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Feds Clueless on Frankensoil

Feds Clueless on Frankensoil
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The laws and policies governing the use of genetically engineered (GE) soil microbes are confusing, outdated, and desperately inadequate given the potential risks to humans and the environment. We need to demand better of our lawmakers. Action Alert!

A few weeks ago, we reported on the next big thing in the agrichemical industry: the use of GE microbes for soil application. This practice can have far-reaching and potentially disastrous consequences for all life on this planet, yet runaway development of this strand of biotech is set to position GE soil microbes as a mainstay of industrial agriculture—unless public and political opinion stands in the way. To make matters worse, the laws on the books are entirely insufficient to manage these risks. We need lawmakers to recognize the scale of the dangers involved and to act accordingly.

We should note at the outset that the entire federal government’s approach to regulating GE products is fundamentally flawed. Simply put, the federal framework for dealing with GE products focuses on the final product rather than the process used to develop that product. This means that there is no comprehensive system to assess and manage risks specifically related to how GE products are made. Whether they are plants, animals, or pesticides, GE products are shoehorned into whatever regulations correspond to the product, when in reality the risks are far different than other products in those categories.

These inadequacies are all too apparent when it comes to GE soil microbes. If the GE microbe is for use in a pesticide, it is regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). There are no specific regulations for GE microbes under this law. As the EPA states, GE microbial pesticides are regulated using “essentially the same data requirements used for naturally occurring microbial pesticides.” FIFRA requires manufacturers of GE microbial pesticides to “register” the product with the EPA. To gain registration, manufacturers must submit data pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide.

This all sounds good, but the bar to register a product under FIFRA is actually quite low. Companies must only be able to show that using the pesticide according to specifications “will not generally cause unreasonable adverse effects on the environment,” which, in the agency’s definition, includes human health. This is madness because the risks posed by GE microbes and non-GE microbial pesticides cannot be compared, and there is no onus on the applicant to unequivocally prove long-term environmental safety.

FIFRA also requires a notification to be submitted to the EPA at least 90 days prior to any field test of a GE microbial pesticide. The notification is supposed to contain basic information such as the nature of the genetic modification, the proposed application sites, and methods of containment and/or monitoring that are in place. As we mentioned in our previous coverage, the idea that GE microbes can be contained once released is a fantasy. Additionally, unlike most other countries, the EPA does not ask for field data demonstrating that the GE microbial pesticide actually works before approving it.

The EPA actually has authority under the Toxic Substances Control Act (TSCA) to regulate GE microbes, but only those that are intergeneric—that is, ones that contain a gene from a different genus of microbe. This excludes microbes that have been gene-edited, which is of course the dominant technology as of now. It’s unclear what, if any, GE soil microbial products will be regulated under TSCA, but as we’ve noted in our coverage of PFAS ‘forever chemicals, this law does very little to protect Americans from dangerous chemicals and other substances for reasons we delve into in our PFAS in kale pilot study.

Finally, under the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule, the USDA has the ability to regulate microbes that it deems a plant pest risk, but this is decided on an ad hoc basis instead of applying a default review system for any GE microbes. This is emblematic of the federal government’s deregulatory approach to GE products overall, and from a human and planetary health point of view, it is deeply concerning.

It’s not hard to notice that there are significant gaps in this regulatory scheme that have been created specifically to give this new technology a rapid route to market. It’s somewhat reminiscent of the fast-track licensing of mRNA genetic vaccines we’ve seen over the last 3 years. For gene-edited microbes that are not used as pesticides, FIFRA and TSCA do not apply. Pivot Bio PROVEN, one of the GE “biologicals” we discussed in our previous coverage, edits the genes of microbes to supercharge their nitrogen production. It’s not a pesticide, and it doesn’t contain genes from a different microbe, so it doesn’t fall under TSCA. These types of products, and those in development—products that can potentially permanently change soil ecosystems over large swaths of territory—will fall through the cracks of this regulatory scheme for GE products that’s clearly not fit for purpose.

The stakes are far too high to allow the development and release of GE microbes without any meaningful oversight. A complete overhaul of this regulatory framework is desperately needed, one that recognizes the unique nature of using genetic engineering or gene-editing to alter microbes that have evolved naturally over eons. Further, we need to stop exempting gene-edited products from the same oversight as other GE products, as has been the case for years. We also need an immediate moratorium on field releases of GE soil microbes until these changes are made and risks can be properly assessed.

Action Alert! Write to Congress and the EPA telling them that we cannot allow Big Ag and Big Biotech to risk human and planetary health with GE soil microbes! Please send your message immediately.

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