The Pew Charitable Trusts’ Food Additive Project has published a paper in Reproductive Toxicology claiming that gaps in the toxicity data for food additives raise questions about the Food and Drug Administration’s (FDA’s) safety assessments for these substances. Thomas Neltner, et al., “Data Gaps in Toxicity Testing of Chemicals Allowed in Food in the United States,” Reproductive Toxicology, August 2013. Comparing data from 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, the study’s authors apparently determined that “almost two-thirds of chemical additives appear to have been declared safe for use in food without the benefit of being fed to an animal in a controlled toxicology study,” while approximately 78 percent of additives lack adequate data to estimate a safe level of exposure and 93 percent lack reproductive or development toxicity testing. They also reported that, according to FDA’s own database, (i) “only one in five chemicals has been evaluated using the simplest lab animal test recommended by FDA to evaluate safety,” and (ii) “only one in eight chemicals that FDA recommended be evaluated for reproductive or development problems had evidence it was tested for these effects.”

Based on these findings, the authors ultimately recommended that FDA partner with industry, public interest organizations and scientists to “establish a strategy to prioritize and review chemical additives that have already been approved for use in food and food packaging.” In particular, the study urges FDA to use “modern scientific tools” and “validated methods, such as computer-based modeling and cell-based studies,” to augment current toxicity data and identify those additives that require additional testing.

“Although FDA is aware of the problem, it lacks the authority and resources to fill the information gaps,” concludes the report, which directs FDA to model its data-collection protocols after the European Food Safety Authority and the Environmental Protection Agency’s High Production Volume Challenge program. “Furthermore, once a chemical is approved, manufacturers have no incentive to add additional toxicology information because FDA neither has a reassessment program in place nor has authority to require additional testing… Therefore, a program is needed to effectively and efficiently fill the significant information gaps to ensure public health is protected.” Additional details about the work of Food Additives Project Director Thomas Neltner appear in Issue 493 of this Update. See Pew Charitable Trusts Press Release, August 14, 2013.