DuPont hit by allegations over safety of packaging chemical
of a chemical used to line grease-resistant packaging for candy,
pizza, microwave popcorn and hundreds of other foods, could affect
processors on both sides of the Atlantic.
The processing industry is under regulatory and consumer pressure to ensure better safety of their food products and the packaging. Health concerns about packaging chemicals, such asphthalates, have raised consumer awareness of about the risks posed by materials that may come into contact with the food they buy.
The latest allegations concern DuPont's marquee paper packaging coating chemical, Zonyl RP, which is cleared for use in the US and the EU. The Environmental Working Group (EWG) and a formerchemical engineer with DuPont claim that the company suppressed studies showing Zonyl RP could contaminate food at over three times the US federal safety standard.
If the chemical is found to be harmful to humans, its use as a means of keeping paper from absorbing food grease may be stopped, leaving processors scrambling for alternatives. They may alsopossibly be on the hook legally, if consumer groups decide to sue.
In a statement DuPont denies the allegations and says Zonyl RP complies with US health regulations relating to food contact materials. The company said Zonyl RP poses no health risks to humans.
Zonyl RP generates about $100 million in revenues a year for DuPont. Since the FDA originally approved the use of the chemical for food packing in 1967, scientists have found the body breaks downfluorotelomers such as Zonyl into PFOA, or perfluorooctanoic acid. PFOA accumulates in the human body.
The Environmental Protection Agency is studying PFOA, which is also used in Teflon-coated pans, to determine if it causes cancer in people and why it is in the blood of most Americans. DuPont holdsthe patent for Teflon.
Quoting US Food and Drug Administration (FDA) letter to the company on 16 November, DuPont said the regulator saw no reason to change its position that the use of both perfluorocarbon resin andtelomer-based coatings are safe for use in contact with food.
In the letter, the FDA stated that fluorotelomer migration from coating paper "should not be equated to PFOA exposure". In its tests, FDA found that migration of PFOA from microwavepopcorn bags coated with telomer-based products were "at a level below the standard of quantification for the analytical technique (less than 1 part per billion in food)."
In another statement, an FDA spokesperson told Bloomberg News that the agency has put the use of Zonyl RP under review. The spokesperson said the food regulator may consider limiting the coating'suses because of concern about health risks.
In correcting a factual error made by the EWG and Glenn Evers, the former DuPont employee, the FDA's office of food additive safety added that the regulator currently has set no limits on how muchof the chemical can be absorbed in the food.
Evers worked at the company as a chemical engineer from 1981 to 2002, and claimed he was fired for voicing his concerns about Zonyl RP. DuPont claims Evers, who participated in EWG's newsconferences on Zonyl PR, lost his job in a restructuring. The company said he did not have any direct involvement in PFOA issues while employed at DuPont.
Evers recently filed a wrongful termination lawsuit against DuPont which the company is contesting. He says he was the company's top chemical engineer involved with designing and developing newuses of perfluorinated, chemical-based grease proof coatings for paper food packaging.
Evers and the EWG alleges the company negotiated with the FDA a weak standard for how much of the paper chemical coating, which is applied to give packaging grease or liquid resistance, couldcontaminate food.
The FDA at the time normally required a two-year study for chemicals it wasn't familiar with, but agreed to base DuPont's approval on a 90-day test with a 1,000-fold safety factor added. Eversclaims that standard, which remains in effect today, was based on the premise that the chemical would leave the body quickly.
He alleges he saw that the company knew, at least by 1981, that another class of perfluorinated chemicals, such as PFOA accumulates in people. A company document released by EWG is alleged to showthat DuPont conducted a toxicological study in 1973 in which it was unable to find a safe level of exposure in lab animals, and that the chemicals were toxic to the kidneys, liver and blood.
EWG also alleges that a key document shows that in 1987, DuPont's Richard Goldbaum found that the company's marquee paper packaging coating chemical, Zonyl RP, could contaminate food at over threetimes the federal safety standard, while two effective alternatives contaminated food at half the federal maximum level.
Evers claims that one of the reasons the company decided to sell Zonyl RP was that it had adopted the practice of blending substandard batches in with better batches - and selling the blendedversions to its industrial customers.
"The company did not provide the information to customers, federal health officials and the public," EWG alleges. "DuPont did not recall the faulty product, did not stopits production, shelved the safer alternatives, and continued to make Zonyl RP - effectively producing for another 18 years the chemicals that would lead to the contamination of consumers' blood."
Evers and EWG claim that 3M, DuPont's competitor, abandoned its $150 million per year business using perfluorinated chemicals on paper food packaging when it realized in 2000 that the chemicalswere producing byproducts accumulating in human blood and that those chemicals were harmful to developing lab animals.
"Despite what it knew from the 1987 results by Dr. Goldbaum and the persistence and toxicity of its own chemicals, DuPont moved quickly to sell its similar chemistry to 3M's formercustomers," EWG alleges.
EWG said it had sent the internal company documents to the FDA's acting commissioner, as well as the inspector general of its parent Department of Health and Human Services (HHS), requesting thatofficials act on the new information. The group is also referring documents to relevant EPA officials.
"These documents indicate a failure to disclose critical public health information about a toxic chemical that never breaks down, that gets into our bodies and stays there," EWGsenior scientist Tim Kropp said at a press conference last week. "If we ever needed a reason to reform the nation's toxic chemical laws, every American now has one, courtesy of DuPont."
The EPA has lodged a civil suit against the company for allegedly suppressing health studies on PFOA, which is used in the production of Teflon pan coatings. The next court date for the civil suitwas negotiated to fall on Wednesday, 23 November.
In response to the Evers and EWG allegations DuPont stated: "Our scientists have tested Zonyl RP and other fluorotelomers used as paper coatings to find out the levels of PFOA that can beextracted from these products. We have concluded that these levels are minute and the paper products are safe for consumer use. We have shared the results of our research with FDA, and wecontinue to update FDA as new information becomes available."
