Opponents of human germline editing hae argued that changing the human gene pool could have unforeseen and irreversible consequences.
The evolution of the science of GMOs, and how that translated into practical application by the large agrochemical companies, influences how society thinks about modern gene editing technology.
US Food and Drug Administration (FDA) regulation of intentional genomic alterations in animals includes an evaluation of safety and effectiveness, with a particular focus on animal and food safety, and is based on risk.
The US Department of Agriculture’s Animal & Plant Health Inspection Service (APHIS) is proposing criteria that will be used to evaluate and recognize livestock compartments in other countries.
The US Food and Drug Administration (FDA) issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus anthracis into class II (moderate-risk) with special controls, which means the agency will continue to require a 510(k) premarket notification for the devices.
Gene editing gives researchers a fast, reliable way to make precise changes in specific genes. But its use in farming is in the balance after a European ruling last year equated it with heavily regulated genetic modification.
A World Health Organization (WHO) advisory committee on editing human DNA will ask the United Nations agency to establish a global registry of all such research, recommend that editors of scientific journals not publish any unregistered studies, and ask science funders to require that their grantees register their studies.
Eighteen scientists from seven countries have called for “a global moratorium on all clinical uses of human germline editing” — that is, changing DNA in sperm, eggs, or early embryos to make genetically altered children, alterations that would be passed on to future generations.
In the wake of CRISPR babies, there is an urgent need to better regulate and debate whether, when and how related research should be done.