What does Generally Recognized as Safe (GRAS) Mean?


In 1986 the Reagan administration determined, through the Coordinated Framework for Regulation of Biotechnology, that it was not necessary to create any new laws for the regulation of biotechnology as these new products did not pose any risk. Yet, the first GE crop, the Flavr Savr tomato, wasn’t approved for cultivation until 1996. The current laws that regulate GE crops and pesticides were established before we could understand the true impact of this technology. This decision set the precedent that GE crops were substantially equivalent to its non-GE counterparts; this bases regulation on the product, not on the process. Substantial equivalence determined that GMO crops are virtually the same as its non-GMO counterparts and therefore pose no substantial risk and should not be treated or regulated differently.

Who is responsible for biotech regulation?

The responsibility of regulating GE crops lies within three different federal agencies; the Environmental Protection Agency (EPA), United States Department of Agriculture (USDA), and Food and Drug Administration (FDA). The FDA is responsible for determining whether or not GE food is safe to consume and does such under the authority granted by the Food Drug and Cosmetics Act(FFDCA). Part of this determination allowed for products to be deemed generally recognized as safe (GRAS). Dating back to 1958, GRAS “is a legal term describing certain food ingredients that are safe enough to enter the market without prior government approval or restrictions.” The GRAS process established streamlined decision making, allowing manufacturers to get their products to market faster and with minimal (if any) oversight.

Who determines GRAS status?

GRAS determination is not made by any federal agency, rather it falls under the decision making of the manufacturer that created the ingredient or product, a blatant conflict of interest. A company determines for itself whether it meets the GRAS standards. With GRAS status, an item requires no prior FDA approval before going to market. Companies can voluntarily submit their GRAS determination for review by the FDA, but are not required. In reviewing GRAS determination, the FDA does not perform any independent research or testing, relying solely on information provided by the company and handpicked relevant published studies. The FDA allows companies to market and use chemicals while under review. The report, Generally Recognized as Secret published by NRDC, found that a shocking number of chemicals had been deemed GRAS and did not participate in the voluntary review process, leaving the FDA with no information or review of the chemicals in question.

In all, the FDA does not determine the safety of new food ingredients and products. GRAS status, which holds that a product has the same structure, function, and composition of food already on the market, is self-determined by biotech companies without consideration for the impacts of its corresponding pesticides.

What else falls under GRAS?

GMOs are not the only GRAS items that are controversial; sweeteners, MSG, and caffeine are all products that were deemed GRAS without consideration for the levels at which they are consumed. These items have infiltrated grocery store shelves leaving consumers with a steady stream of them without true consideration for potential long-term health impacts. Further concern over these regulations is that they contain extremely vague language using words that have no legal definition and can be broadly interpreted, such as qualified experts and adequately safe.

The GRAS process and the hastened approval of a number of new more harmful, GE crops and pesticides raises major concerns and fails to instill much faith in the existing safety regulatory framework. There is a reason teachers don’t let children grade their own exams; so why is the FDA allowing Big Ag and biotech companies to grade themselves, especially when it is at the risk of citizens everywhere?