Abstract
Advances in affordable genetic engineering have accelerated the creation and large-scale
environmental release of genetically modified microorganisms (GMMs). While beneficial applications exist, GMMs may present unique, long-term risks to human and environmental health. Unlike static chemicals, GMMs are biologically active, self-replicating entities capable of rapid mutation and global dispersal. Current regulatory frameworks place responsibility on each country to regulate GMMs, without a clear, coordinated international policy.
This review details critical risk scenarios, including horizontal gene transfer to native species and the possible disruption of vital human microbiomes (gut, oral, and infant), which could increase resistance to degradation, promote traits that expand a microbe’s range of hosts or ecological niches, and enhance the production of novel metabolites with unexpected biological activity.
In soil, GMMs may support the emergence of “super bugs” or destabilize carbon sequestration cycles, potentially impacting climate resilience.
Engineered microbial enzymes in the food supply may also act as environmental drivers
of autoimmunity. Given the limited understanding of microbial ecology, we propose a decision-based biosafety workflow emphasizing pre-release risk assessment and continuous post-release monitoring. We urge national and international regulators to adopt
the precautionary principle to better protect human health and the environment from the
potential negative outcomes of GMMs.
1. Introduction
New technologies may pose risks of harm to human, animal, and environmental health, and ideally should be vetted prior to release for commercial use or consumption.
However, this is not always possible. The demands for a new technology may have to be balanced against policy, need, and cost. GMM as a “microorganism that has had its genetic material (DNA) changed intentionally” [1] is an outcome of such technology. Currently, there is considerable disagreement about the proper regulations of GMMs.
Pre-release safety testing, assessments for human and environmental impact, and monitoring frameworks are lacking. In the US, GMMs for commercial use are primarily regulated by the Environmental Protection Agency (EPA) as toxic substances, which is ill-suited for biological organisms. In addition, most other GMMs (not for commercial use) are unregulated and untracked. With the rapidly advancing landscape of genetic engineering technologies and broad access to these technologies across society, we must address the unique risks of genetically modified microbes and customize regulations based on current evidence and their impact on human and environmental health.
Soil microbes support healthy plants and food crops and are a key component of theEarth’s carbon cycle. Algae produce most of the planet’s oxygen. Fungal networks below the forest floor shuttle nutrients between trees and are the basis of a species communicationsystem we are only beginning to understand [2]. Healthy, thriving microbial communities are essential for our planet’s future. Most microbial functions remain unknown; we have characterized less than 1% of the estimated one trillion varieties on our planet [3]. Yet wherever we look, we find that they play a vital role.
Microbes or microorganisms include bacteria, archaea, fungi, viruses, bacteriophages, and protists. A “microbiome” describes the collection of microbes living within a welldefined habitat or other environment [4]. Humans and their predecessors have been evolving with microbial inhabitants for 1.5 billion years [5].
The microbes that live in and on the human body are known as the “human microbiome” and function like an organ to support immunity, metabolism, detoxification, and resistance to infection.
Lifeforms such as animals, plants, trees, fish, etc., have microbiomes. There can be distinct microbiomes for different parts of the body, such as the human respiratory microbiome, gut microbiome,or skin microbiome [6]. Microbiomes are found everywhere in the natural world. <<Read More>>
Dr. Michelle Perro, MD, Pediatrician
Genetically Modified Microorganisms:
Risks and Regulatory Considerations
for Human and Environmental Health
Authors: Aaron Lerner, Arnon D. Lieber, Cass Nelson-Dooley, Andre Leu , Michelle Perro , Geoffrey Koch, Carina Benzvi and Jeffrey Smith
"Knowledge isn’t power until it is applied."
~ Dale Carnegie