Priority Setting Tool
Prnum: 03100 Chemical/Commodity: CHLOROPHACINONE / ALFALFA
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Region
Name
Comments
Date Entered
WSR
Ronda Hirnyck
We will not pursue at this time. However, would like to keep the project on the books.
08/04/2020
WSR
Ronda Hirnyck
EPA Comments in February, 2020: Based upon their feedback (the Health Effects Division), we would not be able to move forward with the application of an anticoagulant over food crops and make a safety finding under our statute. A summary of HED’s feedback is provided below.
On a case-by-case basis, the HED ChemSAC may determine that a use pattern with direct application to food crops would not be a food use, provided that residues observed in any food and feed commodities are anticipated to be substantially below any practical tolerance (lowest practical is 0.01 ppm) and of no toxicological concern. This is essentially an argument for “negligible” combined exposure and hazard from the proposed use pattern. Similarly, the plant and livestock test guideline OPPTS 860.1300 (d)(4)(i), which details the requirements for identification of residues from a radio-labeled study, permits a compound with concentrations below 1 ppb (0.001 ppm, 10-fold lower than any practical tolerance) total radioactivity to forego residue characterization, but only provided that there are no hazard concerns at or below that level. For anticoagulants, HED believes that there is a clearly demonstrated toxic mode of action and that this hazard is relevant even at minute dosage. As such, chlorophacinone and hemolytic rodenticides would not qualify for a non-food use based upon the combined chemistry and toxicology of the substance.
LiphaTech response: I responded that while we certainly understand the concerns regarding the parent compound, we think that recent advances in analytical techniques and detailed characterization of the metabolism and degradation reactions will be able to demonstrate that no parent compound remains. The existing data on file with EPA demonstrates that chlorophacinone breaks down primarily to CO2 and minor degradates at a rate substantially more rapid than the current 360 day restriction.
06/22/2020
WSR
Ronda Hirnyck
Vole:
First application when alfalfa is breaking dormancy at 10#/A
2nd application no sooner than 30 days after the first application at 10#/A
3rd application after last cutting at 10#/A.
We are proposing a tolerance for 30#/A/12 month period of product. They currently are allowed 20#/12 month period. They have a phone call with EPA next week, and will see if EPA will let us look at 30#/A/12 months.
We are pursuing a 30 day PHI.
Ground squirrels:
First application when alfalfa is breaking dormancy at 10#/A
Two more applications at 4 day intervals. For a maximum of 3 applications/year.
They are currently allowed 20#/12 month period by EPA, would like to look at 30#/A/12 month period, if possible.
They currently have a plant back restriction on the ground squirrel label on non-crop lands for 360 days. They would like that removed, hopefully with this residue study?
We also want to have a grazing allowance for both of these scenarios, after applications are made. We’ll need to establish the timeline for allowed grazing in the alfalfa fields.
LiphaTech has efficacy data, required by EPA for California and Richardson’s ground squirrels. They do not have the required efficacy data for Wyoming and Columbian ground squirrels. This was required for their bait station labels because the squirrels are considered a public health issue, thus the efficacy data requirement by EPA. If we are pursuing these labels for in-crop use, I would think?? the public health issue does not factor in, so EPA would not require the efficacy data.
The company appears to be very supportive of these projects, and willing to help out when/if needed.
09/23/2019
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