Defining Ideas

When Salmon Tread Water

Wednesday, January 20, 2016
Image credit: 
Barbara Kelley

The U.S. Constitution was designed to create a fundamental tension between the legislative and executive branches of the government, a tension whose subtleties President Obama seems neither to understand nor respect. He regularly decides which laws to enforce, according to his whims and ideology. As he nears the finish line, the president’s overreach is sure to continue. Who can forget his arrogant boast, “I’ve got a pen, and I’ve got a phone." In other words, when the president thinks he knows what’s best for the nation, the separation of powers and the rule of law be damned. 

Politics has even intruded on science-based regulation. Abuses of discretion create incentives to bad behavior among individuals and inhibit innovation. Consider, for example, the government’s hands-off attitude towards the illegal “misbranding” of foods by vigilantes—namely, consumers slapping misleading labels on foods on supermarket shelves.

This requires some background. On the basis of both the science and regulatory precedents, the FDA decided in 1992 that food labels need not include information about the use of the newer genetic engineering techniques (sometime called “genetic modification,” or “GM”). That was consistent with federal regulation, which requires that food labels be truthful and not misleading and prohibits label statements that are likely to be misunderstood by consumers even if they are strictly accurate. Following long-standing precedents, the FDA requires special labeling only when a new food raises questions of safety, nutrition, or proper usage.

Instead of educating or serving a legitimate consumers’ “need to know,” regulators believe that mandatory labels on genetically engineered foods would imply a warning, or at least would likely be misconstrued by consumers as a suggestion that the product differs in some significant way (such as safety or nutrition) although it does not.

But this policy left activists dissatisfied. In 2012 they launched the “Just Label It” national campaign to agitate for government-mandated labeling of genetically engineered food. In addition, there have been various state-based proposals, the most prominent and notorious of which was California’s ballot initiative Proposition 37, which was defeated in the 2012 general election.

Pro-labeling activists argue that consumers have a “right to know” the “genetic status” of their food; just tell people if their corn flakes have been genetically engineered and let them decide what to buy, they say. Their protestations notwithstanding, the activists are not in favor of consumers having choices. They make no bones about mandatory labeling being merely the first step toward the complete elimination of such foods—and their benefits—from the marketplace. Their efforts to engender mandatory labeling are destined to fail, however, because federal law trumps state law that conflicts with FDA’s requirements—and as noted above, the FDA considers “produced with genetic engineering” labels to be misleading. (Moreover, a recent decision of the U.S. Supreme Court subjects “content-based” labeling requirements to such a high level of scrutiny that mandatory “genetically engineered” labels are likely to be judged unconstitutional.)

Activists are neither waiting for government-mandated labeling nor concerned with the judgments of the courts. Vigilantes are going through the aisles of supermarkets and applying their own warning labels, examples of which may be found at www.labelityourself.org. And following the high profile, public rejection of California’s Proposition 37, activists’ threatened to increase their “guerilla-labeling” efforts, although they are clearly illegal. Federal law prohibits the “alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.” In plain English, homemade, ad hoc warning labels make the products “misbranded,” and they can no longer be sold legally.

This sort of attack on the rule of law in ways that wreak economic damage is not unlike the radical tactics of groups such as the Earth Liberation Front. Federal and state law enforcement authorities should vigorously prosecute the vigilantes, including Cynthia LaPier—who was shown on the May 24 front page of the New York Times placing “Warning, May Contain GMO’s (Genetically Modified Organisms)” labels on food products at the Big Y grocery in Great Barrington, Massachusetts. But the Obama administration—which has shown a pattern of opposition to genetic engineered foods—has been uninterested in this clear violation of federal law.

A more egregious example of the feds’ malfeasance is the treatment of a fast-growing, genetically engineered Atlantic “AquAdvantage” salmon, which reaches maturity twice as rapidly as its wild cohorts. The genetic change—the addition to the genome of a growth hormone gene from the Chinook salmon and a regulatory DNA sequence from the ocean pout—confers no detectable difference in the fish’s appearance, ultimate size, taste, or nutritional value; it just grows faster, a tremendous economic advantage to those farming the fish in a closed water system. The availability of such a salmon would also be a tremendous boon to consumers seeking low-fat and affordable options for sources of protein, especially in the face of food price inflation and the obesity epidemic.

After several years of deliberation, regulators concluded that the AquAdvantage salmon has no detectable differences and that it “is as safe as food from conventional Atlantic salmon.” And because the fish will all be farmed inland and are all sterile females, there is negligible possibility of any sort of “genetic contamination” of the gene pool or other environmental effects. Even in a worst-case escape scenario, these fish are maladapted to compete in the wild.

When the FDA completed its Environmental Assessment in April 2012 and was ready to publish it—the last necessary hurdle before approving the salmon for marketing—the decision-making was mysteriously expropriated by the White House. The review process vanished from sight until December 2012, when the FDA was finally permitted to publish the EA, which should then have gone out for a brief period of public comment prior to approval. The comment period, which was extended, ended on April 26, 2013. Two-and-a-half years later, in November 2015, the salmon was finally approved.

Some of the reasons for the FDA’s delay were revealed by science writer Jon Entine. He related that the White House interference “came after discussions late last spring [2012] between Health and Human Services Secretary Kathleen Sebelius’ office and officials linked to Valerie Jarrett at the Executive Office, who were debating the political implications of approving the salmon. Genetically modified plants and animals are controversial among the president’s political base, which was thought critical to his reelection efforts during a low point in the president’s popularity.”

There’s another sordid influence at work here. According to three independent, reliable sources interviewed by Entine, the continued delay in the approval of the AquAdvantage salmon was due to opposition to it from then-assistant White House chef Sam Kass. A chef with a bachelor’s degree in history influencing critical governmental regulatory decisions that are typically made by Ph.D. scientists and professional regulators?

Citing the illegality of the White House actions in this instance, Entine wrote in December 2013, “The Federal Food, Drug & Cosmetic Act requires that Health and Human Services secretary approve the AquaBounty application within six months after compliance with Section 512.” The company was notified by the FDA two years ago that every major component of its application had been successfully addressed, but as usual, the president’s political appointees rolled over when instructed to by the White House.

In March 2014 testimony before the Senate Health, Education, Labor and Pensions Committee, then-FDA Commissioner Margaret Hamburg was asked about the pending application for approval of the genetically engineered Atlantic salmon. ”We will be moving forward in a deliberate, science-driven way, reflecting all of the important inputs. . . as we consider this product application,” Hamburg said. But only one “input” counted—the undue influence of the White House over the FDA’s review.

The government’s disreputable treatment has had significant impacts. The dilatory, politicized review will likely kill off an entire once-promising sector of biotechnology: Few will now invest in the development of genetically engineered animals for food. This is the sort of perverse policymaking that has prevented American science and technology from developing the Next Big Thing and will continue to stifle innovation so long as it goes unchallenged.