The peer-reviewed journal Reproductive Toxicology published a paper from The Pew Charitable Trusts' food additives project examining the data used to make safety recommendations for chemicals added to food sold in the United States. The analysis of three major sources of toxicology information found significant gaps in the data for chemicals that are added to food and food packaging.
Pew's analysis reveals:
The Food and Drug Administration or industry decided that almost two-thirds of known additives were safe without having fed the additives to lab animals. This is based on Pew's analysis of data reported in FDA, National Institutes of Health, or other leading toxicology databases.
FDA's own database on chemicals added directly to food indicates that:
Only one in five chemicals has been evaluated using the simplest lab animal test recommended by FDA to evaluate safety.
Only one in eight chemicals that FDA recommended be evaluated for reproductive or development problems had evidence it was tested for these effects.
The lack of data means that often we don't know whether these chemicals pose a health risk to the hundreds of millions of Americans who eat food with untested chemical additives.
The paper analyzed and compared data from the FDA's Priority-based Assessment of Food Additives database, the Accelrys Toxicity Database of chemical studies, and the U.S. National Library of Medicine's TOXLINE database to determine what testing has been done.
The authors note that the current regulatory structure for food additive safety in the United States was approved by Congress in 1958 and allows manufacturers to add chemicals deemed "generally recognized as safe" or "GRAS," to food without review by the FDA. Manufacturers sometimes voluntarily report such safety decisions to FDA.
To maintain confidence in the food we eat, the FDA should:
Develop a plan that leverages modern scientific tools to ensure the safety of chemical additives that have not undergone sufficient testing.
Use validated methods, such as computer-based modeling and cell-based studies, to identify chemical additives that require feeding studies.
In partnership with industry, public interest organizations, and academic scientists, establish a strategy to prioritize and review chemical additives that have already been approved for use in food and food packaging.