UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

 OFFICE OF CHEMICAL SAFETY 

 AND POLLUTION PREVENTION 

July 21, 2011

MEMORANDUM

SUBJECT: Environmental risk assessment for the FIFRA Section 3 new use 

registration of Paecilomyces fumosoroseus Apopka Strain 97 (EPA Reg. 

No. 70051-19) 

FROM: Shannon Borges, Biologist /signed/

Microbial Pesticides Branch

Biopesticides and Pollution Prevention Division, 7511P

THROUGH: Zigfridas Vaituzis, Senior Scientist /signed/

Microbial Pesticides Branch

Biopesticides and Pollution Prevention Division, 7511P

TO: Shanaz Bacchus, Regulatory Action Leader 

Microbial Pesticides Branch

Biopesticides and Pollution Prevention Division, 7511P

I. Environmental Risk Assessment

A. Introduction

Certis U.S.A, L.L.C. (hereafter “Certis”) has submitted an application to allow for additional 

uses of Paecilomyces fumosoroseus Apopka Strain 97 on all outdoor-grown food, non-food, and 

seed crops. Paecilomyces fumosoroseus Apopka Strain 97 is the active ingredient (a.i.) in the 

end-use product (EP) PFR-97 20% WDG. This EP is 20% a.i. and contains 1 x 109cfu/g of 

Paecilomyces fumosoroseus Apopka Strain 97. 

Paecilomyces fumosoroseus is an entomopathogen that is known to have a relatively wide host 

range. It was recently reclassified into Isaria fumosorosea (Zimmermann 2008), but to be 

consistent with the a.i. name, it will be referred to with its previously recognized name 

throughout this assessment. According to Zimmermann (2008) Isaria fumosorosea

(Paecilomyces fumosoroseus) actually forms a species complex, which may account for some 

differences in host range and environmental conditions that it has been found to tolerate. It is 

widely distributed, has been isolated from many species of insects, particularly Lepidoptera, and 

has been collected from air, water, plants, other fungi, and often from soil. It is one of the most 
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common entomopathogens known to affect nymphs and adults of Bemisia spp. of whiteflies, and 

has caused epizootics in this species in the U.S. and other countries (Zimmermann 2008).

This EP containing Paecilomyces fumosoroseus Apopka Strain 97 was previously registered for 

use in greenhouse and interiorscapes only. At that time, several data requirements were waived 

due to the lack of exposure to nontarget organisms. The proposed expanded uses pose an

increased potential for exposure to nontarget organisms, and require submission of additional 

data and a new environmental risk assessment. This memorandum contains BPPD’s ecological 

risk assessment for the proposed new use registration of Paecilomyces fumosoroseus Apopka 

Strain 97.

B. Summary of Nontarget Effects Data

Table 1 provides the status of the data requirements for the active ingredient Paecilomyces 

fumosoroseus Apopka Strain 97 for ecological risk assessment of the new uses. Guideline 

studies and data waiver rationale were submitted to satisfy data requirements for nontarget 

organisms as published in 40 CFR § 158.2150. The avian oral toxicity/pathogenicity data 

requirement was satisfied when this active ingredient was initially registered for greenhouse use, 

and additional data were not required for the new proposed uses. Information from the

additional studies and data waiver rationale is included in the discussion of risk below (see 

section C), and Data Evaluation Records (DERs) are attached. The information provided is 

sufficient to satisfy the Tier I nontarget organism data requirements and for nontarget organism 

risk assessment for the new uses. BPPD (1996) stated that environmental fate data would be 

required for this a.i. if adverse effects are observed from Tier I studies. Additional testing at 

higher tiers is not being required at this time, but may be needed for more refined risk 

assessments (e.g., for endangered species) in the future.

Table 1. Summary of data submitted to comply with nontarget organism data requirements 

published in 40 CFR § 158.2150 for support of the registration of Paecilomyces fumosoroseus

Apopka strain 97.

Data Requirement OPPTS 

Guideline No.

Results Summary and Classification MRID 

No.

Avian oral 

toxicity/pathogenicity

885.4050 A study (supplemental) indicated that P.

fumosoroseus Apopka Strain 97 is not toxic or 

pathogenic to birds. P. fumosoroseus Apopka 

Strain 97 does not grow at avian body 

temperatures and is not expected to pose a 

hazard to birds

43534803

Avian inhalation 

toxicity/pathogenicity

885.4100 Not required. P. fumosoroseus is not 

pathogenic to birds.

N/A

Wild mammal 

toxicity/pathogenicity

885.4150 Tests required by 40 CFR § 158.2140 are 

adequate/ appropriate for assessment of hazards 

to wild mammals. P. fumosoroseus Apopka 

Strain 97 was not toxic or pathogenic to albino 

rats at 1.7 x 106cfu/animal. Scientific rationale 

also support the conclusion that adverse effects 

to wild mammals are not expected.

Classification: Acceptable

47939507
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Data Requirement OPPTS 

Guideline No.

Results Summary and Classification MRID 

No.

• Freshwater fish 

toxicity/pathogenicity 

• Freshwater 

invertebrate 

toxicity/pathogenicity

885.4200

885.4240

Data waiver rationale provides sufficient 

information to determine that 

toxicity/pathogenicity to freshwater fish and 

invertebrates is not expected as a result of all 

applications except for aerial applications.

Classification: Supplemental for aerial 

applications, Acceptable for all other 

applications

47939506

Estuarine/marine fish 

and invertebrate 

testing

885.4280 Not required. P. fumosoroseus is not to be 

applied directly to water and is not expected to 

reach estuarine or marine environments in 

significant quantities. P. fumosoroseus was also 

shown to be nonpathogenic to two species of 

estuarine invertebrates. 

N/A

Nontarget plant 

testing

885.4300 Scientific rationale was sufficient to conclude 

that no adverse effects are expected to nontarget 

plants. Paecilomyces fumosoroseus Apopka 

strain 97 is not related to any known plant 

pathogen and testing is not required.

Classification: Acceptable

47939504

Nontarget insect 

testing

885.4340 Initial scientific rationale (MRID 47939505) 

was unacceptable. Additional rationale 

provides sufficient information to conclude that 

Paecilomyces fumosoroseus Apopka strain 97 

will be pathogenic to some nontarget species of 

insects

Classification: Acceptable

47939505

48357703

Honey bee testing 885.4380 A honey bee study showed that Paecilomyces 

fumosoroseus Apopka strain 97 is not toxic to 

honey bees. 

Classification: Supplemental

Additional rationale show that pathogenicity 

may not be likely, but a conclusion cannot be 

made without uncertainty.

Classification: Acceptable

47939509

48357704

C. Ecological Exposure and Risk Characterization

1. Terrestrial Animals and Plants 

The EP is a water dispersable granule that is proposed for application to all outdoor food, nonfood, and seed crops. The proposed new applications are to be made to foliar surfaces by using 

hand-held, ground, or aerial spray application equipment, or to soil by drench or spray, 

chemigation (including drip, trickle, and overhead sprinkler), or injection. Applications are to be 

made at 1- 2 lbs/acre, and can be repeated every 3-10 days. 
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Data on natural concentrations of Paecilomyces fumosoroseus and persistence of this strain in the 

environment are not available. Many factors influence persistence, including availability of 

hosts and environmental conditions, and population growth of Paecilomyces fumosoroseus

Apopka strain 97 following treatment cannot be predicted. BPPD expects, however, that the 

applied fungus may grow to some degree, but the population levels will be reduced as host 

insects die off. Also, since retreatment is needed every 3-10 days, the a.i. is not expected to 

persist at effective levels in the environment for very long, except with retreatment or in areas 

where host insects may sustain its population. Tier II environmental expression studies would 

resolve uncertainties about the environmental fate of Paecilomyces fumosoroseus Apopka Strain 

97. 

Most soil directed applications (except some sprays) and chemigation are primarily expected to 

confine nontarget exposure to the area intended for treatment, though exposure may occur on the 

treated area via contact with soil and foliar surfaces. Soil applications that require incorporation 

or injection into the soil will reduce exposure to many nontarget organisms, except soil-dwelling 

insects and other sensitive arthropods. Some movement via runoff may occur with heavy rain, 

but since the proposed applications can be made to foliar surfaces via aerial and ground sprays, 

drift is expected to account for the majority of offsite movement. Aerial sprays were expected to 

deposit more of the applied Paecilomyces fumosoroseus Apopka Strain 97 offsite, and also

further away from the treated area. For example, aerial applications are expected to deposit 

22.3% and 17.1% of the applied amount at 25 and 50 feet away, respectively, whereas ground 

sprays (using a 50 inch boom height) are expected to deposit 10.4% and 5.0% at those same 

distances, respectively. These percentages were determined using the AgDRIFT® spray drift 

analysis tool, assuming fine to medium droplet size for aerial applications and very fine to fine 

droplet size for ground applications. BPPD does not have data (e.g., from efficacy studies) to 

determine whether these amounts would result in risk to sensitive arthropods; however, that 

information would be useful in refining determination of nontarget risks and the extent to which 

effects may occur. 

Birds and Mammals

Birds and mammals may be exposed to Paecilomyces fumosoroseus Apopka Strain 97 through 

consumption of treated insects and other food items contacted at application. Any birds and 

mammals present at application could be exposed via inhalation, as well as consumption of 

drinking water nearby or on treated fields. Studies show that adverse effects are not expected in 

birds as a result of exposure to Paecilomyces fumosoroseus Apopka Strain 97, and that this 

fungus does not grow at avian body temperatures. Studies with laboratory rats indicate that 

Paecilomyces fumosoroseus Apopka Strain 97 is not toxic or pathogenic to mammals. Concerns 

were also raised in previous assessments about beauverolides (mycotoxins) that may be produced 

by Paecilomyces fumosoroseus Apopka Strain 97. To support these proposed new uses, the 

registrant submitted information to show that beauverolides were present in negligible 

concentration in liquid fermentation. BPPD concluded that this was not of concern, but required 

testing for beauverolides in production batches. As long as beauverolides are not present in 

significant quantities, there will be no concern for potential toxicity to nontarget organisms. This 

information is sufficient to show that adverse effects to birds and mammals are not expected to 
5

result from exposure following application of Paecilomyces fumosoroseus Apopka Strain 97 for 

the proposed new uses. 

Nontarget Insects

Nontarget insects and other sensitive arthropods are expected to be exposed to Paecilomyces 

fumosoroseus Apopka strain 97 on the treated field, and may be exposed in areas to which 

treatment may drift. Insects may be directly sprayed or they may contact Paecilomyces 

fumosoroseus Apopka Strain 97 that is present on treated foliar and soil surfaces. Some 

exposure to soil dwelling insects may occur in treated areas below the soil surface. Since many 

different crops may be treated with a variety of application types, insects or other sensitive 

arthropods that occupy many different ecological niches are expected to receive exposure as a 

result of the proposed labeled uses. 

Certis presented rationale as well as the results of several studies of various strains of P. 

fumosoroseus with nontarget insects to justify that nontarget effects are not to be expected. 

Current and former registrants of Paecilomyces fumosoroseus Apopka strain 97 performed 

several studies with nontarget insects, but these were not suitable for review. Other studies 

performed on Paecilomyces fumosoroseus Apopka strain 97 on nontarget insects were described 

but not provided for review by BPPD. Copies of studies from the literature were included, 

however, and do provide some information with which to determine the potential for adverse 

effects on insects and the risk to nontarget insects resulting from the proposed new uses.

Based on the information presented, as well as some other information discussed below, it is 

evident that P. fumosoroseus Apopka Strain 97 has the potential to affect some, but possibly not 

all, species of insects and other terrestrial arthropods. It is apparent that the host range of P. 

fumosoroseus may not be as extensive as other entomopathogenic fungi, such as Beauveria 

bassiana or Metarhizium anisopliae; however, P. fumosoroseus does apparently affect insects 

across several orders, and also affects other arthropods (some species of arachnids) 

(Zimmermann 2008). Other studies cited by the registrant in the rationale (but not included for 

review by BPPD) indicate that some avoidance behaviors exhibited by predatory insects may 

reduce their potential for infection by consumption of infected prey, and that synergistic effects 

on the pest population reductions have been observed as a result of the presence of the P. 

fumosoroseus and the predatory insect. These indicate that some species are not susceptible to P. 

fumosoroseus.

There are some uncertainties surrounding the use of these studies for predicting effects on insects 

in the field. One issue related to the studies presented from the literature is that they all present 

results from different strains of P. fumosoroseus. Effects on any particular nontarget species 

may be strain specific, and some strains may be more virulent toward certain species than others. 

Additionally, Zimmermann (2008) describes P. fumosoroseus (I. fumosorosea) as polymorphic 

and a species aggregate or complex. Therefore, while these studies may show effects or lack 

thereof, the extent to which their results represent the potential of those of P. fumosoroseus

Apopka Strain 97 are unknown. 
6

The point was also made in the rationale, as well as several of the papers cited, that laboratory 

conditions, especially high relative humidity, may promote infection and are not necessarily 

representative of the more complex field environment. This is a common factor related to all 

types of laboratory toxicity and/or pathogenicity testing. However, the following points must 

also be considered:

 Laboratory conditions would thus represent the worst-case scenario and, 

therefore, the most conservative representation of the potential for effects

 High humidity can occur in the field, and is common in some regions of the U.S. 

during some seasons

 The authors of these studies also note that effects may be greater in insects that 

are “stressed.” The “stress” was not described, but laboratory conditions may 

offer a reduced-stress environment, since food is usually in plentiful supply, the 

risk of predation is reduced, and environmental conditions do not fluctuate widely 

as they do in the field. Stressful conditions in the field would include extreme 

low humidity and high temperatures of other physiologically strenuous 

conditions, which may result in greater vulnerability to infection.

Conditions in the field would be expected to fluctuate. Some conditions may be more favorable 

for infection than others, but these cannot be predicted. Since P. fumosoroseus Apopka strain 97 

is expected to have some efficacy in the field on the target insects, it is expected that conditions 

favoring infection of other susceptible species would occur.

According to the proposed label, the pest species controlled by P. fumosoroseus Apopka strain 

97 span several insect orders (Hemiptera, Thysanoptera, Diptera, Lepidoptera, and Coleoptera), 

and also include symphylans (Class Symphyla, Order Symphyla), mites (Class Arachnida, Order 

Acari), and “other soil insects.” This is a wide range of arthropods to which P. fumosoroseus

Apopka strain 97 is assumed to be pathogenic. Without extensive testing or a clear

understanding of species-related factors influencing infectivity and pathogenicity of this strain of 

P. fumosoroseus, it is not reasonable to assume that effects would only occur to pest species in 

these classes/orders and not beneficial (or otherwise neutral) species. The review by 

Zimmermann (2008) also includes insects from Orders Blattodea, Hymenoptera, Isoptera, and 

Neuroptera, as well as tick species in the arachnid Order Acari. The neuropteran species listed 

include Crysoperla carnea (green lacewing), which is a beneficial species. The USDA-ARSEF 

ARS Collection of Entomopathogenic Cultures report for Isaria spp. (Humber et al. 2011), lists 

insects from Orders Lepidoptera, Diptera, Coleoptera, Hemiptera, Homoptera, Hymenoptera, as 

well as tick species (some of these reports were included in Zimmermann 2008). 

Based on the available information, Paecilomyces fumosoroseus Apopka Strain 97 could 

potentially result in adverse effects in several species of insects and other terrestrial arthropods. 

While not all species may be affected, the information provided is not sufficient to be able to 

predict which species may or may not be affected by this particular strain with field applications. 

P. fumosoroseus is known to be pathogenic to a wide range of insects and some arachnids, and 

the extent to which the Apopka strain 97 is pathogenic to these arthropods cannot be known 

without extensive testing. Therefore, BPPD concludes that P. fumosoroseus Apopka strain 97 is 

likely to cause adverse effects in nontarget insects as a result of the proposed new uses. 
7

Honey Bees

As with other nontarget insects, honey bees are also expected to receive exposure to 

Paecilomyces fumosoroseus Apopka Strain 97 as a result of the proposed new labeled uses. A 

study was conducted to determine the toxicity of Paecilomyces fumosoroseus Apopka Strain 97 

to honey bees (MRID 47939509). In this study, the oral LD50 was determined to be >21.63 μg 

a.i./bee (calculated intake), and the contact LD50 was >20.0 μg a.i./bee. The study was sufficient 

to show that Paecilomyces fumosoroseus Apopka strain 97 is not toxic to honey bees, but it was 

not of sufficient duration to determine pathogenicity.

Additional rationale was submitted to supplement this study (MRID 48357704). Several pieces 

of information were presented to show that Paecilomyces fumosoroseus Apopka strain 97 may 

be unlikely to cause adverse effects on honey bees. Much research has focused on the microflora 

of honey bees and their hives, and Paecilomyces fumosoroseus is not widely reported as a 

pathogen of honey bees. Additionally, honey bees exhibit individual and communal cleansing 

behaviors that would be expected to reduce exposure, though solitary bees or other species that 

do not have these behaviors might have higher exposure. Goettel et al. (1990) list honey bees 

and bumblebees among the many insect species from which Paecilomyces farinosus had 

reportedly been isolated without apparent effects; however these authors also caution against 

direct exposure of bees to treatments containing entomopathogens. 

The USDA-ARS ARSEF Collection of Entomopathogenic Cultures (ARSEF) annual report does 

not contain references to isolations of Paecilomyces fumosoroseus (or Isaria fumosorosea) from 

bees, but does include isolations from other hymenopterans (ants and parasitoid wasps) (Humber 

et al. 2011). While this may indicate that bees are not hosts of this fungus, a caution with 

reliance on this reference is that the situations in which isolates are provided may vary, and 

isolations will only be included where there is an interest or need to submit samples for 

identification. Some instances of pathogenicity in bees may be missed in this case; however, 

given the recent interest in understanding causes of honey bee mortality, the likelihood is greater 

that attention will be given to discoveries of bee pathogens. 

In the rationale submitted, the registrant states that reports of Beauveria bassiana pathogenicity 

to bees is absent from reviews of the literature, but ARSEF contains several reports of B. 

bassiana associated with bees. Therefore, the extent to which lack of reports in the literature can 

be used as justification for lack of effects is dependent on the extent to which these effects are 

investigated as well as the literature surveyed. An additional literature search was performed by 

BPPD. The Environmental Information Search literature database was searched, for all years 

available (1926 – present) with the terms “Paecilomyces” or “Isaria” and “bee.” This database 

simultaneously searches the Agricola; Biosis Previews; CAB Abstracts; Energy, Science, and 

Technology, General Science Abstracts, and the National Technical Information Service 

literature databases. The ISI Web of Knowledge literature database was also searched with these 

terms for all years available in the database. Several reports were found for exposure of 

Paecilomyces spp. to various species of bees, in some cases through treatments intentionally 

applied to hives for control of varroa mites (Varroa destructor). No reports of adverse effects to 

bees were found in any of these searches, though it was not clear whether the effects on bees 

were the focus of study in all cases. 
8

Based on the information presented as well as an additional search of the available literature, 

adverse effects to honey bees are unlikely as a result of acute toxicity. There is no evidence that 

P. fumosoroseus Apopka strain 97 is likely to be pathogenic to bees; however there is uncertainty 

due to the fact that this has not been adequately tested and because P. fumosoroseus can affect a 

wide range of insects and other arthropods. Therefore, BPPD concludes that pathogenicity of 

Paecilomyces fumosoroseus Apopka strain 97 to honey bees is still a concern at the proposed 

field application rates. Goettel et al. (1990) also noted that while some of the Paecilomyces spp. 

may not be pathogenic where they naturally occur, direct spray is not recommended. Therefore, 

it is recommended that the label contain language prohibiting application of Paecilomyces 

fumosoroseus Apopka strain 97 when bees are present. 

Other Terrestrial Nontarget Organisms

The risk assessment conducted for the initial registration of Paecilomyces fumosoroseus Apopka 

Strain 97 indicated reports of Paecilomyces fumosoroseus infections in other nontarget 

organisms (e.g., a captive giant tortoise, Georg et al. 1962). Most reports were of secondary 

infections in immunocompromised or otherwise physiologically stressed individuals, and 

information from the literature on the potential for beauverolides to exhibit strong immunomodulating activity was noted (BPPD 1996). In the case of the giant tortoise described above, 

Paecilomyces fumosoroseus was isolated from one captive tortoise after the normal temperature 

in its pen had been accidentally lowered. Koch’s postulates were not fulfilled with Paecilomyces 

fumosoroseus to demonstrate that this fungus was the cause of the disease, but the authors 

concluded that while P. fumosoroseus appeared to cause the pulmonary disease, they did not 

know whether it was the cause of the tortoise’s death. They also stated that it was clear that the 

body’s tissues were reacting well to destroy the disease, and that Paecilomyces fumosoroseus

may have been capable of infecting the tortoise because the lowered ambient temperature had 

reduced the normal threshold of resistance for the tortoise. BPPD previously determined that the 

infection may also have been facilitated by the production of beauverolides. As discussed above,

as long as beauverolides are not present in significant quantities in the EP, there will be no 

concern for potential immunomodulating effects of these mycotoxins to other nontarget 

organisms. 

BPPD also noted (USEPA 1998) that no effects were observed in frogs exposed to a single oral 

dose of Paecilomyces fumosoroseus. While the above incident indicates the possibility that 

Paecilomyces fumosoroseus may infect cold-blooded terrestrial animals, it represents one 

isolated case in unnatural conditions. An additional literature search was conducted to find any 

other reports of Paecilomyces fumosoroseus infections in reptiles and amphibians. The same 

databases were used as described above, and the search terms “Paecilomyces” or “Isaria” were 

used with “reptile,” “tortoise,” “amphibian,” and “frog.” No additional reports of associations 

between this fungus and reptiles or amphibians were found. At this time, BPPD does not have 

additional concerns for these nontarget organisms; however, reports of confirmed infections in 

these animals from the literature or elsewhere will trigger the need for additional testing.
9

Nontarget Plants

Nontarget plants on the field and in areas contacted by spray drift would be exposed to 

Paecilomyces fumosoroseus Apopka strain 97. The previous assessment for Paecilomyces 

fumosoroseus Apopka Strain 97 mentioned limited reports of pathogenicity to plants. The 

USDA-ARS Fungal Database (http://nt.ars-grin.gov/fungaldatabases/index.cfm) indicates 26 

host-fungus combinations. Several of these are insects, and reports related to plants do not 

appear to be indicative of pathogenic relationships. A search of the literature using the data 

bases above and the search terms “Paecilomyces fumosoroseus” and “plant pathogen” did not 

produce reports of plant pathogenicity resulting from Paecilomyces fumosoroseus infection. 

Paecilomyces fumosoroseus is not otherwise known to be taxonomically related to any plant 

pathogen, and nontarget plant testing was not required. P. fumosoroseus is commonly also found 

in soils worldwide, and it is reasonable to expect that plants are naturally exposed to this fungus. 

Additionally, P. fumosoroseus has been used in biocontrol programs for control of plant insect 

pests, and adverse effects on plants have not been reported. Based on this information, adverse 

effects of P. fumosoroseus Apopka strain 97 to nontarget plants are not expected as a result of 

the proposed new labeled uses.

2. Aquatic Animals and Plants 

Freshwater Fish and Invertebrates

Certis presented rationale (MRID 47939506) to support the conclusion that exposure in aquatic 

environments would not be significant. Their rationale included studies that showed that 

Paecilomyces fumosoroseus Apopka strain 97 is not expected to be toxic to freshwater fish or 

invertebrates. Additional testing to determine pathogenicity was not performed, but Certis 

submitted rationale stating that the proposed applications to outdoor crops would not result in 

measurable elevated levels due to runoff. However, they did not address the potential for drift. 

The influence of drift is important, since aerial applications are allowed on the proposed label.

Since applications can be made as sprays with both ground and aerial equipment, a spray drift 

analysis was performed using the AgDRIFT® program. For an aerial assessment, a fine to 

medium spray droplet size was assumed to adequately represent a low-volume application. An 

aerial application made directly to a body of water 15 cm deep (consistent with the EPA standard 

wetland) at the maximum rate of 2 lbs PFR-97 per acre (at 1.9 x 109cfu/g) would result in a 

concentration of 2,842 cfu/mL. Spray drift from an aerial spray to the same body of water 

adjacent to the treated area would deposit 12.7% of the applied amount into it, resulting in a 

concentration of approximately 360 cfu/mL. The resulting concentration to an adjacent pond of 

2 m depth (consistent with the EPA standard pond) would be approximately 25 cfu/mL. 

Assuming very fine to fine droplet size for a ground application would result in approximately 

6.2% of the applied amount reaching the water body, which would give a concentration of 170 

cfu/mL to an adjacent wetland or approximately 13 cfu/mL to a pond. BPPD agrees that in most 

cases the resulting concentration of Paecilomyces fumosoroseus Apopka Strain 97 in adjacent 

water bodies will not be significantly elevated, but aerial applications may result in elevated 

concentrations in relatively shallow waters (e.g., wetlands). The label suggests reapplication 

every 3-10 days, and depending on environmental conditions and the viability of the active 
10

ingredient in water, reapplication may result in higher concentrations. Therefore, the waiver 

rationale submitted does not necessarily support all aerial applications of Paecilomyces 

fumosoroseus Apopka strain 97.

Paecilomyces fumosoroseus Apopka Strain 97 has been tested on embryos of Mysoidopsis bahia

and Penaeus duorarum and was not found to be toxic or pathogenic to these aquatic (estuarine) 

invertebrates (USEPA 1997). A search of the literature (using the same databases as described 

above) also did not return any reports of pathogenicity of Paecilomyces fumosoroseus in fish or 

aquatic invertebrates. Additionally, studies by EPA’s Gulf Breeze Ecology Lab indicate that 

pathogenic effects of other entomopathogens (Beauveria bassiana and Metarhizium anisopliae) 

on fish embryos are seen at concentrations of ≥104cfu/mL (Genthner and Middaugh 1992, 

1995). Therefore, BPPD does not expect pathogenicity to fish at the concentrations determined 

above. However, confirmatory data should be submitted to show that elevated concentrations 

resulting from aerial applications due to drift will not result in pathogenicity to freshwater fish 

and invertebrates. These data may include pathogenicity testing on freshwater fish and 

invertebrates, or may include, for example, additional information on viability or natural 

concentrations in water or other scientifically supported rationale.

Marine/Estuarine Fish and Invertebrates 

Based on the expected concentrations calculated above for freshwater environments, exposure in 

marine and estuarine environments is expected to be low as a result of dilution. As noted above, 

Paecilomyces fumosoroseus Apopka Strain 97 was not found to be toxic or pathogenic to two 

species of estuarine shrimp. Therefore, Paecilomyces fumosoroseus Apopka Strain 97 is not 

expected to reach these environments in significant quantities, and adverse effects to 

marine/estuarine fish and invertebrates are not expected as a result of the proposed new uses.

Aquatic Plants 

P. fumosoroseus is commonly found in soils worldwide, and it is reasonable to expect that 

aquatic plants are naturally exposed to this fungus via runoff. Paecilomyces fumosoroseus is not 

taxonomically related to any known plant pathogen, so nontarget testing with aquatic plants was 

not required. BPPD does not anticipate adverse effects to aquatic plants as a result of the 

proposed new uses.

D. Threatened and Endangered Species Assessment

As indicated in the analysis above, EPA has determined that adverse effects to nontarget insects 

as a result of the proposed new uses of Paecilomyces fumosoroseus Apopka strain 97 are likely. 

EPA has determined that risk of adverse effects is minimal to birds, wild mammals, freshwater 

fish and invertebrates, estuarine/marine fish and invertebrates, and nontarget terrestrial and 

aquatic plants. Therefore, EPA makes conclusions as follows regarding federally threatened and 

endangered (listed) species for the proposed new uses of Paecilomyces fumosoroseus Apopka 

97.
11

 EPA makes “No Effect” determinations for direct effects to listed terrestrial vertebrates 

and plants and listed aquatic animals and plants for the proposed new uses. 

 EPA concludes that the proposed new uses of Paecilomyces fumosoroseus Apopka 97 

have the potential to cause direct effects to listed terrestrial insects and arachnids, as well 

as indirect effects to listed species dependent on insects and arachnids (e.g., for food, 

pollination, habitat maintenance). Further analyses are needed to characterize the effects 

that are likely to occur and the species potentially affected. Tier II environmental 

expression studies would allow for a more refined analysis and would likely reduce the 

number of species determined to be affected.

II. Environmental Assessment Summary

The Agency has performed an environmental risk assessment based on the data, literature 

citations, and data waiver rationale provided by the registrant for Paecilomyces fumosoroseus

Apopka Strain 97. Paecilomyces fumosoroseus (recently reclassified into Isaria fumosorosea) is 

an entomopathogen that is known to have a relatively wide host range. It is widely distributed, 

has been isolated from many species of insects, particularly Lepidoptera, and has been collected 

from air, water, plants, other fungi, and often from soil. It is one of the most common 

entomopathogens known to affect nymphs and adults of Bemisia spp. of whiteflies, and has 

caused epizootics in this species in the U.S. and other countries (Zimmermann 2008).

The proposed expanded uses of Paecilomyces fumosoroseus Apopka Strain 97 pose an increased 

potential for exposure to nontarget organisms, and the registrant that the proposed new uses of 

Paecilomyces fumosoroseus Apopka Strain 97 pose risk to nontarget insects and other sensitive 

arthropods (e.g., arachnids), but not to other terrestrial or aquatic animals or plants. A “No 

Effect” determination is made for direct effects to federally listed threatened and endangered 

(“listed”) terrestrial vertebrates and plants and listed aquatic animals and plants for the proposed 

new uses. However, these uses have the potential to result in direct effects to listed insects and 

arachnids as well as indirect effects to listed species dependent on insects and arachnids (e.g., for 

food, pollination, habitat maintenance). Further analyses are needed to characterize the effects 

that are likely to occur and the species potentially affected. Tier II environmental expression 

studies would allow for a more refined analysis and would likely reduce the number of species 

determined to be affected. 

References Cited

Biopesticides and Pollution Prevention Division (BPPD). 1996. Memorandum from G. 

Tomimatsu (OPP/BPPD) to S. Bacchus (OPP/BPPD), Re: Microbial Pesticide Review, 

Paecilomyces fumosoroseus Apopka Strain 97. Dated October 8, 1996.

Genthner, F. J. and D. P. Middaugh. 1992. Effects of Beauveria bassiana on the embryos of the 

inland silverside fish (Menidia beryllina). Applied and Environmental Microbiology 58: 

2840-2845.
12

Genthner, F. J. and D. P. Middaugh. 1995. Nontarget testing of an insect control fungus: 

effects of Metarhizium anisopliae on developing embryos of the inland silverside fish 

Menidia beryllina. Diseases of Aquatic Organisms 22: 163-171.

Georg, L.K., W. M. Williamson, E. B. Tilden, and R. E. Getty. 1962. Mycotic pulmonary 

disease of captive giant tortoise due to Beauveria bassiana and Paecilomyces fumosoroseus. Sabouraudia 2:80-86.

Goettel, M. S., T. J. Poprawski, J. D. Vandenburg, Z. Li, and D. W. Roberts. 1990. Safety to 

nontarget invertebrates of fungal biocontrol agents. Pp. 209-231 In: M. Laird, L. A. 

Lacey, and E. W. Davidson, eds. Safety of Microbial Insecticides. CRC Press, Boca 

Raton. 

Humber, R. A., K. S. Hansen, and M. M. Wheeler. 2011. ARSEF ARS Collection of 

Entomopathogenic Fungal Cultures: Isaria plus Paecilomyces and Evalchovea. January 

24, 2011. USDA-ARS, Ithaca, NY. 50 pp. Accessed at: 

http://www.ars.usda.gov/SP2UserFiles/Place/19070510/Isaria%20Jan2011.pdf. 

U.S. Environmental Protection Agency (USEPA). 1998. Registration Eligibility Document: 

Paecilomyces fumosoroseus Apopka Strain 97 (PC Code 115002). Office of Pesticide 

Programs, Biopesticides and Pollution Prevention Division.

USEPA. 1997. Internal Report: Estuarine invertebrate testing of the entomopathogenic fungus, 

Paecilomyces fumosoroseus Apopka Strain 97. Office of Research and Development, 

Gulf Ecology Division, National Health and Environmental Effects Research Laboratory, 

Gulf Breeze, Florida.

Zimmermann, G. 2008. The entomopathogenic fungi Isaria farinosa (formerly Paecilmoyces 

farinosus) and the Isaria fumosorosea species complex (formerly Paecilomyces 

fumosoroseus): biology, ecology and use in biological control. Biocontrol Science and 

Technology 18: 865-901.