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 www.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 

Preliminary Work Plan (PWP) and was accompanied by the Health Effects Division 

2 
Registration Review Problem Formulation and the Registration Review Preliminary 

Problem Formulation for the Ecological Risk Assessment of Fosetyl-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 were 

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 fosetyl-Al. 

• March 28, 2013 - The agency published the Preliminary Ecological Risk Assessment for 

the Registration Review of Fosetyl-Al and the Registration Review Preliminary 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 invertebrates. Both of these 

comments were addressed in the Proposed Interim Decision. 

• December 2014 - The agency issued the Fosetyl-Al Proposed Interim Registration 

Review Decision, 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, Response to Proposed Interim Decision 

Comments for Fosetyl-Al, dated June 9, 2015 available in the docket, number EPA-HQOPP-2007-0379, which can be accessed at www.regulations.gov 

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 by 

the agency, would adversely impact the benefits of fosetyl- 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 fosetyl-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 agency will conduct an 

ESA consultation for those taxa and habitat where likely effects exist, prior to 

making a final decision. 

3 
o 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 

Registration Review Decision. This response memo, Response to Proposed Interim 

Decision 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.gov 

• 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.gov 

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 

5 
In 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 

6 
Acute 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 

8 
not 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 Based 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. gov/espp / 2013 / nas. html 

r

2 1 http: I /www.nap.edu / cata log. php?recor 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 

which 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 existing hazard database. However, as required by FFDCA section 408(p ), 

fosetyl-Al is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including 

pesticide active and other ingredients) may have an effect in humans or wildlife similar to an 

effect produced by a "naturally occurring estrogen, or other such endocrine effects as the 

Administrator may designate." The EDSP employs a two-tiered approach to making the 

statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify 

the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or 

T) hormonal systems. 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: //www.regula t i ons.gov/ #!docume ntDe tail;D=EPA- HQ - OPPT -2 00 9- 04 7 7 -

0074 for the final second list of chemicals. 

[ 4 J http: //www . epa.gov/endo/ 

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 language5

. 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. 

11 
Therefore, 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: / /www2. epa. gov/sites/ production/ f iles/2 014 -

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

12 
Table 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 

(OECD 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** 

(OECD 75) studies) 

*Tier I (Laboratory-based studies) 

**Tier 2 and 3 (Semi-field and full field colony-level studies) The need for a higher ti er test fo r pollinators will be determined 

based upon lower-ti ered tests and/or other lines of data and the need for a refined pollinator risk assessment. 

B. Tolerance Amendments 

During the registration review of fosetyl-Al, the agency reviewed the fosetyl-Al 

tolerances with respect to international harmonization as well as to identify any 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 Review Preliminary Human Health 

Risk Assessment for Fosetyl-Al. 

C. Endangered Species 

This Interim Registration Review Decision for fosetyl-Al does not contain a complete 

ESA analysis. However, the agency has completed a partial ESA analysis for fosetyl-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, reptiles, 

mammals and terrestrial insects for food or shelter, and (ii) do not have obligate 

relationships with dicot plants, and no modification of designated critical habitat 

for such species. 

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

13 
D. 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 agency 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 Appendix B, are needed to reduce potential ecological risk. 

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

environmental 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 

Appendix 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. 

14 
Appendix A: Summary of Risks and Mitigation for Fosetyl-Al 

Registration Review Case#: 0646 PC Code: 123301 

Chemical Type: Fungicide 

Chemical Family: Phosphonate 

Mode of Action: Phosphonate 

Affected Population(s) Source of Exposure Route of Exposure Duration of Risk(s) of Concern Mitigation Mea

Exposure 

Terrestrial invertebrates Direct applications Dietary Acute Acute effects possible at Remove aerial 

and spray drift site of application and at application from 

off-target due to spray ornamentals, turf

drift. conifer, pineappl

macadamia nut u

Terrestrial plants Spray drift Not applicable Acute Possible acute effects to Define droplet si

off-side non-target plants fine or larger for 

(dicots) up to 7 ft. from the uses 

edge of the field 

Birds, (terrestrial-phase Application to Dietary Acute/chronic Bird, acute RQ = 1.2 Limit the max. si

amphibians, and reptiles), pineapple Bird, chronic RQ = 2.5 application rate f

and mammals pineapple to 3 lb

Mammal, acute RQ = 0.9 per acre; and 

Mammal, chronic RQ=6.0 Limit the max. n

of applications p

to 4 
lAffected Population(s) Source of Route of Duration of lRisk(s) of Concern Mitigation Mea

Exposure Exposure Exposure 

Birds, (terrestrial-phase Application to Dietary Acute/chronic Bird, acute RQ = 1.2 Limit the maximu

amphibians, and reptiles), macadamia nuts Bird, chronic RQ = 2.5 number of applica

and mammals per year to 3 

Mammal, acute RQ = 0.8 Mammal, chronic RQ=4.9 

Birds, (terrestrial-phase !Application to Dietary Acute/chronic Bird, acute RQ = 1. 7 Limit the maximu

amphibians, and reptiles), gmseng Bird, chronic RQ = 3.8 number of applica

and mammals per year to 6 

Mammal, acute RQ = 1.3 Mammal, chronic RQ=7 .5 

Birds, (terrestrial-phase Application to turf [)ietary Acute/chronic Bird, acute RQ = 2.0 Limit the maximu

amphibians, and reptiles), Bird, chronic RQ = 10 number of applica

and mammals per year to: 

Mammal, acute RQ = 2.0 11 applications pe

Mammal, chronic RQ= 10 for turf (sod); and 

8 applications per 

for turf (golf cour

residential) 

Birds, (terrestrial-phase !Application to Dietary Acute/chronic Bird, acute RQ = 2.0 Limit the maximu

amphibians, and reptiles), ornamentals Bird, chronic RQ = 10 number of applica

and mammals per year to 4 for s

Mammal, acute RQ = 2.0 drench, and 11 fo

Mammal, chronic RQ= 10 foliar applications 

Birds, (terrestrial-phase Application to Dietary Acute/chronic Bird, acute RQ = 2.0 Limit the maximu

amphibians, and reptiles), conifers Bird, chronic RQ = 6.0 number of applica

and mammals per year to 9 

Mammal, acute RQ = 2.0 

Mammal, chronic RQ= 10 
Appendix B: Fosetyl-Al Label Table 

Description Amended Labeling Language for Fosetyl-AI Use Products 

End Use Products 

Update label language - Change all instances of restricted entry interval (REI) to "48 hours" 

all fosetyl-AI products 

Update label language - "Treated Seed - Do Not Use for Food, Feed, or Oil Purposes. When opening this bag or loading/pouring the trea

fosetyl-AI seed treatment seed, wear a long-sleeved shirt, long pants, shoes, socks, and chemical resistant gloves. After the seeds have bee

use (SLN ID-3000 I) planted, do not enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 48 hou

Exception: Once the seeds are planted in soil or other planting media, the Worker Protection Standard allows wo

to enter the treated area without restriction if there will be no worker contact with the treated seeds in the soil or 

planting media." 

Removal of aerial "Apply by ground application equipment only. Do not apply by air unless directed by Supplemental or Special L

application to Need labeling." 

pineapples, ornamentals, 

turf, conifer, and 

macadamia nut 

Specify fine or larger "When applying use spray nozzles that will deliver fine or larger spray droplets as defined in the American Soci

spray droplet size for all Agricultural and Biological Engineers (ASABE) standard ANSI/ASAE S572.l (March 2009)" . 

uses 

Specify the maximum For all application methods: "Do not apply more than 3 applications per year". 

number of applications 

on pineapple and 

macadamia nut as 3 per 

year 

Specify the maximum For all application methods: "Do not apply more than 6 applications per year". 

number of applications 

on ginseng as 6 per year 
Specify the maximum For soil drench application: " Do not apply more than 4 applications per year". 

numb

_

er of applications 

on ornamental 

herbaceous plants, 

ornamental nonflowering 

plants, and ornamental 

woody shrubs and vines 

as 4 per year 

Specify the maximum For foliar application: "Do not apply more than 11 applications per year". 

number of applications 

on ornamental 

herbaceous plants, For application by chemigation: "Do not apply more than 11 applications per year". 

ornamental lawns and 

turf, ornamental 

nonflowering plants, 

ornamental sod farm, 

and ornamental woody 

shrubs and vines as 11 

per year 

Specify the maximum For all application methods: "Do not apply more than 9 applications per year". 

number of applications 

on ornamental conifers and conifers in nurseries 

as 9 per year.