Docket Number EPA

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## Triclopyr Final Work Plan

Registration Review

Case Number 2710

June 2015

Approved by:

___________________________ Richard P. Keigwin, Jr.

Director

Pesticide Re

- evaluation Division

Date:

___________________________2 INTRODUCTION

This is the Environm ental Protection Agency’s Final Work Plan (FWP) for the registration

review of triclopyr . This work plan addresses public comments received conc erning the Preliminary Work Plan (PWP), which was posted in the triclopyr registration review docket ( EPA

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- 0576 ). Triclopyr acid and its salts and esters (whi ch will be collectively

referr ed to as triclopyr throughout the F WP) are systemic herbicides within the pyridine carboxylic acid chemical family registered for the control of a number of woody plant and weed species. They are registered for use on a number of agricultural crops

, including rice

, and for non

- agricultural use on range and pasture land, forests, rights of way, turf (commercial and homeowner), and numerous aquatic areas for aquatic weed control.

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 registratio n 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 d ocket is opened 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 con cerning planned 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 triclopyr

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

Pollinator Data Needs On June 23, 2014, EPA, Health Canada’s Pest Management Regulatory Agency, and the California Department of Pesticide Regulation issued Guidance for Assessing Pesticide Risks

to Bees. The guidance describes a tiered risk assessment process, associated data requirements

, for any pesticides with registered uses resulting in non

- target exposures to
bees. In accordance with this guidan ce, EPA plans to require the following two honey bee toxicity studies for the triclopyr registration review case. These additional data are re flected

in this FWP in Table 1: Planned Data Needs for Triclopyr Registration Review.

- Guideline (GLN) 850.3040, Full field testing for pollinators

- Non

- GLN, Field trial of residues in pollen and nectar

Aerobic Soil Metabolism Study (835.4100) and Aerobic Aquatic Metabolism Study (835.4300)

An aerobic soil m et abolism s tudy (TGAI) and an a erobic aquatic metabolism study ( TCP

d egradate) were identified as data gap s in th e EFED Problem Formulation. These studies

were inadvertently left out of t he Preliminary Work Plan and have been added to the Final

Work Plan.

1 http://www.epa.gov/oppsrrd1/registration_review/3 SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the triclopyr Preliminary Work Plan , which opened on December 18, 2014 and closed on February 18, 201 5 , the Agency received public

comments from five sources: the San Francisco Bay Regional Water Quality Control Board

, the California Stormwater Quality Association (CASQA) ; Dow AgroSciences; the Physicians Committee for Responsible Medicine ; and the FIFRA Endangered Species Task Force (FESTF)

. 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 specif ic topics of environmental justice, water quality concerns, and trade irritants

. C omments were received regarding water quality

concerns from a California Water Board and CASQA

. No comments were provided on environmental justice or trade irritants.

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 of a broader regulatory nature and the Agency’s response

. Public comments and EPA responses in their entirety ar e located in the docket, EPA

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. Summarized public comments and Agency

responses related to the planned ecological risk assessment or data needs are in the Response to Public Comments on the EFED Registration Review Problem Formulation for Tr iclopyr

dated June 2 4 , 2015.

Comment submitted by FIFRA Endangered Species Task Force (FESTF) in EPA

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1. Comment: The technical registrants for triclopyr, as identified on the fact sheet in the PWP, are Nufarm Limited (a subsidiary of Nufarm Americas, Inc.), Albaugh, Inc., and Dow AgroSciences, which are FESTF members and are entitled to rely on FESTF

data.

Response: EPA appreciates FESTF’s comments and will consider this information during registration review.

Comment submitted by D ow AgroSciences, LLC in EPA

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1. Comment: Dow AgroSciences provided the Triclopyr Registration Review Benefits

Ass essment in Response to Triclopyr Registration Review Docket No

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Response: EPA appreciates receiving the tricl opyr b enefits a ssessment submitted by Dow AgroSciences and will consider this information during registration review.

Comments submitted by California Stormwater Quality Association (CASQA) in EPA

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1. Comment: CASQA commented that the national total non

- agricultural usage data reported in the BEAD Memorandum (Table 4) of 100,000 lb acid equivalent (a.e.) was grossly underestimated.

Response: EPA appreciates CASQA ’s comments and the submission of the California Department of Pesticide R egulation’s (DPR) Pesticide Use Reports (PUR) from 20124 and C alifornia DPR sales data. In Table 4 of the BEAD Chemical Profile (BCP) for Registration Review: Triclopyr Case , the 100,000 lbs. acid equivalent ( a.e. ) lbs triclopyr applied refers only to the n ational

- level consumer lawn sector data from

2011

. This is not the national total lbs a.e. applied for all non

- agricultural uses of

tri clopyr for 2011

. N on

- agricultural usage data is limited and we do not have a total (all sectors combined including lawn c are , rights

- of

- way, etc.) national

- level t riclopyr

non

- agricultural usage number.

2. Comment: The BEAD Memorandum included conclusions about both rates of non

agricultural use and long

- term trends based on 2002

- 2006 data that included no discussion of possible uses in rights

- of

- way. The California DPR PUR data for 2012 and prior years could provide a useful dataset for evaluating non

- agricultural uses

and trends.

Response: EPA appreciates CAS Q A’s comment and will consider this information during registration review. The n ational

- level poun dage data in Table 1 of the BCP for Registration Review: Triclopyr Case are from 2002 to 2011

. At the time the BCP was drafted, national data on lbs of triclopyr applied to right s

- o f

- way were not available.

3. Comm ent: CASQA requests additional public participation opportunities.

Response: The EPA currently provides several opportunities for public participation at various stages throughout the registration review process , including the opportunity

to comment at the draft risk assessment and the proposed decision phases

. In addition,

t he public may contact the Agency at any time with questions or concerns regarding the process.5 PLANNED DATA NEEDS

Table 1 below summarizes planned data needs for triclopyr . Updates have been made to include the previously omitted stud ies and the pollinator data needs mentioned earlie r in this

document

. For additional discussion of the planned data needs, see:

• Registr ation Review; Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Triclopyr [Triclopyr Acid (PC Code 116001), Triclopyr Triethylamine Salt (PC Code 116002), a nd Triclopyr Butoxyethyl Ester (PC Code 116004)]

, and

• Triclopyr; Triclopyr, Triethylamine Salt (TEA); and Triclopyr, Butoxyethyl Ester (BEE). Human Health Assessment Scoping Document in Support of Registration

Review

.

Table 1: Planned Data Needs for the Triclopyr Registration Review

Guideline

Number 2 Study Title 1 Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Planned Data Needs for Triclopyr

835.2240 Aqueous photolysis TGAI (acid) 12

835.4100 Aerobic soil metabolism TGAI ( TEA, and BEE) 24

835.4200 Anaerobic soil metabolism TGAI (acid, TEA, and

BEE) 24

835.4300 Aerobic aquatic metabolism TGAI (BEE) 24

835.4400 Anaerobic aquatic metabolism TGAI (BEE) 24

850.1300 Freshwater invertebrate lifecycle TGAI (BEE) 12

850.1350 Estuarine/marine invertebrate lifecycle TGAI (BEE) 12

850.1730 Fish BCF TGAI (BEE) 12

850.2100 Avian oral toxicity

– Passerine TGAI (acid) 12

850.3040 Field testing for pollinators TEP 24

870.3465 Subchronic (90

- day) inhalation toxicity study TGAI 24

860.1340 Residue analytical methods 3 TGAI 12

875.2100 Turf transferable residue study TEP 24

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

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3 The results of a radio

- validation study are needed to ensure the ability of the GC/MS method GRM97.02 to recover aged residues.6 Table 1: Planned Data Needs for the Triclopyr Registration Review

Guideline

Number 2 Study Title 1 Test

Material Estimated

Timeframe

(Months from receipt of DCI)

Non

- GDLN (OECD Test Guideline 213) Honey bee adult acute oral toxicity TGAI (acid) 12

Non

- GDLN (OECD Test Guideline 237) Honey bee larvae acute oral toxicity TGAI (acid) 12

Non

- GDLN Honey bee adult chronic oral toxicity TGAI (acid) 12

Non

- GDLN Honey bee larvae chronic oral toxicity TGAI (acid) 12

Non

- GDLN Residues in pollen and nectar/field residue analysis TGAI (acid) 24

Non

- GDLN (OECD Test Guidance 75) Semi

- field testing for pollinators TEP 24

Planned Data Needs for TCP Degradate

835.4300 Aerobic aquatic metabolism Degradate 24

850.1400 Fish e arly l ife s tage 4 Degradate 12 TGAI = technical grade active ingredient; TEP = typical end

- use product

4 Data requirement pending review of submitted study

.7 R ISK 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 triclopyr. For human health, EPA will conduct revised dietary, residential, occupational and aggregate risk assessments during registration review. If toxicological endpoints or points of departure are

revised based on the data that will b e required for registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions.

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

Prelim inary Problem Formulation and Human Health Assessment Scoping Document.

Table 2 : Planned Risk Assessments for the Triclopyr 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

Incidents Will check for updates For a discussion of reported ecological incidents for triclopyr, see page 33 of the Preliminar y Problem

Formulation.

Human Health Dietary

Food Y Drinking water Y Occupational Handlers (mixers, loaders, applicators) Y

Post

- application Y

Residential

Handlers Y

Post

- application Y

Other Aggregate Y Evaluates the combined risk from dietary and residential exposures.

Cumulative N Triclopyr has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances Y During registration review, the Agency will evaluate

the need to harmonize tolerances with Canadian MRLs and the need to update the current tolerance expressions.

Incidents Will check for updates For a discussion of reported human incidents for triclopyr , see page 13 of the Human Health Assessment Scoping Document and the Triclopyr, salts and esters: Tier I Review of Human Incidents

.8 TIMELINE

EPA has created the following estimated timeline for the completion of the triclopyr registration review in Table 3 below.

Table 3 : Projected Triclopyr Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2014

– December

Close Public Comment 2015

– February Case Development

Final Work Plan 2015

– June

Issue DCI 2015 July

– Sept.

Data Submission 2017 July

– Sept.

60

- day Public Comment Period for Draft Risk

Assessments 5 2019 Jan uary

– March

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2019 Oct.

– Dec.

Registration Review Decision and Begin Post

Decision Follow

- up 2020

Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for triclopyr through a D ata C all

- I n Notice , expected to be

issued in September 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; see 40 CFR Part 155.53(c). For conventional pesticides, t he Agency plans to provide a 60 calendar day public comment period generally for draft risk

assessment s

.