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INTRODUCTION

This is the U.S. Environmental Protection Agency’s (EPA) Final Work Plan (FWP) for the 

Registration Review of Coniothyrium minitans strain CON/M/91-08. This FWP follows the 

Preliminary Work Plan (PWP) posted in the Registration Review docket for Coniothyrium 

minitans strain CON/M/91-08 (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).

The EPA is implementing the Registration Review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices occur over time. 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 health or the environment. The public 

phase of Registration Review begins when the initial docket is opened for each case. Information 

on this program is provided on the EPA’s website.

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The FWP begins with any updates since the PWP was issued. Next, it provides a summary of 

substantive comments received, if any, during the public comment period for the PWP 

concerning anticipated data needs, expected risk assessments, or the estimated timeline identified 

in the PWP, and a summary of the EPA’s responses to those comments. This section is followed 

by the planned data needs, risk assessments expected to be conducted, and the projected

Registration Review timeline for Coniothyrium minitans strain CON/M/91-08. Lastly, there is a 

discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no updates for Coniothyrium minitans strain CON/M/91-08 since the PWP.

SUMMARY OF COMMENTS AND THE EPA’S RESPONSES

During the 60-day public comment period on the Coniothyrium minitans strain CON/M/91-08 

PWP, which opened on June 26, 2013, and closed on August 26, 2013, the EPA received no 

public comments. In the PWP, the EPA also solicited comments on the specific topics of 

environmental justice, water quality concerns, and trade irritants, but no comments or 

information were received on those issues.

 1 See http://www.epa.gov/oppsrrd1/registration_review/.
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PLANNED DATA NEEDS

The table below summarizes the current planned data needs for Coniothyrium minitans strain 

CON/M/91-08 based on the EPA’s risk assessment memoranda and other references associated 

with Coniothyrium minitans strain CON/M/91-08.

2 The planned data needs have not changed 

from what was included in the PWP.

Planned 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 pesticide product

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During Registration Review, the EPA will (1) conduct an endangered species assessment for all 

uses of Coniothyrium minitans strain CON/M/91-08; (2) revise/update the product chemistry and 

environmental risk assessments for Coniothyrium minitans strain CON/M/91-08; and (3) 

determine whether, pursuant to Section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act, 

Coniothyrium minitans strain CON/M/91-08 qualifies for exemption from the Endocrine 

Disruptor Screening Program (EDSP). The EPA believes that Coniothyrium minitans strain 

CON/M/91-08 is likely not an endocrine disruptor; as such, the EPA may exempt it from the 

EDSP (if exempted, an order will be issued).

 2 See Section III (“Bibliography”) of the Coniothyrium minitans strain CON/M/91-08 PWP.
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TIMELINE

The EPA has created the following estimated timeline for the completion of the Registration

Review for Coniothyrium minitans strain CON/M/91-08.

Registration Review for Coniothyrium minitans strain CON/M/91-08 – Projected 

Registration Review Timeline

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 – Completed

Close Public Comment Period August 2013 – Completed

Case Development

Issue Final Work Plan March 2014 – Completed

Issue Data Call-in March 2015

Data Submission March 2016

Open 30-day Public Comment Period for Draft Risk Assessments September 2017

Close Public Comment Period October 2017

Registration Review Decision

Open 60-day Public Comment Period for Proposed Registration 

Review Final Decision February 2018

Close Public Comment Period April 2018

Registration Review Final Decision and Begin Post-decision Followup May 2018

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 FWP will be issued at that 

 time. That FWP will identify any newly planned data needs and set forth a new timeline.

NEXT STEPS

As noted previously, the EPA plans to require a product chemistry study and several nontarget 

organism toxicity studies for Coniothyrium minitans strain CON/M/91-08 through a data call-in, 

expected to be issued in March 2015.