A very bad regulation is coming.
Here's the short of it. In 2016 Congress passed the National Bioengineered Food Disclosure Law. That law directed the U.S. Department of Agriculture to promulgate regulations for the mandatory labeling of "bioengineered" (or "genetically engineered") foods for human consumption.
Consequently, the USDA issued the National Bioengineered Food Disclosure Standards (NBFDS) in December 2018. Although those regulations became effective in February 2019, the USDA allowed food manufacturers (the regulated entities) until Jan. 1, 2022, to come into full compliance. As we noted in the Wall Street Journal back in 2019, the clock has been and is ticking.
Unfortunately, these regulations are in the worst traditions of government meddling. In its statutory language, Congress explicitly stated that the mandatory disclosure has nothing to do with food safety or consumer health, thus acknowledging what the scientific community and even the Food and Drug Administration has said consistently for thirty years: Bioengineered, or genetically engineered, foods do not pose any unique health, or environmental risks.
Moreover, precisely because those products do not raise such concerns, Congress did not assign the task of writing regulations to regulators at the FDA or USDA, but rather to the USDA's Agricultural Marketing Service (USDA-AMS), underlining the fact that the exercise is marketing, pure and simple. In its narrative accompanying the regulations, AMS forthrightly admitted, "The NBFDS is not expected to have any benefits for human health or the environment." Nor does the regulation assert other benefits of any kind to consumers.
What elevates the rule from an irritant to an outrage are USDA's own admissions about its costs, which will "range from $569 million to $3.9 billion for the first year." Thereafter, there will be additional costs annually ("in perpetuity," as the rule says) of "$68 million to $234 million at a three percent discount rate and $91 million to $391 million at a seven percent discount rate." And those estimates don't take into consideration the many thousands of hours federal employees will spend fine-tuning, implementing, and enforcing the rule.
How well will consumers be enlightened under this mandatory law? Let us consider corn oil on the shelves of the supermarket.
Under the NBFDS, two identical bottles of corn oil on a supermarket shelf could be labeled differently, one as bioengineered, one not, even though both were derived from the same field and are identical in processing and quality. Both labels would comply with the regulation because the new rule doesn't require a label "if the food does not contain detectable genetically modified material." The NBFDS allows manufacturers to make voluntary disclosures on such products, but not that they "may contain" bioengineered ingredients.
The qualifier "detectable" poses its own problems. Technologies will evolve and become ever more sensitive so that a single molecule of "genetically modified material" would make a food bioengineered. This is an invitation to spurious litigation over what is "detectable."
In a related context, Impossible Foods, which makes its plant-based burgers with leghemoglobin from genetically engineered soybeans, is putting the bioengineered symbol on its products in accordance with the regulations. The Ninth Circuit Court of Appeals recently affirmed that the FDA properly determined that the soy leghemoglobin is safe, which had been challenged by a radical activist group. In response to the decision, Impossible Burgers released a statement that said, "We applaud the court's decision ... to slap down the meritless petition of the Center for Food Safety, an anti-science, anti-GMO activist group that's been spreading lies for years." This is likely a taste of gratuitous litigation to come.
Returning to our question: How is consumer information under this mandatory disclosure working? It's working poorly, at a very great cost in employee time, record-keeping, and money for food manufacturers, with no benefit for consumer safety, health, or the environment.
As in our corn oil example above, in the interest of consumer information or transparency, the USDA-AMS regulation allows food manufacturers voluntarily to disclose that refined products are "derived from bioengineering." We believe that voluntary disclosures should be the way forward. Congress should revisit the 2016 law and repeal its mandatory disclosure provisions while preempting state laws meant to spread fear and misinformation about bioengineered or genetically engineered foods.
Let food manufacturers voluntarily disclose the use of one process or another and food ingredients, so long as the disclosure is not false or misleading. Let consumers who are interested in this information seek out the products with voluntary disclosures. Leave everyone else: consumers, farmers, and food manufacturers alone!
Dr. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA's Office of Biotechnology. Mr. Kershen is a professor emeritus of agricultural law at the University of Oklahoma College of Law.