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### Table of Contents

I. Introduction................................................................................................3

II. Use and Usage.............................................................................................4

III. Scientific Assessments....................................................................................5

A. Human Health Risk Assessment.......................................................................5

1. Risk Conclusions...................................................................................5

2. Tolerances..........................................................................................6

B. Environmental Assessment.............................................................................6 1. Environmental Fate and Exposure...............................................................6 2. Ecological Risk Characterization.................................................................6 3. Ecological Risk Uncertainties....................................................................7 4. Overview of Ecological Risk Conclusions.....................................................7 5. Effects on Aquatic Organisms...................................................................7 6. Effects on Terrestrial Organisms................................................................8 7. Ecological Risk Management Co nclusions for Non-listed Species.........................9

C. Endangered Species Assessment .......................................................................9

D. Endocrine Disrup tor Screening Program............................................................10

IV. Proposed Interim Regi stration Review Decision....................................................11

V. Next Steps and Timeline..................................................................................12

A. Interim Registration Review Decision..............................................................12

B. Implementation of Mitigation Measures............................................................12

Appendix A: Summary of Ac tions Taken for Hexythiazox...........................................13 Appendix B: Hexythiazox Label Table..................................................................143 I. Introduction

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for hexythiazox (PC code 128849) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A regi stration review decisi on is the Agency's determination on whether a pesticid e meets, or does not meet, the st andard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a proposed interim registration review decision before completing a registration review final decisi on. Among other things, the proposed interim registration review decision may 1) require new ri sk mitigation measures; 2) impose interim risk mitigation measures; 3) identify data or information required to complete the review; and 4) include schedules for submitting the required da ta, conducting the new risk assessment and completing the registration review. For fu rther information on hexythiazox, additional documents can be found in EPA’s pub lic docket (EPA-HQ-OPP-2006-0114) at www.regulations.gov

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FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pestic ides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific data showing that they will not cause

unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intende d to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonable a dverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pes ticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

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In 2006, the Agency implemented the regist ration review program pursuant to FIFRA section 3(g) and EPA will review each registered pesticide every 15 years to determine whether

it continues to meet the FIFR A standard for registration.

This document comprises the proposed in terim registration review decision for hexythiazox, an acaricide that acts primarily as a m ite growth inhibitor/ovicide that is registered for use to control mites. Hexythiazox is register ed for use on a variety of agricultural crops, turf, and various residential plants. It was first registered in 1989. Since hexythiazox was registered after 1984, it was not subject to the re registration require ments of FIFRA.

Pursuant to 40 CFR section 155.50, EPA forma lly initiated registration review for hexythiazox (case 7404). The following highlights significant events that have occurred during the registration review of hexythiazox:

 February 2, 2007 – Publication of Hexythiazox Summary Document for a 90-day public comment period. The Summary Document included the preliminary work plan (PWP) and was accompanied by the scoping doc ument and problem formulation.4  July 2, 2007 - Final Work Plan ( FWP ) for hexythiazox was signed -- Three public comments were received during the 90-day comment period for the Hexythiazox Summary Document , but the comments did not address the data requirements, work plan,

or time line described in the Summary Document and, therefore, did not result in changes to the proposed work plan, which was made final in the Hexythiazox Final Work Plan

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 September 22, 2008 – The Agency issued the Registration Review Data Call-In (GDCI128849-879) to the technical registrant for hexythiazox, Gowan Company.

 June 26, 2013 – The Agency published the Preliminary Environmental Fate and Ecological Risk Assessment in Support of the Registrati on Review of Hexythiazox and the Hexythiazox

. Registration Review Pr eliminary Human Health Risk Assessment for a 60- day public comment period. One comment wa s received during the comment period. The National Alfalfa Forage Alliance (NAFA) commented on the importance of hexythiazox to alfalfa growers in the treatmen t of spider mite infestations and commented on its perceived lack of eff ects to beneficial insects.

 July 2014 – The Agency is now publis hing the Hexythiazox Proposed Interim Registration Review Decision, dated July 2014 in docket number EPA-HQ-OPP-2006- 0114 for a 60-day public comment period.

II. Use and Usage

As described in the April 28, 2014 Use and Usage, Pest Management Role, and Response to Comments for Hexythiazox , available in the hexythiazox docket, hexythiazox is a nonsystemic, foliar miticide registered for use on various fruit, nut, vegetable, and row crops, as well as on turf, and residential plants, with appli cations limited to once pe r year. Hexythiazox acts primarily as a mite ovicide, and it is used to control phytophagous mites, including problematic spider mite pests. Hexythiaz ox labels limit applications of ei ther the end-use product or the hexythiazox active ingredient to onc e per year. It is often applie d early in the growing season to target mite eggs in order to control the mite population thr oughout the rest of the growing

season.

Hexythiazox belongs to the Insecticide Resi stance Action Committee’s (IRAC) Group 10 and is classified as a mite growth inhibito r. There is some ambiguity in the Group 10 designation, as this group’s actual defined modes of action are not well characterized. However, the chemicals in this group are presumed to be similar modes of acti on due to their shared ovicidal activity and observed inst ances of cross-resistance. While hexythiazox can be applied at various points in the season to ki ll mite eggs, it is often recomm ended for use as an early-season pest management tool, with the intention to ge t good control of eggs and thus prevent mite outbreaks from developing later in the season. Hexythiazox can be applied as a liquid foliar spray by air or ground application equipment. For most crops, applications are made at rates below the maximum application rate.

While there are a number of miticide alternativ es available that target adult mites (in several different IRAC groups), there are not many other ovicide alternativ es to hexythiazox.5 Clofentazine and etoxazole are the other Group 10 miticides registered for use in the United States. However, these alternatives are not registered for use on all crops covered by hexythiazox registrations. For da tes, citrus, alfalfa (hay produc tion) and sweet corn (grown for seed), hexythiazox is the only ovicidal chem ical registered for mite control.

Relative to other Group 10 miticide alternatives, the cost of application for hexythiazox is comparable to the alternative ovicide etoxazole but more expensive than clofentazine. On the whole, hexythiazox has a higher aver age cost per acre than some of the adulticidal alternatives such as abamectin, spirodiclofen, pyridaben, and fenbutatin oxide. However, some adulticides may be applied multiple times, depending upon both population pressure and the success of early season mite management efforts.

An updated Screening Level Usage Analysis (SLUA) for hexythiazox was conducted in April 2014. SLUA usage data (2004 -2012) show a significant num ber of crops treated with hexythiazox. The crops with the greatest aver age annual usage are as follows: strawberries (25% crop treated); pluots (bas ed on California Department of Pesticide Regulation data); caneberries, dates, nectarines and tangerines (1 5% crop treated); and al monds and peaches (10% crop treated). The updated report, Revised Usage Report in Support of a Registration Review Preliminary Risk Assessment Purposes for the Insecticide Hexythiazox , can be found in the hexythiazox registration review docket (EPA-HQ-OPP-2006-0114) at www.regulations.gov

III. Scientific Assessments

A. Human Health Risk Assessment

The Agency considered recently completed hu man health risk assessments and the most updated science policies a nd methodologies in the Hexythiazox

. Registration Review Preliminary

Human Health Risk Assessmentpublished on June 26, 2013 in the public docket EPA-HQ-OPP2006-0114-0021, which can be accessed on http://www.regulations.gov/ . The hexythiazox human health risk assessments, described belo w, that informed the Agency’s human health preliminary risk assessment are also avai lable in the registration review docket.

1. Risk Conclusions

Dietary, residential, and aggr egate risks for all registered uses of hexythiazox were assessed in the September 25, 2012 Hexythiazox. Human Health Risk Assessment to Support New Uses on Alfalfa and Timothy . There are no dietary, residentia l or aggregate risks of concern for hexythiazox.

The occupational risks associated with the use of hexythiazox were assessed in the September 25, 2012 human health risk assessment; the June 22, 2011 Human Health Risk Assessment to Support Amended Use on Field Corn and New Use on Greenhouse Tomatoes ; and the October 12, 2012 memorandum Hexythiazox: Summary of Hazard and Science Policy Council (HASPOC) Meetings, available in the hexythiazox docket (EPA-HQ-OPP-2006-0114)

. The recently conducted occupational risk asse ssments and the HASPOC memorandum address all registered uses of hexythiazox, and th ere are no occupational risks of concern.6 2. Tolerances

The 2007 Hexythiazox Summary Document recommended the reducti on of 7 tolerances established for hexythiazox under 40 CFR 180.448: pome fruit (crop group 11), apple, wet pomace, and the meat byproducts of cattle, sheep, goat, and horse. Since the 2007 Hexythiazox Summary Document was completed, all of the recommende d tolerance reductions have been

finalized. See the Federal Register (54 FR 17948) for a listing of current hexythiazox tolerances.

Maximum Residue Levels (MRLs) for hexythi azox have been established by Codex for apples, cherries, peaches, dry hops, pears, plum s, fresh prunes, strawberries, citrus fruits, common bean (pods and immature seeds), cucumb ers, currants (red a nd white), grapes and

tomatoes. There are no Canadian MRLs esta blished. One Mexican MRL is established for

strawberries. The Codex and Mexican MRLs ar e not compatible with the U.S. tolerances because the U.S. tolerance expression currently includes parent hexythi azox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3- thiazolidine moiety, while the MRLs are established for hexythiazox alone.

B. Environmental Assessment

The risk assessment supporting this Proposed Interim Registration Review Decision evaluates risks to species that are not subject to the Endangered Species Act (ESA) and provides a screening level assessment for potential risks to listed species under ESA. A summary of the Agency’s environmental risk assessment for he xythiazox is presented below. For detailed discussions of all aspects of the e nvironmental risk assessment, see the Preliminary Environmental Fate and Ecologica l Risk Assessment in Support of the Registration Review of Hexythiazox, published on June 26, 2013 in the public docket EPA-HQ-OPP-2006-0114-0020,

which can be accessed on http://www.regulations.gov/

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1. Environmental Fate and Exposure

Parent hexythiazox is moderately persistent. It degrades to transformation products with a half-life of 27 to 43 days in aerobic soil and 30 to 40 days in aerobic aquatic systems. It is stable to hydrolysis though photol yzes in water with a half-lif e of 17 days. Given the low solubility of hexythiazox and its propensity to adsorb, it is li kely that the compound will readily partition to soil and sediments. Although parent hexythiazox is consider ed slightly mobile, it may reach water through run-off of sediment-bound residues (i.e., erosion). Hexythiazox is not likely to volatilize and is not expected to bioaccumulate in aquatic organisms.

2. Ecological Risk Characterization

To estimate potential ecological risk, EP A integrates the results of exposure and ecotoxicity studies using the risk quotient method. Risk quo tients (RQs) are calculated by dividing peak or multi-day average estimated environmental concentrations (EECs) by acute or chronic ecotoxicity values for various wildlife and plant species . RQs are then compared to levels of concern (LOCs) and when the RQ exceeds the LOC for a particular category, the7 Agency evaluates the potential fo r a risk of concern to that category. Risk characterization provides further information on potential adverse e ffects and the possible impact of those effects by considering the fate of the chemical and it s degradates in the environment, organisms potentially at risk, and the natu re of the effects observed.

3. Ecological Risk Assessment Uncertainties

While there are toxicity data gaps for so me species, the database for hexythiazox is considered substantially complete and sufficien t for risk assessment and regulatory decision making. The major area of uncertain ty is the potential increased sens itivity of early lifestages of non-target terrestrial invertebrate s to hexythiazox. The existing da ta indicate that hexythiazox is practically non-toxic to adult non-target terrestrial insect s, including honey bees, on an acute basis. However, hazard to terrestrial arthropods is presumed to be greatest to egg, larval, and juvenile lifestages as hexythi azox is a mite growth inhibito r/ovicide. Gowan Company has committed to conduct a study designed to address th is uncertainty. EPA will review these data once they are submitted and incorporate findings into an endangered species assessment for hexythiazox.

4. Overview of Ecologic al Risk Conclusions

There are no risks of concern expected for mammals, birds (including reptilian surrogates), pelagic (water column-dwelling) invertebrates, and aquatic plants.

Potential acute risk from the use of hexythiaz ox is not expected to fish (surrogates for aquatic-phase amphibians) at its limit of solubility or to non-target terres trial invertebrates.

Potential chronic risk to fish a nd non-target terrestrial invertebrates is uncerta in due to lack of

data.

Acute risk is not expected for terrestrial and semi-aquatic plants and benthic (sedimentdwelling) aquatic invertebrates. While there is uncertainty in the potential chronic risk to these taxa due to the lack of data, poten tial risk is not expected from th e registered uses of hexythiazox

based on the lines of evidence discussed below.

5. Effects on Aquatic Organisms

Aquatic Invertebrates

Available toxicity data indicate that hexythiazox is not acutely toxic at its solubility limit to aquatic invertebrates, thus acu te risks of concern are not expect ed. In addition, chronic risk to pelagic invertebrates, based on cal culated RQs, does not exceed the Agency’s level of concern. Chronic risk to benthic aquatic inve rtebrates is uncertain due to a la ck of sediment toxicity data. However, the No Observed Adverse Effects Co ncentration (NOAEC) for benthic invertebrates would have to be nearly two times more sensitive than the freshwater pela gic invertebrate growth NOAEC and eight times more sensitive than the reproduction NOAEC to trigger an LOC exceedance. In addition, a 21-day toxicity test with midges ( Chironomus riparius ) found no effect to either emergence or development at con centrations tested up to hexythiazox’s solubility limit (0.120 mg/L). By these lines of evidence, the potential for chronic effects to benthic8 aquatic invertebrates is cons idered to be low.

Fish

As with aquatic invertebrates, hexythiazox is not acutely toxi c at its solubility limit to fish, thus acute risks of concern are not expected. Potential chroni c risk is uncertain due to lack

of data.

Aquatic Plants

The RQs for aquatic vascular and non-vascul ar plants are below the Agency’s LOC and, therefore, are not of c oncern to the Agency.

6. Effects on Terrestrial Organisms

Mammals and Birds

There are no acute or chronic risks of con cern to birds (and to reptiles and terrestrialphase amphibians for which birds serve as surrogat es) or mammals from the registered uses of hexythiazox based on calculated RQs.

Terrestrial Plants

Risk to terrestrial and semi-aquatic plants is uncertain due to lack of Tier II seedling emergence data for two crop species and incomple te Tier I vegetative vigor testing (6 of 10 species tested). While the dataset is incomplete , eight of 10 tested crop species in the Tier I seedling emergence test did not ex hibit a phytotoxic res ponse in excess of th e 25% Tier II trigger risk and the available vegetative vigor testi ngs gave no indication th at hexythiazox causes excessive phytotoxic response when applied at th e maximum labeled rate. Based on these lines of evidence, potential risk to terrestrial and semi-aquatic plants is not expected.

Terrestrial Invertebrates

On an acute exposure basis, hexythiazox is classified as practi cally non-toxic to nontarget terrestrial insects, incl uding honey bees. However, available data may not represent the sensitivity of other insect lifestages (e.g., eggs , larvae, juveniles). Given that hexythiazox’s mode of action affects the eggs and juvenile lifestages of mite s and that chronic reproductive

effects were observed in both the fr eshwater and saltwater aquatic i nvertebrate lifecycle tests, it is possible that non-target terrestrial invertebrates ( e.g. , bees) could be affected by applications of hexythiazox. Therefore, risk to non-target terrestrial invertebrates is c onsidered uncertain.

Subsequent to the completion of EPA’s 2013 Preliminary Environmental Fate and Ecological Risk Assessment in Support of the Registration Review of Hexythiazox, Gowan Company submitted a honey bee semi-field st udy conducted in the United Kingdom to address uncertainty regarding potential risk to early lifestages of non-target terrestrial invertebrates such as bees. However, this study is of limited utility because it was conducted at a rate of 0.09 pounds active ingredient/acr e (lbs ai/A). The U.S. maximum application rate is 0.1875 lb ai/A9 and the typical application rates for hexythiazox , which vary by crop, are generally above 0.09 lb

ai/A.

7. Ecological Risk Man agement Conclusions for Non-Listed Species

The database for hexythiazox is considered substantially complete and sufficient for regulatory decision making. While ch ronic risk to fish and non-target terrestrial invertebrates is uncertain due to data gaps, the risk potential is expected to be low as hexythiazox is applied once per year at a low application rate and is not hi ghly persistent in the environment. Thus, any effects to non-target organisms are expected to be transient and not result in significant chronic effects. Gowan Company has committed to conduct a study to address potential effects to early lifestages of non-target terrestri al invertebrates. EPA will re view these data upon submission and consider them in the upcoming endangered species assessment.

The Agency is currently working with Gowan Company to ensure that all product labels clearly state that only one appli cation of hexythiazox activ e ingredient is allowed per year. Some labels restrict the number of applications of pr oduct (not active ingredient), which may lead to use of more than one hexythiazox product per si te per year. In addi tion, any label language indicating that hexythiazox products are safe to beneficial insect s must, in the absence of data to support this claim, be remove d from hexythiazox labels.

As previously described, there ar e not many ovicide alternatives to hexythiazox, and it is the only ovicidal chemical registered for mite contro l for dates, citrus, alfalfa (hay production) and sweet corn (grown for seed). Early season cont rol of mite eggs can preclude the need for subsequent miticide applications in many crops.

C

. Endangered Species Assessment

In November 2013, the EPA, along with the U. S. Fish & Wildlife Service (USFWS), the

National Marine Fisheries Service (NMFS) (collectively, the Servi ces), and the U.S. Department of Agriculture (USDA) released a summary of the joint Interim Approaches in the white paper “Interim Approaches for National-Level Pestic ide Endangered Species Act Assessments Based

on the Recommendations of the National Academ y of Sciences April 2013 Report,” dated November 1, 2013.

The Interim Approaches were developed join tly by the agencies in response to the National Academy of Sciences’ (NAS) recommenda tions and reflect a common approach to risk assessment shared by the agencies as a way of a ddressing scientific differences between the EPA

and the Services. The NAS 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 thei r obligations under the Endang ered Species Act (ESA) and

FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presen ted the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Co mmittee (PPDC) and State-FIFRA Issues Research and Evaluation Group ( SFIREG) meetings, and held a stakeholder workshop in April10 2014, allowing additional opportunities for stakeholde rs to comment on the Interim Approaches. As part of a phased, iterative process for deve loping the Interim Approaches, the agencies will also consider public comments on the Interim Appr oaches in connection with the development of upcoming Registration Review decisions

Given that the agencies are continuing to de velop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to endangered and threatened (listed) species and their desi gnated critical habitat, the eco logical risk assessment supporting this Proposed Interim Registrati on Review Decision for hexythiazox does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although EPA has not yet completed e ffects determinations for specific species or habitats, for this preliminary assessment EPA conducted a screening-level assessment for all taxa of non-target wildlife and plants that assumes fo r the sake of the assessment that listed species and designated critical habitats ma y be present in the vicinity of the application of hexythiazox. This screening level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists onc e the scientific methods being developed by the agencies have been fully vetted. While the agen cies continue to develop a common method for ESA analysis, the regulatory section of the Proposed Interi m Registration Review Decision document will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully deve loped and implemented the scientific methods necessary to complete risk assessments for listed species and their designat ed critical habitats, these methods will be applied to subsequent anal yses for hexythiazox as part of completing this registration review.

D. Endocrine Disruption Screening Program

As required by FIFRA and FFDCA, EPA review s numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute,

subchronic and chronic toxici ty, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or syst emic toxicity. These studies include endpoints which may be susceptible to endocrine influenc e, including effects on endocrine target organ histopathology, organ weights, es trus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard asse ssments, EPA evaluates

acute tests and chronic studies that assess growth, developmen tal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for hexythiazox,

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

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredie nts) may have an effect in hu mans or wildlife similar to an effect produced by a “naturally occurring estr ogen, 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 w ith the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the11 potential to interact with E, A, or T hormonal sy stems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Ti er 2 tests are necessary based on the available data. Tier 2 testing is designe d to identify any adverse endocr ine-related effects caused by the substance, and establish a dose-re sponse relationship between the dos e and the E, 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 pest icide active ingredients and 9 inert ingredients. A second list of chemicals, including hexythiazox, identified for EDSP screening was published on June 14,

2013 1 and includes some pesticides scheduled fo r Registration Review and chemicals found in

water. For 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 ba ttery, please visit our

website. 2 In this interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of hexythiazox. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

IV. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Proposed Interim Registration Review Decisi on Document for hexythiazox. Except for the EDSP and ESA components of the hexythiazox regi stration review case, the Agency has made the following interim decision: (1) additional data are required to assess the potential reproductive effects to benefici al pollinators; and (2) change s are required to hexythiazox product labels. Gowan Company has agreed to amend any product labels that do not clearly state that no more than one application of hexythi azox active ingredient is allowed per year. In addition, Gowan must remove statements claiming th at hexythiazox is safe to beneficial insects

in the absence of data to support these claims.

In the interim, EPA is making no human h ealth or environmental safety findings associated with the EDSP screening of hexyt hiazox. Before completing this Registration Review, the Agency will make an EDSP FFDCA s ection 408(p) determination. Likewise, before completing this Registration Review, the Agency will conduct an ecological risk assessment to address the Agency’s obligations under both the ESA and FIFRA. While the risk assessment supporting this Proposed Interim Re gistration Review Decision evalua tes risks to species that are not subject to the ESA, EPA is still in the process of conducting a risk assessment for listed species and their designated critic al habitats for hexythiazox. In this Proposed Interim Decision, therefore, EPA has not completed effects determin ations for listed species associated with the registered uses of hexythiazox. The Agency is issuing a Proposed Inte rim Registration Review Decision pending completion of the ESA and EDSP assessments.

1 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.

2 http://www.epa.gov/endo/12 V. Next Steps and Timeline

A. Interim Regist ration Review Decision

A Federal Register Notice will announce the availability of this proposed interim registration review decision for hexythiazox and allow a 60-day co mment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA may i ssue a final interim registration review decision for hexythiazox. A final decision on the hexythi azox registration review case will occur after an ESA and EDSP FFDCA section 408(p) determination have been made.

B. Implementation of Mitigation Measures

Once the Final Interim Registration Review D ecision is issued, registrants must submit proposed amended labels that include the agre ed-upon risk mitigation, described in Appendices A and B below, to the Agency for approval within 60 days of such issuance.Docket Number EPA-HQ-OPP-2006-0114www.regulations.govAppendix A: Summary of Actions Taken for HexythiazoxRegistration Review Case#:7404PC Code: 128849Chemical Type: AcaracideChemical Family: ThiazolidineMode of Action: Unknown; acts asa mite growth inhibitor/ovicidePotentially-AffectedPopulation(s)Source ofExposureRoute of ExposureDuration ofExposureRisk(s) of ConcernAction(s) TakenComment (useto brieflyclarify orelaborate onrisk ormitigation)Non-target terrestrialinsects (early lifestages,i.e., egg, larval, andjuvenile)Residues ontreated pollenpotentiallytransportedback tohive via adultworker beesDermal and/or oral Chronic Reproductive effects tonon-target terrestrialinsects- limit applications ofhexythiazox activeingredient to once peryear per treatmentsite- remove languagestatements claimingproducts are safe tobeneficial insectsN/A14Appendix B: Hexythiazox Label Table - Summary of Labeling Changes for Hexythiazox UsesDescriptionAmended Labeling Language for Hexythiazox ProductsPlacement on LabelEnd Use ProductsLanguage limitingnumber of applications“Do not make more than one application of hexythiazox per year.”Directions for UseAfter statementabout reading entirelabeling and insert.Language relating tobeneficial insectsRemove statements claiming that hexythiazoxproducts are safe to beneficial insects.