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Eat at Your Own Risk: Flawed FDA Risk Assessments Strengthen Arguments for Labeling GMOs


For the past two decades, developers of genetically engineered (GE) crops and their corporate allies have maintained that because their products are so obviously safe, there is no need to label them. Thanks to marketing campaigns, squelched state initiatives and a flood of GE products on the market, the public has largely adopted this belief as well.
Would it shock the public to know that the Food and Drug Administration (FDA) has never formally approved any GE crop as safe for human consumption? Instead, these companies have been trusted to self-regulate with little scientific oversight and even less transparency in their methods.

This was quietly mentioned in December 2014, during a testimony given by Michael Landa, former director of the Center for Food Safety and Applied Nutrition with the FDA, before the House Subcommittee on Health.

His testimony drew attention to a fact often overlooked in the ongoing debate around GE food safety: The FDA has exempted developers of genetically modified organisms (GMOs) from premarket reviews of their products, which would normally result in a formal assessment and either a rejection or approval of their safety for human consumption. Landa's testimony described the risk assessment process for GE crops, which continues to use a policy crafted in 1992, establishing that the FDA sees no essential difference between GE crops and their conventionally grown counterparts.

As a result, the FDA merely invites GE developers to voluntarily consult with the FDA on their products' safety.

According to an article written by William Freese and David Schubert on the FDA's risk assessment process:

    Under voluntary consultation, the GE crop developer is encouraged, but not required, to consult with the FDA. The company submits data summaries of research it has conducted but not the full studies. That is, the FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research. As one might expect with a voluntary process, the FDA does not require the submission of data.

During his testimony, Landa offered assurance that:

    The fact that participation in the process is voluntary should not mislead individuals to believe that the process does not provide for a rigorous food safety evaluation. It is not uncommon for FDA to request additional data and information or clarification about the data and information submitted by the developer.

Landa failed to mention that these requests are often refused or ignored, and when that happens the FDA continues its assessment without the additional data.

A study conducted by David Gurian-Sherman found that when the FDA requested additional information to conduct a complete and thorough safety assessment 50 percent of the time GE food developers "did not comply with that request."

The study goes on to show that of the developer data summaries they reviewed and that were submitted to the FDA, there were "obvious errors that were not identified by FDA during its review process," and the summaries "often lacked sufficient detail, such as necessary statistical analyses needed for an adequate safety evaluation."

Even more concerning, Gurian-Sherman revealed that these submissions to the FDA often did not evaluate dangerous compounds such as toxicants in tomatoes or anti-nutrients in corn and, "allergenicity testing was not always performed using the best tests available."

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