2

I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of cycloate . This work plan addresses public co mments received concerning the Preliminary Work Plan (PWP), which was posted in the cycloate registration review docket (EPA

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- 0288 ). Cycloate belongs to the thiocarbamate family of herbicides. It is a systemic, broad

- spectrum, and pre

- emergent herbicide registered for control of certain grasses and broadleaf weeds in table beets, spinach, and sugar beets.

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 pr ogram 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 op ened for each case.

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

. 1

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 ant icipated 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 cycloate

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

There are no updates on cycloate since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the cycloate Preliminary Work Plan , which opened

on June 24, 2015 and closed on August 24, 2015, the Agency received one public commen t from the Center for Biological Diversity . The comm ent does not address the timeline des cribed in the PWP, but i t do es address the planned ecological assessment . 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.

Summarized below is the comment from the Center for Biological Diversity.

Comments submitted by the Center for Biological Diversity (CBD) in EPA

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Comment: The Center for Biological Diversity’s (CBD) comments focus o n 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

1 http://www.epa.gov/oppsrrd1/registration_review/3

cycloate in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspect s 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 reg arding the rigor of the Agency’s preliminary determinations regarding the effects of cycloate on endangered and threatened (listed) species and their designated critical habitat for the cycloate registration review

.

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

for cycloate and plans to address many of the concerns raised by CBD as part of 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 cycloate in connection with the development of its final registration review

decision for cycloate

.

In November 2013, the EPA, along with the Services and the US DA, 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

r elated 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,

2 013. 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 a stakeholder workshop in Apri l 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 th is Final Work Plan for cycloate 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 doc ument for cycloate , EPA described the screening

- level risk assessment to determine the potential effects of cycloate 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 cycloate . 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 hav e 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 cycloate will describe the level of ESA analysis completed for this particular registr ation review case. Once the4

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 cycloate as part of completing this registration review.

PLANNED DATA NEEDS

Table 1 below summarizes anticipated data needs for cycloate. For additional discussion of the anticipated data needs, see the Registration Review

– Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Cycloate and Cycloate: Human Health Scoping Document in Support of Registration Review

. The table has not been updated since the PWP

.

Table 1: Anticipated Data Needs for the C ycloate Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Cycloate

850.2100 Avian acute oral toxicity test, one passerine

species TGAI 12

Non

guideline Avian inhalation, one species. TGAI 12

Non

guideline Acute oral toxicity to adult honey bees TGAI 12

Non

guideline Acute oral toxicity to larval honey bees TGAI 12

Non

guideline Chronic oral toxicity to larval honey bees TGAI 12

Non

guideline Chronic oral toxicity to adult honey bees TGAI 12

Non

guideline Field trial of residues in pollen and nectar 3 TEP 24

Non

guideline Semi

- field testing for pollinator 3 TEP 24

850.3040 Field testing for pollinators 3 TEP 24

850.4500 Algal toxicity test, three species 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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3 The need for this anticipated data requireme nt is contingent on results of the tier 1 bee studies (including acute oral toxicity to adult honey bees, acute oral toxicity to larval honey bees, chronic oral toxicity to adult honey bees, and chronic oral toxicity to larval honey bees).5 Table 1: Anticipated Data Needs for the C ycloate Registration Review

Guideline

Number 2 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.4550 Cyanobacteria toxicity test TGAI 12

835.2410 Photodegradation on soil TGAI 12

835.4100 Aerobic soil metabolism (with 3 additional

soils) TGAI 24

835.4 3 00 Aerobic aquatic metabolism (with 2 systems) TGAI 24

Outstanding Data Requirements from GDCI

- 041301

- 26252 4

835.6100 ECM and ILV for Terrestrial Field

Dissipation Study TEP Outstanding

850.4100 Seedling emergence toxicity test, 10 species TEP Outstanding

850.4150 Vegetative vigor toxicity test, 10 species TEP Outstanding

850.4400 Aquatic plant toxicity test using Lemna spp. TGAI Outstanding

850.1035 Mysid acute toxicity test TGAI Outstanding

850.1350 Freshwater invertebrate life

- cycle test TGAI Outstanding

850.1075 Fish acute toxicity test, marine TGAI Outstanding

850.1400 Freshwater fish early

- life stage test TGAI Outstanding

850.2300 Avian reproduction toxicity test, two species TGAI Outstanding

860.1900 Field Accumulation in Rotational Crops TEP Outstanding

870.6300 Developmental Neurotoxicity Study TGAI Outstanding

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

4 The studies li sted in this section were previously required through a generic data call

- in issued in February 2006 and are still outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the ear lier DCI.6

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 cycloate

. For human health, EPA

will conduct revised dietary, residential

, and occupational risk assessment s during registration

review

. If toxicological endpoints or points of departure are revised based on the data that are required for registration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

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 Cycloate Registration Review

Type of Risk Assessment Conduct ? Notes

Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Yes The most recent comprehensive risk assessment was completed in 2004 for uses on table beets, sugar beets, and spinach. A revised assessment is necessary

to include the data which have been and will be called

in.

Incidents Will check for updates A review o f the Ecological Incident Information

System (EIIS, version 2.1) and the Avian Monitoring Information System (AIMS) was completed on August 7, 2014, and no ecological incidents involving cycloate or cycloate sulfate were identified. Incident

databases will be reviewed again at the time of the

risk assessment.

Human Health Dietary

Food Yes Since the acute and chronic dietary assessments and the drinking water estimations were conducted several years ago, they will need to be updated during Registration Review to reflect current methods, models and data inputs. Drinking water Yes

Occupational Handlers (mixers, loaders, applicators) Yes There is sufficient information available to assess occupational handler application exposures. During Registration Review a new assessment of occupational handler exposures will be needed

because the most recent assessment was conducted several years ago , and policies and data inputs and assumptions have changed. Also, there were risks of concern for some dermal and all inhalation exposures with varying levels of personal protective equipment ( PPE )

. EPA has since updated its policy on body weights and updated unit exposure values, and other inputs for determining these risk estimates. Post

- application No

Residential

Handlers No There are no registered residential uses; therefore, no residential exposures are expected. However, the Agency will examine the need for a volatilization8

Post

- application/ bystander Yes assessment, as well as evaluate the potential for exposure from spray drift during Registration

Revie w. Residential bystander exposures resulting

from off

- site transport (i.e., spray drift or volatilization) may occur as a result of occupational applications of cycloate. The need for a bystander risk assessment for cycloate will be considered during Regis tration Review.

Other Aggregate Yes A new aggregate assessment will be needed during Registration Review, since the chronic dietary assessment and the drinking water estimations were conducted several years ago and they will need to be updated.

Cumulative No Unlike other pesticides for which EPA has followed a

cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding with cycloate. Cycloate does not appear to produce a toxic metabolite produced by other substances.

Tolerances No Tolerances for cycloate are e stablished in 40 CFR §180.212

. Incidents Will check for updates For a discussion of reported human incidents for

cycloate, see page 9 of the Scoping Document and the Cycloate: Tier I Review of Human Incidents

TIMELINE

EPA has created the following esti mated timeline for the completion of the cycloate registration

review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for C ycloate

– Projected Registration Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period June 2015

– completed

Close Public Comment August 2015

- completed Case Development

Final Work Plan December 2015

- completed

Issue DCI January

- March 2016

Data Submission January

- March 20189

Table 3: Registration Review for C ycloate

– Projected Registration Review Timeline

Activities Estimated Date

60

- day Public Comment Period for Draft Risk Assessments 5 July

- September

2019 Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision October

– December

2020 Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2021 Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate and ecological

effects studies for cycloate through a D ata C all

- I n Notice , expected to be issued in early 2016.

5 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.