US Environmental Protection Agency

Office of Pesticide Programs

BIOPESTICIDES REGISTRATION ACTION DOCUMENT

 Gliocladium catenulatum strain J1446 
(PC Code 021009)



 November 12, 2002
BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Gliocladium catenulatum strain J1446 

(PC Code 021009)

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Gliocladium catenulatum strain J1446 

(PC Code 021009) 

November 12, 2002 
Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

TABLE OF CONTENTS

I. ABSTRACT ................................................................. 1

II. OVERVIEW ................................................................ 1

A. Product Overview ...................................................... 1

B. Use Profile ............................................................. 1

C. Regulatory History ...................................................... 3

III. SCIENCE ASSESSMENT ..................................................... 3

A. Physical and Chemical Properties Assessment ............................... 3

B. Human Risk Assessment ........................................... 5

1. Human Toxicity Assessment ........................................ 5

a. Acute Toxicity .............................................. 5

b. Subchronic Toxicity and Chronic Toxicity ...................... 6

2. Effects on the Immune and Endocrine Systems ......................... 6

3. Dose Response Assessment .......................................... 7

4. Dietary Exposure and Risk Characterization .......................... 7

5. Occupational, Residential, School and Day care Exposure and Risk 

Characterization .............................................. 7

6. Drinking Water Exposure and Risk Characterization ................... 8

7. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly

Infants and Children ........................................... 9

8. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and

Inhalation .................................................... 9

9. Cumulative Effects ................................................ 9

C. Environmental Assessment .............................................. 10

1. Environmental Fate .............................................. 10

2. Ecological Toxicity ............................................... 10

IV. RISK MANAGEMENT AND RE/REGISTRATION DECISION ................... 16

A. Determination of Eligibility ............................................. 16

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

B. Regulatory Position .................................................... 16

C. Labeling Rational ...................................................... 17

V. ACTIONS REQUIRED BY REGISTRANTS .................................... 18

A. Precautionary Labeling ................................................. 18

B. Environmental Hazards Labeling ......................................... 18

1. End-Use Product Environmental Hazards Labeling .................... 19

2. Manufacturing-Use Product Environmental Hazards Labeling .......... 19

3. Application Rate ................................................. 19

C. Labeling .............................................................. 19

BIBLIOGRAPHY .............................................................. 21

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

I. ABSTRACT 

Gliocladium catenulatum strain J1446 is a naturally-occurring saprophytic fungus which is widespread in the environment. Gliocladium catenulatum can be cultured on various types of media, 

where colonies range from whitish with pale-green centers on malt agar to grayish-green on oatmeal 

agar. This organism is the active ingredient of a microbial pesticide, PRIMASTOP Biofungicide. 

PRIMASTOP is used to control damping-off, seed rot, root and stem rot, and wilt diseases caused by 

Rhizoctonia, Pythium, Phytophthora, Fusarium, Didymella, Botrytis, Verticillium, Alternaria, 

Cladosporium, Helminthosporium, Penicillium, and Plicaria. The use of this product had been 

limited to greenhouse and indoor settings, but currently the product is also registered to be used 

outdoors on various vegetables, herbs, ornamental plants, trees, shrubs and turf. No toxicological 

end-point of concern was identified. The health risk is expected to be minimal for oral, dermal, and 

inhalation exposure routes. The risk to non-target organisms, including fish, birds, and insects, is 

expected to be minimal. 

II. OVERVIEW 

A. Product Overview 

! Microbial Pesticide Name: Gliocladium catenulatum strain J1446 

! Trade Name: PRIMASTOP Biofungicide 

! OPP Chemical Code: 021009 

! Basic Manufacturer: Verdera Oy 

( Formerly Kemira Agro Oy) 

! US Agent: Ms. Kim Davis 

RegWest Company 

30856 Rocky Road 

Greeley, CO 80631-9375 

B. Use Profile 

Type of Pesticide: Fungicide 

Mechanism of action: The mode of action is reported to be by an enzymatic mechanism. 

There are no reports indicating that Gliocladium catenulatum strain J1446 produces any 

toxins or antibiotics. 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Use Sites: 

At this time Gliocladium catenulatum J1446 is registered for greenhouse, indoor, and

outdoor use.

Greenhouse and Terrestrial Food Crops

artichokes, asparagus, beans, beets, broccoli, brussel sprouts, cabbage, carrots, cauliflower,

celery, chicory, chinese cabbage, corn, cucumbers, eggplant, endive, garlic, horseradish,

kale, kohlrabi, leeks, lentils, lettuce, melons, New Zealand spinach, onions, parsnips, peas,

peppers, potatoes, pumpkins, radishes, rutabagas, spinach, squash, strawberries, tomatoes,

turnips, watermelons, aniseed, basil, caraway, chives, dill, fennel, lavender, marjoram,

oregano, parsley, rosemary, sage, savory, thyme, watercress

Greenhouse, Indoor and Terrestrial Non-Food Sites

ornamentals (including flowers, foliage and potted, bedding and seedling plants), tree shrub

seedlings, and turf

Target Pests for Active Ingredient: to control damping-off, seed rot, root and stem rot, 

and wilt diseases caused by Rhizoctonia, Pythium, Phytophthora, Fusarium, Didymella, 

Botrytis, Verticillium, Alternaria, Cladosporium, Helminthosporium, Penicillium, and 

Plicaria 

Formulation Types Registered: 

Type: End-use product

Form:wettable powder 37.0 % Gliocladium catenulatum strain J1446 

Method and Rates of Application: 

Types of Treatment 

soil incorporation, soil drench, foliar spray, and dipping of cuttings, bulbs, and tubers 

Equipment

none specified

Timing 

at sowing, potting or transplanting and 2-6 weeks later for potted plants and 2-8 weeks later 

for other plants. Cuttings, bulbs, or tubers may be sprayed after planting or treated before 

planting or storage. 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Rates of Application: 

in soil: 0.05- 1.2 x108 CFU/L (0.05 -1.2 gram of PRIMASTOP/L of growth 

substrate) 

seedling trays or beds: 5- 25 x 108

 CFU/m2 (5- 25 gram of PRIMASTOP /m2) 

foliar spray/ Field spraying

and turf: 1 - 10 x108 CFU/m2 (1- 10 gram PRIMASTOP/m2 )

 Method of Application:

spray, incorporation in potting media or bulb storage mixture, bulb/tuber dipping

C. Regulatory History 

Kemira Agro Oy submitted an application December 4, 1996 for registration of 

PRIMASTOP Biofungicide along with a pesticide petition which proposed establishing an 

exemption from the requirement of a tolerance for residues of the microbial pesticide, 

Gliocladium catenulatum strain J1446, on growing crops. On July 2, 1998 the 

PRIMASTOP Biofungicide product (EPA Reg. No. 64137-8) was registered only for 

greenhouse and indoor use sites. On May 16, 2000, an amendment was submitted to add 

outdoor use sites and reduce the re-entry interval to zero hours. Consequently, the Agency 

has performed a complete ecological risk assessment for these new sites. This Biological 

Registration Action Decision document includes the latest risk assessment information. On 

June 19, 2002 the manufacturer, Kemira Agro Oy, changed its name to Verdera Oy. 

III. SCIENCE ASSESSMENT 

A. Physical and Chemical Properties Assessment

 Product Identity: 

The agency has classified PRIMASTOP as a microbial fungicide. PRIMASTOP contains 

living Gliocladium catenulatum strain J1446 as the active ingredient. Gliocladium 

catenulatum is a naturally-occurring saprophytic fungus, which is widespread in the 

environment. The optimal growth conditions for the fungus include a temperature of 

25- 28°C and an optimum pH of 5-6, with a range of pH 3-8.2.

 “Colonies on malt agar (Oxoid) reaching 29 mm diameter at 25°C, predominately woolly, 

whitish, in the center pale gray-green; on oatmeal agar, 31 mm diameter, elevated and more 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

granular in the center, more pronounced grayish green and reverse slightly pinkish due to 

pigments in the submerged mycelium. On Cherry decoction agar, similar, also turning 

green rather rapidly.” 

“Conidiophores - penicillate, rather irregularly branched predominating, but primary 

verticillate conidiophores also present. Phialides of penicillate conidiophores mostly 12-17 

μm long and approximately 2.5 μm wide in the basal part.” 

“ Conidia - ellipsoidal, bilaterally symmetrical, with an oblique scar of attachment, 

mostly 5.0-6.5 X 2.5-3.0 μm. Chlamydospores may be present, terminal and intercalary, 7­

10 μm diameter.” 

Product chemistry data which support the registration of Gliocladium catenulatum strain 

J1446 are summarized in Table 1. 

Table 1. Physical and Chemical Properties for Gliocladium catenulatum strain J1446 

GUIDELINE 

Number 

STUDY RESULT MRID# 

151A-10 Product Identity and 

Disclosure of Ingredients 

Acceptable 441893-01 

441893-02 

441893-03 

151A-11 Manufacturing Process Acceptable 441893-04 

151A-12 Formation of 

Unintentional 

Ingredients 

G. catenulatum strain J1446 has 

not been reported to produce 

toxins. 

441893-05 

151A-13 Analysis of Samples Acceptable 441893-06 

151A-15 Certification of Limits Limits listed in the CSF are 

adequate 

441893-06 

151A-16 Product Chemistry Acceptable 441893-07 

441893-08 

441893-09 

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Biopesticides Registration Action Document 

B. Human Risk Assessment 

There is a reasonable certainty that no harm will result from exposure to Gliocladium 

catenulatum strain J1446. This includes all anticipated dietary exposures and all other 

exposures for which there is reliable information. 

1. Human Toxicity Assessment 

a. Acute Toxicity 

All mammalian toxicology data requirements have been submitted and adequately 

satisfy data requirements to support registration. The acute oral, acute pulmonary 

toxicity/pathogenicity, acute dermal irritation and acute eye irritation studies resulted 

in Toxicity Category IV classifications and indicated that the microbial pesticide is not 

pathogenic or infective in a single dose. The acute pulmonary toxicity/pathogenicity 

test resulted in a Toxicity Category III classification based upon the dose level. In the 

acute intra-peritoneal toxicity/pathogenicity study G. catenulatum strain J1446 

demonstrated no signs of toxicity or infectivity. 

Table 2. Toxicity Data Requirements 

GUIDELINE 

NUMBER 

STUDY RESULT MRID# 

152A-10 Acute Oral Toxicity/ 

Pathogenicity 

Acceptable, Toxicity Category IV 441893-10 

152A-10 Acute Oral Toxicity/ 

Pathogenicity 

LD50 of G. catenulatum strain 

J1446 in rats is >2000mg/kg. 

Acceptable, Toxicity Category III 

441893-11 

152A-11 Acute Dermal Irritation Acceptable, Toxicity Category IV 441893-12 

152A-11 Acute Dermal Toxicity The LD50 of G. catenulatum strain 

J1446 in rats is >2000mg/kg. 

Acceptable, Toxicity Category IV 

442232-01 

152A-12 Acute Pulmonary 

Toxicity/ Pathogenicity 

Acceptable, Toxicity Category III 441893-13 

152A-12 Acute Pulmonary 

Toxicity 

The LC50 of G. Catenulatum strain 

J1446 is > 5.57 mg/L in rats. 

Acceptable, Toxicity Category IV 

441893-14 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

GUIDELINE 

NUMBER 

STUDY RESULT MRID# 

152A-13 Acute Intra-Peritoneal 

Toxicity/Pathogenicity 

Acceptable. The preparation 

produced inflammation in 

unidentified parts of the rats, but 

there were not signs of infectivity 

or toxicity. 

441893-15 

444995-01 

152A-14 Acute Eye Irritation Acceptable, Toxicity Category IV 441893-16 

152A-15 Buehler Sensitization 

Test 

Supplementary. Although not 

needed for hazard assessment, the 

results were marginal. The 

organism is not typically known to 

be a sensitizer. 

441893-17 

152A-16 Hypersensitivity 

Incidents - Human 

Exposure 

No evidence of allergic reactions 

or other adverse effects in 

personnel working with G. 

catenulatum strain J1446 since 

1991. 

Acceptable 

441893-18 

b. Subchronic Toxicity and Chronic Toxicity 

Subchronic and chronic toxicity were not required because survival, replication, 

infectivity, toxicity, or persistence of the microbial agent was not observed in the test 

animals treated in the acute oral infectivity test. 

2. Effects on the Immune and Endocrine Systems 

The Agency has no information to suggest that Gliocladium catenulatum has an effect 

on the immune and endocrine systems. No specific tests have been conducted with 

Gliocladium catenulatum strain J1446 to determine such effects. However, as is 

expected from a non-pathogenic microorganism, the submitted toxicity/pathogenicity 

studies in rodents indicated that following several routes of exposure, the immune 

system is still intact and able to process and clear the active ingredient. There are no 

reports indicating that Gliocladium catenulatum strain J1446 produces any toxins or 

antibiotics. Therefore, it is unlikely that this organism would have estrogenic or 

endocrine effects because it is practically non-toxic to mammals. 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

 When the appropriate screening and or testing protocols being considered under the 

Agency’s Endocrine Disruptor Screening Program have been developed, Coniothyrium 

minitans strain CON/M/91-08 may be subjected to additional screening and/or testing 

to better characterize effects related to endocrine disruption. Based on the weight of 

the evidence of available data, no endocrine system-related effects have been identified. 

3. Dose Response Assessment 

No toxicological endpoints are identified. 

4. Dietary Exposure and Risk Characterization 

The use of Gliocladium catenulatum strain J1446 is not expected to result in any new 

dietary exposure to this organism. Fungi such as G. catenulatum strain J1446 are 

ubiquitous in the agricultural environment. It is anticipated that the concentrations of 

G. catenulatum on treated plants may be elevated immediately after application but will 

rapidly decline to environmental background levels. The risks anticipated for dietary 

exposure are considered minimal because no signs of toxicity were observed in the 

acute oral toxicity/pathogenicity studies. (Toxicity Category IV) 

5. Occupational, Residential, School and Day care Exposure and Risk 

Characterization 

a. Occupational Exposure and Risk Characterization 

Dermal and inhalation exposure would be the primary routes of exposure for 

mixer/loader applicators. Since unbroken skin is a natural barrier to microbial invasion 

of the human body, dermal absorption could occur only if the skin were cut, if the 

microbe were a pathogen equipped with mechanisms for entry through or infection of 

the skin, or if metabolites were produced that could be dermally absorbed. Gliocladium 

catenulatum is not known to be a human pathogen nor is it known to produce 

metabolites that are dermally absorbed. Since the intravenous study demonstrated no 

adverse effects, it is the Agency's opinion that even cut skin should not pose a risk to 

health if Gliocladium catenulatum strain J1446 was absorbed into the body via entry 

through a cut. Because the pulmonary study showed no adverse effects, the risks 

anticipated for inhalation exposure are considered minimal. 

Based on the application methods listed on the product label, the potential for 

dermal, eye and inhalation exposures for pesticide handlers exists. Occupational 

exposure data, although not required, was provided. This data indicates that research 

with Gliocladium catenulatum J1446 biofungicide has continued at the Agricultural 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Research Centre since 1991 and at Kemira Agro Oy Espoo Research Centre since 1993. 

During these years, an average of 4 persons per year have worked with Gliocladium 

catenulatum J1446 biofungicide on a full-time basis, and 9 persons per year on a parttime basis. There has been no evidence that the Gliocladium catenulatum J1446 

biofungicide has caused allergic reactions or other adverse effects to the personnel 

involved in this work. 

There may be subpopulations yet to be identified that are prone to allergic reactions 

from frequent exposure to concentrated levels of G. catenulatum. The required 

personal protective equipment for applicators and handlers is expected to adequately 

reduce inhalation or dermal exposure to this microbial pesticide. 

Occupational exposures and subsequent risks are negligible because the organism has 

been determined not to be pathogenic to humans. and animals. The risks are expected 

to be minimal based on evaluations of submitted Tier I acute toxicity tests (Table 2). 

b. Residential, School and Day Care Exposure and Risk Characterization 

Other non-occupational exposure of Gliocladium catenulatum strain J1446 via 

residential and indoor uses of it as a pesticide, e.g., uses around homes, parks, 

recreation areas, will be minimal to non-existent. The risk from non-occupational 

exposure is considered minimal as there is no evidence of adverse effects from oral, 

dermal or inhalation exposure to this microbial agent. 

. 

6. Drinking Water Exposure and Risk Characterization 

Gliocladium catenulatum strain 1446 is a naturally-occurring microorganism and is 

widespread in the environment throughout the world. Gliocladium catenulatum is not 

known as an aquatic fungus, and therefore is not expected to proliferate in aquatic 

habitats. Moreover, the risk from non-occupational exposure is considered minimal as 

there is no evidence of adverse effects from oral, dermal or inhalation exposure to this 

microbial agent. Drinking water is accordingly not being screened for Gliocladium 

catenulatum as a potential indicator of microbial contamination or as a direct 

pathogenic contaminant. Both percolation through soil and municipal treatment of 

drinking water would reduce the possibility of exposure to Gliocladium catenulatum 

through drinking water. Therefore, the potential of significant transfer to drinking 

water is minimal to nonexistent. In addition, the risk from consumption of drinking 

water containing Gliocladium catenulatum is considered minimal as there is no 

evidence of adverse effects from oral exposure to this microbial agent. 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

7. Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly 

Infants and Children 

There have been no confirmed reports of immediate or delayed allergic reactions to 

Gliocladium catenulatum strain 1446. 

Based on the acute toxicity information discussed above, EPA concludes that there is a 

reasonable certainty that no harm will result from aggregate exposure to the United 

States population, including infants and children, to residues of Gliocladium 

catenulatum strain J1446 . This includes all anticipated dietary exposures and all other 

exposures for which there is reliable information. The Agency has arrived at this 

conclusion because, as discussed in Unit B. Human Risk Assessment, Gliocladium 

catenulatum strain J1446 is practically non-toxic to mammals and under reasonably 

foreseeable circumstances it does not pose a risk. 

FFDCA section 408 provides that EPA shall apply an additional ten-fold margin of 

exposure (safety) for infants and children in the case of threshold effects to account for 

pre- and post-natal toxicity and the completeness of the database, unless EPA 

determines that a different margin of exposure (safety) will be safe for infants and 

children. Margins of exposure (safety) are often referred to as uncertainty (safety) 

factors. In this instance, the Agency believes there is reliable data to support the 

conclusion that Gliocladium catenulatum strain J1446 is practically non-toxic to 

mammals, including infants and children, and, thus, there are no threshold effects; 

therefore, EPA has not used a margin of exposure (safety) approach to assess the safety 

of Gliocladium catenulatum strain J1446 . As a result, the provision requiring an 

additional margin of exposure (safety) does not apply. 

8. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and 

Inhalation 

The health risk is expected to be negligible for oral, dermal, and inhalation exposure 

routes, as stated above. The potential aggregate exposure, derived from dermal and 

inhalation exposure via mixing, loading and applying Gliocladium catenulatum Strain 

1446, the dietary exposure from drinking water and treated produce containing this 

organism, should fall well below the currently tested microbial safety levels. In 

summary, the potential aggregate exposure, derived from non-dietary and nonoccupational exposure, should be minimal. 

9. Cumulative Effects 

Gliocladium catenulatum strain J1446 is practically non-toxic to mammals. No 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

mechanism of toxicity in mammals has been identified for this organism. Therefore 

no cumulative effect with other related organisms is anticipated. 

C. Environmental Assessment 

1. Environmental Fate 

Environmental fate studies are not required at this time since no adverse risks were triggered 

in Tier I Non-target Organisms Studies. Gliocladium catenulatum strain J1446 is a 

naturally occurring saprophytic soil fungus; as a species, it is found throughout the world in 

a variety of soil types, without pathogenic incidence to plant or animal. The ubiquitous 

nature of the organism suggests that the environmental burden is not likely to increase 

substantially to pose adverse risks to nontarget organisms as a result of the intended 

outdoor uses. 

There were no incidents of pathogenicity or toxicity by G. catenulatum to non-target 

organisms in the literature searches provided. 

Estimated Environmental Concentration of Gliocladium catenulatum Cell Mass: 

Based on the intended rates of application, the estimated environmental concentration of 

Gliocladium catenulatum Cell Mass is not anticipated to exceed ~ 500 mg/L for soil 

incorporation applications; and ~200 mg/L for soil drench applications. 

2. Ecological Toxicity 

Results of non-target avian, freshwater fish, daphnia, honey bee and beneficial insect 

studies submitted to the Agency generally demonstrated a lack of toxicity or pathogenicity 

to the indicator species. Results of these studies indicate that minimal toxic or pathogenic 

effects to terrestrial or freshwater wildlife are expected from currently intended applications 

of Gliocladium catenulatum cell mass. Summaries and conclusions of these studies are 

presented below. 

Table 3: Eco-Toxicology Summary 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Guideline 

No. 

Study Status, Classification & 

Comments 

MRID # 

154-16 

*885-4050 

Avian oral toxicity/ 

pathogenicity 

ACCEPTABLE. The no observed effect dosage 

of Gliocladium catenulatum cell mass was 

determined at approximately 1.4 × 106

 cfu/g body 

weight for five days. This study showed a lack of 

toxicity or pathogenicity of Gliocladium 

catenulatum cell mass to northern bobwhite 

quail. 

445014-01 

154-19 

*885-4200 

Fresh water fish toxicity/ 

pathogenicity 

ACCEPTABLE. The LC50 was calculated as 504 

mg/L (3.5×108

 cfu/L). This study is scientifically 

valid, satisfies current guideline requirements 

445014-02 

154-20 

*885-4240 

Fresh water aquatic 

invertebrate 

toxicity/pathogenicity 

ACCEPTABLE. Under static-renewal 

conditions, the 21-day EC50 value was 7.8 mg/L 

(5.5 x 106

 cfu/L). The LOEC and the NOEC 

were 11 mg/L and 5.6 mg/L, respectively. The 

pathogenicity of Gliocladium catenulatum was 

not evaluated in this study. 

445014-03 

154-22 

*885-4300 

Nontarget plant 

toxicity/pathogenicity 

WAIVED. In the literature review submitted, 

there were no reports of pathogenicity to plants. 

The literature review satisfies current guidelines 

for non-target plant testing and may be used as 

the basis for waiving further non-target plant 

tests, pending appropriate product 

characterization and taxonomic verification. 

441893-20 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Guideline 

No. 

Study Status, Classification & 

Comments 

MRID # 

154-23 

*885-4340 

Nontarget insect 

toxicity/pathogenicity 

Green Lacewing : 

ACCEPTABLE. The dietary LC50 value for 

green lacewing larvae exposed to G. catenulatum 

cell mass for 12 days is presumed greater than 

5200 ppm (3.6×106

 CFU/g) and the no observed 

effect concentration is ~5200 ppm (3.6×106 

CFU/g). This study showed a lack of toxicity of 

Gliocladium catenulatum cell mass to green 

lacewings. There were no evaluations of 

infectivity or pathogenicity. 

Parasitic Hymenoptera 

ACCEPTABLE. The dietary LC50 value for 

parasitic Hymenoptera exposed to G. 

catenulatum cell mass for eight days was 

calculated approximately 1992 ppm (1.4×106 

CFU/mL) and the no observed effect 

concentration determined to be 520 ppm (3.6×105 

CFU/mL). This study showed a lack of toxicity 

of Gliocladium catenulatum cell mass to parasitic 

Hymenoptera. There were no evaluations of 

infectivity or pathogenicity.

 Ladybird Beetles 

ACCEPTABLE. The dietary LC50 value for 

ladybird beetles exposed to G. catenulatum cell 

mass for 16 days is estimated to be greater than 

5200 ppm (3.6×106

 CFU/mL), the highest 

concentration tested, and the no observed effect 

concentration to be 520 ppm (3.6×105

 CFU/mL). 

An LD50 >3.6×106

 CFU/mL and an NOEL of 

3.6×105

 CFU/mL was reported. This study 

showed a lack of toxicity of Gliocladium 

catenulatum cell mass to lady beetles. There were 

no evaluations of infectivity or pathogenicity. 

445014-04 

445014-05 

445014-06 

154-24 

*885-4380 

Honeybee 

toxicological/pathogenicity 

ACCEPTABLE. Reported bee mortalities were 

not dose-responsive nor statistically significant. 

Therefore the dietary LC50 value for honey bees 

exposed to G. catenulatum cell mass for 10 days 

is estimated to be greater than 5200 ppm (3.6×106 

CFU/mL), the highest concentration tested, and 

the no observed effect concentration is estimated 

to be 5200 ppm (3.6×106

 CFU/mL). An LD50 

value >3.6×106 CFU/mL and an NOEL of 

3.6×105

 CFU/mL were reported. 

445014-07 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

*885 series = OPPTS Microbial Pesticide Test Guideline Numbers. 

a. Toxicity to Terrestrial Animals 

(i) Avian Species: Acute Toxicity/Pathogenicity: 

Under conditions of the reported study (MRID# 445014-01) , no adverse effects were 

exhibited by juvenile northern bobwhite after 30 days when administered (by oral gavage) 

daily doses of 1 × 104 Gliocladium catenulatum-cfu/g body weight/day for a five day 

period. This dosage is approximately equivalent to a total dosage of 7 × 106 cfu/g body 

weight for 5 days. The no observed effect dosage of Gliocladium catenulatum cell mass 

was determined at approximately 1.4 × 106 cfu/g body weight for five days. There were no 

evidences of test substance replication, lesions, plaques or other indications of infectivity or 

pathogenicity for the groups treated with Gliocladium catenulatum cell mass in gross 

necropsies. This study showed a lack of toxicity or pathogenicity of Gliocladium 

catenulatum cell mass to northern bobwhite quail. 

This study is scientifically valid, satisfies current guideline requirements, and is acceptable 

for assessing short-term toxic and pathogenic effects of Gliocladium catenulatum Strain 

J1446 to terrestrial avian species. 

(ii) Wild Mammals and Other Terrestrial Animals: Acute

Toxicity/Pathogenicity: 

b. Toxicity to Aquatic Animals 

(i) Freshwater Fish: 

Under static-renewal conditions, the no-observed effect concentration was 179 mg/L 

(1.3×108 cfu/L) for juvenile rainbow trout dual-exposed via aqueous test solutions and in a 

daily diet for 30 days. The no mortality concentration was 357 mg/L (2.5×108 cfu/L). The 

LC50 was calculated as 504 mg/L (3.5×108 cfu/L). 

There were no signs of infection in fish tissues examined for necropsy, and all appeared 

internally and externally normal. Gliocladium catenulatum was isolated from the heart, 

liver and brain samples of fish treated with 179 mg/L test substance; and from the kidney, 

heart, liver and brain samples of fish treated with 357 mg/L test substance. Although the 

test substance was present, target organs did not appear to be affected, and there were no 

apparent effects upon the health of the fish. 

This study (MRID# 445014-02) is scientifically valid, satisfies current guideline 

requirements, and is acceptable for assessing short-term toxic and pathogenic effects of 

Gliocladium catenulatum Strain J1446 to freshwater fish. 

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Biopesticides Registration Action Document 

(ii) Freshwater Aquatic Invertebrate 

Under static-renewal conditions, the 21-day EC50 value for survival of neonate Daphnia 

magna exposed aqueously to Gliocladium catenulatum was 7.8 mg/L (5.5 x 106 cfu/L). 

The LOEC and the NOEC were 11 mg/L and 5.6 mg/L, respectively. 

Of the three parameters assessed (survival, growth and reproduction), reproduction proved 

to be the most sensitive parameter. The EC50 value was 7.8 mg/L (~5.5 x 106 cfu/L); and 

the NOEC and the LOEC were 2.8 (2.0 x 106 cfu/L) and 5.6 mg/L (3.9 x 106 cfu/L), 

respectively. 

This study (MRID# 445014-03) is scientifically valid, satisfies current guideline 

requirements, and is acceptable for assessing short-term toxic effects of Gliocladium 

catenulatum Strain J1446 to aquatic invertebrates. The pathogenicity (or infectivity) of 

Gliocladium catenulatum was not evaluated in this study. 

c. Toxicity to Plants 

A review of the literature resulted in the utility of Gliocladium catenulatum to control plant 

diseases caused by other fungi, Rhizoctonia, Pythium, Botrytis, Fusarium, Didymella, 

Verticillium, Alternaria, Cladosporium, Helminthosporium, Penicillium and Pilcaria. 

There were no reports of pathogenicity to plants. 

Therefore, G. catenulatum is not expected to cause adverse effects to nontarget plants. The 

literature review (MRID # 441893-20) satisfies current guidelines for non-target plant 

testing and may be used as the basis for waiving further non-target plant tests, pending 

appropriate product characterization and taxonomic verification. 

d. Toxicity/Pathogenicity to Honeybees and Nontarget Insects 

Honey Bees: 

This study (MRID# 445014-07) was conducted in compliance with Good Laboratory 

Practice Standards as published by the U.S. Environmental Protection Agency, Office of 

Pesticide Programs in 40 CFR Part 160. 

Reported bee mortalities were not dose-responsive nor statistically significant. Therefore the 

dietary LC50 value for honey bees exposed to G. catenulatum cell mass for 10 days is 

estimated to be greater than 5200 ppm (3.6×106 CFU/mL), the highest concentration tested, 

and the no observed effect concentration is estimated to be 5200 ppm (3.6×106 CFU/mL). 

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Gliocladium catenulatum strain J1446 

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An LD50 value >3.6×106 CFU/mL and an NOEL of 3.6×105 CFU/mL were reported. This 

study showed a lack of toxicity of Gliocladium catenulatum cell mass to honey bees. 

Mortalities were therefore presumed to be associated with other environmental variables 

associated with the test arena. There were no evaluations of infectivity or pathogenicity. 

This study is scientifically valid, satisfies current guideline requirements, and is acceptable 

for assessing short-term toxic effects of Gliocladium catenulatum Strain J1446 to honey 

bees. 

Green Lacewing: 

The rates of mortality and pupation were similar in the treatment groups as in the untreated 

control group. Reported mortalities were not treatment related. Therefore, the dietary LC50 

value for green lacewing larvae exposed to G. catenulatum cell mass for 12 days is 

presumed greater than 5200 ppm (3.6×106 CFU/g) and the no observed effect concentration 

is ~5200 ppm (3.6×106 CFU/g). This study (MRID# 445014-04) showed a lack of toxicity 

of Gliocladium catenulatum cell mass to green lacewings. There were no evaluations of 

infectivity or pathogenicity. 

This study is scientifically valid, satisfies current guideline requirements, and is acceptable 

for assessing short-term toxic effects of Gliocladium catenulatum Strain J1446 to green 

lacewings. 

Parasitic Hymenoptera: 

Mortalities were related to the test substance in one group--treated with 5,200 ppm G. 

catenulatum cell mass. Therefore the dietary LC50 value for parasitic Hymenoptera exposed 

to G. catenulatum cell mass for eight days was calculated approximately 1992 ppm (1.4×106 

CFU/mL) and the no observed effect concentration determined to be 520 ppm (3.6×105 

CFU/mL). This study (MRID# 445014-05) showed a lack of toxicity of Gliocladium 

catenulatum cell mass to parasitic Hymenoptera. There were no evaluations of infectivity 

or pathogenicity. 

This study is scientifically valid, satisfies current guideline requirements, and is acceptable 

for assessing short-term toxic effects of Gliocladium catenulatum Strain J1446 to parasitic 

wasps.

 Lady Beetles: 

Mortalities were not dose-responsive, nor associated with Gliocladium catenulatum cell 

mass . Therefore the dietary LC50 value for ladybird beetles exposed to G. catenulatum cell 

mass for 16 days is estimated to be greater than 5200 ppm (3.6×106 CFU/mL), the highest 

concentration tested, and the no observed effect concentration to be 520 ppm (3.6×105 

CFU/mL). An LD50 >3.6×106 CFU/mL and an NOEL of 3.6×105 CFU/mL was reported. 

15
Gliocladium catenulatum strain J1446 

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This study showed a lack of toxicity of Gliocladium catenulatum cell mass to lady beetles. 

There were no evaluations of infectivity or pathogenicity. 

This study (MRID# 445014-06) is scientifically valid, satisfies current guideline 

requirements, and is acceptable for assessing short-term toxic effects of Gliocladium 

catenulatum Strain J1446 to ladybird beetles. 

IV. RISK MANAGEMENT AND RE/REGISTRATION DECISION 

A. Determination of EligibilitySection 3(c)(5) of FIFRA provides for the registration of new active ingredients 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. 

To satisfy criterion "A" above, Gliocladium catenulatum strain J1446 has well known 

properties. The Agency has no knowledge that would contradict the claims made on the 

label of this product. Criterion "B" is satisfied by the current label and by the data presented 

in this document. It is believed that this new pesticidal active ingredient will not cause any 

unreasonable adverse effects, is a broad spectrum microbial fungicide, and does provide 

protection as claimed satisfying criterion "C". Criterion "D" is satisfied in that Gliocladium 

catenulatum strain J1446 is not expected to cause unreasonable adverse effects when used 

according to label instructions. 

Therefore, Gliocladium catenulatum strain J1446 is eligible for registration. The uses are 

listed in the Section II, B. Use Profile. 

B. Regulatory Position 

1. Unconditional Registration 

The data requirements are fulfilled and the Biopesticides and Pollution Prevention 

Division recommends unconditional registration of the product containing Gliocladium 

catenulatum strain J1446 as the sole Active ingredient (PRIMASTOP). 

2. Tolerances for Food Uses and /or exemptions 

EPA received a pesticide petition (PP 7F806) from Kemira Agro Oy, proposing 

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Biopesticides Registration Action Document 

[pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 

section 346a(d)], to amend 40 CFR part 180 by establishing an exemption from the 

requirement of a tolerance for residues of the microbial pesticide, Gliocladium 

catenulatum strain J1446, on growing crops. 

EPA issued a notice establishing an exemption from the requirements of a tolerance for 

residues of Gliocladium catenulatum strain J1446 in or on all food commodities. 

3. CODEX Harmonization

There are no CODEX values for Gliocladium catenulatum strain J1446 . 

4. Risk Mitigation 

Since there are no risk issues, no risk mitigation measures are required at this time for 

dietary risk, occupational and residential risk, or ground and surface water 

contamination for Gliocladium catenulatum strain J1446 . 

5. Endangered Species Statement 

Impacts to endangered species from intended exposures of PrimastopTM are anticipated 

to be negligible or nonexistent. This assessment is premised upon a combination of 

several factors: (1) low estimated environmental concentration values; (2) data and 

evidence from the public literature as summarized in the Environmental Fate portion 

of this assessment; and (3) the practically nontoxic (and non-infective) status of the 

MPCA in surrogate toxicity/pathogenicity studies summarized in the Ecological Effects 

portion of this assessment. 

C. Labeling Rational 

1. Human Health Hazard (WPS and non-WPS) 

Gliocladium catenulatum strain J1446 products with commercial use sites are subject to 

the Worker Protection Standard. Because of the low toxicity of Gliocladium 

catenulatum strain J1446 , the Re-Entry Interval for uses within the scope of WPS is 

zero hours. Precautionary statements and personal protective equipment as specified 

below are required based on the acute toxicity categories of this organism. 

2. Environmental Hazard 

17
Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Precautionary labeling is required as indicated below. 

V. ACTIONS REQUIRED BY REGISTRANTS 

A. Precautionary Labeling 

Gliocladium catenulatum strain J1446 products must state the following under the heading 

“Precautionary Statements”: 

Caution. Harmful if swallowed or inhaled. Avoid breathing dust or spray mist. Wash thoroughly 

with soap and water after handling. Remove contaminated clothing and wash before reuse. 

Personal Protective Equipment required for Applicators and other handlers must wear: 

Long sleeved shirt and long pants. Waterproof gloves. Shoes plus socks. A NIOSH approved 

respirator with any N, P, R, or HE filter.” 

WPS labels must state the following under the heading “User Safety Recommendations” 

Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the 

toilet. 

Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly and 

put on clean clothing. 

Users should remove PPE immediately after handling this product. If gloves are worn, wash the 

outside of gloves before removing. As soon as possible, wash thoroughly and change into clean 

clothing. 

B. Environmental Hazards Labeling 

Provided the following statement is placed into the environmental hazards statement, the risk of 

Gliocladium catenulatum strain J1446 is minimal to nonexistent to non-target organisms 

including endangered species. 

1. End-Use Product Environmental Hazards Labeling 

"Do not apply directly to water, or to areas where surface water is present or to intertidal 

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Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

areas below the mean high water mark. Do not contaminate water by cleaning of 

equipment or disposal of equipment washwaters. " 

2. Manufacturing-Use Product Environmental Hazards Labeling 

"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, 

oceans, or public water unless this product is specifically identified and addressed in an 

NPDES permit. Do not discharge effluent containing this product to sewer systems 

without previously notifying the sewage treatment plant authority. For guidance, contact 

your State Water Board or Regional Office of the EPA." 

3. Application Rate 

It is the Agency's position that the labeling for the pesticide products containing 

Gliocladium catenulatum strain J1446 as the active ingredient complies with the current 

pesticide labeling requirements. The Agency has not required a maximum number of 

applications per a season of this active ingredient. 

C. Labeling 

The attached label for PRIMASTOP Biofungicide Powder (EPA Reg. No. 64137-8) 

conforms with the labeling requirements for Gliocladium catenulatum strain J1446 . Some of 

the essential label requirements are highlighted below. 

Signal word is "Caution," based on (toxicity category III). The product shall contain the 

following information:

 - Product Name

 - Ingredient Statement

 - Registration Number

 - "Keep Out of Reach of Children"

 - Signal Word (CAUTION)

 - Personal Protective Equipment (PPE) Requirements

 - Environmental Hazard Statement

 - Storage and Disposal Statement

 - Agricultural Use Requirements

 - Non-Agricultural Use Requirements

 - Directions for Use

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Gliocladium catenulatum strain J1446 

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BIBLIOGRAPHY: Citations Considered to be part of the Data Base Supporting the Registration of Gliocladium 

catenulatum strain J1446. 

44189300 Kemira Agro Oy (1996) Submission Product Chemistry, Toxicity, Hazard to Non-Target 

Organisms and Environmental Fate Data in Support of the Application for Registration of 

PRIMASTOP Biofungicide (Gliocladium catenulatum Strain J1446). Transmittal of 22 Studies. 

44189301 Mohammadi, O. (1996) Product Identification and Disclosure of Ingredients Gliocladium 

catenulatum Strain J1446. Unpublished study prepared by Kemira Agro Oy. 14 p. 

44189302 Gams, W. (1996) Independent Third Party Identification of Gliocladium catenulatum Strain 

J1446: Lab Project Number: DET 225 (1996). Unpublished study prepared by Centraalbureau 

Voor Schimmelcultures (CBS), Institute of the Royal Netherlands Academy of Arts and Science. 

6 p. 

44189303 Yli-Mattila, T. (1996) Identification of J1446 Strain by RAPD-PCR Analysis. Unpublished 

study prepared by University of Turku. 23 p. 

44189304 Tuominen, U. (1996) Gliocladium catenulatum Strain J1446: Description of Beginning Materials 

and Manufacturing Process. Unpublished study prepared by Kemira Agro Oy. 50 p. 

44189305 Mohammadi, O.; Lahdenpera, M.; Tuominen, U. (1996) Gliocladium catenulatum Strain J1446 

Biofungicide: Discussion of the Formation of Impurities. Unpublished study prepared by Kemira 

Agro Oy. 65 p. 

44189306 Tuominen, U. (1996) Preliminary Analysis, Certification of Ingredient Limits, and Analytical 

Methods: Gliocladium catenulatum Strain J1446. Unpublished study prepared by Kemira Agro 

Oy. 13 p.

 44189307 Jacobs, R.; Markley, B. (1996) Product Chemistry Testing of the Active Ingredient (A.I.) in 

Gliocladium Biofungicide: Color, Physical State, Odor, Bulk Density and pH: Lab Project 

Number: 293C-101. Unpublished study prepared by Wildlife International Ltd. 22 p. 

44189308 Jacobs, R.; Markley, B. (1996) Product Chemistry Testing of Gliocladium Biofungicide Powder: 

Color, Physical State, Odor, Bulk Density and pH: Lab Project Number: 293C-102. Unpublished 

study prepared by Wildlife International Ltd. 22 p. 

44189309 Jacobs, R.; Markley, B. (1996) Product Chemistry Testing of Gliocladium Biofungicide Powder: 

Corrosion Characteristics: Lab Project Number: 293C-103. Unpublished study prepared by 

Wildlife International Ltd. 16 p.

 44189310 McRae, L. (1996) Acute Oral Toxicity and Pathogenicity to the Rat: Gliocladium catenulatum Cell 

Mass: Lab Project Number: RKY 135/961805/AC. Unpublished study prepared by Huntingdon 

Life Sciences Ltd. 31 p.

 44189311 Wilson, J. (1995) Gliocladium (J1446) Preparation: Acute Oral Toxicity (Limit) Test in Rats: Lab 

Project Number: 556576: 10919. Unpublished study prepared by Inveresk Research 

International. 27 p.

 44189312 Wilson, J. (1995) Gliocladium (J1446) Preparation: Acute Dermal Irritation Test in Rabbits: Lab 

20
Gliocladium catenulatum strain J1446 

Biopesticides Registration Action Document 

Project Number: 556576: 10921. Unpublished study prepared by Inveresk Research 

International. 25 p. 

44189313 McRae, L. (1996) Acute Pulmonary Toxicity and Pathogenicity to Rat: Gliocladium catenulatum 

Cell Mass: Lab Project Number: RKY 137/961808/AC. Unpublished study prepared by 

Huntingdon Life Sciences Ltd. 44 p.

 44189314 Kieran, P. (1995) Gliocladium (J1446) Preparation: Acute Inhalation Toxicity (Limit) Test in 

Rats: Lab Project Number: 654570: 10916. Unpublished study prepared by Inveresk Research 

International. 40 p. 

44189315 McRae, L. (1996) Acute Intra-Peritoneal Toxicity and Pathogenicity to the Rat: Gliocladium 

catenulatum Cell Mass: Lab Project Number: RKY 136/961807/AC. Unpublished study 

prepared by Huntingdon Life Sciences Ltd. 35 p.

 44189316 Wilson, J. (1995) Gliocladium (J1446) Preparation: Acute Eye Irritation Test in Rabbits: Lab 

Project Number: 556576: 10922. Unpublished study prepared by Inveresk Research International. 

27 p.

 44189317 Wilson, J. (1995) Gliocladium (J1446) Preparation: Buehler Sensitisation Test in Guinea Pigs: 

Lab Project Number: 556576: 10923. Unpublished study prepared by Inveresk Research 

International. 33 p.

 44189318 Mohammadi, O. (1996) Gliocladium catenulatum Strain J1446 Biofungicide Hypersensitivity 

Incident Reporting. Unpublished study prepared by Kemira Agro Oy. 4 p. 

44189319 Mohammadi, O. (1996) Gliocladium catenulatum Strain J1446--Literature Search, Avian and 

Aquatic. Unpublished study prepared by Kemira Agro Oy. 11 p. 

44189320 Mohammadi, O. (1996) Gliocladium catenulatum--Literature Search, Nontarget Plants. 

Unpublished study prepared by Kemira Agro Oy. 23 p. 

44189321 Mohammadi, O. (1996) Gliocladium catenulatum--Literature Search, Nontarget Insects. 

Unpublished study prepared by Kemira Agro Oy. 6 p. 

44189322 Tuominen, U. (1996) Storage Stability: Gliocladium catenulatum Strain J1446. Unpublished 

study prepared by Kemira Agro Oy. 4 p. 

44223201 Wilson, J. (1995) Gliocladium (J1446) Preparation: Acute Dermal Toxicity (Limit) Test in 

Rabbits: Lab Project Number: 10920: 556576: IRI 556576. Unpublished study prepared by 

Inveresk Research International. 26 p. 

44499501 McRae, L. (1998) Response to Questions Raised by EPA Regarding MRID Number 44189315 

Entitled “Acute Intra-Peritoneal Toxicity and Pathogenicity to the Rat: Gliocladium catenulatum 

Cell Mass” Unpublished study prepared by Huntingdon Life Sciences Ltd. 16 p. 

44501400 Kemira Agro Oy (1998) Submission of Toxicity Data in Support of the Application for 

Registration of Primastop. Transmittal of 7 Studies. 

44501401 Foster, J.; Grimes, J.; Beavers, J. (1997) Gliocladium catenulatum Cell Mass: An Avian Oral 

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Gliocladium catenulatum strain J1446 

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Pathogenicity and Toxicity Study in the Northern Bobwhite: Lab Project Number: 293-109. 

 Unpublished study prepared by Wildlife International Ltd. 42 p. 

44501402 Palmer, S.; Krueger, H. (1998) Gliocladium catenulatum Cell Mass (Technical Product): A 

Five-Concentration Toxicity and Pathogenicity Test with the Rainbow Trout (Oncorhynchus 

 mykiss): Final Report: Lab Project Number: 293A-104. Unpublished study prepared by 

Wildlife International Ltd. 41 p. 

44501403 Palmer, S.; Krueger, H. (1998) Gliocladium catenulatum Cell Mass (Technical Product): A 21-Day 

Life-Cycle Toxicity and Pathogenicity Test with the Cladoceran (Daphnia magna): Final 

Report: Lab Project Number: 293A-103. Unpublished study prepared by Wildlife International 

Ltd. 43 p. 

44501404 Hoxter, K.; Palmer, S.; Krueger, H. (1998) Gliocladium catenulatum Cell Mass (Technical 

Product): A Dietary Pathogenicity and Toxicity Study with Green Lacewing Larvae (Chrysoperia 

carnea): Lab Project Number: 293-113A. Unpublished study prepared by Wildlife International 

Ltd. 22 p. 

44501405 Hoxter, K.; Palmer, S.; Beavers, J. (1998) Gliocladium catenulatum Cell Mass (Technical 

Product): A Dietary Pathogenicity and Toxicity Study with Parasitic Hymenoptera (Nasonia 

vitripennis): Lab Project Number: 293-112. Unpublished study prepared by Wildlife International 

Ltd. 24 p. 

44501406 Hoxter, K.; Palmer, S.; Krueger, H. (1998) Gliocladium catenulatum Cell Mass (Technical 

Product): A Dietary Pathogenicity and Toxicity Study with the Ladybird Beetle (Hippodamia 

convergens): Lab Project Number: 293-111. Unpublished study prepared by Wildlife 

International Ltd. 25 p. 

44501407 Hoxter, K.; Palmer, S.; Krueger, H. (1998) Gliocladium catenulatum Cell Mass (Technical 

Product): A Dietary Pathogenicity and Toxicity Study with the Honey Bee (Apis mellifera): Lab 

Project Number: 293-110. Unpublished study prepared by Wildlife International Ltd. 24 p. 

22