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New Food Packaging Chemicals: No Health Data

Credibility Gap: Toxic Chemicals in Food Packaging: New Food Packaging Chemicals: No Health Data

June 9, 2008

In March 2008 EWG received from the FDA Center for Food Safety and Applied Nutrition FDA's safety assessments for all 8 new fluorochemical-based food packaging chemicals approved by the agency between 2005 and November 2007, including four based on C6 chemistry. A substantial amount of information in these documents was redacted by FDA as alleged confidential business information, but EWG's review of the remaining information finds no evidence that FDA adequately assessed the safety of people's exposures to C6 from these coatings. In particular, the information provided to EWG demonstrates that:

  • FDA failed to assess how quickly these food coatings would break down into C6, and no mention is made in the FDA documents of companies submitting such data.
  • FDA failed to require industry to submit any safety studies on C6 itself (perfluorohexanoic acid or PFHxA). Of the 4 C6-based chemicals approved by the FDA for food packaging and reviewed by EWG, only Asahi Glass submitted a C6 toxicity study. Even though Asahi research showed smaller than normal growth, lower cholesterol and calcium in PFHxA-exposed test animals (Asahi 2006), FDA did not take into consideration the C6 health effect data when approving the chemical for food packaging.
  • FDA approved the C6-based and other fluorochemical replacements for C8- and larger PFC-based food packaging based on its assessment that since C6 is not C8 (PFOA), there would be little chance of C8 residues in the food package coatings.
  • In all of its new approvals of fluorochemicals for food packaging, FDA failed to consider the long-term health and environmental consequences of the continued use of vast amounts of PFC-based food packaging chemicals that are extraordinarily persistent in the environment and that can cross the human placenta.

In addition to the food packaging chemicals FDA has already approved, DuPont marketing materials indicate that another new, grease-proof paper coating will be available in 2009, made from C6 and related chemicals (see DuPont's CapstoneTM "Paper packaging" factsheet available for download at DuPont 2008a). If the last 3 years of FDA approvals are any indication, DuPont could likely win FDA approval of this product for food packaging with no assessment of the safety of C6.

Although FDA and industry chemists know that food packaging chemicals are not without hazard and can migrate into food, most consumers are surprised to learn that the inner lining of their favorite fast food wrapper may expose them to chemicals linked to potential health consequences ranging from developmental problems to heart disease, stroke and cancer. This includes a wide variety of food packaging that for decades has been treated with fluorochemicals to increase its resistance to oil and water stains (Begley 2005).

Federal records for food packaging fluorochemicals go back to 1969 when a Scotchban paper coating manufactured by 3M was approved as "safe" by the FDA (FDA 1969). Since that time, FDA continued to sanction various kinds of fluorochemicals to be used directly in contact with food. However, much has changed since 1969. We now know that perfluorochemicals (PFCs) contaminate the bodies of 98% of Americans (Calafat, Wong 2007). These are long-lasting, toxic chemicals that, once ingested with food or water, will linger in human bodies for years (Conder 2008). And - unknown to consumers - these chemicals can and do migrate from food packaging into food and then into human bodies (Begley 2005; Deon and Mabury 2007; Sinclair 2007; Tittlemier 2007). One could argue that the time has come for close public and regulatory scrutiny of fluorochemicals in food packaging. Are the purported convenience (however slight) and manufacturers' profits (however big) worth the dangers of getting an extra helping of PFCs into our bodies, already assailed with so many other toxic industrial chemicals from other sources?

Fortunately, the tide is changing as more and more people clearly state that they don't want PFCs on their food packaging. And companies are listening: Burger King, for instance, stopped using PFC-coated take-out boxes in 2002. However, food packaging PFCs are still on the market and are still covered by summary approvals from the FDA, even though their effects, in an assessment by the FDA's own scientists, "may only become apparent many years later" (Begley 2005). Indeed, we are not talking about doses that are immediately harmful after a single helping of microwaved popcorn. Instead, we need to be concerned about on-going, continuous ingestion of small quantities of these chemicals, their documented build up in the human body over the years - and the subsequent health effects with which these chemicals are unambiguously associated.

Of particular concern is the fact that there are no publicly available market surveys quantifying PFC use in packaging. As a result, consumers are unfairly deprived of their essential right to know and to make informed, independent decisions. Meanwhile, two studies detected PFCs leaching out of food packaging under normal cooking temperatures (Begley 2005; Sinclair 2007). However, a consumer going to the store would not know which brands to avoid because manufacturers are conveniently withholding this crucial information. And it is not only the consumers who are in the dark. When the FDA scientists conducted their small-scale survey, they noted that the "paper products [tested by the FDA] were not necessarily treated with perfluoro paper coatings" (Begley 2005). As a result of the secrecy about PFC content in packaging, consumers don't know what to buy and what to avoid, while FDA does not know what market products to test. Manufacturers know but they will not tell anyone.

Following the EPA scrutiny of PFOA (perfluorinated chemical with an 8-carbon backbone, thus also known as C8) and general public outrage over the widespread contamination with this noxious chemical, fluorochemical manufacturers are shifting to smaller PFCs, especially C6 PFC replacements. Clariant Corporation, for example, states in its Annual Report that its “new generation of fluorocarbons [is] based on C6 Chemistry” (Clariant 2008) and will be used for food packaging as well as other end uses (Clariant 2008, Sanitized AG 2008, Nanowerk 2008). Similarly, DuPont has just introduced a new generation of PFC products intended to be used in various applications including paper packaging “where the fluorochemical portion is made up of six or fewer perfluorinated carbons” (DuPont 2008a). And Asahi Glass company has also developed a series of C6-based PFCs for food packaging paper and textile applications (Asahi Glass Co 2007). In fact, of the 10 fluorochemicals that FDA has approved for food contact uses since 2005, 6 of them were based on C6 PFC building blocks (Food Contact Substance Notifications (FCNs) 542, 599, 604, 628, 746, 783) (FDA 2008).

Since the voluntary PFOA phaseout was announced, FDA and the PFC manufacturers seem most interested in claiming that the replacement products are not PFOA, while failing to make public even the most basic health and safety data on the C6 replacements. Unfortunately, DuPont’s statements about the glowing promise C6 (CapstoneTM) chemistry being the answer to PFC contamination of consumer products and the environment are sorely lacking in credibility. We know that PFCs as a class undergo hardly any natural degradation (NAS 1972), so claims about their not being persistent in the environment are likely not true. We know that while the shorter-chain length PFCs may be less bioaccumulative (Martin 2003), they are better able to cross the placenta and transfer from the mother’s body to the fetus (Midasch 2007). We know that these chemicals are already found in people and babies: biomonitoring studies have already found C6 chemicals in adult and cord blood, proving that they do indeed cross the placenta (EWG 2005; Frisbee 2008). We know that the FDA has concerns about the biopersistence of PFCs, including C6-based PFCs (FDA 2006). And we know that shorter-chain PFCs have been already been detected as contaminants in drinking water due to emissions from fluorochemical manufacturing facilities (MDH 2008).

And what we certainly don’t know is that these C6 chemicals are safe. With the exception of one presentation from the Asahi Glass Company delivered at the EPA's PFOA Information Forum (Asahi 2006), there are no published studies on the toxicity of C6 compounds. The FDA’s toxicology reviews of approved C6 food contact substances are cursory. For example, they typically consider only the toxicity of the coating compounds and not the chemicals they break down into over time. Furthermore, companies’ claims of negligible PFOA contamination in their new C6 PFC products are taken as evidence of safety – in the absence of any substantiating data that would look at the toxicity of C6 itself.

Meanwhile, industry is aggressively promoting the C6 replacements for every imaginable application. On April 23, 2008, a scientist representing the Telomer Research Program, a chemical industry group that includes DuPont and other PFC makers, testified before the Health Committee of the California State Senate against a bill to ban both perfluorooctanoic acid (PFOA/C8) and perfluorohexanoic acid (PFHxA/C6) in food packaging. He repeated the claim that PFOA is not harmful to humans, and that an outright ban would be unnecessary in the presence of the voluntary phaseout program. He also repeatedly described C6 as an example of the “green chemistry” approach the state is developing to encourage the production of safer alternative chemicals:

[The bill] would derail a promising example of green chemistry at work . . . [B]y targeting perflourinated compounds with chain links of 6 or higher in this legislation, the bill would frustrate the conversion from the C8 based products, that are the source of the PFOA, to a set of effective C6 based compounds whose breakdown products are much, much less toxic and don’t have the same persistence issues that PFOA and some of the C8s have. . . . [O]ur companies are addressing the concerns about PFOA; we’re aggressively doing so. And we believe the proposed legislation would actually do harm to an effective green chemistry strategy for reducing the concerns about this chemical. (Lawyer 2008)

Green chemistry is sustainable chemistry with products and processes that reduce or eliminate the use and generation of hazardous substances. In the absence of transparent, independently conducted toxicity studies, replacement PFC chemicals in food packaging may very well become new, emergent contaminants whose health consequences will be directly tested on people. And while much remains unknown about C6, what is known – it is bioaccumulative, persistent and crosses the placenta to pollute human blood – is enough to disqualify it as green chemistry.