EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION 

COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN 

THE FEDERAL REGISTER 

LAM International Corporation

5F8411

EPA has received a pesticide petition 5F8411 from LAM International 

Corporation, 117 South Parkmont, Butte, MT 59701 proposing, pursuant to section 

408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for 

the microbial pesticide Purpureocillium lilacinum strain PL11.

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, LAM International 

Corporation has submitted the following summary of information, data, and arguments 

in support of their pesticide petition. This summary was prepared by Technology 

Sciences Group, Inc. and EPA has not fully evaluated the merits of the pesticide 

petition. The summary may have been edited by EPA if the terminology used was 

unclear, the summary contained extraneous material, or the summary unintentionally 

made the reader conclude that the findings reflected EPA’s position and not the position 

of the petitioner.

I. LAM International Corporation’s Petition Summary

5F8411

A. Product Name and Proposed Use Practices

Purpureocillium lilacinum strain PL11 Technical is a 100% ai Technical 

Grade Active Ingredient (TGAI) of Purpureocillium lilacinum strain PL11 and is 

proposed for manufacturing use only, for further formulation into registered enduse products.

BIOSTAT® WP is a 2% ai formulated end-use product that is intended for 

use as a soil incorporated treatment for application and incorporation into soil 

before planting or transplanting crops, or application by drip irrigation after 

planting or transplanting crops, to control plant parasitic nematodes.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Purpureocillium 

lilacinum strain PL11 (CAS No. Not applicable)

2. Magnitude of residues at the time of harvest and method used to determine the 
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residue. An analytical method for residues is not applicable. It is expected that, when 

used as proposed, Purpureocillium lilacinum strain PL11 would not result in 

residues that are of toxicological concern.

3. A statement of why an analytical method of detecting and measuring the levels 

of the pesticide residue are not needed. It is expected that, when used as proposed, 

Purpureocillium lilacinum strain PL11 would not result in residues that are of 

toxicological concern.

C. Mammalian Toxicological Profile

Acute Oral Toxicity/Pathogenicity Study in Rats (OCSPP 885.3050): 

Purpureocillium lilacinum strain PL11 was not toxic or pathogenic in an acute oral 

toxicity/pathogenicity study in rats (MRID No. 496395-03). In this study, groups of 3 

males and 3 females received an oral dose of the test material by gavage and were 

sacrificed 1, 3, 7 or 14 days after exposure to evaluate clearance of the microbe. The 

dose given to all groups of both male and female rats in the toxicity/pathogenicity 

study was 0.5 mL of the undiluted test material. The resulting doses were 1,361 

mg/kg in males and 2,421 mg/kg in females. There were no clinical signs of toxicity 

reported for any of the rats that received test material in this study, no macroscopic 

effects reported in the necropsy, and no histopathologic findings. The results of this 

study are appropriate for evaluation of potential effects in wild mammals.

Acute Pulmonary Toxicity/Pathogenicity Study in Rats (OCSPP 885.3150): 

Purpureocillium lilacinum strain PL11 was not toxic or pathogenic in an acute 

pulmonary toxicity/pathogenicity study in rats (MRID No. 496395-04). Groups of 3 

males and 3 females received a single intranasal dose of the test material and were 

sacrificed 1 hour or 3, 7, 14, or 21 days after exposure to evaluate clearance of the 

microbe, and potential adverse effects. The dose given to all test groups of both male 

and female rats in the pulmonary study was 0.05 mL (50 μl) of a 2% dilution of the 

test material in Tween-80, a non-ionic surfactant. This dose resulted in 1 X 108 CFU 

per rat. All dosed rats in all pulmonary exposure groups survived the exposure and 

gained weight at each interval measured after exposure. The groups most relevant 

to the acute inhalation toxicity data requirement are the groups that were followed 

for 14 or 21 days after exposure, which corresponds to the duration of the acute 

inhalation toxicity study follow-up or longer. No clinical signs of toxicity were 

observed in any group during the study. The No Observed Effect Levels for males 

and females were the high doses tested of 1 X 108 CFU per rat.

Acute Intraperitoneal Toxicity/Pathogenicity Study in Rats (OCSPP 885.3200): 

Purpureocillium lilacinum strain PL11 was not toxic or pathogenic in an acute 

intraperitoneal toxicity/pathogenicity study in rats (MRID No. 496395-05). Five 

groups of 3 females and 3 males each received at least 1.0 x 109 units of test material 

by intraperitoneal route. No clinical signs of evident toxicity or agent pathogenesis 

were observed in tested groups. No macroscopic alterations were observed in 

control and treated groups. Recovery of the microbe reached > 1.5 x 103 on the 1 

hour and 3 days groups, and until 1.2 x 102 on the group of 7 days. For the groups of 
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14 and 21 days, recovery was below the limit of detection (< 1 x 101). Clearance was 

considered to be until 14 days. Under the test conditions, test substance 

Purpureocillium lilacinum strain PL11 was classified as non-pathogenic, non-toxic 

and non-infective.

Acute Dermal Toxicity (OCSPP 870.1200): An acute dermal toxicity study 

conducted on the proposed TGAI, Purpureocillium lilacinum strain PL11 addressed 

the endpoints of concern for dermal irritation and so fulfills the data requirement 

for a Primary Dermal Irritation study (MRID No. 496395-06). In the acute dermal 

toxicity study, 5 male and 5 female Wistar rats received a 2,000 mg/kg body weight 

dose of test substance diluted in carboxymethyl cellulose applied over approximately 

10% of the total body surface area. After a 24-hour exposure the test material was 

removed using de-mineralized water. The normal duration of exposure for dermal 

irritation studies is 4 hours, so any irritation following a 24 hour exposure is 

expected to be more severe than the effect after 4 hours of exposure. 

Primary Eye Irritation (OCSPP 870.2400): Purpureocillium lilacinum strain PL11 

was identified as a dermal irritant following a 24-hour exposure to a dose of 2,000 

mg/kg; consequently, the TGAI also is expected to be an eye irritant (MRID No. 

496395-06). Quantitative structure activity (QSAR) models and supporting data 

indicate that a common molecular mechanism of irritant action exists for eye and 

dermal irritation (MRID No. 496395-17). The common mechanism of action 

described involves 3 factors: 1) irritation increases as the concentration of the 

irritant in an aqueous medium available for membrane uptake increases, 2) the 

strength of irritant interaction with the cellular membrane is directly proportional 

to irritation potency, and 3) both skin and eye irritation are dependent upon the 

chemical reactivity of the irritant. It is expected that the TGAI Purpureocillium 

lilacinum strain PL11, is an eye irritant based on the identification of the TGAI as a 

dermal irritant and the fact that data and models suggest that dermal and eye 

irritation share common molecular modes of action.

The registrant has noted that no incidents of hypersensitivity or any other adverse 

effects have occurred through the research, development or testing of the active 

ingredient and its related end-use product. Should any incidents occur, they will be 

reported per FIFRA Section 6(a)(2) (MRID No. 496395-17).

Data on metabolites (OCSPP 885.1300): A study was carried out to identify 

secondary metabolites in the fungus Purpureocillium lilacinum strain PL11 technical 

grade active ingredient in samples of eight batches of material as manufactured 

(MRID No. 496395-02). 

The results of toxicity and metabolite testing show there is no risk to human health 

from the active ingredient. Purpureocillium lilacinum strain PL11 is not toxic, 

pathogenic, or infective to mammals and does not produce metabolites of 

toxicological concern.
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D. Aggregate Exposure

1. Dietary exposure. Dietary exposure from use of Purpureocillium lilacinum

strain PL11, as proposed, is minimal. The intended use of Purpureocillium lilacinum

strain PL11 is as a soil incorporated treatment for application and incorporation 

into soil before planting or transplanting crops, or application by drip irrigation 

after planting or transplanting crops, to control plant parasitic nematodes. 

Purpureocillium lilacinum is ubiquitous in the environment as a naturally-occurring 

filamentous fungus found in soils (MRID No. 496395-01).

i. Food. Dietary exposure from use of Purpureocillium lilacinum strain PL11, 

as proposed, is minimal. The intended use of Purpureocillium lilacinum strain PL11 

is as a soil incorporated treatment for application and incorporation into soil before 

planting or transplanting crops, or application by drip irrigation after planting or 

transplanting crops, to control plant parasitic nematodes. Purpureocillium 

lilacinum is ubiquitous in the environment as a naturally-occurring filamentous 

fungus found in soils (MRID No. 496395-01).

ii. Drinking water. Exposure to humans from residues of Purpureocillium 

lilacinum strain PL11 in consumed drinking water would be unlikely. Potential 

exposure to surface water would be negligible and exposure to drinking water (well 

or ground water) would be impossible to measure. Purpureocillium lilacinum is 

ubiquitous in the environment as a naturally-occurring filamentous fungus found in 

soils (MRID No. 496395-01). 

2. Non-dietary exposure. The intended use of Purpureocillium lilacinum strain 

PL11 is as a soil incorporated treatment for application and incorporation into soil 

before planting or transplanting crops, or application by drip irrigation after 

planting or transplanting crops, to control plant parasitic nematodes. Personal 

Protective Equipment (PPE) mitigates the potential for exposure to applicators and 

handlers of the proposed products, when used in agricultural settings. 

Purpureocillium lilacinum is ubiquitous in the environment as a naturally-occurring 

filamentous fungus found in soils (MRID No. 496395-01).

E. Cumulative Effects

It is not expected that, when used as proposed, Purpureocillium lilacinum

strain PL11 would result in residues that are of toxicological concern. The intended 

use of Purpureocillium lilacinum strain PL11 is as a soil incorporated treatment for 

application and incorporation into soil before planting or transplanting crops, or 

application by drip irrigation after planting or transplanting crops, to control plant 

parasitic nematodes. The results of toxicity testing indicate there is no risk to human 

health or the environment from Purpureocillium lilacinum strain PL11. There are 

no reports of ecological or human health hazards caused by this microorganism. It 

does not produce recognized toxins, enzymes, or virulence factors normally 

associated with mammalian invasiveness or toxicity. The absence of acute toxicity or 

pathogenicity in laboratory animals demonstrates the benign nature of this strain
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F. Safety Determination

1. U.S. population. Acute toxicity studies have shown that Purpureocillium 

lilacinum strain PL11 is not toxic, pathogenic, infective or irritating to mammals. 

The intended use of Purpureocillium lilacinum strain PL11 is as a soil incorporated 

treatment for application and incorporation into soil before planting or 

transplanting crops, or application by drip irrigation after planting or transplanting 

crops, to control plant parasitic nematodes. The results of toxicity testing indicate 

there is no risk to human health or the environment from Purpureocillium lilacinum

strain PL11. There are no reports of ecological or human health hazards caused by 

this microorganism. It does not produce recognized toxins, enzymes, or virulence 

factors normally associated with mammalian invasiveness or toxicity. The absence 

of acute toxicity or pathogenicity in laboratory animals demonstrates the benign 

nature of this strain. There is a reasonable certainty of no harm to the general US 

population from exposure to this active ingredient.

2. Infants and children. It is not expected that, when used as proposed, 

Purpureocillium lilacinum strain PL11 would result in residues that are of 

toxicological concern. There is a reasonable certainty of no harm for infants and 

children from exposure to Purpureocillium lilacinum strain PL11 from the proposed 

uses. 

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Purpureocillium lilacinum strain 

PL11 functions in a manner similar to any known hormone, or that it acts as an 

endocrine disrupter.

H. Existing Tolerances

There is no US EPA tolerance or tolerance exemption for Purpureocillium 

lilacinum strain PL11.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not 

established for Purpureocillium lilacinum strain PL11.