Posted on October 13, 2016
Along with the flood of news coverage of the Flint water crisis comes the flood of litigation. So far, early indications show a wrong in search of a remedy, and for criminal defendants, just the expected plea deals. Here are some highlights.
In April, a federal district judge dismissed for lack of subject matter jurisdiction a §1983 claim for “safe and portable water” as preempted by the Safe Drinking Water Act. The case is on appeal.
Class actions have been filed against state and municipal officials in federal court, the Michigan Court of Claims, and Genesee County Circuit Court, seeking damages for personal injuries, property damages, and relief from water bills. Along with the usual governmental immunity defense, defendants assert a statute of limitations defense, with a fair likelihood of success. The governmental immunity defense is complicated by Governor Snyder admitting fault. That admission strengthens plaintiffs’ gross negligence exception to governmental immunity.
So far, the Attorney General’s criminal charges have resulted in the usual plea deals by underlings. The Flint water quality supervisor whom I lauded in a previous post as the only principled public servant in this mess (a position with which the Attorney General agrees) pled no contest to willful neglect of duty; the plea is essentially nothing, because the court took the plea under advisement with dismissal in one year if the supervisor cooperates with the investigation. A state official reached a second plea deal, pleading no contest to willful neglect of duty regarding an outbreak of legionnaire’s disease with the usual cooperation clause.
Politics saturates the Flint legal landscape. Attorney General Bill Schuette is widely expected to run for governor in 2018 and must therefore appear to be doing something, such as filing an unusual professional negligence and public nuisance claim against the Flint outside engineering firms. And when the Flint mayor notified Michigan of intent to sue the state, the state receivership board with continuing jurisdiction over Flint removed the city’s authority to sue.
Posted on October 3, 2016
Starting October 1, 2016, Montgomery County, Maryland, requires that before a single family home is sold, it must be tested for radon. The law applies both to existing homes and newly constructed homes being sold for the first time. The law permits either the seller or buyer to perform the test, but both parties must receive a copy of the results, and the test must be performed using a County-approved device. The law does not require that action be taken, or any remediation be performed, regardless of the test results.
Radon hasn’t been in the news much recently, so here’s the CliffsNotes summary: radon is a naturally occurring, odorless and colorless gas that results from the decay of certain radioactive soils and rocks, including uranium and radium. Those substances are present in many areas of the country, including those that have never had a working uranium mine (such as Montgomery County, Maryland, which abuts Washington, DC). People exposed to high levels of radon are at a higher risk for lung cancer, especially if they also smoke. According to the National Cancer Institute’s website, radon is the second leading cause of lung cancer in the United States, and scientists estimate that 15,000 to 22,000 lung cancer deaths in the United States each year are related to radon.
Although the EPA has established guidance levels for radon--currently the agency suggests that people consider taking action if the level of radon in their home exceeds 4 picocuries per liter (pCi/L) of air--there are no enforceable federal radon law laws, and a quick review of state and local laws did not reveal any other jurisdictions that require testing or abatement. Some laws do require disclosure if the seller of a home has knowledge of the presence of radon. The Montgomery County mandatory testing law appears to be one of the first—if not the first--in the nation.
So why is Montgomery County a radon pioneer? The County is affluent, its population well educated, its politicians usually progressive, and as it is home to offices of agencies such as National Institutes of Health (NIH), and National Oceanographic and Atmospheric Administration (NOAA), it has been generally been receptive to environmental concerns. While the County is classified by the EPA as being located in an area with the highest potential for radon (compared to the rest of the country), radon has not been much in the local news.
At the Federal level, in 2015, a number of federal agencies and some private groups (including the American Lung Association) launched the National Radon Action Plan, a long range strategy with the goal (among others) of mitigating 5 million high radon homes by 2020. Still, in the country as a whole, publicity and awareness about radon appears relatively low, compared to other environmental health issues, such as the public water crisis in Flint, Michigan.
So: is the Montgomery County radon law a harbinger of things to come nationally, or it is an outlier? Take a deep breath, then take a guess.
Posted on March 31, 2015
Way back around the turn of the decade from the ‘70s to the ‘80s I was invited by the International Joint Commission to attend a conference in Montreal to discuss whether the Canadians should adopt a statute similar to the Toxics Substances Control Act of 1976 (“TSCA”). The IJC is a largely advisory US-Canadian body whose primary area of interest is the Great Lakes. Also on that delegation was the principal author of the text of TSCA, Clarence (“Terry”) Davies. I did not win many friends on that trip when I argued that TSCA took the wrong approach to regulating chemicals in the stream of commerce and in the environment primarily because it used an inappropriate cost-benefit premised standard of review. I also argued that TSCA’s standards were simultaneously too vague and too complex. I suggested that the Canadians start afresh.
In the years following, Congress ignored repeated calls for significant amendment or replacement of TSCA, including a chorus of suggestions that it be replaced by a statute resembling the European Community’s chemical regulatory regime, REACH. In the meantime, EPA soldiered along, trying to make the best of enforcing an antiquated and fundamentally flawed regulatory statute.
Now after all these years we have two competing bills in the Senate, each of which purports to “reform” TSCA. On the one hand we have S.697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act”, an allegedly “bipartisan” effort co-sponsored by Senators Mark Udall (D-N.M.) and David Vitter (R-La.), the first hearing on which was held on March 18th. And from another corner, we have S.725, the “Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act”, co-sponsored by Senators Barbara Boxer (D-Calif.) and Ed Markey (D.Mass.). At about 175 legislative pages, these bills aren’t capable of being thoroughly analyzed in a blog.
The Udall bill is tepidly supported by the chemical industry and by at least one environmental group, the Environmental Defense Fund. It is opposed by some other environmental and public safety advocacy groups. It would pre-empt state chemical regulatory programs like California’s Proposition 65 and other state-run chemical regulatory programs in California and Washington. The Boxer bill, predictably, because its principal sponsor is from California, preserves state programs. Both bills in one degree or another attempt to address the core problems with TSCA by changing the standard of review to a risk-based standard, overhauling and strengthening EPA’s information gathering authority on hazard, exposure and use data, and prioritizing chemicals for review. The Udall bill throws a bone to the chemical industry by exempting a wide variety of chemicals considered to be of low exposure potential or low risk.
I confess that, although I am not a policy wonk, I have an interest in these bills partly because if either — or a significant element of either — is enacted into law I will have to re-write an entire chapter of The Law of Chemical Regulation and Hazardous Waste. My guess is that, given Congress’s track record of doing little or nothing over the last few years, I won’t have to worry about getting writer’s cramp any time soon.
Posted on January 27, 2015
On December 17, 2014, New York State’s Department of Environmental Conservation (DEC) announced that high volume hydraulic fracturing to recover natural gas (a/k/a “fracking”) will be banned on a state-wide basis. Is this good law, good science, good policy (or politics)? Perhaps the most important question is who should decide – states or local governments?
The DEC’s decision to ban fracking is based on the recommendation of the state’s Department of Health (DOH), which just completed a two-year study of the state of the science on the environmental and public health risks posed by fracking. DEC requested this study after it received over 13,000 public comments on its 2009 draft programmatic environmental impact statement (EIS) for a proposed fracking permit program in New York State.
The DOH study concluded that the cumulative body of scientific information demonstrates that there are “significant uncertainties” about the environmental and public health risks of fracking --- including air pollution, drinking water contamination, surface water contamination, earthquakes, and community impacts such as increased vehicle traffic, noise and odor problems. The DOH concluded that “it would be reckless to proceed in New York until more authoritative research is done.”
In accepting DOH’s recommendation, DEC noted that its own review had identified dozens of potentially significant adverse impacts from fracking, and concluded that “the risks substantially outweigh any potential economic benefits” from fracking. The Commissioner of DEC directed staff to complete the final programmatic EIS for fracking early this year, after which the fracking ban will be put into place. (No fracking has been permitted in New York State in the interim.)
The DEC decision follows a June 2014 ruling by the New York’s highest court affirming local governments’ authority under the state’s constitution and statutes to use zoning laws to ban fracking in their jurisdictions.
There are good policy reasons for leaving the decision of whether to allow fracking up to local communities. After all, they bear most of the environmental and potential public health risks that fracking poses. Local communities may be in the best position to decide whether those risks, or even perceived risks, are worth the economic benefits that fracking development can bring to local economies. The Town of Dryden and Cooperstown cases make it clear that citizens and neighbors do not always agree on the right outcome for their communities.
But many of the local controversies seem to be based, at least in part, on citizens’ differing perceptions of the nature and level of risk that fracking poses to their environment and health. Surely, the scientists in the state departments of health and environmental conservation are in a better position to evaluate that risk than local governments or individual citizens. By making this science-based decision on behalf of all its citizens (whether you agree with it or not), New York State should be given credit for stepping up to perform one of the most basic responsibilities of state government – protecting the public health.
Posted on December 3, 2013
On November 21, 2013 the Delaware Supreme Court issued a final ruling on an appeal closing out a long saga of litigation over the scientific evidence proffered in support claims of birth defects among children born to workers in the semiconductor manufacturing industry. In Tumlinson v. Advanced Micro Devices, the Supreme Court affirmed the trial court’s decision to exclude the plaintiffs’ key medical causation expert on Daubert grounds and thus dismissed one of the lead cases advancing the theory that working in so-called “clean rooms,” used for semiconductor wafer manufacturing, is unhealthy and can lead to birth defects in the offspring of such workers.
Wendolyn Tumlinson, one of the two adult plaintiffs, had worked at an AMD manufacturing site in San Antonio, Texas and her son was born with several birth defects, including anal atresia and stenosis, neurogenic bladder, renal agenesis/hypoplasia, imperforate anus and colo-vesicular fistula. The other adult plaintiff was married to Anthony Ontiveros who had worked at an AMD semiconductor manufacturing site in Austin, Texas and her daughter was born with several birth defects, including pulmonic stenosis, congenital pulmonary valve atresia, ventricular septal defect, right pulmonary hypoplasia, lower limb reduction defects, and situs inversus with dextrocardia. Each mother claimed that the exposures to chemicals in clean rooms were the cause of their child’s birth defects.
Plaintiffs filed their complaint on July 11, 2008 and for the next two years the parties engaged in discovery and motion practice. In December 2010, AMD moved to exclude the expert opinion of the plaintiffs’ expert, Dr. Linda Frazier, claiming it was unreliable and not relevant under Delaware Rule of Evidence 702. In April 2011, the trial court held a four-day Daubert-type evidentiary hearing to evaluate the admissibility of Dr. Frazier’s testimony and concluded that because her methodology was inadequate to establish causation under Texas substantive law (including the Texas’ courts’ interpretation of Daubert), it accordingly failed to satisfy Delaware procedural law and was excluded. As a result of the exclusion, judgment was entered for defendant AMD.
On appeal, the Delaware Supreme Court (there is no intermediate appellate court in Delaware), first remanded the case to the trial court with direction to determine the reliability of Dr. Frazier’s opinion under Delaware (as opposed to Texas) law. This time the trial court evaluated the reliability of Dr. Frazier’s testimony under the US Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals case principles as interpreted under Delaware law, and found Dr. Frazier’s opinion failed to meet that standard.
The Delaware Supreme Court then evaluated the trial court’s second decision and affirmed its conclusion. It focused on, among other things, Dr. Frazier’s failure to base her opinion on studies that were specific to (1) the clean room chemicals the parents were exposed to, and (2) the specific birth defect outcomes the plaintiff children suffered from. It also found that neither Dr. Frazier’s methodology for evaluating the medical literature, nor her conclusions, were peer reviewed or had appeared in any peer reviewed journals. It rejected an argument by plaintiffs that an affidavit submitted by other experts retained by the plaintiffs that “endorsed” Dr. Frazier’s opinion sufficed as a peer review. Further, the Court was critical of the expert’s opinion because it was not consistent with her research and writing outside of the pure litigation context.
As a result of this decision, the Tumlinson case is likely over (the deadline for the plaintiffs to seek en banc review by the Delaware Supreme Court is December 2, 2013). The decision may have a significant impact on the multiple other, nearly identical cases pending in Delaware against most of the major semiconductor manufacturers, as well as similar cases pending in many other state court jurisdictions.
Posted on July 30, 2013
Earlier this month the FDA proposed an “action level” of 10 ppb for inorganic arsenic in apple juice (down from 23 ppb), bringing it to the same level as EPA’s drinking water MCL. One may view this action as the culmination of a campaign of sorts initiated by a 2011 Consumer Reports article whose cause was taken up by Dr. Oz. Yet, the FDA has been monitoring arsenic levels for many years and has never viewed the data as any cause for concern. Should we now believe that the FDA has made us completely safe by adopting a drinking water standard for juice? In a practical sense, yes, but in EPA-Superfund speak, not really; and that is the point of this post.
The poisonous propensities of arsenic have been the stuff of history and literature for centuries; the Poison of Kings and the King of Poisons. Remember elderberry wine from Arsenic and Old Lace? But, arsenic is, after all, not only naturally occurring but rather ubiquitous. The human race has managed to live with some level of arsenic for a few millennia now without evident consequence. Indeed, because of naturally occurring arsenic in groundwater in the western United States, the MCL is actually set “considering cost, benefits and the ability of public water systems to detect and remove contaminants using suitable treatment technologies.” If, in contrast, one turns to the gold-standard of “safe,” the one in a million excess cancer risk level, the drinking water standard required is .02 ppb; that’s right folks, 500 times lower than the current MCL and FDA’s proposed new juice level.
What does it mean? I think it points out that the ultra-conservatism of the “10 to the minus six” environmental risk standard leads to absurd results and hugely unnecessary costs. I still recall with a smile a quite notorious Superfund site (which shall remain nameless to protect a client) that had literally dozens and dozens of polysyllabic chemicals at high levels in soils, groundwater and waste disposal units throughout several hundred acres. In the baseline risk assessment, the only risk to exceed the 10-6 level was that from naturally occurring arsenic in the soil!
The more we know about the genetic basis and causes of cancer, the more we realize how poorly both our animal models and in vitro experiments perform in predicting cancerous effects. (See E. Topol, The Creative Destruction of Medicine (Basic Books 2011) for a good discussion of the limitations and frustrations of our current methods and models for finding cancer fighting drugs.) While we are a long way from tossing EPA’s current approach to carcinogenic risk, we should perhaps take into account far more than we do now the inherent limits of our understanding and incorporate more the practical necessity for “cost, benefits and the ability” to “remove contaminants using suitable treatment technologies.” And yes, my grandchildren will continue to drink their apple juice.
Posted on November 13, 2012
Eighty percent of all the antibiotics sold in the United States are given to farm animals – not humans. Most of these animals aren't even sick. It's standard practice on factory farms, as a substitute for better management practices, to routinely dose healthy pigs, cows, and chickens with antibiotics that are vital for treating human disease. As a result of this non-therapeutic antibiotic use, these farms have become breeding grounds for superbugs--dangerous germs that can't be knocked out with the usual medicines. And that puts human health at risk.
The Natural Resources Defense Council, where I serve as Executive Director, has been at the forefront of this issue. In response to an NRDC initiated lawsuit, twice this year a federal court ordered the FDA to take action. In March, the court required the FDA to withdraw approval for the use of penicillin and tetracyclines in animal feed, unless drug manufacturers can prove this practice is not a public health risk. In June, the court directed the FDA to reconsider its denial of two citizen petitions on antibiotic use in livestock, saying “The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits.”
Superbugs can travel off farms and contaminate the surrounding air and water, as well as our food supply, which puts people at risk of acquiring serious and even life-threatening infections. In 2010, almost 52 percent of retail chicken breasts tested by the FDA were contaminated with antibiotic-resistant E. coli. Drug-resistant bacteria have been detected in air and drinking water near industrial hog farms in three states. Drug-resistant infections caused by antibiotic-resistant bacteria, including those generated by factory farms, have been estimated to cost Americans up to $35 billion every year.
The FDA has known for more than 30 years that antibiotic abuse on factory farms poses a risk to human health. In its March decision, the court determined that the FDA formally found back in 1977 that penicillin and tetracyclines had not been shown to be safe. In its June decision, concerning other antibiotics, the court pointed out that “the Agency has all but made a finding that the subtherapeutic use of antibiotics in food-producing animals has not been shown to be safe.” Nonetheless, the use of penicillin, tetracyclines, and other medically important antibiotics in livestock quadrupled between 1970 and 2009. The agency has not stopped the practice of routinely feeding antibiotics to healthy livestock, relying instead on "voluntary guidance" to address the issue.
The FDA has appealed the March and June decisions and remains focused on the failed strategy of allowing industry to use antibiotics as it chooses instead of standing up to protect public health. NRDC is fighting FDA’s appeals. Under an FOIA request, the FDA will begin releasing public health risk assessment documents on antibiotics to us. NRDC is also working with leading scientific organizations to keep public pressure on the FDA. Health groups from the CDC to the American Medical Association have spoken out against antibiotic abuse on industrial farms. Hundreds of thousands of citizens, including chefs, medical professionals, and progressive food companies, have called on the FDA to do its job and protect the health of our families.
It's time for the FDA to follow the law and do its job. The agency needs to curb antibiotic abuse on factory farms and protect antibiotics for those who need them most--sick people.
Posted on October 29, 2012
The aim of this post is to encourage environmental lawyers to pay more attention to issues and developments in human health risk assessment.
Remedial clean ups under Superfund and RCRA are very largely driven by human health risk assessments carried out under EPA’s Integrated Risk Information System (IRIS) as applied to chemicals on the site. The health-protective regulations under the Clean Air Act also are typically the product of statutorily mandated human health risk assessments. Mass tort cases seeking medical monitoring and personal injury are often based on such assessments. Just as the cost of clean up and CAA compliance are driven by these assessments, so too are numerous corporate decisions on what chemicals to use in manufacturing and commercial activity.
Despite its centrality to so many important activities, IRIS is cordoned off from most of the legal system. It is not rooted in or governed by any statute. Its results are not reviewable except in the context of their application to a particular site – and if that site is governed by Superfund, review, as a practical matter, is available only at the end of the remedial process. Perhaps because of this structure and because human health risk assessments are an intensely scientific undertaking, the presence of lawyers is very little felt.
Nonetheless, environmental lawyers should be aware of some on-going efforts aimed at examining and reforming IRIS and similar systems.
First, the Administrative Conference of the United States commissioned Prof. Wendy Wagner of the University of Texas School of Law to undertake a study entitled “Science in the Administrative Process: A Study of Agency Decisionmaking Approaches.” Prof. Wagner details in 80 pages how the processes of EPA (including IRIS), the Fish and Wildlife Service (endangered and threatened species listing) and the Nuclear Regulatory Commission use science in regulatory decision-making. These useful guides are followed by almost 40 pages of recommendations and suggestions of best practices on issues such as the role of OMB in reviewing proposed agency actions with a major scientific component and the right of staff scientists to dissent from agency actions. Not surprisingly, given Prof. Wagner’s professional background, most of the topics on which she focuses are readily accessible to lawyers.
On September 10, 2012, the Administrative Conference held a workshop open to the public on many of Prof. Wagner’s ideas and proposals. It did not appear to me that very many environmental lawyers were on the stage or in the audience, despite the fact that issues and reforms discussed were central to their professional lives.
Second, in 2009, the National Academies published “Science and Decisions: Advancing Risk Assessment.” The volume focuses on EPA and IRIS. It is a thorough review of the issues and challenges of risk assessment from scientists who are, from time to time, called on to review EPA’s handiwork. Although some of the advice is merely editorial – be succinct and to the point, one chart or figure can be worth a thousand words – the authors address many of the major scientific issues in risk assessment, e.g. the selection of default values given the known sensitivity of a lab animal to a chemical, the probable sensitivity of humans has to be “calculated” or how to treat cumulative risks where there is exposure to two or more chemicals.
EPA is now working on implementing many of the suggestions set out in “Science and Decisions.” In September, 2012, the comment period closed on the draft of EPA’s “Framework for Human Health Risk Assessment to Inform Decision Making.” This document responds in large part to “Science and Decisions,” addressing “the recommendation that EPA formalize and implement planning, scoping, and problem formulation in the risk assessment process and that the agency adopt a framework for risk-based decision making.” EPA is not done absorbing “Science and Decisions” and the National Research Council is not done with EPA. The Council will continue to review how EPA implements IRIS. There will be an emphasis on EPA’s weight-of-evidence analyses and recommended approaches for weighing scientific evidence for chemical hazard and dose-response assessments. See Review of the IRIS Process, National Academies Current Projects.
The ongoing initiatives will provide the structure and the process for human health risk assessments in the future. The work of environmental lawyers will be shaped by what the scientists decide. Environmental lawyers should be engaged in these debates and arguments now.