## ff*tr.Q 

# s 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: 

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Richard P. 

### Keigwin, Jr.



### Director

Pesticide 

### Re-evaluation 

### Division



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Date:2

I NTRODUCTION

This is the Environm ental 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 F IFRA 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.

Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any update s 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 response s to th o se 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 satisf

ied. 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

Du ring 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 Tas k 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 t he 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/3

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, EPA

HQ

- OPP

- 2015

- 0128.

Comments submitted by ISK Biosciences in EPA

- HQ

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- 2015

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- 0009

.

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

studies have been evaluated to dete rmine 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

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- 2015

- 0128

.

Comments submitted by The Center for Biological Diversity in EPA

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- 2015

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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 Endan gered 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 th eir 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 of4

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 f or 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 t heir 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 C ommittee (PPDC) and State

- FIFRA Issues Research and Evaluation Group ( SFIREG) me etings. The agencies also held stakeholder workshops in April 2014 and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. A dditional 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 Assessme nts 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 fut ure 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 screenin g

- 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 com plete 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.5

Comments submitted by FIFRA Endangered Species Task Force in EPA

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- EPA

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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 o f 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 h a s 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 bobwhit e quail or mallard duck is needed for the degradate CCIM.

Table 1: Planned Data Needs for the Cyazofamid Registration Review

Guideline

Number Study Title 2 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 fo r some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA

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3 Study may be waived depending on results of Tier 1 pollinator studies.6 Table 1: Planned Data Needs for the Cyazofamid Registration Review

Guideline

Number Study Title 2 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

Non

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

Non

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

Non

guideline Semi

- field testing for pollinators (tunnel or

colony feeding studies) (Tier 2) 3 TEP 12

Non

guideline Field trial of residues in pollen and nectar (Tier

2) 3 TEP 12

Non

guideline Whole 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, t he 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 registrat ion 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.7

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 d ietary 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 occup ational handler risk assessment is anticipated during registration review to account for recent changes in exposure

assessme nt assu mptions, 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

bod y 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.8

Post

- application N Because residential uses have been assessed

with the most recent SOPs and maximum application rates, a revised residential post

application assessment is not anticipated during Registration Review. However, the Agency

will examine the ne ed 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 Dock et Open Docket and 60

- day Public Comment Period March 2015

- Completed

Close Public Comment May 2015

– Completed Case Development

Final Work Plan S eptember 2015

- Completed

Issue DCI 2015 Oct.

– Dec.

Data Submission 2017 Oct.

– Dec.

60

- day Public Comment Period for Draft Risk

Assessments 4 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.9 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 D ata C all

- I n Notice , expected to be issued in 2015

.