UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: June 18, 2015 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: 

FROM: 

Response to Proposed Interim Decision Comments for Fosetyl-Al 

Ricardo Jones, Chemical Review Manager ~------­ Risk Management and Implementation Branch 1 

THRU: 

Pesticide Re-evaluation Division 

Kristina Garber, Senior Biologist 

ERB2/EFED 

Matthew Lloyd, CIH, Industrial Hygienist & Risk Assessor 

Registration Assessment Branch VII/HED 

TO: Fosetyl-Al Registration Review Docket (EPA-HQ-OPP-2007-0379) 

On December 24, 2014, the agency initiated a 60 day public comment period for the fosetyl-Al Proposed 

Interim Decision for Registration Review, which ended on February 24, 2015. During the public 

comment period, the Agency received fourteen public comments. The full comments are available in the 

fosetyl-Al registration review docket (EPA-HQ-OPP-2007-0379), available at regulations.gov. Table 1 

below, identifies each comment received during the public comment period and provides a brief 

summary of its content. 

Table 1 Summary of Public Comments received for the Proposed Interim Decision for Fosetyl-Al 

Docket ID No. Submitted by Summary of Comments 

EPA-HQ-OPP- Bruce B. Clarke, Director, Center for Recommends against the inclusion 

2007-03 79-003 7 Turfgrass Science, Rutgers University of advisory language for pollinators 

on fosetyl-Al labels. 

EPA-HQ-OPP- Bruce Martin, Ph.D., Professor, Questions the appropriateness of 

2007-03 79-003 8 Department of Agricultural and advisory language for pollinators 

Environmental Sciences, Clemson on labels for managed turf use. 

University 

EPA-HQ-OPP- Brett Hartl, Director, Endangered Species Discusses the agency's requirement 

2007-0379-0039 Policy, Center for Biological Diversity to conduct an Endangered Species 

Act (ESA) consultation for those 

taxa and habitat where likely effects 

exist, prior to making a final 

decision. 

EPA-HQ-OPP- Anonymous States that the Restricted Entry 

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2007-03 79-0040 Interval (REI) should not be 

increased, based on the expected 

impacts of the proposed increase on 

grower's ability to manage disease 

in lettuce and leafy green 

production. 

EPA-HQ-OPP- A. R. Chase, Chase Agricultural Discusses the expected impacts of 

2007-03 79-0041 Consulting, LLC an increased REI on ornamental 

production. Describes benefits to 

disease management and resistance 

management. 

EPA-HQ-OPP- Jonathan Akins, Vice President, Requests agency waive new 

2007-03 79-0042 Regulatory Affairs, Tessenderlo Kerley, pollinator data requirements based 

Inc. (TKI) on available toxicity data and lack 

of indications of exposure to bees. 

Requests that pollinator advisory 

language not be added as current! y 

proposed based on a lack of acute 

toxicity to warrant it. 

EPA-HQ-OPP- Henry L. Giclas, Senior Vice President, Discusses the impact of an 

2007-03 79-0043 Science, Technology & Strategic increased REI on the production of 

Planning, Western Growers fresh produce. Describes the 

benefits of fosetyl-Al in disease 

management. 

EPA-HQ-OPP- Cristi L Palmer, Ornamental Horticulture Questions the appropriateness of 

2007-03 79-0044 Manager, IR-4 Project advisory pollinator language for 

certain indoor, greenhouse, and soil 

drench uses. Recommends 

maintaining current REI based on 

expected impacts of the proposed 

increase on growers and the ability 

of fosetyl-Al to remain an effective 

tool. 

EPA-HQ-OPP- Joseph Bischoff, Director, Regulatory & Requests the agency maintain the 

2007-03 79-0045 Legislative Affairs, AmericanHort and current REI based on the expected 

Lin Schmale, Senior Director, impacts of the· proposed increase on 

Government Relations, Society of greenhouse growers and the ability 

American Florists of fosetyl-Al to remain an effective 

tool. Requests that the agency not 

add advisory pollinator language 

based on a lack of acute toxicity 

seen in the available data. 

EPA-HQ-OPP- Sean McGee, Bayer CropScience Requests the agency maintain the 

2007-03 79-0046 current REI based on the expected 

impacts of the proposed increase on 

growers and cites the demonstrated 

safety of the current requirements. 

Discuses estimated risks to 

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terre trial invertebrates given 

available data, and questions the 

need for the proposed advisory 

pollinator language. Discusses 

estimated risk to terrestrial 

vertebrates and how multiple 

conservative assumptions combined 

with a lack of incidents indicates 

lower risk. 

EPA-HQ-OPP- Michael J. Aerts, Director, Production and Discusses the benefits of fosetyl-Al 

2007-03 79-004 7 Supply Chain Management Division, in disease management, and how 

Florida Fruit and Vegetable Association these pressures are of particular 

(FFVA) concern in Florida. Supports 

maintaining the current REI based 

on expected impacts of the 

proposed increase to growers and 

the ability of fosetyl-Al to remain 

an effective tool. 

EPA-HQ-OPP- Chava E. McKeel, Director, Government Describes the usefulness of fosetyl2007-03 79-0048 Relations, Golf Course Superintendents Al for control of disease in turf 

Association of America (GCSAA) managment. Questions the 

appropriateness of advisory 

language for pollinators on labels 

for managed turf use. 

EPA-HQ-OPP- Leonila Labrada, Plant Health Supervisor, Describes the importance of 

2007-03 79-0049 Creekside Nursery fosetyl-Al as a tool for controlling 

disease and in resistance 

management in greenhouses. 

Questions the appropriateness of 

advisory language for pollinators 

for labels with nursery use. 

EPA-HQ-OPP- Stan Yearwood, Production Manager, Describes the importance of 

2007-03 79-0050 Creekside Nursery fosetyl-Al as a tool for controlling 

disease and in resistance 

management in greenhouses. 

Questions the appropriateness of 

advisory language for pollinators 

for labels with nursery use. 

Comments were submitted by a variety of commenters and related to five main areas of the Proposed 

Interim Decision; 1. Pollinator advisory language; 2. Increased REI; 3. ESA; 4. Pollinator Data; and 5. 

General benefits of fosetyl-Al. For clarity and conciseness, responses will be provided based on each 

topic area. 

Pollinator Advisory Language 

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Comment(s): The commenters listed above discussed the Agency's proposed decision to include 

pollinator advisory language on products that contain fosetyl-Al. Several of the comments pointed out 

that fosetyl-Al is considered practically non-toxic to bees with an acute contact LDSO > 986 ug a.i./bee, 

and an acute oral LDSO > 450 ug a.i./bee. 

EPA Response: The proposed advisory language contains statements that warn that contact and 

ingestion of fosetyl-Al may pose a hazard to bees, and that fosetyl-Al has shown effects to honey and 

other bees. The decision to include these statements on labels was partly a result of toxic effects seen in 

available predatory mite data. However, the agency has since reconsidered the use of predatory mite 

data to predict effects to bees. The agency agrees that in the absence of data showing adverse effects to 

honey bees or other bee species, advisory language will not be added to fosetyl-Al labels. The agency is 

currently in the process of considering collecting additional data on pollinators. 

Increased Restricted Entry Interval (REI) 

Comment(s): Several commenters described the expected negative impacts to growers, which included 

increased costs and reduced effectiveness, if the REI is increased from 12 hours to 48 hours. 

EPA Response: Currently, fosetyl-Al labels contain a 12-hour REI based on requirements that were 

established before the enactment of the WPS in 1992. It is the agency's goal to support grower's needs 

for efficient and effective tools in disease management. However, the 40 CFR § 156.208 (Worker 

Protection Standard) requires that the REI for single-active ingredient products be based upon the most 

severe acute toxicity category assigned to the acute dermal, eye irritation, and skin irritation data for the 

active ingredient in a product. Based on the available agency review of toxicity data for the technical 

grade active ingredient (Pasquet, J. and Nazuret, A. , 1981), the agency has designated the acute eye 

irritation data with an Acute Category 1, therefore requiring an REI of 48 hours. 

Endangered Species Act (ESA) 

Comment(s): The commenter discussed the agency's requirement to conduct an ESA consultation for 

those taxa and habitat where likely effects exist, prior to making a final decision. 

EPA Response: The agency has reviewed the comments from CBD on the fosetyl-Al Proposed Interim 

Decision and plans to address many of them as part of the implementation plan for assessing the risks to 

listed species based on the recommendations of the April 2013 National Academy of Sciences (N AS) 

report. 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 their designated critical 

habitats. As noted in the Proposed Interim Decision, the agency's decision at this time is interim and is 

pending ESA Section 7 consultation with the Services, as well as a decision under the endocrine 

disruption screening program (EDSP). 

Pollinator Data 

Comment(s): Comments from TKI describe the available toxicity data with pollinators, and request that 

the proposed requirement for additional pollinator data be waived. TKI cites the honey bee acute and 

oral LDSO, along with other information, as a justification for not requiring the pollinator studies. 

EPA Response: The agency is currently determining whether additional pollinator data are needed for 

active ingredients in registration review whose dockets opened prior to June 2014, which includes 

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fosetyl-Al. For those active ingredients where EPA determines that additional pollinator exposure and 

effects data are necessary to 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. 

Benefits 

Comment(s): Multiple commenters describe the benefits of fosetyl-Al in disease management in both 

crop and non-crop uses. 

EPA Response: The agency thanks the commenters for this information and considers this information 

as a valuable component of its risk management decision. 

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