### Docket Number EPA-HQ-OPP-2014-0777 www.regulations.gov



# Flonicamid Final Work Plan Registration Review

Case Number 7436

June 2015

Approved by:

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Date: Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Division


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### INTRODUCTION
This is the Environmental Protection Agency ' s (EPA or the Agency) Final Work Plan (FWP) for the registration review of flonicamid. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which were posted in the flonicamid registration review docket (EPA-HQ-OPP-:2014-0777). Flonicamid is a systemic pyridinecarboxamide insecticide registered for use against sap-feeding insects, such as aphids , whiteflies , leafhoppers , plant bugs , and thrips. Agricultural uses including pome fruits , stone fruits , tree nuts , berries , cotton, vegetables , legumes , and crops grown for oil. Flonicamid products are also registered for
use on commercial ornamentals, interiorscapes, and nurseries , but are not allowed for use in residential settings.
The Agency is implementing the registration review program pursuant to Section 3(g) ofthe 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 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 ofregistration review begins when the initial docket is opened for each case. Information 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 planned data needs , expected risk assessments , or the estimated timeline identified in the PWP, and a summary ofthe Agency ' s responses to those comments. This section is followed by registration review planned data needs , risk assessments expected to be conducted, and the projected registration review timeline for flonicamid. Lastly, there is a discussion ofnext steps.


### UPDATES SINCE THE PWP WAS ISSUED
The agency notes that the Non-guideline study for Honey bee Residues in Pollen and Nectar was inadvertently left offthe list of anticipated data in the Flonicamid PWP. This requirement has been included among the data needs for flonicamid, see Table 1 below.


### SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment period on the Flonicamid Preliminary Work Plan, which opened on September 24 , 2014 and closed on November 23 , 2014 , the Agency received four public comments. Comments were submitted by the FIFRA Endangered Species Task Force (FESTF) , the Center for Biological Diversity (CBD), ISK Biosciences Corporation (ISKBC) , and the National Alfalfa & Forage Alliance

. In the PWP, EPA also solicited comments on the specific top!cs ofenvironmentaljustice, water quality concerns, and trade irritants, but no comments or information were received on those issues.
Summarized below are the public comments. The comments in their entirety are located in the docket, EPA-HQ-OPP-2014-0777.

1 http: //www.epa.gov/oppsrrd 1 /registration

_review/
2Comments submitted by CBD in EPA-HQ-OPP-2014-0777-0010.
1. Comment: CBD's comments focus on EPA' s**~uty** to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of flonicamid in accordance with the Endangered Species Act (ESA). CBD's comments mention various aspects ofthe risk assessment process, including use ofthe best available data to develop endangered species risk assessments, and evaluation ofeffects on endangered and threatened species and their designated critical habitat. Response: EPA has reviewed the comments from CBD on the registration review docket opening for flonicamid and plans to address many ofthe concerns raised by CBD as part ofthe implementation plan for assessing the risks ofpesticides to listed species based on the recommendations ofthe April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to flonicamid in connection with the development ofits final registration review decision for this pesticide.
In November 2013, the EPA, along with the Services and the USDA, released a summary of theirjoint 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 NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way ofaddressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development ofpesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA.
Thejoint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented thejoint 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 April 2014, October 2014, and April 2015, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement; the next workshop is scheduled for October 2015. As part of a phased, iterative process for developing the Interim Approaches, the a· gencies will also consider public comments on the Interim Approaches in connection with the development ofupcoming registration review decisions. The details ofthe 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 ofthe Interim Approaches to assess the potential risks ofpesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this Final Work Plan for flonicamid 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 flonicamid, EPA described the screeninglevel risk assessment to determine the potential effects offlonicamid on all taxa ofnon-target wildlife and plants, which will assume that listed species and their designated critical habitats



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### may be present in the vicinity ofthe application offlonicamid. 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 offlonicamid will describe the level ofESA 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 applied to subsequent analyses for flonicamid as part of completing this registration review.
Comments submitted by FESTF in EPA-HQ-OPP-2014-0777-0011.


### 1. Comment: FESTF noted the availability ofdata to inform the Agency's endangered species assessment and identified the FESTF members entitled to rely on FESTF data. Response: The Agency thanks FESTF for its comments and will consider this information during the flonicamid registration review.
Comments submitted by ISK Biosciences Corporation in EPA-HQ-OPP-2014-0777-0012.


### Comments submitted by ISK, not described below, but that are related to the ecological risk assessment are addressed in the memorandum, Response to Public Comments on the Registration Review Problem Formulationfor the Ecological RiskAssessment andDrinking Water Exposure Assessment to be Conducted for Flonicamid 

### (dated June 12, 2015), available in the flonicamid registration review docket (EPA-HQ-OPP-2014-0777).


### 1. Comment: ISKBC identified several errors in the PWP and supporting documents related to the registered formulation types offlonicamid, registered application methods offlonicamid, and flonicamid products status as not restricted use pesticides. Response: The Agency agrees with the corrections noted by ISKBC, and will use the corrected information in future assessments and descriptions offlonicamid.
2. Comment: ISKBC disputed the characterization offlonicamid as a compound related to the neonicotinoid class ofchemical. ISKBC described the structural and functional differences between flonicamid, nicotinic acid derivative nicotinamide, and neonicotinoids. Response: In the Executive Summary ofthe Human Health Scoping Document the agency states that there is an expectation of similarity between flonicamid and neonicotinoid insecticides (based on structural elements), however flonicamid does not interact with similar receptors in insects. The agency acknowledges that any characterization of similarity between flonicamid and neonicotinoids is inaccurate, and clarifies that flonicamid is neither chemically or biologically similar to the neonicotinoid class ofpesticide.
3. Comment: ISKBC commented on the pollinator data requirement stating that the need for tier II data should not be identified until it is determined so by results oflower tier data.

4Response: The agency is including both Tier I and Tier II pollinator data in its data request; which, as ISKBC notes , is consistent with the risk assessment framework. The**ag~ncy** will determine the need for higher tier studies based upon lower tier data. The agency works closely with registrants as pollinator data is received and will have discussions related to the necessity ofhigher-tiered studies as data is received and analyzed.
Comment submitted by National Alfalfa & Forage Alliance (NAFA) in EPA-HQ-OPP-2014- 0777-0013.
1. Comment: The NAFA provided comment on the importance offlonicamid to control lygus bug, a main pest ofalfalfa seed production, but not produce adverse effects to bees that foraging on alfalfa (alkali and alfalfa leafcutting bees). Response: The Agency thanks the NAFA for its comments and will consider this information during the flonicamid registration review.

5PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for flonicamid based on the 

### Registration Review

- Preliminary Problem Formulationfor the Ecological RiskAssessment andDrinking Water Exposure Assessment to be conducted for Flonicamid , and 

### Flonicamid. Human Health Scoping Document in Support of Registration Review. The agency notes that the Non-guideline study for Honey bee Residues in Pollen and Nectar was inadvertently left offthe list of anticipated data in the PWP

. This requirement is a Tier II exposure study for pollinators and has been included among the data needs for flonicamid, see Table 1 below. All other planned data needs remain unchanged from the PWP.

Table 1: Planned Data Needs for the Flonicamid Guideline Study Title2 Number Environmental chemistry methods and 850.6100 associated independent laboratory validation for water 850.1010 Freshwater invertebrate acute toxicity3 850

.l025 Acute toxicity estuarine and marine organisms (oyster shell growth) 3 850.1035 Acute toxicity estuarine and marine organisms (mysid) 3 850.2100 Avian oral toxicity (passerine species) 850.3020* Honey bee acute contact toxicity3 Non-guideline* Honey bee acute oral toxicity3 Non-guideline* Honey bee chronic oral toxicity 3 Non-guideline* Honey bee larval acute toxicity3 Non-guideline* Honey bee larval chronic toxicity3 Non- Residues in pollen and nectar/field residue guideline** analysis

850.3030* Honey bee toxicity ofresidues on foliage 3 Non-guideline** Honey bee Tier II, semi-field3 850.4100 Terrestrial plant toxicity, seedling emergence 850.4150 Terrestrial plant toxicity, vegetative vigor 870.3465 28-day inhalation toxicity TGAI = technical grade active ingredient; TEP = typical end-use product *Tier 1 (Laboratory-based studi es) Registration Review Estimated Test Material Timeframe

TGAI 12

TGAI 12 TGAI 12
TGAI 12 TGAI 12 TGAI 12 TGAI 12 TGAI 12 TGAI 12 TGAI 12 TEP 

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TEP 12 TGAI, TEP 24 TEP 12 TEP 12 TGAI 24

** Tier 2 and 3 (Semi-fi eld and full fi eld colony-level studi es) The need for a hi gher tier test fo r pollinators will be determined based upon lower-ti ered tests and/or other lines of data and the need fo r a refin ed pollinator ri sk assessment.

2 On June 27 , 2012 , EPA announced certain revisions in harmonized guideline series 850

- Ecological Effects Tests

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including renumbering and other designations or changes for some guideline studies

. See "Final Test Guidelines ; OCSPP 850 Series; Notice ofAvailability" 77 FR 38282, June 27, 2012. http ://www. regulation s. gov/# !documentDetail;D=EPA-HQ-OPPT-2009-0154-0028 3 Study protocols should be submitted for evaluation, and will need to be potentially modified to capture the delayed mortality effects offlonicamid.


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### RISK ASSESSMENTS FOR REGISTRATION REVIEW
Table 2 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 Flonicamid Registration Review 

### Type of Risk Assessment Conduct? Notes Ecological and Environmental Fate

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### Comprehensive ecological y 

### At this time, the planned ecological assessment will (species to be assessed focus largely on the identified uncertainties (i.e. , for include terrestrial and aquatic passerines, terrestrial plants and terrestrial/aquatic organisms) , including invertebrates) and the unique mechanism ofaction endangered species and delayed mortality identified with flonicamid. To the extent possible, the ecological risk assessment for registration review will rely on previous risk assessment analyses. A screening-level analysis of risk to endangered species will be completed as part ofregistration review. Incidents Will check for For a discussion ofreported ecological incidents for updates flonicamid, see page 29 ofthe Problem Formulation. Human Health :,, ,,,

4 M I'**~** 

# . Dietary Food N 

### At this time, an updated dietary (food+ water) analysis is not anticipated since a full dietary assessment for flonicamid was recently completed (Dec., 2013 ; 78 FR 75262). However, the need for an updated dietary (food+ drinking water) analysis will be assessed during registration review. Drinking water y See above 

### Occupational Handlers (mixers, loaders, N 

### An updated or revised post-application exposure applicators) assessment is not planned at this time. However, if results from the subchronic inhalation study change the endpoints and result in lower points ofdeparture, then new occupational handler exposure and risk assessments may be needed. Post-application N See above 

### Residential Handlers N 

### There are no registered residential uses and no residential exposures are expected.**~ost-application** y 

### Residential bystander exposures resulting from offsite transport (i.e., spray drift or volatilization) may occur as a result ofoccupational applications of flonicamid. The need for a bystander risk assessment for flonicamid will be considered during registration review. Other Aggregate N 

### Since there are no residential uses an aggregate assessment for flonicamid is not needed. Cumulative N 

### EPA has not made a common mechanism oftoxicity finding for flonicamid.



### 8Tolerances N There are no CODEX MRLs, but there are several Canadian MRL's for flonicamid. The need to revise
or update the expression or values offlonicamid tolerances will be reviewed during registration review. Incidents Will check for For a discussion ofreported human incidents for updates flonicamid, see page 8 ofthe Scoping Document and the Flonicamid: Tier 1Review of Human incidents.

TIMELINE 

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EPA has created the following estimated timeline for the completion ofthe flonicamid registration review in Table 3 below. The projected timeline has not changed since the PWP.

Table 3: Registration Review for Flonicamid
- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period December 2014

- Completed Close Public Comment February 2014

- Completed Case Development Final Work Plan June 2015

- Completed Issue DCI July

- September 2015 Data Submission July

- September 2017 60-day Public Comment Period for Draft Risk January

- March 2018 Assessments4 Registration Review Decision 60-day Public Comment Period for Proposed July

- September 2019 Registration Review Decision Registration Review Decision and Begin Post-Decision 2019 Follow-up Total (years) 5

NEXT STEPS
As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for flonicamid through a Data Call-In Notice, expected to be issued by September 2015.

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.
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