Innovation chaos

March 2018

America, it seems, created a whole regulatory headache for itself in the pre-dawn days of GM crops when it determined that GMOs weren't different from their natural counterparts "in any meaningful or uniform way".

This decision wasn't based on science but on a perceived need to resist the spread of unnecessary regulation so as to promote America as the world leader in biotechnology. The result has been that GM crops have been shoe-horned into existing US regulations on drugs, pesticides, invasive species, and control of plant disease where they sit very uneasily in different government agencies, or sometimes nowhere at all.

By far the biggest player in this game is the US Department of Agriculture (USDA) which exists to promote farmers' and agricultural interests, but which seems to have evolved into a machine to do the biotech industry's bidding.

Also involved is the US Food and Drug Administration (FDA). Despite warnings from its own scientists on the potential for harmful and unpredictable side-effects in GM crops, the FDA came up with a policy in 1992 which very effectively covers its own back but provides no protection for the public it's supposed to be serving. This allows manufacturers of GMOs to determine for themselves whether their novel products are safe. Companies are offered a voluntary pre-market consultation by the FDA, at the end of which they will be given an official letter confirming, for example, that the company has stated it has conducted a safety and nutritional assessment, and has concluded its product is not materially different from equivalent products already on the market. Note that there are no requirements for testing standards, and the FDA regulators don't actually agree the GMO is safe. It remains, from beginning to end, the responsibility of the manufacturer to ensure the safety of its own product.

In light of all the emerging novel DNA-editing technologies, such as CRISPR [1], and recognising the shortcomings of the existing hands-off mish-mash approach to GM regulation, the Obama administration ordered the USDA to overhaul how it regulates biotech products. Inevitably, some might say, the Trump administration has now reversed this. The new instruction to the USDA is to look at regulatory requirements to "foster public confidence" and develop a "review process that doesn't restrict innovation".

Back on the farm... Despite all that encouragement from the White House, despite the absent review process and the free flow of innovation, Monsanto is paying farmers to use its latest GM technology. This has become necessary because the Company is banking on dicamba-tolerant GM soya to take over from its highly lucrative but increasingly controversial Roundup-tolerant GM soya as the dominant US soyabean. Unfortunately for Monsanto, the dicamba herbicide has turned out to be unusable without a very fancy management regime being in place: it requires training on when it can and can't be sprayed, the purchase of extra chemicals to stop it blowing in the wind, and records to prove compliance with label instructions [2]. Farmers could do without the hassle, unless they're paid to.

OUR COMMENT


Perhaps a little more US regulatory review aimed at enabling more thoughtful innovation would better support its agri-industry and foster public confidence without having to resort to bribery?


Background:

[1] CRISPR/Cas9 GENE EDITING - March 2016
[2] THE DICAMBA TSUNAMI - October 2017


SOURCES:
·         Trump's agriculture department reverses course on biotech rules, GM Watch 7.11.17
·         Jeffrey Smith, 2017, Survey Reports Improved Health After Avoiding Genetically Modified Foods, International Journal of Human Nutrition and Functional Medicine
·       Tom Polansek, Monsanto offers cash to U.S. farmers who use controversial chemical, Reuters, 11.12.17

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