TABLE OF CONTENTS

GLOSSARY OF TERMS and ACRONYMS USED......................................................... 3

I. PRELIMINARY WORKPLAN .................................................................................. 6

A. Introduction ....................................................................................................... 6

B. Background and Regulatory Information........................................................... 7

C. Anticipated Risk Assessment and Data Needs................................................. 9

1. Product Analysis ........................................................................................ 9

2. Human Health Risk Assessment Status .................................................. 11

3. Environmental Fate and Ecological Risk Assessment Status.................. 13

4. Risk to Threatened and Endangered Species ......................................... 17

5. Endocrine Disruptor Screening Program ................................................. 17

6. Incidents .................................................................................................. 18

7. Summary of Data Gaps ........................................................................... 19

D. Timeline .......................................................................................................... 20

E. Guidance for Commenters.............................................................................. 20

F. Environmental Justice..................................................................................... 20

G. Water Quality .................................................................................................. 21

H. Trade Irritants.................................................................................................. 21

I. Additional Information ..................................................................................... 22

J. Next Steps ...................................................................................................... 22

II. FACT SHEET ................................................................................................. 23

BIBLIOGRAPHY: Gliocladium virens G-21............................................................... 29

BIBLIOGRAPHY: Gliocladium catenulatum strain J1446 ....................................... 32

LIST OF TABLES 

Table 1. Product Analysis Data Gliocladium virens G-21............................................... 9

Table 2. Product Analysis Data Gliocladium catenulatum strain J1446........................ 10

Table 3. Toxicology Data for Gliocladium virens G-21 ................................................. 12

Table 4. Toxicology Data for Gliocladium catenulatum strain J1446............................ 13

Table 5. Ecological Toxicity Data for Gliocladium virens G-21..................................... 15

Table 6. Ecological Toxicity Data for Gliocladium catenulatum strain J1446................ 16

Table 7. Summary of Data Gaps for Gliocladium virens G-21...................................... 19

Table 8. Summary of Data Gaps for Gliocladium catenulatum strain J1446 ................ 19

Table 9. Projected Timeline for the Registration Review of Case 6020........................ 20

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GLOSSARY OF TERMS and ACRONYMS USED

a.i. Active Ingredient 

BRAD Biopesticides Registration Action Document 

CFR Code of Federal Regulations 

CFU Colony Forming Unit 

CSF Confidential Statement of Formula 

EC50 For ecological assessments, a statistically estimated concentration 

that is expected to cause one or more specified effects in 50% of a 

group of organisms under specified conditions. 

EDSP Endocrine Disruptor Screening Program 

EEC Estimated Environmental Concentration, which is the estimated 

pesticide concentration in an ecosystem. 

EFED Environmental Fate And Effects Division 

EP End-Use Product 

EPA 

Reg. No. 

EPA Registration Number, which is a two-part number assigned by 

EPA to identify each pesticide product registration. 

EPA U.S. Environmental Protection Agency 

FFDCA The Federal Food, Drug, And Cosmetic Act 

FIFRA The Federal Insecticide, Fungicide, And Rodenticide Act 

FQPA Food Quality Protection Act of 1996 

i.p. Intraperitoneal 

i.v. Intravenous 

IDS Incident Data System 

LC50 Lethal Concentration (median), which is a statistically-derived 

concentration of a substance that can be expected to cause death in 

50% of test animals. 

LD50 Lethal Dose (median), which is a statistically-derived single dose that 

can be expected to cause death in 50% of the test animals when 

administered by the route indicated (oral, dermal, inhalation). 

mg/kg Milligrams of test material per kilogram body weight 

-3-
mg/L Milligrams per liter (ppm) 

mL Milliliters 

MRID Master Record Identification (Number), which is EPA's system of 

recording and tracking submitted studies. 

MRL Maximum Residue Limits 

MUP Manufacturing-Use Product 

NPIC National Pesticides Information Center 

OCSPP EPA’s Office of Chemical Safety and Pollution Prevention 

OECD Organization for Economic Cooperation and Development 

OPP U.S. EPA Office of Pesticide Programs 

OPPTS EPA’s Office of Prevention, Pesticides and Toxic Substances 

PC Code Pesticide Chemical Code, six-digit number assigned by OPP to 

identify pesticide chemicals. 

PPLS Pesticide Product Label System 

ppm Parts per million 

RED Registration Eligibility Decision 

TGAI Technical Grade of Active Ingredient 

TMDL Total Maximum Daily Loads 

U.S. EPA U.S. Environmental Protection Agency 

-4-
GLIOCLADIUM REGISTRATION REVIEW TEAM 

Human Health 

Primary: Kathleen Martin; MSES, MPA 

Secondary: John L. Kough, Ph.D. 

Environmental Effects 

Primary: Kathleen Martin; MSES, MPA 

Secondary: Zigfridas Vaituzis; Ph.D. 

Risk Management 

 Kathleen Martin; MSES, MPA 

Office of General Counsel 

 Philip Ross, Esq. 

-5-
I. PRELIMINARY WORKPLAN 

A. Introduction 

 The Food Quality Protection Act (FQPA) of 1996 mandated the continuous 

review of existing pesticides. All pesticides distributed or sold in the United States must 

generally be registered by the U.S. Environmental Protection Agency (EPA or the 

Agency), based on scientific data showing that they will not cause unreasonable risks to 

human health or the environment when used as directed on the product labeling. The 

Registration Review program is intended to make sure that, as the ability to assess risk 

evolves and as policies and practices change, all registered pesticides continue to meet 

the statutory standard of no unreasonable adverse effects. Changes in science, public 

policy, and pesticide use practices will occur over time. Through the Registration 

Review program, the Agency periodically reevaluates pesticides to make sure that as 

change occurs, products in the marketplace can continue to be used safely. Information 

on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/. 

 The Agency has begun to implement the Registration Review program pursuant 

to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will 

review each registered pesticide every 15 years to determine whether it continues to 

meet the FIFRA standard for registration. The Agency will consider benefits information 

and data as required by FIFRA. The public phase of Registration Review begins when 

the initial docket is opened for each case. The docket is the Agency’s opportunity to 

state what it knows about the pesticide and what additional risk analyses and data or 

information it believes are needed to make a Registration Review decision. After 

reviewing and responding to comments and data received in the docket during this 

comment period, the Agency will develop and commit to a final workplan and schedule 

for the Registration Review. 

 This Registration Review Summary Document evaluates two microbial pesticide 

active ingredients (a.i.): (1) Gliocladium virens G-21 (PC Code 129000) and 

Gliocladium catenulatum strain J1446 (PC Code 021009). The genus Gliocladium, 

which is of the Fungi Kingdom, has a number of species and strains; EPA has 

registered two of them as pesticides—Gliocladium virens G-21 and Gliocladium 

catenulatum strain J1446—and they comprise this Registration Review case. 

-6-
B. Background and Regulatory Information 

Gliocladium virens G-21 is a ubiquitous saprophytic soil fungus existing in three 

morphological forms: conidia, mycelia, and chiarrydospores (thick-walled hyphal 

fragments (U.S. EPA 1989b). In a Final Rule published on December 6, 1990 (55 FR 

50325), EPA established an exemption from the requirement of a tolerance for residues 

of Gliocladium virens GL-21 (40 CFR 180.1100). The Agency published a Fact Sheet 

(U.S. EPA 1990b) which summarized the toxicity, use pattern, and science findings. At 

that time, use of this biopesticide was limited to ornamental and food crops grown in 

greenhouses. No human health or ecotoxic risks were identified, and there were no 

data gaps. 

 In a January 1994 transmittal letter (Grace 1994a), W.R. Grace proposed to the 

Agency that the use pattern for this product be expanded to terrestrial outdoor uses on 

both food and nonfood crops. Grace pointed out that the product was exempt from the 

requirement of tolerance when applied to food crops grown in the greenhouse. In the 

same letter Grace stated that it was filing a pesticide tolerance petition to amend the 

existing tolerance exemption at 40 CFR 158.1100 to include terrestrial outdoor 

application to food crops. Additional human health toxicity and ecotoxicity data and 

waivers were submitted. The Notice of Filing was published on September 28, 1994 (59 

FR 49396; PP 4F4368); it announced that W.R. Grace was proposing to “amend 40 

CFR 180.1001 by establishing an exemption from the requirement of a tolerance to 

include use of Gliocladium virens GL-21 on terrestrial food crops grown outdoors.” In its 

review of the data and waivers EPA concluded that the “toxicology data base is 

sufficient to support outdoor use registration [of] Gliocladium virens GL-21 and WRCAP-21” (U.S. EPA 1994a) and that the ecotoxicity data and waivers were acceptable 

(U.S. EPA 1994, 1996). The label was amended to add the outdoor uses and in a 1995 

Final Rule (60 FR 48657), EPA amended the exemption to include terrestrial food crops 

grown outdoors; it reads: “180.1100 Gliocladium virens GL-21; exemption from the 

requirement of a tolerance. An exemption from the requirement of a tolerance is 

established for residues of the biofungicide Gliocladium virens GL-21 in or on all raw 

agricultural commodities when used either as a fungicide for inoculation of plant growth 

media in greenhouses or on terrestrial food crops grown outdoors in accordance with 

good agricultural practices.” In April 2000 EPA issued another Fact Sheet on 

Gliocladium virens GL-21 (U.S. EPA 2000), which included the approved terrestrial 

uses. 

 There is one registered product containing Gliocladium virens G-21: WRC-AP-1 

Microbial Fungicide, 12 % a.i. (EPA Reg. No. 70051-3); it is formulated as a granular. 

This end-use product was first registered in 1990 by W.R. Grace (under EPA Reg. No 

11688-3; please note that in 1996 the registration was transferred to Certis USA, LLC) 

to control damping-off and root rot pathogens. Current registered use sites include both 

commercial and residential applications to ornamental and food plants. WRC-AP-1 is 

applied via soil incorporation, a day before or at the same time as seeding, planting, or 

transplanting. It can also be diluted with water and applied directly to soil or root area of 

plants (U.S. EPA 2000). 

-7-
 Gliocladium catenulatum strain J1446 is a naturally-occurring saprophytic 

fungus that is widespread in the environment (U.S. EPA 2002a). In a 1996 transmittal 

letter (Butts 1996) Kemira Agro Oy informed the Agency that it was applying for 

registration of products containing the new a.i. Gliocladium catenulatum strain J1446 to 

be used on vegetables; herbs and spices; ornamentals; tree and shrub seedlings; turf; 

and home and garden. Please note that in early in 1998 the petitioner removed the 

outdoor uses (Butts 1998). The transmittal included human health and ecotoxicity data 

and waivers. EPA announced receipt of this pesticide application in a Notice published 

on May 23, 1997 (62 FR 28478) and on June 25, 1997 announced the filing of a 

pesticide tolerance petition (PP 7F4137) for the use of Gliocladium catenulatum strain 

J1446 on vegetables, herbs and spices, ornamentals, tree and shrub seedlings, turf, 

home and garden” (62 FR 34271). 

Upon review of the product chemistry and human health toxicity data EPA 

determined that there was a lack of toxicity resulting from exposure to Gliocladium 

catenulatum strain J1446 when used in greenhouse settings and that the submitted 

data were complete and support the proposed registration (U.S. 1998b). Regarding 

ecotoxicity, the Agency stated that “the intended applications of G. catenulatum to 

greenhouse food crop, greenhouse non-food crop and indoor use patterns are not 

expected to pose adverse risk to non-target organisms” (U.S. EPA 1998d). 

 In a Final Rule published on July 10, 1998 (63 FR 37286), EPA established an 

exemption from the requirement of tolerance for residues of Gliocladium catenulatum

strain J1446. The exemption was codified at 40 CFR 180.1198 and read: “180.1198 

Gliocladium catenulatum strain J1446; exemption from the requirement of a tolerance. 

An exemption from the requirement of a tolerance is established for residues 

of the microbial pesticide, Gliocladium catenulatum strain J1446 when used in 

or on all food commodities.” A Registration Eligibility Decision (RED) was issued (U.S. 

EPA 1998d) which provided the background and rationale for the unconditional 

registration of Primastop Biofungicide, along with a Fact Sheet (U.S. EPA 1998e) 

summarizing the use sites and application methods. Use sites were limited to 

greenhouse and indoor settings. No toxicological endpoints of concern were identified, 

and the Agency concluded that the health risks were expected to be minimal for all 

routes of exposure. The exposure and risk to nontarget organisms (including fish, birds, 

and insects) was expected to be minimal because the product was not registered for 

outdoor use at that time. No major data gaps were identified. 

 The use pattern was expanded in 2002 to include outdoor and turf use sites. The 

science assessment and regulatory concerns providing the rationale for the 

unconditional registration of the new use pattern can be found in the Biopesticides 

Registration Action Document (BRAD) and its Fact Sheet (U.S. EPA 2002a,b). In the 

BRAD, the Agency concluded that the data requirements to support outdoor-use had 

been fulfilled, and found that no unreasonable adverse effects to nontarget organisms 

were expected. 

-8-
 Gliocladium catenulatum strain J1446 has two registered products: (1) 

Primastop Biofungicide Powder, 37% a.i. (EPA Reg. No. 64137-8) and (2) Prestop® 

Biofungicide Powder, 32% a.i. (EPA Reg. No. 64137-11). Primastop (64137-8) was first 

registered in 1998 and Prestop® (64137-11) was first registered in 2006. Both end-use 

products are registered by Verdera Oy (formerly Kemira Agro Oy) of Finland. 

Registered uses include control of damping-off, seed rot, root and stem rot, wilt, and 

certain foliar diseases on greenhouse or field grown vegetables, herbs, ornamentals, 

tree and forest seedlings, and turf. The products are applied by via soil incorporation, 

soil drench, foliar spray, and dipping of cuttings, bulbs, and tubers (U.S. EPA 2002a). 

C. Anticipated Risk Assessment and Data Needs 

Below is a discussion of how the current data requirements for microbial 

pesticides are satisfied by available data, both for Gliocladium virens G-21 and 

Gliocladium catenulatum strain J1446. The pertinent data areas include: Product 

Analysis, Residue Data, Toxicology (human health), and Nontarget Organisms and 

Environmental Fate (ecotoxicology). Data gaps are discussed in the text and are 

summarized in Table 7 and Table 8. 

1. Product Analysis 

 (40 CFR 158.2120) 

 

Gliocladium virens G-21. The Product Analysis and chemistry data 

submitted to support the registration of Gliocladium virens G-21 satisfy the 

current data requirements. The requirements for miscibility (OPPTS Guideline 

Number 830.6319) and viscosity (OPPTS Guideline Number 830. 7100) are not 

applicable because the product is a granular formulation. 

Table 1. Summary of Product Analysis Data for Gliocladium virens G-21 

40 CFR 158.2120 How it Has Been Addressed 

Data Requirement 

(OPPTS Guideline) MRID EPA Review 

Product Identity (885.1100) 407198-01; 

407198-07 

U.S. EPA 1989a, 1989b, and 1990a 

Manufacturing process (885.1200) 407198-01; 

407198-07 

U.S. EPA 1989a, 1989b 

Deposition of a sample in a nationally 

recognized culture collection (885.1200) 

U.S. EPA 1989a, 1989b 

Discussion of formation of unintentional 

ingredients (885.1300) 

407198-01; 

407198-07 

U.S. EPA 1989a, 1989b, and 1990a 

Analysis of samples (885.1400) 407198-02; 

407198-08 

U.S. EPA 1989a, 1989b, and 1990a 

Certification of limits (885.1500) 407198-02 U.S. EPA 1989a, 1989b, and 1990a 

Color (830.6302) 407198-03; 

407198-09 

U.S. EPA 1989a, 1989b 

Physical state (830.6303) 407198-03; 

407198-09 

U.S. EPA 1989a, 1989b 

-9-
40 CFR 158.2120 How it Has Been Addressed 

Data Requirement 

(OPPTS Guideline) MRID EPA Review 

Odor (830.6304) 407198-03 U.S. EPA 1989a, 1989b 

pH (830.7000) 407198-03; 

407198-09 

U.S. EPA 1989a, 1989b 

Density/relative density/bulk density 

(specific gravity) (830.7300) 

407198-03; 

407198-09 

U.S. EPA 1989a, 1989b 

Corrosion characteristics (830.6320) 407198-03; 

407198-09 

U.S. EPA 1989a, 1989b 

Storage stability (830.6317) 407198-02; 

407198-08 

U.S. EPA 1989a, 1989b 

Stability to normal and elevated 

temperatures, metals and metal ions 

(830.6313) 

U.S. EPA 1989a, 1989b, and 1990a 

Miscibility (830.6319) U.S. EPA 1989a, 1989b: "Not applicable to products not 

formulated as emulsifiable liquids." 

Viscosity (830.7100) U.S. EPA 1989a, 1989b: "Not applicable to solid formulations." 

 Gliocladium catenulatum strain J1446. The available data are 

adequate to support most of the current Product Analysis requirements for 

Gliocladium catenulatum strain J1446. Three of the Physical and Chemical 

Characteristic data requirements—Stability to normal and elevated temperatures, 

metals and metal ions; miscibility; and viscosity—have not been addressed. EPA 

considers stability to normal and elevated temperatures, metals and metal ions to 

be a data gap and anticipates needing these data for this Registration Review. 

Miscibility is required only for emulsifiable liquid forms of microbial pesticides and 

viscosity is required only for liquid forms of microbial pesticides. Because the 

end-use product is a powder, these two latter data requirements (miscibility and 

viscosity) would not apply and therefore are not considered to be data gaps. 

Provided in Table 2 is a summary of the Product Analysis data requirements and 

how they were met. 

Table 2. Summary of Product Analysis Data for 

 Gliocladium catenulatum strain J1446 

40 CFR 158.2120 How it Has Been Addressed 

Data Requirement 

(OPPTS Guideline) MRID EPA Review 

Product Identity (885.1100) 441893-01; 

466641-01 

U.S. EPA 1998b; 2002a 

Manufacturing process (885.1200) 466641-01 U.S. EPA 1998b; 2002a; 2005a,b 

Deposition of a sample in a nationally 

recognized culture collection (885.1200) 

441893-01 Deposited in Deutsche Sammlung von 

Mikroorganismen und Zellkulturen GmbH 

Butts 1996 

Discussion of formation of unintentional 

ingredients (885.1300) 

U.S. EPA 1998b; 2002a 

Analysis of samples (885.1400) U.S. EPA 1998b; 2002a 

-10-
40 CFR 158.2120 How it Has Been Addressed 

Data Requirement 

(OPPTS Guideline) MRID EPA Review 

Certification of limits (885.1500) 466641-01 U.S. EPA 1998b, 2002a 

Color (830.6302) 441893-07; 

441893-08 

U.S. EPA 1998b; 2002a 

Physical state (830.6303) 441893-07; 

441893-08 

U.S. EPA 1998b; 2002a 

Odor (830.6304) 441893-07; 

441893-08 

U.S. EPA 1998b; 2002a 

pH (830.7000) 441893-07; 

441893-08 

U.S. EPA 1998b; 2002a 

Density/relative density/bulk density 

(specific gravity) (830.7300) 

441893-07; 

441893-08 

U.S. EPA 1998b; 2002a 

Corrosion characteristics (830.6320) 441893-09 U.S. EPA 1998b 

Storage stability (830.6317) 441893-22; 

466641-01 

U.S. EPA 1998b; 2005a,b 

Stability to normal and elevated 

temperatures, metals and metal ions 

(830.6313) 

Data Gap 

Miscibility (830.6319) Not Required—the end-use products are solids. 

Viscosity (830.7100) Not Required—the end-use products are solids. 

 2. Human Health Risk Assessment Status 

 (40 CFR 158.2140) 

 Gliocladium virens G-21 was first registered in 1990 with the use pattern 

limited to greenhouse and indoor sites. In 1995 the use pattern was expanded to 

include outdoor use sites. When the use pattern was changed the toxicological 

data base was re-evaluated; it was deemed sufficient to support the outdoor uses 

and sufficient to support an exemption from requirement of tolerance (U.S. EPA 

1994a). Table 3 includes a list of the current Tier I Toxicology data requirements 

along with a summary of how they are satisfied. 

 The Agency identified three data gaps: acute oral toxicity; acute inhalation 

toxicity; and primary dermal irritation. EPA anticipates needing these data for 

this Registration Review. There is an adequate acute oral toxicity/pathogenicity 

study; however, it was conducted using a single-dose—to establish a doseresponse relationship several doses are needed. For inhalation toxicity, test note 

6 of the data table at 40 CFR 158.2140 states that this study is required “when 

the product consists of, or under conditions of use would result in, an inhalable 

material (e.g., gas, volatile substances, or aerosol particulate).” Regarding 

primary dermal irritation, test note 5 of the 40 CFR 158.2140 data table states 

that for dermal irritation, a waiver “may be granted when the applicant can 

demonstrate that the combination of inert ingredients is not likely to pose any 

significant human health risks. Where appropriate, the limit dose approach to 

testing is recommended.” The acute dermal toxicity study showed no toxicity at a 

dose of 1  108

 CFU/g. 

-11-
 

Table 3. Summary of Toxicology Data for Gliocladium virens G-21 

40 CFR 158.2140 How it Has Been Addressed 

Data Requirement 

 (OPPTS Guideline) MRID EPA Review 

Acute oral toxicity/ 

pathogenicity (885.3050) 

407198-04 Acceptable Study. U.S. EPA 1989b 

Acute dermal 

toxicity (870.1200) 

431271-01 Supplemental Study. When Gliocladium virens G-21 was first 

registered in 1990 the acute dermal toxicity study was waived 

because the label required hand protection. Later, the registrant 

submitted an acute dermal toxicity study (using guideline 152A-11) 

and requested that gloves not be required on the label. Even 

though the study was deemed as supplemental (because the limit 

dose was not used) it did show a lack of dermal toxicity at a dose of 

1  108

 CFU/g. In its review EPA stated that it “does not object to 

the removal of the protective glove statement based on the lack of 

dermal toxicity.” Therefore, additional data are not needed. 

U.S. EPA 1994a 

Acute pulmonary 

toxicity/pathogenicity 

(885.3150) 

407198-05; 

408640-02 

Acceptable Study. U.S. EPA 1989b 

Acute injection toxicity/ 

pathogenicity— 

intravenous (885.3200) 

407198-06; 

408640-01 

Acceptable Study. U.S. EPA 1989b 

Acute eye irritation 

(870.2400) 

431115-01 Unacceptable Study. When Gliocladium virens G-21 was first 

registered in 1990 the primary eye irritation/infectivity study was 

waived because the label required eye protection In 1994 the 

registrant submitted an eye irritation study (guideline 152A-14); 

however, EPA deemed it unacceptable for the purpose of removing 

eye protection from the label because it was not done using the enduse product. Please Note: the product label still requires eye 

protection. 

U.S. EPA 1988, 1989b, 1994a 

Cell culture (885.3500) Not Applicable. A cell culture study was submitted but is not required because 

the a.i. is not a virus. 

U.S. EPA 1989b 

Hypersensitivity 

incidents (885.3400) 

Acceptable Study. The registrant provided a written report stating a 

lack of observed hypersensitivity incidents was provided. Further, 

they mentioned that if any incidents are observed, then this 

information would be reported to the Agency. 

U.S. EPA 1989b 

Acute oral 

toxicity (870.1100) 

Data Gap 

Acute inhalation 

 toxicity (870.1300) 

Data Gap 

Primary dermal 

 irritation (870.2500) 

Data Gap

-12-
 Gliocladium catenulatum strain J1446. Gliocladium catenulatum strain 

J1446 was first registered in 1998 with the use pattern limited to greenhouse and 

indoor sites. In 2002 the use pattern was expanded to include outdoor and turf 

use sites. When the use pattern changed the toxicological data base was 

re-evaluated; it was deemed sufficient to support the outdoor uses and sufficient 

to support an exemption from requirement of tolerance (U.S. EPA 2002a). Table 

4 includes a list of the current Tier I Toxicology data requirements along with 

notation regarding how they are satisfied. No toxicology data gaps were 

identified. 

Table 4. Summary of Toxicology Data for 

Gliocladium catenulatum strain J1446 

40 CFR 158.2140 How it Has Been Addressed 

Data Requirement 

 (OPPTS Guideline) MRID EPA Review 

Acute oral toxicity/pathogenicity 

(885.3050) 

441893-10 Acceptable Study. U.S. EPA 1998b, 2002a 

Acute dermal toxicity (870.1200) 442232-01 Acceptable Study. U.S. EPA 1998b, 2002a 

Acute pulmonary toxicity/pathogenicity 

(885.3150) 

441893-13 Acceptable Study. U.S. EPA 1998a,b; 2002a 

Acute injection toxicity/pathogenicity—

intraperitoneal (885.3200) 

441893-15; 

444995-01 

Acceptable Study. U.S. EPA 1998b, 2002a 

Acute eye irritation (870.2400) 441893-16; 

444928-02 

Acceptable Study. U.S. EPA 1998b, 2002a 

Cell culture (885.3500) Not applicable. A cell culture study is only required for products 

whose a.i. is a virus. Gliocladium catenulatum strain J1446 is a 

fungus. 

Hypersensitivity incidents (885.3400) 441893-18 Acceptable Study. U.S. EPA 1998b, 2002a 

Acute oral toxicity (870.1100) 441893-11 Acceptable Study. U.S. EPA 1998b, 2002a 

Acute inhalation toxicity (870.1300) 441893-14 Acceptable Study. U.S. EPA 1998b, 2002a 

Primary dermal irritation (870.2500) 441893-12; 

444928-01 

Acceptable Study. U.S. EPA 1998b, 2002a 

 

3. Environmental Fate and Ecological Risk Assessment Status 

 (40 CFR 158.2150) 

Gliocladium virens G-21. In 1995 the use pattern was broadened to include 

outdoor food; originally use was limited to food crops and ornamentals grown in 

greenhouses. When Grace requested the expanded use pattern the Agency reevaluated the ecological toxicity data base. In reviewing the available data for the 

Registration Review, no ecological toxicity data gaps are identified.

-13-
Table 5 Table 5 includes a summary of how the Tier I requirements have been met. 

-14-
Table 5. Ecological Toxicity Data for Gliocladium virens G-21 

40 CFR 158.2150 How it Has Been Addressed 

Data Requirement 

 (OPPTS Guideline) MRID EPA Review 

Avian oral toxicity 

(885.4050) 

Waived Waived for all uses. For greenhouse uses this was waived because it is 

unlikely that birds would be exposed to the pesticide due to how the product 

is applied (in-furrow). U.S. EPA 1994b 

For turf uses this requirement was waived because the registrant 

demonstrated that this fungus does not proliferate in birds because of their 

body temperature. 

U.S. EPA 1995b 

Avian inhalation 

toxicity/pathogenicity 

(885.4100) 

Waived Waived for all uses. This requirement is only required when it is believed that 

there will be a unique respiratory exposure to birds. 

U.S. EPA 1994b 

Wild mammal toxicity/ 

pathogenicity 

(885.4150) 

Waived Waived for all uses. This requirement is normally fulfilled by the mammalian 

toxicity requirements; this requirement has been fulfilled by the human health 

studies. 

 U.S. EPA 1994b 

Freshwater fish 

toxicity/ 

pathogenicity 

(885.4200) 

Waived 

Freshwater 

invertebrate toxicity/ 

pathogenicity 

(885.4240) 

Waived 

Estuarine/Marine fish 

testing 

Estuarine and marine 

invertebrate testing 

(885.4280) 

Waived 

Waived for the greenhouse uses—because of the application method (infurrow) significant runoff is not expected to occur. 

U.S. EPA 1994b 

No Longer Required for Turf—For turf, a study was required. However, in 

1995 Grace notified the Agency that turf uses would be removed from the 

proposed label. 

Grace 1995; U.S. EPA 1994b 

Nontarget plant 

testing (885.4300) 

407198-10; 

438460-01 

Acceptable Study. U.S. EPA 1996

Nontarget insect 

testing (885.4340) 

438460-02 Supplemental Study. A supplemental study was submitted which consisted 

of two published studies. Because neither of the studies was conducted at a 

testing facility that had a formal Good Laboratory Practices program in place, 

EPA deemed it as supplemental. Additional testing is not justified because: 

(1) Gliocladium virens is a naturally-occurring fungal saprophyte; (2) 

populations decline to natural levels shortly after application; and (3) the toxin 

(gliotoxin) is active only for a short period of time, after which in converts to a 

biologically-inactive derivative. 

U.S. EPA 1996 

Honey bee testing 

(885.4380) 

Waived Waived for all uses. Significant exposure to honey bees due to use of 

Gliocladium virens G-21 is not expected. 

U.S. EPA 1994b 

 

-15-
 Gliocladium catenulatum strain J1446. In 2002 the use pattern for 

Gliocladium catenulatum strain J1446 was expanded to include outdoor and turf 

sites; previously the use was limited to greenhouse and indoor sites. When the 

use pattern changed the ecological toxicity data base was re-evaluated (U.S. 

EPA 2002a). Table 6 includes a list of the current Tier I ecotoxicology data 

requirements along with a summary of how they were satisfied. EPA identified 

three data gaps and anticipates needing these data for this Registration Review: 

avian inhalation toxicity/pathogenicity; wild mammal toxicity/pathogenicity; and 

estuarine/marine fish testing & estuarine and marine invertebrate testing. Avian 

inhalation testing is “required when the nature of the microbial pesticide and/or its 

toxins indicates potential pathogenicity to birds” (40 CFR 158.2150; test note 3). 

For wild mammal toxicity/pathogenicity, this study is required on a case-by-case 

basis if results of tests required by §158.2140 are inadequate or inappropriate for 

assessment of hazards to wild mammals (40 CFR 158.2150; test note 4). 

Finally, estuarine studies are required “if the product is intended for direct 

application into the estuarine or marine environment or expected to enter this 

environment in significant concentrations because of expected use or mobility 

pattern” (40 CFR 158.2150; test note 6). 

Table 6. Ecological Toxicity Data for Gliocladium catenulatum strain J1446 

40 CFR 158.2150 How it Has Been Addressed 

Data Requirement 

 (OPPTS Guideline) MRID EPA Review 

Avian oral toxicity (885.4050) 445014-01 Acceptable Study. U.S. EPA 2001, 2002a 

Avian inhalation toxicity/ 

pathogenicity (885.4100) 

Data Gap

Wild mammal toxicity/ 

pathogenicity (885.4150) 

Data Gap

Freshwater fish toxicity/ 

pathogenicity (885.4200) 

445014-02 Acceptable Study. U.S. EPA 2001, 2002a 

Freshwater invertebrate toxicity/ 

pathogenicity (885.4240) 

445014-03 Acceptable Study. U.S. EPA 2001, 2002a 

Estuarine/Marine fish testing 

Estuarine and marine 

invertebrate testing (885.4280) 

Data Gap 

Nontarget plant 

testing (885.4300) 

441893-20 Waived. In the submitted literature review, there were no 

reports of pathogenicity to plants. 

U.S. EPA 2001, 2002a 

Nontarget insect 

testing (885.4340) 

441893-21; 

445014-04; 

445014-05; 

445014-06 

Acceptable Study. U.S. EPA 2001, 2002a 

Honey bee testing (885.4380) 445014-07 Acceptable Study. U.S. EPA 2001, 2002a 

-16-
4. Risk to Threatened and Endangered Species 

 

Based on the specific use patterns and data gaps in ecological data, the 

Agency anticipates the need for new data for both Gliocladium virens G-21 and 

Gliocladium catenulatum strain J1446. In addition, because both a.i.’s have 

products that are registered for outdoor use, the Agency is required to consider 

any effects on nontarget species, particularly those with endangered and 

threatened status. 

EPA has not conducted a risk assessment that supports a complete 

endangered species determination for Gliocladium virens G-21 and Gliocladium 

catenulatum strain J1446. The ecological risk assessment planned during 

Registration Review will allow the Agency to determine whether use of 

Gliocladium virens G-21 and Gliocladium catenulatum strain J1446 have “no 

effect”1

 or “may affect”1 federally-listed threatened or endangered species (listed 

species) or their designated critical habitat. When an assessment concludes that 

a pesticide’s use “may affect” a listed species or its designated critical habitat, 

the Agency will consult with the U.S. Fish and Wildlife Service and/or National 

Marine Fisheries Service (the Services), as appropriate. 

 EPA has identified three data gaps that it expects to need to be fulfilled for 

the endangered species review. They are for Gliocladium catenulatum strain 

J1446, as follows: avian inhalation toxicity/pathogenicity (885.4100); wild 

mammal toxicity/pathogenicity (885.4150); estuarine/marine fish testing/estuarine 

and marine invertebrate testing (885.4280). 

5. Endocrine Disruptor Screening Program 

 As required under the Federal Food, Drug, and Cosmetic Act (FFDCA) 

section 408(p), EPA 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 

 

1

In assessing ecological risk EPA makes an “effects determination.” The effects determination may 

conclude that the pesticide’s use will have: “no effect" on a listed species, "may affect but is not 

likely to adversely affect" a listed species, or is "likely to adversely affect" a listed species. 

http://www.epa.gov/espp/litstatus/eseffects.htm 

-17-
 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 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 EPA 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 

endocrine related 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, EPA issued test orders/data 

call-ins for the first group of 67 chemicals which contains 58 pesticide active 

ingredients and nine 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 postapplication agricultural scenarios. This list 

should not be construed as a list of known or likely endocrine disruptors. 

 The Gliocladium spp. are 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, 

EPA anticipates issuing future EDSP test orders/data call-ins for all Registration 

Review cases, including those for which EPA has already opened a Registration 

Review docket for a pesticide active ingredient. 

 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/. 

 6. Incidents 

 The National Pesticides Information Center (NPIC) database reported no 

incidents associated with products containing Gliocladium virens G-21 or 

Gliocladium catenulatum strain J1446. The Office of Pesticide Programs’ 

Incident Data System (IDS) indicates that there have been four reports of 

adverse human, domestic animal, or environmental incidents for products 

containing Gliocladium virens G-21 and none for Gliocladium catenulatum strain 

J1446. 

 Between 1992 and the end of 2009 a total of four incidents were reported. 

Using the classification system described at 40 CFR 159.184(c)(5), three of the 

incidents are considered to be “H-D,” which means that if the person alleged or 

exhibited some symptoms, but they were minimally traumatic. The symptoms 

resolved rapidly and usually involve skin, eye or respiratory irritation. One 

incident was classified as “P-B,” which means that the incident occurred on 

plants and it caused damage in excess of $5,000. The Agency will consider any 

incident data or comments submitted to this docket in response to this 

preliminary workplan. 

-18-
7. Summary of Data Gaps 

 Tables 7 and 8 include the data gaps for Gliocladium virens G-21 and 

Gliocladium catenulatum strain J1446. 

Table 7. Summary of Data Gaps for Gliocladium virens G-21 

Product Analysis Human Health Risk Environmental Fate 

and Ecological Risk 

Acute oral toxicity 

(870.1100) 

Acute inhalation toxicity 

(870.1300) No data gaps. 

Primary dermal irritation 

(870.2500)

No data gaps. 

 Table 8. Summary of Data Gaps for Gliocladium catenulatum strain J1446 

Product Analysis Human Health Risk Environmental Fate 

and Ecological Risk 

Avian inhalation toxicity/ 

pathogenicity 

(885.4100) 

Wild mammal toxicity/ 

pathogenicity 

(885.4150) 

Stability to normal and 

elevated temperatures, metals 

and metal ions 

(OPPTS 830.6313) 

No data gaps. 

Estuarine/marine fish testing 

Estuarine and marine 

invertebrate testing 

(885.4280) 

-19-
D. Timeline 

The projected timeline for Case 6020—Gliocladium virens G-21 and 

Gliocladium catenulatum strain J1446—Registration Review is listed in 

 Table 9, below. 

 Table 9. Projected Timeline for the Registration Review of Case 6020 

Activity Estimated Month 

and Year 

Phase 1: Open the Public Docket

Open Comment Period for Docket June 2010 

Close Comment Period August 2010 

Phase 2: Case Development

Develop Final Workplan December 2010 

Issue Data Call-in (DCI) December 2011 

Data Submission December 2013 

Open Public Comment Period for Preliminary Risk Assessments June 2015

Close Public Comment Period September 2015

Phase 3: Registration Review Decision

Open Comment Period for Proposed Registration Review Decision December 2015 

Close Comment Period March 2016 

Final Decision and Begin Post-Decision Followup 2016 

Estimated Total (years) 6 

E. Guidance for Commenters 

 The public is invited to comment on EPA’s preliminary Registration 

Review workplan and rationale. The Agency will consider all comments as well 

as any additional information or data provided in a timely manner prior to issuing 

a final workplan for the case. 

 

 

F. Environmental Justice 

 EPA seeks to achieve environmental justice, the fair treatment and 

meaningful involvement of all people, regardless of race, color, national origin, or 

income, in 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 of their location, cultural practices, or other factors, 

may have atypical, unusually high exposure to Gliocladium virens G-21 and/or 

Gliocladium catenulatum strain J1446, compared to the general population. 

-20-
Please comment if you are aware of any subpopulations that may have atypical, 

unusually high exposure compared to the general population. 

G. Water Quality 

 The Gliocladium spp. are not identified as a cause of impairment for any 

water bodies listed as impaired under section 303(d) of the Clean Water Act, 

based on information provided at: http://www.epa.gov/owow/tmdl/. In addition, 

no Total Maximum Daily Loads (TMDL) have been developed for the Gliocladium 

spp. based on information provided at: 

http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_search_form. More 

information on impaired water bodies and TMDL’s can be found at: 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality 

data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the Office of Pesticide Program’s (OPP) Standard 

Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality 

Data in OPP’s Registration Review Risk Assessment and Management Process 

(see: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm) to 

ensure they can be used quantitatively or qualitatively in pesticide risk 

assessments. 

H. Trade Irritants 

 Through the Registration Review process, the Agency intends to solicit 

information on trade irritants and, to the extent feasible, take steps toward 

facilitating irritant resolution. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from lack of Maximum Residue 

Limits (MRL’s) or disparities between United States tolerances and MRL’s in key 

export markets, providing as much specificity as possible regarding the nature of 

the concern. In the case of Gliocladium spp. (Case 6020), there are currently no 

established residue tolerances. Additionally, there is no MRL established for 

either of the Gliocladium spp. Therefore, the Agency does not anticipate that 

current uses of Gliocladium spp. will pose concerns as trade irritants. 

-21-
I. Additional Information 

 Stakeholders are also specifically asked to provide information and data 

that will assist the Agency in refining the risk assessments, including any 

species-specific ecological effects determinations. The Agency is interested in 

obtaining the following information regarding the use of Gliocladium spp: 

1. Confirmation on the following label information: 

a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum 

 number of applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for nonagricultural uses (e.g., materials 

 preservation) 

5. Typical application interval 

6. State or local use restrictions 

7. Monitoring data

 

J. Next Steps 

 After the 60-day comment period closes, the Agency will review and 

respond to any comments received in a timely manner and then issue a Final 

Workplan for Case 6020: Gliocladium virens G-21 and Gliocladium catenulatum 

strain J1446. 

-22-
II. FACT SHEET

Gliocladium virens G-21 and 

Gliocladium catenulatum strain J1446 

Case 6020 

A. Background Information 

Gliocladium virens G-21 Gliocladium catenulatum 

strain J1446 

Registration Review 

Case Number: 6020 

PC Code: 129000 021009 

Registrant: Certis USA, LLC Verdera Oy (formerly Kemira 

Agro Oy) of Finland 

First Registered: 1990 1998 

Products: WRC-AP-1 

Microbial Fungicide 

(70051-3) 

Primastop Biofungicide 

Powder (64137-8) 

Prestop® Biofungicide 

Powder (64137-11) 

Previous 

Regulatory 

Documents: 

Fact Sheet 

(U.S. EPA 1990b) 

Fact Sheet 

(U.S. EPA 2000) 

Registration Eligibility 

Decision (U.S. EPA 1998d) 

Fact Sheet (U.S. EPA 1998e) 

Biopesticides Registration 

Action Document 

(U.S. EPA 2002a) 

Fact Sheet (U.S. EPA 2002b)

Biopesticide and Pollution Prevention Division (BPPD) 

Registration Review Lead: 

Kathleen Martin; martin.kathleen@epa.gov 

Products Labels 

 Labels for the Gliocladium spp. products may be found at: 

http://oaspub.epa.gov/pestlab1/ppls.home, which is the Office of Pesticide 

Programs’ the Pesticide Product Label System (PPLS) website. 

-23-
B. Description of Active Ingredient

The Gliocladium spp. are saprophytic, naturally-occurring soil fungi that are 

widespread in the environment. Both Gliocladium virens G-21 and Gliocladium 

catenulatum strain J1446 are used to control “damping-off,” seed rot, root and stem rot, 

wilt, and certain foliar diseases on greenhouse or field-grown food crops and 

ornamentals. In addition, Gliocladium catenulatum strain J1446 is registered for use on 

turf. Damping-off is destruction “of seedlings by one or a combination of pathogens that 

weaken the stem or root” (http://www.ipm.ucdavis.edu/). Gliocladium virens G-21 is 

formulated as a granular and Gliocladium catenulatum strain J1446 is formulated as a 

dry powder. Both are applied by soil incorporation or as an aqueous solution. 

C. Use Information 

Gliocladium virens G-21 

Product Name and 

% Active Ingredient:

WRC-AP-1, 12% active ingredient (1x106 CFU/g) 

 EPA Reg. No.: 70051-3 

Commercial: ornamental and food crop plants grown 

in greenhouses, nurseries, homes, and 

interiorscapes and outdoors on agricultural and 

ornamental crops 

 Use Sites:

Residential: ornamental and vegetable plants grown 

indoors and outdoors in home gardens 

Application 

Methods:

Commercial: soil incorporation; and soil drench, root 

dip, through irrigation (when mixed with water) 

Residential: soil incorporation 

Gliocladium catenulatum strain J1446

Product Name and 

% Active Ingredient:

Primastop Biofungicide Powder, 

37% active ingredient (1x108 CFU/g) 

 EPA Reg. No.: 64137-8 

 Use Sites: turf; forest seedlings; greenhouse or field grown 

vegetables and herbs; greenhouse or field grown 

ornamentals 

Application 

Methods:

soil incorporation, either as a dry powder or by 

aqueous solution (drenching, foliar or field spray) 

-24-
Product Name and 

% Active Ingredient:

Prestop® Biofungicide Powder, 

32% active ingredient (1x108 CFU/g) 

 EPA Reg. No.: 64137-11 

 Use Sites: turf; greenhouse or field grown vegetables, herbs, 

spices; greenhouse or outdoor-grown ornamentals, 

trees, and shrubs 

Application 

Methods:

soil incorporation, either as a dry powder or by 

aqueous solution (drenching, foliar or field spray) 

D. Recent Actions

Gliocladium virens G-21

EPA Reg. No. 70051-3: 

May 20, 2008: Label amendment to clarify homeowner use directions. 

October 18, 2007: Label amendments to: expand the Directions for Use 

section to provide more detailed use instructions; and 

add chemigation statements. 

February 24, 2005: Label amendments pertaining to residential use (e.g., 

added the terms “for organic gardening” and “home 

gardens”) and revised the heading for disposal 

instructions. 

Gliocladium catenulatum strain J1446

EPA Reg. No. 64137-8

No actions within the last five years. 

 EPA Reg. No. 64137-11

January 24, 2006: First registration 

-25-
E. Product Analysis

The Product Analysis and Chemistry data submitted to support the registration of 

Gliocladium virens G-21 (EPA Reg. No. 70051-3) satisfy the current data requirements 

for microbial pesticide product analysis (40 CFR 158.2120). Such data and information 

included morphological, nutritional, serological, DNA analysis, and biochemical data 

specific to the active ingredient intended for reregistration. No additional Product 

Analysis data and/or information are expected to be needed for this strain (at this time) 

for this Registration Review. 

 But, the Product Analysis data submitted to support the registration of 

Gliocladium catenulatum strain J1446 (EPA Reg. Nos. 64137-08 and -11) do not fully 

satisfy the current data requirements. There is one data gap: stability to normal and 

elevated temperatures, metals and metal ions; miscibility; and viscosity (OPPTS 

(830.6313) . EPA anticipates needing the data from this study for this Registration

Review. 

F. Human Health Risk Assessment (human health toxicology)

 Meeting the Current Data Requirements: Status 

 The Toxicology data submitted to support the registration of Gliocladium 

virens G-21 do not fully support the current data requirements—three data gaps 

were identified: acute oral toxicity; acute inhalation toxicity; and primary dermal 

irritation. Regarding acute toxicity, there is an adequate acute oral 

toxicity/pathogenicity study; however, it was conducted using a single-dose—to 

establish a dose-response relationship several doses are needed. For inhalation 

toxicity, test note 6 of the data table at 40 CFR 158.2140 states that this study is 

required “when the product consists of, or under conditions of use would result in, 

an inhalable material (e.g., gas, volatile substances, or aerosol particulate).” 

Regarding primary dermal irritation, test note 5 of the 40 CFR 158.2140 data 

table states that for dermal irritation, a waiver “may be granted when the 

applicant can demonstrate that the combination of inert ingredients is not likely to 

pose any significant human health risks.” EPA anticipates needing these data 

from these three studies for Registration Review of Case 6020. 

 For Gliocladium catenulatum strain J1446, the Toxicology data submitted 

to support the registrations of Primastop Biofungicide Powder (EPA Reg. No. 

64137-8) and Prestop® Biofungicide Powder (EPA Reg. No. 64137-11) satisfy 

the current data requirements for microbial pesticide toxicology (40 CFR 

158.2140). No additional toxicology data and/or information are expected to be 

needed for this strain at this time for the Registration Review of Case 6020. 

 

-26-
 Exposure Assessment

 The products registered for the Gliocladium spp. may be used by 

commercial applicators and by home gardeners. Uses include: food crops 

grown indoors and outdoors; turf; and ornamentals.

 

Dietary (Food and Water). Products containing the Gliocladium spp. may 

be applied to food crops. However, their use is not expected to result in 

any dietary exposure to the organism. First, fungi such as the Gliocladium 

spp. are ubiquitous in the agricultural environment. EPA anticipates that 

concentrations of this pesticide may be elevated immediately after 

application but will rapidly decline to environmental background levels. 

Regarding exposure through drinking water, the Gliocladium spp. have not 

been identified as a cause of impairment for any water bodies listed as 

impaired under section 303(d) of the Clean Water Act. 

Residential exposure is expected as WRC-AP-1 (70051-3); Primastop 

Biofungicide Powder (64137-8); and Prestop® Biofungicide Powder 

(64137-11). Home gardeners may be exposed through handling and 

applying the product. Secondary exposure may occur through the 

application in around schools, parks, and recreational areas. 

Occupational exposure is expected to individuals who handle this 

pesticide through mixing and loading and to those who apply the pesticide. 

Handlers and applicators are expected to be exposed through the dermal 

and inhalation routes. 

 Tolerance Exemptions 

 There are two tolerance exemptions for the Gliocladium spp: 

 40 CFR 180.1100 Gliocladium virens GL-21. An exemption from 

the requirement of a tolerance is established for residues of the 

biofungicide Gliocladium virens GL-21 in or on all raw agricultural 

commodities when used either as a fungicide for inoculation of 

plant growth media in greenhouses or on terrestrial food crops 

grown outdoors in accordance with good agricultural practices. 

 180.1198 Gliocladium catenulatum strain J1446. An exemption 

from the requirement of a tolerance is established for residues of 

the microbial pesticide, Gliocladium catenulatum strain J1446 when 

used in or on all food commodities. 

-27-
G. Environmental Fate and Ecological Risk Assessment 

(ecotoxicology) 

Meeting the Current Data Requirements: Status

 The Nontarget Organisms and Environmental Fate data (requirements are 

listed at 40 CFR 158.2150) submitted to support the registration of Gliocladium 

virens G-21 (EPA Reg. No. 70051-3) satisfy the current data requirements. No 

additional Nontarget Organisms and Environmental Fate data are expected to be 

needed for Gliocladium virens G-21(at this time) for this Registration Review. 

 For Gliocladium catenulatum strain J1446 the Nontarget Organisms and 

Environmental Fate data submitted to support the registrations of Primastop 

Biofungicide Powder (64137-8); and Prestop® Biofungicide Powder (64137-11) 

do not fully support the current data requirements—EPA indentified three data 

gaps: avian inhalation toxicity/pathogenicity; wild mammal toxicity/pathogenicity; 

and estuarine/marine fish testing & estuarine and marine invertebrate testing. 

Avian inhalation testing is “required when the nature of the microbial pesticide 

and/or its toxins indicates potential pathogenicity to birds” (40 CFR 158.2150; 

test note 3). For wild mammal toxicity/pathogenicity, this study is required on a 

case-by-case basis if results of tests required by §158.2140 are inadequate or 

inappropriate for assessment of hazards to wild mammals (40 CFR 158.2150; 

test note 4). Finally, estuarine studies are required “if the product is intended for 

direct application into the estuarine or marine environment or expected to enter 

this environment in significant concentrations because of expected use or 

mobility pattern” (40 CFR 158.2150; test note 6). The Agency anticipates that it 

will need these data for the Registration Review. 

. 

Exposure Assessment

 The Gliocladium spp. are ubiquitous in the natural environment. The 

available data show that there is little toxicity to nontarget species including birds, 

freshwater fish, and plants and insects resulting from exposure to Gliocladium 

virens G-21 and Gliocladium catenulatum strain J1446. 

-28-
BIBLIOGRAPHY: Gliocladium virens G-21 

Studies 

407198-00 W.R. Grace & Co. 1988a. Submission of Product Chemistry and Toxicological Data to 

Support the Registration of WRC-GL-21 and WRC-AP-1. Transmittal of 11 studies. July 

6, 1988. MRID 407198-00. 

407198-01 Walter, J. 1988a. WRC-GL-21 Product Chemistry: Identity, Manufacturing Process, and 

Discussion of Unintentional Ingredients. Unpublished study prepared by W.R. Grace & 

Co. 59 p. July 6, 1988. MRID 407198-01. 

407198-02 Walter, J. 1988b. WRC-GL-21 Product Chemistry: Analysis of Samples and Certification 

of Ingredient Limits. Unpublished study prepared by W.R. Grace & Co. 9 p. July 6, 

1988. MRID 407198-02. 

407198-03 Walter, J. 1988c. Physical and Chemical Properties of WRC-GL-21. Unpublished study 

prepared by W.R. Grace & Co. 5 p. July 6, 1988. MRID 407198-03. 

407198-04 David, R. 1988a. Acute Oral Toxicity/Pathogenicity Study of Alginate Prill of Strain GL21 

in Rats: Final Rept: Study No. G 7131.222. Unpublished study prepared by 

Microbiological Associates Inc. 22 p. July 6, 1988. MRID 407198-04. 

407198-05 David, R. 1988b. Acute Pulmonary Toxicity/Pathogenicity Study of Spores of Strain 

GL21 in Rats: Interim Report: Study No. G-7131.225. Unpublished study prepared by 

Microbiological Associates Inc. 20 p. July 6, 1988. MRID 407198-05. 

407198-06 Davis, R. 1981. Acute Intravenous Toxicity/Pathogenicity Study of Mycelia of Strain 

GL21 in Rats: Interim Report: Study No. G-7131.224. Unpublished study prepared by 

Microbiological Associates Inc. 21 p. July 6, 1988. MRID 407198-06. 

407198-07 Walter, J. 1988d. WRC-AP-1 Product Chemistry: Identity, Manufacturing Process, and 

Discussion of Unintentional Ingredients. Unpublished study prepared by W.R. Grace & 

Co. 17 p. July 6, 1988. MRID 407198-07. 

407198-08 Walter, J. 1988e. WRC-AP-1 Product Chemistry: Analysis of Samples and Certification 

of Ingredient Limits. Unpublished study prepared by W.R. Grace & Co. 15 p. July 6, 

1988. MRID 407198-08. 

407198-09 Walter, J. 1988f. Physical and Chemical Properties of WRC-AP-1. Unpublished study 

prepared by W.R. Grace & Co. 5 p. July 6, 1988. MRID 407198-09. 

407198-10 Walter, J. 1988g. Environmental Data: WRC-GL-21: Report WRC-4695-ED. 

Unpublished study prepared by W.R. Grace & Co. 10 p. July 6, 1988. MRID 407198-10. 

407198-11 Walter, J. 1988h. Product Performance of WRC-AP-1: Rept. No. WRC-4695-EF. 

Unpublished study prepared by W.R. Grace & Co. 14 p. July 6, 1988. MRID 407198-11. 

408640-00 W.R. Grace & Co. 1988b. Submission of Data To Support Registration Application of 

Spores of Strain: Toxicology Data. Transmittal of 2 studies. October 18, 1988. MRID 

408640-00. 

408640-01 David, R. 1988c. Acute Intravenous Toxicity/Pathogenicity Study of Mycelia of Strain 

GL21 in Rats: Final Report: MBA Study No. G.7131.224. Unpublished study prepared by 

Microbiological Associates Inc. 23 p. October 18, 1988. MRID 408640-01. 

-29-
408640-02 David, R. 1988d. Acute Pulmonary Toxicity/Pathogenicity Study of Spores of Strain 

GL21 in Rats: Final Report: MBA Study No. G-7131.225. Unpublished study prepared by 

Microbiological Associates Inc. 23 p. October 18, 1988. MRID 408640-02. 

409545-00 E.I. du Pont de Nemours & Co. 1989. Resubmission of Data To Support Registration of 

Du Pont Accent Herbicide: Product Chemistry Data. Transmittal of 1 study. October 18, 

1988. MRID 409545-00. 

409545-01 Brennan, D. 1988. DPX-V9360: Product Identity and Composition, Analysis and 

Certification of Product Ingredients and Physical and Chemical Characteristics: Project 

ID: 9360.A. Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc. 171 

p. October 18, 1988. MRID 409545-01. 

431115-00 W. R. Grace & Co. 1884b. Submittal of Toxicology Data in Support of Pesticide 

Amendment for WRC-AP-1 (Gliocladium virens GL-21 fungus). Transmittal of 1 study. 

February 3, 1994. MRID 431115-00. 

431115-01 Wenk, M. 1993. Primary Eye Irritation Study of Gliocladium virens GL-21 in Rabbits: 

Final Report: Lab Project Number: G-7445.230. Unpublished study prepared by 

Microbiological Associates Inc. 35 p. February 3, 1994. MRID 431115-01. 

431271-00 W.R. Grace & Co. 1884a. Submission of toxicity data in support of the registration for 

WRC-AP-1 (Gliocladium virens). Transmittal of 1 study. February 3, 1994. MRID 

431271-00. 

431271-01 David, R. 1994. Acute Dermal Toxicity Test of GL-21 Alginate Prill in Albino Rabbits: 

Lab Project Number: G-7131.232. Unpublished study prepared by Microbiological 

Associates Inc. 11 p. February 3, 1994. MRID 431271-01. 

434194-00 W.R. Grace & Co. 1984c. Submission of Product Chemistry Data in Support of 

Registration Amendment for WRC-AP-1. Transmittal of 1 Study. October 20, 1994. 

MRID 434194-00. 

434194-01 Eyal, J. 1884. WRC-AP-1 Alternate Manufacturing Process: Granulation: Lab Project 

Number: 4695-GL-21-WDG-CHEM. Unpublished study prepared by W.R. Grace & Co.-

Conn. 10 p. October 20, 1994. MRID 434194-01. 

438460-00 W.R. Grace & Co. 1995. Submission of Hazard to Nontarget Organisms and Plants 

Data in Support of the Registration of WRC-AP-1. Transmittal of 2 Studies. November 

13, 1995. MRID 438460-00. 

438460-01 Walter, J. 1995a. WRC-AP-1 Nontarget Plant Data: Lab Project Number: 4695-GL21-

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438460-02 Walter, J. 1995b. WRC-AP-1 Nontarget Insect Data: Lab Project Number: 4695-GL21-

NTI. Unpublished study prepared by Grace Biopesticides. 20 p. November 13, 1995. 

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EPA Reviews 

U.S. EPA. 1988. Memorandum from Roy D. Sjoblad to L. Schnaubelt. “New Chemical Screen”; Toxicology 

Branch screen for registration of the fungus Gliocladium virens for greenhouse ornamental and 

greenhouse food crop uses. U.S. Environmental Protection Agency Office of Pesticide Programs. 

August 16, 1988. 

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U.S. EPA. 1989a. Memorandum from William J. Hazel to Larry Schnaubelt. Gliocladium virens. New Chemical 

Standard. PP#8F3659/Reg. Nos. 11688-G and -U. W.R. Grace & Co. (MRID Nos. 407198-01, -02, -03, -

07, -08, and -09; HED Project No. 9-0610; Caswell No. 467B). U.S. Environmental Protection Agency 

Office of Pesticide Programs. January 4, 1989. 

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and -U; W.R. Grace & Co.; (MRID Nos. 407198-01, -02, -03, -04, -05, -06, 07, -08, -09); HED Project No. 

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Record No. 263826 and 263827; MRID No. N/A; HED Project No. 0-1229; Caswell No. 467B). U.S. 

Environmental Protection Agency Office of Pesticide Programs. May 29, 1990. 

U.S. EPA. 1994a. Memorandum from Cindy Schaffer to Carl Grable, Clarence Lewis. SAB Review of Data 

Submitted by W.R. Grace and Company to Support the Outdoor Use Registration and Exemption from 

Tolerance of Gliocladium virens GL-21 and the End-Use Product, WRC-AP-1. (Submission No’s.: 

5468683, 8468684; DP Barcode No’s.: D2048l8, D204820; ID No.: 011688-00003; Chemical ID No.: 

129000). U.S. Environmental Protection Agency Office of Pesticide Programs. August 16, 1994. 

U.S. EPA. 1994b. Review by Robert W. Pilsucki. EFED Biotechnology Review Gliocladium virens strain GL-21: 

Label amendment to add terrestrial food and nonfood uses. U.S. Environmental Protection Agency Office 

of Pesticide Programs. August 25, 1994. 

U.S. EPA. 1995b. Memorandum from Denise Greenway to Robert Rose. Concurrence on Acceptance of W.R. 

Grace & Co.-Conn.'s November 3, 1995 Request for a Waiver From the Acute Avian Oral Study for the 

Turfgrass use of Gliocladium virens strain GL-21, S497759/D221419. U.S. Environmental Protection 

Agency Office of Pesticide Programs. December 7, 1995. 

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Other Information 

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Protection Agency. “Pre-registration Meeting for Neem Oil Foliar Fungicide and Gliocladium Soil 

Fungicide.” September 19, 1990. 

Grace. 1994a. Letter from Karen E. Warkentien, W.R. Grace & Co.-Conn. to Clarence Lewis, U.S. 

Environmental Protection Agency. “WRC-AP-1, EPA Reg. No. 11688-3 Application for Pesticide 

Amendment Addition of Terrestrial Outdoor Food and Nonfood Uses.” January 31, 1994. 

Grace. 1995. Letter from Karen E. Warkentien, W.R. Grace & Co.-Conn. to Denise Greenway, U.S. 

Environmental Protection Agency. “WRC-AP-1, EPA Reg. No. 11688-3; Follow-Up to Our Meeting of 

November 1, 1995. November 3, 1995. 

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110528. 

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-31-
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441893-12 Wilson, J. 1995b. Gliocladium (J1446) Preparation: Acute Dermal Irritation Test in 

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444928-01 Edgar, F. 1997a. Response to Questions Raised by EPA Regarding MRID Number 

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445014-04 Hoxter, K., Palmer, S., Krueger, H. 1998a. Gliocladium catenulatum Cell Mass 

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466641-01 Seiskari, P. 2005. Product Chemistry Data of Prestop. Project Number: 

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EPA Reviews 

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for the Intra-Peritoneal Toxicity/Pathogenicity Test for Gliocladium catenulatum (strain J1446) from 

Kemira Agro Oy. U.S. Environmental Protection Agency Office of Pesticide Programs. April 21, 1998. 

U.S. EPA. 1998b. Memorandum from Michael Watson to Susanne Cerrelli. BPPD Review of Product Chemistry 

and Toxicity/Pathogenicity Data Submitted by Kemira Agro Oy for the Registration of Primastop, which 

contains Gliocladium catenulatum (strain J1446) and the applicability of a Tolerance Exemption for this 

microbial. U.S. Environmental Protection Agency Office of Pesticide Programs. April 21, 1998. 

U.S. EPA. 2001. Memorandum from Robyn Rose to Susanne Cerrelli. Technical review summary of non-target, 

beneficial insect, avian and aquatic studies submitted by Kemira Agro Oy in support of the registration of 

Primastop® (EPA Reg. No. 64137-8) Gliocladium catenulatum Cell Mass (Technical Product) for outdoor 

uses. Barcode Nos.: D244243 & D267225; Submission Nos.: S539189 & S580869; Chemical No.: 

021009. U.S. Environmental Protection Agency Office of Pesticide Programs. August 21, 2001. 

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Other Information

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Containing the New Active Ingredient -Gliocladium catenulatum Strain J1446. December 4, 1996. 

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Questions Raised by EPA. February 18, 1998. 

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U.S. Environmental Protection Agency Office of Pesticide Programs. June 22, 1998. 

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Agency Office of Office of Prevention, Pesticides and Toxic Substances. June 1998. EPA 730-F-98-017. 

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021009). U.S. Environmental Protection Agency Office of Pesticide Programs. November 12, 2002. 

http://www.epa.gov/pesticides/biopesticides/ingredients/tech_docs/brad_021009.pdf. 

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Agency Office of Pesticide Programs. February 2002. 

http://www.epa.gov/pesticides/biopesticides/ingredients/factsheets/factsheet_021009.htm