October 1, 2010 (Vol. 30, No. 17)

Henry I. I. Miller, M.D. Physician and fellow Stanford University

Crop Damage Due to Freezing Could Be Mitigated If Not for Overzealous Regulators

In much of the world, consumers’ morning glass of orange juice is going to become more expensive. Think of the price increase as a tax that benefits no one, but emanates from government stupidity.

As a result of the January freeze that badly damaged Florida’s oranges (as well as other fruits and vegetables) in March, Florida-based Tropicana was forced to raise its prices on some containers of orange juice and shrink the package size of others to pass along higher costs. By July, the price of orange juice on the commodity markets had more than doubled from the price in early 2009.

Frost damage to crops is not unusual; losses to American farmers average in the billions of dollars annually. Peaches, plums, citrus, and other crops are regularly threatened by frost in the Southeast. California is also susceptible: A January 2007 freeze there cost farmers more than $1 billion in losses of citrus, avocados, and strawberries, and a 1990 freeze that caused about $800 million in damage to agriculture resulted in the layoff of 12,000 citrus industry workers, including pickers, packers, harvesters, and salespeople. In 2002, lettuce prices around the country went through the roof after an unseasonable frost struck the Arizona and California deserts.

Technology can mitigate much of the damage—or, more accurately—it could have, had not government regulation placed obstacles in the way of innovative solutions. Those obstacles illustrate what innovators are up against and how flawed, unscientific public policy prevents science and technology from spurring a robust recovery from the recession.

Currently, farmers attempt to prevent frost damage with pathetically low-tech methods. These include burning smudge pots to produce warm smoke; running wind machines to move the frigid air; and spraying water on the plants to form an insulating coat of ice. The only high-tech solution, a clever application of biotechnology, has been frozen out by federal regulators.

In the early 1980s, scientists in industry and at the University of California devised an ingenious new approach to limiting frost damage. They knew that a harmless bacterium, which normally lives on many plants, contains an “ice nucleation” protein that promotes frost damage. Therefore, they sought to produce a variant of the bacterium that lacked the ice-nucleation protein, reasoning that spraying this variant bacterium (dubbed “ice-minus”) on plants might prevent frost damage by displacing the common, ice-promoting kind. Using gene splicing, the researchers removed the gene for the ice nucleation protein and planned field tests with ice-minus bacteria.

Then the government stepped in, and that was the beginning of the end.

The Environmental Protection Agency (EPA) classified as a pesticide the obviously innocuous ice-minus bacterium that was to be tested in northern California on small, fenced-off plots of potatoes and strawberries. The regulators considered the naturally occurring, ubiquitous, “ice-plus” bacterium a “pest” because its ice-nucleation protein promotes ice-crystal formation that damages plants. Therefore, according to their reasoning, other bacteria intended to displace it would be a “pesticide.” This is the kind of absurd, sophistic reasoning that could lead EPA to regulate outdoor trash can lids as a pesticide because they deter or mitigate a “pest”—namely, raccoons.

At the time, scientists inside and outside the EPA were unanimous that the test posed negligible risk. (I wrote the analysis submitted by the Food and Drug Administration.) No new genetic material had been added, only a single gene whose function was well known had been removed, and the organism was obviously harmless. Nonetheless, the field trial was subjected to an extraordinary long and burdensome review—by both the National Institutes of Health and EPA—only because the organism was genetically engineered.


Henry I. Miller, M.D.

It is noteworthy that experiments using bacteria with identical traits but constructed with older, cruder techniques require no governmental review of any kind. When tested on less than 10 acres, nonengineered bacteria and chemical pesticides are completely exempt from regulation. Moreover, there is no government regulation of the use of vast quantities of the ice-plus organisms (which contain the ice-nucleation protein) commonly blown into the air during snow-making at ski resorts.

Although the ice-minus bacteria proved safe and effective at preventing frost damage in field trials, further research and commercialization were discouraged by the combination of onerous government regulation, the inflated expense of doing the experiments, and the prospect of huge downstream costs of pesticide registration. As a result, the product was never commercialized, and plants cultivated for food and fiber throughout much of the nation remain vulnerable to frost damage. We have the EPA to thank for farmers’ livelihoods in jeopardy, jobs lost, and inflated produce prices for consumers.

That last point illustrates the ripple effect—in this case the public health impact—of such government actions: Higher prices for fresh fruits and vegetables, the demand for which is elastic, reduces consumption, so consumers get less of the antioxidant, vitamin, and high-fiber benefits that these products afford.

EPA’s flawed approaches to biotechnology regulation, which date from the 1980s, are ancient history, but there is a modern-day angle. Lynn Goldman, the EPA’s chief pesticide regulator during the Clinton administration, defended and publicly misrepresented her agency’s policies toward biotechnology.

Responding to an article in Science, she wrote in a letter to the same journal that it was inaccurate to contend that the EPA “regulates or singles out for special treatment products because they are created using” genetic engineering; she remonstrated that “EPA’s activities reassure the public concerning biotechnology products.” 

Goldman was wrong on both counts. As noted above, the use of genetic engineering techniques for anything that falls within the regulatory definition of a “pesticide”—even when that definition is tortured to claim jurisdiction—triggers case-by-case review, which is not necessary for small-scale field trials for other pesticides, regardless of risk.

As to reassuring the public, a more defensible view of biotechnology regulation was expressed by the president of the consumer-advocacy group Consumer Alert: “For obvious reasons, the consumer views the technologies that are most regulated to be the least safe ones. Heavy involvement by government, no matter how well intended, inevitably sends the wrong signals. Rather than ensuring confidence, it raises suspicion and doubt.”

Well, Goldman, who never met a regulation she didn’t like, is back in government as an Obama political appointee, this time as a senior science advisor at the FDA. Yet another example of the Washington tradition that no bad deed goes unrewarded.

Another nexus of history and current events is that Jeremy Rifkin, antibiotechnology fanatic, was recently on the talk-radio circuit touting a new book. It was Rifkin’s lawsuit that first delayed the field trials of the ice-minus bacteria almost 30 years ago and offered a foretaste of the mindless, irresponsible activism to come.

The EPA’s discouragement of development of a product that can prevent or mitigate frost damage is yet another example of the actions of regulators creating a situation in which everyone loses. When will they rethink their policies and let science and common sense show the way?  Probably not before hell freezes over.

Henry I. Miller, M.D. ([email protected]), a physician and fellow at the Hoover Institution, headed the FDA’s Office of Biotechnology from 1989–1993.

Previous articlePositive Phase III Data Mean Cosmo and Santarus Plan 2011 NDA for Ulcerative Colitis Drug
Next articleAPR and Labtec License Registrational Oral Film Donepezil to Ferrer for Three EU Countries