EPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION NOTICE OF FILING TEMPLATE FOR PESTI CIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER EPA Biopesticides and Pollution Prevention Division contact: Shanaz Bacchus (703) 308 - 8097 EPA has received a pestici de petition [insert petition number] from Certis USA LLC , 9145 Guilford Road, Suite 175, Columbia, MD 21046 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 residues of the microbial pesticide Paecilomyces fumosoroseus Apopka strain 97 in or on all agricultural commodities . Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Certis USA LLC has sub mitted the following summary

of information, data, and arguments in support of their pesticide petition. This summary was prepared by Certis USA LLC and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by

E PA if the terminology

used was unclear, the summary

contained extraneous material, or the summary unintentionally

made the reader conclude that the findings reflected EPA’s position and not the position of the petitioner. I. Certis USA LLC Petition Summary PP 9F7665 A. Product name and Proposed Use Practices The microbial pest control agent is Paecilomyces fumosoroseus . Apopka strain 97 . Paecilomyces fumosoroseus Apopka strain 97 belongs to the class of Fungi imperfecti. It was isolated on a large numbe r of insects throughout the world. The insecticidal activity is related to the ability

of the blastospores to infect a host insect. The spores form appressoria and penetrate into the insect cuticle. The fungus continues to grow within the insect which fina lly leads to the disruption of the host. In high moisture conditions, conidia and conidiophores are produced after the death of the insect. The species Paecilomyces fumosoroseus Apopka strain 97 h a s wide range of insect hosts. The proposed use by

Certis U SA is for application to growing crops and ornamental plants for control of aphids, mites and whiteflies.EPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption B. Product Identity/Chemistry 1. Identity of the pesticide and corresponding residues . The microbial pest control agent Paecilomyces fumosoroseus Apopka strain 97 is a naturall y occurring soil fungus which is entomopathogenic to many orders of insects. Itwill infect and control several insect pests including whiteflies, thrips, aphids and spider mites. Under proper environmental conditions spores o f the fungus attach to and penetrate the cuticle of the insect. The fungus grows inside the insect causing its death. Paecilomyces fumosoroseus Apopka stain 97 has been reported to be originally isolated in 1986 from a meal y bug in a greenhouse in Apopka , FL. The pure culture was identified in 1988 and deposited at the American Ty pe Culture Collection (ATCC # 20874). Paecilomyces species occur naturally in populations of infected and dead insects and randoml y in soils around the world. The active ingredie nt can be cultured readil y on various culture media and exists in several morphological stages, depending upon the culture medium. On solid medium, conidiophores, conidia and m ycelia are predominant while submerged culture produces blastospores and mycelia . 2. Magnitude of residue at the time of harvest and method used to determine the residue . Paecilomyces fumosoroseus Apopka strain 97 is a naturally occurring fungus which has been isolated in soils worldwide and as such, humans, animals, and plants are co nstantly exposed to this fungus . Itis expected that, when used as proposed, Paecilomyces fumosoroseus Apopka strain 97 would not result in residues that are of toxicological concern. Paecilomyces fumosoroseus Apopka strain 97 is affected by sunlight, temperature, humidity , substrate, and chemicals , which reduces the potential for residues to occur. Normal washing after harvest and before sale would further reduce or remove an y residues . Additionally , there is a low probability

of germination in the a

bsence of an insect host on harvested crops , further reducing the chance of residues on treated crops. Any potentiall y occurring residual deposits on crops will not harm humans because the strain shows no toxicity , infectivit y, or pathogenicit y in appropriate tests . Further the optimal temperature range for growth, germination and sporulation is between 20 and 30 degrees C while the normal body temperatures of humans, other mammalian species and avian species is significantly higher than 30 degrees C and therefore unsuitable for growth and reproduction of Paecilomyces fumosoroseus Apopka strain 97. The active substance is produced in liquid fermentation. Secondary metabolites such as beauverolides and beauvericine have been detected in still culture, but not in liquid fermentation.EPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption 3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed . The acute toxicity

and genotoxicity

studies discussed in Section C of this document are sufficient t o show that there are no foreseeable human or domestic health hazards likely to arise from the use of the product as proposed. This fungus occurs naturally and is present on foods regardless of treatment. Since enforcement of residue levels would not be ne eded, an enforcement anal yt ical method is not required. Certis USA is requesting an exemption from the requirement for a tolerance for an y residues remaining in/on all agricultural commodities . C. Mammalian Toxicological Profile Acute oral toxicity

/path ogenicity - rat

– In an acute test with rats, oral application of 1.7 x 10 6 colony forming units per animal in form of a conidia spore suspension did neither cause mortality nor abnormal clinical effects. No signs of fungal contamination of brain, mesenteric ly mph nodes, blood, kidney , spleen, liver, lung or caecum or infectivity or pathogenicit y were recorded. Acute intraperitoneal toxicity /pathogenicit y – rat

– the test substance was administered to 18 male and 18 female rats. No signs of toxicity or pathog enicity

were observed under the condition of the test. Single intraperitoneal doses of suspensions containing 1.6x 10 7 conidia spores per animal had no toxic or pathogenic effects in rats and the spores were cleared from the body within two day s. EPA has c lassified the product as toxicity category IV. Acute pulmonary

toxicity /pathogenicity - rat

– in this test a single intratracheal dose was administered to test animals . No deaths occurred and there were no signs of toxicity observed in an y animal under th e conditions of this test . No signs of infection were seen and no colonization of the lungs was observed. Total clearance of the fungus was attained b y da y eight after treatment. EPA has classified the product as toxicity category IV. Acute dermal toxici ty

/pathogenicity - rat

– in this test 2 grams of test substance was applied to the skin of rabbits. No deaths occurred and there was no evidence of s ys temic toxicity under the conditions of this test . EPA has classified the product as toxicity category II I. Primary ey e irritation

– the test substance was instilled in the eye of albino rabbits and examined at 1, 24, 48 and 72 hours and at 4 and 7 day s after treatment. The test substance produced slight irritation which was reversible by day 4 after treatment. Based on the test results EPA has classified the product as toxicity

category IV. Dermal irritation

– rabbit

– in a four hour dermal exposure to the skin of rabbits, the test substance was found to be a slight dermal irritant and EPA has classifi ed the product as toxicity category IV. Dermal sensitization

– guinea pig

– the test substance was administered dermally to guinea pigs. The test substance produced no irritation or sensitization reaction in treated animals. EPA has c lassified the prod

uct as ‘not a dermal sensitizer’.EPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption Mutagenicity

Test on Salmonella Ty

phimurium (Ames Assay)

– Sonicated blastospores and mycelium of Paecilomyces fumosoroseus Apopka strain 97 yi elded negative results in a Salmonella microsome reverse mutation assay in both the presence and absence of microsomal enzy mes (S9) . D. Aggregate Exposure 1. Dietary exposure . i. F ood Paecilomyces fumosoroseus Apopka strain 97 is a naturally occurring fungus which has been isolated in soils worldwide and as such, humans, animals , and plants are constantly exposed to this fungus . Itis expected that, when used as proposed, Paecilomyces fumosoroseus Apopka strain 97 would not result in residues that are of toxicological concern. Paecilomyces fumosoroseus Apopka strain 97 is affec ted b y s unlight, temperature, humidity , substrate, and chemicals. As a pestic i de it germinates and grows on insect hosts, but cannot grow on the treated crops per se . When exposed to sunlight, Paecilomyces fumosoroseus Apopka strain 97 lose their viabil ity rapidly with half - lives that may be as short as 2 - 3 hours. After harvest an y remaining fungal spores on crops will be exposed to unfavorable conditions (e.g. dry ness), and are not likely

to germinate and grow on the harvested crop. Any potentiall y occ urring residual deposits on these crops will not harm humans because the strain shows no toxicity , infectivity , or pathogenicity in appropriate tests . Further the optimal temperature range for growth, germination and sporulation is between 20 and 30 degre es C while the normal body temperatures of humans, other mammalian species and avian species is significantl y higher than 30 degrees C and therefore unsuitable for growth and reproduction of Paecilomyces fumosoroseus Apopka strain 97. While the proposed use pattern may result in dietary

exposure with possible residues in or on certain agricultural commodities, negligible, to no risk, is expected for the general population, including infants and children, or animals because Paecilomyces fumosoroseus Apopka strain 97 demonstrated no p athogenicity

or toxicity

at the maximum dose s tested . Since Paecilomyces fumosoroseus Apopka strain 97 is a fungus that is naturally occurring in insects and in soils, humans may be exposed dermall y and orally to this common fungus when they get soil on their hands or clothing, or handle pets that have played in soil. Importantly , no toxicological endpoints were identified for Paecilomyces fumosoroseus Apopka strain 97 and there is no evidence of adverse effects from oral, derma l, or pulmonary exposure to this MPCA. It is not expected that the pesticidal use of Paecilomyces fumosoroseus Apopka strain 97 will significantly increase the non - dietary

and non - occupational exposure to the fungus. Based on the proposed use patter ns, in which Paecilomyces fumosoroseus Apopka strain 97 is applied directl y to soil of agricultural and ornamental crops, the potential for non - dietary , non occupational exposures to Paecilomyces fumosoroseus Apopka strain 97 pesticide residues b y theEPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption gene ral population, including infants and children, is low. Moreover, even in the unlikely event of non - dietary , non - o ccupational exposures to Paecilomyces fumosoroseus Apopka strain 97 pesticide residues, no harm is expected because no toxicity or pathogenici ty

was found in mammalian studies that included high levels of oral, pulmonary , and dermal exposure. . Drinking water . Paecilomyces fumosoroseus Apopka strain 97 is not known as an aquatic microorganism, and therefore is not expected to proliferate in aquatic habitats. There are no aquatic use sites permitted for this pesticide, so exposure to drinking water is not expected. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to Paecilomyces f umosoroseus Apopka strain 97 through drinking water. Accordingl y, the use of this MCPA on terrestrial plants is not anticipated to lower the quality of drinking water. Even if low levels of the microbe were present in drinking water, no risk to the general public would be expected because Paecilomyces fumosoroseus Apopka strain 97 demonstrated no pathogenicity or toxicity

at the maximum dose tested. The potential of significant transfer to drinking water is minimal to nonexistent. 2. Non - dietary exposure . Since Paecilomyces fumosoroseus Apopka strain 97 is naturally a occurring fungus , there may be non - dietary

exposure from these naturall y occurring background levels. However, it is not expected that the pesticidal use of Paecilomyces fumosoroseus Apopka strain 97 will significantl y increase the non - dietary and non - occupational exposure to the fungus . E. Cumulative Exposure There is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposures to residues of Paecilomyces fumosoroseus Apopka strain 97 as a result of its proposed uses. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. There appears to be no potential for harm, fro m this fungus in its use as a microbial pesticide in agricultural commodities. Furthermore, the organism is naturally occurring in soils, and is non - toxic and non - pathogenic to animals and humans. This conclusion is based on the results of the mammalian to xicity tests referenced in Section C. Moreover, potential non - occupational inhalation or dermal exposure is not expected to pose any adverse effects to exposed populations via aggregate and cumulative exposure. Therefore no cumulative effects from the re sidues of this product with other related microbial pesticides are anticipated. F. Determination of Safety for U.S. population, Infants and ChildrenEPA - HQ - OPP - 2010 - 0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption There is reasonable certainty that no harm will result to the U.S. population, including infants and chil dren, from aggregate exposures to residues of Paecilomyces fumosoroseus Apopka strain 97 as a result of its proposed uses. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previ ousl y, there appears to be no potential for harm, from this f

ungus in its use as a microbial pesticide in production of growing crops or in production of ornamental plants . Furthermore, the organism is naturally occurring in the environment , and non - toxic and non - pathogenic to animals and humans. This conclusion is based on the results of the mammalian toxicity tests discussed in Section C. Moreover, potential non occupational inhalation or dermal exposure is not expected to pose any adverse effects to e xposed populations via aggregate and cumulative exposure. G. Effects on the Immune and Endocrine Systems There is no information to indicate that Paecilomyces fumosoroseus Apopka strain 97 would have an effect in humans similar to an effect produced b y a naturally - occurring estrogen or other endocrine effects. There is no known metabolite produced by this y east that acts as an endocrine disruptor. The submitted toxicity

/pathogenicity

studies in rodents indicate that following dosing that no viable conid ia or blastospores were found in organs or tissues of test animals. It is concluded that there will be no incremental adverse effects to the endocrine sy stem. H. Existing Tolerances There are no existing tolerances or tolerance exemptions for Paecilomyces fumosoroseus Apopka strain 97. EPA has established an exemption from the requirement of a tolerance for residues of the fungus Paecilomyces lilacinus in or on all agricultural commodities at 40 CFR Part 180.1257 . I. International Tolerances The E uro pean Food Safety Authorit y Scientific Report (2007), 115, 1 - 161 , determined that under Regulation (EC) No 396/2005 of the European Parliament and of the Council on Maximum Residue Levels for pesticides ( 28 October 2007 ) that no MRL s and no residue definiti ons have to be established for the use of Paecilomyces fumosoroseus Apopka strain 97 on agricultural crops. T here is no CODEX maximum residue level for residue of Paecilomyces fumosoroseus Apopka strain 97.