DATA EVALUATION RECORD

PAECILOMYCES FUMOSOROSEUS APOPKA STRAIN 97

(PFR-97 20% WDG)

STUDY TYPE: Request for Exemption From the Requirement of a Tolerance

No MRID Number

Prepared for

Biopesticides and Pollution Prevention Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

One Potomac Yard

2777 South Crystal Drive

Arlington, VA 22202

Prepared by

Toxicology and Hazard Assessment Group

Environmental Sciences Division

Oak Ridge National Laboratory

Oak Ridge, TN 37830

Task Order No. 10-013

Primary Reviewer:

Eric B. Lewis, M.S. Signature:

Date:

Secondary Reviewers:

Sylvia Milanez, Ph.D., D.A.B.T. Signature:

Date:

Robert H. Ross, M.S., Group Leader Signature:

Date:

Quality Assurance:

Lee Ann Wilson, M.A. Signature:

Date:

Disclaimer

This review may have been altered subsequent to the contractor’s signatures above.

 

Oak Ridge National Laboratory managed and operated by UT-Battelle, LLC., for the U.S. Department of Energy 

under Contract No. DE-AC05-00OR22725.
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DATA EVALUATION RECORD

EPA Secondary Reviewer: Ibrahim S. Barsoum, Ph.D.

STUDY TYPE: Request for an Exemption from the Requirement of a Tolerance

MRID NO: None

DECISION NO: 425259

DP BARCODE: DP374463

TEST MATERIAL: PFR-27 20% WDG (a.i., 20.0% Paecilomyces fumosoroseus 

Apopka Strain 97)

PROJECT STUDY NO: Not provided

SPONSOR: Certis U.S.A., L.L.C., 9145 Guilford Road, Suite 175, Columbia, 

MD 21046

TESTING FACILITY: Not applicable

TITLE OF REPORT: Petition Proposing an Exemption From the Requirement of a 

Tolerance for the Use of the Microbial Pest Control Agent 

Paecilomyces fumosoroseus Apopka Strain 97

AUTHOR: Wagner, J.

STUDY COMPLETED: December 14, 2009

CONFIDENTIALITY 

CLAIMS: None.

GOOD LABORATORY

PRACTICE: Not applicable

CONCLUSION: The petition supports the requested exemption from the 

requirement of a tolerance Paecilomyces fumosoroseus Apopka 

Strain 97 in/on all agricultural commodities.

Summary of Petition

Proposed Use

PFR-27 20% WDG is an end use product currently registered (EPA Reg. No. 70051-19) for 

control of insects and mites on ornamental plants grown in greenhouses and nurseries. The 

registrant proposes to amend the product label to allow use on vegetables, fruits, ornamental 

plants, and other crops grown either outdoors, in greenhouses or under other cover, or in 

nurseries. As a result, the registrant has submitted a petition for an exemption from the 

requirement of a tolerance for residues of the active ingredient, Paecilomyces fumosoroseus 

Apopka Strain 97, in/on all agricultural commodities.

Product Identity/Chemistry/Magnitude of the Residue

Paecilomyces fumosoroseus Apopka Strain 97 is a naturally-occurring entomopathogenic fungus 

that can infect and control several insect pests, including whiteflies, thrips, aphids, and spider 

mites. Under the proper environmental conditions, spores of the fungus penetrate the cuticle of 

the insect and grow inside it, causing its death. Paecilomyces fumosoroseus Apopka Strain 97 

was originally isolated in 1986 from a mealybug in a greenhouse in Apopka, Florida. The pure 

culture was identified in 1988, and deposited at the American Type Culture Collection (ATCC 

#20874). 
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Since Paecilomyces fumosoroseus Apopka Strain 97 occurs naturally in soils worldwide, 

humans, other animals, and plants are constantly exposed to this fungus. Its use as proposed is 

not expected to 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. There is a low probability of its germination on harvested 

crops in the absence of an insect host, which further reduces the chance of residues that are of 

toxicological concern. 

Furthermore, any potentially-occurring residue on crops would not harm humans, since the strain 

shows no toxicity, infectivity, or pathogenicity in the appropriate tests. The optimal temperature 

range for growth, germination, and sporulation of the strain is 20 to 30°C, while the normal body 

temperatures of humans, other mammals, and avian species are significantly higher. 

Paecilomyces fumosoroseus Apopka Strain 97 is produced using a liquid fermentation. 

Secondary metabolites such as beauverolides and beauvericine have been detected in still 

culture, but not in liquid fermentation. 

Mammalian Toxicity Profile

Acute oral toxicity/pathogenicity – rat: an oral dose of 1.7 x 106cfu/animal in a conidia spore 

suspension did not produce mortality or abnormal clinical effects. No signs of fungal 

contamination were reported for the brain, mesenteric lymph nodes, blood, kidney, spleen, liver, 

lung or cecum, and no infectivity or pathogenicity was recorded. 

Acute intraperitoneal toxicity/pathogenicity – rat: Single intraperitoneal doses of suspensions 

containing 1.6 x 10

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conidia spores per animal had no toxic or pathogenic effects and the spores 

were cleared from the body within two days. 

Acute pulmonary toxicity/pathogenicity – rat: a single intratracheal dose (106 conidia 

spores/animal) resulted in no deaths and there were no signs of toxicity in any animal. 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. The product was classified as Toxicity

Category IV.

Acute dermal toxicity/pathogenicity – rat: 2 grams of test substance applied to the skin of rabbits

produced no deaths and there was no evidence of systemic toxicity. The product was classified 

as Toxicity Category III.

Primary eye irritation – rabbit: 0.1 mL of diluted test substance containing ≥107 cfu was instilled 

in the eye, which was 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. The 

product was classified as Toxicity Category IV.

Dermal irritation – rabbit: in a four-hour exposure, the test substance (2 g/animial) was found to 

be a slight dermal irritant. The product was classified the product as Toxicity Category IV.

Dermal sensitization – guinea pig: The test substance (3.0 x 107 – 5.3 x 109 cfu) produced no 
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irritation or sensitization reaction in treated animals. The product was not a dermal sensitizer.

Mutagenicity Test on Salmonella typhimurium (Ames Assay): Sonicated blastospores and 

mycelium of Paecilomyces fumosoroseus Apopka strain 97 (100 – 5000 μg/plate) yielded 

negative results in a reverse mutation assay in both the presence and absence of microsomal 

enzymes (S9).

Aggregate Exposure

Food

It is expected that, when used as proposed, Paecilomyces fumosoroseus Apopka strain 97 will

not result in residues that are of toxicological concern. Its growth and survival is affected by 

sunlight, temperature, humidity, substrate, and chemicals, especially fungicides. After harvest,

any remaining 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 potential residues on these crops 

will not harm humans because the fungal 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°C while the normal body temperatures of humans, other mammalian species and avian 

species are significantly higher and 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, generally limit doses.

Drinking Water

Paecilomyces fumosoroseus Apopka strain 97 is not known as an aquatic microorganism, and 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. Percolation through soil and municipal 

treatment of drinking water would reduce the possibility of exposure to Paecilomyces 

fumosoroseus Apopka strain 97 via drinking water. The potential of significant transfer to 

drinking water is minimal to nonexistent. 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.

Non-Dietary Exposure

Since Paecilomyces fumosoroseus Apopka strain 97 occurs naturally, there may be non-dietary

exposure from background levels. Humans may be exposed dermally or orally via soil on their 

hands or clothing, or by handling pets that have played in soil. However, no toxicological 

endpoints were identified for Paecilomyces fumosoroseus Apopka strain 97, and there is no 
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evidence of adverse effects from oral, dermal, or pulmonary exposure. 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, the potential for non-dietary, non-occupational exposures to 

residues by the general population, including infants and children, is low. 

Cumulative Exposure/Determination of Safety for U.S. Population, Infants, and Children

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 non-toxic and non-pathogenic to animals and humans, based on the results of the 

mammalian toxicity tests. Moreover, potential non-occupational inhalation or dermal exposure is 

not expected to pose any adverse effects to exposed populations via aggregate and cumulative 

exposure.

Effects on 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 fungus that acts as an 

endocrine disruptor. The submitted toxicity/pathogenicity studies in rodents indicate that no 

viable conidia or blastospores were found in organs or tissues of the test animals. It is concluded 

that there will be no incremental adverse effects to the endocrine system.

Existing Tolerances

None.

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.

Reviewers’ Comments

The reviewers believe the registrant’s petition supports the requested exemption from the 

requirement of a tolerance provided that the registrant test for beauverolides in production 

batches.