2 I NTRODUCTION

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

R egistration R eview of Coniothyrium minitans strain CON/M/91

- 08

. This FWP follows the Preliminary Work Plan (PWP) posted in the R egistration R evie w docket for Coniothyrium

minitans strain CON/M/91

- 08 (EPA

- HQ

- OPP

- 2013

- 0259 ). Coniothyrium minitans s train

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 certai n crops (e.g., bulb and leafy vegetables).

The EPA is implementing the R egistration R eview program pursuant to Section 3(g) of the Federal Insecticide, Fungici de, 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

R egistration R eview program is inte nded 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 R egistration R eview begins when the initial docket is opened for each case. Informatio n on this program is provided on the EPA’s website

. 1

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

substantive comments recei ved , 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 response s to th o se comments

. This section is followed by the planned data needs, risk assessments expected to be conducted , and the projected

R egistration R eview 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 c losed 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/

.3 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 as sociated

with Coniothyrium minitans strain CON/M/91

- 08

. 2 The planned data needs have not changed

from what was included in the PWP.

Planned D ata 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, T EP = typical end

- use pesticide product

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During R egistration R eview, the EPA will (1) conduct an endangered species assessment for all

uses of Coniothyrium minitans strain CON/M/91

- 08 ; (2) re vise/update the product chemistry and

environmental risk assessment s 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 Pr ogram (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.4 TIMELINE

The EPA has created the following estimated timeline for the completion of the R egistration

R eview 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 D ata 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 D ecision February 2018

Close Public C omment P eriod April 2018 Registration Review Final D ecision and Begin P ost

- d ecision F ollow

up May 2018

Total ( years ) * ~5
* This schedule is subject to revision should unforeseen issues arise during the Registration R eview 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 F WP 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 s tudies for Coniothyrium minitans strain CON/M/91

- 08 thr ough a data call

- in, expected to be issued in March 2015

.