When evaluating the safety of a substance it is important to understand if exposure to the substance can cause adverse effects and, if so, at what exposure level those effects can occur. If there is an adverse effect, is it an acute effect from short-term exposure, or does the adverse effect manifest itself after chronic exposure? Are there levels of exposure to the substance in question at which adverse effects are not expected to occur?
To answer these questions, FDA relies on toxicological data to determine if chemicals or substances may be harmful, what the potential health risks are, and at what levels of exposure harm might occur. This information can help FDA determine what uses of CFSAN regulated substances are safe and in what amount.
Strong science underpins everything FDA does. The scientific discipline of toxicology is particularly essential to FDA’s mission and is crucial to the Agency’s ability to evaluate product safety and reach sound regulatory decisions.
Historically, researchers gained information about the toxicity of a substance through rodent and other animal studies in which the substance in question was administered to the study animals and adverse impacts were observed. However, these studies can take a long time, be expensive, and there are sometimes limitations to the type of information they can provide. In recent years, there has been a concerted effort to develop approaches to gathering toxicological information using methods that are faster, less expensive, and more informative than traditional animal studies. These methods, which researchers aspire to develop for use in place of animal testing, are often referred to as new approach methods (NAMs). Of course, before any NAM is used to assess safety, it is critical that the validity and reliability of the method has been established. It should be equally or more informative than existing guideline studies designed to evaluate a substance’s safety. As these NAMs are developed, validated, refined, and adopted they present an opportunity to: reduce the number of animals used in testing; refine the methods still requiring animals so they are less stressful to the animals; and replace animal testing altogether, when possible.
Irrespective of the method or methods used to acquire toxicological information, the goal is to be reasonably certain that, at the anticipated exposure levels, the substance will cause no harm.