Public’s opportunity to demand more testing and stricter regulation ends on May 7
BELLINGHAM, Wash—May 4, 2021. Genetically engineered animals are being developed at an accelerating pace, and could, with few regulations and limited testing, be arriving on dining room tables in the US in 2021. That’s due in part by efforts made by the previous administration to deregulate biotechnologies. On the final day of Sonny Perdue’s tenure as head of the US Department of Agriculture, a proposal was made to move oversight and regulation of GE animals from the FDA to the USDA -- a move that would significantly reduce the safeguards that protect the US public dating back to the Obama administration.
The next day, however, President Biden was inaugurated. And soon afterward, the period of public comment on Perdue’s proposal was extended by the new Secretary of the USDA, Tom Vilsack (who was previously Secretary under President Obama). This extension offers a rare opportunity for the public to influence the new administration to withdraw the dangerous proposal. The window of opportunity closes this Friday, May 7.
The Non-GMO Project joins numerous other non-profit organizations and consumer advocacy groups urging US families to make their opinions known. In a recent article titled “ What businesses and consumers need to know about genetically modified animals entering the marketplace”(New Hope Network, 27 April 2021), the Project says, “It’s quite a big deal to move oversight from the FDA to USDA. Between the two federal agencies, the FDA is more rigorous and stringent in how it regulates drugs, [and] any products intended for human ingestion. It requires more testing around safety issues. So moving this on to the USDA is a clear form of deregulation.” Furthermore, the Project says, “We all have a fundamental right to at least know what is in our food. And if we want to avoid GMOs, we want to know if they are in there or not. Otherwise it’s not up to us. It’s up to the companies and we have no idea what we’re buying and putting on the table in front of kids.”
The risks are real, despite the biotechnology industry’s lobbying effort to deregulate, and its claims that these technologies are safe. IIn 2019, the FDA discovered that a gene-edited cow developed by a Minnesota company had off-target effects, including remnant bacteria as well as antibiotic-resistance genes. This discovery revealed that despite the gene editing precision claims promoted by biotech developers, off-target effects are not only possible but they could be
disastrous. It also speaks to the need for a stringent FDA review process for genetically engineered animals so that the meat and/or milk of these animals doesn't eventually slip into the food supply chain. Other GMOs have slipped into the food system and done grave harm. In 1986, an over-the-counter GMO sleep-aid, untested and unlabelled, led to 80 deaths and thousands sickened.
Watch: Megan Westgate, Founder and Executive Director of the Non-GMO Project, urges the public to comment on Federal deregulation of GE animals.
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.
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 choices1. Of shoppers aware of GMOs:
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)5 is “an organism to which Biotechnology has been applied and derivatives of such an organism; cloned animals are included within this definition.” Biotechnology6 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 Biosafety7, the Codex Alimentarius8, 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
The National Bioengineered Food Disclosure Standard (NBFDS) is the culmination of two decades of Americans overwhelmingly demanding mandatory labeling of GMO foods. The draft version published by the USDA on May 3 leaves many questions unanswered and indicates plenty of cause for alarm. The USDA is currently accepting comments through July 3. In order to support you in making your voice heard, the Non-GMO Project has created a short webinar explaining key points for comments, and has drafted a customizable template for comment submission to the USDA.
Watch the 35-minute webinar with Non-GMO Project Executive Director Megan Westgate which provides background on the proposed USDA standard, implications of the draft rule, and context for the proposed comments:
Here’s what’s at risk if we don’t comment; the final rule might:
The draft NBFDS includes the above symbols. Tell the USDA it is NOT acceptable to confuse the American public by using a newly invented acronym and smiling, winking symbols!
Step 1. Download a template letter suggesting comments to the USDA
Option A. Paste the template letter onto your letterhead. Add a short statement about your company and a signature. If you want to change or add to the comments, though, please do so!
Option B (preferred). Letters that integrate the direct impacts of the proposed rule on your business are much more effective. After pasting the template content on your letterhead, please add personal statements to each comment providing context for how this element of the proposed USDA standard impacts your business or customers.
Resources for commenting:
Your comments must be submitted by 11:59 EST on July 3, 2018 via the Federal eRulemaking Portal. There is a character limit on comments written or pasted directly into the comment text field; rather than pasting your comments, we suggest directing the USDA to your attached letter, with a simple statement such as “Please see attached letter.” You are also encouraged to submit supplemental evidence supporting your comments.
We appreciate your attention to this critical matter. While the Non-GMO Project will continue to lead efforts to ensure that this law is as meaningful as possible, it’s clear based on what was released that Non-GMO Project Verified will remain the most trustworthy and accessible way for consumers to avoid GMOs.
Please do not hesitate to contact the Non-GMO Project if you have any questions. Thank you!
