The European Union recently passed new registration requirements for all agrichemical products. Under the new rules, agrichemical companies are now required to evaluate exposure and accumulation in fish in addition to livestock. They now must be able to demonstrate that the bioaccumulation in fish under expected usage scenarios do not threaten fish population levels or present human health risks if the fish are ingested. In order to meet the new requirements, agrichemical manufacturers needed a new kind of study designed to assess how chemicals are metabolized by fish and how they accumulate in living tissue.
Fish can be exposed to agrichemicals in two primary ways: through residues present in crops that are incorporated into fish food, and through exposure to water that is contaminated with agricultural runoff. Typical bioaccumulation studies with livestock involve exposing animals to controlled doses of the chemical through feed or drinking water. However, fish populations present special challenges. Battelle partnered with [NAME] to develop new types of studies in order to help companies meet the new registration requirements.
For each chemical to be evaluated, we first look at how and where the chemical is used and the most likely routes of exposure for fish populations. Then we design a custom study in order to evaluate how the chemical is metabolized and how it accumulates in tissues. In feeding studies, we apply controlled doses of the chemical in fish food and measure the eventual tissue accumulation. Accumulation levels can then be checked against Acceptable Daily Intake guidelines to determine if the levels present a risk to human health if the fish is ingested at normal consumption levels. In metabolism studies, we evaluate how the chemical is broken down or excreted by fish.
Our fish metabolism and bioaccumulation studies are helping agrichemical companies meet the new EU requirements for reregistration or new product registration. By combining both bioaccumulation and metabolism studies together, we can save time and money for agrichemical companies and provide all of the information they need for product registration in one well-designed study. As EU, U.S. and global registration requirements change, our study designs will continue to evolve to help companies meet the new requirements safely and cost-effectively.