Poultry Feed Additive Efficacy & Safety for Agrochemical Producer

Industry Agrochemical
Species Poultry

The Challenge

A global agrochemical producer had developed a novel phytogenic feed additive designed to improve growth performance and feed efficiency in commercial poultry. To achieve market registration, the company required both target animal safety data and efficacy data that would satisfy USDA Center for Veterinary Biologics requirements for the US market and European Food Safety Authority (EFSA) requirements for EU market access. The additive needed evaluation in both broiler and layer production systems, as the company intended to market a single product for all commercial poultry applications. Additionally, EFSA required demonstration that the additive did not affect egg quality or result in tissue residues that could impact food safety.

Our Solution

Meramec designed a comprehensive four-arm study program across our dedicated poultry research facility. Study 1: Broiler growth performance trial with 2,000 Ross 308 broilers across 5 treatment groups, measuring daily weight gain, feed intake, feed conversion ratio (FCR), and mortality over a 42-day growing period. Study 2: Layer production trial with 500 Hy-Line W-36 hens across 4 treatment groups, measuring egg production rate, egg weight, shell quality, and feed consumption over 16 weeks. Study 3: Target animal safety study at 5x and 10x the recommended inclusion rate in both broilers and layers, including hematology, clinical chemistry, gross pathology, and histopathological examination. Study 4: Residue depletion study to quantify tissue and egg residue levels at multiple time points post-withdrawal. All studies followed VICH GL43 guidelines with GLP compliance for the safety and residue components.

The Results

The feed additive demonstrated statistically significant improvements across multiple performance metrics: 8.3% improvement in broiler FCR (P<0.01), 4.2% increase in daily weight gain, and 2.1% improvement in layer feed efficiency. Egg production and quality parameters were maintained or improved. The safety study at 10x dose showed no adverse effects on any measured parameter, establishing a wide safety margin. Residue studies confirmed tissue levels below the limit of detection within 24 hours of withdrawal, and no detectable residues in eggs at any time point. The comprehensive data package supported simultaneous registration submissions to USDA and EFSA, with both agencies granting approval within their standard review timelines.

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