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BIOPESTICIDES REGISTRATION ACTION DOCUMENT

PC Code 115002

Isaria fumosorosea (formerly Paecilomyces fumosoroseus)

Apopka Strain 97

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

September 15, 2011
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TABLE OF CONTENTS

I. BACKGROUND .................................................................................................................. 4

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 4

III. REGULATORY BACKGROUND..................................................................................... 5

A. Applications for Pesticide Registration..................................................................................... 5

B. Food Tolerance Exemptions.................................................................................................... 6

 C. Microbial Pesticide Data Requirements ........................................................................... 6

IV. RISK ASSESSMENT .......................................................................................................... 6

A. Product Analysis Assessment (40 CFR § 158.2120).................................................................... 7

B. Human Health Assessment (40 CFR § 158.2140)....................................................................... 7

C. Environmental Assessment (40 CFR § 158.2150) .................................................................... 10

V. ENVIRONMENTAL JUSTICE....................................................................................... 11

VI. RISK MANAGEMENT DECISION................................................................................ 12

VII. TERMS AND CONDITIONS OF THE REGISTRATION(S)...................................... 12

VIII.GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................ 13

IX. BIBLIOGRAPHY.............................................................................................................. 14

A. Studies Submitted to Support the PFR-97 Pesticide Product..................................................... 14

B. Environmental Protection Agency Risk Assessment Memoranda .............................................. 16

C. Other References................................................................................................................. 16

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS............................. 18
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs (OPP)

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

Ibrahim Barsoum, Ph.D. Product Analysis, Human Health

John Kough, Ph.D. Product Analysis, Human Health

Shannon Borges Environmental Effects

Zigfridas Vaituzis, Ph.D. Environmental Effects

Gail Tomimatsu Environmental Effects

Regulations

Sheryl Reilly, Ph.D. Chief, Microbial Pesticides Branch

Shanaz Bacchus Regulatory Action Leader
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I. BACKGROUND

The fungal active ingredient (ai), Paecilomyces fumosoroseus Apopka strain 97 (PC Code 115002), has 

been reported to be originally isolated in 1986 from a mealy bug living in a greenhouse in Apopka, FL. 

It was recently reclassified as Isaria fumosorosea (United States Department of Agriculture (USDA) 

Agricultural Research Services Collection of Entompathogenic Fungal (ARSEF) Cultures, January 24, 

2011; Zimmermann, 2008). In this and other Agency documents, it is referred to as Isaria fumosorosea 

(formerly Paecilomyces fumosoroseus) Apopka strain 97, Paecilomyces fumosoroseus Apopka strain 97,

or as PFR-97. The pure culture was identified in 1988 and deposited at the American Type Culture 

Collection (ATCC # 20874). This fungal strain is a pathogen of many orders of insects. It occurs 

naturally in populations of infected and dead insects and randomly in soils around the world. It can be 

grown 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. 

PFR-97TM MUP is the manufacturing use product (MUP) registered under the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA). It is formulated into the end-use product (EP), PFR-97TM 20% 

WDG, and contains blastospores, mycelia, and conidia of the fungal active ingredient. Under proper 

environmental conditions, spores of the fungus attach to and penetrate the cuticle of the target pest. The 

fungus grows inside the insect causing its death. The fungus then emerges from the dead insect to 

release more spores to infect other insects.

The product identity data submitted by the registrant were sufficient in 1998 to allow the proposed 

limited (non-food) use patterns in greenhouses. The registrant submitted an amendment to the 

registration in 2009 to expand the uses to include food crops.

On October 1, 2009, the Environmental Protection Agency (EPA or the Agency) announced a new 

policy to provide a more meaningful opportunity for the public to participate in major registration 

decisions before they occur. According to this new policy, the Agency intends to provide a public 

comment period prior to making a registration decision for, at minimum, the following types of 

applications: new active ingredients; first food uses; first outdoor uses; first residential uses; and any 

other registration decisions for which the Agency believes there may be substantial public interest.

Consistent with the new policy of making registration actions more transparent, Paecilomyces 

fumosoroseus Apopka strain 97 was subject to a 30-day comment period as a previously registered 

active ingredient whose registration amendment would result in a “first outdoor use,” a “first food use,” 

and possibly a “first residential use.” No comments were received during public comment period

(August 12, 2011 to September 11, 2011; docket number EPA-HQ-OPP-2010-0088). The science 

reviews and risk assessments the Agency relied upon in making its decision to allow food, outdoor, and 

residential uses for Paecilomyces fumosoroseus Apopka strain 97 are provided in this Biopesticides 

Registration Action Document (BRAD). 

II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Isaria fumosorosea (formerly Paecilomyces fumosoroseus)

Apopka strain 97
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Culture Deposit: American Type Culture Collection in Manassas, Virginia under 

Accession Number 20874

OPP Chemical Code: 115002

Type of Pesticide: Microbial Pesticide/Biofungicide

III. REGULATORY BACKGROUND

A. Applications for Pesticide Registration

On July 6, 1994, the Agency received an application from W.R.Grace to register PFR- 97TM MUP, a 

microbial insecticide/miticide, containing Paecilomyces fumosoroseus Apopka strain 97 as the active 

ingredient for manufacturing and end-use pesticide products. The registrant also requested the 

registration of two end-use products (EPs), PFR-97TM 20% WDG and PFR-97TM WDG, containing 20 

percent (%) and 12 % Paecilomyces fumosoroseus Apopka strain 97, respectively. The proposed 

pesticidal use was for control of whiteflies, aphids, thrips and spider mites on ornamentals in green 

houses, as well as food crops outdoors. A notice of receipt of the application for registration under 

FIFRA of Paecilomyces fumosoroseus Apopka strain 97 as a new active ingredient was published in the 

Federal Register (FR) on November 2, 1994 (59FR54093). 

A pesticide petition for an exemption from tolerance (PP4F4372) was filed concurrently with the 

proposed Section 3 registration applications. The Notice of this Filing was published in the Federal 

Register simultaneously with the Notice above (59FR54092, Number 211 (Wednesday, November 2, 

1994)). No comments were received in response to either of the Federal Register Notices within the 30-

day comment period. On June 13, 1996, the pending products were transferred to Thermo Trilogy, 

which did not repropose the exemption from tolerance petition as required by the Food Quality 

Protection Act (FQPA) of 1996. At that time, the Agency did not take any further action either on the 

request for the tolerance exemption or the pending food use registration application for PFR-97TM

WDG. On April 22, 1998, the following PFR-97 products were registered to Thermo Trilogy for nonfood uses: (1) PFR-97TM MUP (EPA Reg. No. 70051-17), a manufacturing use product; and (2) PFR97TM 20% WDG (EPA Reg. No. 70051-19), an end-use product. 

The Agency published the notices of registration for these products in the Federal Register on July 8, 

1998 (63FR36899). Both products contained Paecilomyces fumosoroseus Apopka strain 97 as the active 

ingredient, and were intended for use on ornamentals in greenhouses and in interiorscapes. The company

was informed that additional data would be required for more extensive use patterns. On September 30, 

1998, Thermo Trilogy formally withdrew the registration application for PFR-97TM WDG (12% ai), 

indicated that it would repropose the petition for food use as required by the FQPA and requested six 

months for providing non-target organism data required for additional uses. The company did not follow 

through on these actions.

In 2004, the product registrations were amended to remove the interiorscape use from the labels.

Thermo Trilogy has since changed its name to Certis USA, LLC (hereinafter referred to as “Certis”),

currently located on 9145 Guilford Road, Suite 175, Columbia, MD 21046.

On December 17, 2009, Certis applied to amend these pesticide registrations to include new uses on all 
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food commodities. The Agency announced receipt of the application in the Federal Register on March 5, 

2010 (EPA HQ-OPP-2010-0088; 75FR10259), and opened a 30-day public comment period pursuant to 

the provisions of FIFRA section 3(c)(4). No comments were received in response to this publication. 

This docket was reopened on August 12, 2011, to provide the public 30 days to review and submit 

comments on the posted documents that informed the Agency’s proposed decision regarding

Certis’proposed amendment to allow food uses to the product registrations. No comments were received 

during the public comment period, which ended on September 11, 2011. During the 30-day public 

comment period, Certis applied for labeling of PFR-97TM 20%WDG (EPA Reg. No. 70051-19) for 

organic production. The Agency evaluated and approved the label amendment concurrently with the 

proposed food, outdoor and residential uses of Isaria fumosorosea Apopka strain 97. 

B. Food Tolerance Exemptions

A numeric tolerance or exemption from the requirement of a tolerance was not required when the first 

products were registered in 1998, since they were not intended for use on food or animal feed 

commodities. Nevertheless, safety factors from the Food Quality Protection Act of 1996 (FQPA) were 

considered for potential secondary transfer of residues to drinking water during applications.

Included with the December 17, 2009, application to amend the product registrations was a petition to 

establish an exemption from the requirement of a tolerance on all food commodities for Paecilomyces 

fumosoroseus Apopka strain 97 (Pesticide Petition [PP] 9F7665) under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(d). The Notice of Filing of the petition was published in the Federal 

Register of March 10, 2010 (EPA HQ-OPP-2010-0087, 75 FR11171), and opened a 30-day comment 

period. No comments were received in response to the Federal Register publication. The Agency has 

published a Final Rule to establish an exemption from tolerance for residues of Isaria fumosorosea

(formerly Paecilomyces fumosoroseus) Apopka strain 97 on all food commodities when used as an 

insecticide or miticide in accordance with good agricultural practices (40 CFR 180.1306). This decision 

is based on the data and information that were evaluated by the Agency and disclosed to the public from 

August 12, 2011 to September 11, 2011.

C. Microbial Pesticide Data Requirements

On October 26, 2007, the Agency issued a Final Rule in the Federal Register on the data requirements to 

support registration of microbial pesticides and updated the definition for microbial pesticides (72 FR 

61002). The rule became effective on December 26, 2007. The data and information evaluated for this 

BRAD were considered in light of these requirements.

IV. RISK ASSESSMENT

The Agency assessed the data submitted by Certis in 2009 to support the company’s proposed 

amendments to its pesticide registrations. The classifications assigned by Agency science reviewers to 

data that are submitted to support registration of a pesticide are an indication of the usefulness of the 

information contained in the documents for risk assessment. A rating of “Acceptable” indicates the study

is scientifically sound and is useful for risk assessment. A “Supplemental” rating indicates the data 

provide some information that can be useful for risk assessment. The studies may have certain aspects 

determined not to be scientifically acceptable (“Supplemental: Upgradable”). If a study is rated as 

“Supplemental: Upgradable,” the Agency always provides an indication of what is lacking or what can 
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be provided to change the rating to “Acceptable.” If there is simply a “Supplemental” rating, the 

reviewer will often state that the study is not required by the current 40 Code of Federal Regulations 

(CFR) part 158. Both “Acceptable” and “Supplemental” studies may be used in the risk assessment 

process as appropriate. An “Unacceptable” rating indicates that new data must be submitted.

For the acute toxicity data requirements, toxicity categories are assigned based on the 

hazard(s) identified from studies and/or other information submitted to the Agency in support of a 

pesticide registration. The active ingredient or particular product is classified into Toxicity Category I, 

II, III, or IV, where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates 

the lowest toxicity. 

Refer to Tables 1, 2a, 2b, 3 and 4 in Appendix A for a brief summary of the data requirements, including 

both generic and product-specific information. Additionally, the comprehensive Agency risk 

assessments that evaluate these data are available either in the Appendix of this BRAD as summaries or 

as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0088 at 

http://www.regulations.gov

A. Product Analysis Assessment (40 CFR § 158.2120)

All product analysis data requirements for the proposed food uses of Isaria fumosorosea (formerly

Paecilomyces fumosoroseus) Apopka strain 97 have been satisfied (Tables 1, 2a, 2b – Appendix A). A 

storage stability study shows that the pesticide product has a shelf life of 1 year at 4o C, but is less stable 

at 25o C. The sample stored at 4

o C for 1 year was still effective at colonizing host insects, while that 

stored at 25o C was not.

B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity

All toxicology data requirements for Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka 

strain 97 have been satisfied. Acceptable Tier I mammalian toxicology data/information support the 

registration of this fungal active pesticide ingredient. Furthermore, Tier II and Tier III studies were not 

required for PFR-97 based on the lack of acute toxicity/pathogenicity in the Tier I studies. Refer to 

Table 3 in Appendix A for a brief summary of these data requirements, including both generic and 

product-specific information. Additionally, the summaries of the Agency risk assessments that evaluate 

these data are available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP2010-0088 at http://www.regulations.gov.

2. Endocrine Disruptors 

As required under FFDCA section 408(p), the Agency has developed the Endocrine Disruptor Screening 

Program (EDSP) to determine whether certain substances (including pesticide active and other 

ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally 

occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP 

employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a 

battery of 11 screening assays to identify the potential of a chemical substance to interact with the 

estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 
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screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed 

to the next stage of the EDSP where the Agency will determine which, if any, of the Tier 2 tests are 

necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrinerelated effects caused by the substance, and establish a quantitative relationship between the dose and 

the E, A, or T effect.

Between October 2009 and February 2010, the Agency issued test orders/data call-ins for the first group 

of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of 

chemicals was selected based on the potential for human exposure through pathways such as food and 

water, residential activity, and certain post-application agricultural scenarios. This list should not be 

construed as a list of known or likely endocrine disruptors.

PFR-97 is not among the group of 58 pesticide active ingredients on the initial list to be screened under 

the EDSP. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Accordingly, 

the Agency anticipates issuing future EDSP orders/data call-ins for all pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, 

the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

3. Food Quality Protection Act (FQPA) Considerations

Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act allows the Agency to establish an 

exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on 

a food) only if the Agency determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA 

defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate 

exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other 

exposures for which there is reliable information.” This includes exposure through drinking water and in 

residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of 

FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, the 

Agency must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require the 

Agency to give special consideration to exposure of infants and children to the pesticide chemical 

residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will 

result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, 

section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the 

cumulative effects of [a particular pesticide's] residues and other substances that have a common 

mechanism of toxicity.”

The Agency performs a number of analyses to determine the risks from aggregate exposure to pesticide 

residues. First, the Agency determines the toxicity of pesticides. Second, the Agency examines exposure 

to the pesticide through food, drinking water, and through other exposures that occur as a result of 

pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, the Agency has reviewed the available scientific data 

and other relevant information, and considered its validity, completeness, and reliability and the 

relationship of this information to human risk. The Agency has also considered available information 

concerning the variability of the sensitivities of major identifiable subgroups of consumers, including 

infants and children.
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Based on the acute toxicity/pathogenicity data presented in Table 3 in Appendix A, the data required for 

a FQPA risk assessment for Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 

97 have been satisfied. (See also, “Supporting & Related Materials” within Docket Number EPA-HQOPP-2010-0088 at http://www.regulations.gov.)

a. Aggregate Exposure

In examining aggregate exposure, section 408 of FFDCA directs the Agency to consider 

available information concerning exposures from the pesticide residue in food and all other 

nonoccupational exposures, including drinking water from ground water or surface water and exposure 

through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Dietary Exposure: 

Dietary exposure to the microbial pesticide is unlikely to occur, but if humans were exposed to Isaria 

fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 through the diet, no adverse 

effects would be expected, based upon the lack of acute oral toxicity, infectivity, and/or pathogenicity in 

laboratory animals (results presented in Appendix A of this BRAD, and “Supporting & Related 

Materials” within Docket Number EPA-HQ-OPP-2010-0088 at http://www.regulations.gov). The 

following information is provided to demonstrate why residues of 

Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 are not expected in food or 

feed commodities, or drinking water.

1. Food. Dietary exposure to the microbial active ingredient is expected to be minimal to nonexistent. Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 is intended for 

directed ground and spray application, or soil application, to food and feed commodities. The active 

ingredient rapidly degrades at room temperature, and as an insect pathogen, residues are not likely to 

accumulate on crops.

2. Drinking Water: Drinking water exposure is expected to be negligible to non-existent, because 

the microbial fungicide will not be applied to water. Further, the insect pathogen Isaria fumosorosea 

(formerly Paecilomyces fumosoroseus) Apopka strain 97 would not proliferate in aquatic environments. 

The large fungal spores within the soil will not likely percolate into water due to their size and the fact 

that they readily adhere to soil particles. 

3. Other Nonoccupational Exposure: PFR-97 is a naturally occurring microorganism and is 

ubiquitous in the environment. As a pesticidal active ingredient, PFR-97 will be applied to agricultural 

crops in the field and to crops grown in greenhouses and nurseries that are not expected to be in close 

proximity to residential areas. If applications take place in residential areas, there is no evidence for 

inhalation or dermal toxicity at exposure levels even several orders of magnitude higher than expected 

for a typical residential end-product user (see Appendix A of the BRAD and “Supporting & Related 

Materials” within Docket Number EPA-HQ-OPP-2010-0088 at http://www.regulations.gov). 

Additionally, there have been no reports of adverse effects to humans from inhalation or dermal 

exposure to this widespread fungus, which has been in use in greenhouses as a pesticide for the past 

thirteen years.
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b. Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or 

revoke a tolerance, the Agency consider “available information concerning the cumulative effects of [a 

particular pesticide’s] residues and other substances that have a common mechanism of toxicity.” Acute 

toxicity studies demonstrated that PFR-97, an insect pathogen, is practically non-toxic to mammals and 

no cumulative effects are anticipated.

c. Determination of Safety for the U.S. Population, Infants, and Children

FFDCA section 408(b)(2)(C) provides that the Agency shall assess the available information about 

consumption patterns among infants and children, special susceptibility of infants and children to 

pesticide chemical residues, and the cumulative effects on infants and children of the residues and other 

substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides 

that the Agency shall apply an additional tenfold margin of safety for infants and children in the case of 

threshold effects to account for prenatal and postnatal toxicity and the completeness of the database 

unless the Agency determines that a different margin of safety will be safe for infants and children. 

Margins of Exposure (safety), which are often referred to as uncertainty factors, are incorporated into 

Agency risk assessments, either directly, or through the use of a margin of exposure analysis, or by

using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk.

Based on the acute toxicity and pathogenicity data discussed in Table 3 in Appendix A of the BRAD and 

“Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0088 at 

http://www.regulations.gov , EPA concludes that there is a reasonable certainty that no harm will result 

to the United States population, including infants and children, from aggregate exposure to the residues 

of PFR-97. This includes all anticipated dietary exposures and all other exposures for which there is 

reliable information. The Agency has arrived at this conclusion because the data and information 

available on PFR-97 do not demonstrate toxic, pathogenic, and/or infective potential to mammals. Thus, 

there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary.

3. Occupational Exposure and Risk Characterization

In light of the Tier I acute toxicity/pathogenicity studies, which did not show any toxicity or 

pathogenicity via the oral, pulmonary, or intraperitoneal injection routes of exposure, handler exposure 

to PFR-97 is not expected to pose any undue risk. Regardless, appropriate personal protective equipment 

and precautionary statements are required to be on the product label to mitigate any potential risks to 

pesticide handlers due to prolonged exposure. Handlers working with PFR-97 must wear a long-sleeved 

shirt, long pants, socks, shoes, waterproof gloves, and a dust/mist filtering respirator meeting National 

Institute for Occupational Safety and Health (NIOSH) standards of at least N-95, R-95, or P-95 when 

mixing, loading, or applying the product.

C. Environmental Assessment (40 CFR § 158.2150)

1. Nontarget Organism Toxicology 

All nontarget toxicology data requirements for the proposed uses of PFR-97 have been satisfied. 

Acceptable Tier I nontarget toxicology data/information support the registration of PFR-97. Refer to 

Table 4 in Appendix A for a brief summary of these data requirements. Additionally, the summaries of 
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the Agency risk assessments that evaluate Table 4 in Appendix A of this BRAD are available as 

“Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0088 at 

http://www.regulations.gov.

2. Environmental Fate and Ground Water Data 

As the information provided is sufficient to both satisfy the Tier I nontarget organism data requirements 

and for nontarget organism risk assessment for PFR-97, further testing at higher tier levels (i.e., Tiers II, 

III, and IV) is not required. 

3. Ecological Exposure and Risk Characterization

The Agency has performed an environmental risk assessment based on the literature citations and 

studies provided by the registrant. PFR-97 is a naturally occurring strain of Isaria fumosorosea 

(formerly Paecilomyces fumosoroseus). Isaria fumosorosea 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

species of whiteflies, and has caused epizootics in this species and in the United States and other 

countries (Zimmerman, 2008). Data on natural concentrations of Paecilomyces fumosoroseus and 

persistence of this strain in the environment are not available. Exposure on the field is expected to occur 

at levels that would affect sensitive insects. Some offsite movement may occur with spray drift, but 

exposure is expected to occur at lower levels outside of treated areas (US EPA memorandum dated July

21, 2011, from Shannon Borges to Shanaz Bacchus)

The applicant has submitted data and rationales to waive testing to satisfy data requirements for 

nontarget organism risk assessment with the technical grade of the active ingredient (TGAI). Submitted 

data, data waiver rationales, and a search by the Agency of several literature databases provided

sufficient information to determine that toxicity/pathogenicity to wild mammals, avian wildlife, 

freshwater and marine/estuarine vertebrates and invertebrates, and terrestrial and aquatic plants is not 

expected from the proposed label uses. There is uncertainty about the potential for adverse effects to 

certain non target insects and arachnids. While the honey bee study showed no toxicity to these 

beneficial insects, it was not of long enough duration to determine pathogenicity to them. Thus, the 

pesticide must not be applied while honey bees are actively foraging. Further testing of nontarget 

organisms at higher tier levels is not required at this time, but may be required in the future (US EPA 

Borges, July 21, 2011, Appendix A and “Supporting & Related Materials” within Docket Number EPAHQ-OPP-2010-0088 at http://www.regulations.gov).

 

4. Threatened and Endangered Species Assessment

A complete Endangered Species (ES) has not been completed for this registration amendment and will 

be conducted during the registration review process. As indicated in the Environmental Risk Assessment 

(US EPA, Borges, July 21, 2011), included in this docket, EPA has determined that adverse effects to 

nontarget insects as a result of the proposed new uses of Paecilomyces fumosoroseus Apopka strain 97 

are possible. 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.
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 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 may 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.

V. ENVIRONMENTAL JUSTICE

The Agency seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. To help address 

potential environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result their location, cultural practices, or other factors, may have atypical, 

unusually high exposure to PFR-97, compared to the general population. Please comment if you are 

aware of any subpopulations that may have atypical, unusually high exposure compared to the general 

population. During the public comment period, the Agency sought comment on any subpopulations that 

may have atypical, unusually high exposure compared to the general population. No comments were 

received on this issue.

For additional information regarding environmental justice issues, please visit the Agency’s web site at 

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is determined that 

(A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials 

required to be submitted comply with the requirements of FIFRA; (C) it will perform its intended 

function without unreasonable adverse effects on the environment; and (D) when used in accordance 

with widespread and commonly recognized practice, it will not generally cause unreasonable adverse 

effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the 

science assessments supporting the product containing Isaria fumosorosea (formerly Paecilomyces 

fumosoroseus) Apopka 97. This product is not expected to cause unreasonable adverse effects and is

likely to provide protection as claimed when used according to label instructions. The Agency believes, 

therefore, that Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka 97 is eligible for 

registration for the proposed uses. 

VII. TERMS AND CONDITIONS OF THE REGISTRATION(S)

As a term of registration, the registrant must submit analyses of unintentional ingredients in five 

production batches (40 CFR § 158.2120).
Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 Final September 15, 2011 Page 13 of 24

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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

cfu colony-forming units

cfu/g colony-forming units per gram

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g/mL grams per milliliter

IR-4 Interregional Research Project Number 4 

LLC limited liability company

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

OCSPP Office of Chemical Safety and Pollution Prevention

OPP Office of Pesticide Programs

PP Pesticide Petition

TGAI technical grade of the active ingredient
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IX. BIBLIOGRAPHY

A. Studies Submitted to Support the Paecilomyces fumosoroseus Apopka strain 97 Pesticide Product 

Registration

Bibliography

MRID Citation Reference

43139800 W.R. Grace & Co. (1994) Submittal of Product Chemistry, Toxicity/ Pathogenicity, and 

Environmental Fate Data in Support of Registration of PFR-MUP. Transmittal of 4 

studies. 

43139801 Eyal, J. (1994) PFR-MUP Product Chemistry: Lab Project Number: 4775-MUPCHEM. Unpublished study prepared by W.R. Grace & Co.--Conn. 128 p. 

43139802 Jones, M. (1993) Acute Pulmonary Toxicity/Pathogenicity Study of Paecilomyces 

fumosoroseus var. Apopka in Rats: Final Report: Lab Project Number: G-7444.228.001. 

Unpublished study prepared by Microbiological Associates, Inc. 83 p. 

43139803 Jones, M. (1993) Acute Intraperitoneal Toxicity/Pathogenicity Study of Paecilomyces 

fumosoroseus var. Apopka in Rats: Final Report: Lab Project Number: G-7444.226.001. 

Unpublished study prepared by Microbiological Associates, Inc. 65 p. 

43139804 Eyal, J. (1994) PFT-MUP Environmental Fate Data: Lab Project Number: 4775-MUPENVFATE. Unpublished study prepared by W.R. Grace & Co.--Comm. 19 p. 

43139900 W.R. Grace & Co. (1994) Submittal of Product Chemistry Data in Support of 

Registration of PFR-97 WDG. Transmittal of 1 study. 

43139901 Eyal, J. (1994) PFR-97 WDG Product Chemistry: Lab Project Number: 4775-PFR-97-

CHEM. Unpublished study prepared by W.R. Grace & Co.--Conn. 89 p. 

43146200 W. R. Grace & Co.-Conn. (1994) Submittal of Toxicity Data in Support of Registration 

of PFR-MUP and PFR-97 WDG. Transmittal of 3 studies. 

43146201 Wenk, M. (1994) Primary Eye Irritation Study of Paecilomyces fumosoroseus var. 

Apopka in Rabbits: Final Report: Lab Project Number: G-7473.230. Unpublished study

prepared by Microbiological Associates, Inc. 32 p. 

43146202 Wenk, M. (1994) Primary Dermal Irritation Test of Paecilomyces fumosoroseus var. 

Apopka in Rabbits: Final Report: Lab Project Number: G-7444.242. Unpublished study

prepared by Microbiological Associates, Inc. 29 p. 

43146203 Wenk, M. (1994) Dermal Sensitization Test of Paecilomyces fumosoroseus var. Apopka 

in Guinea Pigs: Final Report: Lab Project Number: G-7444.245. Unpublished study

prepared by Microbiological Associates, Inc. 37 p. 

43163900 W. R. Grace & Co. (1994) Submission of Toxicity Data for Paecilomyces fumosoroseus

Apopka Strain 97 in Support of Registration. Transmittal of 1 study. 

43163901 Jones, J. (1994) Acute Oral Toxicity/Pathogenicity Study of Paecilomyces fumosoroseus
Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 Final September 15, 2011 Page 15 of 24

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var. Apopka in Rats: Final Report: Lab Project Number: G-7444.222.006: 1602.222.006. 

Unpublished study prepared by Microbiological Associates Inc. 78 p. 

43225500 W.R. Grace & Co. (1994) Submission of Toxicity Data for Paecilomyces fumosoroseus

Apopka Strain 97 in Support of Registration. Transmittal of 1 study. 

43225501 Wenk, M. (1994) Acute Dermal Toxicity Test of Paecilomyces fumosoroseus var. 

Apopka In Rabbits: Final Report: Lab Project Number: G-7444.232. Unpublished study

prepared by Microbiological Associates, Inc. 36 p. 

43292900 W.R. Grace & Co.-Conn. (1994) Submission of product chemistry data in support of 

registration for PFR-97 20% WDG. Transmittal of 1 study. 

43292901 Eyal, J. (1994) PFR-97TM 20 (percent) WDG Product Chemistry: Lab Project Number: 

4775/PFR/97/20/CHEM. Unpublished study prepared by W. R. Grace & Co. Conn. 89 p. 

43534800 W. R. Grace and Co. (1995) Submission of toxicology data in support of registration of 

PFR-MUP, PFR-97, and PFR-97 20% WDG. Transmittal of 3 studies. 

43534801 Wenk, M. (1994) Repeat Primary Eye Irritation Study of Paecilomyces fumosoroseus var. 

Apopka in Rabbits: Final Report: Lab Project Number: G/7373/230R. Unpublished study

prepared by Microbiological Associates, Inc. 34 p. 

43534802 Lawlor, T. (1994) Mutagenicity Test on Paecilomyces fumosoroseus Apopka Strain 97 in 

Salmonella/Mammalian-Microsome Reverse Mutation Assay (Ames Test) with a 

Confirmatory Assay: Final Report: Lab Project Number: 16203/0/401R. Unpublished 

study prepared by Hazleton Washington, Inc. 30 p. 

43534803 Frey, L.; Grimes, J.; Beavers, J. (1994) Paecilomyces fumosoroseus Apopka Strain 97: 

An Avian Oral Pathogenicity and Toxicity Study in the Northern Bobwhite: Lab Project 

Number: 390/101. Unpublished study prepared by Wildlife International Ltd. 25 p. 

43664400 W. R. Grace & Co.--Conn. (1995) Submission of Hazard to Non-Target Insects Data in 

Support of Applications for Registration of PFR-97 and PFR-97 20% WDG. Transmittal 

of 1 Study. 

43664401 Eyal, J. (1995) PFR-97 20% WDG: Nontarget Insect Data: Effects on Beneficial Insects: 

Lab Project Number: 4775-20WDG-NTI. Unpublished study prepared by W. R. Grace & 

Co.--Conn. 101 p. 

47939500 Certis USA, LLC (2009) Submission of Product Chemistry and Toxicity Data in Support 

of the Amended Registration of PFR-97 20% WDG and the Petition for Tolerance of 

Paecilomyces fumosoroseus Apopka Strain 97. Transmittal of 9 Studies.

47939501 Simpson, A. (2009) Discussion of Formation of Unintentional Ingredients: PFR-97 20% 

WDG. Unpublished study prepared by Certis USA, LLC. 38 p.

47939502 Simpson, A. (2009) PRF-97 20% WDG: Product Property Data Waivers: Physical and 

Chemical Characteristics. Unpublished study prepared by Certis USA, LLC. 6 p.

47939503 DeVane, W. (2009) PRF-97 20% WDG: Product Property Data Waivers: Storage 

Stability. Project Number: TTC0026/10. Unpublished study prepared by Certis USA, 

LLC. 20 p.
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47939504 Dively, C. (2009) Paecilomyces fumosoroseus Apopka Strain 97: End Use Product: PFR97 20%: Non-Target Plant Studies. Unpublished study prepared by Certis USA, LLC. 25 

p.

47939505 Dively, C. (2009) Paecilomyces fumosoroseus Apopka Strain 97: End Use Product: PFR97 20%: Non-Target Insect Studies. Unpublished study prepared by Certis USA, LLC. 45 

p.

47939506 Dively, C. (2009) Paecilomyces fumosoroseus Apopka Strain 97: End Use Product: PFR97 20%: Non-Target Freshwater Aquatic Invertebrate Testing, Tier I: Non-Target 

Freshwater Fish Testing, Tier I. Unpublished study prepared by Certis USA, LLC. 23 p.

47939507 Dively, C. (2009) Paecilomyces fumosoroseus Apopka Strain 97: End Use Product: PFR97 20%: Non-Target Wild Mammal Studies. Unpublished study prepared by Certis USA, 

LLC. 16 p.

47939508 Dively, C. (2009) Paecilomyces fumosoroseus Apopka Strain 97: End Use Product: PFR97 20%: Acute Toxicity Studies/End Product (Alternative Formulation). Unpublished 

study prepared by Certis USA, LLC. 10 p.

47939509 Nengel, S. (1998) PreFeRal WG: Acute Oral and Contact Toxicity to the Honey Bee, Apis 

mellifera L., in the Laboratory: Final Report. Project Number: 98338/01/BLEU. 

Unpublished study prepared by GAB Biotechnologie Gmbh. 23 p.

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 1995. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity studies of 

the end use product (EP) PFR-97 (EPA Reg. Nos. 70051-17, 70051-19) containing the active 

ingredient (AI) Paecilomyces fumosoroseus Apopka strain 97. Memorandum from Cindy

Schaffer and Roy Sjoblad, Ph.D. to Shanaz Bacchus dated September 8, 1995. Reviews of 

Product chemistry - MRIDs 43292901, 43139901, 43139801, acute toxicology - MRIDs 

431363901, 43225501, 43139802, 43139803, 43146201, 43146202, 43146203, 43534802. 

U.S. EPA. 2011. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity studies of 

the end use product (EP) PFR-97 (EPA Reg. Nos. 70051-17, 70051-19) containing the active 

ingredient (AI) Paecilomyces fumosoroseus. Memorandum from I. Barsoum, Ph.D. and J. 

Kough, Ph.D. to Shanaz Bacchus, dated April 28, 2011 and July 20, 2011. See Tables 1, 2a, 2b, 

3.

U.S. EPA. 2011. Environmental risk assessment for the FIFRA Section 3 new use registration of 

Paecilomyces fumosoroseus Apopka Strain 97 (EPA Reg. No. 70051-19). Memorandum from 

Shannon Borges and Zigfridas Vaituzis to Shanaz Bacchus, dated July 21, 2011.

C. Other References

ARS collection of Entompathogenic Fungal (ARSEF) Cultures. January 24, 2011. Isaria, plus 

Paecilomyces and Evlachovea USDA-ARS Biological Integrated Pest Management Research, 

Robert W. Holley Center for Agriculture and Health. 538 Tower Road, Ithaca, New York 14853-

2901.
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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.
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Appendix A. Microbial Pesticides Data Requirements (40 CFR Part 158 - Subpart V)

*NOTE: Master Record Identification Numbers listed in the following tables are representative 

 of supporting data for the original registration of the product containing Isaria fumosorosea (formerly 

Paecilomyces fumosoroseus) Apopka strain 97. 

1. Product Identity and Mode of Action

Product Identity

The Agency has classified Paecilomyces fumosoroseus Apopka strain 97 as an active ingredient for use 

in microbial pesticides. This fungal strain is an entomopathogenic fungus of many orders of insects. It 

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

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. PFR-97TM 20% WDG contains blastospores, 

mycelia and conidia.

The genus Paecilomyces was created in 1907 by Banier and was considered to be related to Penicillium. 

One taxonomic revision, done by Samson (1974), redefined and monographed the genus as “those 

species with verticillate conidiophores bearing divergent whorls of branches and phialides”. The latest 

taxonomic revision is reported in ARS collection of Entompathogenic Fungal (ARSEF) Cultures in

January 24, 2011, which classifies the genus and species as Isaria fumosorosea.

When PFR-97 is grown on agar media or insects, the following observations have been noted. Colonies 

grow moderately fast on malt-agar, attaining a diameter of approximately 4 cm within 14 days at 25C. 

These colonies consist of a basal felt with raised floccose overgrowth, powdery when freshly isolated. In

some isolates pink synnemata occur which may be branched. They are white at first, remaining so or 

changing to pink shades, especially when sporulating abundantly. Reverse is uncolored or yellow. Odor 

is absent. Vegetative hyphae are smooth-walled, hyaline, and 1.5 - 3.5 μm wide. Conidial structures are 

mostly complex, consisting of erect conidiophores arising from submerged or laterally from aerial 

hyphae. Conidiophores are mono-or synnematous, up to 100μm in length, 1.5 - 2 μm wide, smoothwalled, hyaline, consisting of verticillate branches bearing whorls of 4 to 6 phialides. Phialides are 5.7-8 

x 1-2 μm, with a globose or ellipsoidal basal portion which tapers into a long distinct neck, about 0.5μm 

wide. PFR Apopka strain 97 in the MUP has verticillate branches bearing whorls of 6 phialides. Conidia 

are cylindrical to fusiform, smooth-walled, hyaline to slightly pink, 3-4 x 1-2 μm. Chlamydospores are 

absent.

Growth on insects. On insects the fungus produces monomenatous conidiophores or distinct but loose 

synnemata. Synnemata are erect, branched appearing pink and powdery due to the conidia, and can grow 

up to 3 cm in length and 400μm in diameter. Conidiogenous elements are inflated. Condiophores are 

2.5-4μm wide. Verticillate branches are more or less globose or broadly cylindrical, 4-9 x 3-4.5 μm. 

Phialides with a globose basal portion can be 2.3 - 3.5 μm wide.

Mode of Action:

Conidia of the fungus attach to, and penetrate the cuticle of the host insect, where they germinate and 
Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 Final September 15, 2011 Page 19 of 24

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grow. This leads to pathogenesis and eventual death of the diseased insect host. 

Product Chemistry

TABLE 1. Product Analysis Data Requirements for the Manufacturing Use Product (MUP), Isaria fumosorosea

(formerly Paecilomyces fumosoroseus) Apopka strain 97, and Its Associated End-Use Product (EP)

(40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement

Results

MRID No.

MUP EP

885.1100 Product Identity A sample of Paecilomyces

fumosoroseus Apopka strain 97 is 

filed at American Type Tissue 

Collection # 20874.

(DER dated 09/08/1995, from Cindy 

Schaffer to Shanaz Bacchus, MRIDs 

43139901, 43139801). Change in 

taxonomic identification in 2011 

identifies fungus as Isaria 

fumosorosea (Zimmerman, 2008)

Apopka strain 97. Acceptable.

Submitted data satisfy the 

requirement for product 

identity. This product contains 

20% w/w of the MUP 

Paecilomyces fumosoroseus

Apopka strain 97 (ranged from 

1.5 x 109to 3.26 x 109cfu/g). 

(DER dated 09/08/1995 from 

Cindy Schaffer to Shanaz 

Bacchus, MRID †43292901).

Acceptable

†

43292901

†

43139901

†

43139801

885.1200 Manufacturing 

Process

The MUP is manufactured as liquid 

fermentation product at 108cfu/ml 

onsite and is formulated into the 

End-use Product that is labeled at 109

cfu/gram (DER dated 09/08/95 from 

Cindy Schaffer to Shanaz Bacchus, 

MRID †43139801, Supplementalrequired analysis of unintentional 

ingredients. See 885.1300 below.

Manufacturing process for 

PFR-97 20% WDG was 

previously submitted in MRID 

43292901. MSDS for the inert 

ingredients were provided in 

in MRID 47939508

**US EPA DER I. Barsoum to 

S. Bacchus, 04/28/11.

Acceptable

†

43292901

†

43139901

†

43139801

47939508**

885.1300 Discussion of 

Formation of 

Unintentional 

Ingredients

‘Beauveralides’ were detected as 

secondary metabolites during the 

manufacturing process; significance 

of this was not determined, but

secondary metabolites not a human 

health concern for the non-food 

greenhouse uses. Supplemental.

Levels of fungal and bacterial 

metabolites and MS-HPLC assay of 

negligible total beauverolides in 

broth acceptable; calculated 

beauverolides in sediment.

Confirmation required in five 

production batches. ***US EPA 

DER 05/20/11 from I. Barsoum to S. 

Bacchus, MRIDs 48383001, 

48357702.

Additional data provided for 

proposed food uses of the EP

in 2011 are acceptable for 

detection and Quality 

Assurance and Quality control 

of fungal, bacterial and other 

potential metabolites. **US 

EPA DER 04/28/11 from I. 

Barsoum to S. Bacchus; MRID 

47939501, 47939508, dated 

05/20/11; ***US EPA DER 

dated 05/20/11 from I. 

Barsoum to S. Bacchus,

MRIDs 48383001, 48357702.

Acceptable

†

43292901*

†

43139901*

†

43139801*

47939501**

47939501**

47939508**

48383001**

*

48357702**

*

Not 

applicable

Deposition of a 

Sample in a 

Nationally 

Recognized Culture 

Collection

Paecilomyces fumosoroseus Apopka 

strain 97 is on deposit with ATCC

Manassas, Virginia under Accession 

Number 20874. 

Not required for EP Certis’

MSDS.

885.1400 Analysis of Samples Submitted data satisfy the 

requirement for analysis of samples.

The content of active 

ingredient ranged from 1.5 x 

109to 3.26 x 109cfu/g, which 

meets the label claim. DER

†

43139801

†

43139901

†

43292901

47939501
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TABLE 1. Product Analysis Data Requirements for the Manufacturing Use Product (MUP), Isaria fumosorosea

(formerly Paecilomyces fumosoroseus) Apopka strain 97, and Its Associated End-Use Product (EP)

(40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement

Results

MRID No.

MUP EP

04/28/11 from I. Barsoum to S. 

Bacchus, MRID 47939501.

885.1500 Certification of 

Limits

Limits listed on the Confidential Statement of Formula (CSF) are 

adequate/acceptable.

†

43139801

†

43139901

†

43292901

47939501

Additional Studies

830.1800 Enforcement Analytical 

Method

Not applicable Acceptable 47939501

†DER dated 09/08/95 from Cindy Schaffer to Shanaz Bacchus, MRIDs †

43139801, 

†

43292901*, †43139901*, †43139801

*DER Hanna Daoud, CA Dept. Pesticide Registration, April 27, 1995; †43139801, 

†

43292901*, †43139901*, †43139801

For the initial registration of the active ingredient, US EPA evaluated the data submitted for this registration action in 1995, 

but considered and utilized the CA data assessments in order to streamline the review process.

**US EPA DERs from I. Barsoum to S. Bacchus; MRID 47939501 (04/28/11), 05/20/11;

***US EPA DER from I. Barsoum to S. Bacchus MRID 48357702, 48383001, dated 05/20/11.

TABLE 2a. Physical and Chemical Characteristics for the Manufacturing-Use Product (MUP), Isaria fumosorosea 

(formerly Paecilomyces fumosoroseus) Apopka strain 97 (40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement Results

MRID 

Number

830.6302 Color Brown

830.6303 Physical State Solid and liquid (10% precipitate in broth) 43139801

830.6304 Odor Smoke flavor 

830.6313 Stability to Normal and 

Elevated

Temperatures, Metals,

and Metal Ions

Stable at 4o C up to 3 weeks; not stable at 25 o C. Stability to 

metals and metal ions not reported.

43139801

830.6317 Storage Stability Up to three weeks @ 4oC. (C. Schaffer, 1995) up to 6 months 

at 4C (BRAD 050405). 

43139801

830.6319 Miscibility Not required because PFR 97 is not an emulsifiable form of 

microbial pesticide [refer to test note #2 of 40 CFR § 

158.2120(d)].

N/A

830.6320 Corrosion Characteristics Not corrosive in fermentation test vessels.

43139801

830.7000 pH 5.7

830.7100 Viscosity 6.4 Centipoise

830.7300 Density 1.06

830.6315 Flammability Not flammable

N/A

830.6314 Oxidation/Reduction; 

Chemical Incompatibility 

N/A

830.6316 Explodability N/A.

830.6321 Dielectric Breakdown 

Voltage

N/A.

N/A = Not applicable
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TABLE 2b. Physical and Chemical Characteristics for the End-Use Product (EP), Isaria fumosorosea 

(formerly Paecilomyces fumosoroseus) Apopka strain 97 (40 CFR § 158.2120)

Guideline Reference No./Property Description of Result Methods

830.6302 Color Yellow/Brown

MRID 

47939502

Certis’ 

MSDS

830.6303 Physical State Granular solid

830.6304 Odor Not required for EP

830.6313 Stability Not required for EP

830.6314 Oxidation/Reduction: 

Chemical Incompatibility

Not applicable, the product does not contain oxidizing or 

reducing agents.

830.6315 Flammability Not applicable, the product does not contain flammable 

ingredients.

830.6316 Explodability Not applicable, the product does not contain explosive 

ingredients.

830.6317 Storage Stability Stable in product packaging at 4°C for 12 months. 

Less stable in product packaging at 25°C after 12 

months. (Product label recommends storage at 4° to 

6°C in a dry place. Sample stored at 4

o C for 1 year 

was still effective at colonizing host insects while 

that stored at 25 o C was not).

MRID 

47939503

830.6319 Miscibility Not applicable, the product is not an emulsifiable liquid.

MRID 

47939502

830.6320 Corrosion Characteristics Non-reactive to the product containers.

830.6321 Dielectric Breakdown Voltage Not applicable, the product is not for use around electrical 

equipment.

830.7000 pH 6.4-6.5a

6.0-7.00b

830.7100 Viscosity Not applicable, the product is a solid.

830.7200 Melting Range Not required for EP

830.7220 Boiling Range Not applicable, the product is a solid.

830.7300 Density/Relative Density/Bulk 

Density

0.60-0.65 g/mLa

600 g/Lb

830.7370 Dissociation Constant in Water Not required for EP

830.7550 Partition Coefficient Not required for EP

830.7840 Water Solubility Not required for EP

830.7950 Vapor Pressure Not required for EP

aData from CSF for basic formulation. Basic formulation withdrawn 07/28/11 (email from Chris Dively, Certis,USA, to 

Shanaz Bacchus, US EPA/OPP/BPPD).

bData from CSF for alternate formulation. This is new basic formulation.
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TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Isaria 

fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data Requirement Results MRID

Number

Tier I

885.3050 Acute Oral 

Toxicity/ 

Pathogenicity

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. [DERs to Shanaz Bacchus from Cindy 

Schaffer (09/08/95)* and from Ibrahim Barsoum (04/28/11)**] 

Acceptable. Toxicity Category IV

43163901*

47939508**

885.3150 Acute Pulmonary 

Toxicity/ 

Pathogenicity

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. 

Acceptable Toxicity Category IV

43139802

885.3200 Acute Injection 

Toxicity/

Pathogenicity

Single intraperitoneal doses of suspensions containing 1.6 x 107

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

spores were cleared from the body within two days. 

43139803

870.1200

Acute Dermal 

Toxicity

2 grams of test substance applied to the skin of rabbits produced no 

deaths and there was no evidence of systemic toxicity. 

Acceptable Toxicity Category III.

43225501

870.2500 Primary dermal 

irritation

In a four-hour exposure, the test substance (2 g/animal) was found to 

be a slight dermal irritant. 

Acceptable Toxicity Category IV.

870.2400 Acute eye Irritation 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 Acceptable Toxicity Category IV.

43146201

Dermal 

Sensitization

In guinea pig: The test substance (3.0 x 107 – 5.3 x 109 cfu) produced 

no irritation or sensitization reaction in treated animals. The product 

was not a dermal sensitizer.

Supplemental. Not required for registration

43146202

885.3400 Hypersensitivity 

Incidents

Published literature pertaining to incidents involving other strains of 

Paecilomyces have been evaluated and data submitted to demonstrate 

that those incidents do not involve PFR Apopka 97 strain. Incident 

data must be reported in a timely manner. None reported with regard 

to pesticide use during the time that the registered pesticide has been 

in use.

885.3500 Cell Culture Not required for a fungal active ingredient – required for viruses. NA

Mutagenicity assay

(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).

43534802

Tiers II and III

Not required for Paecilomyces fumosoroseus Apopka strain 97 based on the acceptability of the data and waiver rationales 

evaluated for Tier I.
Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 Final September 15, 2011 Page 23 of 24

Biopesticides Registration Action Document – EPA HQ-OPP-2010-0088 FIFRA EPA HQ-OPP-2010-0087 FFDCA

Subchronic, Chronic Toxicity and Oncogenicity

Tier II tests (Guidelines 152-40 through 152-49) involving acute oral, acute inhalation, subchronic oral, 

acute intraperitoneal, intracerebral, primary dermal, primary eye, immune response, teratogenicity, 

virulence enhancement, and mammalian mutagenicity were (40 CFR 158.740(C)(2)(vi through xv) not 

required since survival, replication, infectivity, toxicity, or persistence of the microbial agent was not 

observed in the test animals treated in the Tier I acute oral infectivity test. Tier III tests (Guidelines 152-

50 through 53) involving chronic testing, oncogenicity testing, mutagenicity, and teratogenicity were not 

required (40 CFR 158.740(C)(2)(xvi through xix) since Tier II tests were not required.

Acute toxicity – End-use Product

For the End-use Product (EP) PFR-97 20% WDG, the registrant requested that testing for data 

requirements be waived based on the results of the tests conducted on the TGAI and the nature of the 

inert ingredients (MRID 47939508). The rationales justifying these requests were acceptable to the 

Agency (US EPA DER dated 04/28/11 from I. Barsoum to Shanaz Bacchus).

Waiver Requests granted for EP:

Acute Oral Toxicity (OPPTS 870.1100)

Acute Dermal Toxicity (OPPTS 870.1200):

Acute Inhalation Toxicity (OPPTS 870.1300)

Acute Eye Irritation (OPPTS 870.2400)

Acute Dermal Irritation (OPPTS 870.2500)

Ecological and Environmental Effects

See US EPA Borges July 21, 2011, for Nontarget Organism Toxicity and Environmental Fate Data 

Requirements for the Technical Grade of the Active Ingredient (TGAI), for Isaria fumosorosea

(formerly Paecilomyces fumosoroseus) Apopka strain 97 (40 CFR § 158.2150) in this docket for 

summaries of the data reviewed and presented in the table below.

Table 4. 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.

Acceptable

47939507

• Freshwater fish 

toxicity/pathogenicity 

• Freshwater 

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 

47939506
Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka strain 97 Final September 15, 2011 Page 24 of 24

Biopesticides Registration Action Document – EPA HQ-OPP-2010-0088 FIFRA EPA HQ-OPP-2010-0087 FFDCA

Data Requirement OPPTS 

Guideline No.

Results Summary and Classification MRID No.

invertebrate 

toxicity/pathogenicity

except for aerial applications.

Supplemental for aerial applications. Acceptable for all 

other applications

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.

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

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. 

Supplemental

Additional rationale show that pathogenicity may not be 

likely, but a conclusion cannot be made without 

uncertainty.

Acceptable

47939509

48357704