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**Exposure and Risk**  **Considerations for Methyl Salicylate for use on Pre**  **- flowering Bell**  **Peppers and Tomatoes Docket ID Number: EPA**  **- HQ**  **- OPP**  **- 2014**  **- 0898** 

**Date: September 3 , 2015**  **ACTION REQUESTED** Valent Biosciences Corp. has submitted a request for registration for VBC
- 60347 Biological Insecticide Emulsifiable Suspension, an end
- use product (EP), which contains methyl salicy late and B acillus thuringiensis subsp kurstaki strain ABTS
- 351 as its active ingredient s. The product is intended for use as a foliar application to tomatoes and bell peppers up to the flowering stage of growth. This new use represents the first use of methyl salicy late as delivered in a manner where it is not enclosed in materials. Meth yl salicy late has been previousl y characterized in the Reregistration Eligibility Decision (RED) Document for Meth yl Salicy late, November 2005, available at: http://www.epa.gov/pesti cides/reregistration/REDs/methyl_salicy late_red.pdf This document supersedes the RED with regards to the exposure and risk assessment of methy l salicy late. **BACKGROUND AND USE PROFILE** Methy l salicy late was first registered in 1972 for use as an animal r epellant in impregnated twist tabs to be hung on plants to repel dogs and cats from flower gardens. A subsequent registration of methy l salicy late followed in 1996 as an insect repellent to be used as a constituent of food and feed packaging material to re pel 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). The proposed new registration, VBC
- 60347 Biological Insecticide Emulsifiable Suspension , is a highl y selective insecticide for use against listed caterpillars (lar vae) of Lepidopterous insects. It is formulated as an emulsifiable suspension which contains 5.95% of the active ingredient (a.i.) methy l salicy late (CAS Number 119
- 36
- 8). VBC
- 60347 is applied 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 frequentl y than every

5 day s. The personal protective equipment statement on the VBC
- 60347 Biological Insecticide Emulsifiable Suspension proposed pro duct label indicates that all applicators and other handlers must wear a long sleeved shirt and long pants, chemical resi stant gloves, socks and shoes. Mixer/loaders and applicators must wear a dust/mist filtering respirator meeting NIOSH standards of at l east 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 ABTS
351, listed on the proposed label can c ause an allergic sensitization.2

**EXPOSUR E**  **AND RISK ASSESSMENT**  Dietary Exposure and Risk The proposed new use of methy l salicylate as a foliar spray on field and greenhouse pre
flowering tomatoes and peppers is considered a non
- food use since the residue data indicate that methyl salicy late will not be present on the crop at the time of harvest. Methy l salicy late has a half
- life of less than two and a half hours on foliage. It is readil y biodegradable in screening tests and may be expected to biodegrade in soils and surface waters ( U.S. EPA, 2005 ). Moreover, methyl salicy late is likely to hy drol yz e in water, especially at alkaline pH ( U.S. EPA, 2005 ). Therefore, the potential for dietary exposure is negligible and there are no risks of concern associated with the proposed use. Residential Exposure and Risk The proposed new use as a foliar application to field and greenhouse pre
- flowering tomatoes and bell peppers is not intended for use in residential settings. However, meth yl salicylate is registered for use in residential gardens as a r epellent to dogs and cats. The registered residential product is formulated as read y to use, self
- contained impregnated twist tabs which are hung in home gardens thereb y significantly limiting the potential for dermal and inhalation exposure. The potential for post
- application dermal and inhalation exposure resulting from entry into treated areas is also anticipated to be negligible. Vapors released from the plastic matrices twist ties are released in small amounts over an extended period of time. Ther efore, it is very highl y likely that an y trace of the active ingredient will have completel y dissipated. Although there is potential for incidental non
- dietary exposure to young children, the likelihood of an incident is anticipated to be very

low. The ext ent to which young children will be engaged with the end
- use product in home gardens for prolonged periods of time is low and significant non dietary ingestion exposure is not expected. Aggregate Exposure and Risk In accordance with the Food Quality Protection Act (FQPA), the Agency must consider and aggregate pesticide exposures and risks from three major sources; food, drinking water and residential exposures. Methy l salicy late is currently registered as an insect repellent in food packaging. An exe mption from the requirements of a tolerance for residues of the insecticide Methy l salicy late in or on food, when used as an insect repellent in food packaging and animal feed packaging at an application rate that does not exceed 0.2 mg of meth yl salicy lat e per square inch of packing material was established at 40 CFR §180.1189. To mitigate and offset potential exposure to workers handling this manufacturing use product, explicit product labeling statements requiring personal protective equipment (e.g., rub ber gloves, splash
- proof goggles, and/or full face shield) are required. The proposed new use of methy l salicylate as a foliar spray on field and greenhouse pre
flowering tomatoes and peppers is considered a non
- food use since the residue data indicate th at methyl salicy late will not be present on the crop at the time of harvest. It is readil y biodegradable3

in screening tests and may be expected to biodegrade in soils and surface waters ( U.S. EPA, 2005 ). Therefore, the potential for dietary exposure is negligible and there are no risks of concern associated with the proposed use. There are two registered pesticidal uses for meth yl salicylate as cat and dog repellents on ornamental shrubs and bushes. Since the end use product is formulated as read y to use, self
contained impregnated twist tabs which are hung in home gardens thereb y significantl y limiting the potential for applicator de rmal and inhalation exposure. The potential for post
- application der mal and inhalation exposure resulting from entry into treated areas is also anticipated to be negligible. The exposure to humans from the pesticidal use of methy l salicy late is expected to be minimal, compared with the widespread use of meth yl salicy late as a flavoring ingredient in foods. 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 salicy late would result in minimal additional exposure; expected exposure levels from these uses would be well below defined acceptable levels, even considering the sensitivity of infants and children. Occupational Exposure and Risk VBC
- 60347 is applied as foliar spray using ground or handheld equipment to pre - flowering bell peppers and tomatoes in fields and or greenhouses at an application rate of 1.0 to 4.0 pints/acre. Applications are to be made up to the flowering stage of growth. There is potential for dermal and inhalation exposure to occupationa l handlers, specificall y females of child bearing age, while mixing/loading and applyingthe proposed product. However, the low level of potential exposures (dermal and inhalation) during the mixing/loading and application process of this biochemical are more than adequatel y mitigated by the use of personal protective equipment and precautionary

language statements placed on end
- use product labels. In addition, any potential inhalation exposure from methyl salicylate are deemed to be minimal because inhal ation exposures will be less than those conducted in a saturated (more concentrated) atmosphere which had no indication of toxic effect in laboratory animals. Furthermore, since methyl salicy late has a half
- life of less than two and a half hours on foliag e and is readil y biodegradable and may be expected to biodegrade in soils, the potential for post
application dermal and inhalation exposure is anticipated to be negligible and risk of concern to workers entering treated areas. Cumulative Effects Unlike other pesticides 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 methy l salicylate and any other substances and methy l salicy late does not appear t o produce a toxic metabolite produce d by other substances. For the purposes of this action, therefore, EPA has not assumed that methy l salicylate has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the4

policy statements released by

EPA’s Office of Pesticide Programs concerning common m echanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at: http://www.epa.gov/pesticides/cumulative/
. **REFERENCES CITED** U.S. EPA, 2005. Reregistration Eligibility Decision (RED) Document for M ethyl Salicy late, United States Environmental Protection Agency (U.S. EPA). November, 2005. A vailable at: http://www.epa.gov/pesticides/reregistration/REDs/methyl_salicy late_red.pdf U.S. EPA, 2006. Inert Reassessments: One Exemption from the Requirement of a Tolerance fo r Wintergreen oil (CAS Reg. No. 119
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- 8). Memorandum from Pauline Wagner to Lois A. Rossi. United States Environmental Protection Agency (U.S. EPA). June 8, 2006. A vailable at: http://www. epa.gov/opprd001/inerts/wintergreen.pdf