STATS ARTICLES 2006

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FDA Letter Dismisses Activist Group’s Concerns Over DuPont Chemical Test
January 10, 2006
Trevor Butterworth
Environmental Working Group’s “smoking gun” DuPont memo “irrelevant” to chemical’s safety

The Environmental Working Group (EWG) made a huge splash last November with claims, apparently backed up by internal company documents, that the Delaware chemical giant DuPont had failed to notify the Food and Drug Administration of a test with important implications for food safety. The group claimed that

“A key document shows that in 1987, DuPont's Dr. Richard Goldbaum found that the company's marquee paper packaging coating chemical, Zonyl RP, could contaminate food at over three times the federal safety standard.”

As STATS noted at the time, there was no such federal standard – an inconvenient fact that eluded almost all of the news organizations who “reported” the story.

Nevertheless, the EWG contacted the FDA to warn about the possible suppression of important evidence by DuPont. On December 20, Laura M. Tarantino Ph.D., Director of the Office of Food Additive Safety at the FDA’s Center for Food Safety and Applied Nutrition replied that the 1987 test was “irrelevant” for the following reasons:

Zonyl RP was first regulated for packaging food at room temperature conditions and below in 1967, and DuPont showed, at that time, that the chemical migrated at 0.2 parts per million (ppm) under these conditions.

The way the FDA regulated coatings in 1967 in the following way: assume there is a uniform distribution of Zonyl RP in ALL foods (in other words, assume everything – apples, cereal, steak - was packaged in paper treated with Zonyl RP, and assume that the chemical migrated at its maximum level uniformly throughout all these foods). An extraction level of 0.2ppm would mean that an average person would potentially consume 0.6mg of Zonyl RP per day (that is, in the unlikely event that every molecule of Zonyl RP was absorbed). Under these circumstances, Zonyl RP was certified as safe for use as a coating on packaged foods.

Between 1967 and 1972, the FDA realized that this was not a particularly realistic way to model human exposure. Not every foodstuff is wrapped, and among those foods that are wrapped not all of the food will absorb the migrating chemical. Similarly, the migration rates will not be uniform. Additionally, it made sense to test packaging at higher than room temperatures, which included boiling water sterilization.

As part of its testing to use the coating on packaging that would hold food at higher temperatures, DuPont found that Zonyl RP migrated at a higher level - 0.94ppm (water at 212 degrees for 0.5 hour followed by 24 hours at 120 degrees and in cottonseed oil at 212 degrees for 1 hour followed by 24 hours at 120 degrees). This was expected; however, when the new FDA model for realistic exposure was applied to 0.94ppm of Zonyl RP, the potential exposure was found to be just 0.0044ppm. This translated into 0.013mg of Zonyl RP per day.

As Tarantino notes in her letter to the Environmental Group’s Vice President, Richard Wiles, “This level is approximately 45 times lower than the 0.2 ppm (0.6mg/day) concentration in the diet determined to be safe in 1967.”

So where does the 1987 test fit in– the one that the EWG suggested was a smoking gun? The 1987 test was more severe than the 1967 testing which was designed only to study migration at room temperature, but it was less severe than the 1972 tests for higher temperatures (0.62ppm v 0.94ppm). As the 1972 tests showed that potential human exposure was much lower than once estimated, Tarantino concludes, “the 1987 test performed by DuPont is irrelevant to the safety determination on the use of Zonyl RP and the company would not have been required to provide this information to FDA.”

All this wasted effort by the Environmental Working Group might have been prevented if they had considered the 1972 tests and regulations. Or indeed, if they had taken seriously, not merely the lack of scientific evidence, but the burden of scientific implausibility, for the suggestion that a flurotelomer such as Zonyl RP breaks down into Perflurooctanoaic Acid (PFOA) in the body (Unwarranted fears about PFOA exposure is the bugbear driving all this sound an fury).

All the needless panic generated by dozens of news stories might have been assuaged, as we noted last year, if reporters had bothered to call the FDA or taken the time to understand the science before rushing into print or on air – or even, for that matter, corrected the record after these stories ran.

But the Environmental Working Group is a media darling – a crusading watchdog out to protect the public from one of the oldest clichés in journalism’s big book of bad guys – the powerful, profit-driven corporation. Rarely, if ever, are readers or viewers warned that EWG has a history of not letting facts get in the way of a good scare story.

This was rather dryly pointed out in an earlier instance of the group’s campaign against DuPont, when it petitioned for products coated with non-stick coatings such as Teflon to carry a label warning of the “acute hazard the coating poses to pet birds and potential health risks to humans.”

Stephen Lemberg, Assistant General Counsel for the U.S. Consumer Product Safety Commission responded to the EWG on June 27, 2003:

“Your request meets most of the petition requirements. It is in English, provides your name and address and describes the substance of the rule you request.… The regulations also require, however, that a petition set forth facts establishing a claim that a rule is necessary.”

Sound advice for reporters to bear in mind when they cover the next “muckraking” scandal from the Environmental Working Group.