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One Month After West Virginia Chemical Spill Major Data Gaps and Uncertainties Remain

Energy

By Richard Denison

Yesterday marked exactly a month since what is now said to be 10,000 gallons of “crude MCHM”—mixed with what was later found to have included other chemicals—spilled into West Virginia’s Elk River, contaminated 1,700 miles of piping in the water distribution system for nine counties, and disrupted the lives of hundreds of thousands of the state’s residents. 

Despite declining levels of the chemical in the water being fed into the distribution system, late this past week five area schools were closed due to detection of the distinctive licorice-like odor of MCHM and multiple reports of symptoms such as eye irritation, nausea and dizziness among students and staff.

The facility where the spill occurred is owned by Freedom Industries—a subsidiary of Etowah River Terminal, LLC—and sits on the banks of the Elk River. Photo credit: Democracy Now!

The latest sampling data (for Feb. 7 and 8) at locations such as area fire hydrants and hospitals and at schools shows that MCHM is at non-detect levels (<10 parts per billion) in most samples, but the chemical is still being detected in a minority of the samples despite extensive flushing. Despite repeated calls to do so, officials appear to have yet to conduct any sampling of taps in residents’ homes.

This past week also featured a press conference by state and federal officials seeking to explain their response to the spill (a video of the entire press conference is available in four parts here; it’s worth watching).

Yesterday’s Charleston Gazette features the latest in a long series of outstanding front-line reports by Ken Ward, Jr., and his colleagues, who have closely followed every twist and turn of both the spill and the government’s response to it. Yesterday’s article makes clear the extent to which federal officials were winging it in the hours and days after the spill was discovered as they rushed to set a “safe” level for MCHM in tap water.

In this post I’ll delve a little deeper into CDC’s rush to set the “safe” level and the many ways in which CDC inadequately accounted for major data gaps and uncertainties. I’ll end by saying what I think CDC should have done instead. 

CDC’s Rush to Set A “Safe” Level

On full display in last week’s press conference was CDC’s remarkable effort to claim that every new data point and every new source of uncertainty that have arisen since it set what Ken Ward calls the “magic number” of 1 part per million (1 ppm) had already been taken into account. The Charleston Gazette piece makes clear that this “safe” level was first derived by CDC late in the evening of Jan. 9, the day the spill was first discovered.

Bear in mind CDC set the 1 ppm level:

  • before CDC had any data other than a single median lethal dose (LD50) value cited in Eastman Chemical’s 2005 Material Safety Data Sheet for crude MCHM.
  • before CDC had knowledge of the existence of Eastman’s studies.
  • before Eastman provided any of those studies to CDC or state officials.
  • before CDC decided to switch from its indefensible reliance on the LD50 value to use a “no observed effect level” asserted by Eastman in a 1990 study of “pure MCHM,” a different test substance than that which actually spilled.
  • before CDC recommended that the state consider advising pregnant women not to drink the water until MCHM could not be detected, and the state did so.
  • before the announcement that a second chemical (actually a mixture called “PPH, stripped”) was present in and had leaked from the tank.
  • before concerns were raised about CDC’s reliance on a study that only examined MCHM’s toxicity by oral ingestion, in light of its claim that the water would be safe for all uses, including showering and bathing that would involve exposures through inhalation and dermal contact.

A CDC official, when asked about these and other concerns at last week’s press conference, stated unequivocally: “I can tell you: you can use your water however you like, you can drink it, you can bathe in it, you can use it however you like.” In support of that statement, she repeatedly invoked the third of what she called the three 10-fold “safety protection factors” used in CDC’s calculation as sufficient to account for each and every “lack of information on specific questions.”

Overloading the Third 10x Factor

The third 10-fold factor is what is known as a “database uncertainty factor.” It is intended to be applied where, for example, one has only a single study of a chemical’s toxicity, or studies done only on adult animals, or studies done in only one species of animal. In the present case, all three limitations apply—more than justifying use of the third 10-fold database uncertainty factor.

But in this case, we also have other major gaps and uncertainties: 

  • The Eastman study that CDC relied on looked only at short-term exposures and effects (it exposed rats and looked for effects over only a 28-day period).
  • Whether the study actually identified a no-effect level—as claimed by Eastman and apparently accepted at face value by CDC—has been questioned, with some arguing that effects were seen at the lowest dose tested (which would all by itself justify reducing the “safe” level by factor of 40). 
  • CDC appears never to have gained access to the full study report and underlying data, which is necessary to ascertain whether or not Eastman’s interpretation of the data is correct.
  • The study, conducted in 1990, used an old protocol dating back to 1981. That protocol has been significantly upgraded at least twice in the intervening two decades to address deficiencies in the original protocol and include important health endpoints such as neurotoxicity, immunotoxicity and endocrine disruption that were clearly not examined in the Eastman study. 
  • The test substance used in the study was pure MCHM, and only contained one (albeit the major one) of the six synthetic chemicals present in the crude MCHM, which was the substance that actually spilled.
  • The study obviously did not examine the toxicity of what we now know was a second mixture of chemicals—“PPH, stripped”—that was also present in the tank, which contains four additional chemicals.
  • The study considered toxicity by only one route of exposure—oral ingestion—despite the obvious potential for exposure by other routes.
  • The effectiveness of the flushing procedures being employed for MCHM is unstudied and hence unknown. Both sampling data and reports of residual odor indicate the chemical is still present in parts of the distribution system a month after the spill and despite extensive flushing. This situation—coupled with the lack of sampling data at the actual point of exposure, i.e., in residents’ homes—calls into question what assumptions should be used as to the levels and durations of exposure.

To use, as CDC did, a single 10-fold factor to account for all of these myriad data gaps and uncertainties is wholly inadequate. It also deviates from standard risk assessment practice. For example:

The U.S. Environmental Protection Agency (EPA)’s risk assessment guidance calls for use of an additional 10-fold uncertainty factor to extrapolate from acute or short-term effects and exposures to longer-term ones.

Where the only studies available find effects at the lowest dose of a chemical tested, the EPA typically uses a 10-fold factor to account for starting with a lowest-observable-adverse-effect level (LOAEL) instead of a no-observable-adverse-effect level (NOAEL); see pp. 46-7 here.

Finally, rather than try to cram the uncertainty due to lack of data on toxicity by other routes of exposure into the same 10-fold database uncertainty factor—as CDC did—the EPA often applies a separate “relative source contribution” factor (or RSC) to account for the additive nature of other sources of exposure to a given chemical. In the absence of data to the contrary, the EPA typically assumes that the exposure route for which data exist—in this case oral ingestion—accounts for 20 percent of total exposure. That amounts to another five-fold factor.

While the EPA does not always apply the RSC in calculations for shorter-term exposures, it does so in setting Provisional Health Advisory values “developed to provide information in response to an urgent or rapidly developing situation;” see the EPA’s Provisional Health Advisories for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) (p. 3). Clearly, CDC could and should have done so in this case.

CDC Still Erroneously Maintains Its 1000-Fold “Blanket of Protection” is Highly Conservative

In last week’s press conference, a CDC official doubled down on CDC’s claim that its calculations of the “safe” level were highly conservative. Consider these statements made by the official:

“The levels are really 1000-fold more protective than those that were shown to cause harm.”

“The blanket of protection we have put of 1000 is an extremely strong blanket of protection and would prevent any harm at the levels.”

As I have noted in an earlier post, these statements indicate a fundamental misunderstanding or misrepresentation of the nature of, and the intent behind applying, the various uncertainty factors—which CDC continues to erroneously refer to as “safety factors.” I will repeat here what the National Academy of Sciences, in its 2009 report, Science and Decisions: Advancing Risk Assessment has to say on this subject (p. 132, emphases in original):

Another problem … is that the term uncertainty factors is applied to the adjustments made to calculate the RfD [reference dose, derived from, e.g., a no-effect level] to address species differences, human variability, data gaps, study duration and other issues. The term engenders misunderstanding: groups unfamiliar with the underlying logic and science of RfD derivation can take it to mean that the factors are simply added on for safety or because of a lack of knowledge or confidence in the process. That may lead some to think that the true behavior of the phenomenon being described may be best reflected in the unadjusted value and that these factors create an RfD that is highly conservative. But the factors are used to adjust for differences in individual human sensitivities, for humans’ generally greater sensitivity than test animals’ on a milligrams-per-kilogram basis, for the fact that chemicals typically induce harm at lower doses with longer exposures, and so on. At times, the factors have been termed safety factors, which is especially problematic given that they cover variability and uncertainty and are not meant as a guarantee of safety.

What Should CDC Have Done?

Yesterday's article in the Charleston Gazette quotes me saying that state and federal officials "were faced with the clearly daunting task of having exceedingly limited information to go on as they tried to assess and communicate about the risks of a chemical contaminating the tap water of hundreds of thousands of people.”

I believe that. It was a thankless situation. I also believe, in the face of the extremely limited data available and the enormous uncertainties involved, CDC should have refused to recommend a “safe” level and made clear there was no scientific basis for setting one. Instead, CDC and the state of West Virginia should have told affected residents to avoid contact with the water until the chemical could not be detected—something they did for pregnant women a week into the spill.

As a practical matter, that decision would have effectively applied a 100-fold actual safety factor, because the limit of detection for MCHM in the sampling officials have conducted is at 10 parts per billion, a level 100-fold lower than the 1 ppm level. It appears that, with some exceptions, that no-detect level is being achieved in most of the distribution system—with the major caveat that the lack of sampling in residents’ homes is a remaining large unknown.

While this idea of CDC refusing to set a level may sound extreme to some, it would have actually reflected the available science. It would also have avoided much of the ensuing missteps by and mistrust of government officials that we’ve witnessed.

In an interview Thursday, Rafael Moure-Eraso, the Chairman and Chief Executive of the U.S. Chemical Safety Board, which is investigating the spill, put it succinctly: “There should be no MCHM in drinking water….period. There is no safe level.”

Visit EcoWatch’s WATER and COAL pages for more related news on this topic.

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Guillain-Barre syndrome occurs when the body's own immune system attacks and injures the nerves outside of the spinal cord or brain – the peripheral nervous system. Niq Steele / Getty Images

By Sherry H-Y. Chou, Aarti Sarwal and Neha S. Dangayach

The patient in the case report (let's call him Tom) was 54 and in good health. For two days in May, he felt unwell and was too weak to get out of bed. When his family finally brought him to the hospital, doctors found that he had a fever and signs of a severe infection, or sepsis. He tested positive for SARS-CoV-2, the virus that causes COVID-19 infection. In addition to symptoms of COVID-19, he was also too weak to move his legs.

When a neurologist examined him, Tom was diagnosed with Guillain-Barre Syndrome, an autoimmune disease that causes abnormal sensation and weakness due to delays in sending signals through the nerves. Usually reversible, in severe cases it can cause prolonged paralysis involving breathing muscles, require ventilator support and sometimes leave permanent neurological deficits. Early recognition by expert neurologists is key to proper treatment.

We are neurologists specializing in intensive care and leading studies related to neurological complications from COVID-19. Given the occurrence of Guillain-Barre Syndrome in prior pandemics with other corona viruses like SARS and MERS, we are investigating a possible link between Guillain-Barre Syndrome and COVID-19 and tracking published reports to see if there is any link between Guillain-Barre Syndrome and COVID-19.

Some patients may not seek timely medical care for neurological symptoms like prolonged headache, vision loss and new muscle weakness due to fear of getting exposed to virus in the emergency setting. People need to know that medical facilities have taken full precautions to protect patients. Seeking timely medical evaluation for neurological symptoms can help treat many of these diseases.

What Is Guillain-Barre Syndrome?

Guillain-Barre syndrome occurs when the body's own immune system attacks and injures the nerves outside of the spinal cord or brain – the peripheral nervous system. Most commonly, the injury involves the protective sheath, or myelin, that wraps nerves and is essential to nerve function.

Without the myelin sheath, signals that go through a nerve are slowed or lost, which causes the nerve to malfunction.

To diagnose Guillain-Barre Syndrome, neurologists perform a detailed neurological exam. Due to the nerve injury, patients often may have loss of reflexes on examination. Doctors often need to perform a lumbar puncture, otherwise known as spinal tap, to sample spinal fluid and look for signs of inflammation and abnormal antibodies.

Studies have shown that giving patients an infusion of antibodies derived from donated blood or plasma exchange – a process that cleans patients' blood of harmful antibodies - can speed up recovery. A very small subset of patients may need these therapies long-term.

The majority of Guillain-Barre Syndrome patients improve within a few weeks and eventually can make a full recovery. However, some patients with Guillain-Barre Syndrome have lingering symptoms including weakness and abnormal sensations in arms and/or legs; rarely patients may be bedridden or disabled long-term.

Guillain-Barre Syndrome and Pandemics

As the COVID-19 pandemic sweeps across the globe, many neurologic specialists have been on the lookout for potentially serious nervous system complications such as Guillain-Barre Syndrome.

Though Guillain-Barre Syndrome is rare, it is well known to emerge following bacterial infections, such as Campylobacter jejuni, a common cause of food poisoning, and a multitude of viral infections including the flu virus, Zika virus and other coronaviruses.

Studies showed an increase in Guillain-Barre Syndrome cases following the 2009 H1N1 flu pandemic, suggesting a possible connection. The presumed cause for this link is that the body's own immune response to fight the infection turns on itself and attacks the peripheral nerves. This is called an "autoimmune" condition. When a pandemic affects as many people as our current COVID-19 crisis, even a rare complication can become a significant public health problem. That is especially true for one that causes neurological dysfunction where the recovery takes a long time and may be incomplete.

The first reports of Guillain-Barre Syndrome in COVID-19 pandemic originated from Italy, Spain and China, where the pandemic surged before the U.S. crisis.

Though there is clear clinical suspicion that COVID-19 can lead to Guillain-Barre Syndrome, many important questions remain. What are the chances that someone gets Guillain-Barre Syndrome during or following a COVID-19 infection? Does Guillain-Barre Syndrome happen more often in those who have been infected with COVID-19 compared to other types of infections, such as the flu?

The only way to get answers is through a prospective study where doctors perform systematic surveillance and collect data on a large group of patients. There are ongoing large research consortia hard at work to figure out answers to these questions.

Understanding the Association Between COVID-19 and Guillain-Barre Syndrome

While large research studies are underway, overall it appears that Guillain-Barre Syndrome is a rare but serious phenomenon possibly linked to COVID-19. Given that more than 10.7 million cases have been reported for COVID-19, there have been 10 reported cases of COVID-19 patients with Guillain-Barre Syndrome so far – only two reported cases in the U.S., five in Italy, two cases in Iran and one from Wuhan, China.

It is certainly possible that there are other cases that have not been reported. The Global Consortium Study of Neurological Dysfunctions in COVID-19 is actively underway to find out how often neurological problems like Guillain-Barre Syndrome is seen in hospitalized COVID-19 patients. Also, just because Guillain-Barre Syndrome occurs in a patient diagnosed with COVID-19, that does not imply that it was caused by the virus; this still may be a coincident occurrence. More research is needed to understand how the two events are related.

Due to the pandemic and infection-containment considerations, diagnostic tests, such as a nerve conduction study that used to be routine for patients with suspected Guillain-Barre Syndrome, are more difficult to do. In both U.S. cases, the initial diagnosis and treatment were all based on clinical examination by a neurological experts rather than any tests. Both patients survived but with significant residual weakness at the time these case reports came out, but that is not uncommon for Guillain-Barre Syndrome patients. The road to recovery may sometimes be long, but many patients can make a full recovery with time.

Though the reported cases of Guillain-Barre Syndrome so far all have severe symptoms, this is not uncommon in a pandemic situation where the less sick patients may stay home and not present for medical care for fear of being exposed to the virus. This, plus the limited COVID-19 testing capability across the U.S., may skew our current detection of Guillain-Barre Syndrome cases toward the sicker patients who have to go to a hospital. In general, the majority of Guillain-Barre Syndrome patients do recover, given enough time. We do not yet know whether this is true for COVID-19-related cases at this stage of the pandemic. We and colleagues around the world are working around the clock to find answers to these critical questions.

Sherry H-Y. Chou is an Associate Professor of Critical Care Medicine, Neurology, and Neurosurgery, University of Pittsburgh.

Aarti Sarwal is an Associate Professor, Neurology, Wake Forest University.

Neha S. Dangayach is an Assistant Professor of Neurology and Neurosurgery, Icahn School of Medicine at Mount Sinai.

Disclosure statement: Sherry H-Y. Chou receives funding from The University of Pittsburgh Clinical Translational Science Institute (CTSI), the National Institute of Health, and the University of Pittsburgh School of Medicine Dean's Faculty Advancement Award. Sherry H-Y. Chou is a member of Board of Directors for the Neurocritical Care Society. Neha S. Dangayach receives funding from the Bee Foundation, the Friedman Brain Institute, the Neurocritical Care Society, InCHIP-UConn Center for mHealth and Social Media Seed Grant. She is faculty for emcrit.org and for AiSinai. Aarti Sarwal does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Reposted with permission from The Conversation.


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Unity Task Forces formed by presumptive Democratic presidential nominee Joe Biden and Sen. Bernie Sanders unveiled sweeping party platform recommendations Wednesday that—while falling short of progressive ambitions in a number of areas, from climate to healthcare—were applauded as important steps toward a bold and just policy agenda that matches the severity of the moment.

"We've moved the needle a lot, especially on environmental justice and upping Biden's ambition," said Sunrise Movement co-founder and executive director Varshini Prakash, a member of the Biden-Sanders Climate Task Force. "But there's still more work to do to push Democrats to act at the scale of the climate crisis."

The climate panel—co-chaired by Rep. Alexandria Ocasio-Cortez (D-N.Y.) and former Secretary of State John Kerry—recommended that the Democratic Party commit to "eliminating carbon pollution from power plants by 2035," massively expanding investments in clean energy sources, and "achieving net-zero greenhouse gas emissions for all new buildings by 2030."

In a series of tweets Wednesday night, Ocasio-Cortez—the lead sponsor of the House Green New Deal resolution—noted that the Climate Task Force "shaved 15 years off Biden's previous target for 100% clean energy."

"Of course, like in any collaborative effort, there are areas of negotiation and compromise," said the New York Democrat. "But I do believe that the Climate Task Force effort meaningfully and substantively improved Biden's positions."

 

The 110 pages of policy recommendations from the six eight-person Unity Task Forces on education, the economy, criminal justice, immigration, climate change, and healthcare are aimed at shaping negotiations over the 2020 Democratic platform at the party's convention next month.

Sanders said that while the "end result isn't what I or my supporters would've written alone, the task forces have created a good policy blueprint that will move this country in a much-needed progressive direction and substantially improve the lives of working families throughout our country."

"I look forward to working with Vice President Biden to help him win this campaign," the Vermont senator added, "and to move this country forward toward economic, racial, social, and environmental justice."

Biden, for his part, applauded the task forces "for helping build a bold, transformative platform for our party and for our country."

"I am deeply grateful to Bernie Sanders for working with us to unite our party and deliver real, lasting change for generations to come," said the former vice president.

On the life-or-death matter of reforming America's dysfunctional private health insurance system—a subject on which Sanders and Biden clashed repeatedly throughout the Democratic primary process—the Unity Task Force affirmed healthcare as "a right" but did not embrace Medicare for All, the signature policy plank of the Vermont senator's presidential bid.

Instead, the panel recommended building on the Affordable Care Act by establishing a public option, investing in community health centers, and lowering prescription drug costs by allowing the federal government to negotiate prices. The task force also endorsed making all Covid-19 testing, treatments, and potential vaccines free and expanding Medicaid for the duration of the pandemic.

"It has always been a crisis that tens of millions of Americans have no or inadequate health insurance—but in a pandemic, it's potentially catastrophic for public health," the task force wrote.

Dr. Abdul El-Sayed, a former Michigan gubernatorial candidate and Sanders-appointed member of the Healthcare Task Force, said that despite major disagreements, the panel "came to recommendations that will yield one of the most progressive Democratic campaign platforms in history—though we have further yet to go."

 

Observers and advocacy groups also applauded the Unity Task Forces for recommending the creation of a postal banking system, endorsing a ban on for-profit charter schools, ending the use of private prisons, and imposing a 100-day moratorium on deportations "while conducting a full-scale study on current practices to develop recommendations for transforming enforcement policies and practices at ICE and CBP."

Marisa Franco, director of immigrant rights group Mijente, said in a statement that "going into these task force negotiations, we knew we were going to have to push Biden past his comfort zone, both to reconcile with past offenses and to carve a new path forward."

"That is exactly what we did, unapologetically," said Franco, a member of the Immigration Task Force. "For years, Mijente, along with the broader immigrant rights movement, has fought to reshape the narrative around immigration towards racial justice and to focus these very demands. We expect Biden and the Democratic Party to implement them in their entirety."

"There is no going back," Franco added. "Not an inch, not a step. We must only move forward from here."

Reposted with permission from Common Dreams.

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