Licensing CRISPR for Agriculture: Policy considerations

Broad researchers and their collaborators have pioneered the development and sharing of new genome editing tools, such as CRISPR-Cas9, which are revolutionizing and accelerating nearly every aspect of disease research and drug discovery around the world.

In addition to making these genome editing tools and techniques freely available to the academic and non-profit communities, the Broad Institute has since 2013 issued more than a dozen licenses for commercial research, such as in human biomedicine.

Broad has also been approached by agriculture companies seeking to license CRISPR technology for commercial use.

There are many potential benefits of using CRISPR in agriculture that could benefit human health. Responsible use of CRISPR gene editing technology in agriculture has the potential to help reduce world hunger, reduce our reliance on pesticides, help society adapt to the effects of climate change, reduce the diversion of water from drinking supplies to farms, and increase nutrition and raise the efficiency of crop yields.

However, just as in biomedicine, the use of genome editing in agriculture raises important ethical and safety concerns.

Challenging issues include:

• Gene drive. This is a way to rapidly spread a new gene throughout an entire species in nature. This approach might be used to block the transmission of malaria by mosquitoes, but has the potential to disrupt ecosystems. (The National Research Council recently issued a thoughtful report on gene drive.)
• Sterile seeds. This is an approach that seed companies could use to force farmers to purchase seed each year, by preventing plants from producing fertile seeds. Although the concept was proposed more than 30 years ago, none have been commercially deployed. In 2000, the United Nations Convention on Biological Diversity recommended a global moratorium on their development, a position we support.
• Tobacco. Smoking is extraordinarily harmful to human health. It increases risk of: lung cancer (by 25-fold) as well as almost every other kind of cancer; coronary heart disease, stroke and diabetes; rheumatoid arthritis; complications in pregnancy; and many other conditions. As health researchers, we would be concerned about efforts to use genome editing to increase tobacco usage. However, we know that tobacco plants can be used as an important model organism for basic research and can be used as a way to manufacture therapeutic proteins.

After consulting with external experts and careful internal consideration, the Broad Institute has decided to make available non-exclusive research and commercial licenses for the use of CRISPR technology in agriculture -- but with important restrictions. These include:

• Gene drive: We prohibit the use of the licensed technology for gene drive.
• Sterile seeds: We prohibit the use of the licensed technology to create sterile seeds (sometimes called “terminator” seeds), but do not prohibit the use in naturally sterile plants.
• Tobacco: We prohibit the use of the licensed technology to modify tobacco for any use other than (i) in the context of a model organism for research not directed to the commercialization of tobacco, and (ii) for manufacturing purposes of non-tobacco products.

Many of these issues already fall under the oversight of federal agencies in the United States, including the USDA, FDA, and EPA.

Still, the Broad feels it is important to include explicit restrictions in the technology licenses as well. We wanted to share our thinking with others who may be considering licensing of related technologies.