Thorny policy issues follow advances in genetic modification technology

Astounding advances in biotechnology offer an opportunity for a more measured and informed debate on genetic modification than has happened previously, according to two patent attorneys involved in navigating through the thorny policy and legal issues.

The new breeding technologies (NBTs) are different from first generation in that they allow targeted changes to the genome, or gene editing, rather than inserting entirely foreign sequences into a plant, for example.

This CRISPR/Cas9 technology essentially allows modification to take place within the organism and is creating huge excitement among scientists and biotechnology experts across different fields.

Patent attorneys Brian Reese and Nishat Shaikh, along with colleague Nathan Billings, of the Boston-based law firm of Choate, Hall & Stewart LLP, recently authored a piece published in the genetic engineering and biotechnology magazine, GEN, noting the astounding potential of the technology but also raising questions about how it should be regulated.

In a recent interview with Crop Protection News, Reese and Shaikh said the article wanted to note the difference between what regulators might describe as traditional genetically modified organisms and those modified by the newer technology.

“It is interesting that these two generations are regulated differently,” Reese said.

The regulation of first generation transgenic genetically modified crops by the USDA is covered by the Plant Protection Act (PPA), which gives the agency authority to regulate plant pests or noxious weeds, including GM organisms.

However, the agency has signaled that genetically engineered crops that do not contain “foreign” DNA are not considered to be GM crops, and thus do not require regulation.

But there are concerns about CRISPR, that it may lead, at some point, to a dangerous narrowing of biodiversity and the potential of an attack by a super insect immune to a plant’s defenses, Reese and Shaikh said.

Further, there is still the public wariness of genetically modified foods, and a negative public perception of the business practices of large agribusiness companies, the attorneys said. Reese, and co-author, are also both scientists.

To essentially have little regulation of the new technology is not a good approach from a public policy point of view, the authors said.

“This is a unique chance for a reset of the debate over genetically modified foods, to put the messaging differently and address concerns,” Reese told Crop Protection News.

They should be regulated the same, with all issues on the table, and decide on a plan, and what degree of modification is allowed, Shaikh said.

In their piece in GEN, the authors said, “These technologies are capable of providing astounding improvements to crops, such as improving disease resistance or increasing metabolic efficiency; and this has led to a flurry of activity as many researchers and companies seek to expand and further develop gene-editing technologies in plants."

But, they added, “The classification of CRISPR-engineered crops as non-GM has the potential to exacerbate public distrust around GMOs if communication with the public regarding these technologies is not handled in an open and engaging way."