Docket Number EPA-HQ-OPP-2007-0379 www.regulations.gov



## Fosetyl-Al

Interim Registration Review Decision Case Number 0646

Approved by:

Date: 

## June 2015

Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Division

### I. 

### INTRODUCTION

This document is the Environmental Protection Agency ' s (EPA or the agency) Interim Registration Review Decision 

### for fosetyl-Al (PC code 123301) 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 Rodenticide 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 require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on fosetyl-Al, additional documents can be found in EPA's public docket (EPA-HQOPP-2007-0379) at www.regulations.gov.

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 umeasonable risks to human health or to 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 the statutory standard of no umeasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program , the agency periodically re-evaluates pesticides 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 ww w.epa.gov / oppsrrdl/registration review/.

In 2006
, the agency implemented 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.

Fosetyl-Al (Aliette) is a phosphonate fungicide registered for use to control various Oomycyete pathogens that cause Phytophthora rots and Downy Mildews on numerous crops. Fosetyl-Al is registered for use on agricultural crops including avocado, almond, brassica
, caneberry, citrus
, cucurbits
, grape, leafy greens , macadamia nut, stone fruit, strawberry
, tomato , and tobacco. Fosetyl-Al is also registered for commercial use on ornamentals
, turf
, and conifer (nurseries).

Fosetyl-Al, PC Code 123301
, was first registered in 1983 and a Reregistration Eligibility Decision (RED) was issued for fosetyl-Al in December 1990. EPA initiated registration review for fosetyl-Al (case 0646) in November 2007. The following highlights significant events that have occurred during the registration review of fosetyl-Al and can be found in EPA's public docket, (EPA-HQ-OPP-2007-0379) which may be accessed at www.regulations.gov.

• December 19, 2007

- Issuance of Fosetyl-Al (Aliette) Summary Document: Registration Review 

### for a 60-day public comment period. The Summary Document 

### included the Pr e liminary Work Plan 

### (PWP) and was accompanied by the Health Effects Division

2Registration Review Problem Formulation and the Registration Review Preliminar y Probl e m Formulation for the Ecological Risk Assessment of Fo s etyl-Al. The agency received three comments during the public comment period. Comments were addressed in the Final Work Plan

, and did not modify either the anticipated data needs or the anticipated schedule for fosetyl-Al.

• May 7
, 2008

- Final Work Plan (FWP) for fosetyl-Al was issued. Public comments w ere received which did not modify the PWP
, so no modifications to the PWP were made. The FWP indicated no data requirement needs for the registration review of foset y l-Al.

• March 28
, 2013

- The agency published the Preliminary Ecological Risk A s sess ment for th e R e gistration Review of Fosetyl-Al and the Registration Revi e w Preliminar y Human Health Risk Assessment for Fosetyl-Al for a 60-day public comment period. Two
comments were received ; one from the Center for Biological Diversity discussing the
agency ' s Endangered Species consultation responsibilities
, and another from Bayer Cropscience discussing the several components of the ecological risk assessment including use rate assumptions and toxicity data for terrestrial in v ertebrates. Both of these
comments were addressed in the Proposed Interim Decision.

• December 2014

- The agency issued the Fosetyl-Al Proposed Interim Regi s tration R e vi ew D e ci s ion
, for a 60-day public comment period. Fourteen comments to the Proposed Interim Decision were submitted by a variety of commenters , and related to five main areas ; 1. Pollinator advisory language ; 2. Increased Restricted Entry Interval (REI) ; 3. Endangered Species Act (ESA) ; 4. Pollinator data requirements; and 5. General benefits of fosetyl-Al. A summary of each comment and EPA responses to these
comments are addressed in the memorandum
, Re s ponse to Proposed Interim D e cision C omment s for Fo s etyl- A l

, dated June 9
, 2015 available in the docket
, number EPA-HQOPP-2007-0379
, which can be accessed at www .regulation s.g o v

o Commenters disagreed with the agency ' s proposal to include precautionary pollinator protection language on fosetyl

- Al labels. The agency has modified its proposal regarding precautionary pollinator protection language on product labels
, no longer requiring them. See Section A.
, Changes from the Proposed Interim Decision
, for details.

o Commenters noted that increasing the REI from 12 to 48 hours
, as proposed b y the agency , would adversely impact the benefits of foset y l- Al products. The
agency has determined that based upon the requirements of the Worker Protection Standard Section 156.208
, it will not modify its proposal to require that foset y l-Al products bear a 48-hour REL

o One commenter noted EPA ' s responsibilities under the Endangered Species Act. The agency notes that it is currently working with its federal counterparts and other stakeholders to implement an interim approach for assessing potential risk
to listed species and their designated critical habitats

. The agenc y w ill conduct an ESA consultation for those taxa and habitat where likely effects exist
, prior to making a final decision

.

3o Several commenters provided information on the use and benefits of fosetyl-Al
, particularly as a component in effective disease management. The agency acknowledges their submission and appreciates substantive benefits information

on pesticide products.

• June 2015

- Concurrent with this Interim Decision
, the agency is issuing a memorandum summarizing comments and agency responses for the Fosetyl-Al Proposed Interim Regi s tration Review Decision. This response memo , Response to Proposed Interim Deci s ion Comments for Fosetyl-Al

, dated June 18, 2015
, is available in the docket
, number EPA-HQ-OPP-2007-0379
, which can be accessed at www

. regulations.go v

• June 2015 -The agency is now publishing the Interim Decision for fosetyl-Al in docket number EPA-HQ-OPP-2007-0379, which can be accessed at www.regulations.go v

A. Changes from the Proposed Interim Decision

In the Proposed Interim Decision
, the agency identified several proposed label changes to products that contain fosetyl-Al. Among the proposed label changes was the addition of pollinator protection warning language which stated that contact and ingestion of fosetyl-Al may pose a hazard to bees
, and that fosetyl-Al has shown effects to bees. The agency received several
comments that the agency not include the proposed precautionary pollinator protection language

on fosetyl-Al product labels.

The agency notes that-the proposal to include precautionary pollinator protection language on fosetyl-Al labels was in part due to adverse effects seen in available predatory mite data
, and marginal exceedances identified in a screening-level acute analysis of risk to honey bees. After reviewing comments , the agency has reconsidered the use of predatory mite data to predict effects to honey bees and other non-Apis bee species. As a result
, estimation of potential effects of fosetyl-Al to bees is reduced, and therefore the precautionary language is no longer warranted. The agency is currently determining the need for additional pollinator data for active ingredients in registration review whose dockets opened prior to June 2014
, which includes fosetyl-Al. In the near future
, EPA will provide further information and guidance on this effort.

II. USE AND USAGE

Fosetyl-Al is a fungicide registered for the control of fungal diseases on agricultural crops , commercial ornamentals, and turf. Fosetyl-Al can be applied as a root treatment (soil application, dip), trunk spray, and as a foliar treatment to crops by ground or aerial application. In agriculture
, fosetyl-Al is generally applied as a preventative treatment against downy mildew. Fosetyl-Al is reported to provide additional benefit in resistance management , as it does not exhibit cases of fungicide resistance seen in other chemicals used to control these diseases. Fosetyl-Al is registered for use on ornamental plants in residential areas , and is registered for use

on golf course turf grass. From 1998-2008, lettuce was the largest agricultural use , consisting of 64% of total pounds of active ingredient applied to crops. Data on fosetyl-Al use on golf course turf showed that use peaked in 2001 with approximately 370,000 pounds of active ingredient applied.

4

### III. SCIENTIFIC ASSESSMENTS

A. Human Health

A summary of the agency's human health risk assessment is presented below. For a detailed summary of the human health risk assessment, see Fosetyl-Al Proposed Interim Registration Review Decision, in the public docket (EPA-HQ-OPP-2007-0379) which can be accessed at http: // www.regulations.gov /

.

1. Human Health Risk Summary

Dietary Assessment

The agency relied on the 2001 assessment, which remains sufficient to characterize dietary risk from fosetyl-Al. The agency's conclusion remains that dietary risks (food and water)

are not of concern from the registered uses of fosetyl-Al.

Residential Assessment

Residential exposures to fosetyl-Al may occur from applications to residential ornamentals and from applications to commercial or recreational turf (e.g., golf course). Exposure scenarios include both residential handler and residential post-application. The
assessment indicated no risks of concern with residential handler Margins of Exposure (MO Es) ranging from 120,000 to 7, 100,000 where the level of concern (LOC) is 100. The assessment of residential post-application exposure, including children's incidental oral exposure, indicated no risks of concern with MO Es ranging from 1, 100 to 500,000. No residential risks of concern were identified for registered uses of fosetyl-Al.

Aggregate Assessment

The agency combined aggregate exposure estimates (previously assessed in the 2001 ), with updated drinking water estimates and concluded that there are no aggregate risks of concern for the registered uses of fosetyl-Al.

Occupational Assessment

No dermal endpoint was identified in the fosetyl-Al toxicity database, so occupational
assessments were conducted for the inhalation route of exposure only. No inhalation risk of

concern was identified for occupational handlers of fosetyl-Al, with MOEs for various exposure scenarios estimated to be greater than 1,900 (LOC is 100). Because the vapor pressure of fosetylAl is considered low, and because EPA believes that the handler scenario is protective of any post-application scenarios, no post-application assessment was conducted, and no risk of concern is expected. The agency also assessed occupational risk from the use of fosetyl-Al as a seed
treatment and found that MOEs ranged (28,000-390,000), indicating no risks of concern.

2. Human Health Incidents

5In 2007 the agency conducted a search of available incident information to identify human incidents attributable to fosetyl-Al exposure. The agency searched the National Poison Center System (NPCS), the Office of Pesticide Programs (OPP) Incident Data System (IDS), and the National Institute of Occupational Safety and Health Sentinel Event Notification System for Occupational Risk (NIOSH/SENSOR), for the years 1993 through 2005. NPCS data indicated sixteen reports associated with fosetyl-Al. There were nine incidents associated with occupational exposures, and six incidents associated with non-occupational exposures. IDS reported four cases, and NIOSH/SENSOR reported one occupational case. None of the incidents warranted mitigation action based on a review by the agency; and based upon the low frequency and low magnitude of incidents, additional incident queries were not conducted for the registration review of fosetyl-Al. The full review of incident reports can be found in the Review of Aliette Incident Reports, located in the public docket under EPA-HQ-OPP-2007-0379, which

can be accessed at www.regulations.gov.

3. Food Tolerances

Tolerances for residues offosetyl-Al on food are established in 40 CFR § 180.415. Tolerances for several crops have been reviewed for possible harmonization with Canadian MRLs
, and/or for possible updates to crop groupings or subgroupings. The agency will propose revisions to 40 CFR 180.415 during registration review to harmonize with established international tolerances where possible, and/or to reflect the most up-to-date crop group or crop subgroup definitions. For more information on tolerance harmonization review for fosetyl-Al, please see the section, "International Harmonization/Tolerance Considerations", in the Registration Review Preliminary Human Health Risk Assessment for Fosetyl-Al.

B. Ecological Risk Summary

A summary of the agency's ecological risk assessment is presented below. The agency used the most updated science policies and risk assessment methodologies to prepare a quantitative risk assessment in support of the registration review of fosetyl-Al. For a detailed discussion of revised ecological fate and effects for fosetyl-Al see Preliminary Ecological Risk Assessment for the Registration Review of Fosetyl-Al, dated March 2014, in the public docket (EPA-HQ-OPP-2007-0379) which can be accessed at http: // www.regulations.gov /

.

The agency's risk assessment also constitutes a screening-level endangered species
assessment. Based upon its analysis of fosetyl-Al, the agency found that estimated RQs are below the agency's acute and chronic level of concern (LOC) for certain listed species. Therefore, the agency is making a "no effect" finding for aquatic animals, including fish, aquatic-phase amphibians, aquatic invertebrates and for plants, including aquatic plants, and terrestrial monocot plants exposed to fosetyl-Al that (i) do not rely upon birds, terrestrial-phase amphibians, reptiles, mammals and terrestrial insects for food or shelter, and (ii) do not have obligate relationships with dicot plants.

1. Terrestrial Assessment

Mammals

6Acute LOC exceedance were identified for mammals and were mainly identified in mammals consuming short grass, and for uses where the single application rate is greater than 2.9 lb

. a.i

. per acre. Use sites with the highest RQ include: turf (RQ=2) ; conifer (RQ = 2); and ornamental (RQ=2). Chronic LOC exceedances for mammals were also identified for most uses and ranged from< LOC

- 10 (where the chronic LOC is 1.0). Use sites with the highest chronic RQs include: turf (RQ= 1 

### O) ; conifer (RQ= 1 

### O); ornamental (RQ= 1 

### O); ginseng (RQ = 7 .5) ; brassica
, cucurbit
, and leafy vegetable (RQ=6.7); and pineapple (RQ = 6.0).

Birds

Acute LOC exceedances were identified for birds, and include uses where the single application rate is greater than 6.0 lb. a.i. per acre. Use sites with the highest acute RQ include: turf (RQ = 2) ; conifer (RQ=2); and ornamental (RQ=2). Chronic LOC exceedances to birds (all sizes) were also identified for most uses and ranged from below the chronic LOC to 10. Use sites with the highest chronic RQs include: turf (RQ= 1 

### O); ornamental (RQ= 1 

### O); conifer (RQ = 6) ; ginseng (RQ = 3.8); and brassica
, cucurbit, and leafy vegetable (RQ=3.2).

Terrestrial Invertebrates

For honey bees (which serve as a surrogate for terrestrial invertebrates)
, limited (tier I) data was available. The agency identified an acute oral endpoint (acute oral LDso) of 455 ug / bee
, which results in LOC exceedances for uses where the single application rate is greater than 5 .6 lbs a.i./acre (includes macadamia nuts, pineapple, ornamental conifers, and ornamentals).

Available data suggest that the effects of fosetyl-Al may differ between Apis (honey bee)
, and non-Apis terrestrial invertebrate species
, where these non-Apis species are more sensitive. The agency reviewed a number of open literature sources and identified a lowest endpoint for predatory mite equivalent to a maximum application rate of 1.8 lbs a.i./acre *

. Other effects were

seen in studies conducted with Sweetpotato whitefly at a dose equivalent to 4.0 lbs a.i ./ acre* (effects included decreased number of adults, number of eggs and number of nymphs). Effects

seen with these non-Apis species may be informative of potential effects to non-Apis species from registered uses of fosetyl-Al.

Terrestrial Plants

Vegetative vigor data (with terrestrial dicotyledonous plants) provided an endpoint (EC25) equivalent to 7 .6 lb a.i./acre
, therefore all use sites with a single application rate greater than 7 .6 lb a.i./acre exceed the LOC of 1.0 (includes turf
, ornamentals
, conifer
, and pineapple). Using this endpoint and the AgDrift model
, the distance from the edge of the field to the point of

no effect concentration is estimated to be 7 ft. This off-site risk is considered negligible as the effect area is relatively small and only applies to the downwind side of the field.

2. Aquatic Assessment



### * Converting from ug a.i./bee method described in USEPA, PMRA, CADPR 2012.

7

### Based on the most conservative acute and chronic endpoints, fosetyl-Al does not pose a risk to aquatic organisms. Acute RQs for fish, aquatic invertebrates, and aquatic plants range from < LOC

- 0.12, which are below the acute endangered LOC of0.1. Chronic RQs were estimated for aquatic invertebrates which were below the LOC. While chronic RQs were not calculated for fish and aquatic plants, risk is not expected due to the lack of toxicity seen in the available data.

3. Ecological Incidents



### In August 2009, the Ecological Incident Information System (EIIS), Avian Incident Monitoring System (AIMS), and aggregate incident databases were searched for reports. Two ecological incidents potentially involving fosetyl-Al were found. Both incidents occurred from registered applications to spinach, but only one report included application information (i.e., 3.0 lb a.i./acre). Based upon the low frequency and low magnitude of ecological incidents, additional incident queries were not conducted for the registration review of fosetyl-Al. A detailed summary can be found in Appendix A. of Preliminary Ecological Risk Assessment for the Registration Review of Fosetyl-Al.



### IV. Risk Characterization

A. Ecological Risk



### Based on the agency ' s assessment, the highest risks from fosetyl-Al are to birds (including reptiles and terrestrial phase amphibians), mammals
, terrestrial invertebrates, and terrestrial plants (i.e., 

### di cots). These risks are associated mainly with the higher application rates for which fosetyl-Al is labeled. Details regarding uncertainties and assumptions associated with the estimation of ecological risk are contained in the Fosetyl-Al Proposed Interim Registration Review Decision. 

### A brief discussion of the assumptions and uncertainties most relevant to the risk management of fosetyl-Al
, are summarized below.

For risk to birds
, there is some uncertainty associated with both the acute and chronic endpoints used to estimate risk. While several median lethal dose (LD50) values were identified in the ecotoxicity database, the agency estimated risk utilizing the lowest of these values. Further, the study from which the (lowest) acute endpoint was drawn (LD50 

### = 4,976 mg a.i./kgbw) reflected several deficiencies in study design. The agency notes that use of the next sensitive avian acute endpoint in the data base (LD50 > 

### 8,000 mg a.i./kg-bw) would yield acute RQs lower than those identified in the screening level analysis. With respect to the chronic endpoint used to estimate chronic RQs, the agency notes that at the NOAEC, (1414 mg a.i./kgdiet) no statistically significant effects were observed. Furthermore, alternative chronic data is unavailable to further characterize this endpoint and estimated chronic RQ for birds. The absence of a definitive effect indicates that the true endpoint may be higher, which would lead to lower chronic LOC exceedances. Risks for mammals were marginal and only existed in the highest exposure scenanos.

With respect to terrestrial invertebrates
, the agency notes that the marginal LOC exceedance is based upon a limited set of tier I data with the honey bee (lacking larval and chronic adult data with bees), and is based upon screening-level exposure assumptions that do

8not take into account the attractiveness of any of the use sites for which the application rate is 2: 5.6 lbs a.i./acre
, cultural practices of subject use sites that may influence potential exposure , or pollen/nectar residue data from the subject use sites.

B. 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 the joint Interim Approaches in the white paper [I] Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Ba s ed on the Recommendations of the National Academy of Sciences April 2013 Report
, dated November 1
, 2013.

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 risk
assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report [ 2 1 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 their obligations under the ESA and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented 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 stakeholder workshops in April and October 2014, and April 2015, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. 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 Registration Review decisions.

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 ecological risk assessment supporting this Interim Registration Review Decision for fosetyl-Al 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 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 fosetyl-Al. 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 scientific methods being developed by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis
, the regulatory section of the Interim Registration Review Decision document describes the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments

[lJ http: // www. e p a. go v/e spp / 2013 / nas. html

r 2 1 http: 

### I /www.nap.edu / cat a log. php?reco r d id=l8344

9

### for listed species and their designated critical habitats
, these methods will be applied to subsequent analyses for fosetyl-Al as part of completing this registration review.

C. Endocrine Disruptor Screening Program



### As required by FIFRA and FFDCA
, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals

. Collectively
, these studies include acute , subchronic and chronic toxicity, including assessments of carcinogenicity
, neurotoxicity
, developmental
, reproductive
, and general or systemic toxicity. These studies include endpoints

w hich may be susceptible to endocrine influence
, including effects on endocrine target organ histopathology, organ weights
, estrus cyclicity
, sexual maturation
, fertility
, pregnancy rates , reproductive loss
, and sex ratios in offspring. For ecological hazard assessments , EPA evaluates
acute tests and chronic studies that assess growth
, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for fosetyl-Al, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the e x isting hazard database. However
, as required b y FFDCA section 408(p )
, fosetyl-Al is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

E PA has de v eloped th e EDSP to determine whether certain substances (including pesticide acti v e and other ingredients) may ha v e an effect in humans or wildlife similar to an effect produced by a " naturally occurring estrogen , or other such endocrine effects as the Administrator ma y designate. " The EDSP emplo y s a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identif y the potential of a chemical substance to interact with the estrogen , androgen
, or thyroid (E
, A
, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E
, A
, or T hormonal systems will proceed to the next stage 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 establish 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[ 3 ] 

### and includes some pesticides scheduled for 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 battery
, please visit our website. r 4 1



### In the interim
, EPA is making no human health or environmental safety findings associated with the EDSP screening of fosetyl-Al. Before completing this Registration Review
, the agency will make an EDSP FFDCA section 408(p) determination.

[ 3 J See http: //w w w .regul a t i ons.go v/ #!docum e ntD e tail;D = EPA

- HQ

- OPPT -2 00 9- 0 4 7 7

- 0074 for the final second list of chemicals.

[ 4 J http: //w ww

. epa.gov/en d o/



### 10

### V. BENEFITS

The agency has identified benefits of fosetyl-Al for those uses where risk has been identified. A summary of these benefits is contained in the Proposed Interim Decision
, issued December 17, 2014 and located in the public docket under EPA-HQ-OPP-2007-0379
, which can be accessed at www.regulations.gov. The agency's understanding of benefits from fosetyl-Al

was supported by comments received in response to the Proposed Interim Decision. Two
comments provided to the agency described the benefits of fosetyl-Al in managing disease on turfgrass and on pineapple. Commenters supported current application rates , and discussed the effectiveness of fosetyl-Al in controlling diseases such as Pythium root and anthracnose in turf grass. A commenter also indicated support of fosetyl-Al for use on pineapple
, describing the benefits of fosetyl-Al as a preventative treatment for Pineapple Heart and root rot, and providing information on the use pattern and usage rates for fosetyl-Al use on pineapple. A summary of
comments can be found in the memorandum, Response to Proposed Interim Decision Comments for Fosetyl-Al

, available in the public docket at EPA-HQ-OPP-2007-0379, accessible at, www.regulations.gov.

VI. INTERIM REGISTRATION REVIEW DECISION

A. Risk Mitigation and Regulatory Rationale

Human Health

The agency did not identify any human health risks of concern for fosetyl-Al. However
, updates to fosetyl-Al labels are required in order to be consistent with current agency policy on seed treatment uses and worker protection language 5

. These changes are listed below and detailed in Appendix B: Fosetyl-Al Label Table.

• Because fosetyl-Al is considered a Toxicity Category I compound for primary eye irritation, fosetyl-Al labels need to include a 48-hour restricted entry interval (REI).

• The fosetyl-Al FIFRA sec. 24( c) registration for seed treatment (ID 30001) needs
to include the most current seed treatment label language, see Appendix B for specific language.

Ecological

The agency identified LOC exceedances for birds (amphibians and reptiles)
, mammals
, terrestrial invertebrates and terrestrial plants ( dicots) for a number of uses. However the highest RQs are limited to certain uses with high application rates (compared to other fosetyl-Al uses) including turf, ornamentals, ornamental conifers, ginseng, macadamia nut and pineapple. As such
, the agency's risk mitigation focuses on these uses. Based upon comments received on the Proposed Interim Decision, the agency has modified one of its proposed label changes, and will
not require the addition of precautionary language for pollinators on fosetyl-Al labels.

l 5 l For more information on the Worker Protection Standard requirements
, please see the EPA site: http :// www.epa

. gov / agriculture / twor.html.

11Therefore, the following changes are needed to mitigate potential ecological risks from certain

uses of fosetyl-Al.

• Removal of aerial application from fosetyl-Al labels for ornamentals, turf, conifer, pineapple, and macadamia nut uses.

• Change current fosetyl-Al labels for pineapple use to limit the maximum single application rate to 3 lb. a.i. per acre per, and the maximum number of applications to 4 applications per year.

• Change current fosetyl-Al labels for macadamia nut use to limit the number of applications to a maximum of 3 applications per year.

• Change current fosetyl-Al labels for ginseng use to limit the number of applications to a maximum of 6 applications per year.

• Change current fosetyl-Al labels for turf to limit the number of applications to a maximum of 11 applications per year for sod; and to 8 applications per year for golf

course and residential uses.

• Change current fosetyl-Al labels for ornamental use to limit the number of applications to

a maximum of 11 applications per year for foliar applications, and to 4 applications per year for soil drench applications.

• Change current fosetyl-Al labels for conifer use to limit the number of applications to a maximum of 9 applications per year.

• Requirement of a minimum droplet size of fine or larger as defined in the American Society of Agricultural and Biological Engineers (ANSI/ ASABE 572.1) on fosetyl-Al labels for all foliar uses.

These measures are expected to reduce acute RQ exceedances to levels at or below the LOC, and are expected to bring the chronic RQ exceedances close to LOCs. The addition of a minimum droplet size will reduce off-site risk associated with foliar applications made with ground equipment. Fosetyl-Al is a valuable tool for growers in preventing disease resistance and

as a preventative treatment for fungal disease. While these changes do not bring all the potential risks below LOCs, when viewed in light of the benefits of fosetyl-Al (described in Section V), the remaining risk is considered acceptable in the interim.

Pollinator Studies and Assessment

When initially scoping the registration review for fosetyl-Al, EPA did not identify the need for any additional studies to evaluate potential effects on pollinators. However, since the issuance of the June 2014 Guidance for Assessing Pesticide Risks to Bee [ 6 1, EPA has begun to require these data where applicable. EPA is currently determining whether additional pollinator data are needed for active ingredients in registration review whose dockets opened prior to June 2014. For those active ingredients where EPA determines that additional pollinator exposure and effects data are necessary to help make a final registration review decision, EPA intends to issue

a DCI to obtain these data. In the near future, EPA will provide further information and guidance

on this effort. The pollinator studies that could be required are included in Table 1 below. The Agency will require data it believes are needed to help inform the pollinator risk assessment.

[GJ http: / /www 2. epa. go v/ sites / production / f iles/2 014

- 06 / documents / pollinator risk assessment guidance 06 19 14.pdf

12Table 1. Potential Pollinator Data Requirements Guideline# Study
850.3020* Acute contact toxicity study with adult honey bees
850.3030* Honey bee toxicity of residues on foliage
850.3040** Field testing for pollinators
Non-Guideline* Honey bee adult acute oral toxicity (OECD 213)
Non-Guideline* Honey bee larvae acute oral toxicity (O E CD 237)
Non-Guideline* Honey bee adult chronic oral toxicity
Non-Guideline* Honey bee larvae chronic oral toxicity
Non- Residues in pollen and nectar/field residue analysis Guideline**
Non- Semi-field testing for pollinators (tunnel or colony feeding Guideline** (O E CD 75) studies)

*T i e r I ( L a bo ra tor y -b ase d s tudi es) **T i e r 2 a nd 3 ( S e mi-fi e ld a nd full field c o lon y -l eve l s tudi es) Th e n ee d for a hi g h e r ti e r t es t fo r pollin a t o r s w ill b e d e t e rmin ed b ase d up o n l owe r-ti e r e d t es t s a nd / or oth e r lin es of d a ta a nd th e ne e d for a r e fin e d p o llin a tor ri s k assess m e nt.

B. Tolerance Amendments

During the registration review of fosetyl-Al
, the agency reviewed the foset y l-Al tolerances with respect to international harmonization as well as to identify an y updates to crop groupings or subcrop groupings. Modifications to fosetyl-Al tolerances have been identified for several crops/crop groupings including: blackberries and caneberries ; citrus fruit crop group ; ginseng ; bushberry crop subgroup ; and
, the pome fruit crop group , and will be implemented prior
to a final decision. For more information see Registration Revi e w Pr e liminary Human H e alth Risk Assess m e nt for Fo se tyl-Al.

C. Endangered Species

This Interim Registration Review Decision for fosetyl-Al does not contain a complete E SA analysis. However
, the agency has completed a partial ESA analysis for fo s et y l-Al
, and in the absence of any new information that modifies the agency ' s current assessment , it is making the following determination:

• A " no effect " determination under the ESA to listed species of fish
, aquatic invertebrates
, aquatic plants and monocot plants (in terrestrial and wetland habitats) that (i) do not rely upon birds
, terrestrial-phase amphibians
, reptile s, mammals and terrestrial insects for food or shelter
, and (ii) do not ha v e obligate relationships with dicot plants
, and no modification of designated critical habitat for such species.

• For all other species
, the effect determinations are uncertain.

13D. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58
, the agency is issuing this Interim Registration Review Decision. Except for the EDSP and ESA components of this case , the agenc y has made the following Interim Registration Review Decision: ( 1) there are no human health risk concerns based on the current use patterns of fosetyl-Al
, and the needed label changes
, identified in Appendix B
, make fosetyl-Al labels consistent with existing policies regarding worker protection standards
, and pesticide products labeled for use as a seed treatment ; and (2) label changes
, identified in Appendi x B
, are needed to reduce potential ecological risk.

In this interim registration review decision
, EPA is making no human health or

en v ironmental safety findings associated with the EDSP screening of fosetyl-Al
, nor is it making

a complete endangered species finding

.



### VII. NEXT STEPS AND TIMELINE

A. Implementation of Mitigation Measures

Registrants are required to submit amended labels that include the changes described in A ppendix B to the agency for approval within 60 days following issuance of the Interim Registration Review Decision.

B. Final Registration Review Decision

A final decision on the fosetyl-Al registration review case will occur after EDSP FFDCA section 408(p ), complete pollinator and ESA determinations have been made.

14AppendixA:SummaryofRisksandMitigationforFosetyl-AlRegistrationReviewCase#:0646PCCode:123301ChemicalType:FungicideChemicalFamily:PhosphonateModeofAction:PhosphonateAffectedPopulation(s)SourceofExposureRouteofExposureDurationofRisk(s)ofConcernMitigationMeasuresCommentExposureTerrestrialinvertebratesDirectapplicationsDietaryAcuteAcuteeffectspossibleatRemoveaerialReducesdistanceandspraydriftsiteofapplicationandatapplicationfromfromfieldwhereoff-targetduetosprayornamentals,turf,effectsareseendrift.conifer,pineapple,andmacadamianutusesTerrestrialplantsSpraydriftNotapplicableAcutePossibleacuteeffectstoDefinedropletsizeofReducesexposuretooff-sidenon-targetplantsfineorlargerforallnon-targetplantsand(dicots)upto7ft.fromtheusesotherorganismsfromedgeofthefieldspraydriftBirds,(terrestrial-phaseApplicationtoDietaryAcute/chronicBird,acuteRQ=1.2Limitthemax.singleReducesamphibians,andreptiles),pineappleBird,chronicRQ=2.5applicationrateforenvironmentalandmammalspineappleto3lb.a.i.exposureMammal,acuteRQ=0.9peracre;andMammal,chronicRQ=6.0Limitthemax.numberofapplicationsperyearto415lAffectedPopulation(s)SourceofRouteofDurationoflRisk(s)ofConcernMitigationMeasuresCommentExposureExposureExposureBirds,(terrestrial-phaseApplicationtoDietaryAcute/chronicBird,acuteRQ=1.2LimitthemaximumofReducesamphibians,andreptiles),macadamianutsBird,chronicRQ=2.5numberofapplicationsenvironmentalandmammalsperyearto3exposureMammal,acuteRQ=0.8Mammal,chronicRQ=4.9Birds,(terrestrial-phase!ApplicationtoDietaryAcute/chronicBird,acuteRQ=1.7LimitthemaximumReducesamphibians,andreptiles),gmsengBird,chronicRQ=3.8numberofapplicationsenvironmentalandmammalsperyearto6exposureMammal,acuteRQ=1.3Mammal,chronicRQ=7.5Birds,(terrestrial-phaseApplicationtoturf[)ietaryAcute/chronicBird,acuteRQ=2.0LimitthemaximumLimittomaxnumberamphibians,andreptiles),Bird,chronicRQ=10numberofapplicationsofapplicationsandmammalsperyearto:clarifiesthefosetylMammal,acuteRQ=2.011applicationsperyearAllabelMammal,chronicRQ=10forturf(sod);and8applicationsperyearforturf(golfcourses;residential)Birds,(terrestrial-phase!ApplicationtoDietaryAcute/chronicBird,acuteRQ=2.0LimitthemaximumLimittomax.numberamphibians,andreptiles),ornamentalsBird,chronicRQ=10numberofapplicationsofapplicationsandmammalsperyearto4forsoilclarifiesthefosetylMammal,acuteRQ=2.0drench,and11forAllabelMammal,chronicRQ=10foliarapplicationsBirds,(terrestrial-phaseApplicationtoDietaryAcute/chronicBird,acuteRQ=2.0LimitthemaximumLimittomaxnumberamphibians,andreptiles),conifersBird,chronicRQ=6.0numberofapplicationsofapplicationsandmammalsperyearto9clarifiesthefosetylMammal,acuteRQ=2.0Allabel.Mammal,chronicRQ=1016AppendixB:Fosetyl-AlLabelTableDescriptionAmendedLabelingLanguageforFosetyl-AIUseProductsPlacementonLabelEndUseProductsUpdatelabellanguage-Changeallinstancesofrestrictedentryinterval(REI)to"48hours"DirectionsforUseallfosetyl-AIproductsUpdatelabellanguage-"TreatedSeed-DoNotUseforFood,Feed,orOilPurposes.Whenopeningthisbagorloading/pouringthetreatedDirectionsforUsefosetyl-AIseedtreatmentseed,wearalong-sleevedshirt,longpants,shoes,socks,andchemicalresistantgloves.Aftertheseedshavebeenuse(SLNID-3000I)planted,donotenterorallowworkerentryintotreatedareasduringtherestricted-entryinterval(REI)of48hours.Exception:Oncetheseedsareplantedinsoilorotherplantingmedia,theWorkerProtectionStandardallowsworkerstoenterthetreatedareawithoutrestrictioniftherewillbenoworkercontactwiththetreatedseedsinthesoilorplantingmedia."Removalofaerial"Applybygroundapplicationequipmentonly.DonotapplybyairunlessdirectedbySupplementalorSpecialLocalSpecificCropUsesapplicationtoNeedlabeling."pineapples,ornamentals,turf,conifer,andmacadamianutSpecifyfineorlarger"WhenapplyingusespraynozzlesthatwilldeliverfineorlargerspraydropletsasdefinedintheAmericanSocietyofApplicationIspraydropletsizeforallAgriculturalandBiologicalEngineers(ASABE)standardANSI/ASAES572.l(March2009)".ApplicationusesEquipmentSpecifythemaximumForallapplicationmethods:"Donotapplymorethan3applicationsperyear".SpecificUsesInumberofapplicationsRestrictionsandonpineappleandmacadamianutas3perLimitationsyearSpecifythemaximumForallapplicationmethods:"Donotapplymorethan6applicationsperyear".SpecificUsesInumberofapplicationsRestrictionsandonginsengas6peryearLimitations17SpecifythemaximumForsoildrenchapplication:"Donotapplymorethan4applicationsperyear".SpecificUsesInumb_erofapplicationsApplicationon ornamentalherbaceousplants,Instructionsornamentalnonfloweringplants,andornamentalwoodyshrubsandvinesas4peryearSpecifythemaximumForfoliarapplication:"Donotapplymorethan11applicationsperyear".SpecificUsesInumberofapplicationsApplicationonornamentalherbaceousplants,Forapplicationbychemigation:"Donotapplymorethan11applicationsperyear".Instructionsornamentallawnsandturf,ornamentalnonfloweringplants,ornamentalsodfarm,andornamentalwoodyshrubsandvinesas11peryearSpecifythemaximumForallapplicationmethods:"Donotapplymorethan9applicationsperyear".SpecificUsesInumberofapplicationsApplicationon ornamentalconifersandconifersinnurseriesInstructionsas9peryear.18