Is The GRAS System Conflict Free?

By Melissa Lind, contributing writer

In order for an additive to become generally recognized as safe, it may not have to undergo chemical testing. However, once on the GRAS list, safety never has to be addressed. Critics say that this system is rife with bias.

Food industry standards allow a food additive to be used if a particular ingredient is listed in the FDA’s generally recognized as safe (GRAS) database. This listing was established by a 1958 regulation which allows food companies to use ingredients based on scientific consensus that the chemical is safe for human consumption. However, some food industry groups have expressed concern about food additives and the GRAS listing, stating that the process may have inherent conflict of interest in determinations.

A recent review of GRAS notices conducted by the Center for Public Integrity (CPI) shows that of publicly available GRAS determinations, more than 60 percent of them had their determinations made using the scientific panels. These panels are comprised of three experts who are to review literature and unpublished data to determine likelihood of safety. Unfortunately, says Center for Science in the Public Interest (CSPI), attorney Laura MacCleery, many of “these are standing panels of industry-hired guns.”  Once a panel has classified an additive as GRAS, it can automatically be used in any food product, with no notice or review by the FDA.

Critics of the process, including those at CPI, CSPI, and the National Resources Defense Council (NRDC) state that the process gives food companies incentive to employ experts that have easily identified products as GRAS in the past and gives those same experts reason to approve the additive. Many of the most-frequently used experts on such panels may also be called for advice on other industries. CPI found nearly half of the most-frequently used analysts have ties to the tobacco industry. Of those top 10, each had sat on over twenty panels, sometimes together as a group. The reason behind this: experience. “If you're good at something, of course you're going to be in demand,” says Joseph Borzelleca, who has appeared on more than 40 percent of these panels over the last 17 years.

Scientist’s claim that the GRAS process ensures that reviews are thorough and that the safety of food additives is preserved, but even the government has doubts. Specifically, addressing the frequency of use of certain panelists, Steve Morris, acting director of natural resources and environment for the Government Accountability Office (GAO), says that repetition and familiarity “could potentially breed a conflict. GAO had published a 2010 report, which cited financial conflict of interest in the GRAS process as a concern.