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I Background 

On March 20, 2014, the U.S. Environmental Protection Agency (EPA) received a proposed 

registration application from Valent Biosciences Corporation (Valent) for a new use of VBC60347 Biological Insecticide Emulsifiable Suspension (VBC-60347) to control army and pod 

worms in tomatoes and bell peppers in agricultural fields and greenhouses. VBC-60347 is 

formulated as an emulsifiable suspension which contains 5.95% of the active ingredient (a.i.) 

methyl salicylate (CAS Number 119-36-8). 

Methyl salicylate is classified as a biochemical pesticide and is the primary constituent in oil of 

wintergreen, a naturally fragrant oil. It is characterized as a colorless, yellowish or reddish, oily 

liquid with the distinct odor and taste of wintergreen or gaultheria. Methyl salicylate is naturally 

extracted via steam distillation of macerated leaves from the low growing plant, Gaultheria 

procumbens Lime. (fam. Ericaceae) or from the bark of Betula lenta (Sweet Birch). Methyl 

salicylate can also be manufactured synthetically. 

Methyl salicylate was first registered in 1972 for use as an animal repellant in impregnated twist 

tabs to be hung on plants to repel dogs and cats from flower gardens. A subsequent registration 

of methyl salicylate followed in 1996 as an insect repellent to be used as a constituent of food 

and feed packaging material to repel insects in stored commodities. This registration was 

considered to be a “food use,” and thus necessitated the establishment of an exemption from the 

requirement of a tolerance (see 40 CFR §180.1189). Methyl salicylate also has a long history of 

use in consumer products as a counterirritant and as an analgesic for the management of aching 

and painful muscles and joints as well as suntan lotions (as an UV-absorber) and perfumery as a 

modifier of blossom fragrances (EPA, 2005). 

The new proposed use put forth by Valent (VBC-60347 Biological Insecticide Emulsifiable 

Suspension) is intended for use as a foliar application to tomatoes and bell peppers up to the 

flowering stage of growth, and is therefore a non-food use. VBC-60347 is a highly selective 

insecticide for use against listed caterpillars (larvae) of Lepidopterous insects. VBC-60347 is 

proposed for application as foliar spray using ground or handheld equipment to bell peppers and 

tomatoes in fields and or greenhouses at an application rate of 1.0 to 4.0 pints/acre, up to a total 

of 16 pints per acre per season. Applications are to be applied up to the flowering stage of 

growth and must not be applied more frequently than every 5 days. The personal protective 

equipment (PPE) statement on the proposed label indicates all applicators and other handlers 

must wear long sleeved shirt and long pants, chemical resistant gloves, socks and shoes. 

Mixer/loaders and applicators must wear a dust/mist filtering respirator meeting NIOSH 

standards of at least N-95, R-95, or P-95. Repeated exposure to high concentrations of microbial 

proteins from the second active ingredient, Bacillus thuringiensis, subsp. kurstaki, strain ABTS351, listed on the proposed label can cause an allergic sensitization. 

This proposed new use represents the first use of methyl salicylate as delivered in a manner 

where it is not enclosed in materials. On October 1, 2009, EPA announced a new policy to 

provide a more meaningful opportunity for the public to participate on major registration 

decisions before they occur. According to this policy, EPA provides a public comment period 

prior to making a registration decision for the following types of applications: new active 

ingredients, first food use, first outdoor use, first residential use; and any registration decisions 
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for which the Agency believes there may be substantial public interest. The Agency believes that 

the new use proposed for methyl salicylate falls into the category of “substantial public interest.” 

2.0 Evaluation 

In evaluating a pesticide registration application, the EPA performs risk assessments to 

determine the potential of adverse effects (i.e., risk) resulting from exposures associated with the 

proposed use. The assessments evaluate a product’s potential to affect a wide range of nontarget organisms including humans, terrestrial, and aquatic wildlife (plants and animals) as well 

as the environmental fate of the compound (i.e., how the chemical will move in the 

environment). On the basis of these assessments, EPA evaluates and approves language for each 

pesticide label to ensure the directions for use and safety measures are appropriate to mitigate 

any potential risk. In this way, the pesticide’s label helps to communicate essential limitations 

and mitigations that are necessary for public safety. In fact, the pesticide law has a provision 

which indicates that it is a violation to use a pesticide in a way that conflicts with the label. 

2.1 Assessment of Risk to Human Health 

2.1.1 Toxicity 

EPA requires a wide range of studies in order to assess a pesticide. For methyl salicylate, the 

toxicological database is adequate to support the assessment of risk to human health from 

pesticidal use on tomatoes and peppers, pre-flowering: 

 Methyl salicylate is moderately acutely toxic by the oral route, but non-toxic by the 

dermal route. It is a severe skin and eye irritant (Toxicity Category II). 

 Subchronic studies indicate no toxic effects in 90-day oral, dermal or inhalation studies. 

However, a No Observed Adverse Effect Level (NOAEL) for reproductive effects was 

established at 250 milligrams per kilograms (mg/kg) and a Lowest Observed Adverse 

Effect Level (LOAEL) was established at 500 mg/kg based on the decreased number of 

litters per breeding pair and reduced live litter size. The available mutagenicity studies 

were negative. 

 The evaluation of the chronic toxicity studies indicates that methyl salicylate is not 

carcinogenic. 

2.1.2 Exposure 

In the proposed new use of methyl salicylate as a foliar spray on field and greenhouse preflowering tomatoes and peppers, the potential for dietary exposure is negligible and this is 

considered by the Agency to be a non-food use based on the following: 

 Residue data indicate that methyl salicylate will not be present on the crop at time of 

harvest. 

 Methyl salicylate has a half-life of less than two and a half hours on foliage. 

 Methyl salicylate is readily biodegradable in screening tests and may be expected to 

biodegrade in soils and surface waters. 
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 Methyl salicylate is likely to hydrolyze in water, especially at alkaline pH. 

Residential and occupational exposure are also expected to be negligible for the proposed new 

use: 

 The VBC-60347 label is for agricultural use only. The proposed product is not for use in 

residential sites. 

 The exposure to humans from the pesticidal use of methyl salicylate is expected to be 

minimal, compared with the widespread use of methyl salicylate as a flavoring ingredient 

in foods. 

 The low level of potential exposures (dermal and inhalation) during the mixing/loading 

and application process of this biochemical are more than adequately mitigated by the use 

of personal protective equipment and precautionary language statements placed on enduse product labels. 

2.1.3 Human Health Conclusions 

Although reproduction effects were seen for methyl salicylate at a LOAEL of 500 mg/kg, 

significant human exposure to this biochemical is not expected under the conditions of current or 

proposed product use. Current products are ready to use, self-contained impregnated twist tabs 

and food packing material. The proposed product is a foliar spray for peppers and tomatoes preflowering with PPE required on the proposed product label and appropriate precautionary 

language statements, which mitigates the low level of potential exposure for the proposed new 

use. 

Acute toxicity studies performed on the proposed end-use product (EP) “VBC-60347 Biological 

Insecticide Emulsifiable Suspension” (ai. Bacillus thuringiensis subsp. kurstaki, Strain ABTS351, 26.55% and Methyl Salicylate, 5.9%) demonstrate labeling precautionary signal word must 

be “CAUTION.” 

Based on these considerations and those listed in the previously described hazard assessments, an 

assessment of an aggregate exposure for all pesticidal uses of methyl salicylate would result in 

minimal additional exposure beyond what consumers already receive from other uses. Expected 

exposure levels from these uses would be well below defined acceptable levels, even considering 

methyl salicylate sensitivity to infants and children. 

2.2 Ecological Exposure and Risk 

The battery of tests required to assess the environmental fate and ecological effects of methyl 

salicylate is complete. The biochemical is readily biodegradable in screening tests and may be 

expected to biodegrade in soils and surface waters (HSDB, 1996). Moreover, methyl salicylate is 

likely to hydrolyze in water, especially at alkaline pH (HSDB, 1996). At pH 7.5, its hydrolysis 

half-life is estimated to be 14.1 days (HSDB, 1996). Methyl salicylate absorbs UV radiation 

>2990 nm and therefore may undergo direct photolysis under environmental conditions (HSDB, 

1996); the photolysis half-life was reported to be 48 minutes in one study (HSDB, 1996). In the 

atmosphere, methyl salicylate reacts with photochemically produced hydroxyl radicals with an 
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estimated rate constant of 11.6 x 10-12cm3 /molecule. Assuming a hydroxyl radical concentration 

of 5 x 10-5 radicals/cm3

, the half-life of methyl salicylate in the atmosphere would be 1.4 days 

(HSDB, 1996). 

Ecotoxicity data on methyl salicylate show that the compound is: 

 slightly to practically non-toxic to avian species; 

 slightly to practically non-toxic to fish; 

 slight toxicity to aquatic invertebrates; 

 not phytotoxic; 

A contact toxicity study on honey bees using the proposed EP showed no toxic effects (24-hr and 

48-hr LD50 for contact toxicity was greater than 125 μg ai/bee). 

Non-target plant data requirements were addressed with approved waiver rationales based upon 

1) methyl salicylate’s high vapor pressure, which results in volatilization and rapid losses from 

surfaces, 2) its demonstrated nontoxicity of the compound to plants in the applicant-submitted 

efficacy studies, and 3) its natural occurances in many plant species. 

Moreover, with regards to ecological toxicity, methyl salicylate is currently released to the 

environment in effluents and emissions as a result of it production, disposal and use as a 

flavoring in foods and beverages, as a fragrance agent in cosmetics and perfumes, as a 

pharmaceutical agent (counterirritant) in ointments and oral rinses, as a UV-absorber in suntan 

lotions, as a carrier for fabric dyes, and as a UV-stabilizer in acrylic resins. The Agency 

estimates that pesticidal use of methyl salicylate is very small in comparison to its current nonpesticidal uses. Therefore, the Agency believes that pesticidal use of methyl salicylate, including 

the proposed new use as a foliar spray, will not contribute significantly to ecological exposure of 

this biochemical. 

4.0 Alternatives 

Methyl salicylate can be used alone or alongside currently registered biochemical or 

conventional animal or insect repellents and plant growth regulators; methyl salicylate can be an 

important component of an Integrated Pest Management (IPM) system. The use of this 

biochemical animal and insect repellent and insecticide may displace and reduce the amount of 

conventional active ingredients required for these purposes. Growers may prefer to use methyl 

salicylate as a viable alternative to conventional products since methyl salicylate products 

contain shorter Re-Entry Intervals (REI) and short half-life (less than two and a half hours on 

foliage). 

5.0 Benefits and Public Comments 

By definition alone, biochemicals are favorable when compared to currently registered 

conventional alternatives because biochemicals are naturally-occurring substances (or substances 

structurally-similar and functionally identical to naturally-occurring substances) with a history of 

exposure to humans and the environment demonstrating minimal toxicity and a non-toxic mode 

of action to the target pest(s). Benefits of biochemical pesticides as compared to conventional 
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pesticides typically include lower toxicity profiles for humans and non-target organisms, and 

faster degradation in the environment. As outlined above, methyl salicylate is a viable alternative 

to conventional animal and insect repellents and plant growth regulators due to its low toxicity 

profile and half-life of less than two and a half hours on foliage. 

On January 14, 2015, EPA published in the Federal Register a Notice of Receipt of the Valent 

application for registration of methyl salicylate as a foliar spray and announced a public 

comment period of 30 days. No comments were received in response to this Notice of Receipt. 

6.0 Regulatory Decision 

The Agency’s methyl salicylate database is comprised of 40 studies and is considered to be 

complete. The proposed use of methyl salicylate as a foliar spray on tomatoes and bell peppers in 

agricultural fields and greenhouse is well supported by this database. In considering the assessed 

risk to human health and the environment, the Agency concludes that methyl salicylate meets the 

regulatory standard under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). 

There are no outstanding data requirements for this biochemical. Therefore, the EPA is granting 

the unconditional registration of this use of methyl salicylate under Section 3(c)(5) of FIFRA. 

One product will be registered: “VBC-60347 Biological Insecticide Emulsifiable Suspension” is 

an end-use product (EP) containing the active ingredient Bacillus thuringiensis subsp. kurstaki

strain ABTS-351 in addition to methyl salicylate. Application of this product is approved for use 

outdoors on tomato and pepper plants, pre-flowering. The application rate is 1.0-4.0 pints of 

product per acre, up to a total of 16 pints per acre per season. Application must not be made 

more frequently than every 5 days. 

The risk assessments supporting this decision can be found at the following locations: 

 Memorandum from Michael Rexrode to Gina Burnett. June 17, 2015. Regulatory docket 

EPA-HQ-OPP-2014-0898; Document ID: EPA-HQ-OPP-2014-0898-0002 

 Exposure and Risk Considerations for Methyl Salicylate for use on Pre-flowering Bell 

Peppers and Tomatoes. September 3, 2015. Regulatory docket EPA-HQ-OPP-2014-0898; 

Document ID: EPA-HQ-OPP-2014-0898-0003 

 Reregistration Eligibility Decision (RED) Document for Methyl Salicylate, United States 

Environmental Protection Agency (U.S. EPA). November, 2005. Available at:

http://www.epa.gov/pesticides/reregistration/REDs/methyl_salicylate_red.pdf

 Inert Reassessments: One Exemption from the Requirement of a Tolerance for 

Wintergreen oil (CAS Reg. No. 119-36-8). Memorandum from Pauline Wagner to Lois 

A. Rossi. United States Environmental Protection Agency (U.S. EPA). June 8, 2006. 

Available at: http://www.epa.gov/opprd001/inerts/wintergreen.pdf