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I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Interim Registration Review Decision for Fosthi azate and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rod enticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may : 1) require new risk mi tigation 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 data, conducting the new risk assessment and completing the registration re view. For further information on Fosthiazate , additional documents can be found in EPA’s public docket (EPA

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

unreasonable risks to human health or t o the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet

t he statutory standard of no unreasonable adverse effects. 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 th ese 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 /.

In 2006, the Agency impleme nted the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

Fosthiazate was first registered as a pesticide in 2004, and therefore not subject to reregistration.

Pursuant to 40 CFR §155.50, the Agency formally initiated registration review for fosthiazate (case 7604). T he following timeline highlights significant events that have occurred during the registrat ion review of fosthiazate, and all associated documents can be found in the public docket (EPA

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 June 24, 2009

– The Agency published the Fosthiazate Summary D ocument , dated June 16, 2009

for a 60

- day public comment period. The Summary Document included the Agency’s Preliminary Work Plan for Fosthiazate . The Agency also posted the fosthiazate Preliminary Problem Formulation Document for the Ecological Risk Ass essment and Drinking Water Exposure Assessment, and the Registration Review Scoping Document for Human Health Assessments . The Agency received one comment on the Fosthiazate registration review case, which provided chemical specific background data but di d not result in any changes to the timeline or anticipated data needs

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3  December 10, 2009

– The Agency published the Fosthiazate Final Work Plan, which stated that the Agency would conduct a comprehensive ecological risk assessment and a human health

risk assessment.

 August 24, 2010

– The Agency issued the Generic Data Call

- I n for the registration review of fosthiazate, data requirements included: UV/visible absorption study (GLN 830.7050), and an immunotoxicity study (GLN 870.7800)

 March 20, 2013

– The Agency published the Preliminary Ecological Risk Assessment for the Registration Review of Fosthiazate and the Fosthiazate Preliminary Human Health Risk Assessment for Registration Review

, for a 60

- day public comment period, the Agency received one commen t during the comment period

 July 23, 2014

– The Agency published the Proposed Interim Registration Review Decision , for a 60

- day public comment period, in addition to supporting documents which included the Revised Fosthiazate: Human Health Risk Assessmen t for Registration Review

, dated January 14, 2014 and the Response to Public Comments on the Preliminary Ecological Risk Assessment for Fosthiazate

, dated December 12, 2013 . No comments were received during th is public comment period.

 December 2014

- The Agency is now publishing the Fosthiazate Interim Registration

Review Decision on regulations.gov under docket number E P A

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Public Commen t s

Proposed Interim Decision:

No public comment s w ere submitted to the Agency during the 60 day publ ic comment period for the Fosthiazate Proposed Interim Registration Review Decision.

I I

. SCIENTIFIC ASSESSMENT

A. Human Health Risk Assessment

During the 60

- day public comment period for the preliminary risk assessments, the technical registrant submitte d additional occupational exposure information and data which was used in the development of the Revised Human Health Risk Assessment

. A summary of the human health risk

conclusions are presented below, for detailed information pertaining to the revised h uman health risk assessment, see the Revised Fosthiazate: Human Health Assessment for Registration Review (January 14, 2014) in the public docket at EPA

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1. Risk Conclusions

No new information was received during the comment period for the preliminary risk assessments that informed the dietary assessment, and, as a consequence, dietary risk estimates forDoc ket Number EPA

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4 fosthiazate have not been revised from the Agency’s preliminary risk assessment. Dietary exposure to fosthiazate (food + drinking water) to the most sensitive population subgroup, (all infants less than 1 year old), was estimated to be 15% of the acute population adjusted dose (aPAD) and 45% of the chronic population adjusted dose (cPAD), while for the general U.S. population fosthiazate exposure was estimated to be 5.6% of the aPAD and 19% of the cPAD.

Since there are no registered residential uses of fosthiazate, no residential assessm ent was conducted. Consequently, t he Agency did not perform an aggregate assessment where dietary (food + drinking water) exposures are combined with exposure from residential exposure

.

Occupational risk estimates were revised based upon information subm itted by the technical registrant during the comment period on the preliminary risk assessments

. T he Agency updated the dermal toxicity endpoint by accounting for the differen ce in dermal penetration between the rat and

human

, and updating the inhalation toxicity endpoint by correcting the dose conversion , and by adjusting the inhalation endpoint to a human equivalent concentration/dose (HEC) . With these changes, the revised occupational assessment indicated no risks of concern. Potential risk from

combin ed dermal and inhalation exposure is below the Agency’s level of concern, where the target aggregate risk index (ARI) is equal to or greater than 1 (ARI > 1)

, and the revised estimated ARI for

fosthiazate is 3.7.

2. Human Incidents

At the time the Agency in itiated the registration review of fosthiazate, a search for incidents

was initiated within the Office of Pesticide Programs Incident Data System (IDS) was conducted. Available information between 2002 and 2009 was reviewed, and no human poisoning inciden t reports were identified for fosthiazate. No further review has been performed.

3. Cumulative

The Food Quality Protection Act (FQPA) requires the Agency to consider the cumulative risks of chemicals sharing a common mechanism of toxicity. Fosthiazate is a member of the organophosphate common mechanism group. The most recent cumulative risk assessment for the organophosphates was published on July 31, 2006 and is available at

htt p://www.epa.gov/pesticides/cumulative/2006

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4. Tolerances

The only U.S., tolerances established for fosthiazate are for tomatoes under 40 CFR 180.596. No CODEX, Canadian, or Mexican maximum residue limits (MRLs) have been established fo r fosthiazate. No change to the U.S. tolerance is being sought for fosthiazate during registration

review.

B. Environmental Risk Assessment

During the 60

- day public comment period for the preliminary risk assessments, the technical registrant submitted add itional effects and exposure data on terrestrial invertebrates which modified the Agency’s assessment for this taxa. During the registration review of fosthiazate, the Agency identified no risk concerns for aquatic animals or plants from fosthiazate. How ever, potential risksDoc ket Number EPA

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5 were identified for birds, terrestrial mammals and terrestrial invertebrates

. A summary of ecological risk conclusions for fosthiazate is presented below. For detailed discussion of all aspects of the environmental risk assessment, see the Preliminary Ecological Risk Assessment for the Registration Review of Fosthiazate, dated March 11, 2013, and the Response to Public Comments on the Preliminary Ecological Risk Assessment for Fosthiazate , dated December 12, 2013, in the public docke t EPA

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The Agency also completed a screening

- level threatened and endangered (listed) species

assessment for fosthiazate and identifie d potential risks to several taxa (birds, mammals and terrestrial invertebrates). The Agency is currently working with its federal counterparts and other stakeholders to implement an interim approach for assessing potential risk to listed species and thei r designated critical habitats. Once, the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the Agency will complete its listed species assessment for fosthiazate. As such, only screening

- level risks to listed species will be enumerated here. Risk to listed species will not be characterized herein.

1. Ecological Exposure and Risk Conclusions

Environmental fate information available to the Agency indicates that fosthiazate is

both persisten t and mobil e. However, due to the application method of fosthiazate

, by drip irrigation under a plastic mulch, potential movement of fosthiazate in to the terrestrial

environment beyond the site of application is also limited. Likewise, t he potential for fosthiazate to move into surface water or groundwater is also limited

.

Birds and Mammals :

Potential exposure to fosthiazate for birds and mammals comes from consuming either contaminated arthropods or contaminated earthworms. Risk q uotient (RQ) estimates ranged depending upon the weight of the bird or the environmental fate parameters used to estimate RQs. For birds only acute level of concern (LOC) exceedances were identified

, and for mammals only

chronic LOC e xceedances were ident ified. Acute RQs for birds that may consume contaminated arthropods range from 0.11 to 0.25, which exceed the LOC for listed species but does not exceed

the LOC for non

- listed species ( Appendix A below provides the LOCs for non

- listed and listed species f or ecological risk assessment ) . Acute RQs for birds that may consume contaminated earthworms range from 0.2 to 0.98 (which exceed LOCs for both listed as well as non

- listed species). Chronic RQs for mammals that may consume contaminated arthropods range from 1.26 to 1.48, and chronic RQs for mammals that may consume contaminated earthworms range from 1.16 to 5.7, which exceed s the Agency’s LOC.

Terrestrial Invertebrates :

Since fosthiazate is a systemic insecticide and applied to the soil via drip irrigat ion, potential

contact and oral exposure to terrestrial invertebrates can occur. RQs were estimated for those organisms that are soil

- bound (utilizing acute contact data) and for those that are not soil

- bound, such as bees (utilizing acute oral data that were submitted during the initial public comment period). An acute RQ for soil- bound terrestrial invertebrates was estimated to be 6.9 (which exceeds the LOC). The acute RQ for terrestrial invertebrates which are not soil

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6 2. Ecolog ical Incidents

At the time the Agency initiated the reg istration review of fosthiazate (2009)

, a review of the Office of Pesticide Programs Ecological Incident Information System (EIIS,) was conducted for

fosthiazate related adverse incident information. No adverse effect reports were found that were attributed to fosthiazate. Again, in 2012, a review of EIIS, as well as a review of the Avian Incident Monitoring System (AIMS), and the Incident Data System (IDS) was conducted to search for any

fosthiazate related adverse incident information. In general, the Agency believes that the lack of ecological incident reports does not necessarily indicate a lack of incidents but rather could be lack of reporting. In the case of fosthiazate, the lack of incidents may also be attributed to its lack of use

.

3. Risk Characterization

Ecological risk estimates for fosthiazate represent screening

- level analysis where the Agency

uses reasonable worst

- case scenarios and conservative assumptions with the intention that esti mates do not underestimate risk. Because non

- standard methods were used to estimate risk to certain taxa, e.g., soil

- bound invertebrates, the Agency presented risk ranges and conducted additional modeling to estimate RQs.

The Agency considers the exposur e estimates, and therefore risk estimates, for birds and mammals to be conservative for a number of reasons. When the Agency estimated dietary exposure to birds and mammals via consumption of contaminated earthworms and arthropods, the Agency

assumed that the dose received by the bird/mammal via the contaminated article (the arthropod or earthworm) is equal to the concentration of fosthiazate applied to the soil. It is likely however, that avian/mammalian food sources in the soil do not reach equilibrium with the concentration of the pesticide in the soil. In addition, the limited availability of the contaminated food source was not accounted for in the fosthiazate exposure assessment. That is, since fosthiazate is applied under plastic tarp, the bird or mammal would have to p uncture the plastic tarp to access the contaminated

food source

, an aspect of exposure that the Agency acknowledges but for which it cannot quantitatively account. Instead, the Agency's assessment assumes that an organism's entire d iet (i.e., bird or mammal) for one day consists solely of the contaminated food article. Additionally, with respect to estimated risk to terrestrial soil

- bound invertebrates, risk to these taxa have also been conservatively estimated because with the drip irrigation application method, the distribution of the compound throughout the soil is both targeted and limited to the root zone of the plant resource to be protected (tomatoes) from the target pest (nematodes). Therefore, while estimated risks to soil

dwelling invertebrates may exist, the risk is likely to be limited to those organisms directly in the root zone, and less so to organisms that may be in the areas between plants or within furrows.

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 Services), and the U.S. Department of Agriculture (USDA) released a summary of t heir joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendations and reflect a common approach to ris k assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The AS report outlines recommendations on specific scientificDoc ket Number EPA

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7 and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the Endangered 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 prese nted the joint Interim Approaches at the December

2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Regist ration Review decisions. The details of the joint Interim Approaches are contained in the

white paper "Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences Ap ril 2013 Report," dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the e cological risk assessment supporting this Interim Registration Review Decision for fosthiazate does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although EPA has not y et completed effects 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 for the sake of the assessment that listed species and designated critical habitats may be present in the vicinity of the application of fosthiazate. This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scie ntific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designate d critical habitats, these methods will be applied to subsequent analyses for fosthiazate as part of completing this registration review.

D. Endocrine Disruptor Screening Program

As required by FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA), EPA

r eviews 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 that may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reprod uctive 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 d ecision for fosthiazate, 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), fosthiazate is subject to the endocrine scre ening part of the Endocrine Disrupter Screening Program (EDSP).Doc ket Number EPA

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8 EPA has developed the EDSP to determine whether certain substances (including pesticides and other active 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 iden tify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or 1) 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 of the 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 establi sh a

dose

- response relationship between the dose 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 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 and includes some pesticides scheduled for registration review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disrupters.

Fosthiazate is not among the compounds on either list one or list two. In the interim, EPA is making no human health or environmental safety finding s associated with the EDSP screening of fosthiazate. Before completing this registration review, the Agency will make an EDSP FFDCA section 408(p) determination.

I I I. USE AND USAGE

Fosthiazate is an organophosphate (OP) nematicide registered for use only on tomatoes; it is formulated as an emulsifiable concentrate and applied via drip irrigation under plastic mulch prior to insertion of tomato transplants into the bed. There are two registrations for fosthiazate, one technical product, and one end

- us e product. The Agency has found no data indicating use of fosthiazate in the U.S. Based upon comments submitted by the technical registrant (ISK Bioscience) , the marketing of fosthiazate was intended to represent a soil sterilization option for

growers a s the availability of methyl bromide and other soil fumigants decreased. However, fosthiazate would only be a selective replacement, as it is intended to mainly control nematodes,

such as root

- knot nematode ( Meloidogyne incognita

), or spiral nematode ( Hel

icotylenchus spp .), and is not

effective in controllin g weeds or soil pathogens. ISK believes that any future use of fosthiazate would likely be in conjunction with integrated pest management (IPM) programs for crops where

control of nematodes is necessar y (ISK submission, Fosthiazate: Methyl Bromide Replacement and Reduced

Risk Status , Oct. 18, 1999)

I V

. INTERIM REGISTRATION REVIEW DECISION

A. Tolerance Amendments No tolerance changes for fosthiazate are recommended as part of the fosthiazate registrat ion

Review process

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9 B. Risk Mitigation Measures and Rationale

Based upon (i) the Agency's risk analysis incorporates a number of conservative exposure elements; (ii) there are no reported adverse incidents associated with fosthiazate; and, (iii) estimate d risk from fosthiazate to birds and mammals range from below the LOCs to slightly above the LOCs, (depending upon the assumptions employed), the Agency believes that any ecological risks from fosthiazate are low, and as noted in the ecological risk assess ment, are restricted only to the application site. As noted earlier, the Agency has no information indicating use of fosthiazate and therefore, benefits of fosthiazate are considered to be low.

In order to reduce potential ecological risks

, fosthiazate l abels must be changed to increase the minimum irrigation volume from the current 0.5

- 1 inches of water per acre to 1.25 inches of water per acre. Increasing the volume of irrigation water per acre will reduce the concentration of

fosthiazate in the soil , and therefore potential exposure to all non

- target organisms, including birds

and mammals that may eat c ontaminated arthropods or earthworms, soil

- dwelling invertebrates and other terrestrial invertebrates (such as bees).

Increasing the required volume of water to 1.25 inches per acre, will:

o r educe estimated acute risks to birds, and chronic risk to mammals that consume arthropods to below the listed LOC.

o r educe the estimated acute risk to birds and chronic risk to mammals that consume

earthworms , but not likely below the listed LOC.

o r educe estimated risks to soil

- dwelling invertebrates, but not below LOCs.

C. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registra tion Review Decision. Except for the EDSP and ESA components in this case, the Agency has made the following Interim Registration Review Decision: (1) no additional data are required at this time; and (2) changes to the affected registrations and their la beling are needed at this time (see Appendix C: Fosthiazate Label Table).

In this Fosthiazate Interim Registration Review Decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of fosthiazate, nor is i t making a complete endangered species finding. The Agency's final registration review decision for

fosthiazate will be issued once ESA Section 7 Endangered Species consultation with the Services has taken place, and an EDSP FFDCA section 408(p) determina tion has been made.

V. NEXT STEPS AND TIMELINE

A. Implementation of Mitigation Measures

The registrant must submit am ended labels that include the risk mitigation described in this

interim decision to the Agency for approval within 60 d ays following the i ssuance of th is InterimDoc ket Number EPA

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10 Registration Review Decision. Mitigation measures are described in Appendix B, and changes to labels are described in Appendix C.

B. Final Registration Review Decision

EPA will make a final registration review decision for fosthiaz ate after ESA Section 7

consultation with the Services is completed and an EDSP FFDCA section 408(p) determination has

been made

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### Appendix A: Levels of Concern (LOC) for Ecological Risk Assessment

Taxa Non

- Listed Species LOC Listed Species LOC

Acute Chronic

! Birds and Wild Mammals 0.5 1 0.1
Aquatic Animals 0.5 1 0.05

I Plants 1 1 1

Terrestrial Invertebrates 0.4 1 0.05 (interim)

I



### Appendix B: Summary of Mitigation for Fosthiazate

R egistration Review Case#: 7604

Chemical N ame: Fosthiazate

PC Code: 129022

C hemical Type: Nemat

i cide Chemical Family: Organophosphate Mode of Action: Cholinesterase (ChE) Inhalation

IM_odc of Action: Cholinesterase (ChE) Inhibition Birds Contaminated

arthropods Route of

Exposure Duration of

Exp osure Risk(s) of Concern Mitigation

Birds Contaminated

arthropods Dietary acute Estimated RQs range from

below LOC to 0.25 Increase the minimum irrigation

volume from the current 0.5

- 1 inches of water per acre to 1.25 inches of water per acre

Birds Con taminated

earthworms Dietary acute Estimated RQs from below

LOC to 0.98 Increase the minimum irrigation

volume from the current 0.5

- 1 inches of water per acre to 1.25 inches of water per acre

Mammals Contaminated

arthropods Dietary chronic Estimated RQ s range from

below LOC to 1.48 Increase the minimum irrigation

volume from the current 0.5

- 1 inches of water per acre to 1.25 inches of water per acre

Mammals Contaminated

earthworms Dietary chronic Estimated RQs range from

b elow LOC to 5.71 Increase t he minimum irrigation

volume from the current 0.5

- 1 inches of water per acre to 1.25 inches of water per acre

Soil

- dwelling

invertebrates Contamination of its

environment by drip irrigation Dietary/contact acute Estimated RQ = 6.9 Increase the minimu m irrigation

volume from the current 0.5

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### Appendix C: Fosthiazate Label Table

Summary of Labeling Changes for Fosthiazate Uses

Description Amended Labeling Language for Fosthiazat e Use Products Placement on Label

End Use Products

Current Label Language Change Current:

Use sufficient water to allow thorough incorporation throughout the bed to achieve, efficacy, but not cause run cause run off or excessive leaching. In most soils, 1/2 to 1 inch of irrigation water/A i s required for incorporation of the product when applied through a drip irrigation system.

Change to: Use sufficient water to allow thorough incorporation throughout the bed to achieve efficacy, but not cause runoff or excessive leaching. Use of 1.25 inches of irrigation water/A is required for incorporation of the product when applied through a drip irrigation system. Directions for Use