The USDA has extended the public comment period for its proposed regulation of certain genetically engineered animals. Under its framework, the USDA would oversee these GMO animals and products from them, such as  meat, eggs, milk or other derivatives, as they move throughout the supply chain. In our submission, outlined below, the Non-GMO Project explains why any regulation of genetically engineered animals must meet the public’s demands for GMO transparency and deliver the rigorous oversight required to monitor such a complex industry.

As the leading third-party certification for GMO avoidance, the Non-GMO Project has unique and unparalleled expertise regarding the public’s opinions of GMOs and GMO transparency. Additionally, we know firsthand from a technical standpoint what’s required to provide that transparency, including traceability and segregation at all points in the supply chain. This deep knowledge gives us grave concerns about any change to the regulation of GE animals that could reduce rigor. Below we strive to offer clear and informed reasons for our position. Read our full comments here.

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1. Regulation must be designed and conducted with the utmost rigor
The genetic manipulation of animals is a scientific endeavor that’s extremely complex. Its esoteric techniques introduce vast amounts of variables and implications for people, animals and the environment--many of which are still unknown due to lack of long-term testing and independent research. 

The regulatory framework for genetically engineered animals must be sufficiently and thoroughly rigorous. It is imperative that the safety of the animal and the safety of those who consume that animal are ensured through ironclad policy and scrupulous oversight.

No company modifying or engineering the genetic material of animals should be allowed to self-determine whether their products qualify for exemptions from regulation. Moreover, all company efficacy claims should pass regulatory approval, and environmental impacts must be adequately reviewed. Relaxed regulatory oversight only introduces unnecessary and unknown new risks.

2. The regulatory framework must adhere to public demand for GMO transparency
The public expects that if genetic engineering has been used in the development of an animal (or in their feed), then the resulting product is a GMO. It is the technique, not the outcome, that makes an organism genetically engineered or modified in the public’s mind. Under this assessment, these genetically engineered animals and products from them, including meat, eggs, milk or other derivatives, introduce GMOs at entry points in the supply chain.

In 2007, the Non-GMO Project Standard was developed to answer the public’s call for GMO transparency -- not just in finished products but through the entire supply chain. Our voluntary consensus Standard has been developed over time by input from the public, including supply chain members, consumers, and scientists. From its inception, these stakeholders have prohibited the use of genetically modified animals in Non-GMO Project Verified products. The diversity present in the supply chain today gives consumers the opportunity to choose what they purchase based on their preferences and values. The 60,000 products verified to the Non-GMO Project Standard showcase the significant consumer demand for GMO transparency and non-GMO options. 

Research conducted in 2020 concludes that 1 in 3 shoppers is more likely to buy non-GMO choices[note] Linkage Research January 2020[/note]. Of shoppers aware of GMOs:

• 65% believe GMO labeling should be mandatory[note] Organic & Beyond © 2020 The Hartman Group, Inc.[/note].
• 40% say they actively try to find out which products contain GMOs[note] Organic & Beyond © 2020 The Hartman Group, Inc. [/note].
• Nearly 40% consider GMOs unsafe to eat[note] Pew Research Center, Sept. 2020, "Science and Scientists Held in High Esteem Across Global Publics" [/note].

Because the public recognizes the lack of long-term testing on genetically engineered animals and the potential for off-target effects, consumers continue to demand transparency and deserve the right to choose what they’re eating. These genetically engineered animals and products from them, such as meat, eggs, milk or other derivatives, must be identified and labeled at all steps in the supply chain, from input to finished product.

3. The regulation must align its definition of “genetically engineered animal” with international standards and adopt the terms “Biotechnology” and “Genetically Modified Organism”
Under the Non-GMO Project Standard, a Genetically Modified Organism (GMO)[note] https://www.nongmoproject.org/wp-content/uploads/Non-GMO-Project-Standard-Version-16.pdf [/note] is “an organism to which Biotechnology has been applied and derivatives of such an organism; cloned animals are included within this definition.”  Biotechnology[note]Adapted from Secretariat of the Convention on Biological Diversity (2000). Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes. Montreal: Secretariat of the Convention on Biological Diversity.[/note] is defined as “the application of:

 a. in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and the direct injection of nucleic acid into cells or organelles; or
b. fusion of cells beyond the taxonomic family, that overcame natural physiological, reproductive, or recombination barriers and that are not techniques used in traditional breeding and selection.” 

This paradigm defines a GMO based on the process used to modify the organism and considers any derivative of the organism, regardless of degree of processing, to be genetically modified. In this way, a non-GMO food ingredient is derived from a non-GMO crop source, non-GMO animal source, and so forth.

A GMO or genetically engineered organism should be defined based on the process used to create it, not the traits present in the final product. All forms of biotechnology including gene-editing techniques resulting in what is commonly referred to as changes that could allegedly be found in nature or developed through conventional breeding methods produce a GMO. 

Defining a genetically engineered animal based on the process used to create it, not by the modification present in the animal, is consistent with the Cartagena Protocol on Biosafety[note]Secretariat of the Convention on Biological Diversity. (2000). Handbook of the Convention on Biological Diversity: Including its Cartagena Protocol on Biosafety. Montreal: Secretariat of the Convention on Biological Diversity.[/note], the Codex Alimentarius[note]Joint FAO/WHO Codex Alimentarius Commission. (1992). Codex alimentarius. Rome: Food and Agriculture Organization of the United Nations.[/note], and the European Union’s GMO Legislation. Failure to harmonize definitions, allowable thresholds for accidental or technically unavoidable GM contamination, and failure to segregate GM animals and their derivatives, could negatively impact international trade and domestic producers by resulting in costly rejected shipments. Alignment with these international agreements, standards, and regulations will facilitate international trade and support domestic exports.

4. Responses to Specific Questions Posed by USDA

• Question: Are there types of modifications that should make an animal of an amenable species modified or developed using genetic engineering eligible or ineligible for the expedited safety review process outlined above?
  • All amenable species modified or developed using genetic engineering should be held to the same level of rigorous evaluation for safety of the animal, the safety of anyone who may eat the animal, claim efficacy, and ongoing environmental impact; no expedited reviews should be granted based on the type of modification.
• Question: Should USDA exempt certain types of genetic modifications of amenable species intended for agricultural use from regulation? If so, what types of modifications and why?
  • USDA should base the regulations on the process used to genetically engineer or modify the animal in accordance with international standards and regulations. For this reason, all amenable species should be subject to the same level of rigorous ongoing safety evaluation and environmental impact evaluation and no genetically engineered or modified animals, regardless of the type of genetic modification, should be exempt from regulation.
• Question: What documentation, if any, should accompany amenable species modified or developed using genetic engineering destined for slaughter, certifying that their modifications have been assessed by USDA (APHIS and FSIS)?
  • Documentation supporting segregation and traceability of genetically engineered or modified amenable species should accompany the animals at every step in the supply chain from birth to slaughter. Documentation supporting segregation, traceability, and labeling should accompany all derivatives of genetically engineered or modified animals, regardless of degree of processing, to facilitate transparency in the marketplace, and to respect and support domestic and international specialty markets that may prohibit or require the labeling of the derivatives of genetically engineered or modified animals.