FDA regulates gene-edited animals like drugs, not food. That’s a mistake.

Although plants and animals produced in conventional breeding programs are routinely measured for production performance, susceptibility to disease, fertility and product quality, they are not normally evaluated at the DNA level prior to commercial release. Tremendous DNA sequence variation, or mutations, exists between perfectly healthy, unremarkable individuals of the same species.

To put this in perspective, one study of whole genome sequence data from over 2,700 bulls in the 1000 Bull Genomes Project revealed over 86 million genetic variations between individual bulls of the same species. These included 2.5 million insertions or deletions of one or more nucleotides, and 84 million nucleotide variants, in which one nucleotide substituted for another. No two steaks from different animals are genetically alike, and every meal you have ever eaten contained a unique assembly of DNA sequences.

Human intention results in a drug

Such applications are unlikely to reach the market if intentional DNA alterations are regulated as drugs. The mandatory approval process for animal drugs is understandably rigorous. It requires proof that the drug works, the absence of harmful residues in food animal products, and both animal and environmental safety.

What is unclear is how DNA alterations fit into this rubric. There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food.

How can the absence of something, a snippet of DNA – as in the case of a deletion – be considered “a drug residue,” when an analogous deletion in the genome of a mushroom is not?

When I think of a drug I picture something like aspirin – a chemical with biological activity, often taken to prevent or treat a disease. As with most things in life, a small dose can be helpful, and a high dose can cause harm.

Some South American countries including Argentina have indicated that gene-edited plants and food animals won’t be treated differently from a regulatory perspective. If no DNA sequences novel to that species are introduced using gene editing, then no added regulatory oversight will be triggered. Brazil has ruled it will not regulate hornless cows as GMOs.

Moving gene editing to permissive countries

However, in the United States gene-edited food animals with intentional genomic alterations that could otherwise have been developed through traditional breeding will be subject to a multigenerational, pre-market evaluation as new animal drugs.

This evaluation will be undertaken irrespective of whether there is any risk or novelty associated with the alteration. Edits that exactly mimic existing sequence variations will trigger evaluation. Surely novel product risk, if any, should be the focus of regulatory oversight, and not what method a breeder used to introduce genetic variation.

As a result, U.S. animal geneticists are starting to move their gene-editing research to other countries. Innovative startups are forming partnerships with foreign companies in countries with product risk-based regulatory systems.

In the absence of sensible regulation of the breathtaking genetic variation that exists naturally in our food species – which is generally regarded as safe – innovation will emigrate. If intentional DNA alterations are shoehorned into a century-old regulatory framework, research exploring the introduction of sustainability traits like disease resistance, climate adaptability and animal welfare into U.S. livestock breeding programs will be thwarted, harming American agriculture and food production.

This article is republished from The Conversation. Read the original article here.