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Docket Number EPA-HQ-OPP-20 1 5-0 I 28

www.regulations.gov

Cyazofamid Final Work Plan

Registration Review

Case Number 7056

September 2015

Approved by: Qil)-n^a?MqD\44\

Richard P. Keigwin, Jr.

Director

Pesticide Re-evaluation Division

Q^ ^ { Date:
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INTRODUCTION

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

the registration review of cyazofamid. This work plan addresses public comments received 

concerning the Preliminary Work Plan (PWP), which was posted in the cyazofamid registration 

review docket (EPA-HQ-OPP-2015-0128). Cyazofamid is a selective fungicide with products 

registered for use on a variety of food crops, ornamentals, and turf to control fungal pathogens 

such as Downy mildew and Pythium. Products containing cyazofamid are registered for both 

agricultural and residential uses.

The Agency 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. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency’s website.

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The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received 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 Agency’s responses to those comments. This section is followed by registration 

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

registration review timeline for cyazofamid. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

At the time of the cyazofamid PWP a storage stability study was under review. The Agency has 

completed its review of the storage stability data and found it acceptable. The data requirement 

has been satisfied. Also, an updated BEAD Chemical Profile for cyazofamid will be posted to 

the docket to address some of the comments made during the public comment period on the 

PWP. Other comments will be addressed below.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the Cyazofamid Preliminary Work Plan, which 

opened on March 30, 2015 and closed on May 29, 2015, the Agency received public comments 

from three submitters. Comments were submitted by the FIFRA Endangered Species Task Force, 

the Center for Biological Diversity, and technical registrant ISK Biosciences. The comments do 

not address the timeline described in the PWP, but they do address the planned ecological and 

human health risk assessments and data requirements. In the PWP, 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 http://www.epa.gov/oppsrrd1/registration_review/
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This section does not capture every comment made about the PWP nor all of the Agency’s 

responses. Summarized below are public comments that resulted in changes to the anticipated

registration review data needs, risk assessments, or timeline, or are of a broader regulatory 

nature. Public comments and EPA responses in their entirety are located in the docket, EPAHQ-OPP-2015-0128. 

Comments submitted by ISK Biosciences in EPA-HQ-OPP-2015-0128-0009.

1. Comment: ISK Biosciences requested waivers for Tier 2 honey bee studies until Tier 1 

studies have been evaluated to determine if Tier 2 would be necessary.

Response: The Agency will include both Tier 1 and Tier 2 studies in the Data Call-in. 

However, if the results of the Tier 1 studies suggest that Tier 2 data are not necessary, then 

the Tier 2 studies may be waived.

2. Comment: ISK Biosciences provided several comments on the BEAD Chemical Profile for 

cyazofamid. 

Response: A revised BEAD Chemical Profile will be added to the docket to address the 

comments.

3. Comment: ISK Biosciences provided several comments in response to the cyazofamid Human 

Health Scoping Document and Ecological Problem Formulation.

Response: Summarized comments and Agency responses related to the anticipated ecological 

risk assessment or data needs are in the document titled EPA Response to Comments Related 

to the Environmental Fate and Ecological Risk Assessment Preliminary Problem 

Formulation in Support of Registration Review of Cyazofamid, while those relevant to the 

anticipated human health risk assessment or data needs are in the document titled

Cyazofamid. Response to ISK Biosciences Corporation Comments Submitted to Cyazofamid 

Docket, both located in the cyazofamid docket EPA-HQ-OPP-2015-0128.

Comments submitted by The Center for Biological Diversity in EPA-HQ-OPP-2015-0128-

0008.

1. Comment: The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty 

to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service 

(the Services) on the registration review of cyazofamid in accordance with the Endangered 

Species Act (ESA). The CBD comments mention various aspects of the risk assessment 

process, including use of the best available data to develop endangered species risk 

assessments, and evaluation of effects on endangered and threatened species and their 

designated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s 

preliminary determinations regarding the effects of cyazofamid on endangered and threatened 

(listed) species and their designated critical habitat for the cyazofamid registration review. 

Response: EPA has reviewed the comments from CBD on the registration review docket 

opening for cyazofamid and plans to address many of the concerns raised by CBD as part of 
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the implementation plan for assessing the risks of pesticides to listed species based on the 

recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will 

address concerns specific to cyazofamid in connection with the development of its final 

registration review decision for cyazofamid. 

In November 2013, the EPA, along with the Services and the USDA, released a summary of 

their joint Interim Approaches for assessing risks to endangered and threatened (listed) 

species from pesticides. The Interim Approaches were developed jointly by the agencies in 

response to the National Academy of Sciences’ (NAS) recommendations and reflect a 

common approach to risk assessment shared by the agencies as a way of addressing scientific 

differences between the EPA and the Services. The NAS report outlines recommendations on 

specific scientific and technical issues related to the development of pesticide risk assessments 

that EPA and the Services must conduct in connection with their obligations under the ESA 

and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder 

workshops in April 2014 and October 2014, allowing additional opportunities for stakeholders 

to comment on the Interim Approaches. Additional workshops are planned to enhance 

stakeholder involvement. As part of a phased, iterative process for developing the Interim 

Approaches, the agencies will also consider public comments on the Interim Approaches in 

connection with the development of upcoming Registration Review decisions. The details of 

the joint Interim Approaches are contained in the white paper “Interim Approaches for 

National-Level Pesticide Endangered Species Act Assessments Based on the 

Recommendations of the National Academy of Sciences April 2013 Report,” dated November 

1, 2013. 

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

designated critical habitat, the ecological problem formulation supporting this Final Work 

Plan for cyazofamid does not describe the specific ESA analysis, including effects 

determinations for specific listed species or designated critical habitat, to be conducted during 

registration review. In the ecological problem formulation document for cyazofamid, EPA 

described the screening-level risk assessment to determine the potential effects of cyazofamid

on all taxa of non-target wildlife and plants, which will assume that listed species and their 

designated critical habitats may be present in the vicinity of the application of cyazofamid. 

This screening-level assessment will allow EPA to focus its future evaluations on the types of 

species where the potential for effects exists once the scientific methods being developed by 

the agencies have been fully vetted. While the agencies continue to develop a common 

method for ESA analysis, the planned screening-level risk assessment for the registration 

review of cyazofamid will describe the level of ESA analysis completed for this particular 

registration review case. Once the agencies have fully developed and implemented the 

scientific methods necessary to complete risk assessments for endangered and threatened 

(listed) species and their designated critical habitats, these methods will be applied to 

subsequent analyses for cyazofamid as part of completing this registration review.
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Comments submitted by FIFRA Endangered Species Task Force in EPA-HQ-OPP- EPAHQ-OPP-2015-0128-0010.

1. Comment: The FIFRA Endangered Species Task Force (FESTF) submitted a comment to 

inform the Agency that the technical registrant for cyazofamid, ISK Biosciences, is a FESTF 

member and is entitled to rely FESTF data.

Response: The Agency thanks FESTF for its comment and will take this under 

consideration.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for cyazofamid based on the Problem 

Formulation for Registration Review of Cyazofamid, Cyazofamid Human Health Assessment 

Scoping Document in Support of Registration Review, EPA Response to Comments Related to 

the Environmental Fate and Ecological Risk Assessment Preliminary Problem Formulation in 

Support of Registration Review of Cyazofamid, and Cyazofamid Response to ISK Biosciences 

Corporation Comments Submitted to Cyazofamid Docket. The table has been updated since the 

PWP to reflect that the Agency has completed its review of the storage stability data. Also, 

several clarifications were made: The sequence of pollinator data requirements has been clarified 

and the avian acute oral toxicity data needs were clarified to show that a passerine study is 

needed for parent cyazofamid while a study on the bobwhite quail or mallard duck is needed for 

the degradate CCIM.

Table 1: Planned Data Needs for the Cyazofamid Registration Review

Guideline 

Number Study Title2

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

Planned Data Needs for the Parent Cyazofamid

850.1075 Acute toxicity estuarine and marine organisms TGAI 12

850.1300 Freshwater invertebrate life cycle TGAI 12

850.1350 Estuarine/marine invertebrate life cycle TGAI 12

850.1400 Estuarine/marine fish early life stage TGAI 12

850.2100 Avian acute oral toxicity (passerine species) TGAI 12

850.3040 Field testing for pollinators (Tier 3)3 TEP 24

850.4550 Toxicity to cyanobacteria TEP, TGAI 12

 

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests 

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; 

OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028

3 Study may be waived depending on results of Tier 1 pollinator studies.
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Table 1: Planned Data Needs for the Cyazofamid Registration Review

Guideline 

Number Study Title2

Test Material

Estimated 

Timeframe

(Months from 

receipt of DCI)

850.6100 Environmental chemistry methods/independent 

laboratory validations in soil, sediment, and water TGAI 12

OECD 

TG237 Acute oral toxicity to larval honey bees (Tier 1) TGAI 12

Nonguideline Chronic oral toxicity to adult honey bees (Tier 1) TGAI 12

Nonguideline Chronic oral toxicity to larval honey bees (Tier 1) TGAI 12

NonguidelineSemi-field testing for pollinators (tunnel or 

colony feeding studies) (Tier 2)3 TEP 12

NonguidelineField trial of residues in pollen and nectar (Tier 

2)3 TEP 12

NonguidelineWhole sediment chronic toxicity invertebrates 

(Chironomid, Leptocheirus, and Hyalella)

TGAI 24

Planned Data Needs for Degradates

850.1300 Freshwater invertebrate life cycle CTCA 12

850.1400 Freshwater fish early life stage CTCA 12

850.2100 Avian acute oral toxicity (mallard or bobwhite) CCIM 12

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, 

including an endangered species assessment, for all uses of cyazofamid. For human health, EPA 

will conduct revised occupational handler and post-application exposure and risk assessments 

during registration review to account for recent changes in exposure assessment assumptions, 

including body weight, amount treated, and transfer coefficients. New dietary exposure and 

aggregate risk assessments are not anticipated during Registration Review, unless there are 

significant increases to the drinking water exposure estimates that need to be incorporated. 

Table 2 below summarizes the planned registration review risk assessments based on the EFED 

Problem Formulation and HED Scoping Document. The planned assessments have not changed 

from what was included in the PWP.
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Table 2: Planned Risk Assessments for the Cyazofamid Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate

Comprehensive ecological 

(species to be assessed 

include terrestrial and 

aquatic organisms), 

including endangered 

species 

Y The assessment will consider risk from the 

parent compound as well as cyazofamid 

degradates. 

Incidents Will check 

for updates

No incidents have been reported to the Agency. 

For a discussion of reported ecological 

incidents for cyazofamid, see page 19 of the 

Problem Formulation.

Human Health

Dietary

Food N A revised dietary exposure risk assessment is 

not anticipated during Registration Review, 

unless there are significant increases to the 

drinking water exposure estimates that need to 

be incorporated. 

Drinking water Y A new drinking water assessment may be 

necessary following review of requested fate 

and transport data and to incorporate updated 

models.

Occupational

Handlers (mixers, loaders, 

applicators)

Y A revised occupational handler risk assessment

is anticipated during registration review to 

account for recent changes in exposure 

assessment assumptions, including body weight 

and amount treated.

Post-application Y A revised occupational post-application risk 

assessment is anticipated during registration 

review to account for recent changes in 

exposure assessment assumptions, including 

body weight and transfer coefficients. 

Residential

Handlers N Because residential uses have been assessed 

with the most recent SOPs and maximum 

application rates, a revised residential handler 

assessment is not anticipated during 

Registration Review. 
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Post-application N Because residential uses have been assessed 

with the most recent SOPs and maximum 

application rates, a revised residential postapplication assessment is not anticipated during 

Registration Review. However, the Agency 

will examine the need for a volatilization 

assessment, as well as evaluate the potential 

cyazofamid exposure from spray drift during 

Registration Review.

Other

Aggregate N Evaluates the combined risk from dietary and 

residential exposures.

A new aggregate assessment is not anticipated 

during Registration Review, unless changes in 

uses, procedures, or drinking water exposure 

estimates occur.

Cumulative N Cyazofamid is not a member of a cumulative 

group and no cumulative risk assessment is 

planned.

Tolerances N

Incidents Will check 

for updates

For a discussion of reported human incidents 

for cyazofamid, see page 8 of the Scoping 

Document and the Cyazofamid. Tier I Review 

of Human Incidents.

TIMELINE

EPA has created the following estimated timeline for the completion of the cyazofamid 

registration review in Table 3 below. The projected timeline has not changed since the PWP. 

Table 3: Projected Cyazofamid Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and 60-day Public Comment Period March 2015 - Completed

Close Public Comment May 2015 – Completed

Case Development

Final Work Plan September 2015 - Completed

Issue DCI 2015 Oct. – Dec.

Data Submission 2017 Oct. – Dec.

60-day Public Comment Period for Draft Risk 

Assessments4

2019 April - June

 

4 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.
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Table 3: Projected Cyazofamid Registration Review Timeline

Activities Estimated Date

Registration Review Decision

60-day Public Comment Period for Proposed 

Registration Review Decision

2020 Jan. - March

Registration Review Decision and Begin Post-Decision 

Follow-up

2021

Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to require several ecological effects studies for 

cyazofamid through a Data Call-In Notice, expected to be issued in 2015.