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Is the GRAS Process Broken?

From spices to preservatives, U.S. food manufacturers have access to thousands of globally sourced substances to enhance the flavor, texture, and appeal of their products. But some question whether the U.S. Food and Drug Administration (FDA) adequately regulates the safety of these abundant substances.

Groups such as The Pew Charitable Trusts and the Natural Resources Defense Council (NRDC) are spearheading efforts to reform the food additives regulatory process. These groups are especially critical of the “generally recognized as safe” (GRAS) process for adding substances to food.

“This system is fundamentally broken,” said Tom Neltner, who has extensively studied and issued reports on the GRAS process with Pew and who recently transitioned to NRDC.

But not everyone agrees that the GRAS process is broken, such as Robert McQuate, CEO of GRAS Associates, LLC. McQuate worked directly on GRAS evaluations in FDA’s GRAS Review Branch in the late 1970s and early 1980s before launching a food ingredient consulting firm specializing in GRAS determinations.

McQuate says the GRAS process does not leave the public overly vulnerable. He cites FDA’s recent proposal to de-GRAS partially hydrogenated oils (PHOs), the major source of trans fat in processed food, as a prime example of how the process does protect the public.

“If FDA sees that there is an issue that adversely affects public health, even if [the substance] has previously enjoyed GRAS status, FDA does have the authority and capability to make changes,” he says.

While most agree that FDA’s proposal to de-GRAS PHOs is a step in the right direction, some suggest that the time it took the agency to take action shows that the current process is flawed. 

“We shouldn’t have to wait a decade for something to be officially de-GRASed when it’s been known for a decade that it shouldn’t be in the food supply,” says Neil Fortin, director of the Institute for Food Laws & Regulations at Michigan State University’s College of Agriculture and Natural Resources.

To McQuate, FDA’s actions with regard to PHOs reflect diligence as well as a systematic process. He explains that safety determinations are not cut and dried. For example, unlike a straightforward test for the acidity of a solution, safety determinations require scientists to analyze an accumulation of information in a lot of different areas. That information is not easily deciphered and requires professional judgment calls, he says.

But, timing aside, some have questioned FDA’s expansive reliance on professional judgment calls. While professional judgment may be a necessary part of safety determinations, some suggest FDA should also update its review process. For instance, Pew has suggested that FDA update its science, require companies to submit GRAS notifications, and implement a systematic review process for existing GRAS substances.

And FDA’s expansive reliance on professional judgment compounds conflicts of interest issues as well, according to Neltner.

“When a company hires people, whether consultants or employees, who make the safety decisions, then it’s a conflict of interest,” he says.

Neltner emphasizes that a conflict of interest does not mean that a manufacturer is intentionally putting something dangerous on the market. Rather, the conflict is a bias that may shift the decision of whether a substance is safe.

“Where you have both a lot of professional judgment and conflicts of interests, now you have a recipe for a problem, for bad decisions,” explains Neltner. “If you had wonderful data — if all these chemicals were robustly studied — then there is less room for professional judgment. But that’s not the case with GRAS.”

Mark Itzkoff, an attorney at Olsson Frank and Weeda who has been a food lawyer for 25 years working on GRAS determinations, says conflict of interest is probably less of an issue than some reports suggest. In his experience, expert panels are careful with their reputation and do credible research.

“Part of the system is depending upon people to do the jobs they were hired to do — to provide expert independent opinions,” says Itzkoff.

In 2010, the U.S. Government Accountability Office (GAO) issued a report on the GRAS process. In addition to conflict-of-interest issues, the report noted several shortcomings of GRAS and suggested FDA update the process. Since the GAO report, FDA has reopened comments on the 1997 proposed rule, which outlines the GRAS program currently used by manufacturers.

But FDA is not likely to make any changes or issue a final rule in the very near future. According to an FDA spokeswoman, FDA is aware of calls to finalize the proposed rule, but the agency is working on other priorities, including implementation of the Food Safety Modernization Act (FSMA) and nutrition-related activities.

© Food Safety News
  • Bill Pilacinski

    It’s interesting that I don’t see a lot of actual illnesses or deaths documented either in Food Safety News or in CDC reports having to do with GRAS issues. I do however see a lot related to microbial contamination. Yet FDA is getting a lot heat from the organic folks and others, related to their recently announced efforts to deal with REAL food safety issues. Why don’t PEW or NRDC compare the food safety effectiveness of various food safety agencies around the world sometime. We need some good news for a change and some praise for an agency that maintains effectiveness in the face of political forces from both sides.