2 I NTRODUCTION

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

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- 0368 ). Pymetrozine is a pyridine azomethine insecticide that is currently registered for use on ornamental plants, non

- bearing fruit and nut trees in nurseries, Christmas trees, and a variety of agricultural crops. This group of insecticides exhibits a unique mode of action characterized as neural inhibition of feeding behavior in its target pests (i.e., insect s in the order Homoptera, including aphids, whiteflies, and leafhoppers). Pymetrozine has residual activity in the plant and is intended to control pests that move onto the plant after spraying.

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

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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 pymetrozine

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

A fter further review and based on a weight

- of

- evidence approach, the Agency has concluded that the immunotoxicity study is not required at this time for the registration review of pymetrozine.

Additionall y, as a result of public comments received, G uidelines 835.2120, Hydrolysis and 835.6100, Terrestrial Field Dissipation studies have also been removed. More details are provided in the following section.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During t he 60

- day public comment period on the Pymetrozine Preliminary Work Plan , which opened on June 26, 2013 and closed on August 26, 2013 , the Agency received two public

comment s . Comments were submitted by Syngenta Crop Protection, LLC (Syngenta) and the

FIF RA Endangered Species Task Force (FESTF)

. The comments do not address the timeline described in the PWP, but they do address the planned ecological and endangered species risk

assessments. The majority of Syngenta’s c omments addressed the Agency’s review of

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

- submitted environmental fate studies, citing additional information on degradates for use in the planned ecological risk assessment . EPA will review the additional fate information cited by Syngenta upon submission to the Agency. Syngenta also submitted a comment regarding the planned endangered species assessment, which is addressed in the Environmental Fate and Effects Division's Response to Public Comments on Registration Review: Preliminary Problem F ormulation for Pymetrozine

. 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 e very 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. Publ ic comments and EPA responses in their entirety are located in the docket, EPA

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- 0368 . Summarized public comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the Environmental Fate and Effects Division's Response to Public Comments on Registration Review: Preliminary Problem Formulation for Pymetrozine

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Comments submitted by FESTF in EPA

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1. Comment: The FIFRA Endangered Species Task Force commented that Syngenta is a current member of FESTF and, as such, is entitled to the FESTF data on federally

- listed threatened and endangered species.

Response: The Agency thanks FESTF for their comment and will consider this information during registration rev iew

.

Comments submitted by Syngenta in EPA

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1. Comment: Syngenta cites additional information that was not considered in the EFED Problem Formulation regarding the storage stability of degradates detected in several

terrestrial field dissipation studies. Syngenta believes that this information is sufficient to support the ecological risk assessment

.

Response: EPA reviewed the additional cited information and will consider it in the ecological risk assessment. While this information does not address all of uncertainties

associated w ith the storage stability of pymetrozine degradates, requiring additional storage

s tability data is not expected to eliminate uncertainties . Therefore, Guideline 835.6100, Terrestrial Field Dissipation (storage stability data ) has been removed from the list of data

needs

.

2. Comment : While results are not consistent among the three s ubmitted hydrolysis studies, Syngenta believes that sufficient information exists regarding the degradation rate at pH 5.

Response : EPA reexamined the previously submitted hydrolysis studies and recalculated

half

- life values at pH 5. While the incons istencies remain regarding degradation rates, additional data is not expected to eliminate uncertainties. Therefore, Guideline 835.2120,4 Hydrolysis has been removed from the list of data needs. In the absence of new data, the Agency will assume a hydroly sis half

- life of 28 days at pH 5.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for pymetrozine based on the Registration Review: Preliminary Problem Formulation for Pymetrozine

, Pymetrozine. Human Health Assessment Scoping Document in Support of Registration

, and the Environmental Fate and Effects Division’s Response to Public Comments on Registration Review: Preliminary Problem Formulation for Pymetrozine

. The table has been updated since the PWP to reflect changes to

the data nee ds , specifically the removal of the immunotoxicity , hydrolysis, and terrestrial field dissipation studies

.

Table 1: Planned D ata Needs for the Pymetrozine Registration Review

Guideline

Number 2 Study Title 2 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic Aquatic Metabolism TGAI 24

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation for soil and

water TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.4100 Terrestrial plant toxicity, seedling emergence TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor TEP 12

Non

Guideline Semi

- field Toxicity Test with Honey Bee TGAI 24

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

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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- 00285 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 pymetrozine

. For human health,

EPA will conduct revised d ietary, 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 and the planned assessmen ts have not changed from what was included in the PWP

.

Table 2: Planned Risk Assessments for the Pymetrozine 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 Y The registration review assessment will consider the 5 major degradates estimated to exhibit approximately equal toxicity to the pa rent pymetrozine (CGA 359009, CGA 215525, GS 23199, CGA 249257, and CGA 300407).

Incidents Will check for updates No incidents were reported. See page 24 of the

Problem Formulation.

Human Health Dietary

Food Y EPA will incorporate updated percent crop treated estimates in accordance with Agency policies regarding the use of anticipated residues for dietary risk assessment. The major degradate CGA 359009 is currently considered a residue of concern in drinking water. I n the last dietary assessment, water was considered the key dietary risk driver. As drinking water will likely be the primary risk driver in the new dietary assessment, a revised drinking water assessment will be performed. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y The Agency will need to conduct an occupational assessment to update doses and endpoints, maximum rates for applications to ornamentals using handheld equipment, along with chemical

specific dislodgeable foliar r esidue data (DFR), and updated transfer coefficients and activity data. Post

- application Y

Residential6 Handlers Y A residential assessment will be needed due to updated doses and endpoints, revisions to the HED Residential SOPs, and the available

chemical

- specific DFR data. Post

- application Y

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

Cumulative N/A Pymetrozine is not a member of a cumulative

group. Tolerances Y EPA expects to revise the tolerance expression.

Incidents Will check for updates For a discussion of reported human incidents for pymetrozine, see page 10

- 11 of the Scoping

Document and the Pymetrozine: Review of Human

Incidents . Between 2007 and 2012, two moderate severity and two low

- severity incidents were reported.

TIMELINE

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

. The projected timeline has not changed since the PWP.

Table 3: Projected Pymetrozine Registration Review Timeline

Activities Estimated Date
Opening the Docket
Open Docket and 60

- day Public Comment Period June 2013

– Completed

Close Public Comment August 2013

– Completed Case Development

Final Work Plan Dec. 2013

- Completed

Issue DCI 2014: Jan.

- March

Data Submission 2016: Jan.

- March

60

- day Public Comment Period for Draft Risk Assessments [1] 2017: July

– Sept.
Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 2018: Jan.

- March

Registration Review Decision and Begin Post

- Decision Follow

- up 2019
Total (years) 6

[1] The regulations governing Registration Review gen erally 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.7 NEXT STEPS

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

and human health studies for pymetrozine through a D ata C all

- I n Notice , expected to be issued

in early 2014

.