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New Chemicals & Risks are Confidential

Credibility Gap: Toxic Chemicals in Food Packaging: New Chemicals & Risks are Confidential

June 9, 2008
In the wake of the voluntary PFOA phaseout agreement, US industries are shifting the kinds of chemicals they are using in consumer products, including in food packaging. But when it comes to the new fluorochemicals manufacturers are developing at a breakneck speed, the only available data on toxicity come not from published scientific studies but from “substantial risk” notifications that federal law requires companies to submit to the Environmental Protection Agency (EPA). Though the submissions are publicly available, an EWG review shows that companies are claiming as confidential the chemical name in 90% of the studies and the company name in 70% of the studies. Redacted studies that conceal the chemical name and the company name and that contain no information on the range of consumer products the chemicals might be used in are of little use to the public. This lack of transparency means, in effect, that DuPont, 3M and other companies are either already manufacturing or gearing up to produce millions of pounds of chemicals for application to food packaging in place of PFOA but that have no openly accessible and scientifically supported safety data. A key section of the federal Toxic Substances Control Act (TSCA), known as section 8(e), requires U.S. chemical manufacturers, importers, processors and distributors to notify the EPA within 30 calendar days of any new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment (US EPA 2008). These TSCA 8(e) notices are the only glimpse that anyone outside of the EPA and the chemical industry may have into the potential toxicity of the replacement fluorochemicals. But when EWG analyzed the industry studies submitted to EPA's 8(e) docket between January 2007 and April 2008, what we found was startling. During this eighteen-month period, EPA received at least nineteen notices from chemical manufacturers that reported toxicity of fluorochemicals (US EPA 2008). All of these notices report at least one health effect seen in test animals, and the health endpoints themselves were often quite serious. Deaths of exposed animals were reported in five studies. In one 2007 study submitted by 3M, every single female animal tested died after 4-5 exposures to the chemical. [PDF file] Overall, these 19 studies found a staggering array of different health effects, including irregular breathing, muscle incoordination, lowered fertility, birth defects, increased numbers of stillborn pups, absence of pupilary light reflex in the eye, lack of normal startle response, dermal sensitization, and changes in the weights and/or size of vital organs such as the heart, kidney, liver, spleen, thymus, prostate, ovaries, and adrenal glands. Yet, despite these reams of troubling health data, 90% of the time the public has no way of knowing what compound was responsible: EWG found that for 17 of the 19 notices submitted to the EPA from January 2007 to April 2008 the name of the chemical has been redacted from the text under the claim of confidential business information. For example, while we know that there is a fluorochemical that was associated with death of a dam, reduced pup weight per litter, increased percentage of dams with all pups dying, reduced live-born pups per litter, and increased number of stillborn pups per litter, but all we know about the chemical’s identity is that it is a “fluorinated surfactant salt." [PDF file submitted by 3M on December 14, 2007] Similarly, a different study found that gestational exposure to a fluorochemical was associated with abnormal/difficult birth, lower fertility, reduced offspring body weights, skeletal abnormalities in offspring (effects on teeth, appearance of bent rib and 7th cervical rib), and lower maternal and offspring viability during lactation, but all we know is that the chemical was a “hydrofluorocarbon.” [PDF file 1 and PDF file 2 submitted by an unnamed manufacturer on 15 August 2007]

Table. Manufacturers’ submissions to TSCA 8(3) docket

Date Submitter Chemical Description Health effects reported
25-Feb-08 Unknown Hydrofluorocarbon Increased kidney weight Increased liver weight Increased spleen weight Increased cardiomyopathy
15-Jan-08 Unknown Perfluorinated aliphatic carboxylic acid, Ammonium salt Decreased body weight gain Decreases in red blood cells Increased liver weight Decreased heart weight Increased kidney weight
15-Jan-08 Unknown Perfluorinated aliphatic carboxylic acid Decreases in red blood cells Decreases in serum lipids (triglycerides and/or cholesterol) Increased liver weight Increased liver b-oxidation Hepatocellular hypertrophy
14-Dec-07 3M [Fluorinated surfactant salt] Death of dam Reduced pup weight per litter Increased percentage of dams with all pups dying Reduced live-born pups per litter Increased stillborn pups per litter
20-Nov-07 3M [Fluorinated surfactant salt] Dermal sensitization
30-Oct-07 Unknown Perfluorinated aliphatic carboxylic acid, Ammonium salt Ulceration Erythema
30-Oct-07 Unknown Polyfluorosulfonic acid Substantial cytotoxicity Reduced body weight
18-Oct-07 Unknown Ammonium salt of fluoroalkyl
carboxylic acid
Substantial cytotoxicity
17-Oct-07 DuPont Poly[oxy[trifluoro(trifluoromethyl)-1,2-ethanediyl]],
a-(1-carboxy-1,2,2,2-tetrafluoroethyl)
-ω-[tetrafluoroethyl(trifluoromethyl)ethoxy]-
Dermal sensitization
10-Oct-07 Unknown Ammonium salt of fluoroalkyl carboxylic acid Death Ataxia
15-Aug-07 Unknown Hydrofluorocarbon Reduced motor activity Reduced forelimb grip strength Reduced hindlimb grip strength Reduction in live born index Lower food efficiency
15-Aug-07 Unknown Hydrofluorocarbon Dystocia (abnormal or difficult birth) Lower fertility Lower maternal and offspring viability during lactation Effects on teeth Reduced offspring body weights
15-Aug-07 Unknown Hydrofluorocarbon Decreased maternal body weight gain Increased occurrence of skeletal malformations in offspring (bent rib and 7th cervical rib)
7-Aug-07 Unknown Ammonium salt of fluoroalkyl carboxylic acid Death
26-Jul-07 Unknown Fluorinated aliphatic alcohol Death Ataxia (nervous dysfunction and incoordination of muscle movements)
11-Jul-07 3M [Fluorochemical intermediate] Reduced prostate and seminal vesicle size Reduced absolute epididymes weight Reduced absolute adrenal weight Reduced absolute ovary weight Reduced absolute thymus weight Reduced absolute spleen weight Reduced relative thymus weight
12-Mar-07 Unknown Fluorocarbon "Became anesthetized" Irregular breathing No startle response Body weight losses
26-Feb-07 3M [Fluorinated surfactant salt] Death (six out of six female rats died after 4-5 doses; no mortality in male rats)
5-Jan-07 3M Ammonia perfluorobutanoate (PFBA) Absence of pupillary light reflex in both eyes Increase in hepatocellular hypertrophy Increased incidence and/or severity of hypertrophy/hyperplasia of follicular epithelium of the thyroid glands Increased liver weight

It should also be noted that in the vast majority (70%) of cases, the public also doesn’t even know what company sponsored the study and submitted to the EPA: in 13 of 19 submissions, this information has been redacted under claims of confidential business information. Essentially, the only piece of information that the general public is usually allowed to know is how hazardous an anonymous chemical may be. But what the identity of that chemical is, which company manufactures it, how much is being produced, and what consumer products it might be used in, remains a secret. This is hardly an assurance for safety. While we obviously don’t know the identities of the fluorinated compounds that were tested in these studies, we can be reasonably certain that they are not PFOA, PFOS, or their higher homologues, which are the chemicals subject to the voluntary phaseout DuPont, 3M, and other manufacturers have agreed to under pressure from EPA. Animal testing is expensive, and chemical companies would have no incentive to pay for testing of compounds that had few remaining uses. And since TSCA requires companies to report the results of new studies indicating significant health concern within 30 days, there is also little chance of these being old PFOA or PFOS studies that are only now being submitted to the EPA. What this means is that these studies showing dramatic adverse health effects are probably PFCs designed to be replacements for PFOA, PFOS and/or their higher homologues. And there is a decent chance that they are C6 fluorinated chemicals since market trends and FDA records indicate that many fluorochemical producers and secondary business users are shifting to the C6 PFC chemistry (Asahi Glass Co 2007; Clariant 2008; DuPont 2008a; DuPont 2008b; FDA 2006; FDA 2008; Nanowerk 2008; Sanitized AG 2008). But we will likely never know. Because the identity of the compounds found toxic in these 8(e) TSCA studies are held secret, not only from the general public, but even from regulators in state agencies that may be making decisions about these same compounds.