Author: Paul Enríquez


Last week, the USDA published a series of questions seeking input to establish a National Bioengineered Food Disclosure Standard, as mandated by amendments to the Agricultural Marketing Act of 1946 that went into effect in July 2016.

The National Bioengineered Food Disclosure Standard Act requires the Secretary of the Department of Agriculture to establish disclosure standards for bioengineered food. The Act preempts state-based labeling laws for genetically modified organisms (GMOs), such as those adopted in Vermont last year.

The USDA is considering public input on the disclosure standards until July 17, 2017. Two key issues are under consideration. The first is whether certain genetic modifications should be treated as though they are found in nature — for example, a mutation that naturally confers disease resistance in a crop. The second concerns what types of breeding techniques should be classified as conventional breeding — among "conventional breeding" techniques are hybridization and the use of chemicals or radiation to introduce random genetic mutations.

These seemingly mundane questions strike at the heart of GMO controversies and implicate the use of breakthrough CRISPR gene editing technologies. Gene editing allows novel and precise genetic modifications to be introduced into crops and animals intended for human consumption. The answers to the USDA's questions are significant because the Disclosure Standard Act exempts from mandatory disclosure genetic modifications obtained without recombinant DNA (rDNA) techniques that can otherwise be found in nature.

Older genetic engineering methods relying on rDNA technology combine genes from foreign organisms and transfer them into plant or animal cells — thus, creating "transgenic" organisms.

However, CRISPR gene editing need not rely on using any foreign DNA and can introduce genetic modifications that mirror those already found in nature. Unlike rDNA and conventional breeding methods, CRISPR technologies introduce genetic changes with far greater accuracy and precision.

In 2016, the USDA declined to regulate two CRISPR crops — a mushroom and a waxy corn — under regulations governing traditional GMOs. But other regulatory agencies, including the FDA and EPA, have not yet made determinations on crops or animals modified with CRISPR technology, and uncertainty looms concerning the regulatory status of this new breed of GMOs.

Opponents of GMOs, who commonly argue that GMOs are harmful to human health, decried the USDA's decision not to regulate CRISPR crops and argued that powerful corporations had found ways to circumvent the law through technical loopholes in outdated regulations.

Yet three decades of scientific research suggest that present-day GMO controversies are not grounded in scientific fact. For instance, despite frequent rumors about GMO-induced cancers, a scientific consensus has now formed to support the health and environmental safety of genetically modified crops for animal and human consumption. That proposition is supported by investigations of the U.S. National Academies of Science, Engineering, and Medicine as well as scientific panels including the American Association for the Advancement of Science, the American Medical Association, the European Commission, and National Academies of Science in Australia, Brazil, China, France, Germany, India, the United Kingdom, and other countries.

In its rulemaking process, the USDA should rely upon science and facts. With regard to crops and animals with DNA altered through gene editing, rulemakers ought to distinguish among ways that CRISPR technology may be used to edit genes. For instance, CRISPR technology can be used as a DNA construct that is incorporated into the DNA of plant or animal cells, or as a preassembled RNA and protein complex.

How gene editing is carried out matters, because some methods appear to fall within the disclosure requirements while others do not. The law defines bioengineered food as food that contains genetic material modified through in vitro rDNA techniques. Thus, under the Disclosure Standard Act’s statutory constraints, CRISPR food created using DNA constructs that are incorporated into plant or animal cells would likely fall under the mandatory disclosures.

However, food derived from rDNA-free CRISPR gene editing using transient preassembled RNA and protein complexes should be excluded from the bioengineered food definition because such complexes are degraded shortly after gene editing takes place and do not insert themselves into the target organism DNA.

The nuances of ever-evolving biotechnological innovation highlight the complexity of our regulatory system and the need to modernize it. The National Bioengineered Food Disclosure Standard Act is just one of the latest pieces of that regulatory patchwork to emerge. Rules establishing bioengineered food disclosures should be coherent and science-based. Gene editing that uses no foreign DNA, is more precise than conventional breeding methods, and causes genetic modifications already found in nature should not be subject to onerous disclosure standards.

Paul Enríquez is a lawyer and scientist currently doing research in Structural & Molecular Biochemistry at North Carolina State University. His work focuses on the intersection of science and law and has been featured in both legal and scientific journals. He explores rising legal and regulatory issues concerning genome editing in crop production in depth and makes policy recommendations in his recently published article “CRISPR GMOs.”