Risks of Gene Editing in Agriculture to Human and Environmental Health

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

Risks of Gene Editing in Agriculture to Human and Environmental Health

A recent report examines the growing body of scientific studies highlighting the risks and unintended consequences from the use of new genetic engineering techniques like gene editing in agriculture. The report cites studies that show that gene-edited organisms are prone to unintended and unexpected effects at the molecular level. These could pose a threat to human health and the environment if commercialized. Furthermore, gene drives, designed to drive a particular trait through the entire population of a species, could have far-reaching and unpredictable negative consequences for organisms and the environment.

The report emphasizes significant research and data gaps in the analysis of how the unintended genetic mutations resulting from gene editing may impact human health and ecosystems. It provides recommendations for further research and points to the lack of regulatory oversight in the U.S., while also addressing the question of whether gene editing in agriculture is necessary.

The authors make two main recommendations:

* All genetic engineering techniques should fall within the scope of government regulatory oversight of genetic engineering and GMOs, using the Precautionary Principle to protect human health and the environment.
* Oversight and regulations for GMOs, including gene-edited organisms, should include independent assessment for environmental and food safety and long-term impacts before entering the market or environment, and products of all genetic engineering should be traceable, and labeled as GMOs.

With best wishes,

Item 1

GENE-EDITED ORGANISMS IN AGRICULTURE: RISKS AND UNEXPECTED CONSEQUENCES

by Dr. Janet Cotter and Dana Perls
Friends of the Earth and Logos Environmental
September 2018
http://foe.org/wp-content/uploads/2018/09/FOE_GenomeEditingAgReport_final.pdf

In the U.S., companies are racing to incorporate genetically modified organisms (GMOs) produced using new genetic engineering technologies such as CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and other “gene editing” (or “genome editing”) techniques into our food system with little to no oversight and public disclosure, despite scientific research that is demonstrating the potential for significant unintended consequences.

For example, in a recent study published in Nature Biotechnology, scientists from the Wellcome Sanger Institute in the UK found that new genetic engineering techniques like CRISPR may cause “genetic havoc”. Specifically, researchers found large deletions and rearrangements of DNA near the target site that were not intended by researchers. Prior to that study, two recent independent studies published in Nature Medicine, one by the biotech company, Novartis and the other by the Karolinska Institute, found that cells genetically engineered with CRISPR “have the potential to seed tumors”, or may initiate tumorigenic mutations.

Earlier studies found that gene-edited plants such as soybeans had off-target effects, in which gene editing occurred at unintended locations with DNA sequences similar to the targeted location. These studies are a small sample of the growing research demonstrating the unintended consequences and surprise impacts that may result from genetically engineering organisms.

The new genetic engineering techniques are being proposed for a wide range of applications from pharmaceuticals to genetic therapy in humans to agriculture. Within agricultural proposals, the most common trait for gene edited plants is herbicide tolerance. This prevalence implies that, like current genetically engineered crops, the application of techniques like CRISPR will further entrench a chemical intensive approach to agriculture. In fact, the first product to go to market was Cibus’ SU Canola^TM, which is resistant to the herbicide sulfonylurea.

The unexpected and unintended effects of all genetically engineered organisms, regardless of whether ‘traditional’ or gene-edited genetic engineering techniques have been used, have the potential to cause environmental and human health problems. While some studies describe gene editing such as CRISPR as “precise,” most studies have been “proof of concept” studies that look at specific intended changes that might be achieved. But these studies haven’t looked at collateral effects of gene editing, such as unintended changes to DNA in other genes. As the current research shows, precise edits do not necessarily result in precise outcomes. Additional concerns about gene editing applications in agriculture include increased agrochemical use, effects on pollinators, impacts from stacking genetically engineered traits and genetic contamination of crops’ wild relatives.

While recent studies raise concerns about unintended effects, more research is needed to understand the implications of CRISPR and other engineering techniques on non-target genes and surrounding ecosystems. Yet food products such as the CRISPR mushroom are being allowed into fields and onto the market in the U.S., with insufficient evidence to demonstrate their safety, without regulatory oversight and without being labeled as GMO products.

Item 2

PRESS RELEASE:

CONTACT: Jordan Wilhelmi | +1.612.281.2310 | jordan@unbendablemedia.com

NEW REPORT: GENE EDITING IN AGRICULTURE POSES NEW RISKS TO HEALTH, ENVIRONMENT

New report documents growing body of science demonstrating need for safety assessment, oversight


Washington, DC
— On the heels on the European Court of Justice’s ruling requiring organisms developed using new genetic engineering techniques to undergo GMO risk assessments, and several new studies revealing “genetic havoc” as a result of gene editing, Friends of the Earth and Logos Environmental released a new report today, Gene-edited organisms in agriculture: Risks and unexpected consequences.

With the breakneck speed of recent developments in genetic engineering that could be used to alter DNA in plants, animals, bacteria, and even humans, the report examines the growing body of scientific studies highlighting the risks and unintended consequences from the use of genetic engineering techniques like gene editing in agriculture.

“Increasingly, scientific publications are revealing the genetic errors that gene-editing can create. It’s becoming clear that, if gene-edited GMOs are to be used in U.S. agriculture, they need to be carefully scrutinized for any unexpected effects,” said co-author Dr. Janet Cotter of Logos Environmental. “The real question is whether GMOs are needed in agriculture at all. Advanced conventional breeding is now highly effective at producing the traits in plants and animals that both farmers and consumers desire and entails less risks to the environment and human health.”

“New genetic engineering techniques like gene editing are risky and may result in surprise consequences for people and the planet,” said Dana Perls, report co-author and senior food and technology campaigner with Friends of the Earth. “These new GMOs must be properly assessed for health and environmental impacts before they enter the market and our food system.”

In recent years, there has been much discussion of how gene editing techniques, such as CRISPR, can broaden the scope of genetic engineering in agriculture. However, it’s becoming clear that gene editing techniques are error prone. In July 2018, scientists from the Wellcome Sanger Institute in the U.K. found that new genetic engineering techniques like CRISPR may
cause  “genetic havoc”. Earlier this year, researchers found  large deletions and complex rearrangements of DNA near the target site that were not intended by researchers. Two recentindependent studiesfound that cells genetically engineered with CRISPR “have the potential to seed tumors”, or may initiate mutations that develop into tumors.

This new report compiles growing evidence demonstrating the unintended consequences and surprise impacts that may result from gene-edited plants and animals, including so-called “gene drives”. It highlights the unintended effects and potential risks related to gene editing applications in agriculture as reported in peer-reviewed scientific studies and identifies research gaps in the analysis of how gene editing in agriculture may negatively impact human health and ecosystems.

Key Findings:

*   Studies show that gene-edited organisms are prone to unintended and unexpected effects at the molecular level. These could pose a threat to human health and the environment if commercialized without comprehensive mandatory safety assessment and oversight.
* Gene drives, designed to drive a particular trait through the entire population of a species, could have far-reaching and unpredictable negative consequences for organisms and the environment.
*  The prevalence of herbicide-tolerant gene-edited plant proposals implies that gene editing applications will further entrench a chemical-intensive approach to agriculture.
*  There are significant gaps in research about how unintended consequences at the genetic level may impact the whole organism or interact with complex environmental factors.

Recommendations from the report:

*    All genetic engineering techniques should fall within the scope of government regulatory oversight of genetic engineering and GMOs, using the Precautionary Principle to protect human health and the environment.

*    Oversight and regulations for GMOs, including gene-edited organisms, should include independent assessment for environmental and food safety and long-term impacts before entering the market or environment, and products of all genetic engineering should be traceable, and labeled as GMOs.