Whose Wish List Counts?

One of the chief defenders of the plastics/chemicals industry is the Washington DC law firm of Keller and Heckman. Founding partner Jerome Heckman has represented plastics  for decades going back to  the industry’s first public relations crisis in 1959 when dozens of infants and toddlers accidentally suffocated on the filmy plastic dry cleaner bags that were just being introduced to the market. Communities across the country threatened to ban the bags; Heckman, representing the Society for the Plastics Industry, helped repulse the wave of proposed bans.

One of the firm’s areas of expertise is negotiating the Food and Drug Administration’s labyrinth of regulations on “indirect food additives”  –the substances that can leach into food from packaging or equipment used in processing food. A 2002 memo — taken from the  firm’s website and excerpted below – discusses how the firm helped industry win approval for chemicals used to coat food and beverage cans, including the controversial chemical bisphenol A. According to the memo, in the late 1950s, industry submitted a “wish list” of chemicals for approval. FDA regulators deleted the ones they had concerns about and approved the remainder based on what the memo refers as the FDA’s “unwritten assumptions” about exposure.

What were the assumptions at the time? One was the age-old notion that the dose makes the poison. FDA regulators assumed that the risks of a chemical depended on the amount someone was exposed to. Provided only minute amounts migrated into food, the substance was presumed to be safe. But research in the past twenty years has found that some chemicals don’t act like classic toxins, but more like hormones, and that even very small doses of exposure can trigger health effects. BPA is, in fact, a synthetic estrogen and animal and research suggests it can disrupt the effect of that hormone in the body. Animal and some human studies have associated BPA exposure with health problems, including cancer, heart disease, diabetes, early puberty, even learning disabilities. The research is not conclusive, still many experts and health advocates think it has thrown up enough warning signs that the chemical ought to be banned from food-contact uses.

To date, the FDA has rejected those calls. Most recently, in late March, it denied a petition by the Natural Resources Defense Council, saying that there wasn’t enough evidence to warrant a ban. “While evidence from some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans,” the FDA wrote.

It’s true: the evidence is uncertain, particularly in relation to humans. Still, reading the memo, it’s striking to see how casually the FDA approved BPA some 50 years ago.  As one expert on the issue told me, “It seems odd that FDA held NRDC to such a high standard for its petition to reverse an original safety decision that demanded far less.” It sure seems the bar is a whole lot higher for health advocates’ wish list that it was for industry’s.

Here’s an excerpt from the memo:

Shortly after the Food Additives Amendment of 1958 was added to the Federal Food, Drug, and Cosmetic Act (“the Act”), FDA surveyed industry to compile a list of substances that were being used to manufacture can coatings.

FDA was comfortable seeking industry input because the agency generally believed that these coatings were applied as a very thin layer over a metal substrate, such that there was only a small reservoir, if any, of the substance available to migrate to food. Additionally, at the time, can coatings were invariably baked on the metal substrate to form an enamel from which essentially nothing was expected to migrate to food.

These “unwritten” assumptions provided FDA with the necessary measures of safety it needed to allow industry to submit a list of substances that it desired to use in coatings. Furthermore, at the time the can coatings regulation was promulgated, FDA imposed a 50 parts per million (ppm) limit on the overall migration of non-volatiles from the coating to food (i.e., the “global” migration limit that is still in place today).

In response to FDA’s survey, members of the Can Manufacturers Institute provided the agency with an omnibus petition containing a list of common materials used in can coatings. Rather than subject these substances to the usual substance-by-substance food additive petition review process, industry’s “wish list” was simply reviewed by FDA’s toxicologists, who deleted from the list any substance that posed a potential safety concern.

The revised list was then reviewed and agreed to by industry, and subsequently published as a regulation.

You can find the whole memo at: http://www.khlaw.com/showpublication.aspx?Show=2293


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