## TABLE OF CONTENTS

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

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

A. Introducti on ....................................................................................................... 6

B. Background and Regulato ry Information........................................................... 7

C. Anticipated Risk Assessment and Data Needs................................................. 9 1. Product Anal ysis ........................................................................................ 9 2. Human Health Risk A ssessment St atus .................................................. 11 3. Environmental Fate and Ecologic al Risk Assessm ent Status.................. 13 4. Risk to Threatened and Endangered S pecies ......................................... 17 5. Endocrine Disruptor Screening Pr ogram ................................................. 17 6. Incidents .................................................................................................. 18 7. Summary of Da ta Gaps ........................................................................... 19

D. Timeli ne .......................................................................................................... 20

E. Guidance for Co mmenters.............................................................................. 20

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

G. Water Qual ity .................................................................................................. 21

H. Trade Irrita nts.................................................................................................. 21

I. Additional In formati on ..................................................................................... 22

J. Next St eps ...................................................................................................... 22

II. FACT SH EET ................................................................................................. 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

EC 50 For ecological assessments, a stat istically estimated concentration that is expected to cause one or mo re 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, F ungicide, And Rodenticide Act

FQPA Food Quality Protection Act of 1996
i.p. Intraperitoneal

i.v. Intravenous

IDS Incident Data System

LC 50 Lethal Concentration (median), whic h is a statistically-derived concentration of a substance that can be expected to cause death in 50% of test animals.

LD 50 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 indicat ed (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 (N umber), 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 Sa fety and Pollution Prevention

OECD Organization for Economic Cooperation and Development

OPP U.S. EPA Office of Pesticide Programs

OPPTS EPA’s Office of Prevention, Pe sticides 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

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### GLIOCLADIUM REGISTRA TION 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.

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### I. PRELIMINARY WORKPLAN

A. Introduction

The Food Quality Protection Act (F QPA) of 1996 mandat ed the continuous review of existing pesticides. All pesticides distributed or sold in the United States must generally be registered by the U.S. Envi ronmental 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 ma ke 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 occu r over time. Through the Registration Review program, the Agency peri odically 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 Rod enticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 year s to determine whether it continues to meet the FIFRA standard for r egistration. The Agency will c onsider 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 an d commit to a final workplan and schedule for the Registration Review.

This Registration Review Summary Docu ment 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 th is 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 exempt ion 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 lim ited 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 produ ct was exempt from the requirement of tolerance when applied to fo od 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 CF R 158.1100 to include terrestrial outdoor application to food crops. Additional hum an 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 require ment of a tolerance to include use of Gliocladium vir ens GL-21 on terrestrial food cr ops grown outdoors.” In its review of the data and waivers EPA conclu ded 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 ecotox icity 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 exem ption to include terrestrial food crops grown outdoors; it reads: “180.1100 Gliocladium virens GL-21; exemption from the requirement of a tolerance. An exempti on 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 Apr il 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 pl ants. WRC-AP-1 is applied via soil incorporation, a day before or at the same ti me as seeding, planting, or transplanting. It can also be diluted with water and applied direct ly to soil or root area of plants (U.S. EPA 2000).

-7-Gliocladiu m catenulatum strain J1446 is a naturally-occurring saprophytic fungus that is widespread in the environmen t (U.S. EPA 2002a). In a 1996 transmittal letter (Butts 1996) Kemira Ag ro 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; ornam entals; tree and shrub seedlings; turf; and home and garden. Please note that in early in 1998 t he 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 s train J1446 on vegetables, herbs and spices, ornam entals, tree and shrub seedlings, turf, home and garden” (62 FR 34271).

Upon review of the product chemistr y and human health toxicity data EPA determined that there was a lack of toxicity resulting from exposure to Gliocladium catenulatum s train 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 t hat “the intended applications of G. catenulatum to greenhouse food crop, greenhouse non-food cr op 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 re quirement of tolerance for residues of Gliocladium catenulatum strain J1446. The exemption was codifi ed at 40 CFR 180.1198 and read: “180.1198 Gliocladium catenulatum strain J1446; exemption from t he requirement of a tolerance. An exemption from the r equirement 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 toxicologica l endpoints of concer n were identified, and the Agency concluded that the health ri sks 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 be cause the product was not registered for outdoor use at that time. No ma jor data gaps were identified.

The use pattern was expanded in 2002 to in clude outdoor and turf use sites. The science assessment and regulatory concer ns providing the rationale for the unconditional registration of the new use pattern can be found in the Biopesticides Registration Action Document (BRAD) and it s 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 effe cts to nontarget organisms were expected.

-8-Gliocla dium catenulatum strain J1446 has two registered products: (1) Primastop Biofungicide Pow der, 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 Ve rdera Oy (formerly Kemira Agro Oy) of Finland. Registered uses include control of damping-o ff, seed rot, root and stem rot, wilt, and certain foliar diseases on greenhouse or fi eld grown vegetables, herbs, ornamentals, tree and forest seedlings, and turf. The produc ts 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 curr ent 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 N ontarget Organisms and Environmental Fate (ecotoxicology). Da ta 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 require ments for miscibility (OPPTS Guideline Number 830.6319) and viscosity (OPPTS Gu ideline 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

How it Has Been Addressed 40 CFR 158.2120 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-How it Has Been Addressed 40 CFR 158.2120 Data Requirement MRID EPA Review (OPPTS Guideline) 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 te mperatures, 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 t he Product Analysis data requirements and how they were met.

Table 2. Summary of Product Analysis Data for Gliocladium catenulatum strain J1446

How it Has Been Addressed 40 CFR 158.2120 Data Requirement (OPPTS Guideline) MRID EPA Review
Product Identity (885.1100) 441893-01; 466641-01 U.S. EPA 1998b; 2002a

Manufacturing process (885.1200) 46664 1-01 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-How it Has Been Addressed 40 CFR 158.2120 Data Requirement MRID EPA Review (OPPTS Guideline)

Certification of limit s (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 Ri sk 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 pa ttern 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 t he current Tier I Toxic ology data requirements along with a summary of how they are satisfied.

The Agency identified three data gaps: ac ute oral toxicity; acute inhalation toxicity; and primary dermal irritation. EPA anticipates needing these data for this Registration Review. There is an adequate acute oral to xicity/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 condition s of use would result in, an inhalable material (e.g., gas, volatile substances, or aerosol particu late).” 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 combi nation of inert ingredients is not likely to pose any significant human health ri sks. Where appropriate, th e limit dose approach to testing is recommended.” The acute dermal toxicity study showed no toxicity at a dose of 1  10 8 CFU/g.

-11-Table 3 . Summary of Toxicology Data for Gliocladium virens G-21

How it Has Been Addressed 40 CFR 158.2140 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 prot ection. 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  10 8 CFU/g. In its review EPA stat ed that it “does not object to the removal of the protective gl ove 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 irri tation study (guideline 152A-14); however, EPA deemed it unacceptable for the purpose of removing eye protection from the label becau se 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 in cidents was provided. Further, they mentioned that if any in cidents 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-Gliocladiu m 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 c hanged the toxicological data base was re-evaluated; it was deemed sufficient to support the outdoor uses and sufficient to support an exemption fr om requirement of tolerance (U.S. EPA 2002a). Table 4 includes a list of the current Tier I Toxicolog y data requirements along with notation regarding how they are satisfied. No toxi cology data gaps were identified.

Table 4. Summary of Toxicology Data for Gliocladium catenulatum strain J1446
How it Has Been Addressed 40 CFR 158.2140 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 Ecol ogical 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 limit ed 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 summar y of how the Tier I require ments have been met.

-14-Table 5

. Ecological Toxicity Data for Gliocladium virens G-21

How it Has Been Addressed 40 CFR 158.2150 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 tu rf 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 neit her 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-Gliocladiu m 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 requiremen ts along with a summary of how they were satisfied. EPA identified three data gaps and anticipates needing thes e 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 natur e of the microbial pes ticide and/or its toxins indicates potential pathogenicity to birds” (40 CFR 158.215 0; 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
How it Has Been Addressed 40 CFR 158.2150 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 te sting (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, par ticularly 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 ecologic al 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 habi tat. When an assessment concludes that a pesticide’s use “may affect” a listed s pecies 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); est uarine/marine fish testing/estuarine and marine invertebrate testing (885.4280).

5. Endocrine Disrupt or 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 subs tances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estr ogen, 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 th yroid (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 test ing is designed to identify any adverse endocrine related effects caused by the substance, and est ablish a quantitative relationship between the dose an d 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 chemic als which contains 58 pesticide active ingredients and nine inert ingr edients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain postapplicat ion agricultural scenarios. This list should not be construed as a list of k nown 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 fo r all Registration Review cases, including those for wh ich EPA has already opened a Registration Review docket for a pesticide active ingredient.

For further information on the stat us of the EDSP, the policies and procedures, the list of 67 c hemicals, the test guidelin es and the Tier 1 screening battery, please visit our webs ite: http://www.epa.gov/endo/.

6. Incidents

The National Pesticides Informati on 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,” wh ich 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 R egistration 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 A gency will consider all comments as well as any additional information or data provid ed 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, regardl ess of race, color, national origin, or income, in the development, implementatio n, and enforcement of environmental laws, regulations, and policies. To hel p 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 pr actices, 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 c ause of impairment for any water bodies listed as impaired under sect ion 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 Impai red Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrr d1/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 resolu tion. Growers and other stakeholders are asked to comment on any trade irritant issues re sulting from lack of Maximum Residue Limits (MRL’s) or disparities between Unit ed States tolerances and MRL’s in key export markets, providing as much specif icity as possible regarding the nature of the concern. In the case of Gliocladium spp. (Case 6020), there are currently no established residue tolerances. Additi onally, 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 s pecifically asked to prov ide information and data that will assist the Agency in refini ng the risk assessments, including any species-specific ecological effects dete rminations. The Agency is interested in obtaining the following information regarding the use of Gliocladium spp :
1. Confirmation on the fo llowing 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 potenti al use distribution

3. Use history

4. Usage/use information for nona gricultural 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 cl oses, 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 Verder a 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, wh ich is the Office of Pesticide Programs’ the Pestic ide Product Label System (PPLS) website.

-23-

### B. Description of Active Ingredient

The Gliocladium spp . are saprophytic, naturally-o ccurring soil fungi that are widespread in the environment. Both Gliocladium virens G-21 and Gliocladium catenulatum strain J1446 are used to control “dampi ng-off,” seed rot, ro ot and stem rot, wilt, and certain foliar diseases on gr eenhouse or field-grown food crops and ornamentals. In addition, Gliocladium catenulatum strain J1446 is registered for use on turf. Damping-off is destruction “of seedlin gs by one or a combination of pathogens that weaken the stem or root” (h ttp://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 in corporation or as an aqueous solution.



### C. Use Information

Gliocladium virens G-21

Product Name and % Active Ingredient: WRC-AP-1, 12% active ingredient (1x10 6 CFU/g)

EPA Reg. No.: 70051-3

Commercial : ornamental and food crop plants grown in greenhouses, nurseries, homes, and interiorscapes and out doors on agricultural and ornamental crops Use Sites:

Residential : ornamental and vegetable plants grown indoors and outdoors in home gardens

A pplication 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 Biofung icide Powder, 37% active ingredient (1x10 8 CFU/g) EPA Reg. No.: 64137-8

Use Sites: turf; forest seedlings; greenhouse or field grown vegetables and herbs; greenhouse or field grown ornamentals

A pplication Methods: soil incorporation, either as a dry powder or by aqueous solution (drenching, fo liar or field spray)

-24-Product Name and % Active Ingredient: Prestop® Biofungicide Powder, 32% active ingredient (1x10 8 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

A pplication Methods: soil incorporation, either as a dry powder or by aqueous solution (drenching, fo liar 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) satisf y the current data requirements for microbial pesticide product analysis (40 CFR 158.2120). Such data and information included morphological, nutritional, serologi cal, 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 requi rements. There is one data gap: stability to normal and elevated temperatures, metals and meta l 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 curr ent data requirement s—three data gaps were identified: acute oral toxicity; ac ute inhalation toxicity ; and primary dermal irritation. Regarding acute toxici ty, 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 th at 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, te st note 5 of the 40 CFR 158.2140 data table states that for dermal irritati on, a waiver “may be granted when the applicant can demonstrate that the combination of iner t ingredients is not likely to pose any significant human health risks. ” EPA anticipates needing these data from these three studies for Regi stration 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 Powd er (EPA Reg. No. 64137-11) satisfy the current data requirem ents 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 gardener s. 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, thei r use is not expected to result in any dietary exposure to the organi sm. First, fungi such as the Gliocladium spp . are ubiquitous in the agricultural environment. EPA anticipates that concentrations of this pesticide ma y be elevated immediately after application but will rapidl y 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 W RC-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 ex posure 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 toleranc e exemptions for the Gliocladium spp :

 40 CFR 180.1100 Gliocl adium 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 wit h good agricultural practices.

 180.1198 Gliocladium cat enulatum strain J1446 . An exemption from the requirement of a toleranc e 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 Environm ental Fate data (requirements are listed at 40 CFR 158.2150) submitt ed to support the registration of Gliocladium virens G-21 (EPA Reg. No. 70051-3) satisfy the current data requirements. No additional Nontarget Organism s and Environmental Fate data are expected to be needed for Gliocladium virens G-21(at this time) for th is 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® Biofungi cide Powder (64137-11) do not fully support the current data r equirements—EPA indentified three data gaps: avian inhalation toxicity/pathogenicit y; wild mammal toxicity/pathogenicity; and estuarine/marine fish testing & est uarine and marine invertebrate testing. Avian inhalation testing is “required w hen the nature of the microbial pesticide and/or its toxins indicates potential pat hogenicity 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 ma mmals (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 conc entrations because of expected use or mobility pattern” (40 CFR 158.2150; test not e 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 to xicity to nontarget species including birds, freshwater fish, and plants and inse cts 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 WR C-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. Un published study prepared by W.R. Grace & Co. 59 p. July 6, 1988. MRID 407198-01.

407198-02 Walter, J. 1988b. WRC-GL-21 Product Chem istry: Analysis of Samples and Certification of Ingredient Limits. Unpublished study prep ared 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/P athogenicity 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 To xicity/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 Toxi city/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 C hemistry: Identity, Manufacturing Process, and Discussion of Unintentional Ingredients. Un published study prepared by W.R. Grace & Co. 17 p. July 6, 1988. MRID 407198-07.

407198-08 Walter, J. 1988e. WRC-AP-1 Product Chem istry: Analysis of Samples and Certification of Ingredient Limits. Unpublished study prep ared by W.R. Grace & Co . 15 p. July 6, 1988. MRID 407198-08.
407198-09 Walter, J. 1988f. Physical and Chemic al 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 Performa nce 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. Transmi ttal of 2 studies. October 18, 1988. MRID 408640-00.

408640-01 David, R. 1988c. Acute Intravenous To xicity/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 Toxi city/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 Ne mours & 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 Physic al and Chemical Charac teristics: 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 to xicity data in support of the registration for WRC-AP-1 (Gliocladium virens). Transmitta l 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. Unpublis hed 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. Trans mittal 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. Unpublishe d 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 Nontar get Plant Data: Lab Project Number: 4695-GL21- NT. Unpublished study prepared by Grace Biopesticides. 164 p. November 13, 1995. MRID 438460-01.
438460-02 Walter, J. 1995b. WRC-AP-1 Nontarget Insect Data: Lab Project Number: 4695-GL21- NTI. Unpublished study prepared by Grace Bi opesticides. 20 p. November 13, 1995. MRID 438460-02.

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 Pr otection Agency Office of Pesticide Programs. August 16, 1988.

-30-U.S. EPA. 1989a. Memorandum from William J. Hazel to Larry Schnaubelt. Glioclad ium 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.

U.S. EPA. 1989b. Memorandum from Roy F. Sjoblad to Larry Schnaubelt. SACB Review of Data to Support Registration of the New Microbial Pest Control A gent Gliocladium virens [PP#8F3659/Reg. Nos. 11688-G and -U; W.R. Grace & Co.; (MRID Nos. 407198-01, -02, - 03, -04, -05, -06, 07, -08, -09); HED Project No. 9-0610; Caswell No. 467B.]. U.S. Environmental Protection Agency O ffice of Pesticide Programs. January 19, 1989.

U.S. EPA. 1990a. Memorandum from J. Thomas McClinto ck to Susan Lewis/Carl Grable. SACB Review of Data Submitted by W. R. Grace to Suppo rt the Registration of Gliocladium virens (I.D. No. 11688 -U and -G; 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 Lew is. SAB Review of Data Submitted by W.R. Grace and Co mpany 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 O ffice of Pesticide Programs. August 16, 1994.
U.S. EPA. 1994b. Review by Robert W. Pilsucki. EFED Biotechnology Review Glioclad ium 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 Robe rt 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.

U.S. EPA. 1996. Review from Gail Tomimatsu to Denise Greenway. EPA, OPP, BPPD Microbial Pesticide Review: 129000 Gliocladium virens G-21. U.S. En vironmental Protection Agency Office of Pesticide Programs. June 19, 1996.

Other Information

Grace. 1990. Letter from Jow-Lih Su, Ph.D., W.R. Grace & Co.-Conn. to Susan Lewis, U.S. Environmental 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.

U.S. EPA. 1990b. Pesticide Fact Sheet. Gliocladium Vi rens GL-21. U.S. Envir onmental Protection Agency. Office of Pesticide Programs. Fact Sheet Number : 217. November 1990. 540/FS-91-118. PB91- 110528.

U.S. EPA. 2000. Gliocladium virens GL-21 (129000) Fact Sheet. U.S. Environmental Protection Agency Biopesticides and Pollution Prevention Division. April 2000. www.epa.gov/pesticides/biopesticides/ingr edients/factsheets/factsheet_129000.htm.

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### BIBLIOGRAPHY: Gliocladium catenulatum strain J1446

Studies
441893-00 Kemira Agro Oy. 1996b. Submission Produ ct Chemistry, Toxicity, Hazard to Non-Target Organisms and Environmental Fate Data in S upport of the Application for Registration of PRIMASTOP Biofungicide (Gliocladium catenulatum Strain J1446). Transmittal of 22 Studies. December 16, 1996. MRID 441893-00.

441893-01 Mohammadi, O. 1996a. Product Identific ation and Disclosure of Ingredients Gliocladium catenulatum Strain J1446. Unpublished study prepared by Kemira Agro Oy. 14 p. December 16, 1996. MRID 441893-01.

441893-02 Gams, W. 1996. Independent Third Part y Identification of Gliocladium catenulatum Strain J1446: Lab Project Number: DET 225. 1996. Unpublished study prepared by Centraal bureau Voor Schimmel cultures (C BS), Institute of the Royal Netherlands Academy of Arts and Science. 6 p. December 16, 1996. MRID 441893-02.

441893-03 Yli-Mattila, T. 1996. I dentification of J1446 Strain by RAPD-PCR Analysis. Unpublished study prepared by University of Turku. 23 p. December 16, 1996. MRID 441893-03.

441893-04 Tuominen, U. 1996a. Gliocladium catenul atum Strain J1446: Description of Beginning Materials and Manufacturing Process. Unpublis hed study prepared by Kemira Agro Oy. 50 p. December 16, 1996. MRID 441893-04.

441893-05 Mohammadi, O., Lahdenpera, M., Tuominen, U. 1996. Gliocladium catenulatum Strain J1446 Biofungicide: Discussion of the Form ation of Impurities. Unpublished study prepared by Kemira Agro Oy. 65 p. December 16, 1996. MRID 441893-05.

441893-06 Tuominen, U. 1996b. Preliminary Anal ysis, Certification of Ingredient Limits, and Analytical Methods: Gliocladium catenulatum Strain J1446. Unpublished study prepared by Kemira Agro Oy. 13 p. December 16, 1996. MRID 441893-06.

441893-07 Jacobs, R., Markley, B. 1996a. 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 pr epared by Wildlife International Ltd. 22 p. December 16, 1996. MRID 441893-07.
441893-08 Jacobs, R., Markley, B. 1996b. Product Chemistry Testing of Gliocladium Biofungicide Powder: Color, Physical State, Odor, Bu lk Density and pH: Lab Project Number: 293C102. Unpublished study prepared by Wildlife In ternational Ltd. 22 p. December 16, 1996. MRID 441893-08.

441893-09 Jacobs, R., Markley, B. 1996c. Produc t Chemistry Testing of Gliocladium Biofungicide Powder: Corrosion Characteristics: Lab Pr oject Number: 293C-103. Unpublished study prepared by Wildlife International Ltd. 16 p. December 16, 1996. MRID 441893-09.

441893-10 McRae, L. 1996a. Acute Oral Toxici ty 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. December 16, 1996. MRID 441893- 10.
441893-11 Wilson, J. 1995a. Gliocladium (J1446) Pr eparation: Acute Oral Toxicity (Limit) Test in Rats: Lab Project Number: 556576: 10919. Unpublished study prepared by Inveresk Research International. 27 p. December 16, 1996. MRID 441893-11.

-32-441893-12 Wilson, J. 1995b. Gliocladium (J1446) Preparation: Acute Dermal Irritation Test in Rabbits: Lab Project Number: 556576: 10921. Unpublished study prepared by Inveresk Research International. 25 p. December 16, 1996. MRID 441893-12.
441893-13 McRae, L. 1996b. 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. December 16, 1996. MRID 441893- 13.
441893-14 Kieran, P. 1995. Gliocladium (J1446) Pr eparation: Acute Inhalation Toxicity (Limit) Test in Rats: Lab Project Number: 654570: 10916. Unpublished study prepared by Inveresk Research International. 40 p. December 16, 1996. MRID 441893-14.

441893-15 McRae, L. 1996c. Acute Intra-Pe ritoneal 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. December 16, 1996. MRID 441893-15.

441893-16 Wilson, J. 1995c. Gliocladium (J1446) Pr eparation: Acute Eye Irritation Test in Rabbits: Lab Project Number: 556576: 10922. Unpublished study prepared by Inveresk Research International. 27 p. December 16, 1996. MRID 441893-16.

441893-17 Wilson, J. 1995d. Gliocladium (J1446) Pr eparation: Buehler Sensitisation Test in Guinea Pigs: Lab Project Number: 556576: 10923. Unpublished study prepared by Inveresk Research International. 33 p. December 16, 1996. MRID 441893-17.
441893-18 Mohammadi, O. 1996b. Gliocladium catenulatum Strain J1446 Biofungicide Hypersensitivity Incident Reporting. Unpublished study prepared by Kemira Agro Oy. 4 p. December 16, 1996. MRID 441893-18.

441893-19 Mohammadi, O. 1996c. Gliocladium catenulatum Strain J1446—Literature Search, Avian and Aquatic. Unpublished study prepared by Kemira Agro Oy. 11 p. December 16, 1996. MRID 441893-19.

441893-20 Mohammadi, O. 1996d. Gliocladium cat enulatum—Literature Search , Nontarget Plants. Unpublished study prepared by Kemira Agro Oy. 23 p. December 16, 1996. MRID 441893-20.

441893-21 Mohammadi, O. 1996e. Gliocladium catenul atum—Literature Search, Nontarget Insects. Unpublished study prepared by Kemira Agro Oy. 6 p. December 16, 1996. MRID 441893-21.
441893-22 Tuominen, U. 1996c. Storage Stability: Gliocladium catenulatum Strain J1446. Unpublished study prepared by Kemira Agro Oy. 4 p. December 16, 1996. MRID 441893-22.
442232-00 Kemira Agro Oy. 1996e. Submission of To xicity Data in Support of the Application for Registration of Primastop Fungicide and Tolerance Petition for Gliocladium catenulatum Strain J1446 on All RACs. Transmittal of 1 Study. December 16, 1996. MRID 442232- 00.
442232-01 Wilson, J. 1995e. Gliocladium (J1446) Pr eparation: Acute Dermal Toxicity (Limit) Test in Rabbits: Lab Project Number: 10920: 556576: IRI 556576. Unpublished study prepared by Inveresk Research International. 26 p. December 16, 1996. MRID 442232-01.

444928-00 Kemira Agro Oy 1998a. Submission of To xicity Data in Support of the Application for Registration of Primastop. Transmittal of 2 Studies. February 19, 1998. MRID 444928- 00.

-33--34- 444928-01 Edgar, F. 1997a. Response to Questions Raised by EPA Regarding MRID Number 441893-12 Entitled Gliocladium (J1446) Preparation: Acute Dermal Irritation Test in Rabbits: Lab Project Number: 556576. Unpublished study prepared by Inveresk Research. 3 p. February 19, 1998. MRID 444928-01.

444928-02 Edgar, F. 1997b. Response to Questions Raised by EPA Regarding MRID Number 441893-16 Entitled Gliocladium (J1446) Preparation: Acute Eye Irritation Test in Rabbits: Lab Project Number: 556576. Unpublished study pr epared by Inveresk Research. 3 p. February 19, 1998. MRID 444928-02.
444995-00 Kemira Agro Oy 1998b. Submission of To xicity Data in Support of the Application for Registration of Primastop. Transmittal of 1 St udy. February 27, 1998. MRID 444995-00.

444995-01 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: Lab Project Number: RKY 136: RKY 136/961807/AC. Unpublished study prepared by Huntingdon Life Sciences Ltd. 16 p. February 27, 1998. MRID 444995-01.
445014-00 Kemira Agro Oy 1998c. Submission of To xicity Data in Support of the Application for Registration of Primastop. Transmittal of 7 Studies. March 4, 1998. MRID 445014-00.

445014-01 Foster, J., Grimes, J., Beavers, J. 1997. Gliocladium catenulatum Cell Mass: An Avian Oral Pathogenicity and Toxicity Study in the Northern Bobwhite: Lab Project Number: 293-109. Unpublished study prepared by Wildlife In ternational Ltd. 42 p. March 4, 1998. MRID 445014-01.
445014-02 Palmer, S., Krueger, H. 1998a. 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. March 4, 1998. MRID 445014-02.
445014-03 Palmer, S., Krueger, H. 1998b. 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. March 4, 1998. MRID 445014-03.
445014-04 Hoxter, K., Palmer, S., Krueger, H. 1998a. 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. March 4, 1998. MRID 445014-04.

445014-05 Hoxter, K., Palmer, S., Beavers, J. 1998b. Gliocladium catenulatum Cell Mass (Technical Product): A Dietary Pathogenici ty and Toxicity Study with Parasitic Hymenoptera (Nasonia vitripennis): Lab Project Number: 293-112. Unpublished study prepared by Wildlife International Ltd. 24 p. March 4, 1998. MRID 445014-05.
445014-06 Hoxter, K., Palmer, S., Krueger, H. 1998c. Gliocladium catenulatum Cell Mass (Technical Product): A Dietary Pathogenicity and Toxicity Study with the Ladybird Beetle (Hippodamia convergens): Lab Project Numb er: 293-111. Unpublished study prepared by Wildlife International Ltd. 25 p. March 4, 1998. MRID 445014-06.
445014-07 Hoxter, K., Palmer, S., Krueger, H. 1998d. 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. March 4, 1998. MRID 445014-07.-35- 466641-01 Seiskari, P. 2005. Product Chemis try Data of Prestop. Project Number: D/PRESTOP/SUPPLEMENT. Unpublished stud y prepared by Verdera Oy. 33 p. October 12, 2005. MRID 466641-01.

466641-00 Verdera Oy. 2005. Submission of Product Chemistry Data in Support of the Application for Registration of Prestop. Transmittal of 1 Study. October 12, 2005. MRID 466641-00.

EPA Reviews

U.S. EPA. 1998a. Memorandum from Jo hn L. Kough to Susanne Cerrelli. Review of Additional Data Provided for the Intra-Peritoneal Toxicity/Pathogenicity Test for Gliocladium catenulatum (strain J1446) from Kemira Agro Oy. U.S. Environmental Protection Ag ency Office of Pesticide Programs. April 21, 1998.

U.S. EPA. 1998b. Memorandum from Michael Watson to Susanne Cerrelli. BPPD Revi ew of Product Chemistry and Toxicity/Pathogenicity Data Submitted by Kemira Ag ro 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 O ffice of Pesticide Programs. April 21, 1998.

U.S. EPA. 2001. Memorandum from Robyn Rose to Susa nne Cerrelli. Technical re view 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 catenul atum Cell Mass (Technica l Product) for outdoor uses. Barcode Nos.: D244243 & D267225; Submission Nos.: S539189 & S580869; Chemical No.: 021009. U.S. Environmental Protection Agency Offi ce of Pesticide Programs. August 21, 2001.
U.S. EPA. 2005a. Memorandum from John L. Kough to Susan Cerrelli. Review of Manufacturing Process and Storage Stability for Prestop® a biological fungicide based on Gliocladium Cantenulatum Strain J1446 from Verdera Oy. U.S. Environmental Protection Agenc y Office of Pesticide Programs. September 9, 2005.
U.S. EPA. 2005b. Memorandum from John Kough to Susanne Cerrelli. Review of Modifications to Manufacturing Process for Prestop® a Biological Fungicide Based on Gliocladium Cantenulatum Strain J1446 From Verdera Oy. U.S. Environmental Protection Agency Office of Pesticide Programs. November 11, 2005.

Other Information
Butts. 1996. Letter from Edgar R. Butts, Regulatory Consultant and Agent fo r Kemira Agro Oy to Willie Nelson, U.S. Environmental Protection Agency. Applicat ion for Registration of PRIMASTOP Biofungicide Containing the New Active Ingredient - Gliocladium catenulatum Strain J1446. December 4, 1996.
Butts. 1998. Letter from Edgar R. Butts, Regulatory Consultant to Susanne Cerrelli, U.S. Environmental Protection Agency. PRIMASTOPTM - Gliocladium catenulatum - EPA File Symbol 64137-1. Response to Questions Raised by EPA. February 18, 1998.

U.S. EPA. 1998d. Registration Eligibility Decision: Gliocladium catenulatum stra in J1446 (PC Code 021009). U.S. Environmental Protection Agency Office of Pesticide Programs. June 22, 1998.

U.S. EPA 1998e. Pesticide Fact Sheet. Gliocladium cate nulatum strain J1446. U.S. Environmental Protection Agency Office of Office of Prevention, Pesticides and Toxic Substances . June 1998. EPA 730-F-98-017.
U.S. EPA. 2002a. Biopesticides Registration Action Do cument. Gliocladium catenul atum strain J1446 (PC Code 021009). U.S. Environmental Protection Agency Offi ce of Pesticide Programs. November 12, 2002. http://www.epa.gov/pesticides/biopesticides/ingredients/tech_docs/brad_021009.pdf.

U.S. EPA 2002b. Fact Sheet. Gliocladium catenulatum st rain J1446 (021009). U.S. Environmental Protection Agency Office of Pesticide Programs. February 2002. http://www.epa.gov/pesticides/biopesticides/ ingredients/factsheets/factsheet_021009.htm