Endocrine disruptor (ED) testing is not just about scientific acumen, study execution and assay excellence. Regulatory insight is critical as it guides you through legal complexities and evidence interpretation so you can create compelling arguments to justify your substance's ED potential to regulators.
Labcorp has the acumen and experience to address complex regulatory questions and ease the passage of your substance through its regulatory journey.
The regulatory environment for endocrine disruptors varies worldwide and is evolving
The regulatory environments across the world vary considerably in their approach to assessing endocrine disruptor potential. If your substance is sold in multiple markets, you need an ED data set and study program that can be leveraged effectively across regulatory environments. But it can be hard to identify the correct regulatory strategy for your substance. You want to optimize existing data, study efficiency and cost-effectiveness without jeopardizing regulatory success. That means leveraging what you already have and making some hard decisions about designing testing approaches and employing data waivers.
Creating compelling weight of evidence arguments based on published data, QSARs and read across
Leveraging the existing information on a substance is the foundational step in building your regulatory strategy. Our regulatory scientists conduct literature searches in line with mandated standards to build a robust evidence base from published data. Combining this with QSAR modelling and read across, we can build compelling arguments that may enable avoid additional testing. The weight of evidence approach is also used as a primary strategy when preparing the argument for or against a test item being classified as an endocrine disruptor or not.
Aligning ED submissions to regulatory requirements
Worldwide regulations vary and understanding how to interpret the requirements of different regulators is critical to success. With expertise across regulators and an in depth understanding of ED endpoints, our team are well positioned to help guide you through any regulatory hurdles. From strategic advice on how to optimize regulatory success, build scientific justification for waivers, or assemble a comprehensive dossier, Covance can provide a range of services to suit your needs.
Building scientific arguments to justify waivers and derogations
In some regulatory situations, ED assessment may be waived. Common reasons for waiving ED assessment relate to the physico-chemical and ecotoxicological properties of the active substance. Waivers are made on a case-by-case basis and must be justified by clear and compelling scientific arguments. This includes demonstrating that an ED assessment is not scientifically necessary or not technically possible.
In some circumstances, it is possible to apply for derogation for an active substance known to be or suspected of having endocrine disrupting potential. In these situations, it is important to demonstrate negligible human exposure under realistic usage conditions. For effective derogations arguments, you need to combine knowledge of an active substance’s mode of action, its agricultural use and relevance to regional plant pest control.