The International Biomass Smoke Health Effects (IBSHE) conference was convened in Missoula, MT, to define our current knowledge of smoke exposure and the potential health effects. In an effort to ascertain the relative health effects of an exposure to biomass smoke, numerous studies have utilized either animal or in vitro systems. A wide variety of systems that have been employed ranged from more mainstream animal models (i.e., rodents) and transformed cell lines to less common animal (piglets and dogs) and explant models. The Toxicology and Animal Study Design Workgroup at IBSHE was tasked with an analysis of the use of animal models in the assessment of the health effects of biomass smoke exposure. The present article contains a mini-review of models utilized historically, in addition to the adverse health effects assessed, and an overview of the discussion within the breakout session. The most common question that arose in discussions at the IBSHE conference was from local and federal health departments: What level of smoke is unhealthy? The present workgroup determined categories of exposure, common health concerns, and the availability of animal models to answer key health questions.