My company manufactures a chemical which is used as a food additive. Why doesn my chemical have an indicator of “1” on the HPV Challenge Program Chemical List?
Some of the chemicals on the HPV Challenge Program Chemical List have food additive, drug, or cosmetic uses, and, thus, are subject to Food and Drug Administration (FDA) requirements for these respective uses. However, these chemicals, which may have been approved by FDA for specific uses, may still have SIDS data gaps in areas which may not be germane to food additive, drug or cosmetic uses, e.g., environmental fate and environmental toxicity, which are of concern to EPA and are required under the HPV Challenge Program. These endpoints may not have been taken into account for food additive, drug or cosmetic reviews. In addition, exposure scenarios different from those considered in the FDA review (e.g., occupational exposures in manufacture or use, or releases of the chemicals to the environment from industrial manufacturing sites) may have the potential to cause adverse impacts on health or the environment. Furthermore, chemicals which are approved by FDA for certain uses may have be
