FDA Internal Review: Update ‘Redbook’ to Reflect Current Science

The FDA has completed a chemical safety assessment review focusing on the scientific capacity, efficiency, and management of its chemical safety resources. As a result of the review within the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), the agency will update the FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (the so-called “Redbook”), the guidance document used primarily by CFSAN for evaluation of human food products.

An updated Redbook will reflect current science, according to FDA spokesperson Noah J. Bartolucci, in the Office of the Deputy Commissioner for Foods and Veterinary Medicine. “Advances in science and technology are influencing the manufacture of many of the products that the FDA regulates,” Bartolucci says. “In the area of conventional foods, chemical technologies are being used in the manufacture and processing of foods to make them tastier and more resistant to spoilage.”

Along with these changes in food manufacturing and processing, scientific methods and capabilities are also rapidly advancing, he says, allowing the FDA to detect smaller and smaller amounts of chemicals in foods and to identify and measure the more harmful forms of certain chemicals.

One of the recommendations from the review is that the FDA establish an in silico knowledgebase—information obtained using a computer or via computer simulation—to assist in the proactive identification and ranking of emerging chemical hazards, risks, and to stay abreast of relevant new science. The FDA maintains a database of safety information on food chemicals, but the expansion of the database will include incorporating new types of data, such as high throughput in vitro assays; developing new search capabilities and analytics; and building predictive toxicology tools, Bartolucci explains.

Another significant outcome of the chemical safety assessment review is that the centers will jointly develop a process to ensure consistency of methodologies used for safety and risk assessments within and across the offices at CFSAN, and between CFSAN and CVM.

Two additional internal reviews are planned, including a nutrition review to help CFSAN identify how to meet the challenges of nutrition over the coming decade, and a microbiology laboratory review that will focus on the scientific capacity, efficiency, and management of microbiology work in its laboratories.