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Comments on Ecological Effects:

Valent provided comments on ecological effects data gaps identified in the problem formulation 

regarding their intent to submit studies (OCSPP 850.4500 for freshwater and marine/estuarine 

diatoms and OCSPP 850.4150 for ryegrass) to address data gaps. Submitted studies should 

adhere to the applicable OCSPP/OPPTS test guidelines.

EPA Response:

EFED will review studies associated with the data call in. 

Specific comment on 850.1350:

“Because of fluopicolide’s low solubility in test solutions and low toxicity of TGAI to 

Daphnia magna, Valent proposes to use the EC50 of 5.3 mg a.i./L, (calculated from EC50 of 

11 mg formulation/L of the study with TEP) as a definitive acute endpoint for Daphnia 

magna to calculate an Acute to Chronic Ratio for freshwater invertebrate to predict chronic 

toxicity to estuarine/marine invertebrate.” 

TEP data should not be used to calculate an acute-to-chronic ratio (ACR) for freshwater 

invertebrates as it would result in additional uncertainty because the formulation may have 

reduced or enhanced the toxicity of fluopicolide. An ACR based on TEP to TGAI may differ 

from that of the TGAI to TGAI. An ACR may be calculated in lieu of conducting 850.1350 if a 

definitive acute toxicity endpoint is available from an acceptable study testing the TGAI on 

Daphnia magna. Otherwise, a study on chronic toxicity to marine/estuarine invertebrates 

(850.1350) is needed to address risk.

 

Specific comment on 850.4100 and 850.4150:

Valent proposes to submit a waiver request for the seedling emergence study and conduct Tier 2 

vegetative vigor testing on species where a NOAEC was not achieved in the available Tier 1 

study. EFED reiterates that risk to terrestrial plants cannot be precluded because the available 

Tier 1 studies tested at applications rates well below currently labeled rates for some uses (e.g.

turf). Therefore, additional testing (seedling emergence and vegetative vigor) is needed on all 

ten plant species. Tier 1 testing could be conducted at the maximum labeled application rate in 

lieu of Tier 2 testing; however, Tier 2 would be required for any species showing effects in a 

Tier 1 study (conducted at the maximum labeled application rate). As an alternative, the 

available Tier 1 studies could be used for risk assessment if all labeled application rates are 

lowered to the tested rate (0.121 lb ai/A). In that case, Tier II testing would be needed only for 

the species that showed effects in the currently available Tier I studies (buckwheat – seedling 

emergence* and ryegrass – vegetative vigor).

* Valent commented in error that the DER concluded that the NOAEC = 0.121 lb ai/A for all test 

species. The DER concluded that the NOAEC < 0.121 lb ai/A for buckwheat. 
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Comments on Environmental Fate:

Valent intends to submit an aerobic aquatic metabolism study.

EPA Response:

EFED will review the submitted study. Submitted studies should adhere to the applicable 

OCSPP/OPPTS test guidelines.

Comments on Use and Usage Information: 

Valent will provide information regarding agricultural use patterns, label inconsistencies, and 

label ambiguities. Valent will work with RD to clarify intended application rates and restrictions 

regarding container grown ornamental plants.

EPA Response:

EFED appreciates assistance regarding label information. EFED notes that soil drench 

applications at the reported 27.133 lb ai/A rate are also labeled for uses such as Christmas tree 

plantations, which are more realistically extrapolated to a whole acre of land.

Comments (Other):

The correct MRID is 467085-09 (Tier II green algae study) not 467086-09 as reported in the 

problem formulation.

EPA Response:

EFED appreciates the response and will correct the error.