Docket Number: EPA

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- 0920 www.regulations.gov



## Dinotefuran Final Work Plan Registration Review

June 20 1 23 Introduction:

This is the Environmental Protection Agency’s (EPA o r the Agency) Final Work Plan (FWP) for the registration review of dinotefuran. The FWP includes the expected registration review timeline. The FWP also addresses any public comments received on the Preliminary Work Plan (PWP) in the Summary Document

, wh ich was posted in the dinotefuran registration review docket ( EPA

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, dated December 14 , 2011, provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Ag ency believes are needed to make a registration review decision.

The Agency’s implementation of the registration review program requires review of each registered pesticide every 15 years to determine whether it continues to meet the Federal

Insecticide , Fungicide, and Rodenticide Act (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 a s policies and practices change, all registered pesticides continue to meet that statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

.

Dinotefuran is a broad

- spectrum , second generation neonicotinoid insecticide that is currently registered for agricultural use o n a variety of food and fee d commodities, including: brassica; leafy and fruiting vegetables; grapes; curcurbits ; pineapp le; and nut trees

. I t is also register ed for

non

- agricultural use i n residential and commercial settings, including : forest trees ; ornamental s ( plants, lawns and turf ) ; pets and pet premises ; and commercial

, institutional

, and industrial buildings

. Dinotefuran was first registered for use in the United States in 2004 and

, therefore

, was not subject to r eregistration under FIFRA. There are currently thirty

- seven FIFRA Section 3 product registrations

, and sixteen S ection 24 (c) Special Local Need (SLN) registrations for use

on turf, ornamental, and vegetable transplants in enclosed structures

.

Updates Since the Summary Document was Issued:

As mentioned in the dino tefuran PWP, a fur dislodgeability study (Guideline 875.2300) was previously required as a condition of registration for dinotefuran dog and cat spot

- on products ( due January 26, 2013 ). I n addition, this study is required in support of registration review

. After the dinotefuran PWP was issued, a f ur d islodgeability study was submitted to the Agency and is currently in review . EPA expects to finish its review of this study prior to issuance of the registration review data call

- in ( DCI ) . Once the study ha s been reviewed and classified, EPA will determine whether or not it should be included in the registration review DCI

.

Comments Received on the Preliminary Work Plan:

The dinotefuran docket was open for a 60

- day comment period, beginning December 21, 20 11 and closing February 21, 2012 . During the 60

- day comment period, one public comment was
received regarding dinotefuran

. Th is comment is addresse d below and did not result in change s to the work plan

, data requirements, or timeline as de scribed in the dinotefuran Summary

Document and PWP. T hree comments relevant to another neonic otinoi d registration review4 case, clothianidin, were inadvertently posted to the dinotefuran docket and are not addressed in this FWP. For further information regarding these comments and the Agency’s response, refer to

the clothianidin docket (EPA

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- 0865 ).

Comment : Jeff Durand of Durand Farms in St

. Martinville

, Louisiana commented that dinotefuran is very important to southern Louisiana ’s rice crop for controlling rice stinkbugs . In his comments, Mr. Durand noted the following: (1) d inotefuran was very effective in controlling ri ce stinkbugs on

their 2011 rice crop ; (2) he did not observe injury to crawfish which were harvested from his ponds located close to the d inotefuran

- treated rice crop s ; and, (3) he believes that dinotefuran will play a significant part in managing pest resistance because it is a different class of chemistry

and c an be rotated with pyrethroids, in some areas.

Agency Response : The Agency tha nks Mr. Durand for his comment and will consider this informati on during registration review.

Risk Assessment and Data Needs:

The Agency will requir e data for use in conduct ing a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of dinotefuran . The Agency will also require data for use in conducting an updated human health risk assessment for registration

review

. A summary of the issues relevant to the registration review of dinotefuran is given

bel ow

.

E cological Risk :

**•** The most recent comprehensive ecological risk assessment for dinotefuran was completed in 2004 in support of its initial registration for use on leafy vegetables, turf

grasses
, and various residential uses. All subsequent ecological risk assessments have

relied on the conclusions of this assessment.

**•** The most recent ecological risk assessment in support of FIFRA Section 3 registrations

was c ompleted on May 3, 2011 for forestry use s ( Christmas trees, trees in plantations,

reforestatio n nurseri es, forests, and woodland areas ). In June 2011

, an ecological risk

assessment was completed in support of FIFRA S ection 18 e mergency exemptions for use on commercial pome and stone fruit to control the b rown m armorated s tink b ug during the 2011 g rowing season ; these Section 18 exemptions expired on October 15,

2011

.

**•** The Agency has not conducted a risk assessment that supports a complete endangered species determination for dinotefuran

. The ecological risk assessment planned during registration r eview will allow the Agency to determine whether dinotefuran use 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 use5 “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.

**•** On January 19, 2011, the Center for Biological Diver sity and the Pesticide Action

Network North America filed a lawsuit in the United States District Court for the Northern District of California, against the Environmental Protection Agency (EPA) for allegedly failing to undergo consultation with the Servic e s regarding the effects of over 350 pesticides, including dinotefuran, on over 200 endangered and threatened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C

11

- 00293 (N.D.Cal.).

**•** The Agency is requiring the following data for use in conduct ing a comp rehensive ecological risk assessment, including an endangered species assessment , for the registration review of dinotefuran :

o GDLN 835.4400

– Anaerobic Aquatic Metabolism

o GDLN 850.1350

– Estuarine/Marine Inve rtebrates

– L ife C ycle T est (mysid)

o GDLN 850.2100

– Acute Avian Oral Toxicity ( p asserine)

o GDLN 850.3040

– Field Testing for Pollinators

o Non

- G DLN

– Pollinator Larval Toxicity S tudy (Special Study)

o Non

- G DLN

– Lab oratory Pollinator Chronic Feeding S tudy (Spec ial Study)

o Non

- G DLN

– Residues in Pollen and Nectar /Field Residue Analysis (Special Study)

**•** The EPA is aware of registrant

- submitted studies and other open literature studies regarding the potential effects of neonicotinoid insecticides on insect pollinato rs and specifically on honey bees. The Agency is also aware of concerns regarding the potential association between the use of neonicotinoids and honey bee losses characterized as Colony Collapse Disorder (CCD) and the broader phenomenon of declining hone y bee health globally. While a number of factors ( e.g ., nutrition, habitat loss, disease, parasites, bee management practices, and pesticides) have been hypothesized, no single factor has yet to be identified as the “cause” of declines.

As part of the r eview process, EPA examines the effects of chemicals on bees based on both laboratory and when appropriate, field studies to determine whether individual bees and entire bee colonies may be affected by the use of a compound and to support risk mitigation d ecisions. EPA is currently revising its process for assessing pesticide risks to bees to reflect advancements in the state of the science that underlie bee exposure and effects assessments. Interim guidance (USEPA 2011 1

1 USEPA. 2011. Pesticides: Science and Polic y. Interim Guidance on Honey Bee Data Requirements. ) on factors to consider when

evalu ating exposure and effects to bees is available to ecological risk assessors. In 2012, EPA will present to a FIFRA Scientific Advisory Panel (SAP) a proposed process for

http://www.epa.gov/pesticides/science/efed/policy_gui dance/team_authors/terrestrial_biology_tech_team/honeybee _data_interim_guidance.htm6 quantifying risks to honeybees and identifying exposure and effect studies needed to inform that process. Based on input from the SAP, EPA will incorporate its revised assessment process to quantify risks to bees in a similar manner as that used to evaluate

risks to other taxa.

As EPA’s understanding of the science evolves, its need for data and its evaluation of those data will evolve as well. Therefore, as with all taxa, EPA reserves the right to require additional data it deems necessary to inform its understanding of potential ecological risks and support its associated risk managem ent decisions. Additional data requirements for pollinators may extend beyond those identified in problem formulations and preliminary work p lans written in support of the registration r eview process.

**•** The Agency has also identified additional informa tion needs (i.e.

, independent laboratory validation, purity of test compounds, missing study information) regarding several existing studies , which are described in “ Appendix C ” of the Problem F ormulation ; and, is interested in receiving information to sup plement these existing data. This

information , though not considered data gaps, will be useful in refining potential ecological risks and reducing the use of default assumptions for the registration review of

dinotefuran

.

**•** Please refer t o the December 13, 2011 document, Registration Review

– Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Dinotefuran

, located in docket EPA

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.

Human Health Risk :

**•** The most recent human health risk assessment for dietary , residential and aggregate

exposure of dinotefuran w as conducted in May of 2011 in support of the FIFRA Section

18 e mergency exemptions for use on p ome and stone fruits

. T he most recent human

health risk assessment for occupational exposure ( in support o f FIFRA Section 3 registrations) was conducted in February 2011 for forestry use s

.

**•** The existing human health toxicity database is sufficient and the Agency will not require

additional toxicity data in support of registration review. However, the Agency will re

evaluat e toxicological endpoints (points of departure) and uncertainty factors

, and updat e the human health toxicity profile at the time of th e risk assessment, as needed

.

**•** D uring registration review, a revised dietary (food and drinking water) risk assessment may be needed to incorporate refined estimated drinking water concentrations (EDWCs)

, updated food residues and Pesticide Data Program (P DP) data

, and any changes to toxicological points of departure or uncertainty factors

.

**•** The residential and occup ational exposure databases for dinotefuran are adequate with the exception of the following study , which is needed for use in this registratio n review

.7 This study will be used to assess exposure of dinotefuran to humans handling pets treated with spot

- on product s.

o GDLN 875.2300

- Fur Dislodge ability

This study has been identified previously as a conditional requirement for the registration of dinotefuran dog and cat spot

- on products.

**•** T he Agency will revise residential and occupational handler and post

- application risk

assessments using standards and exposure and/or risk assessment policies/procedures that are in place at the time of the ris k assessment

, including any changes to the points of departure or the uncertainty factors

.

**•** The Agency will be revising t he aggregate risk assessment using standards and exposure and/or risk assessment policies / procedures that are in place at the time of t he risk

assessment ; including any changes to the points of departure or the uncertainty factors;

and potential changes to dietary exposure estimates from food and/ or drinking water (e.g., updated EDWCs )

.

**•** Residential and occupational bystander inhalation e xposure may occur as a result of

dinotefuran aerial applications and/or off

- site transport (e.g.

, spray drift or volatilization). The Agency is examining its policies and procedures regarding inhalation risk assessment, and will re

- evaluate the need for r esidential and occupational bystander risk

assessment s based on current Agency policy at the time of the risk assessment.

**•** The tolerance expression in 40 CFR §180. 603 has been reviewed to ensure that it appropriately covers the metabolites and degradates o f dinotefuran and that it specifies the residues to be measured for each commodity.

**•** There are no established or proposed international Codex, Canadian, or Mexican MRLs for dinotefuran. However, should MRLs be established, the Agency will work to

harmoniz e tolerances/MRLs, where possible, in key export markets during registration

review.

**•** P lease refer to Dinotefuran . Human Health Scoping Document in Support of Registration Review

, September 15

, 2011

, located in the docket, for a detailed discussion

of the risk assessment and data needs for human health

.

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 acu te, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be8 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 tha t assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for dinotefuran

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenari os from the existing hazard database. However, as required by FFDCA section 408(p), dinotefuran is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substa nces (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 assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Ch emicals 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 of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable 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 the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen a ll 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. Dinotefuran is not among the group of 58 pes ticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screening assays for dinotefuran. For further info rmation on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

Timelin e:

EPA has created the following estimated timeline for the completion of the dinotefuran registration review

.

Registration Review for D in o tefuran

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Pu blic Comment Period 2011

– December

Close Public Comment 2012

– February Case Development

Final Work Plan 2012

– June

Issue DCI 2013

– Jan.

– March

Data Submission 201 6

– Jan.

– March9 Registration Review for D in o tefuran

– Projected Registration Review Timeline

Activities Estimated Date Open Public Comment Period for Draft Risk Assessments 201 7

– July

– Sept.

Close Public Comment Period 201 7

– Oct.

– Dec. Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 201 8

– Jan.

– March

Close Public Comment Period 201 8

– April

– June Registration Review Decision and Begin Post

- Decision Follow

- up 201 8 Total (years) 7

Next Steps:

The Agency will require ecological effects and human health studies through a DCI , which is expected to be issued in early 2013. This new information will be used to conduc t risk assessments for all registered uses of dinotefuran.10 Summary of Data Needs

– Dinotefuran:

The table below summarizes the data needs for dinotefuran . For additional discussion of the data needs, see the Registration Review

– Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Dinotefuran

, December 13, 2011

, a nd Dinotefuran. Human Health Scoping Document in Support of Registration Revie w , Decembe r 15, 2011

.

Ta ble 1. Data Needs for Dinotefuran Registration Review

Guideline

Number Data Requirement Test

Material Estimated

Timeframe

(Months from receipt

of DCI)

835.4400 Anaerobic Aquatic Metabolism TGAI 24

850.1350 Estuarine/marine I nvertebrate s

– L ife C ycle (mysid species) TGAI 12

850.2100 Avian Oral Toxicity (passerine species) 2 TGAI 12

850.3040 Field T esting for P ollinators 3 TEP 24

Non

- Guideline (Special Study) Pollinator L arval T oxicity S tudy 4 TGAI 12

Non

- Guideline (Special Study) Lab or atory Pollinator Chronic F eeding S tudy 4 TGAI 12

Non

- Guideline (Special Study) Residues in P ollen and N ectar /Field Residue Analysis 4, 5 TGAI 36

875.2300 Fur Dislodgeability TGAI January 26,

2013

( In review ) 6

2 The DCI will require the submission of a study protocol for review and approval by the Agency prior to study

initiation.

3 The DCI will require that the test crop be one on which bees will actively forage for both nectar and pollen (e.g., cotton, melon, alfalfa).

4 The DCI will require the submission of a study protocol for review and appro val by the Agency prior to study

initiation. T he registrant should not assume t hat any California Department of Pesticide Regulation data have

satisfied the Agency data requirements.

5 The Agency recommends residue studies of leaves, fruit, seeds, wax, sap, as well as blooming, pollen

- shedding, and nectar producing parts ( i.e. , flowe rs and, if present, extra floral nectarines) on pollinator

- attractive crops on which the compound is registered for use.

6 I n addition to being a data requirement for the registration review of dinotefuran , GLN 875.2300, fur dislodgeability is required as a condition of registration for dinotefuran dog and cat spot

- on products . Conditions stipulate a due date of January 26, 2013 and the Agency still requires the study by this date. This study was r ecently

submitted to the Agency and is currently in review . O nce the study has been fully reviewed and classified, EPA will determine whether or not it should be included in the registration review DCI

.