In case you haven’t been keeping up-to-date with the latest news in the biotechnology regulatory system (and how could you not?), the system is under revision. As part of the new Coordinated Framework the FDA stated it would clarify how it will deal with the hot-button topic of genome editing, and update its guidance documents accordingly. As part of this process the FDA opened a docket on regulations.gov to receive public comments about the issue. As you might expect, a large majority of the comments have been less than scientific.

They are asking for your evidence-based input.  Please give it to them!

Why This is Important.

Genome editing is potentially the biggest scientific discovery in decades. The technology allows researchers to precisely change specific DNA sequences. If breeding or standard genetic engineering are like a shotgun and a hammer, gene editing is the most delicate microsurgical scalpel. The scientist decides which changes need to be made, and the gene editing technology makes them happen.

The technique mimics the changes in DNA that could arise from natural processes, just on a time scale of months rather than decades.  This means that instead of spending years breeding and screening acres of plants for a certain trait, it is now possible to orchestrate the desired genetic change to create that same change in a matter of months. This is why this technique is so powerful and exciting.

The technique also is different from current genetic engineering techniques because scientists  introduce the genome editing machinery, it does its work, and then it is removed. This means that the modified plant contains no foreign, introduced DNA, and cannot be distinguished from a naturally occurring mutant. The technology is new, and researchers are just starting to realize its potential. It is imperative that regulations exist that embrace both safety and practicality, weighing real benefit against real risk, in order for the full potential to be realized.

This is why you must be involved.

What Can You Do?

The FDA has asked for public comments. To respond online simply navigate to the docket website and click “Comment Now!” in the upper right corner. Remember that scientific comments attached to traceable people, rather than an “anonymous” comment, carry more weight with regulators trying to understand who to trust. Once you have submitted your comment online, the system will give you a tracking number, don’t be surprised if it takes a few days for your comment to appear on the site.

Alternatively, you may submit comments via mail: Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

What Should I say?

The FDA is not asking for general comments on genome editing. They want specific questions addressed, and want data/sources to support the comments.

To summarize the questions:

1. Do we know if food produced with genome engineering is safe?  
2. If the same changes could be made with traditional breeding, should the FDA still require a regulatory process?  
3. Is it possible for genome edited plants to cause a higher risk?  
4. How should the FDA help small developers navigate a new regulatory system?  

If you are interested in a more detailed breakdown:

1. Would food made with genome engineering be different in safety than other methods?
2. Is our current understanding of biotechnology relevant to the discussion? Is there anything new we need to consider?    
3. Can we say scientifically that there are plants that can be produced with genome editing would be the same risk as current methods? Is it possible to make the same plants with genome editing that could be made with traditional breeding?Should the FDA identify those types of plants?
4. How can the FDA make sure developers are always thinking about food safety?
5. Should the FDA make developers communicate with them even if the plant has no risks?
6. Since genome editing covers a wide range of technologies, how should the FDA decide if a plant needs to be reviewed?  
7. Are there any genome edited plants that could potentially cause more risk than traditional breeding?
8. How should the FDA help small developers navigate the regulatory system put in place?

 A Well-Supported Comment has Influence

 It is not my goal to tell you how to answer these questions.The regulatory system is in place to ensure that we have a safe and reliable food system and any modifications to that system should not be taken lightly.However, there is a strong scientific consensus that genetic engineering is a safe technology and gene editing is simply an even more precise version of existing technologies, offering even less risk.  

You are not required to answer all, or for that matter any, of the questions posed in the docket.

If you have a strong scientific background in the field, please take the time to answer with sources and provide background information.

The FDA, in its own guidance document says, “one well supported comment is often more influential than a thousand form letters”. Looking through the comments currently on the docket, there are already plenty of form letters. We need scientists to counter with well-reasoned arguments.

What if I’m not a Scientist?

That is ok! In the FDA guidance document they say they would like arguments to be based on sound reasoning, science, and/or how you will be impacted. If you aren’t a scientist, take the time to explain how amore rapid regulatory system can help the consumer. Currently it takes over 13 years for a product to enter the market, 5 to 7 years is just the regulatory process! In its current state, most small companies or universities are simply unable to assemble the resources required to bring a new genetically engineered product to the market. Removing the burden of a cumbersome regulatory system can go a long way to helping open up the market from just the big players. 

Gene editing will likely be one of the most profound technological transformations of our time. The scientific foundations of the technology are not inherently any more risky than the biotechnology techniques we are already using today that the scientific community has deemed safe. Make sure that the FDA hears your thoughts on this issue.