Expert response from Cathleen Enright
Former Executive Director of the Council for Biotechnology Information
Wednesday, 31/07/2013 15:18
We will not cut corners on safety and are committed to full disclosure of scientific research related to the health and safety of GM seeds. We are also required by law to provide information that is not favorable to our products. In submitting food safety information to the government for review, we cannot and would not pick and choose which research to present.
During the development of a new GM seed, much of the research is conducted by independent third-party laboratories certified to conduct safety testing using protocols required by the government. If a study were ever to yield a result that raised any food safety concern, we are required to present that information to the FDA. We take this requirement very seriously. Failure to provide such statements to the government is a crime.
Please see the relevant legal requirements at the end of this answer for each of the agencies (FDA, USDA, EPA) that have regulatory authority over GM seeds.
USDA regulations (7CFR340.6) include the following statement regarding submissions (petitions):
- A person shall also include information known to the petitioner which would be unfavorable to a petition. If a person is not aware of any unfavorable information, the petition should state, “Unfavorable information: NONE.”
- "The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which to base a determination, and that it includes relevant data and information known to the petitioner which are unfavorable to the petition.”
EPA has a provision of FIFRA terms 6(a)2, Adverse Event Reporting, that requires registrants to report any harmful or adverse effects of registered products. Read more here.
The FDA also includes the following language in its letter inquiries letters to throughout consultation process:
“Based on the information [insert company name] has presented to FDA, we have no further questions concerning food ingredients derived from [product name] and feed derived from [product name]. However, as you are aware, it is [company name] continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.”
For more detailed information:
Technology providers have obligations under federal law to disclose adverse effects involving their GMO products. In their petitions for the regulatory authorizations needed to commercialize a GMO product (i.e., deregulation), companies are obligated to disclose any such adverse effects (cf., 7 CFR 340.6 (A)). Additionally, companies are obligated under the Federal Insecticide, Rodenticide and Fungicide Act, which regulates pesticides, including pesticides expressed in insect-resistant crops, to promptly disclose adverse effects related to these products, regardless whether the effects were noted in safety testing or in experience with the in-plant pesticide in the field (cf., FIFRA 6(a)(a)(2)). Failure to disclose information about adverse effects to the relevant authorities, whether deliberate or unintentional, may not only jeopardize product approvals but also be punishable by significant fines. Still more damaging, however, would be the loss of confidence that failure to report would create for a technology provider with the regulators who control authorizations for its current and future products. Finally, given the time and cost involved in bringing a new GMO technology to the market (estimated time and costs are more than 10 years and $135 million), technology providers must take a long-range view of their business to remain competitive in their industry and cannot afford to invest in products that will not meet regulatory hurdles or that will prove unsustainable in the marketplace due to subsequent concerns about risk. These dynamics create powerful, built-in motivators for rigorous attention to product safety, transparent dialogue with external stakeholders, collaboration with third party researchers and continuing improvements in product stewardship. Companies failing in their commitment to these prerequisites will not survive in the present regulatory and social environment.
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