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 PESTICIDE PETITIONS PUBLISHED IN THE

FEDERAL REGISTER 

EPA Biopesticides and Pollution Prevention Division contact: Shanaz Bacchus (703) 308-8097

EPA has received a pesticide 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 submitted 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 EPA 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 

number 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 finally 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 has wide range of insect hosts. The 

proposed use by Certis USA 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 naturally 

occurring soil fungus which is entomopathogenic to many orders of insects. It will infect and control 

several insect pests including whiteflies, thrips, aphids and spider mites. Under proper 

environmental conditions spores of 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 mealy bug in a greenhouse in Apopka, FL. The pure culture was identified in 1988 and 

deposited at the American Type Culture Collection (ATCC # 20874). Paecilomyces species occur 

naturally in populations of infected and dead insects and randomly in soils around the world. The 

active ingredient can be cultured readily on various culture media and exists in several 

morphological stages, depending upon the culture medium. On solid medium, conidiophores, 

conidia and mycelia 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 constantly exposed to this 

fungus. It is 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 any residues. Additionally, there is a low

probability of germination in the absence of an insect host on harvested crops, further reducing the 

chance of residues on treated crops.

Any potentially occurring residual deposits on 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 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 to 

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 needed, an enforcement analytical 

method is not required. Certis USA is requesting an exemption from the requirement for a tolerance 

for any residues remaining in/on all agricultural commodities.

C. Mammalian Toxicological Profile 

Acute oral toxicity/pathogenicity- rat – In an acute test with rats, oral application of 1.7x106colony

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 lymph nodes, blood, 

kidney, spleen, liver, lung or caecum or infectivity or pathogenicity were recorded.

Acute intraperitoneal toxicity/pathogenicity – rat – the test substance was administered to 18 male 

and 18 female rats. No signs of toxicity or pathogenicity were observed under the condition of the 

test. Single intraperitoneal doses of suspensions containing 1.6x107conidia spores per animal had 

no toxic or pathogenic effects in rats and the spores were cleared from the body within two days. 

EPA has classified 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 any 

animal under the 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 by day eight after treatment. EPA has 

classified the product as toxicity category IV.

Acute dermal toxicity/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 systemic toxicity under the 

conditions of this test. EPA has classified the product as toxicity category III.

Primary eye 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 days 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 classified 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 

classified the product 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 Typhimurium (Ames Assay) – Sonicated blastospores and 

mycelium of Paecilomyces fumosoroseus Apopka strain 97 yielded negative results in a Salmonella 

microsome reverse mutation assay in both the presence and absence of microsomal enzymes (S9).

D. Aggregate Exposure 

1. Dietary exposure. 

i. Food

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. It is 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. As a pesticide 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 viability rapidly with half-lives 

that may be as short as 2-3 hours.

After harvest any remaining fungal spores on crops will be exposed to unfavorable conditions (e.g. 

dryness), and are not likely to germinate and grow on the harvested crop. Any potentially occurring 

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 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.

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 pathogenicity or toxicity at the maximum doses tested.

Since Paecilomyces fumosoroseus Apopka strain 97 is a fungus that is naturally occurring in insects 

and in soils, humans may be exposed dermally 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, dermal, 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 patterns, in which Paecilomyces fumosoroseus Apopka strain 97 is 

applied directly to soil of agricultural and ornamental crops, the potential for non-dietary, nonoccupational exposures to Paecilomyces fumosoroseus Apopka strain 97 pesticide residues by the 
EPA-HQ-OPP-2010-0087 Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance exemption

general population, including infants and children, is low. Moreover, even in the unlikely event of 

non-dietary, non-occupational exposures to Paecilomyces fumosoroseus Apopka strain 97 pesticide 

residues, no harm is expected because no toxicity or pathogenicity 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 

fumosoroseus Apopka strain 97 through drinking water. Accordingly, 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 naturally occurring background levels. However, 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.

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, from 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 toxicity 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 residues of this product with other related microbial 

pesticides are anticipated.

F. Determination of Safety for U.S. population, Infants and Children
EPA-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 

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. As discussed previously, there appears to be no potential for 

harm, from this fungus 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 nonoccupational inhalation or dermal exposure is not expected to pose any adverse effects to exposed 

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 by a naturally-occurring estrogen or other endocrine 

effects. There is no known metabolite produced by this yeast that acts as an endocrine disruptor. 

The submitted toxicity/pathogenicity studies in rodents indicate that following dosing that no viable 

conidia 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 system.

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 European Food Safety Authority 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 MRLs and no residue definitions have

to be established for the use of Paecilomyces fumosoroseus Apopka strain 97 on agricultural crops.

There is no CODEX maximum residue level for residue of Paecilomyces fumosoroseus Apopka 

strain 97.