I NTRODUCTION

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

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- emergent herbicide registered for agricultural use in barley, Bermudagrass (grown for seed and hay), lentils, peas (dried and succulent), triticale, sugar beets, and wheat to control certain types of weeds such as wild oat, bromegrass, Japanese brome, cheat, downy brome, yellow foxtail, pigeon grass, green foxtail, and annual ryegrass.

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 FI FRA 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 regis tered 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

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The FWP begins with any upd ates sin ce 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 Agenc y’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 triallate

. Lastly , there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

The public comments received on the PWP did not result in any changes to the anticipated data requirements listed in the PWP; however, the list of planned data requirements has been updated in the FWP to include Tier 2 pol linator studies (semi

- field testing for pollinators, residues in pollen and nectar/field residue analysis, and 850.3040 field testing for pollinators). The need for these additional Tier 2 pollinator studies is contingent on results of the Tier 1 bee studi es (adult honeybee chronic oral toxicity, larval honeybee acute oral toxicity, and larval honeybee chronic oral toxicity).

There are no additional updates on triallate since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comm ent period on the Triallate Preliminary Work Plan , which opened

on September 24, 2014 and closed on November 24, 2014 , the Agency received comments from

three stakeholders. Comments were submitted by the Center for Biological Diversity (CBD ), the

FIFRA End angered Species Task Force (FESTF), and Gowan Company (Gowan), the triallate

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

2technical registrant. The comments do not address the timeline described in the PWP, but they do address the plan ned ecological 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.

This section does not capture every comment made about the PWP nor all of the Agency’s

responses. Summarized below are public comments that are o f a broader regulatory nature. Public comments and EPA responses in their entirety are located in the docket, EPA

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. Detailed Agency responses to Gowan’s comments, wh ich pertain to environmental fate properties derived from available aerobic soil metabolism and aerobic aquatic metabolism

studies as discussed in the Registration Review Problem Formulation for Triallate

, are provided

in a separate memo titled Response to Gowan Company’s Comments on Environmental Fate Data Cited in the EFED Registration Review Problem Formulation for Triallate

.

Comments submitted by CBD in EPA

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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 triallate in accordance with the Endangered Species Act (ESA)

. The CBD comments mention various asp ects 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 r egarding the rigor of the Agency’s preliminary determin ations regarding the effects of triallate on endangered and threatened (listed) species and their designated critical habitat for th e triallate registration review.

Response : EPA has reviewe d the comments from CBD on the registration review docket opening for triallate 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 Aca demy of Sciences (NAS) report. EPA will

add ress concerns specific to triallate in connection with the development of its final registration review decision for triallate.

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 Scien ces’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific

differences be tween 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 oblig ations

under the ESA and FIFRA.

The joint Interim Approaches were released prior to a stakeholder works hop 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 a stakeholder

3workshop s in April 2014 and October 2014 , allowing additional opportunities for

stakeholders to comm ent on the Interim Approaches. Additional workshops are planned to

en hance stakeholder involve ment. 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 j oint 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 Scie nces April 2013 Rep ort,” 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 habita t, the ecological problem formulation supporting this Final Work

Plan for triallate does not describe the specific ESA analysis

, includ ing effects determinations for specific listed species or designated critical habitat , to be conducted during registration review

. In the ecological problem formulation document for triallate, EPA

described the screening

- level risk assessment to det ermine the potential effects of triallate on all taxa of non

- target wildlife and plants , which will assume that lis ted species and their designated critical habitats may be present in the vicinity of the applicati on of triallate. 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 triallate 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 app lied to subsequent analyses for triallate as part of completing this registration review.

Comments submitted by FESTF in EPA

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2. Comment: “The technical registrant, as identified on the fact sheet included in the Registration Review work plan, is Gowan Company, which is an FESTF member and is entitled to rely on FESTF data.”

Response: The Agency thanks FESTF for the comment and will consider this information during reg istration review.

4PLANNED DATA NEEDS

Table 1 below summarizes the data needs for triallate and for the d egradate 2,3,3

- trichloro

- 2

- propenesulfonic acid (TCPSA)

. In addition, submittal of analytical reference standards will be required for TCPSA

. The c urrent stock of TCPS A standards available in the EPA National Pesticide Standards Repository has expired. Analytical reference standards of TCPSA will be required to be provided to the Repository with an updated certificate of analysis (COA), or new

materi als sent to the Repository. For additional discussion of the anticipated data needs or the required submittal of analytical reference standards, see the Registration Review Problem Formulation for Triallate and Triallate Human Health Risk Assessment Scopin g Document in Support of Registration Review

.

The public comments received on the PWP did not result in any changes to the anticipated data requirements listed in the PWP; however, the following list of planned data requirements has been updated in the FWP to include Tier 2 pollinator studies (semi

- field testing for pollinators, residues in pollen and nectar/field residue analysis, and 850.3040 field testing for pollinators). The need for these additional Tier 2 pollinator studie s is contingent on results of the Tier 1 bee studies (adult honeybee chronic oral toxicity, larval honeybee acute oral toxicity, and larval honeybee chronic oral toxicity).

Table 1: Planned Data Needs for the Triallate Registration Review

Guideline Number

1F 2 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4400 Anaerobic aquatic metabolism TGAI 24

850.6100 Environmental chemistry methods and associated independent laboratory

v alidation s for water and soil TGAI and

the d egradate 2,3,3

- trichloro

- 2

- propenesulfonic

acid (TCPSA) 12

850.1025 Acute toxicity estuarine and marine organisms (oyster shell growth)

2F 3 TGAI 12

850.1035 Acute toxicity estuarine and marine organisms (mysid) TGAI 12

850.1045 Acute toxicity estuarine and marine organisms (penaeid) 3 TGAI 12

850.1055 Acute toxicity estuarine and marine organisms (bivalve) 3 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 Data for only one invertebrate mollusk is nec essary. Data maybe generated for either the oyster (GLN 850.1025), penaeid (850.1045), or bivalve (850.1055).

5Table 1: Planned Data Needs for the Triallate Registration Review

Guideline Number

1F 2 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.1075 Acute toxicity estuarine and marine organisms (saltwater fish) TGAI 12

850.1350 Saltwater invertebrate life cycle TGAI 12

850.1400 Saltwater fish early

- life stage TGAI 12

850.4550 Cyanobacteria toxicity TGAI 12

850.2100 Avian acute oral toxicity (passerine species) TGAI 12

850.2300 Avian reproduction (waterfowl) TGAI 24

Non

- guideline (GDLN) Special Study Honeybee adult chronic oral toxicity TGAI 12

Non

- GDLN Special Study Honeybee larval acute oral toxicity TGAI 12

Non

- GDLN Special Study Honeybee larval chronic oral toxicity TGAI 12

Non

- GDLN Special Study Semi

- field testing for pollinators

3F4 TEP 12

Non

- GDLN Special Study Residues in pollen and nectar/Field residue analysis 4 TEP 24

850.3040 Field testing for pollinators 4 TEP 36

Non

- GDLN Special Study Whole sediment: chronic invertebrates freshwater, Chironomus dilutus TGAI 24

Non

- GDLN Special Study Whole sediment: chronic invertebrates freshwater, Hyalella azteca TGAI 24

Non

- GDLN Special Study Whole sediment: chronic invertebrates marine, Leptocheirus plumulosus TGAI 24

TGAI = technical grade active ingredient; TEP = typical end

- use product

4 The need for this anticipated data requirement is contingent on results of the tier 1 bee studies (including adult honeybee chronic oral toxici ty, larval honeybee acute oral toxicity, and larval honeybee chronic oral toxicity).

6RISK 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 triallate. For human health, EPA will conduct an updated drinki ng water assessment and will also consider the need for a residential bystander assessment. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in the new assessments, as will any changes to the standard operating procedures or default exposure assumptions. EPA does not anticipate conducting updated dietary, residential, occupational, or aggregate assessments during registration review, unless th ere are significant changes to the points of departure, estimated drinking water concentrations, uncertainty factors, or safety

factors.

Table 2 on the following page 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.

7Table 2: Planned Risk Assessments for the Triallate Registration Review

Type of Risk Assessment Conduct? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Yes EPA anticipates conducting an updated comprehensive ecological risk assessment during registration review. The new assessment will incorporate the most up

- to

- date modeling methodologies, updated toxicological endpoints, and

data submitted under the antici pated registration

review Data Call

- In Notice.

Incidents Will check for updates For a discussion of reported ecological incidents for

triallate , see page 14 of the Problem Formulation.

Human Health Dietary

Food No The most recent dietary exposure assessment was
conducted for the 2008 human health risk assessment. No dietary risks of concern were identified. EPA does not anticipate conducting an updated dietary assessment for registration review unless there are significant changes to the drinking

water estimated concentrations or if there are significant changes to the points of departure, uncertainty factors, or safety factors. Drinking water Yes EPA anticipates conducting an updated drinking water assessment during registration review to incorporate updated estimated drinking water

concentrations. Occupational Handlers (mixers, loaders, applicators) No The most recent occupational exposure assessment

was conducted for the 2008 human health risk assessment. All of the handler exposure an d post

application exposure non

- cancer risk estimates were below the level of concern with the PPE required on triallate labels. EPA does not anticipate conducting an updated occupational assessment during registration review unless warranted by any chang es to policy or points of departure. Post

- application No

Residential

Handlers No There are no residential uses registered for triallate.

Post

- application Yes Residential bystander exposure resulting from off

site transport (i.e., spray drift or volatilization) may occur as a result of occupational applications of triallate. The need for a bystander risk assessment will be considered during registration review.

Other

8Aggregate No An aggregate assessment e valuates the combined risk from dietary and residential exposures.

The most recent aggregate assessment was conducted

for the 2008 human health risk assessment. No risks of concern were identified. EPA does not anticipate conducting an updated aggregate risk assessment for registration review unless there are significant changes to the toxicological points of departure, uncertainty factors, dietary exposure estimates, or estimated drinking water concentrations.

Cumulative No Not applicable. Triallate has not been identified as a

member of a cumulative group that shares a common mechanism of toxicity.

Triallate is a member of the thiocarbamate class of pesticides; however, EPA has determined that the thiocarbamate pesticides should not undergo

cumulative assessments since chemicals in the group do not act the same way in the body. In late 2001 and early 2002, EPA provided an opportunity for the public to comment on the Agency’s common mechanism determinations for the thiocarbamates, which also belong to the carbamate group of pesticid es. EPA determined that the thiocarbamates do not share a common mechanism of toxicity. Therefore, a cumulative risk assessment has not been performed.

Tolerances Update The tolerance expressions for triallate should be revised during registration revie w. Please refer to page 12 of the HED Scoping Document.

Incidents Will check for updates EPA has evaluated the available incident data and concludes that there does not appear to be a concern at this time that would warrant further investigation,

since t here were no incidents involving triallate reported to either IDS or SENSOR

- Pesticides. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

See page 12 of the Scoping Document and the Triallate Tier I Review of Human Incidents

.

9TIMELINE

EPA has created the following estimated timeline for the completion of the triallate registration

review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Triallate

– Projected Registration Review Timeline

Activity Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period Completed September 2014

Close Public Comment Completed

November 2014 Case Development

Final Work Plan Completed

March 2015

Issue DCI 2015

– April

- June

Data Submission 2017

– April

- June

6 0

- day Public Comment Period for Draft Risk Assessments

4F 5 2018

– Oct.

– Dec. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

D ecision 2019

– July

– Sept.

Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2020 Total ( years ) 6

NEXT STEPS

As noted previously, the Agency plans to require several ecological effects studies for triallate through a D ata C all

- I n Notice , expected to be issued in mid

- 2015

.

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; se e 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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