Next week, on June 19th, is the deadline to submit comments for the FDA’s and USDA’s proposed new rules to the Coordinated Framework for the Regulation of Biotechnology, the multi-agency framework that regulates biotech crops.
And with a Trump administration adamantly against introducing any new regulation, the legal system may be our only savior.
The Coordinated Framework, which came out in 1986 and was slightly modified in 1992, is antiquated beyond imagination and completely insufficient to deal with today’s complex and advanced gene-editing techniques. Technology has moved at lightening speed, and the government, which is supposed to oversee biotech products and protect the public, has been unable to keep up.
One prominent example of this is the gene-editing technology called CRISPR-Cas9. The CRISPR mushroom was made famous by scientists at Penn State University who engineered it so that it doesn’t turn brown when cut open. Due to the fact that CRISPR silenced a section of genetic code in the mushroom (turned off the code that makes it turn brown) and did not insert a plant pest, it did not trigger oversight from the USDA.
When the FDA approved genetically-engineered salmon, it did so without a legal framework in place but moved forward anyway. Environmental groups quickly filed a lawsuit to overturn it.
“The FDA does not have the legal authority to approve genetically-engineered animals for food. The agency is using its authority to approve vaccines for animals and jumping to approve genetically-engineered animals. That is not what the law says,” asserts Jaydee Hanson, Senior Policy Analyst at the Center for Food Safety, whose organization is leading the GE-salmon lawsuit.
Dana Perls, Senior Food and Technology Campaigner at Friends of the Earth, is equally as concerned. “GE-animals are being reviewed at the FDA using outmoded rules, and what is being proposed is weak and completely inadequate. There should be full human health and environmental impact assessments (which is not required as of now), long-term safety testing, mandatory labeling of GE-animals, manufacturer liability, and no additional GE-animals should be approved until the GE-salmon litigation is resolved.”
While the proposed FDA and USDA rules may offer increased government oversight in a select number of areas, there will still be far too many gaping holes, which will leave the consumer and environment dangerously unprotected.
“The agencies are still trying to squeeze new gene-editing technologies into models that are decades old. They need to issue new regulations appropriate to the new techniques,” says Jaydee Hanson.
If the courts find that the FDA overstepped its authority by approving GE-salmon, the ruling would force Congress to issue new regulations for GE-animals.
The Trump administration’s anti-regulation stance may backfire, however. A lack of new and modern biotech regulations would hurt us on the global stage as our international trading partners would no longer trust that we are adequately overseeing our food supply. This would lead to more products being blocked for sale to countries around the world.
When it comes to new gene-editing products being labeled, there are many differing opinions as to how last year’s GMO-labeling law will be interpreted and implemented. With the law set to go into effect in 2018, the USDA has not made any final decisions and no one can say with any degree of certainty which gene-edited foods will require labeling.
In regards to organic, there are a few things to consider.
More risky and unregulated GE-products on the market can only mean more contamination and more unintended consequences for the organic food supply. A perfect example of this is how dead GMO-moth larvae could end up in organic broccoli, cauliflower and cabbage, something I wrote about in last week’s Organic Insider.
At the 2016 National Organic Standard Board (NOSB) meeting in St. Louis, members voted to classify new gene-editing techniques, such as CRSIPR, as excluded methods, therefore prohibiting them in organic production. However, the USDA/National Organic Program does not have to accept the NOSB’s recommendation and has yet to make a decision on this.
With gene-editing technologies advancing so rapidly, we are at a time in history when we need new regulations more than ever. A failure to have them will not only hurt organic but will put all consumers, the environment and parts of our economy at real risk.
Sadly, whatever improvements that are eventually made to the Coordinated Framework will just not be enough.
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Have a great day! 
Max Goldberg, Founder |
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