Docket Number EPA-HQ-OPP-2014-0777 

www.regulations.gov 

Flonicamid Final Work Plan 

Registration Review 

Case Number 7436 

June 2015 

Approved by: r~~,n 

Date: 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

lo /d.i.c / a.01s 

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) 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 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. 

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 of the 

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 of next 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 off the 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 of environmental justice, 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/ 

2 
Comments 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 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. 

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

opening for flonicamid 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 flonicamid in connection with the development of its final 

registration review decision for this pesticide. 

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 N AS 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 

N AS 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 obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop 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 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 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 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 of flonicamid on all taxa of non-target 

wildlife and plants, which will assume that listed species and their designated critical habitats 

3 
may be present in the vicinity of the application of flonicamid. 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 flonicamid 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 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 of data 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 Formulation for the Ecological Risk Assessment and Drinking 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 of flonicamid, registered application methods of flonicamid, 

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 of flonicamid. 

2. Comment: ISKBC disputed the characterization of flonicamid as a compound related to the 

neonicotinoid class of chemical. ISKBC described the structural and functional differences 

between flonicamid, nicotinic acid derivative nicotinamide, and neonicotinoids. 

Response: In the Executive Summary of the 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 of pesticide. 

3. Comment: IS KBC 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 of lower tier data. 

4 
Response: 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 

of higher-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 NAF A provided comment on the importance of flonicamid to control lygus 

bug, a main pest of alfalfa 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. 

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PLANNED DAT A NEEDS 

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

Review - Preliminary Problem Formulation for the Ecological Risk Assessment and Drinking 

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 off the 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. l 025 Acute toxicity estuarine and marine organisms 

(oyster shell growth)3 

850.1035 Acute toxicity estuarine and marine organisms 

(mysid)3 

850.2100 A vi an oral toxicity (passerine species) 

850.3020* Honey bee acute contact toxicity3 

Non-guideline* Honey bee acute oral toxicity3 

Non-guideline* Honey bee chronic oral toxicity3 

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 of residues 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 24 

TEP 12 

TGAI, TEP 24 

TEP 12 

TEP 12 

TGAI 24 

**Ti er 2 and 3 (Semi-fi eld and full fi eld colony-level studi es) The need for a higher 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 risk assessment. 

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-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 of flonicamid. 

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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. 

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Table 2: Planned Risk Assessments for the Flonicamid Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate . ' ' 

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 of action 

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 

of registration review. 

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

updates flonicamid, see page 29 of the 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 of departure, 

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 of occupational 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 of toxicity 

finding for flonicamid. 

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Tolerances 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 of flonicamid 

tolerances will be reviewed during registration 

review. 

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

updates flonicamid, see page 8 of the Scoping Document and 

the Flonicamid: Tier 1 Review of Human incidents. 

TIME LINE I 

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