status as GRAS 

and as a direct food additive with the FDA, and the ingredient’s status as a minimum risk 

active ingredient with the EPA (MRID No. 487536-07).

Studies performed on structurally similar degradates are of low toxicity in subchronic and 

teratogenicity studies and had negative results in genotoxicity studies, and that 2-Phenethyl 

Propionate is a common ingredient in the diet as a result of its natural occurrence in food 

and as a food additive. Further, 2-Phenethyl Propionate is classified by EPA as a minimum 

risk active ingredient and is known to be non-hazardous to humans and animals. 2-

Phenethyl Propionate meets the criteria for minimum risk in that it is 1) listed GRAS by the 

FDA, 2) has a non-toxic mode of action and is generally considered non-toxic, 3) has 

negligible human or environmental exposure, and 4) is nonpersistent. Moreover, 2-

Phenethyl Propionate has been shown to rapidly degrade in water and soil and in the gut. 

Its primary degradates are well studied, are rapidly metabolized and excreted, and pose no 

significant risk. 

Toxicity of Degradates PEA and Propionic Acid:

2-PEP rapidly degrades to PEA and Propionic Acid which are the principal residues following use of 

2-PEP. Both compounds are approved for use in food by FDA. The toxicology of PEA has been 

extensively documented in the literature, and the Agency has conducted robust reviews of that 

information (MRID No. 487536-06). Moreover, Propionic Acid is a normal metabolite in mammalian 

systems and would be expected to undergo the same metabolic process as endogenous Propionic

Acid.

The results of toxicity testing on 2-PEP, information on toxicity of the major degradates, the direct 

food additive status of 2-PEP, and its status as a minimum risk active ingredient show there is no 

risk to human health from 2-Phenethyl Propionate. Both dietary and non-dietary exposures would 

not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern. 
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SECTION D Aggregate Exposure

1) Dietary Exposure:

Dietary exposure from use of 2-PEP, as proposed, is minimal. The intended use of 2-PEP is 

as a crack and crevice treatment in food and feed handling and processing facilities for the 

control of insect pests. 2-PEP is a plant volatile that rapidly degrades into PEA and 

Propionic Acid in the environment. It is a naturally occurring ingredient and is not considered 

persistent based on its characteristics, properties or known degradation pathways. 

The results of toxicity testing, information on toxicity testing of degradates, and the 

ingredient’s status as GRAS, as a direct food additive, and as a minimum risk active 

ingredient show there is no risk to human health from 2-PEP. There are no reports of 

ecological or human health hazards caused by 2-PEP. Dietary exposures would not be 

expected to pose any quantifiable risk, due to a lack of residues of toxicological concern. 

2) Drinking Water Exposure:

Similarly, exposure to humans from residues of 2-PEP or it’s degradates in consumed 

drinking water would be unlikely. Potential exposure to surface water would be unlikely and 

exposure to drinking water (well or ground water) would be impossible to measure. The 

intended use of 2-PEP is as a crack and crevice treatment in food and feed handling and 

processing facilities for the control of insect pests. The ingredient is not applied directly to 

water.

The results of toxicity testing, information on toxicity testing of degradates, and the 

ingredient’s status as GRAS, as a direct food additive, and as a minimum risk active 

ingredient show there is no risk to human health from 2-PEP. There are no reports of 

ecological or human health hazards caused by 2-PEP. Drinking water exposures would not 

be expected to pose any quantifiable risk due to a lack of residues of toxicological concern. 

3) Non-Dietary Exposure:

The potential for non-dietary exposure to the general population, including infants and 

children, is unlikely as the proposed use sites are commercial food handling and processing 

facilities. The intended use of 2-PEP is as a crack and crevice treatment in food and feed 

handling and processing facilities for the control of insect pests. 2-PEP is a plant volatile 

that rapidly degrades into PEA and Propionic Acid in the environment. It is a naturally

occurring ingredient and is not considered persistent based on its characteristics, properties 

or known degradation pathways. 

The results of toxicity testing, information on toxicity testing of degradates, and the 

ingredient’s status as GRAS, as a direct food additive, and as a minimum risk active 

ingredient show there is no risk to human health from 2-PEP. There are no reports of 

ecological or human health hazards caused by 2-PEP. Non-dietary exposures would not be 

expected to pose any quantifiable risk due to a lack of residues of toxicological concern. 
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SECTION E Cumulative Effects

It is not expected that, when used as proposed, 2-PEP would result in residues that are of 

toxicological concern. The intended use of 2-PEP is as a crack and crevice treatment in food and 

feed handling and processing facilities for the control of insect pests. 2-PEP is a plant volatile that 

rapidly degrades into PEA and Propionic Acid in the environment. It is a naturally occurring 

ingredient and is not considered persistent based on its characteristics, properties or known 

degradation pathways. The results of toxicity testing, information on toxicity testing of surrogates, 

and the ingredient’s status as GRAS, as a direct food additive, and as a minimum risk active 

ingredient show there is no risk to human health from 2-PEP. There are no reports of ecological or 

human health hazards caused by 2-PEP. 
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SECTION F Safety Determination

1) General US Population:

The results of toxicity testing, information on toxicity testing of degradates, and the 

ingredient’s status as GRAS, as a direct food additive, and as a minimum risk active 

ingredient show there is no risk to human health from 2-PEP. The intended use of 2-PEP is

as a crack and crevice treatment in food and feed handling and processing facilities for the 

control of insect pests. It is not expected that, when used as proposed, 2-PEP would result 

in residues that are of toxicological concern. 2-PEP is a plant volatile that rapidly degrades 

into PEA and Propionic Acid in the environment. It is a naturally occurring ingredient and is 

not considered persistent based on its characteristics, properties or known degradation 

pathways. There are no reports of ecological or human health hazards caused by 2-PEP. 

There is a reasonable certainty of no harm to the general US population from exposure to 

this active ingredient.

2) Infants and Children:

As mentioned above, it is not expected that, when used as proposed, 2-PEP would result in 

residues that are of toxicological concern. There is a reasonable certainty of no harm for 

infants and children from exposure to 2-PEP from the proposed uses. 
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SECTION G – Effects on Immune and Endocrine Systems

To date there is no evidence to suggest that 2-PEP or its degradates PEA or Propionic Acid function 

in a manner similar to any known hormone, or that they acts as an endocrine disrupter. 
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SECTION H – Existing Tolerances

There is no US EPA tolerance or tolerance exemption for 2-PEP. 

There is an existing exemption from the requirement of a tolerance for residues of the degradate 

Propionic Acid, when used as an active or an inert ingredient, on all foods at 40 CFR 180.1023.
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SECTION I – International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for 2-PEP or 

it’s degradates PEA and Propionic Acid.