studies_callisto

Review of what studies should have been conducted & where they should be archived.

There should also be a complete qa program IE ISO9000 that dictates all the procedures to be followed when there are variances IE crop damage.
These programs are mandatory in some regions.
More advanced companies also embrace SIGMA programs which strive for zero defect.
Quality assurance protocols are generally more stringent in Europe.

Syngenta Herbicide Division

1. Dose-response studies:

Laboratory testing: Controlled experiments expose plants to varying doses of the pesticide, assessing growth, yield, and any physical damage. This typically involves different plant species, growth stages, and application methods. (Which varieties were tested?)
Field trials: Real-world settings provide additional data on effectiveness and toxicity. Crops are monitored for yield impact, visible damage, and potential residue build-up.

2. Data analysis and risk assessment:

LD50 and NOEC: From the dose-response data, two vital thresholds are calculated:
- LD50 (Lethal Dose for 50%): The dose at which half the exposed plants suffer significant harm.
- NOEC (No Observed Effect Concentration): The highest dose showing no adverse effects on plant growth or health.
Risk-benefit analysis: The potential benefits of pest control are weighed against the risks to the crop and the environment. Regulatory agencies like the EPA use this analysis to set acceptable residue levels and application guidelines.

3. Additional factors: Keep in mind there are several ways to formulate commercial mesotrione
which have variances in the percentage of batches that may not be fit for distribution.

Formulation: Factors like carrier materials and additives can influence toxicity and efficacy. Different formulations may require separate testing.
Crop-specific considerations: Plant sensitivity and metabolic pathways can vary greatly between species. This necessitates targeted testing for each crop intended for the pesticide.
Environmental factors: Soil type, climate, and irrigation practices can affect pesticide behavior and crop sensitivity. Testing often encompasses diverse conditions.

It's important to note that these are general steps, and specific protocols may vary depending on the pesticide type, crop, and regulatory requirements which varies by nation and state.

Vegetative Vigor Test:This test is designed to assess the overall health of plants after exposure to a pesticide. Plants are typically treated with different concentrations of the pesticide and then observed for a period of time, usually 14 to 28 days. During this time, researchers will measure plant growth, such as shoot height and weight, and look for signs of damage, such as chlorosis (yellowing of leaves), necrosis (death of plant tissue), wilting, and leaf and stem deformation

Studies that should he at EPA

46726300	Syngenta Crop Protection, Inc. (2005) Submission of Residue and Exposure Study in Support of the Registration of Callisto Herbicide and the Petition for Tolerance of Mesotrione on Cranberries, Berry Crop Group, Flax, and Millet. Transmittal of 8 Studies.	No CBI	100	SYNGENTA CROP PROTECTION, LLC		PO BOX 18300	GREENSBORO, NC 27419	2005-12-27	467263	100-1131	100	SYNGENTA CROP PROTECTION, LLC
46726301	Lin, K. (2005) Mesotrione: Mesotrione - Magnitude of the Residues in or on Berry, Group 13: Final Report. Project Number: T010288/04. Unpublished study prepared by Syngenta Crop Protection, Inc., A.C.D.S. Research, Inc. and Agricultural Systems Associates. 92 p.	No CBI	100	SYNGENTA CROP PROTECTION, LLC		PO BOX 18300	GREENSBORO, NC 27419	2005-12-27	467263	100-1131	100	SYNGENTA CROP PROTECTION, LLC