THE FDA’S SAFETY ASSESSMENTS

Submissions to the US Food and Drug Administraion (FDA) may be worse, the agency doesn’t actually require any data. Their policy says that biotech companies can determine if their own foods are safe. Anything submitted is voluntary and, according to former Environmental Protection Agency scientist Doug Gurian‐Sherman, PhD, “often lack[s] sufficient detail, such as necessary statistical analyses needed for an adequate safety evaluation.” Using Freedom of Information Requests, Dr. Gurian‐Sherman analyzed more than a fourth of the data summaries (14 of 53) of GM crops reviewed by the FDA. He says,

“The FDA consultation process does not allow the agency to require submission of data, misses obvious errors in company‐submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat.”

Similarly, a Friends of the Earth review of company and FDA documents concluded:

“If industry chooses to submit faulty, unpublishable studies, it respond to an agency request with deficient data, it does so without reprimand or follow‐up. . . . If a company finds it disadvantageous to characterize its product, then its properties remain uncertain or unknown. If a corporation chooses to ignore scientifically sound testing standards . . . then faulty tests conducted instead, and the results are considered legitimate. In the area of genetically engineered food regulation, the ‘competent’ agencies rarely if ever (know how to) conduct independent research to verify supplement industry findings.”

At the end of the consultation,the FDA doesn’t actually approve the crops,Rather,they issue a letter that includes a statement such as the following:

“Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . . As you are aware, it is Monsanto’s responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements.”


 

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