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 commentperiod 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 commentperiod and provides a brief summary ofits content.


### Table 1 Summary ofPublic Comments received for the Proposed Interim Decision for Fosetyl-Al Docket ID No. Submitted by Summary ofComments EPA-HQ-OPP

- Bruce B. Clarke, Director, Center for Recommends against the inclusion 2007-0379-0037 Turfgrass Science, Rutgers University ofadvisory language for pollinators on fosetyl-Al labels. EPA-HQ-OPP- Bruce Martin, Ph.D., Professor, Questions the appropriateness of 2007-0379-0038 Department ofAgricultural and advisory language for pollinators Environmental Sciences, Clemson on labels for managed turfuse. 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 Page 1of52007-0379-0040 Interval (REI) should not be increased, based onthe expected impacts ofthe 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 2007-0379-0041 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 2007-0379-0042 Regulatory Affairs, Tessenderlo Kerley, pollinator data requirements based Inc

. (TKI) on available toxicity data and lack ofindications ofexposure to bees. Requests that pollinator advisory language not be added as current!y proposed based on a lack ofacute toxicity to warrant it. EPA-HQ-OPP- Henry L. Giclas, Senior Vice President, Discusses the impact ofan 2007-0379-0043 Science, Technology & Strategic increased REI on the production of Planning, Western Growers fresh produce. Describes the benefits offosetyl-Al in disease management. EPA-HQ-OPP- Cristi L Palmer, Ornamental Horticulture Questions the appropriateness of 2007-0379-0044 Manager, IR-4 Project advisory pollinator language for certain indoor, greenhouse, and soil drench uses
. Recommends maintaining current REI based on expected impacts ofthe proposed increase on growers and the ability offosetyl

-Al to remain an effective tool. EPA-HQ-OPP- Joseph Bischoff, Director, Regulatory & Requests the agency maintain the 2007-0379-0045 Legislative Affairs, AmericanHort and current REI based on the expected Lin Schmale, Senior Director, impacts ofthe·proposed increase on Government Relations, Society of greenhouse growers and the ability American Florists offosetyl-Al to remain an effective tool. Requests that the agency not add advisory pollinator language based on a lack ofacute toxicity seen in the available data. EPA-HQ-OPP- Sean McGee, Bayer CropScience Requests the agency maintain the 2007-0379-0046 current REI based on the expected impacts ofthe proposed increase on growers and cites the demonstrated safety ofthe current requirements. Discuses estimated risks to Page 2 of5

### 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 ofincidents indicates lower risk. EPA-HQ-OPP- Michael J. 

### Aerts, Director, Production and Discusses the benefits offosetyl-Al 2007-0379-0047 

### Supply Chain Management Division, in disease management, and how Florida Fruit and Vegetable Association these pressures are ofparticular (FFVA) concern in Florida. Supports maintaining the current REI based on expected impacts ofthe proposed increase to growers and the ability offosetyl-Al to remain an effective tool. EPA-HQ-OPP- Chava E. McKeel, Director, Government Describes the usefulness offosetyl2007-0379-0048 

### Relations, GolfCourse Superintendents Al for control ofdisease in turf Association ofAmerica (GCSAA) managment. Questions the appropriateness ofadvisory language for pollinators on labels for managed turfuse. EPA-HQ-OPP- Leonila Labrada, Plant Health Supervisor, Describes the importance of 2007-0379-0049 

### 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 2007-0379-0050 

### 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 ofcommenters and related to five main areas ofthe Proposed Interim Decision; 1. Pollinator advisory language; 2. Increased REI; 3. ESA; 4. Pollinator Data; and 5. General benefits offosetyl-Al. For clarity and conciseness, responses will be provided based on each topic area.
Pollinator Advisory Language

Page 3 of5Comment(s): The commenters listed above discussed the Agency's proposed decision to include pollinator advisory language onproducts that contain fosetyl-Al. Several ofthe 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 offosetyl-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 oftoxic effects seen in available predatory mite data. However, the agency has since reconsidered the use ofpredatory mite data to predict effects to bees. The agency agrees that in the absence ofdata 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 ofconsidering 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, ifthe 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 ofthe WPS in 1992. Itis 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 oftoxicity 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 of48 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 ofthem as part ofthe implementation plan for assessing the risks to listed species based on the recommendations ofthe April 2013 National Academy ofSciences (NAS) 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).
PollinatorData 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 ajustification 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 Page4of5

### 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 offosetyl-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 ofits risk management decision.

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