UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

Flupyradifurone: Response to Public Comment s on EPA’s “Proposed Registration of the New Active Ingredient Flupyradifurone” (Docket ID: EPA-HQ-OPP-2013-0226)Page 2 of 12 Summary

This document summarizes the U.S. Environmen tal Protection Agency’s (the Agency, EPA) responses to public comments received through th e public notification of the receipt of the application for registration of the new active in gredient flupyradifurone, and the announcement of the proposed decision to unconditionally regi ster flupyradifurone under Section 3(c)5 of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA).

The Agency, as required by FIFRA, published in the Federal Register on May 29, 2013 a Notice of Receipt (NOR) of applications for regi stration of flupyradifurone, submitted by Bayer CropScience, and announced a public comment peri od of 30 days. Two comments were received during this period. The first expressed concern that neonicotinoid chemicals and other toxic substances are poisoning the environment, speci fically citing concerns over cancer (generally) and concerns regarding pollinator exposure to toxic substances. The second comment was not specifically directed toward the application to re gister flupyradifurone but generally directed at the registration of pesticides. Both comments were addressed in the Proposed Registration Decision document, available in the regulat ions.gov docket (Document ID: EPA-HQ-OPP-2013- 0226-0015).

EPA announced the proposed decision of the unconditional registration of flupyradifurone on September 25, 2014, and held a public comment pe riod for 30 days. Twenty-three distinct comments posted to the docket dur ing the public comment period (t wenty-one in support of the Agency’s proposed decision, two opposing the Ag ency’s decision). The Agency’s review and responses are summarized in this document.

Summary of Comments Supporting the Agency’s Proposed Decision

There were twenty-one comments submitted to the docket supporting the Agency’s proposed decision to register flupyradifurone as a new insecticide active ingredient. Comments were submitted by University Research and Extension ag ents, IR-4, as well as grower and commodity organization groups representing potatoes, appl es, hydroponic tomato and cucumbers, citrus, hops, cotton, winegrapes and alfalfa. Specifical ly, University Agricult ural Researchers and Extension agents cited the growing need in the south, southeast and midwest for effective

insecticide tools for use in cott on and cereal grains (sorghum) to combat key pests that have a propensity to rapidly develop resistance, su ch as the cotton aphid and surgarcane aphid (Document IDs: EPA-HQ-OPP-2013-0226- 0016, -0017, -0024, -0025, -0026, -0035). Researchers and commodity groups commented on the lack of effective tools to control whiteflies, aphids and leafhoppers in vegetable crops (squash, toma toes, potatoes), tree nuts, and fresh fruit crops, where flupyradifurone has shown e ffective control of thes e target pests with a new mode of action (Document IDs: EPA-HQ-OPP-2013-0226-0019, -0024, -0027, -0032, - 0038). Commenters also noted flupyradifurone ha s shown effective control of additional key devastating pests such as hop aphids (EPA -HQ-OPP-2013-0226-0034), Asian citrus psyllid in Florida and California (EPA- HQ-OPP-2013-0226-0020, and -0031), spider mites and blue alfalfa aphid in alfalfa (EPA-HQ-OPP-2013-0226-0028, and - 0041). Commenters also noted that therePage 3 of 12 is an identified lack of cross-resistance between other insecticides targeting the same target pests and flupyradifurone which make it an effective tool in an Inte grated Pest Management (IPM) program (EPA-HQ-OPP-2013- 0226-0019, -0020, -0030, -0040).

As the commenters noted, flupyradifurone demons trates efficacy against a variety of piercing, sucking insects, including speci es that are challenging to co ntrol (e.g., scales, whiteflies), transmit disease (Asian citrus psyllid) and/or are known to ra pidly develop resistance (e.g., whiteflies). Registration of flupyr adifurone can provide growers with a new pest management

tool with a new mode of action that has no evidence of cross-resi stance with currently registered pesticides.

Comment: Pollinator Stewardship Council, Mich ele Colopy, Program Director (Document ID: EPA-HQ-OPP-2013-0226-0033)

Though the commenter does not explicitly stat e which public document they are submitting comments on, the Agency understood the comments to be attributable to the “Environmental Fate and Ecological Risk Assessm ent for Foliar, Soil Drench, and Seed Treatment Uses of the New Insecticide Flupyradifurone (BYI 02960)” (Document ID: EPA-HQ-OPP-2013-0226- 0010). The environmental fate and ecological data submitted in support of the registration decision for flupyradifurone is relatively compre hensive. These data have been reviewed by EPA, Health Canada’s Pest Management Regulat ory Agency (PMRA), the Australian Pesticides and Veterinary Medicine Au thority (APVMA) and the Aust ralian Department of the

Environment. All of the studies have been cat egorized as scientifica lly sound and appropriate for use in assessing the potential risks of flupyradifurone to both humans and the environment. Since there are numerous comments within the submitted document, individual comments are summarized below followed by the Agency’s response to each numbered comment.

1) Flupyradifurone has greater persistence in the water column than sediment, thus exposing honey bees through the ingestion of water with a Flupyradifurone half-life of 330.1 days.

EPA Response:

While flupyradifurone is characteri zed as persistent to very persistent in soil, sediment and water, the available environmental fate data indicate that the compound degrades rapidly via aqueous photolysis with DT50 values of 2.5 days. Although aqueous photolysis would be limited to surface waters that are shallow/clear, it is likely that these conditions would be present where honey bees ( Apis mellifera L.) may be ingesting water.

2) Flupyradifurone is very highly toxic to freshwater insects, and the chemical is mobile and persistent in the water. You clearly state “m ethodologies are not av ailable to determine

the distance that is needed to eliminate the risk concern from transport to runoff.”

EPA Response:Page 4 of 12 As an insecticide, flupyradifurone may be expected to be toxic to non-target insects (invertebrates) whether they are located in te rrestrial and/or aquatic environments. The ecological effect data indicate a relatively broad range of sensitivities in aquatic and terrestrial invertebrates. The compound is classified as sl ightly to practically non-toxic to freshwater invertebrates ( Daphna magna ) on an acute exposure basis while is it very highly toxic to benthic invertebrates ( Chironomous riparius ). As noted by the Commenter, the environmental fate data indicate that the compound is more likely to be associated with the water column than the sediments; therefore, the likelihood of exposure to benthic invertebrates is reduced. The second part of the comment above regarding the reduc tion in exposure with distance from the treated site is contextually part of the labeling statem ent advising the pesticide applicator to install a maintained vegetative buffer between the treated site and sensitive aquatic systems. The Agency recognizes that any setback buffer, vegetative or otherwise, between a water body and the treated field is expected to reduce e xposure, however, methodologies are not available to determine the

exact distance that is needed to eliminate the ri sk concern from transport in runoff because of the complex dissipation and degradation that occurs within the buffer. Therefore the Agency included a maintained vegetative buffer statement on the label in order to reduce the potential exposure of flupyradifurone in water bodies re sulting from runoff of the treated field.

3) ...the research appears to show this systemic insecticide may not be acutely toxic upon the first exposure, but the second and third applications show effects upon honey bee mortality, behavior, brood development, and food storage. You also stated there is a “potential for effects of Flupy radifurone to non-target terr estrial arthropods” “at or below proposed application rates.”

EPA Response:

The comment is apparently based on an understa nding of research ac ross multiple systemic insecticides; however, the assessment is specif ic to flupyradifurone and is not intended to generalize across all systemic insecticides as su ch an analysis is beyond the scope of the risk assessment. Flupyradifurone has a relatively comprehensive database with respect to the potential effects of the compound on honey bees. Semi- and full-fi eld studies accounted for the systemic uptake of the compound by plants as we ll as potential for dir ect contamination of pollen, nectar and bees via foliar applications through their use of see d, soil drench and foliar applications within the same study. These studies evalua ted a range of colony-level measurement endpoints that included effects on developing brood (eggs, larvae, and pupae) and adults during, immediately afte r and for prolonged periods follo wing exposure. None of the studies indicated any long-ter m effects on bee colonies from exposure through overwintering. The label limits the applicati on of flupyradifurone to a single season per year (especially for pollinator attractive crops); therefore, the appl ication scenarios evaluated in the field-based studies of honey bees are belie ved to represent worst-case expos ures from residues taken up by the plant and distributed to pollen/nectar as well as thos e that may occur through foliar deposition. None of these studi es demonstrated any long-term adverse effect on honey bee

colonies.Page 5 of 12 4) Flupyradifurone degrades into four other products: 6-ch loronicotinic acid (6-CANwhich is a degradate for Flupyradifurone, a cetamiprid, and imidacloprid); difluoroacetic acid (DFA); BYI 02960-succinamide (M48 ); and BYI 02960-azabicyclosuccinamide (M47). These degradates you state are persist ent in aquatic environments with half-lives of 3-951 days. Additionally, Flupyradifurone and its degradates were found in the “top 15 cm” of soil, but as deep as 40cm. A “ portion of applied Flupyradifurone does have the potential to build up in soil with subseque nt applications from year to year.” The degradates may not appear to be more to xic than their parent chemical, but you acknowledge “toxicity studies with transformation products we re not carried out at high enough concentrations to defin itively conclude that they ar e not of equal or greater toxicity to the organism s tested as compared to the parent compound.”

EPA Response:

Across the species tested with th e degradates of flupyradifurone, the studies either resulted in non-definitive endpoints where the median lethal c oncentration to 50% of the organisms tested ( i.e ., LC 50 ) exceeded the highest concen tration tested or the LC 50 value exceeded the limit test concentration of 100 mg/L. The ri sk assessment chapter is correct in noting that in cases where

the LC 50 is non-definitive, studies were not conducted up to the same concentrations as the parent compound. Based on the available data t hough, there is no evidence to indicate that any of the degradation/transformation products ar e more toxic than the parent compound.

5) The research concerning the residues of Flupyradifurone in n ectar and pollen found different levels of the chemic al in pollen and nectar, the leve l varied per plant, and if the plant had extra nectaries. Pollen appeared to contain higher levels of Flupyradifurone, than nectar (3.5-106x), and the levels increase d with the number of applications of Flupyradifurone. Table 28 in your documentatio n further highlights this concern as your comments to studies and pollen in various crops shows the increase of Flupyradifurone at the second, and third applic ations during the same growing season. Further, the concentration remains high for 1-7 days after the second and third applications (depending on the crop). If residues of Flupyra difurone take 7-14 days to dissipate in the pollen and nectar, beekeepers will have to re move their bees during this timeframe in order to protect them. However, moving honey bees away from a blooming crop is not a reasonable mitigation measure. The crop will lose 7-14 days of pollination if beekeepers are required to move their livestock to protec t them from exposure to this systemic

insecticide.

EPA Response:

As noted in previous responses, the dataset for flupyradifurone and honey bees is relatively comprehensive and the field studies indicate that under what are considered relatively worst-case exposure conditions, there are no long-term adverse effects to bee colonies. While monitoring data indicate that flupyridifurone residues are higher in pollen than in nectar, feeding bees up to 10,000 μ g ai/kg diet did not result in adverse acute, short-term, or l ong-term effects on mortality, colony strength and development, brood development, food storage, honey bee behavior, andPage 6 of 12 overall hive vitality and colony health, as well as on overwintering performance. Following the risk assessment, the label was revised to addr ess the potential risk associated with multiple cropping cycles per year; a limit of 1 per year for pollinator attractive crops was instituted. The Agency did not impose the relocation of bees in order to protect them from application of flupyradifurone; therefore, the Agency has no re sponse to that aspect of the commenter’s

statement.

6) Studies of caged honey bees fed Flupyradifuro ne do not reflect the real world of honey bees. Flupyradifurone will be u tilized in a tank mix, and ef fects of Flupyradifurone, its degradates, mixed with herbicides, and fungici des is unknown. The synergistic effects of these chemicals upon honey bees is unknown; yet that will be how honey bees will encounter this compound.

EPA Response:

The ecological risk assessment chapter evaluates the data submitted to support the registration of flupyradifurone and does not evaluate the potential effects of bees that may occur from complex mixtures of pesticides that may occur in the environment. The risk assessment evaluates multiple lines of evidence extending from labor atory-based studies on individual bees to semiand full-field studies of whole co lonies to determine whether ther e is an indication of long-term effects on honey bee colonies from relatively high-end exposure to flupyradifurone. The whole colony studies from feeding spiked sucrose and fo liar applications under se mi-field conditions to full field conditions are intended to represent incr easing levels of environmental realism that may

occur under actual use conditi ons. At the full-field level, colonies would be exposed to the same

environmental mixtures as well as other f actors that can affect pollinator health ( e.g ., disease, pests, nutritional stressors); how ever, across these studies, there was no indication of long-term adverse effects on the colony from e xposure to flupyradifurone.

7) While a ten-day honey bee feeding study was conducted, what happened at day 16, 21, and 24—developmental stages of honey bees? To state there were “no consistent adverse effects” except “some increases in mo rtality and decreases in foraging activity immediately following applications . . . and in some cases there was recovery from the effects on mortality by test te rmination,” does not inspire confidence in the use of this compound.

EPA Response:

As with any ecological effect (toxicity) study, th ere can be fluctuations in test organism responses over the course of the study. The Ag ency considers multiple lines of evidence in characterizing the likelihood of adverse effects from exposure to a compound, i.e ., risk. Consistent with data provided from control colonies, there can be shifts in brood and/or adult bee strengths that represen t what are considered normal fluc tuations. The likelihood of such

fluctuations increases when colonies are confined to enclosures and/or when the colonies are manipulated for the purposes of collecting data. The intent of the field studies is to record multiple measures of colony performance over the course of the study and to determine whether,Page 7 of 12 in the face of these effects, there appears to be any long-term adverse effect on the colonies from exposure to the test compound. Across the six se mi-field studies, the feeding study, and two full-field studies, there were fluctuations in mortality and sub-lethal measurement endpoints; however, the multiple lines of evidence consistently demonstrate that exposure of honey bee colonies to flupyradifurone did not result in long-term adverse eff ects to the study colonies. The

intent of the risk assessment is to inform the risk management decision of the potential adverse effects that may occur from exposure to a spec ific compound. The risk management decision

balances the risks identified in the risk asse ssments with the benefits provided by the compound

and determines whether thos e risks are unreasonable.

8) You further state you question the “large variation in starting colony size” and the “low number of replicates per trea tment group” limit th e ability to detect the effects of Flupyradifurone.

EPA Response:

The Agency has reviewed a large number of studies to evaluate the potential effects of pesticides across multiple taxa. One of the inherent limitati ons to conducting toxicity studies is in having sufficient replication to improve the power of the study to diffe rentiate (detect) a treatmentrelated effect and to avoid maki ng a Type II error, i.e., concludi ng that there is not an effect

when there is. This limitation exists in labor atory-based studies where environmental conditions are relatively well controlled. It is amplified in field-based studies where environmental

conditions can be difficult to contro l. With respect to honey bee stud ies, the ability to replicate is even more challenging given the distance that be es can forage and the difficulty in normalizing colony size. The Agency recognizes the logistic al challenges of conductin g field studies and is transparent in identifying study limitations in its assessment, however these complex studies provide significant addition to the understa nding of how flupyradif urone moves in the environment and are necessary to understandi ng the overall impact a chemical may have on nontarget oranisms.

9) Relying on the label guideline to protect against mixing Flupyradifurone with azole fungicides is unrealistic.

EPA Response:

Pesticide labeling is legally enforceable and the Ag ency relies on it to ensure that pesticides pose

no unreasonable adverse effects. The Directions for Use portion of a pesticide label describes how the product can legally be used and direct how the product cannot be used. In the Use Restriction for mixing flupyradifurone with azole fungicides; the label e xplicitly states “Do not tank mix with azole fungicides (FRAC group 3) during bloom period.”

10) This statement on page 79 is worrisome, “Max imum residues in comb pollen, nectar, and wax varied, but generally occurred one w eek to several months after the second application indicating that re sidues were translocated within the hives to varyingPage 8 of 12 extents.” Flupyradifurone appears to have pre- lethal effects which long term, replicated

studies would reveal.

EPA Response:

From a risk assessment perspective, if data fa iled to demonstrate that bees were exposed to

residues it would be difficult to conclude that in the absence of effects, there was actually exposure. The available data in dicate that residues were movi ng into the colony and that bees were exposed to the flupyradifurone through a ra nge of matrices including pollen, nectar, bee bread and wax. Although the compound is not expect ed to readily partition into wax, given the low octanol-water partition coefficient (K ow = 1.2), the data indicate th at it appears to be stored in the comb. These exposure data though must be considered in the cont ext of whether adverse

effects were observed concurrent with the exposure. The data provided on flupyradifurone via feeding studies demonstrate that much higher levels of exposure than those measured in the various colony matrices did not result in long-term effect s on overall colony strength/performance. The semi-field and full-fiel d studies also demonstrat e that residues that may be stored in the colony over prolonged periods did not appear to impact colony overwintering success. Although th e available studies have limite d numbers of replicates, none of the studies suggest significant adve rse effects on colony performance.

11) While Flupyradifurone is “practically non-to xic to bees on an acute contact exposure basis,” “the greatest area of uncertainty su rrounding the potential ri sk to bee pollinators is for foliar application at full bloom.” “In addition, pollen, nectar, and wax residue data from one of the full field st udies with Flupyradifurone (MRIDs 48844517) indicate that average residues did not reach their maxima unt il up to several months after the pesticide was applied.

EPA Response:

As noted in previous responses, the semi- and full-field studies with flupyridurone utilized a combination of seed, soil and foliar applicati ons and the second foliar application was made during full bloom while bees were actively foragi ng. Therefore, the studi es represent relatively high-end exposure from residues that may have been systemically translocated to pollen/nectar by plants as well as through dire ct contamination by contact with the foliar-applied compound. The residue data collected in various colony matr ices indicate that bees were exposed to the compound and that exposure occurred for a protracted period of time. The field studies indicate that from both the perspective of acute expos ure to longer-term chr onic exposure to residues stored in the colony, there is no evidence of long- term adverse effects. This understanding is further informed by feeding studies where exposure was considerably higher than levels detected in colony matrices, yet these exposure levels did not result in long-te rm impacts to colony strength/performance. The data are also consistent with the observations that as residues move through the colony, they tend to dr op substantially in royal/br ood jelly and that effects to developing brood were not appa rent based on laboratory st udies demonstrating that flupyradifurone is practically non-toxic to honey bee larvae on an acute exposure basis. The Agency is aware that developing larvae transition away from royal/ brood jelly as they approachPage 9 of 12 pupation; however, again, the longer-term col ony-level studies available for flupyradifurone do not demonstrate long-term adverse effects on colo nies relative to contro l performance.

12) As a systemic insecticide it will translocate to pollinator forage ar eas developed through

Federal and State initiatives.

EPA Response:

The environmental fate assessment indicates that flupyradifurone is moderately mobile to mobile depending on soil conditions and that it has the potential to dissipate from the point of application through various transport mechanism, including runoff, erosion and leaching to groundwater. The Commenter presumes that dissipati on will in turn make residues available for plant uptake and distribution in ar eas adjacent to the treatment site. However, it is likely that the residues in non-target plants as a result of the dissipation of the compound from treatment sites will be lower than those that occur from direct ap plication to the treatment site. The available

data from semi-field and full-field studies do not indicate any long-term adverse effect on colony health/performance/condition; therefore, the impact of the potential dissipation and uptake of residues on pollinator forage is uncertain, though understandably less than the concentrations bees were exposed to in the full-field studies th at indicated no long-term adverse effects.

13) Its mobility in water will affect honey bees, and other pollinators.

EPA Response:

Terrestrial invertebrates such as bees would most likely collect water from shallow surface

waters and the available data indi cate that flupyradifurone is unst able in shallow waters where it is susceptible to aqueous photolysis. Theref ore where residues do move into water through various routes of dissipation, resi dues are likely to degrade rapi dly (t 1⁄2 = 2.5 days) in shallow

clear waters which terrestrial invertebrates such as bees use to collect water.

14) The repeated use of Flupyradifurone has s hown to increase its toxicity with each application with a half-life of one application lasting 3-951 da ys in the plants, soil, and

water.

EPA Response:

It is unclear what the Commenter is referring to when saying that repeated use of flupyradifurone “...has shown to increase its toxicity with each a pplication with a half-l ife of one application lasting 3 – 951 days in plants, soil and water.” Presumably, the comment is intended to mean that the compound is likely to accumulate in various environmental compartments and that

cumulative residues could reach a level that would in turn be toxic to non-target organisms. While the ecological risk assessment is correct in noting that times to 90% decline of pesticide mass (DT90) from surface soils in terrestrial field dissipation studies often exceeded one year, DT50 values for the majority (83%) of the field dissipation studies were le ss than 100 days. If the Agency’s interpretation of the comment is co rrect, then the Agency is not aware of specificPage 10 of 12 data demonstrating that the compound is accumula ting through multiple applications to levels

that will in turn be toxic to non-target organisms beyond what has already been characterized in the ecological risk assessment es pecially given that estimated environmental concentration in the assessment are based on 30-yr simulations.

15) The use of this compound will further exacerbate the concerns over the honey bees’ food supply: pollen, nectar, and water.

EPA Response:

The proposed use of flupyradifurone is not likely to impact the suppl y of pollen/nectar and water. Presumably, the Commenter is refe rring rather to the qua lity of the food/wate r supply in terms of pesticide residues. As discussed in the precedi ng comments, the availabl e data do not indicate

that residues will reach levels in either pollen/nectar that will result in long-term effects on overall colony performance. While there is uncerta inty regarding the potential residue levels that may occur in water, where residues are present in shallow, clear water, which is most likely a bee’s source of water, degradation of fl upyradifurone by aqueous photolysis is rapid.

Comment: Center for Biological Diversity, B rett Hartl, Director, Endangered Species Policy (Document ID: EPA-HQ-OPP-2013-0226-0039)

1) The EPA has an independent duty under the Endange red Species Act to consult with the U.S. Fish and Wildlife Service and National Marine Fi sheries Service on the registration of any new active ingredient that may affect protected species.

and

2) The EPA has an independent duty under the Endange red Species Act to consult with the U.S. Fish and Wildlife Service and National Marine Fi sheries Service on the approval of any enduse product that may affect protected species.

EPA Response:

The Agency appreciates the suppor t and encouragement that the Ce nter for Biological Diversity (CBD) provided in the submitted comment regarding the use of Bulletins Live! , and the comparative hazard assessment for flupyradifur one. The Agency acknowledges the comment CBD submitted regarding the duty to consult. The Agency is focusing most of its resources for assessing impacts to listed species on the Agen cy’s registration review program for currently registered pesticides. EPA believes that, as a general matter, currently registered pesticides present a greater degree of risk to listed speci es than most new chemistries coming to market, including flupyradifurone, and that it is therefore environm entally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designed to compete with more risky alte rnatives. EPA believes that is especially true for flupyradifurone , where the alte rnatives include

, organophosphates,Page 11 of 12 nitroguanadine neonicotinoids, and pyrethroids. As a result, EPA does not believe the environment or the public would be best served by delaying the registration of flupyradifurone to complete consultation. Focusing EPA’s, FWS’ , and NMFS’ limited resources on completing a consultation on the effects of flupyradifurone woul d by necessity come at the expense of putting more resources into evaluating – and consequen tly regulating, where appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greate r risk, to endangered species than does flupyradifurone.

3) The ecological risk assessment for flupyradifurone is under- protective of listed species and should be revisited in light of the findings of the Na tional Academy of Sciences report and the interim approaches document...T he Interim Approaches document lays out an analytically sound, thre e-step approach for conducting pesticide reregistration – a process which should apply equally to pesticide registrations.

EPA Response:

It is important to understand th at the development of the Inte rim Approaches does not by its terms suggest that existing or recently developed ri sk assessments using the criteria articulated in OPP’s 2004 Overview document ( http://www.epa.gov/espp/consu ltation/ecorisk-overview.pdf ) are necessarily “under-pro tective.” The Interim Approaches are intended to identify interim thresholds for interagency review as the Agencies jointly work to implement the recommendations of the NAS on certain specific re gistration review actions . The Agencies have

made no determination that these thresholds are necessary to prevent ta ke and preclude likely jeopardy and, in any case, the In terim Approaches do not establis h legally binding thresholds for consultation under the Services’ implementing re gulations. As EPA and the Services work through the initial actions that are being reviewed unde r the Interim Appro aches, the Agencies

will determine whether these thresholds should be modified before they are extended more broadly to additional regulatory actions. The de tails of the joint Interim Approaches are contained in the white paper “Interim Appro aches for National-Leve l Pesticide Endangered Species Act Assessments Based on the Recommenda tions of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available at http://www.epa.gov/espp/2013/nas.html

.

As the Agency has emphasized in multiple forums (including above), EPA is focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA believe s that, as a general matter, currently registered pesticides present a greater degree of risk to listed speci es than most new chemistries coming to market, including flupyradifurone, and that it is therefore environm entally preferable in most circumstances for EPA to assess the impacts of existing pesticides sooner in the process than newer pesticides that are designe d to compete with more risky alternatives. As a result, EPA does not believe the environment or the public w ould be best served by delaying the registration of flupyradifurone to complete consultation. Fo cusing EPA’s and the Services’ limited resources on completing a consultation on the effects of fl upyradifurone would by n ecessity come at the expense of putting more resources into eval uating – and consequently regulating, wherePage 12 of 12 appropriate – what EPA believes to be more toxic compounds, that, among other things, pose greater risk to endangered species than does fl upyradifurone. With respect to the evaluation of flupyradifurone specifically, it is important to understand that unde r any internal or interagency review, the ecological risk evalua tion will continue to rely on the body of information used in the current EPA ecological assessment.

For the reasons explained above, EPA is not cons ulting with the Services on the issuance of the flupyradifurone registration. However, EPA is cu rrently working to prio ritize its consultation

activities with Services and will evaluate the appropriate timing and scope of consultation on flupyradifurone in connection with those efforts. In addition, to the extent EPA receives new information indicating that flupyr adifurone may pose a greater risk to listed species than indicated by the existing scientific database for this pesticide, EPA will re-evaluate the terms of registration and determine whether additional use restrictions to protect listed species are

necessary.