Politics & Policy

How Does the Government Decide What Is — and What Is Not — ‘Toxic’?

(David McNew/Getty)
The EPA should rely on data before it bows to the demands of anti-technology activists.

An increasingly frequent and worrisome phenomenon that unnecessarily threatens human health and the natural environment is “regrettable substitutions,” which refers to bans or limitations on certain products, even though the alternatives might pose risks that are uncertain or greater. It calls to mind the old saying “out of the frying pan and into the fire.”

Today, members of the Senate Environment and Public Works Committee are marking up legislation to reform the nation’s law on chemicals — the Toxic Substances Control Act. As they work, they should heed the lessons related to regrettable substitutions.

A recent academic study demonstrates how product manufacturers themselves may perpetuate spurious product concerns and drive consumers to take greater health risks. Entitled “The Psychology of ‘Regrettable Substitutions’: Examining Consumer Judgments of Bisphenol A and Its Alternatives,” the study examines how product labeling affects people’s evaluation of the risks of BPA (a chemical that is a component of many plastics and that is used in the resins that line food cans to prevent bacterial contamination) compared with alternatives to BPA. Consumers “may be guided less by what people know and more by the order in which they learn it,” the study reported. “Notably, it appears that people evaluate a situation in which scientific evidence is tempered by controversy similarly to a situation in which there is no scientific evidence at all.”

The safety of BPA continues to be debated, although arguably controversy should have been put to rest long ago. Years of ongoing research and repeated assessments conducted by the FDA have concluded that BPA is, in fact, safe in normal use. A just-released report from Europe’s food regulator, the European Food Safety Authority, reached the same conclusion:

EFSA’s comprehensive reevaluation of bisphenol A (BPA) exposure and toxicity concludes that BPA poses no health risk to consumers of any age group (including unborn children, infants, and adolescents) at current exposure levels. Exposure from the diet or from a combination of sources (diet, dust, cosmetics, and thermal paper) is considerably under the safe level.

The title of the article refers to the fact that BPA is often replaced with other, less-studied chemicals whose health implications are more uncertain. Thus, there is the prospect that replacement products might be inferior. In the case of BPA, if the replacement resins that line metal cans fail to perform as well, we could see more people getting sick from deadly bacteria, such as the bacteria that cause botulism.

This would be a regrettable substitution, because the substitute material might prove worse than the material that it replaces. The conclusion of the study is striking: “Our findings indicate that such [“BPA-free”] labels are misleading and cause some people to accept a substitute chemical that they might otherwise reject.”

General Mills and Post Foods give us another example of “regrettable substitutions.” These food-production behemoths capitulated to demands from activists to reformulate their iconic Cheerios and Grape Nuts cereals, respectively, so they can label them as free of “genetically engineered” ingredients. Their regrettable substitution is the elimination of certain added vitamins from their products, because they cannot obtain them from sources certified to be non-genetically engineered.

We have food producers trying to meet a perceived consumer demand but supplying products that are more expensive and inferior.

Thus, we have food producers trying to meet a perceived consumer demand but supplying products that are more expensive and inferior — inferior in having reduced nutrients.

Similarly, two of the United States’ largest producers of baby food, Heinz and Gerber, bowed to intimidation by anti-technology activists and shifted to non-genetically engineered ingredients for their products — even if those ingredients are nutritionally inferior or less safe than those made from genetically engineered plants.

How could they be less safe? Consider the example of “Bt-corn,” crafted by splicing into commercial corn varieties a bacterial gene that codes for a protein toxic to corn-borer pests but not to mammals. As it fends off the insect pests, the genetically engineered corn also reduces the levels of Fusarium, a toxic fungus often carried into the plants by the insects. That, in turn, reduces the levels of fumonisin, a potent and dangerous fungal toxin that can lead to fatal diseases in horses and swine that ingest infected corn and that can cause miscarriages and esophageal cancer in humans.

Using genetically engineered corn for food processing therefore lowers the probability that harmful levels of fumonisin will be in the final product. But simply because anti-biotechnology extremists have demanded it, Heinz, Gerber, and other companies — including, just this week, Chipotle — have chosen to forgo such genetically improved sources of foods that could yield healthier and safer products. Even worse, Gerber has announced it will use mostly organic corn, which is especially prone to insect and bacterial infestations. But raising corn without insecticides and other chemicals is labor-intensive and produces lower per-acre yields, so production costs will increase. Organic corn will probably have far greater amounts of fumonisin and bacterial contamination.

When manufacturers capitulate to demands that are based on irrational fears, consumers can be lured into dubious choices — they evaluate products after reading labels that are strictly accurate but fail to tell the whole story.

Sometimes the dubious choices are made by “institutional consumers,” rather than individuals. Consider DEHP, a chemical in a category called phthalates. In 2008, Congress banned DEHP in toys in amounts greater than 0.1 percent. Hype from activists about DEHP risks has also led the medical community to seek alternatives in such vital products as blood bags, although the chemical is very valuable in medical applications and the risks from such exposures are negligible. As researchers in one medical journal observed, “For RBCs [red blood cells], however, there are few convincing alternatives offering RBC the same protecting qualities of DEHP and allowing their long-term storage with equal qualities.” The sad reality is that our blood supply could be placed in jeopardy because of misinformation and hype about the risks of these valuable chemicals. Regulators should not contribute to such alarmism by acting on weak science and unsubstantiated claims about risk.

At times the regrettable substitutions result more directly from hasty, wrong-headed decisions by government. The EU for instance buckled under political pressure and placed a two-year ban starting in December 2013 on a class of pesticides called neonicotinoids. Forced to resort to older, more toxic, less effective pesticides — primarily pyrethroids, which had been largely phased out — farmers in Europe are seeing a resurgence of insect predation. As a result, insect infestations could lead to a 15 percent drop in this year’s European harvest of canola, the continent’s primary source of vegetable oil used in food ingredients and as biodiesel.

Congress might produce more such outcomes if they pass misguided reforms to the Toxic Substances Control Act, which is one of the few laws on the books that requires regulators to consider the impact of substitutions. Under TSCA’s “unreasonable risk” standard, the U.S. Environmental Protection Agency may regulate when a chemical poses “an unreasonable risk” to human health or the environment. That includes the requirement that the EPA apply the “least burdensome requirements” to meet its objectives. To determine the “least burdensome” approach, the EPA must consider the effects and exposure of the substance on humans and the environment, benefits of the product being regulated, availability of adequate substitutes, and economic consequences.

This reasonable standard has prevented the EPA from making some regrettable decisions. In one case, a federal court stopped a 1989 TSCA regulation that banned the use of asbestos in automobile brakes and other products. The Fifth Circuit Court of Appeals opinion in Corrosion Proof Fittings v. EPA explained:

What we cannot ignore is that the EPA failed to study the effect of non-asbestos brakes on automotive safety, despite credible evidence that non-asbestos brakes could increase significantly the number of highway fatalities, and that the EPA failed to evaluate the toxicity of likely brake substitutes. . . . The EPA, in its zeal to ban asbestos, cannot overlook, with only cursory study, credible contentions that substitute products actually might increase fatalities.

Not only did the EPA ban possibly increase road fatalities; it was also unlikely to yield benefits. During the 1980s, exposure and use of asbestos were already well regulated by Occupational Safety and Health Administration, and other EPA rules were in place to ensure safe management of these substances. In addition, as an American Council on Science and Health study details, the type of asbestos used in the brakes (chrysotile fibers) poses negligible risks when managed properly. Occupational illnesses caused by asbestos result from amphibole fibers, which are not used in brakes.

Lawmakers should understand that it’s a good idea to make sure that the EPA avoids passing rules that might kill people. But rather than praise TSCA’s unreasonable-risk standard, many lawmakers lamented it during recent congressional hearings. Instead, they seem to advocate TSCA “reforms” that would eliminate the requirement for EPA to apply the “least burdensome” regulations, opening a door to more shortsighted and potentially dangerous regulations.

Lawmakers should understand that it’s a good idea to make sure that the EPA avoids passing rules that might kill people.

Among the potential targets discussed at the TSCA hearings are life-saving flame-retardant chemicals, such as those used on furniture. While the risks associated with these products are largely theoretical, fire risks are real and substantial. In 2013, there were more than 1.2 million fires in the United States, causing 3,240 deaths, nearly 16,000 injuries, and $11.5 billion in damage, according to the National Fire Protection Association. And there is plenty of evidence that flame retardants can prevent and slow fires, giving people more time to escape. The regrettable result here could well be more fire-related deaths and injuries as manufactures are forced to abandon the most effective flame retardants.

There are important lessons in these examples. Decisions by governments should be driven by data, and manufacturers and retailers should resist the demands of activists and rely instead on scientific evidence, lest they stumble into a morass of eventual customer dissatisfaction, damage to their brand, and potential product liability. (In product-liability law, according to the Legal Information Institute, “a design defect exists when a defect is inherent in the design of the product itself . . . [and] a plaintiff can only establish a design defect exists when he proves there is hypothetical alternative design that would be safer that the original design, as economically feasible as the original design, and as practical as the original design.”)

While scholars recognize the potential risks associated with product substitution, activists’ efforts to undermine certain technologies continue to gain a foothold in both the marketplace and government. But unless we maintain a healthy skepticism about the claims of these self-interested, self-styled “consumer advocates,” we’ll continue to suffer from regrettable outcomes.

— Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the FDA’s Office of Biotechnology. Angela Logomasini, Ph.D., is the Senior Fellow in Environmental Risk, Regulation, and Consumer Freedom at the Competitive Enterprise Institute.


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