## Coniothyrium minitans strain CON/M/91-08

(PC Code: 028836)

Preliminary Work Plan and Summary Document

Registration Review: Initial Docket

June 2013

Case 6022

Approved by:

Keith A. Matthews, Director Biopesticides and

Pollution Prevention Division

Date:Coniothyrium minitans strain CON/M/91

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2 

### T

ABLE 

### O F 

### C ONTENTS

I. PRELIMINARY WORK PLAN

................................ ................................ ................................ ...... 4

A. Overview

................................ ................................ ................................ ................................ ................................ .. 4

B. Statutory and Regulatory Authority

................................ ................................ ................................ ..................... 4

C. Background and Regulatory Information

................................ ................................ ................................ ............ 5

D. Anticipated Data Needs and Risk Assessments

................................ ................................ ................................ .... 7

E. Risk to Threatened and Endangered Species

................................ ................................ ................................ ..... 10

F. End ocrine Effects

................................ ................................ ................................ ................................ .................. 10

G. Incidents

................................ ................................ ................................ ................................ ................................ 11

H. Summary of Anticipated Data Needs

................................ ................................ ................................ .................. 12

I. Timeline

................................ ................................ ................................ ................................ ................................ . 13

J. Guidance for Commenters

................................ ................................ ................................ ................................ ... 13

K. Next Steps

................................ ................................ ................................ ................................ .............................. 15

II. FACT S UMMARY FOR CASE 6 022

................................ ................................ ............................ 15

III. BIBLIOGRAPHY

................................ ................................ ................................ ........................... 16

A. Studies Supporting Regis tration Review of Coniothyrium minitans strain CON/M/91

- 08

............................. 16

B

. U.S. Environmental Protection Agency Risk Assessment Memoranda

................................ ........................... 17

C

. Other References

................................ ................................ ................................ ................................ .................. 17Coniothyrium minitans strain CON/M/91

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3 

### ACRONYMS AND ABBREVIATIONS

BPPD The EPA’s Biopesticides and Pollution Prevention Division

C

. F

. R

. Code of Federal Regulations

DCI Data call

- in

EDSP Endocrine Disruptor Screening Program

EPA U.S. Environmental Protection Agency

FFDCA Fed eral Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

FWP Final Work Plan

IDS Incident Data System

MRID No. Master Record Identification Number : The EPA's s ystem of recording and tracking studies submitted to the Office of Pesticide Programs.

MRL Maximum R esidue Limit

OPP The EPA’s Office of Pesticide Programs

PC Code Pesti cide chemical c ode: a six

- digit number assigned by OPP to identify pesticide chemi cals.

PMRA Health Canada’s Pest Management Regulatory Agency

PWP Preliminary Work Plan

TGAI Technical grade of the active ingredient

TMDL Total Maximum Daily Load

U.S. United StatesConiothyrium minitans strain CON/M/91

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4 I. PRELIMINARY WORK PLAN

A. Overview

The docket for Coniothyrium minitans strain CON/M/91

- 08 (case 6022 ) is now open, initiating the first public comment period for this R egistration R eview case ( docket number EPA

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- 0259 ). Coniothyrium minitans strain CON/M/91

- 08 is registered for applications to soil in agricultural fields, greenhouses, and nurseries to control the common plant pathogens, Sclerotinia sclerotiorum and

Sclerotinia minor , that cause white mold, pink rot , and water soft rot on certain crops (e.g., bulb and leafy vegeta bles). This Preliminary Work Plan (PWP) document explains what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs knows about Coniothyrium minitans strain

CON/M/91

- 08 , highlighting anticipated data and assessment needs, identifyi ng types of information that would be especially useful to the EPA in conducting the review, and providing an anticipated timeline for completing review of Coniothyrium minitans strain CON/M/91

- 08

.

The R egistration R eview process was designed to include a public participation component to solicit input from interested stakeholders. The EPA intends, by sharing this information in the docket, to inform the public of what it knows about Coniothyrium minitans strain CON/M/91

- 08 and what types of new

data or ot her information would be helpful for the EPA to receive as it moves toward a decision on Coniothyrium minitans strain CON/M/91

- 08

. The EPA encourages all interested stakeholders to review the PWP and to provide comments and additional information that will help the EPA ’s d ecision

- making process for this microbial pesticide . In addition to general areas on which persons may wish to comment,

there are some areas identified in the PWP about which the EPA specifically seeks comments and

information. Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The PWP begins by discussing the statutory and regulatory authority for Registration Review. Next, it provides background on Coniothyrium minitans strain CON/M/91

- 08 , which includes a description of its mode of action, current ly registered pesticide product

, appli cation rates and methods, use sites, and tolerance exemption information. Then, it lists the anticipated data needs and risk assessments and a projected Registration Review timeline for Coniothyrium minitans strain CON/M/91

- 08 . Finally, the

PWP describes g uidance for commenters , explains the next steps EPA will be taking for this Registration Review, summarizes background information for this Registration Review, and lists supporting studies, risk assessment memoranda, and other documents.

Further inform ation about this case, including background and supporting documents, is available at http://www.regulations.gov (u nder “ SEARCH for: Rules, Comments, Adjudications or Supporting
Documents, ” enter the docket identifi cation number, w hich is indicated above)

.

B

. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review program

. All pesticides distributed or sold in the United States (U.S.) must generally be registered by the EPA , 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

intend ed 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 to humanConiothyrium minitans strain CON/M/91

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5 health or the environment . Changes in science, p ublic policy, and pesticide use practices will occur over time. Through the Registration Review program, the EPA periodically reevaluates pesticides to make

sure that

, as change occurs, products in the marketplace can continue to be used safely. Informatio n on this program is provided on the EPA’s website

. 1

The EPA is implementing 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 regulations governing Registration Review begin at 40 C.F.R. § 155.40. The EPA will consider benefits information and data as required by FIFRA. The public phase of Registrati on Review begins when the initial docket is opened

for each case. The docket is the EPA ’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 initial comment period, the EPA wil l develop a F inal W ork P lan (FWP) and anticipated schedule for the Registration Review of Coniothyrium minitans strain CON/M /91

- 08

.

C

. Background and Regulatory Information

i. Summary of the Active Ingredient and the Associated Pesticide Product 2

Coniothyrium minitans strain CON/M/91

- 08 is a naturally occurring soil microorganism and mycoparasite 3 of the sclerotia of Ascomyco tina and Deuteromycotina (e.g., the common plant pathogens, Sclerotinia sclerotiorum and Sclerotinia min or ). Spores of Coniothyrium minitans strain

CON/M/91

- 08 germinate in the presence of a host and enter that host through small pores o r lacerations

to pe netrate into the subcortex an d medulla. Sclerotial walls consist mainly of glucans and chitin , and Coniothyrium minitans strain CON/M/91

- 08 secretes β

- 1,3

- glucanase to degrade the se walls

. Once

inside sclerotial cell s , the infection progresses and asexual fruiting bodies (pycnidia)

, containing large amounts of conidiospores

, are produced from the metabolized substrates inside the parasitized sclerotia. The cytoplasm of the parasitized cells exhibit plasmolysis, aggregation and vacuolation, often leading to lysis of the hyphae.

On March 16, 200 1, the EPA registered the first and only pesticide product (Contans ® WG) containing Coniothyrium minitans strain CON/M/91

- 08 for use to reduce/control Sclerotinia sclerotiorum and

Sclerotinia minor in agricultural soil

. When Contans ® WG was registered, the uses were limited to preplant and postharvest applications that w ere made by conventional ground equipment and that were incorporated into the upper layer o f agricultural soil. I n December 2002, the labeled uses of Co ntans ®
WG began to expand (e.g., to at planting and greenhouse applications that were still incorporated in to
the upper layer of soil) through an EPA

- approved label amendment. Subsequently, the EPA approved

several additional label amendments that now allo w Contans ® WG to be broadly applied through different methods (i.e., ground equipment, aerial equipment, and sprinkler chemigation) at varying times ( i.e., prior to planting, at planting, just after planting, at transplant, and postharvest) to agricultural

, greenhouse, and nursery soil where plants susceptible to Sclerotinia sclerotiorum and Sclerotinia minor will be/are being grown. Currently, Contans ® WG is still registered, and the registrant of this end

- use pesticide product is PROPHYTA Biologischer Pfl anzenschutz GmbH (see Table 1).

1 See http://www.epa.gov/oppsrrd1/registration_review/

. 2 Technical information in this section extracted from U.S. EPA (2000a), U.S. EPA (2001), and/or PMRA (2008).

3 A parasitic fungus whose host is another fungus.Coniothyrium minitans strain CON/M/91

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6 TABLE 1. Summary of the Currently Registered Coniothyrium minitans strain CON/M/91

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EPA Registration

Number Product Name (% Active Ingredient

,

Formulation Type ) Date Registered Application Rate s App lication Methods Use Sites

72444

- 1 Contans ® WG (5.30 % , Water Dispersible Granule ) March 16, 2001 1

– 6 lb product/acre (field & chemigation applications) Chemigation (Sprinkler)

and Conventional

Ground or Aerial Application Equipment Agricultural, greenhous e, and nursery soil where plants susceptible to

Sclerotinia

sclerotiorum and

Sclerotinia minor will be/are being

grown 0.75

– 1.5 oz product/1,000 ft 2
(greenhouse & nursery applications) Conventional Ground Application Equipment

ii

. Tolerance Actions

Given that many of the uses associated with the registered Coniothyrium minitans strain CON/M/91

- 08 pesticide product involve treating agricultural, greenhouse, and nursery soil where plants susceptible to

Sclerotinia sclerotiorum and Sclerotinia minor ( e.g., certain food or feed crops ) will be/are being

grown

— meaning that pesticide residues could be found in or on such food or feed

— PROPHYTA Biologischer Pflanzenschutz GmbH petitioned the EPA to establish a tolerance exemption for Coniothyrium minitans s train CON/M/91

- 08 . In light of available toxicity /pathogenicity and exposure data, the EPA concluded that there was a reasonable certainty that no harm w ould result to the U.S. population, including infants and children, from aggregate exposure to residues of Coniothyrium

minitans strain CON/M/91

- 08 . Therefore, the EPA established a tolerance exemption for resi dues of this active ingredient

. Since this tolerance exemption took effect after FQPA amended FIFRA in 1996, it did not require reassessment. The cur rent tolerance exemption expression for Coniothyrium minitans strain

CON/M/91

- 08 is as follows:

40 C.F.R. § 180. 1213 ( Coniothyrium minitans strain CON/M/91

- 08 )

An exemption from the requirement of a tolerance is established for residues of the microbial pesticide Coniothyrium minitans strain CON/M/91

- 08 when used in or on all food commodities.

Federal Register Citations

– Notice of Filing ( 65 FR 3696, January 24, 2000 ) and Final R ule ( 66 FR 16871, March 28, 2001 )Coniothyrium minitans strain CON/M/91

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7 D

. Anticipated Data Needs and Risk Assessment s

Provided below are tables of the current data requirements for micr o bial pesticides as set f orth in 40 C.F.R. part 158, subpart V . They are arrayed by scientific discipline (i.e., product analysis

, toxicology

, and nontarget organisms and environmental fate) and descri ptions are included regarding how the data requirements have been fulfilled or w here data gaps (anticipated data needs) have been identified.

P resently

, Coniothyrium minitans strain CON/M/91

- 08 has product analysis and n ontarget organism data

gap s. Data gaps have been identifi ed for studies that were not submitted (indicated with a “No

– Data Gap” designation in Table s 3 and 5 ) or for information provided that, in large part, claims lack of exposure to nontarget organisms based on limited uses (indicated wit h a “No

– Data Gap” designation, along with a footnote explanation, in Table 5). For a succinct summary of data gaps, please see Table 6.

i. Product Analysis ( 40 C.F.R. § 158.2 120 )

TABL E 2

. Summary of Product Analysis Data for Coniothyrium minitans strain CON/M/91

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Harmonized

G uideline

Number Data Requirement Has Data Requirement Been

Addressed? How? Source MRID No.

885.1100 Product Identity Not applicable to the TGAI test substanc e.

885.1200 Manufacturing Process Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

450887

- 00

885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

885.1300 Discussion of Formation of Unintentional Ingredients Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

450887

- 00

885.1400 Analysis of Samples Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

450887

- 01

885.1500 Certification of Limits Not applicable to the TGAI test substance.Coniothyrium minitans strain CON/M/91

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8 TABLE 3

. Summary of Physical and Chemical Characteristics for Coniothyrium minitans strain CON/M/91

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Harmonized

Guideline

Number Data Requirement Has Data Requirement Been

Addressed? How? Source MRID No.

830.6302 Color Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

830.6303 Physical State Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a )

U.S. EPA (2001) 448687

- 01

830.6304 Odor Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

830.6313 Stability to Normal and Elevated Temperatures, Metals and Metal Ions No

– Data Gap Not applicable

830.6317 Storage Stability Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

830.6319 Miscibility Not applicable to the TGAI test substance.

830.6320 Corrosion Characteristics Not applicable to the TGAI test substance.

830.7000 pH Yes

– Study U.S. EPA (Undate d(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

830.7100 Viscosity Not applicable to the TGAI test substance.

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) Yes

– Study U.S. EPA (Undated(a)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 01

ii. Toxicology ( 40 C.F.R. § 158. 2140 )

TABLE 4

. Summary of Toxicology Data for Coniothyrium minitans strain C ON/M/91

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Harmonized

Guideline

Number Data Requirement Has Data Requirement Been

Addressed? How? Source MRID No. or Other Reference

885.3050 Acute Oral Toxicity/Pathogenicity Yes

– Study U.S. EPA (Undated(b )) U.S. EPA (Undated(c)) U.S. EPA (2000 a )

U.S. EPA (2001) 448687

- 02

449569

- 01

449569

- 02

450887

- 00

885.3150 Acute Pulmonary Toxicity/Pathogenicity Yes

– Study U.S. EPA (Undated(b)) U.S. EPA (Undated( d )) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 04

449569

- 01

449569

- 02

450887

- 00Coniothyrium minitans strain CON/M/91

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9 TABLE 4

. Summary of Toxicology Data for Coniothyrium minitans strain C ON/M/91

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Harmonized

Guideline

Number Data Requirement Has Data Requirement Been

Addressed? How? Source MRID No. or Other Reference

885.3200 Acute Injection Toxicity/Pathogenicity (Intravenous or Intraperitoneal) Yes

– Study U.S. EPA (Undated(b)) U.S. EPA (Undated(e)) U.S. EPA (2000 a ) U.S. EPA (2001) 448687

- 0 5

449569

- 01

449569

- 02

450887

- 00 Roberts (2000)

885.3400 Hypersensitivity Incidents No hypersensitivit y incidents

— occurring during testing, production, or use

of Coniothyrium minitans strain CON/M/91

- 08

— were reported by the registrant . Any future hypersensitivity incidents must be reported to the

EPA

. 1

885.3500 Cell Culture Not required 2

870.1100 Acute O ral Toxicity

Not applicable to the TGAI test substance. 870.1200 Acute Dermal Toxicity

870.1300 Acute Inhalation Toxicity

870.2400 Acute Eye Irritation

870.2500 Primary Dermal Irritation

1 Refer to test note #3 of 40 C.F.R. § 158.2140(d).

2 Coniot hyrium minitans strain CON/M/91

- 08 is not a virus. Refer to test note #4 of 40 C.F.R. § 158.2140(d).

iii. Nontarget Organisms and Environment Fate ( 40 C.F.R. § 158.2 150 )

TABLE 5

. Summary of No ntarget Organism Data for Coniothyrium minitans strain CON/M/91

- 08

Harmonized

Guideline

Number Data Requirement Has Data Requirement

Been Addressed? How? Source MRID No.

8 85.4050 Avian Oral Toxicity Yes

– Scientific Rationale U.S. EPA (2000b)

U.S. EPA (2001) 448687

- 00

885.4100 Avian Inhalation Toxicity/Pathogenicity Yes

– Scientific Rationale U.S. EPA (2000b) U.S. EPA (2001) 448687

- 00

885.4150 Wild Mammal Toxicity/Pathog enicity Not required 1

885.4200 Freshwater Fish Toxicity/Pathogenicity No

– Data Gap 2 U.S. EPA (2000b) U.S. EPA (2001) 448687

- 12

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity No

– Data Gap 2 U.S. EPA (2000b) U.S. EPA (2001) 448687

- 1 1

885.4280 Es tuarine/Marine Fish and Invertebrate Testing No

– Data Gap Not applicableConiothyrium minitans strain CON/M/91

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10 TABLE 5

. Summary of No ntarget Organism Data for Coniothyrium minitans strain CON/M/91

- 08

Harmonized

Guideline

Number Data Requirement Has Data Requirement

Been Addressed? How? Source MRID No.

885.4300 Nontarget Plant Testing No

– Data Gap 2 U.S. EPA (2000b) U.S. EPA (2001) 448687

- 00

885.4340 Nontarget Insect Testing No

– Data Gap 2 U.S. EPA (2000b) U.S. EPA (2001) 448687

- 00

885.4380 Honey Bee Testing No

– Data Gap 2 U.S. EPA (2000b) U.S. EPA (2001) 448687

- 00

1 The tests conducted with laboratory mammals (see Table 4) are adequate and appropriate for determining risks to wild mammals. Refer to test note #4 of 40 C.F.R. § 1 58.2150(e).

2 When Contans ® WG was first registered, its uses were limited to preplant and postharvest applications that were incorporated into the upper soil layer (see label dated March 16, 2001 in the Pesticide Product Label System ) . Much of the data/information provided to the EPA supported these limited uses, based upon, in large part, an assumption of lack of exposure to nontarget organisms. The most recent label (see label dated

November 22, 2010 in the Pesticide Product Label System ) allow s broader application methods (e.g., aerial applications done prior to planting, at planting, just after planting, at transplant, and postha rvest) that could possibly result in more exposure to nontarget organisms. Since the registrant has not updated the nontarget organism data/information provided with the initial registration of Contans ® WG and has expanded the labeled uses, this is conside red a data gap.

E

. Risk to Threatened and Endangered Species

The EPA has not prepared a risk assessment that supports a complete endangered species determination

for Coniothyrium minitans strain CON/M/91

- 08

. During Registration Review, the EPA plans on conducting an ecological risk assessment t o determine whether use of Coniothyrium minitans strain

CON/M/91

- 08 will have “no effect” or “may affect” federally listed threatened or endangered species (listed species) and/ or thei r designated critical habit at. When an assessment concludes that a pesticide’s use “may affect” a listed species and/ or its designated critical habitat, the EPA will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropria te.

F

. Endocrine Effects

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act ( FFDCA) section 408(p), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order 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 suc h endocrine effects as the Administrator may designate.”

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determinat ion is made that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance.

Between October 2009 and February 2010, the EPA issued test orders/data call

- ins for the first g roup of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Coniothyrium

minitans strain CON/M/91

- 08 is not among the group of 58 pesticide active ingredients on the initial list

to be screened under the EDSP.Coniothyrium minitans strain CON/M/91

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11 The EPA , as part of this Preliminary Work Plan , believes tha t Coniothyrium minitans strain CON/M/91

- 08 , the active ingredient involved in this Registratio n Review case, likely is a substance that would not produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. As such, pu rsuant to Section 408(p)(4), the EPA will determine in the future whether it can

exempt Coniothyrium minitans strain CON/M/91

- 08 from the requirements of the Section 408(p) EDSP.

In the event the EPA does determine to exempt this substance from the EDSP, an order will be issued.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our website at http://www.epa.gov/endo/

.

G

. Incidents

From January 1, 1992 through April 17, 2013, the Office of Pesticide Programs’ Incident Data System (IDS) indicates that there have been no reports of adverse human, domestic animal, or environmental incidents for the pesticide product containing Coniothyrium minitans strain CON/M/91

- 08. On June 17, 2013, t he EPA conducted a search of the Ecological Incident Information System database covering the

t ime period from J a n u a r y 1 9 6 0 t o M a y 2 0 1 3

, a n d f o u n d no reports of adverse field effects to nontarget plants and animals as a result of exposure to Coniothyrium minitans strain CON/M/91

- 08

. The EPA will

cons ider any incident data or comments submitted in response to this Preliminary Work Plan.Coniothyrium minitans strain CON/M/91

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12 H

. Summary of Anticipated Data Needs

Table 6 summarizes the anticipated data needs for Coniothyrium minitans strain CON/M/91

- 08

.

Table 6. Anticipated Data Needs for the Registration Review of Coniothyrium minitans strain CON/M/91

- 08

Harmonized Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from Receipt of DCI)

830.6313 Stability to Normal and Elevated Temperatures,

Metals and Metal Ions

TGAI 8 months

885.4200 Freshwater Fish Toxicity/Pathogenicity

12 months 885.4240 Freshwater Invertebrate Toxicity/Pathogenicity

885.4280 Estuarine/Marine Fish and Invertebrate Testing

885.4300 Nontarget Plant Testing TEP

8 85.4340 Nontarget Insect Testing

TGAI

885.4380 Honey Bee Testing

TGAI = technical grade of the active ingredient , TEP = typical end

- use productConiothyrium minitans strain CON/M/91

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13 I

. Timeline

The projected timeline for case 6022

— Coniothyrium minitans strain CON/M/91

- 08

— R egistration

Review follows.

Activities Estimated Month/Year

Opening the Docket Open Docket and 60

- Day Public Comment Period for Coniothyrium

minitans strain CON/M/91

- 08 June 201 3

Close Public Comment Period August 2013

Case Development

Issue Final Work Plan February 2014

Issue Data Call

- in February 201 5

Data Submission February 2016

Open 30

- Day Public Comment Period for Draft Risk Assessments August 201 7

Close Public Comment Period September 201 7

Registration Review Dec ision

Open 60

- Day Public Comment Period for Proposed Registration Review

Decision January 201 8

Close Public Comment Period March 201 8

Final Decision April 201 8

*Estimated Total (years)

~ 5

* This schedule is subject to revision should unfo reseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time. That Final Work Plan will identify any newly anticipated dat a needs and set forth a new timeline.

J

. Guidance for Commenters

The public is invited to comment on the EPA ’s Preliminary Work P lan and rationale. The areas below highlight topics of special interest to t he EPA where comments, data submissions, or reference to sources of additional information could be of particular use. The EPA will consider all comments

, as well as any additional information or data provided in a timely manner

, prior to issuing a Final W ork P lan for this

case.

i. Environmental Justice

The 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

enf orcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factor s, may have atypical, unusually high exposure to Coniothyrium minitans strain CON/M/91

- 08 , compared to the general population. Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general pop ulation.Coniothyrium minitans strain CON/M/91

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14 ii. Water Quality

Coniothyrium minitans strain CON/M/91

- 08 not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 4 In addition, no Total Ma ximum Daily Loads (TMDL s ) have been developed fo r Coniothyrium minitans strain CON/M/91

- 08

. 5 More

information on impaired water bodies and TMDL s c an be found at the EPA ’s website. 6 The EPA invites submission of water quality data for these pesticides. To t he 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 Assessm ent and Management Process 7 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

iii. Trade Irritants

Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to

the extent fe asible, take steps toward facilitating irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to commen t on any trade irritant issues resulting from lack of MRL s or disparities between U.S. tolerances and MRLs in key export markets

, providing as much specificity as possible regarding the nature of the concern.

Coniothyrium minitans strain CON/M/91

- 08 has a n exemption from the requirem ent of a tolerance

. Moreover, there are n o known MRLs for Coniothyrium minitans strain CON/M/91

- 08 . Therefore, the

EPA does not anticipate that current uses of Coniothyrium minitans strain CON/M/91

- 08 will pose

concerns as trad e irritants.

iv. Additional Information

Stakeholders are also specifically asked to provide information and data that will assist the EPA in refining the risk assessments

. The EPA is interested in obtaining the following information regarding Coniothyrium m initans strain CON/M/91

- 08 :

 Any data, information, and/or scientific rationale that could be used to fill data gaps

 Confirmation on the following label information:

- Sites of application

- Formulations

- Application methods and equipment

- Maximum a pplication rates

- Frequency of application, application intervals, and maximum number of applications

- Geographic limitations on use

 Use or potential use distribution (e.g., acreage and geographical distribution of relevant use sites)

4 Based on inform ation provided at http://www.epa.gov/owow/tmdl/

. 5 B ased on information provided at http://iaspub.epa.gov/tmdl_waters10/text_search.tm dl_search_form

. 6 See http://www.epa.gov/owow/tmdl/

. 7 This document can be found at http://www.epa.gov/oppsrrd1/registration_ review/water_quality_sop.htm

.Coniothyrium minitans strain CON/M/91

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15  Median and 90 th percentile reported use rates (lbs active ingredient/1,000 square feet) from usage data

– national, state, and county

 Application timing (date of first application and application intervals)

– national, state, and

county

 Usage/use information for nonagricultural use s

 Typical application interval (days)

 State or local use restrictions

 Monitoring data

K

. Next Steps

After the 60

- day comment period closes, the EPA will review and respond to any comments recei ved in a timely manner and then issue a F inal W ork P lan for case 6022 : Coniothyrium minitans strain

CON/M/91

- 08

.

II. FACT SUMMARY FOR CASE 60 22

TABLE 7

. Background Information for the Coniothyrium minitans strain CON/M/91

- 08 Registration Review

Fi rst Registered Currently Registered

Pesticide Products 1 Publicly Available EPA Science and Regulatory

Documents Additional Risk Assessment Needed? (Yes or No)

Product Analysis Human Health Ecological

2001 1 end

- use product (Contans ® WG) Biopesticides Registration

Action Document

BPPD Fact Sheet Yes 2 No Yes

1 See Table 1 for additional information (e.g., use sites) on t he currently registered product

. The label for this product can be found in the

Pestici de Product Label System

. 2 Only information on storage stability (under certain circumstances, e.g., normal and elevated temperatures) needs to be integrated into the

current risk assessment.Coniothyrium minitans strain CON/M/91

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16 II I

. BIBLIOGRAPHY

A. Studies Supporting Registr ation Review of Coniothyrium minitans strain

CON/M/91

- 08

MRID No. Study Description

448687

- 00 Prophyta Biologischer Pflanzenschutz GmbH. 1999. Submission of Product Chemistry, Toxicity, Environmental Fate, Risk Assessment and Exposure Data in Supp ort of the Application for Registration of Contans WG. Transmittal of 13

Studies.

448687

- 01 Roberts A. 1999

. Product Chemistry of Contans WG. Unpublished study prepared by Technology Sciences Group. 48 pages.

448687

- 02 Leuschner P. 1994. Acute Toxici ty Study of CON/M/91

- 08 by Oral Administration to Sprague

- Dawley Rats. Lab Project Number: 8659/94. Unpublished study prepared by LPT Laboratory of Pharmacology and Toxicology. 23 pages.

448687

- 04 Leuschner P. 1995. Acute Inhalation Toxicity Study of CON/M/91

- 08 in Sprague

Dawley Rats. Lab Project Number: 8887/94. Unpublished study prepared by LPT Laboratory of Pharmacology and Toxicology. 39 pages.

448687

- 05 Leuschner P. 1995. Acute Toxicity Study of CON/M/91

- 08 Intraperitoneal

Administration to Sprague

- Dawley Rats. Lab Project Number: 9480/95. Unpublished study prepared by LPT Laboratory of Pharmacology and Toxicology. 23 pages.

448687

- 11 Kamp N. 1995. Study on the Toxicity Towards Daphnia of Spore Isolate

CON/M/91

- 08 According to OECD Test Guideline 202. Lab Project Number: 1F

94/06075

- 02. Unpublished study prepared by Institut Fresenius. 19 pages.

448687

- 12 Kamp N. 1995. Study on the Toxicity Towards Fish of Spore Isolate

CON/M/91

- 08 Acco rding to OECD Test Guideline 203 . Lab Project Num ber: 1F

94/06075

- 03 . Unpublished study pr epared by Institut Fresenius. 17 pages.

449569

- 01 Roberts A. 1999. Supplemental Data on Acute Toxicity Studies for CON/M/91

- 08. Unpublished study prepared by Technology Sciences Group. 2 7 3 pages.

449569

- 02 Den gler D. 1999. Influence of Temperature on Germination Capacity and Mycelium Growth of Conidia of Coniothyrium minitans strain CON/M/91

- 08. Lab Project Number: 99028/01. Unpublished study prepared by Prophyta Biologischer Pflanzenschutz GmbH and GAB Biot echnologie GmbH. 39 pages.Coniothyrium minitans strain CON/M/91

- 08 EPA

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17 MRID No. Study Description

450887

- 00 Prophyta Biologischer Pflanzenschutz GmbH. 2000. Submission of Product Chemistry Data in Support of the Application for Registration of Contans WG. Transmittal of 1 Study

.

450887

- 0 1 Dengler D. 1999

. Determination of Purity of Five Batches of Contans WG

. Lab Project Number: 99028/02

- ALMP. Unpublished study prepared by GAB Biotechnologie GmbH & IFU Umweltanalytik G mbH. 14 pages.

B. U.S. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 200 0 a

. BPPD Review of Product Chemistry and Toxicity/Pathogenicity Data Submitted by PROPHYTA Biologischer Pflanzenschutz GmbH for the Registration of CONTANS ® WG,

w hich Contains Coniothyrium minitans strain CON/M/91

- 08 . Memorandum from C. Etsitty through R. Sjoblad, Ph.D. to S. Cerrelli, dated November 28, 2000.

U.S. EPA. 2000b. Review of Ecotoxicology Data Requirements for Coniothyrium minitans strain

CON/M/91

- 08 and Contans for Registrant Prophyta Biologischer Pflanzenschutz GM BH and Request for Waiver of Non

- Target Organism Testing. Memorandum from D. Gurian

- Sherman, Ph.D. through G. Tomimatsu, Ph.D. to S. Cerrelli, dated September 12, 2000.

C. Other References

PMRA. 2008. Proposed Registration Decision

– Coniothyrium minitan s strain CON/M/91

- 08 (PRD2008

- 17) (Dated December 19, 2008). Available from http://www.hc

- sc.gc.ca/cps

- spc/alt_formats/pacrb

dgapcr/ pdf/pest/part/consultations/prd/prd2008

- 17

- eng.pdf

.

Roberts AP. 2000. Contans ® WP, EPA File Symbol 72444

- R

– Response to EPA Review Dated November 28, 2000 on Acute Intraperitoneal Toxicity Study (Graded Supplemental) (Letter Dated December 7, 2000 ).

U.S. EPA. 2001

. Coniothyrium minitans strain CON/M/91

- 08 (PC Code 028836 ) Biopesticides Registration Action Document ( Dated August 1, 2001 ). Available from http://www.epa.gov/opp00001/chem_search/reg_actions/registration/decision_PC

- 028836_1

- Aug

- 01.pdf

.

U.S. EPA. Undated(a). Data Evaluation Report for Product Identification and Disclosure of Ingredients (MRID No s. 448687

- 01, 450887

- 00, and 450887

- 01 ). Prepared by C. Etsitty and R. Sjoblad

, Ph.D.

U.S. EPA. Undated(b). Data Evaluation Report for Temperature (MRID No. 449569

- 02). Prepared by C. Etsitty and R. Sjoblad, Ph.D.

U.S. EPA. Undated(c). Data Evaluation Report for Acute Ora l Toxicity (MRID Nos. 448687

- 02,

449569

- 01, and 450887

- 00). Prepared by C. Etsitty and R. Sjoblad, Ph.D.Coniothyrium minitans strain CON/M/91

- 08 EPA

- HQ

- OPP

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18 U.S. EPA. Undated(d). Data Evaluation Report for Acute Inhalation Toxicity (MRID Nos. 448687

- 04,

449569

- 01, and 450887

- 00). Prepared by C. Etsit ty and R. Sjoblad, Ph.D.

U.S. EPA. Undated(e). Data Evaluation Report for Acute Injection Toxicity and Pathogenicity (MRID

Nos. 448687

- 05, 449569

- 01, and 450887

- 00). Prepared by C. Etsitty and R. Sjoblad, Ph.D.