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/91-08 EPA-HQ-OPP-2013-0259

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TABLE OF CONTENTS

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. Endocrine 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 SUMMARY FOR CASE 6022 ............................................................................................ 15

III. BIBLIOGRAPHY ........................................................................................................................... 16

A. Studies Supporting Registration Review of Coniothyrium minitans strain CON/M/91-08.............................16

B. U.S. Environmental Protection Agency Risk Assessment Memoranda ...........................................................17

C. Other References ..................................................................................................................................................17
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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 Federal 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 system of recording and tracking studies submitted to the 

Office of Pesticide Programs.

MRL Maximum Residue Limit

OPP The EPA’s Office of Pesticide Programs

PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals.

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 States
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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 Registration Review case (docket number EPA-HQ-OPP-2013-0259). 

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 vegetables). 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, identifying 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 Registration Review 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 other 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 decision-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, currently registered pesticide product, application 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 guidance 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 information about this case, including background and supporting documents, is available at

http://www.regulations.gov (under “SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents,” enter the docket identification number, which 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 

intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all 

registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 
Coniothyrium minitans strain CON/M/91-08 EPA-HQ-OPP-2013-0259

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health or the environment. Changes in science, public 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. Information 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 Registration 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 will develop a Final Work Plan (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 Product2

Coniothyrium minitans strain CON/M/91-08 is a naturally occurring soil microorganism and 

mycoparasite3 of the sclerotia of Ascomycotina and Deuteromycotina (e.g., the common plant 

pathogens, Sclerotinia sclerotiorum and Sclerotinia minor). Spores of Coniothyrium minitans strain 

CON/M/91-08 germinate in the presence of a host and enter that host through small pores or lacerations 

to penetrate into the subcortex and medulla. Sclerotial walls consist mainly of glucans and chitin, and 

Coniothyrium minitans strain CON/M/91-08 secretes β-1,3-glucanase to degrade these walls. Once 

inside sclerotial cells, 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, 2001, 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 were made by conventional ground equipment and that were 

incorporated into the upper layer of agricultural soil. In December 2002, the labeled uses of Contans®

WG began to expand (e.g., to at planting and greenhouse applications that were still incorporated into 

the upper layer of soil) through an EPA-approved label amendment. Subsequently, the EPA approved 

several additional label amendments that now allow 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 Pflanzenschutz 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.
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TABLE 1. Summary of the Currently Registered Coniothyrium minitans strain CON/M/91-08 Pesticide Product

EPA 

Registration 

Number

Product Name

(% Active Ingredient, 

Formulation Type)

Date 

Registered Application Rates Application 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, 

greenhouse, 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 ft2

(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 strain 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 would 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 residues of this 

active ingredient. Since this tolerance exemption took effect after FQPA amended FIFRA in 1996, it did 

not require reassessment. The current 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 Rule (66 FR 

16871, March 28, 2001)
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D. Anticipated Data Needs and Risk Assessments

Provided below are tables of the current data requirements for microbial pesticides as set forth 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 descriptions are included regarding how the data 

requirements have been fulfilled or where data gaps (anticipated data needs) have been identified.

Presently, Coniothyrium minitans strain CON/M/91-08 has product analysis and nontarget organism data 

gaps. Data gaps have been identified for studies that were not submitted (indicated with a “No – Data 

Gap” designation in Tables 3 and 5) or for information provided that, in large part, claims lack of 

exposure to nontarget organisms based on limited uses (indicated with 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. § 158.2120)

TABLE 2. Summary of Product Analysis Data for Coniothyrium minitans strain CON/M/91-08

Harmonized 

Guideline 

Number 

Data Requirement

Has Data 

Requirement Been 

Addressed? How?

Source MRID No.

885.1100 Product Identity Not applicable to the TGAI test substance.

885.1200 Manufacturing Process Yes – Study

U.S. EPA (Undated(a))

U.S. EPA (2000a)

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 (2000a)

U.S. EPA (2001)

448687-01

885.1300 Discussion of Formation of Unintentional 

Ingredients Yes – Study

U.S. EPA (Undated(a))

U.S. EPA (2000a)

U.S. EPA (2001)

448687-01

450887-00

885.1400 Analysis of Samples Yes – Study

U.S. EPA (Undated(a))

U.S. EPA (2000a)

U.S. EPA (2001)

448687-01

450887-01

885.1500 Certification of Limits Not applicable to the TGAI test substance.
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TABLE 3. Summary of Physical and Chemical Characteristics for Coniothyrium minitans strain CON/M/91-08

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 (2000a)

U.S. EPA (2001)

448687-01

830.6303 Physical State Yes – Study

U.S. EPA (Undated(a))

U.S. EPA (2000a)

U.S. EPA (2001)

448687-01

830.6304 Odor Yes – Study

U.S. EPA (Undated(a))

U.S. EPA (2000a)

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 (2000a)

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 (Undated(a))

U.S. EPA (2000a)

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 (2000a)

U.S. EPA (2001)

448687-01

ii. Toxicology (40 C.F.R. § 158.2140)

TABLE 4. Summary of Toxicology Data for Coniothyrium minitans strain CON/M/91-08

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 (2000a)

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 (2000a)

U.S. EPA (2001)

448687-04

449569-01

449569-02

450887-00
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TABLE 4. Summary of Toxicology Data for Coniothyrium minitans strain CON/M/91-08

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 (2000a)

U.S. EPA (2001)

448687-05

449569-01

449569-02

450887-00

Roberts (2000)

885.3400 Hypersensitivity Incidents

No hypersensitivity 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 required2

870.1100 Acute Oral 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 Coniothyrium 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. § 158.2150)

TABLE 5. Summary of Nontarget Organism Data for Coniothyrium minitans strain CON/M/91-08

Harmonized

Guideline 

Number 

Data Requirement Has Data Requirement 

Been Addressed? How? Source MRID No.

885.4050 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/Pathogenicity Not required1

885.4200 Freshwater Fish Toxicity/Pathogenicity No – Data Gap2 U.S. EPA (2000b)

U.S. EPA (2001) 448687-12

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity No – Data Gap2 U.S. EPA (2000b)

U.S. EPA (2001) 448687-11

885.4280 Estuarine/Marine Fish and Invertebrate 

Testing No – Data Gap Not applicable
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TABLE 5. Summary of Nontarget 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 Gap2 U.S. EPA (2000b)

U.S. EPA (2001) 448687-00

885.4340 Nontarget Insect Testing No – Data Gap2 U.S. EPA (2000b)

U.S. EPA (2001) 448687-00

885.4380 Honey Bee Testing No – Data Gap2 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. § 158.2150(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) allows broader application methods (e.g., aerial applications done prior to planting, at 

planting, just after planting, at transplant, and postharvest) 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 considered 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 to 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 their designated critical habitat. 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 appropriate.

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 such 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 determination 

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 group 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.
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The EPA, as part of this Preliminary Work Plan, believes that Coniothyrium minitans strain CON/M/91-

08, the active ingredient involved in this Registration 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, pursuant 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 battery, 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, the EPA conducted a search of the Ecological Incident Information System database covering the 

time period from January 1960 to May 2013, and found 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 

consider any incident data or comments submitted in response to this Preliminary Work Plan.
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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

885.4340 Nontarget Insect Testing

TGAI

885.4380 Honey Bee Testing

TGAI = technical grade of the active ingredient, TEP = typical end-use product
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I. Timeline

The projected timeline for case 6022— Coniothyrium minitans strain CON/M/91-08—Registration 

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 2013

 Close Public Comment Period August 2013

 Case Development

 Issue Final Work Plan February 2014

 Issue Data Call-in February 2015

 Data Submission February 2016

 Open 30-Day Public Comment Period for Draft Risk Assessments August 2017

 Close Public Comment Period September 2017

 Registration Review Decision

 Open 60-Day Public Comment Period for Proposed Registration Review 

 Decision 

January 2018

 Close Public Comment Period March 2018

 Final Decision April 2018

*Estimated Total (years) ~5

* This schedule is subject to revision should unforeseen 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 data needs and set forth a new timeline. 

J. Guidance for Commenters

The public is invited to comment on the EPA’s Preliminary Work Plan and rationale. The areas below 

highlight topics of special interest to the 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 Work Plan 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 

enforcement 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 factors, 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 population.
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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 Maximum 

Daily Loads (TMDLs) have been developed for Coniothyrium minitans strain CON/M/91-08.

5 More 

information on impaired water bodies and TMDLs can be found at the EPA’s website.6 The EPA invites 

submission of water quality data for these pesticides. To the extent possible, data should conform to 

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

Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration 

Review Risk Assessment and Management Process7 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 feasible, 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 comment on any trade irritant issues 

resulting from lack of MRLs 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 an exemption from the requirement of a tolerance. 

Moreover, there are no 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 trade 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 minitans 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 application 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 information provided at http://www.epa.gov/owow/tmdl/. 5 Based on information provided at http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_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.
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 Median and 90th 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 uses

 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 received in 

a timely manner and then issue a Final Work Plan for case 6022: Coniothyrium minitans strain 

CON/M/91-08. 

II. FACT SUMMARY FOR CASE 6022

TABLE 7. Background Information for the Coniothyrium minitans strain CON/M/91-08 Registration Review

First 

Registered

Currently Registered 

Pesticide Products1

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

Yes2 No Yes

1 See Table 1 for additional information (e.g., use sites) on the currently registered product. The label for this product can be found in the 

Pesticide 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.
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III. BIBLIOGRAPHY

A. Studies Supporting Registration 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 

Support 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 Toxicity 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 SpragueDawley 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: 1F94/06075-02. 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 According to OECD Test Guideline 203. Lab Project Number: 1F94/06075-03. Unpublished study prepared 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. 273 pages.

449569-02 Dengler 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 Biotechnologie GmbH. 39 pages.
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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.

450887-01 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 GmbH. 14 pages.

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

U.S. EPA. 2000a. BPPD Review of Product Chemistry and Toxicity/Pathogenicity Data Submitted by 

PROPHYTA Biologischer Pflanzenschutz GmbH for the Registration of CONTANS® WG, 

which 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 GMBH 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 minitans strain CON/M/91-08 

(PRD2008-17) (Dated December 19, 2008). Available from 

http://www.hc-sc.gc.ca/cps-spc/alt_formats/pacrbdgapcr/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 Nos. 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 Oral Toxicity (MRID Nos. 448687-02,

449569-01, and 450887-00). Prepared by C. Etsitty and R. Sjoblad, Ph.D.
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U.S. EPA. Undated(d). Data Evaluation Report for Acute Inhalation Toxicity (MRID Nos. 448687-04, 

449569-01, and 450887-00). Prepared by C. Etsitty 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.