Docket Number EPA-HQ-OPP

-2014-0777 www.regulations.gov



## Flonicamid Preliminary Work Plan Registration Review: Initial Docket Case Number 7436

Approved by :

Date: 

## December 2014

9z:.<-hcu.cl 

### ;P**"'1.-VL** 1 

## J":> Richard P. Keigwin, 

### Jr. Director Pesticide Re-evaluation Division 

### ...

...

### Flonicamid Preliminary Work Plan- Table of Contents

OVERVIEW
..... . .................................. . ................ .. ........ .. ........ . ... . .............. . .......... . .. . ............. .. .. . .. 4 ANTICIPATED DATA NEEDS
.......... . .. . .. . .. .. . . ... . .. . ..... ...... ..... .. .............. . ...... . . .. .. . ...... .. .. ..... .. . ...... 5 STATUTORY AND REGULATORY AUTHORITY
........................................ . .......................... 6 CHEMICAL FACTS
.................. .. .......... . .. . .. .. .. . .. . ..... . .. . .. . .................... .... .. . ...... . .. . ...... . .. .. .............. 6 USE AND USAGE INFORMATION
. . ................. . ................................ . .. . ...... . ................ . .. .. ..... . .. 7 RECENT ACTIONS
... . . .. ....... . ..... . ..... . ... . ........ . . . ... . .. . .. . ..... .. .. .. ........ .. ........ .. .... .. ..... .. . .. .. .. ................ 8 ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW
.. . . .... . .. .. .......... :...... 10 TIMELINE
............................................. . .. . . .................................................... . ........ . ................ . ... 11 NEXT STEPS
...................................... . .......................... . ....................... . ..................................... 12 Appendix

- Additional Areas Considered in the Flonicamid Registration Review
............... .. 13

References: This Preliminary Work Plan summarizes the Environmental Protection Agency ' s current position based on the following documents: 1. Registration Review

- Preliminary Problem Formulation for the Ecological Risk Assessment and Drinking Water Exposure Assessment to be conducted for Flonicamid. Colleen M. Rossmeisl. November 24, 2014. 2. Flonicamid Human Health Scoping Document in Support of Registration Review. Barry O'Keefe, Cassi Walls, Nancy Dodd, and Myron Ottley. November 25 , 2014. 3. Flonicamid : Tier I Review of Human Incidents. Sharma Recore. September 30 , 2014
. 4
. BEAD Chemical Profile (BCP) for Registration Review: Flonicamid. Colwell Cook, Rafael A. Prieto, and Elizabeth Hill. December 1 , 2014. 5. Flon icamid (128016) Screening Leve l Usage Analysis (SLUA). April23, 2014.

26. Flonicamid EFED Table 1 Report. June 17, 2014. 7. Flonicamid HED Master Label Report. June 17, 2014. These and other supporting documents for the flonicamid registration review case may be found in the docket EPA-HQ-OPP-2014-0777 at http: //www.regulations
. gov .

3OVERVIEW The docket for flonicamid is now open, initiating the first public comment period for this registration review (docket number EPA-HQ

- OPP

-2014-0777). Flonicamid is a systemic pyridinecarboxamide insecticide registered for use against many sap-feeding insects, such as aphids , whiteflies, leafhoppers , plant bugs , and thrips. There are numerous 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. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about flonicamid, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review , and providing an anticipated timeline for completing the registration review for flonicamid. The registration review process was designed to include a public -participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about flonicamid and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on flonicamid. The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency ' s decision

-making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholders could include: environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial , institutional , residential, and other users of pesticides ; or the public at large
. The Preliminar y Work Plan begins by listing the anticipated data needs for flonicamid. Next, it discusses the statutory and regulatory authority for Registration Review. Then the document provides chemical facts, use.and usage information, recent actions , the anticipated risk assessments, and a projected registration review timeline for flonicamid. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in Registration Review along with some additional chemical case - specific information.

4ANTICIPATED DATA NEEDS Table 1 below summarizes anticipated data needs for flonicamid. For additional discussion of the anticipated data needs , see the Registration Review- Preliminary Problem Formulation for the Ecological Risk Assessment and Drinking Water Exposure Assessment to be conducted for Flonicamid and the Flonicamid Human Health Scoping Document in Support of Registration Review which can be found in the docket EPA-HQ-OPP-2014

- 0777 at http: //www.regulations.gov. Table 1: Anticipated Data Needs for the Flonicamid Registration Review Estimated Guideline Study Title 1 Timeframe Number• Test Material (Months from receipt of DCI) 850.6100 Env ironmental chemistry method s and associated TGAI 12 independent laboratory validation for water 850.1010 Freshwater invertebrate acute toxicity2 TGAI 12 850.1025 Acute toxicity estuarine and marine organisms TGAI 12 (oyster shell growth)2 850.1035 Acute toxicity estuarine and marine organisms TGAI 12 (mysid) 2 850.2100 Avian oral toxicity (passerine species) TGAI 12 850.3020 Honey bee acute contact toxicity 2 TGAI 12

Non- Honey bee acute oral toxicity 2 TGAI 12 guideline

Non- Honey bee chronic oral toxicity 2 TGAI 12 guideline

Non

- Honey bee larval acute toxicity 2 TGAI 12 guideline

Non- Honey bee larval c hr onic toxicity2 TGAI 12 guideline 850.3030 Honey bee toxicity of residues on foliage2 TEP 12

No"n- Honey bee Tier II, semi-field2 TGAI, TEP 24 guideline 850.4100 Terrestrial plant toxicity , seedl ing emergence TEP 12 850.4150 Terrestrial plant toxicity , vegetative vigor TEP 12 870.3465 28-day inhalation toxicity TGAI 24 TGAI = technical grade active ingredient; TEP = typ1cal end-use product;

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

- Ecological Effects Tests

- including renumbering and other de signations or changes for some guideline studies
. See "Final Test Guidelines ; OCSPP 850 Series ; Notice of Avai lability" 77 FR 38282, June 27 , 2012
. http: // www.regul ations.go v /#! docume ntDetail;D=EPA-HQ-OPPT-2009

-0154

-0028 2 Study protocols should be submitted for evaluation, and will need to be potentially modified to capture the delayed mortality effects offlonicamid. 5STATUTORY AND REGULATORY AUTHORITY The Food Quality Protection Act (FQPA) of 1996 mandated a registration rev iew program. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. 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 ofno unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided on EPA's website. 3 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. The regulations governing registration review begin at 40 CFR § 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency's opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period , the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of flonicamid. CHEMICAL FACTS Table 2 provides a summary of the chemical facts for flonicamid. Table 2: Chemical Facts for Flonicamid PC code 128016 Case Number 7436 CAS Number 15 8062-67-0 Year first registered 2003 Pesticide Type Insecticide Chemical class pyridinecarboxamide Reregistration Eligibility Because it was registered after November 1984 , flonicamid was Decision (RED) not subject to reregistration. Tolerance Reassessment Not applicable Eligibility Decision (TRED)

3 http :// www.epa .gov /oppsrrd 1/registration_review/ 6

### Table 2: Chemical Facts for Flonicamid Cumulative group Not applicable. Flonicamid has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation To lerances for flonicarnid are established in 40 CFR §180.613. Dual-use Flonicarnid is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non

-pesticidal uses There are no identified non-pesticidal uses of flonicarnid. Pesticide Re

-evaluation Ricardo Jones Division, Chemical 

### Jones.ricardo@epa. gov Review Manager 703-347-0493 Registration Division, Carmen Rodia Product Manager Rodia.carmen @epa.gov 703

- 3060327 

### USE AND USAGE INFORMATION Table 3 summarizes the use and usage information for flonicarnid. For more details please see the BEAD Chemical Profile (BCP)for Registration Review: Flonicamid which can be found in the docket EPA

-HQ

- OPP

-2014-0777 at http: //www
.regulations.gov.

Summary of Use

Use Sites

Summary of Usage 

### Table 3: Flonicamid Use and Usage Information Systemic insecticide registered for use against many sa p-feeding insects such as aphids, whiteflies, leafhoppers , plant bugs, and thrips. Flonicarnid products are often used as part of a broader integrated pest management strategy and can be used in rotation with other pesticides to reduce or delay resistance in target pests, especially in crops such as fruiting vegetables, leafy vegetables, celery , and carrots . Flonicarnid is registered for use on pome fruits, stone fruits, tree nuts , berries, hops ,**cot~on,** vegetables (including leafy, fruiting, and root/tubers) , legumes, and crops grown for oil. It is also registered for use on commercial ornamentals , interiorscapes, and nurseries . Based upon proprietary data, between 2006-2012 , flonicarnid annual agricul tural usage was approximately 19,000 pounds a.i., treating an average of260,000 acres. From 2004- 2012, the crop with the highest us age (in pounds a.i. applied per year) is cotton with 10,000 average pounds used per year. The next highest usage crop s were potatoes (3,000 average pounds per year) then alfalfa, celery and lettuce with 1,000 pounds used each.

7Table 3: Flonicamid Use and Usage Information Proprietary data available to EPA also reported about 50 pounds offlonicamid used on US ornamental and turf in 2012. Formulation
.Type(s) Dry flowable , flowable concentrate, pressurized liquid, and emulsifiable concentrate. Application Method(s) Products can be applied by aerosol application, band treatment, broadcast, chemigation, dip treatment, directed spray, high volume spray (dilute), root treatment, seed treatment, soil drench treatmen t, soil in-furrow treatment, spot treatment, and spray. Technical Registrant(s) ISK Biosciences Corporation No. of Registrations 8 - Section 3 registrations and 12- 24C (Special Local Need) registrations 4 Restricted Use No Guidance for Commenters : Additional areas of use and usage related information requested for this registration review, and ofparticular interest to EPA, are described below.
• The application rates included on the currently registered labels are on a per season/crop cycle basis. Information is needed on the number of applications of flonicamid that can be applied per calendar year, as several of the currently registered uses may result in multiple seasonal applications per year. • Site /crop specific inf ormation on the target pests , damage, economic thres ho lds, best time to treat, as well as alternatives to floni camid. • Site/crop specific information on the formulation, application method, application rates , frequency of application, and timing of applications.
. • Site /crop specific information on barriers of adopting chemical and non-chemical alternatives to flonicamid (e.g. price, efficacy, application methods, use restrictions , etc.). Typical application timing (date of first application and application intervals)

- national, state, and county. • Usage/use information for non-agricultural uses. • Typical application interval (days) for non- agricultural uses offlonicamid. • State or local use restrictions. • Foreign technical registrants not li sted above who supply technical flonicamid to the US market. RECENT ACTIONS In December 2013 new uses and tolerances were established for flonicamid inion alfalfa and clover grown for seed, mint, greenhouse grown tomatoes, and tree nuts (78 FR 75262). ANTICIPATED RISK ASSESS MENTS FOR REGISTRATION REVIEW

4 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http: / /oaspub.epa.gov/pestlab 1/ppls. home). 

### 8The most recent comprehensive human health risk assessment for flonicamid was completed on August 20, 2013 for a new use request for alfalfa and clover grown for seed. The most recent ecological and environmental fate risk assessment was completed in 2013 for the same purpose. Findings and conclusions from these risk assessments are summarized in the Registration Review

- Preliminary Problem Formulation for the Ecological RiskAssessment and Drinking Water Exposure Assessment to be conducted for Flonicamid and 2. Flonicamid Human Health Scoping Document in Support of Registration Review which can be found in the docket EPA-HQ

- OPP2014-0777 at http :// www.regulations.gov. · During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of flonicamid. For human health, EPA will examine the need for a bystander risk assessment, and does not anticipate the need to update or revise the post
- application exposure analysis. However, any revision to the occupational handler assessment will be contingent upon the results from the subchronic inhalation study that is anticipated to be required. If other 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 well as any changes to the standard operating procedures or default exposure assumptions. Table 4 below summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Seeping Document.

9Table 4: Anticipated Risk Assessments for the Flonicamid Registration Review Type of Risk Assessment Conduct? Notes**Ecolo~ical** 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 ofthe Problem Formulation. Human Health Dietary Food N An updated drinking water assessment may be conducted during registration review, which may impact the need to revise the dietary analysis. Dr inking water y See above Occupational Handlers (mixers, loaders, N An updated or revised post
- application exposure applicators) assessment is not anticipated at this time. However, if results from the subchronic inhalation**~tudy** that is expected to be required 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
. Post

- 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. T he 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 findin g for :flonicamid.

10Tolerances N There
. are no CODEX MRLs, but there are several Canadian MRL ' s for flonicamid. Revisions or updates to flonicamid 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 I Review of Human Incidents
. Guidance for Commenters: Additional ecological information requested for this registration review , and ofparticular interest to EPA, is described below.
• Ecological incidents (non

-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency. • Water quality monitoring data (see Appendix for further details). Guidance for Commenters: Additional human health information requested for this registration review, and of particular interest to EPA, is described below.
• Human incidents not already reported to the Agency. TIMELINE EPA has created the following estimated timeline for the completion ofthe flonicamid registration review in Table 5 below. Table 5: Projected Flonicamid 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- May Issue DCI 2015 July- Sept. Data Submission 2017 July

- Sept. 60

-day Public Comment Period for Draft Risk 2019 Jan.

- March Assessments 5 Registration Review Decision 60-day Public Comment Period for Proposed 2019 Oct.

- Dec. Registration Review Decision Registration Review Decision and Begin Post-D ecision 2020 Follow-up Total (years) 6

5 The regulations governing Registration Review generally require the Age ncy to provide a public comment period

of at l east 30 cal endar days for draft risk assessments; see 40 CFR Part l55.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period generall y for draft risk assessments. 11

# ..

,, NEXT STEPS After the 60

- day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration review of flonicamid
.

12

### Appendix - Additional Areas Considered in the Flonicamid Registration Review PUBLIC COMMENTS AND FEEDBACK: Guidance for Commenters : The areas below highlight topics of special interest to the Agency where your comments , data submissions , or reference to sources of additional information could be ofpartic
. ular use. Trade Irritants: Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution
. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so , when possible. Growers and other stakeholders are asked to comment on any trade irritant**issu~s** resulting from lack ofMRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature ofthe concern. Water Quality: Flonicarnid is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) ofthe Clean Water Act. 6 In addition, no Total Maximum Daily Loads (TMDL) ha ve been developed for flonicarnid. 7 More information on impaired water bodies and TMDLs can be found at the Agency' s website. 8 The Agency invites submission ofwater quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e : Inclusion of Impa ired · Water Body and Other Water Quality Data in OP P 's Registration Review Risk A ssessment and Manag ement Process 9 in order to ensure they can be used quantitatively or qualita tively in pesticide risk assessments. Environmental Justice: EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people , regardless ofrace, color, national origin, or income, in the development, implementation , and enforcement of environme ntal laws , regulations , and policies. To help address potential env ironmental justice is sue s, the Agency seeks information on any groups or segments of the population who , as a result of their location, cultural practices, or other f actors, may have atypical , unusually high exposure to flonicarnid compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

6 htt p:/ / iaspub
.epa .gov/ tmdl w a tersl O /attain s nation c y .ca u se detai l 303d?p c ause gro up id=8 8 5 7 http ://iaspub. epa. gov/ tmdl w aters I 0/attains na tion. tmdl polluta nt detail?p p ollutant group id=8 8 5&p p o llutant group name=PESTI CIDES 8 http:/ /www.epa.gov/owow/tmd l / 9 http: //www .epa .gov/oppsrrd !/registrat ion review/water qualit y s op.htm 13ENDANGERED SPECIES: A risk assessment that supports a ·complete endangered species determination has not been conducted for flonicamid. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of flonicamid has " no effect" or " may affect" federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide's use "may affect" a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service · and/or National Marine Fisheries Service (the Services), as appropriate. ENDOCRINE DISRUPTOR SCREENING PROGRAM: As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental , reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology , organ weights , estrus cyclicity , sexual maturation, fertility, pregnancy rates , reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth , developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for flonicamid , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p ) , flonicamid is subject to the endocrine screening part ofthe Endocrine Disrupter Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate. " The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assay s to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A , or T) hormonal systems . Chemicals that go through Tier 

### 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage ofthe EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data
. Tier 2 testing is designed to identify any adverse endocrine

-related effects caused by the substance, and establish a dose

-response relationship between the dose and theE, A , or T effect. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals , which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14 , 2013 10 and includes some pesticides scheduled for registration review and chemicals found in water. Neither of these lists should be construed as a list ofknown or likely endocrine disrupters.

10 S ee http: //www.regulations
.gov/# !documentDetail;D=EPA-HQ

-OPPT

- '009-0477

-0074 for the final second list of

chemicals. 14For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists , the test guidelines and the Tier 1 screening battery, please visit our website. 11 HUMAN STUDIES: Past flonicamid risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure da tabases such as the Pesticide Handlers Exposure Database (PHED) , the Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases , and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted
. All applicable requirements of EPA's Rule for the Protection
.ofHuman Subjects of Research (40 C FR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies
.

11 http :// www . epa .gov / endo/ 15