Sustained Outrage

Study says EPA advisory for C8 is far too weak

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Earlier this month, Callie Lyons wrote an important piece about lingering questions regarding exposure to toxic C8 among residents of the Mid-Ohio Valley area. She explained:

… More than a decade after the deadly controversy came to light, in many ways the extent of the contamination remains unknown. The impact on local cattle, hens, milk, eggs and produce remains largely unmeasured … An extensive paper trail reveals that DuPont promised to fill in data gaps identified by the EPA as early as 2003, then repeatedly failed to deliver the requested information.

 
And now, we have a new peer-reviewed study from Harvard University that raises serious questions about the provisional health advisories that EPA issued in the final days of the Bush administration in response to concerns about water supplies polluted with C8:

The current EPA limit for this PFC is 300-fold higher. Thus, the recent evidence on PFC immunotoxicity in humans and toxicity in animal models suggests that current limits for drinking water contamination are too permissive and must be decreased substantially.

Current drinking water limits therefore need to be reconsidered in the light of the observed immunotoxicity associated with PFC exposure.

UPDATED, APRIL 30, 2013 — Read more in this story.

New studies raise more questions about C8

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There are two new studies out this week that raise more questions about the dangers of DuPont Co.’s chemical, C8.

First, there’s this paper published in the journal Environmental Health Perspectives, concluding:

This study suggests an association between PFC exposure and juvenile asthma. Due to widespread exposure to these chemicals, these findings may be of potential public health concern.

Then, there’s this paper, also published yesterday in that same journal:

This study suggests that higher PFOA serum levels may be associated with testicular, kidney, prostate, and ovarian cancers and non-Hodgkin’s lymphoma. Strengths of this study include near-complete case ascertainment for state residents, and well characterized contrasts in predicted PFOA serum levels from 6 contaminated water supplies.

That one is especially interesting, given that it was co-authored by Tony Fletcher of the London School of Hygiene and Tropical Medicine. Dr. Fletcher was a member of the C8 Science Panel, which previously ruled that the only “probable links” between C8 exposure and cancers were for testicular and kidney cancers.

UPDATED: I asked Dr. Fletcher to explain the contradictions between this new study and the Science Panel’s probable link findings, and this is the email he sent me:

This is a general issue of assessing the evidence which has been faced for all the probable link assessments.  As described in the Science Panel Probable Links reports, for each evaluation we considered evidence together from published studies done by others, and from published and unpublished work done by the Science Panel. We considered the weight of the evidence, including consistency across studies. We took into account the capability of different study designs to detect a disease risk if such a risk exists: this capability of each study depends on both study size (a large study is better able to show the presence or absence of risk) and study quality (how good was the exposure assessment, how complete was the study population, how well controlled were the potential confounding factors etc). In many cases we found that some results were quite different , where one study suggested a risk and another did not, or within one study, different ways of analysing the results lead to different patterns of results. In each case we then judged whether the balance of evidence convinced us that it is more likely than not that an observed excess risk was explained by the connection between PFOA exposure and the particular human disease. Or alternatively we judged that an excess was more likely than not due to chance or study artefact. Where an individual positive association was based on stronger evidence (for example with a convincing pattern of increasing risk with exposure category and strong statistical significance), this carries more weight than results with weaker significance tests and without supportive results from other studies/analyses. Such considerations guide us in determining what is a “probable link” as defined in the Settlement Agreement.

The specific questions you raise are examples of this. Some of the particular set of results you can see in this paper (prostate cancer, ovarian cancer and non-Hodgkin’s lymphoma) were based on small numbers or showed unimpressive p-values or were not replicated by other studies, and when we put the evidence together we concluded for these that there was overall insufficient evidence to support a probable link with C8.

Finally, there was a third paper, this article, published in late December in the journal Environmental Science and Technology:

The present study investigated variation in perfluorocarbon levels of 9,952 women of childbearing age who had been exposed to perfluorooctanoic acid (PFOA) in drinking water contaminated by industrial waste. An analysis of variance with contrast was performed to compare the levels of PFOA and perfluorooctanesulfonic acid (PFOS) in pregnant and nonpregnant women overall and during each trimester of pregnancy. We found that pregnant women had lower circulating PFOA and PFOS concentrations in peripheral blood than nonpregnant women and that PFOA levels were consistently lower throughout all trimesters for pregnancy, suggesting transfer to the fetus at an early stage of gestation. These results are discussed in the context of the endocrine-disrupting properties of perfluoroalkyl substances that have been characterized in animal and human studies. Our conclusion is that further, systematic study of the potential implications of intrauterine perfluorocarbon exposure during critical periods of fetal development is urgently needed.

Final C8 Science Panel reports due out Monday

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The C8 Science Panel has scheduled a press conference for Monday morning in Parkersburg, to announce its final reports of its long investigation into the dangers of the DuPont chemical. Here’s the media advisory sent out this morning:

On the morning of Monday, October 29, final reports on whether there is a probable link between C8 and human disease will be delivered to the Wood County Court on behalf of the C8 Science Panel.  Immediately following submission to the court, the three Science Panel members will hold a press conference in Parkersburg/Vienna, WV at 10 am at the Wingate Hotel (next to Lowe’s).

The Science Panel has already released three rounds of its “probable link” reports, finding connections between C8 exposure and a variety of illnesses: High blood pressure during pregnancy, kidney and testicular cancer, and thyroid and bowel disease. The panel is now due to make public its findings regarding liver disease, kidney disease, osteoarthritis, parkinson’s disease, heart disease, hypercholesterolemia and hypertension.

Interestingly, there were a couple of stories in the Parkersburg paper today related to C8. One of the stories reported this development:

The first three West Virginia lawsuits have been filed in Wood County Circuit Court against DuPont alleging personal injury and, in one case, a death allegedly linked to C8 exposure.

These new suits were filed by Charleston lawyer Kathy Brown, who is apparently working with an Alabama law firm, Cory Watson Crowder & DeGaris, as the Parkersburg paper reported:

Brown is working with the law firm of Cory Watson Crowder & DeGaris, P.C. Cory Watson is a Birmingham, Ala., personal injury law firm known for handling similar multi-plaintiff and personal injury lawsuits. Cory Watson has also handled contamination litigation throughout the country involving other multi-national corporate defendants such as Monsanto, BP Oil, Pharmacia, Pfizer and Chevron.

Continue reading…

Study suggests C8 link to cardiovascular disease

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There’s a new study out this week from West Virginia University researchers that concludes exposure to C8 is associated with increased risk of cardiovascular disease, or CVD, and peripheral arterial disease, or PAD. According to a news release:

Anoop Shankar, M.D., Ph.D., and colleagues from the West Virginia University School of Public Health, Morgantown, examined the association between serum (blood) levels of PFOA and the presence of CVD and PAD, a marker of atherosclerosis, in a nationally representative group of adults. The study used merged data from the 1999-2000 and 2003-2004 National Health and Nutrition Examination Survey (NHANES).

The study suggests that increasing serum PFOA levels were positively associated with the presence of CVD and PAD, and the association appeared to be independent of confounders such as age, sex, race/ethnicity, smoking status, body mass index, diabetes mellitus, hypertension and serum cholesterol level, the authors comment.

“Our results contribute to the emerging data on health effects of PFCs [perfluoroalkyl chemicals], suggesting for the first time that PFOA exposure is potentially related to CVD and PAD. However, owing to the cross-sectional nature of the present study, we cannot conclude that the association is causal,” the authors comment.

The study, published in the Journal of the American Medical Association’s Archives of Internal Medicine, is available online (through a subscription only site) here.   Readers who are following C8 issues may recall that the C8 Science Panel has issued a report concluding that there is no “probable link” between C8 exposure and stroke, but that the Science Panel’s findings about heart disease are not due out now until sometime next month.

In a commentary also published in the journal, Dr. Debabrata Mukherjee of Texas Tech University Health Sciences Center, El Paso, writes:

These results contribute to the evolving data on the adverse health effects of PFOA, suggesting that PFOA exposure may be potentially related to CVD.  However, a major limitation is the cross-sectional nature of the study. Given this significant limitation, causality or the temporal nature of the association between PFOA and CVD cannot be concluded from the current analysis.  Although it seems clear that additional prospective research is needed to tease out the true adverse cardiovascular effects of PFOA, given the concerns raised by this and prior studies, clinicians will need to act now. From a societal point of view, it would make sense to limit or to eliminate the use of PFOA and its congeners in industry through legislation and regulation while improving water purification and treatment techniques to try and remove this potentially toxic chemical from our water supply.

C8 update: Another paper, but still no regulations

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There’s a very interesting new paper out on C8 that concludes:

Girls with higher prenatal exposure to each of the PFCs examined were smaller at birth than those with lower exposure. In addition, those with higher exposure to (PFOS) were larger at 20 months.

This is especially interesting, given the previous findings of the C8 Science Panel last December:

On the basis of epidemiologic and other scientific data available to the C8 Science Panel, we conclude that there is not a probable link between exposure to PFOA (C8) and preterm birth or low birthweight.

Meanwhile, Callie Lyons had an important blog post on C8 issues, reporting this:

Despite lawsuits and health studies, the controversial manufacturing substance C8 remains unregulated by the US Environmental Protection Agency. Cincinnati attorney Rob Bilott is urging the agency to take swift action in light of recent findings from the C8 Science Panel.

Bilott says he is concerned because he recently discovered EPA intends to delay actual regulatory activity until 2025 – or 24 years after he first requested action on the part of his Mid Ohio Valley clients.
“On behalf of our individual resident clients who have been and/or continue to be exposed to PFOA in their residential drinking water, we again urge US EPA to take action more quickly to release appropriate limits and guidelines for PFOA in drinking water applicable to long-term, chronic exposures, particularly given the recent data confirming thousands of cases of serious human disease linked to such exposures among impacted residential communities,” Bilott said in an Aug. 20 letter to EPA. “Twenty four years is far too long to ask our clients to wait.”

Judge: C8 Science Panel delay ‘frustrating’

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Earlier today, Wood Circuit Judge J.D. Beane held a brief hearing in Parkersburg, so that members of the C8 Science Panel would have to explain in a public forum the reasons for their announced three-month delay (see here and here)  in releasing final results of their examination of the chemical’s impact on the health of Mid-Ohio Valley residents.

Until late last month, Science Panel members were publicly sticking to their promise that the last of their “probable link” determinations would be done and released by the end of July. Now, they say it will be the end of October before this work is completed and results relayed to area residents. Here’s the reason, as explained by the Science Panel:

The primary reason that we were not able to fulfill our commitment to meet the deadline of July for all the assessments was that we underestimated the painstaking process of resolving several assessments that are very close to the balance between presence or absence of a Probable Link. The process of preparing a Probable Link assessment involves generating data from our own research, integrating that information with studies conducted by others, careful evaluation and deliberation, and then writing a document to summarize the evidence and explain our reasoning. The process of assessing the evidence and composing the documents is far more demanding than we had anticipated at the outset, and each disease is handled separately.

In each case we have had to examine the data we have, consider consistency with published data where available, confer on how to make the results more definitive and, where necessary, go back to the data for additional analysis. For diseases which are borderline between yes and no, this necessitates additional effort, sometimes in several cycles. For all diseases, but especially those for which the evidence places them close to the “more probable than not” threshold, the process demands substantial time. In judging whether to try to truncate that level of scrutiny and rush through the remaining diseases, including some of the most important ones of concern, versus incurring a delay in order to be sure that each of the reports received our full attention, we have chosen the latter.

Lawyers for residents and for DuPont Co. seemed to accept this explanation, and neither side offered any criticism of the panel’s delay. Judge Beane, though, did say:

It’s frustrating when deadlines are set and then those deadlines are not met. The people who live throughout this community are wanting to know and we set these deadlines for a reason.

And if October comes and there’s another delay? Judge Beane said:

If it continues to be an issue, with whatever means I have to look into that, I will.

FDA reaches deals on C8 food packaging phase-out

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Today, the U.S. Food and Drug Administration posted this potentially important announcement on its website, revealing the somewhat old news that three makers of C8-based food packaging have agreed to voluntarily withdraw those products from the market. The FDA announcement spun it this way:

Recent scientific studies have raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds. These compounds have perfluorinated chain lengths of 8-carbons (C8) or longer. The studies indicate that these C8 compounds persist in the environment and can have toxic effects on humans and animals.

In response to these studies, FDA initiated a comprehensive review of the available data on C8 compounds and worked with several manufacturers to remove greaseproofing agents containing C8 perfluorinated compounds from the marketplace. As a result of FDA’s initiative, these manufacturers volunteered to stop distributing products containing C8 compounds in interstate commerce for food-contact purposes as of October 1, 2011. Existing supplies of these greaseproofing agents already in the marketplace and paper products with these greaseproofing agents can be used until they run out.

The industry’s voluntary action to cease using greaseproofing agents containing C8 perfluorinated compounds means that these products will be out of the marketplace in a relatively short period of time. Because the potential danger from C8 compounds is a result of chronic exposure to such substances, FDA has determined that the exposure which will occur during this sell-off period will not impact public health. The agency will also conduct a market survey to determine whether any manufacturers are still using greaseproofing agents which contain C8 compounds.

We’ve written before in the Gazette about the link between food packaging and C8 exposure (see here, here and here), and today’s announcement comes just after the C8 Science Panel — which has linked chemical exposure to human disease — announced last week that it needs more time to complete all of its work. The FDA announcement was first reported on the website Food Poisoning Bulletin. There’s also been some very interesting reporting on C8 issues recently from Callie Lyons, including this story and a follow-up piece.

Keep in mind that makers of these products had already agreed to a voluntary phase out in a deal with the U.S. Environmental Protection Agency, so the meaning of FDA’s announcement is not exactly clear yet. Leann Brown, spokeswoman for the Environmental Working Group told me today:

This isn’t a groundbreaking announcement. Several companies have reaffirmed that they are in the process of voluntarily phasing out these toxic chemicals from commerce, and the FDA is officially acknowledging their intention.

 

Just a few weeks after the latest probable link finding from the C8 Science Panel in the Mid-Ohio Valley, we’ve got a very interesting new paper out that focuses attention on how some health effects related to C8 exposure appear to be happening at very low levels — levels to which the general public is exposed.

The new paper was written by Gloria Post of the New Jersey Department of Environmental Protection, Perry Cohn of the New Jersey Department of Health, and Keith Cooper of Rutgers University. It’s called “Perfluorooctanoic acid (PFOA), an emerging drinking water contaminant: A critical review of recent literature” and was published online by the peer-reviewed journal Environmental Research (subscription required).

Among other things, the study reports:

— Continued exposure to even relatively low concentrations in drinking water can substantially increase total human exposure, with a serum drinking water ratio of about 100:1.

— Infants are potentially a sensitive sub-population for PFOA’s developmental effects, and their exposure through breast milk from mothers who use contaminated drinking water and/or from formula prepared with contaminated drinking water is higher than in adults exposed to the same drinking water concentration.

— Numerous health endpoints are associated with human PFOA exposure in the general population, communities with contaminated drinking water, and workers.

While the study notes that, “as is the case for most such epidemiology studies, causality for these effects is not proven,” it also reports:

Unlike most other well-studied drinking water contaminants,the human dose-response curve for several effects appears to be steepest at the lower exposure levels,including the general population range,with no apparent threshold for some end points.

And, the study says:

This information suggests that continued human exposure to even relatively low concentrations of PFOA in drinking water results in elevated body burdens that may increase the risk of health effects.

We’ve got the story online  here about the latest findings from the C8 Science Panel:

A three-person team of experts has found a “probable link” between exposure to the chemical C8 and the development of kidney and testicular cancer in humans, the scientific panel announced this morning.

Members of the C8 Science Panel made those conclusions in the second set of significant findings in their six-year study of the DuPont Co. chemical.

Panel members cited previous studies of DuPont workers, as well as the results of their own still-to-be-published analysis of health data for thousands of Mid-Ohio Valley residents.

In its press release, the Science Panel said:

The only two cancers where the Panel found a reasonably consistent and strong relationship between past exposure and cancer were testicular cancer and kidney cancer. Both these cancers are rare. In the Science Panel data there were 19 confirmed cases of testicular cancer and 113 confirmed cases of kidney cancer. After dividing the population into four categories (“quartiles”) of increasing level of cumulative C8 in the blood, the kidney cancer rate in the upper categories of the population was 20%, 40%, and 60% higher for the 2nd, 3rd, and 4th quartile compared to those with the lowest exposure. For testicular cancer the corresponding numbers were 80%, 120%, and 170% higher for the upper quartiles compared to the lowest.

You can read the panel’s latest findings here and here.

Readers who have followed these issues know that DuPont has for years included this standard disclaimer in its public statements about C8 issues:

There are no known human health effects associated with exposure to PFOA.

What does DuPont say now? Here’s the entire statement issued by the company today:

Today the Science Panel filed two “probable link” reports in connection with the West Virginia class action litigation. The Science Panel reports address type-II adult onset diabetes and cancer. The Science Panel found no probable link between PFOA and diabetes. The Science Panel found a probable link with two cancers (kidney and testicular), but found no probable link with the remaining nineteen categories of cancer evaluated.

The settlement defines the standard for “probable link” as whether it is more likely than not that PFOA exposure among class members is linked to a human disease. A probable link report does not mean that the Science Panel has concluded that PFOA exposure has caused or will cause any human disease among the class members as a whole, including the Washington Works employees, or any individual.

Consistent with our core values of health, safety and environmental stewardship and before any reports from the Science Panel, DuPont took actions to minimize PFOA exposure.

For decades, DuPont has had industrial hygiene measures in place to minimize worker exposures to PFOA. Data shows that these measures are effective. DuPont has reduced total PFOA emissions by more than 98 percent in our global manufacturing operations since 2000. We also have developed and commercialized new technologies to make fluoropolymers without using PFOA, and to make surface protection products that cannot break down to PFOA in the environment. Regulatory authorities around the world have affirmed that these products are safe for their intended uses.

DuPont will continue to meet its obligations under the West Virginia litigation. DuPont will evaluate additional information from the Science Panel as part of our long-standing commitment to the safety of our employees and customers and to responsible environmental and product stewardship.

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Panel named to oversee C8 medical monitoring

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Here’s the release just in from lawyers for DuPont and attorneys for residents of the Mid-Ohio Valley:

DuPont and attorneys for local residents who settled a class action lawsuit against DuPont in 2005 over releases of ammonium perfluorooctanoate, also known as C-8 or PFOA, from DuPont’s Washington Works plant, announced today that they have jointly selected a three-member panel of independent, well-qualified and respected medical doctors – the “C-8 Medical Panel” – to determine the nature and extent of whatever medical monitoring may be appropriate for class members under the terms of the settlement.

As part of the settlement, a separate panel of three independent epidemiologists jointly selected by the parties – the “C-8 Science Panel” – was tasked with determining whether there are any “probable links” between PFOA exposure and human disease. The C-8 Medical Panel determines the nature and extent of any medical monitoring that would be appropriate for class members for any disease for which the C-8 Science Panel finds a probable link. Thus, after the C-8 Science Panel released its first set of probable link reports in December 2011 and announced that it had found a probable link between PFOA exposure and pregnancy induced hypertension, including preeclampsia, the parties immediately began working together to identify potential Medical Panelists to evaluate medical monitoring for this disease. After interviewing multiple well-qualified candidates, the parties have agreed to the following C-8 Medical Panel:

— Dean Baker, MD, M.P.H.  — Dr. Baker is Professor of Medicine, Pediatrics, and Epidemiology at the University of California, Irvine, School of Medicine. He is also director of the UC Irvine Center for Occupational and Environmental Health, a state mandated center for the study and prevention of occupational and environmental exposures, diseases, and injuries. For more than three decades, Dr. Baker has conducted substantive and methodological research in occupational and environmental health particularly on environmental exposures and diseases of children and work-related diseases of adults. He also directs an occupational medicine residency program to train physicians as specialists in occupational and environmental health.

— Melissa McDiarmid, MD, M.P.H., D.A.B.T. — Dr. McDiarmid is a Professor of Medicine, Epidemiology and Public Health at the University of Maryland. She is also the Director of the school’s Occupational/Environmental Health Program. From 1991-1996, Dr. McDiarmid was Director of the Office of Occupational Medicine for the United States Occupational Safety & Health Administration (OSHA). Dr. McDiarmid has authored numerous journal articles and book chapters on occupational and environmental medicine related to healthcare workers, medical surveillance and management, reproductive hazards, occupational cancers, and Gulf War environmental exposures.

— Harold Sox, MD, M.A.C.P. —  Dr. Sox is a Professor of Medicine Emeritus at the Dartmouth Medical School and the Associate Director for Faculty at the Dartmouth Institute for Health Policy and Clinical Practice. Dr. Sox was the President of the American College of Physicians from 1998-1999. He also was Chairman of the United States Preventive Services Task Force from 1990-1995 and chaired the Institute of Medicine Committee to Study HIV Transmission through Blood Products and the Institute of Medicine Committee on Health Effects Associated with Exposures Experienced in the Gulf War.

The C-8 Science Panel will announce additional reports soon, and expects to announce all remaining reports by July 30, 2012. If the C-8 Science Panel finds any additional probable links between PFOA exposure and human disease, this C-8 Medical Panel will be tasked with evaluating the appropriateness of medical monitoring for any such additional disease, in addition to pregnancy induced hypertension, including preeclampsia.