USDA’s Animal and Plant Health Inspection Service (APHIS) has been regulating genetically engineered (GE) crops over the last two decades based on whether development of those products involved use of organisms deemed “plant pests.” (Whether that strategy has been science-based is debatable, in my opinion.)

In light of the fact that more and more GE organisms are now being developed without the use of “plant pests,” the agency is seeking input on how APHIS should regulate the products of biotechnology from here on out. The deadline for submitting comments is Monday, June 22, 11:59PM Eastern Time.

I encourage anyone interested in how GMOs are regulated in the United States to submit comments.

I just submitted mine to the agency; here is a copy of them:

I am a molecular geneticist and former crop genetic engineer. Thank you for seeking input on how APHIS should regulate the products of biotechnology. The following are my comments addressing the four question areas that APHIS is seeking input on.

1. APHIS should regulate biotechnology products based on the fact that they were created using biotechnology processes because any individual biotechnology product (as currently produced) may present potential risks that can not be anticipated based on the product’s intended characteristics; these risks relate to unexpected, unintended changes that could result from insertional mutagenesis, unintentional insertion of vector “backbone” sequences, or off-target effects. The criterion used to determine what APHIS regulates should therefore be the fact that the organism was created using a biotechnology process like genetic engineering, which includes processes that utilize the biolistic gun, Agrobacterium tumefaciens and RNAi technologies, as well as the newer CRISPR-related methods. Until scientists know more about genomic processes governing global gene expression and how those processes might be disrupted by the processes of biotechnology, all biotechnology products should undergo some level of APHIS regulation.
2. Yes, APHIS should add noxious weed provisions to its biotechnology regulations. The intended characteristic of herbicide tolerance that has been genetically engineered (GE) into many biotechnology products grown on vast acreages of U.S. farmland over the last two decades, has, predictably, substantially contributed to the significant noxious weed problem facing many American farmers (and many other farmers around the world). APHIS should therefore require any biotechnology product designed to be tolerant to any herbicide to undergo additional regulatory oversight by APHIS. This oversight should include monitoring herbicide-resistant crop systems for their potential to foster herbicide-resistant weed populations and imposing appropriate control measures if monitoring reveals a problem, as well as regulating direct and indirect harms from these systems to the livelihoods of GE, non-GE and organic farmers, to biodiversity generally and to public health. APHIS should consider protection goals that align with making American agriculture more sustainable, more environmentally friendly and less in need of future “solutions” to GE-produced noxious weed problems that involve additional GE crops engineered to be tolerant of more noxious herbicides.

3. My understanding is that the 2008 Farm Bill gives USDA additional authority to regulate biotechnology, especially with regard to issues of contamination and gene flow to food crops from field trials of GE crops that have not yet been “de-regulated” for commercial release, or from GE crops producing industrial chemicals or drugs. Given the history of contamination and gene flow events from field trials, APHIS should utilize its authority to the fullest extent to regulate GE crop production systems and prevent cases of contamination, such as the pig vaccine-producing GE corn that contaminated a soybean field, and cases of inadequate regulation based on the “intended” use of a GE crop, as was the case for the avidin-producing GE corn product.

4. The history of GE crop contamination events that have occurred in the U.S. in spite of APHIS oversight meant to prevent them is testimony for the need of more federal regulation of GE organisms, not less. The biotechnology industry has not proven that it is capable of regulating itself and yet there are now examples of GE crops ready for commercialization that would not come under APHIS’s “plant pest-based” criteria for regulation of GE organisms. There is certainly no evidence supporting the notion that non-regulatory solutions, i.e. those without the force of law, would be in the best interest of American agriculture, farmers or the public and non-regulatory “solutions” should therefore not be considered as a complement to APHIS’s regulatory program. Increasing regulatory oversight of GE organisms at this time would have the added advantage of instilling more confidence in the U.S. public with regard to products of biotechnology.