“In the past, we would review animal studies and look at outcomes,” FDA’s Suzanne Fitzpatrick, PhD, told FoodProductionDaily. “Now, we’re using in vitro high-throughput testing and computational toxicology to better understand the mechanism of action of chemicals in the human body.”
The change in orientation applies not only to FDA, but to the whole field of toxicology, said Fitzpatrick, who is the senior advisor for toxicology in FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
It has led the agency to comprehensively assess how it evaluates foodborne chemical risks within CFSAN and FDA’s Center for Veterinary Medicine (CVM). The findings of that assessment, which was conducted from 2012 through 2014, have prompted FDA to take steps to strengthen its internal processes.
“We want to make sure we’re keeping up with technology,” Fitzpatrick said. “We’re examining how some new methodologies can fit with our chemical risk assessment program.”
“People regularly come up with new methods to assess chemical safety, but FDA has to validate them before we can use them agency-wide,” she pointed out. “People who do research in academic or private settings don’t have the responsibility that we do. From an outsider’s perspective, FDA may seem conservative, but we’re making decisions that affect millions of people.”
In addition to evaluating new methodologies, CFSAN and CVM will jointly develop a process to ensure consistency among all the safety and risk assessment methodologies used within and across offices at CFSAN, and between CFSAN and CVM. The centers will also develop a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (also called the “Redbook”), to reflect current science.
Protecting susceptible populations
Fitzpatrick said the FDA collects and analyzes a wide range of foods for chemical contaminants under two ongoing programs: 1) the Total Diet Study, and 2) the Toxic Elements in Food and Foodware, and Radionuclides in Food program.
“These programs cast a wide net, looking for dozens of analytes,” she said. “Those include pesticide residues, industrial chemicals and toxic and nutrient elements.”
Three chemical contaminants that have been a particular focus of CFSAN’s work in recent years include inorganic arsenic, methylmercury, and acrylamide.
“We also are seeking to inform how we can best help protect susceptible populations from chemical contaminants in food,” Fitzpatrick noted. “To this end, the FDA convened its Food Advisory Committee on December 16-17, 2014, to help shape our efforts to understand when and how risk assessments should integrate concern for susceptible populations.”