Shaping the Future of EPA

Posted on January 29, 2020 by Ridgway Hall

What should EPA and environmental protection look like in the future? A report issued by American University’s Center for Environmental Policy in December, entitled Moving Forward: Future Directions for EPA and Environmental Protection, provides 6 principal recommendations.

The report was written by John Reeder, Executive in Residence at the Center and a 30-year veteran of EPA, based on a conference that was cosponsored last April by AU’s School of Public Affairs (where the Center is housed), its law school and ELI, with a talented and diverse field of speakers including 4 former EPA Administrators.  It was also informed by 5 focus group reports prepared by the EPA Alumni Association, which helped organize the conference.

At ACOEL’s October meeting, Dan Esty issued a challenge to us to undertake a multi-year project to transform our environmental protection framework from the existing “command and control” regulations to one using primarily market-based incentives. On November 21, I posted a blog article titled Dan Esty’s Challenge to ACOEL: Let’s Do It. I pointed out that 25 years ago a wave of thoughtful studies recommended moving away from command and control regulation towards systems featuring multimedia permitting, ecosystem-wide approaches, financial incentives, marketable pollution rights and other innovations, but that very little had come of these.

So what’s changed? Among other things, there appears to be an increasing recognition that when a company acts because it is in its financial interest to do so rather than because a regulation is requiring it to do so, it is more economically efficient (the transaction costs are lower) and the managers are likely to feel better about the fact that they were free to make the choice. Shifting the emphasis in the implementation of environmental laws in this way can yield better outcomes within the underlying regulatory framework. This translates to political acceptance by both industry and the public. In addition, thanks in part to the internet, we have more scientific, technical and economic data regarding environmental issues, we have far more sophisticated methods of using and transmitting that data, and we have more sophisticated abilities to monitor actions and impacts.

Furthermore, the nature of our environmental challenges has expanded to include climate change, energy policies, loss of biodiversity, agricultural practices, water availability and distribution (not just quality), land use, and the environmental behavior and effects of manufacturing wastes like endocrine disruptors and microplastics. Many of these issues must be addressed by multiple federal departments or agencies (Interior, Energy, Agriculture, NOAA  and the Corps of Engineers to name a few). Some, like climate change and the protection of oceans and fisheries, must be addressed on an international basis. Most of these issues cannot be effectively addressed through regulatory controls alone. Finally, issues relating to allocation of costs, environmental justice and public acceptance have become more prominent.

The challenges facing EPA are of two types: 1) threats to the environment or human health, and 2) “system” challenges, reflecting in large part the statutory framework under which EPA addresses those threats. The AU report focuses on EPA’s institutional capacity rather than on  specific policy proposals. The 6 major recommendations are as follows:

  1. Pursue State of the Art Science Capability. EPA will need to keep abreast of rapidly emerging scientific challenges, manage data from numerous sources, and reestablish technical assistance as part of its core mission. Sound science must be a top priority.
  2. Renew the “Environmental Protection Enterprise”. This involves striking the right balance in its relationships with states and tribes between maintaining a level playing field and encouraging flexibility and innovation, partnering with private sector entities, and focusing on outcomes rather than just regulatory compliance. It includes working with other federal agencies and encouraging regional approaches involving multiple layers of government and the private sector (“cooperative federalism”), such as the Great Lakes and Chesapeake Bay initiatives.
  3. Strengthen International Cooperation. Because many of our biggest environmental challenges are global, like climate change and protection of ocean resources, EPA should work with the State Department and other relevant agencies to strengthen relationships with other countries and international organizations to share information and address these issues on an international scale.
  4. Harness the Power of Consumer Choice and the Marketplace.The use of pollution pricing, cap and trade programs and other market-based incentives should be promoted, with existing regulations largely left in place as a backstop. EPA should continue to encourage corporate sustainability programs, public information campaigns like the Toxic Release Inventory and ecolabeling.  
  5. Advance a Forward-looking Regulatory System. EPA’s regulatory programs should anticipate rapid technological change and make use of vastly expanding monitoring and reporting technologies. They should emphasize transparency and public accountability, help reduce the “overhead” costs of regulations, and include market-based approaches wherever possible.
  6. Engage the Public to Raise Awareness About the Environment. EPA should promote public awareness and education from elementary school through college on environmental issues, challenges and opportunities. Its regional offices should work with state and local entities to make scientific information and teaching materials and online instruction available.

There is a lot more in this report than I can summarize here. It is thoughtful and important reading for anyone interested in the future direction of EPA and environmental protection.

A Story of Homecoming: Kisor Helps Auer Find Its Way Back To Seminole Rock

Posted on January 28, 2020 by Sanne Knudsen

Shortly before the new year, when the holidays were in full swing, Kisor v. Wilkie celebrated its half-birthday.  That was quick.  Just six months ago – when short winter days were long summer nights, when peppermint mochas were cold beers served in frosted mugs – the U.S. Supreme Court decided by the narrowest of margins to spare the life of Auer deference, the strong form of deference that for decades had been routinely given to federal agencies for interpretations of their own ambiguous regulations.  In a splintered decision, Justice Kagan penned a decision in Kisor in which Justices Ginsburg, Breyer, and Sotomayor joined. Those four agreed that Auer deference is theoretically justified, that it does not undermine the APA or the Constitution, and that principles of stare decisis counsel for judicial restraint.

Notably, Justice Kagan failed to capture a majority on her justifications for Auer deference. This is important.  Before Kisor, the Supreme Court had never really provided a firm theoretical rationale for Auer deference.  After Kisor, the justifications for Auer deference are even more suspect given that only four Justices even agreed that the doctrine was a theoretically defensible idea.  Given those shaky foundations, it is not surprising that in order to save Auer, in order to earn the critical fifth vote from Chief Justice Roberts, Justice Kagan had to weaken it. She had to articulate a version of Auer that is more cabined in its scope and restrained in its application than has been common practice over the past few decades. In particular, she admonished lower courts to engage in a rigorous and independent review of an allegedly ambiguous agency regulation to determine if it is genuinely as advertised. She describes a framework for review that looks very much like the Chevron doctrine, only with more bite and with a warning label: this is a test that an agency can fail.

After six months, in a time of reflection and resolutions, we can pause from the heft of eggnog and the specter of twinkle lights to ask whether Kisor has made a discernible impact on the landscape of administrative law.  In doing so, we might observe two things: First, there has been an impact. Second, the new Auer is not really new at all.  In order to save Auer, Justice Kagan was not weakening it.  Rather, she was simply helping Auer return to its roots, reminding courts to engage in the rigorous, independent-style review that was commonplace at the time of its creation.  If we are prone to the sentimentality of the season, we might say that Kisor is a story of homecoming.

A bit of history might help us gain some perspective: Auer deference originated not with the 1997 case of Auer v. Robbins, but a half-century earlier with the 1946 case of Bowles v. Seminole Rock & Sand Co.  It began as a doctrine with significant constraints, at a vastly different moment in administrative law under in highly specific circumstances of the post-war era. To that end, it was applied only in the price control context and only to official agency interpretations. And notably, courts applying the doctrine took a heavy hand in examining the text of the regulation—often deferring only after engaging in an independent review of the regulatory text. In other words, the rigorous review that Kisor articulates follows closely the pattern of how courts approached Seminole Rock deference in the early years.

Over the course of thirty years, Seminole Rock became completely divorced from these modest and restrained origins. By the 1970s, it was transformed; it was mechanically applied and reflexively treated as a constraint upon the careful inquiry that one might ordinarily expect of courts engaged in textual analysis. With the transformation of both the doctrine and the administrative state, discomfort with the doctrine grew – first among scholars like John Manning in the mid-1990s and then in the Supreme Court jurisprudence about a decade ago. Eventually, we arrived at the doorstep of Kisor and now appear to have returned nearly full circle to Seminole Rock.

Early signs indicate that Kisor has been more than lip service. Ordinarily, six months is hardly enough time for a change like this to take root in the jurisprudence.  Kisor, however, has already been cited in over 80 judicial opinions.  Influential jurisdictions like the U.S. District Court for the District of Columbia have taken Kisor to heart and are engaging in rigorous textual review of agency regulations before deciding whether deference is warranted.  See, e.g., Stand Up for California! v. DOI  (emphasizing the courts obligation under Kisor to “exhaust[] all the traditional tools of construction to determine the meaning of the regulation”); cf. Am. Tunaboat Ass'n v. Ross (deferring only after engaging in rigorous review). The D.C. Circuit has even cited Kisor for the proposition that Chevron deference should not be “reflexively” given to agency interpretations. Mozilla Corp. v. FCC, (“[W]e do not apply Chevron reflexively, and we find ambiguity only after exhausting ordinary tools of the judicial craft.”).

Other circuits have similarly indicated that Auer deference is to be earned, not afforded as a matter of course. The Ninth Circuit, for example, declined to defer to the Department of Energy in a case alleging a violation of the Energy Policy and Conservation Act's error-correction rule. NRDC v. Perry (engaging in rigorous review of the regulatory language and declining to defer because “the absence of genuine ambiguity in the rule’s meaning precludes us from deferring to DOE’s contrary interpretation.”).  See also Romero v. Barr (citing Kisor to describe the demanding Auer framework, engaging in independent textual analysis, and declining to defer to the agency after finding the regulation unambiguous).

Of course, as with the application of other deference doctrines, the outcomes of cases involving Kisor review will vary greatly.  As the body of cases available for analysis grows, empiricists will undoubtedly have ample data to begin exploring the particular contours of Kisor’s impacts on judicial deference.  For now, however, a bird’s eye view of the early cases indicates that Auer is homeward bound.

The historical analysis provided in this post is based on the work of Sanne H. Knudsen & Amy J. Wildermuth, Unearthing the Lost History of Seminole Rock, 65 Emory L.J. 47 (2015). 

Sanne Knudsen is the Stimson Bullitt Endowed Professor of Environmental Law at the University of Washington.

The PFAS Battle Heats Up In The Northeast?

Posted on January 27, 2020 by Barry Needleman

New Hampshire, like many northeast states, is pursuing a concerted regulatory and litigation approach to address contamination from emerging contaminants in the so-called PFAS suite of chemicals, (per- and poly-fluoroalkyl substances).  Over the last few years, the State has enforced cleanups at certain manufacturing facilities, and required the provision of alternative water supplies in several communities.  Early in 2019, it began a rare, statutorily required rulemaking process to set drinking water and ambient groundwater quality rules for four chemicals - PFOA, PFOS, PFHxS and PFNA.  The new rules were approved in July 2019.

In late May 2019, New Hampshire also filed suit against the manufacturers of AFFF, the firefighting foam used at military bases, airports and fire training facilities.  This case was transferred to the AFFF multi-district litigation in South Carolina.  In a separate case, the State sued 3M, Dupont and Chemours for alleged investigation and clean-up costs incurred under the parens patriae theory, among other claims.  That case is in the initial stages of litigation.

Several plaintiffs (3M Company, a town water and sewer district, a sewage sludge disposal company and a farmer) challenged the new regulatory limits in Court.  In October 2019, the court ruled that the State had failed to perform an adequate cost/benefit analysis as required by statute.  Plymouth Village Water & Sewer District v. Scott, No. 217-2019-CV-00650, (N.H. Super. Ct., Nov.26, 2019). The final rules set standards that were 50-80% lower than the initially proposed limits, and the costs had increased by 1200%.  The State conceded it could not determine the benefits from the lower limits.  Consequently, the court issued a preliminary injunction, enjoining New Hampshire’s drinking water and groundwater quality limits.  The parties are preparing interlocutory appeals to the New Hampshire Supreme Court.  The case presents issues of first impression in New Hampshire, under its rulemaking statute and certain constitutional provisions limiting unfunded State mandates. 

And So It Goes, New WOTUS Rule Final

Posted on January 24, 2020 by Rick Glick

The EPA today announced that the Waters of the United States (WOTUS) rule, jointly proposed by EPA and the Army Corps of Engineers in June 2019, is now final.  The new rule replaces the 2015 Obama Administration’s rule, which EPA and the Corps rescinded last October. 

The Clean Water Act confers federal jurisdiction over “navigable” waters, defined in the Act as “waters of the United States, including the territorial seas.”  Congress left it to the agencies and courts to add meat to this skeletal definition. As it turns out, that has been no easy task. 

The agencies have tried multiple times to bring clarity to the scope of CWA jurisdiction, resulting in an enormous body of litigation and a few Supreme Court cases.  These cases culminated in the 2006 ruling in Rapanos v. U.S., in which a divided Supreme Court agreed that the government had overreached, but could not agree as to how.  Justice Scalia, writing for the plurality, would have limited jurisdiction to running waters and adjacent wetlands.  In a concurring opinion, Justice Kennedy instead would have conferred jurisdiction where there is a “significant nexus” to a navigable water.

The subsequent 2015 rule adopted the Kennedy approach, whereas the new 2020 rule follows Scalia.  As reported here, the new rules are not likely to implement the lofty goals of the CWA, to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.”  That is the conclusion of EPA’s own Science Advisory Board:

At the EPA Science Advisory Board (SAB) meeting on June 5-6, 2019, the SAB discussed the scientific and technical underpinnings of the proposed WOTUS rule and concluded that aspects of the proposed rule are in conflict with established science, the existing WOTUS rule developed based on the established science, and the objectives of the Clean Water Act.

Several states and environmental organizations have announced their intent to challenge the rule’s disregard for what is known about the interconnectedness of wetlands and running waters.  As quoted in the New York Times coverage of the new rule, ACOEL’s own Patrick Parenteau concisely summarized the case:  “The legal standing all has to do with whether you have a rational basis for what you’re doing. And when you have experts saying you’re not adhering to the science, that’s not rational, it’s arbitrary.”

Lawyers advising clients as to the reach of CWA jurisdiction can only recommend caution.  We will not have clarity on the scope of WOTUS any time soon.

Children’s Climate Case Coming to a Close

Posted on January 23, 2020 by Rick Glick

In an extraordinary opinion issued January 17, the Ninth Circuit U.S. Court of Appeals concluded that the redress sought by the Juliana v. United States plaintiffs is beyond the power of federal courts.  It is not the conclusion that is extraordinary, which was widely expected, but rather the court’s extended expression of dismay in having to reach it. 

Plaintiffs in this case are a group of young people alleging that through policies promoting or acquiescing to fossil fuels use, the federal government has violated their constitutional rights to a “climate system capable of sustaining human life.”  The court never reaches the merits of the case.

The basis for the court’s conclusion is that the plaintiffs lack standing, meaning the right to prosecute their case in federal courts.  There is a three-part test for standing.  First, the plaintiffs must show “concrete and particularized injury.”  Second, plaintiffs must show that their injury is caused by defendant.  Third, the plaintiffs must demonstrate that the alleged injury can be redressed by court order.  The court found that plaintiffs satisfied the first two prongs, but not the third.

The court noted that the “plaintiffs have compiled an extensive record” that the government “affirmatively promotes fossil fuel use in a host of ways,” from tax credits to extraction leases on public lands.  These policies “will wreak havoc on the Earth’s climate if unchecked.”  The court had no trouble finding particularized injury to specific plaintiffs and that there is a genuine issue as to whether these government policies are a “substantial factor” in plaintiffs’ injuries.  The harder question is what a court could or should do to remedy the problem.

The court found that the scope of the desired remedy—an injunction to end pro-fossil fuel policies and to direct the government to prepare a plan to reduce emissions—is better left to the political branches to resolve.  The court recognized the harm from government policies, which the government does not refute.  However, such an order is problematic because:

  • Plaintiffs own experts acknowledge that the injunction would not “suffice to stop catastrophic climate change or even ameliorate their injuries. . . . Rather, these experts opine that such a result calls for no less than a fundamental transformation of this country’s energy system, if not that of the industrialized world.”
  • “As the opinions of their experts make plain, any effective plan would necessarily require a host of complex policy decisions entrusted, for better or worse, to the wisdom and discretion of the executive and legislative branches.”
  • “Although the plaintiffs’ invitation to get the ball rolling by simply ordering the promulgation of a plan is beguiling, it ignores that an Article III court will thereafter be required to determine whether the plan is sufficient to remediate the claimed constitutional violation of the plaintiffs’ right to a ‘climate system capable of sustaining human life.’ We doubt that any such plan can be supervised or enforced by an Article III court. And, in the end, any plan is only as good as the court’s power to enforce it.”

The plaintiffs have indicated the case is not over, that they will seek reconsideration of the three-judge panel’s decision before the entire Ninth Circuit en banc, and possibly the Supreme Court.  Reconsideration rarely overturns decisions and bringing the case to the Supreme Court is risky.  If the Court accepts the case, the result may be an even more adverse standing ruling for such cases.  There are cases pending in which the relief sought is not so broad as in Juliana, cases in which states are asking for money damages for harm caused by government fossil fuel policies.  The Ninth Circuit’s denial of standing based on redressability may not be as limiting in those cases, as courts are accustomed to cases seeking damages.

Even if the Juliana case ends here, it will have served an important public service.  The plaintiffs’ tenacity—and the extraordinary advocacy by their attorney Julia A. Olson—have shone a spotlight on the abject failure of the government to address climate change.  The court expressed its sympathy to that effort and its regret at the limited ability of the judiciary to correct the government’s failure:

The plaintiffs have made a compelling case that action is needed; it will be increasingly difficult in light of that record for the political branches to deny that climate change is occurring, that the government has had a role in causing it, and that our elected officials have a moral responsibility to seek solutions. We do not dispute that the broad judicial relief the plaintiffs seek could well goad the political branches into action. We reluctantly conclude, however, that the plaintiffs’ case must be made to the political branches or to the electorate at large, the latter of which can change the composition of the political branches through the ballot box. That the other branches may have abdicated their responsibility to remediate the problem does not confer on Article III courts, no matter how well-intentioned, the ability to step into their shoes.

It was always unlikely that U.S. courts would feel empowered to issue orders to address so complex and global a problem.  The Trump Administration’s open hostility to aggressive action to restrain fossil fuels use—reaffirmed by the President at the Davos conference just this week—coupled with congressional inaction, suggests leaving the matter to the legislative and executive branches is a slim reed indeed.  But as the court concludes, Juliana and other climate cases make it harder for politicians to ignore the catastrophic consequences and get reelected.  The question is, how much more time do we have to take meaningful action?

Being On the Eve of Destruction Does Not Provide a Basis for Judicial Relief

Posted on January 23, 2020 by Seth Jaffe

Last week, the 9th Circuit Court of Appeals ruled that the plaintiffs in Juliana v. United States do not have standing.  Given where we are, this is about as momentous a decision as I can imagine.  I get the majority opinion.  Under traditional standing doctrine, it may even be right, though I think it’s a close call.

However, this is not a time for timidly falling back on the easy jurisprudential path.  Extraordinary times demand something extraordinary, from our judges as well as our elected leaders.  If our government is even around in a hundred years, I think that this decision will likely be seen as of a piece with Dred ScottPlessy v. Ferguson, and Korematsu

The cruel irony underlying the opinion is that it is the very scope of the climate problem and the comprehensive government response that it demands that is the basis of the court’s decision that courts are not in a position to oversee the response.  Is this the first case ever brought before our nation’s courts in which the court ruled that it could not grant relief, precisely because relief is so necessary?

I’ll note one other issue.  The majority opinion was clearly sympathetic to the plaintiffs, but ultimately concluded that:

the plaintiffs’ case must be made to the political branches or to the electorate at large.

What if, however, our legislative and executive branches are literally incapable of addressing climate change?  That’s pretty much the view of my intellectual hero, Daniel Kahneman.  If we are truly on the eve of destruction and Congress can’t do anything about it, must the courts remain powerless to step in?  And so I’ll leave you with the conclusion of the dissent:

Were we addressing a matter of social injustice, one might sincerely lament any delay, but take solace that “the arc of the moral universe is long, but it bends towards justice.” The denial of an individual, constitutional right—though grievous and harmful—can be corrected in the future, even if it takes 91 years. And that possibility provides hope for future generations.

Where is the hope in today’s decision? Plaintiffs’ claims are based on science, specifically, an impending point of no return. If plaintiffs’ fears, backed by the government’s own studies, prove true, history will not judge us kindly. When the seas envelop our coastal cities, fires and droughts haunt our interiors, and storms ravage everything between, those remaining will ask: Why did so many do so little?

COURT-ORDERED REDUCTIONS OF GREENHOUSE GASES? THE URGENDA AND JULIANA DECISIONS

Posted on January 22, 2020 by John C. Dernbach

Two major climate change cases were decided in the last month—State of the Netherlands v. Urgenda (Dec. 20, 2019) and Juliana v. United States (Jan. 17, 2020).  They illustrate sharply contrasting views about the role of courts in forcing reductions in greenhouse gas emissions.

The Urgenda decision, issued by the Supreme Court of the Netherlands, upheld lower court decisions in 2015 and 2018 requiring the national government to “reduce greenhouse gases by the end of 2020 by at least 25% compared to 1990.”  The government’s current goal of a 20% reduction by 2020, the Court held, violates Articles 2 and 8 of the European Convention on Human Rights (ECHR), a human rights treaty to which 47 nations are parties, including the Netherlands.  As our colleague Michael Gerrard has pointed out, this is the first judicial decision anywhere in the world to explicitly require a government to reduce its greenhouse gas emissions.  

Article 2 of the EHCR ‘protects the right to life,” and means that a nation has a “positive obligation to take appropriate steps to safeguard the lives of those within its jurisdiction.”  Article 8 “protects the right to respect for private and family life,” which includes a nation’s “positive obligation to take reasonable and appropriate measures to protect individuals against serious damage to their environment.”  Finally, and significantly, Article 13 “provides that if the rights and freedoms under the ECHR are violated, there exists the right to an effective remedy before a national authority.” 

Climate change science, the Court said, compels the conclusion that there is a “genuine threat of dangerous climate change,” and that the “lives and welfare of Dutch residents could be seriously jeopardized.”  In addition, “there is a high degree of international consensus” on the need to achieve at least a 25% reduction of greenhouse gas emissions by 2020 to prevent dangerous climate change.  The government violated its duties under the ECHR with a less ambitious short-term goal, the court held.  (The 2019 Dutch Climate Act sets a 49% reduction goal for 2030 and a 95% reduction goal for 2050, and there was no dispute about long-term goals.) 

The Supreme Court rejected the government’s argument that “it is not for the courts” to make political decisions “on the reduction of greenhouse gas emissions.”  ”The protection of human rights…is an essential component of a democratic state under the rule of law,” the Court said.  “This case involves an exceptional situation. After all, there is the threat of dangerous climate change.”  The government, not the courts, will decide which measures to employ to achieve the required reduction, the court explained.  

In the Juliana case, 21 young people are the principal plaintiffs in a lawsuit against the United States, claiming, among other things, a right under the Due Process Clause of the Fifth Amendment to a “climate system capable of sustaining human life.”  They developed a “substantial record” establishing the severity of existing and projected climate change impacts, and showing that the government had not only failed to act but that it “affirmatively promotes fossil fuel use in a host of ways.”  They sought declaratory and injunctive relief requiring the “government to implement a plan to ‘phase down fossil fuel emissions and draw down excess atmospheric [carbon dioxide].’”

The U.S. Court of Appeals for the Ninth Circuit, by a 2-1 vote, “reluctantly” held that youth plaintiffs did not have standing.  All three judges agreed that climate change caused by human activity presents grave, even existential, risks.  For the majority, Judge Andrew Hurwitz wrote that the plaintiffs met the first two requirements for standing—some had suffered concrete and particularized injuries, and their injuries were “fairly traceable to” carbon emissions.  But even assuming that there is a constitutional right to a “climate system capable of sustaining human life,” the court said, they do not meet the third requirement because “it is beyond the power of an Article III court to order, design, supervise, or implement the plaintiffs’ requested remedial plan.”

The plaintiffs had argued that the legislative and executive branches of government can figure out which particular measures to employ to “phase down fossil fuel emissions and draw down excess atmospheric [carbon dioxide].”  But even then, the court said, a court would have to decide whether the government’s response is sufficient.  There is no “limited and precise” standard, the majority wrote, by which a court could determine the adequacy of the government’s response.

Judge Josephine Staton’s lengthy dissenting opinion states that the plaintiffs are seeking to “enforce the most basic structural principle embedded in our system of ordered liberty: that the Constitution does not condone the Nation’s willful destruction.”  The discernible standard, she wrote, is “the amount of fossil-fuel emissions that will irreparably devastate our nation.”  This is a scientific question, she said, not a political one.  

Julia Olson, co-counsel for plaintiffs in the case, issued a statement saying the next step would be a petition for en banc review in the Ninth Circuit. 

As both cases indicate, there is no universal answer on the authority of courts to order reduction of greenhouse gas emissions, and this issue is not going away.

MAKING MIRACLES HAPPEN

Posted on January 21, 2020 by Charles F. Becker

I’ve known Drew Tierney since I was 10. I’d call him a friend, but he’d find a way to argue about it.  You know the type, they live to disagree – you desperately want to prove them wrong, but it never happens.

DT (as his friends call him) and I met for lunch last week. He was in fine form and clearly ready for a fight.  We ordered a beer and food and started watching a game.

DT: “So, it’s a good thing we finally got that Soleimani dude, right?”

DT is one of those people that put “right” at the end of every sentence so that you have to agree or become bait. I wasn’t in the mood.

Me: “I suppose, but we’ll just have to see where it goes.”

That seemed to satisfy him as he took a bite out of his chicken sandwich, then said:

“Does it really count as an impeachment if nothing is sent over to the Senate? That wouldn’t be fair, right?”

I chomped down hard on a piece of celery causing a neighboring table to stop talking for a moment. But I bit my tongue at the same time.

Me: “I’ll leave that one to the scholars.”

I could see DT process my comment and he apparently decided that yet another impeachment debate wasn’t worth the effort. He took another bite and said:

“It’s a real shame that the Dems can’t get their act together on that climate change thingy.”

He kind of spit out the word “thingy.” He knew that would do it  . . . and it did.

Me: “Climate change thingy? Are you kidding me? Climate change is a disaster, and everyone knows it!”

DT: “Really? Everyone?”

Finally!  One I could win.  I knew this stuff.

Me: “Do you know that 69% of all Americans believe that we need to take aggressive action to fight climate change?  And that includes 56% of Republicans and 71% of independents.  That’s pretty impressive.”

DT: “Yeah, but 43% say they wouldn’t pay a dime to deal with climate change.  And only 28% overall would be willing to pay even an extra $10 a month to help.  That’s $120 a year!  That means about two-thirds of your support will talk the talk but won’t walk the walk.

Me: “Well, OK, but from 2014 to 2019, the people who saw climate change as an actual crisis went from 23% to 38%. That means more than one-third of the country see it as critical.”

DT: “But for Republicans, it started out at 12% and stayed at 12%. Not what I’d call a burning issue, is it? In fact, the polls of all the voters in 2012, 2016, and 2019 show that of the top issues for voters, climate change has always ranked right near the bottom.”

Me: “That’s because Republicans skew the results!”

I had him. 

Surprisingly, DT seemed unpersuaded.

DT: “I don’t think that word means what you think it means. I think you mean to say Republicans participated in the results. There are as many Republicans as Democrats. The problem is you keep forgetting that. “

Me: “I can’t help it if 88% of them can’t read.”

DT:  “Let me suggest that telling Republicans they’re illiterate doesn’t seem to be a particularly persuasive argument, right?”

This wasn’t going exactly as I planned.

DT: “Whether you like it or not, the difference in the parties’ view on climate change has the biggest gap of any of the priority issues -- there’s a 46% difference between the parties in how important climate change is to the country. Heck, Trump shut down the government over a border wall and the difference between the parties on immigration is a measly 28%.  You’re not going to close the gap by pounding your fist and saying ‘you just don’t get it’ to the people whose vote you need.”

Me: “But DT, it doesn’t matter what the difference is . . . what about our children?”

DT stopped eating, looked at me, and sighed.

DT: “Well, there it is. The ‘you’re-killing-our-children’ argument. The last bastion of the self-righteous. But you know what, I’ll give you that argument. You’re right, we might be killing our children, but all you’ve succeeded in doing is to make both parties dig in deeper. The problem is you believe that climate change is a moral issue.  Maybe it was at one time, but not anymore. You know that whatever the solution is going to be, it will have to be instigated by the federal government. You keep telling me it’s going to cost billions of dollars and will go on for decades.  It seems to me that makes it, by definition, a problem for Congress.  Like it or not, you’ve made it political, right?  And once you make it a political problem, in this day, good luck.”

That really was a show stopper.  DT was right about it being a money issue.  And at this scale, it was going to have to be done by Congress, so clearly it was political. In years past, maybe some sort of middle ground was possible, but not today – or tomorrow.   So does DT win again?

But then I saw it.  I realized DT wasn’t really a bad person, he was just a good arguer.  And he was a good arguer because he always forced you to argue in his ballpark.  The real problem was we were just in the wrong stadium.

Me: “OK DT, you’re right.  The costs are really big.  I doubt that we’ll ever agree on a solution, so it’s not worth arguing about.”

DT was puzzled for a moment, but he seemed satisfied.  We ordered another beer and continued to watch the game.

Me: “By the way, how’s your daughter doing at Southeastern?”

DT: “Don’t get me started.  The cost of that place is killing me.”

Me: “I hear ya.  I’ve got the same problem.  I’m just happy the investments are working out.”

Next to politics, DT’s favorite topic is money and he’s nothing if not a creature of habit – thankfully.

DT: “Really?  What’s working for you?”

Me: “I put a lot into Sunkist Dynamics a few years ago. They’ve been going nuts!”

DT: “What do they do?”

Me: “Solar panels, and they’re American made.  It’s sort of like buying Exxon at $5 a share.”

DT: “So, there’s really money there?”

Me: “Ohhh, yeah.”  And I added an eye roll that implied that you were an idiot if you weren’t already on this gravy train.  DT looked around, leaned over and sort of whispered to me:

“You think I can I get in?”

Me: “Oh, no.  Sorry DT, it was a private placement deal.”  I took a sip of beer and let that sink in for a moment.  “But I do know about a group of investors that are going to fund a wind farm.  The possibilities are huge.  Think about it – you make money whenever the wind blows.”

I saw DT stop for a moment and sort of gaze into the distance.  He was calculating how much money he might make when the primary input was free. 

DT: “That sounds like a pretty good buy . . . right?”

Me: “Well, it’s up to you.  Just don’t tell a lot of people – I want to keep this between us.”

DT: “Not a problem – I get it – too many cooks kind of thing.”  He ran his two fingers across his lips and added: “Zipped tight.” 

Then a minor miracle happened:

DT: “By the way, lunch is on me today.”

I ordered dessert.

In re PennEast Pipeline Company: A New Twist in the Pipeline or Established Constitutional Law?

Posted on January 17, 2020 by Catherine R. McCabe

Adding another chapter to the legal controversies that continue to rage over the siting of new gas pipelines, on September 10, 2019 the Third Circuit upheld the State of New Jersey’s sovereign immunity objection to the PennEast Pipeline Company’s attempt to condemn a right-of-way through state-owned property.   The Court held that, while the National Gas Act delegates the federal government’s power of eminent domain to private pipeline companies, that power cannot be used by private parties to overcome a state’s assertion of sovereign immunity.

PennEast sought to construct a new pipeline to carry natural gas from the Marcellus shale fields of Pennsylvania into central New Jersey.  PennEast’s proposed route would pass through more than 40 properties either owned by the State of New Jersey or protected by state-held easements for conservation, agricultural or recreational purposes.  The route was approved by the Federal Energy Regulatory Commission (FERC), over the objections of the state and many private parties. 

Armed with its FERC certification, PennEast initiated condemnation actions against the state and private property owners along its proposed route.  The state objected, invoking, among other arguments, its right of sovereign immunity from suits by private parties.  The U.S. district court ruled in favor of PennEast, citing the Natural Gas Act’s authorization for private gas companies to use the power of eminent domain to acquire rights-of-way for pipeline routes approved by FERC. 

On appeal, a three-judge panel of the Third Circuit reversed, ruling that the Natural Gas Act does not go so far as to delegate the federal government’s exemption from states’ sovereign immunity to private parties.  The panel cited the Supreme Court’s prior decisions in Blatchford v. Native Village of Noatak and Dellmuth v. Muth holding that Congress can override the sovereign immunity of states only by making its intention to do so “unmistakably clear” in the language of the statute.  The panel found nothing in the text of the National Gas Act to support the argument that Congress did so in that statute.  

Moreover, while not reaching the issue, the court expressed strong doubt that Congress would have the constitutional authority to override states’ sovereign immunity, even if it chose to amend the statute to make that intent clear.  The court pointed out that Congress relied on its Commerce Clause powers to enact the Natural Gas Act and that, under the Supreme Court’s ruling in Seminole Tribe of Fla. V. Florida Congress cannot invoke its Commerce Clause powers to abrogate state sovereign immunity.

PennEast’s petition for en banc review was denied by the Third Circuit on November 5, 2019.  The company has publicly stated its intent to seek Supreme Court review, but has not explained what basis for review it would urge upon the Court.  There is no conflict among the circuits, as no other court of appeals has addressed this issue. 

PennEast may argue that this case presents a new and important question of law that has not been settled by the Supreme Court.  But the Third Circuit opinion rests firmly on established Supreme Court precedent that will be difficult to overcome.

So is this the end of the pipeline for PennEast?  Will the Supreme Court take up an invitation to rule against states’ constitutionally-protected sovereign rights?  Will PennEast turn back to FERC and ask for direct federal condemnation?  It’s too early to tell.  In any case, either route poses significant challenges – including PennEast’s own argument, noted by the Third Circuit, that FERC does not actually have direct condemnation authority under the Natural Gas Act.

What’s in a (Tribal) Name?

Posted on January 16, 2020 by Tom Sansonetti

At the time of the American Revolution in what is now upstate New York, there lived a branch of the Iroquois Nation known as the Oneida Indians.  As the 18th Century came to a close, two groups of Oneidas left the area to seek a better homeland.  One group moved to Canada and the other to Wisconsin.  Approximately one thousand Oneida remained behind.

In the ensuing two hundred years, the Wisconsin Oneidas and New York Oneidas each overcame many hardships.  Despite their shared original heritage, the two tribes have had little to do with one another, until more recently.

The Department of the Interior (“DOI”) through its Bureau of Indian Affairs (“BIA”), is required by law to publish annually an official list of federally recognized tribes.  There are many economic benefits for tribes included on the list.  At the present time, there are 562 federally recognized tribes. 

In 2010, the tribe then known as the “Oneida Tribe of Indians of Wisconsin” (the “Wisconsin Oneidas”) passed a resolution requesting that DOI conduct a special election on its reservation to amend the tribe’s constitution by, among other things, changing the tribe’s name to the “Oneida Nation.”  In 2011, the DOI notified the Wisconsin Oneidas that the proposed election could proceed but noted that the Wisconsin Oneidas should consider the potential that the name change may cause confusion with the New York Oneidas, who then called themselves the “Oneida Nation of New York.”  The Wisconsin Oneidas thereafter voted to adopt the proposed name change and received approval from DOI in a June 2015 document signed by the Acting Assistant Secretary for Indian Affairs, who happened to be an enrolled member of the Wisconsin Oneidas.

In 2016, the revised list of federally recognized tribes published in the Federal Register referred to the Wisconsin Oneidas as “Oneida Nation.”  The Oneida Nation of New York was never consulted or conferred with by DOI about the Wisconsin Oneidas’ name change ambitions.  The New York Oneidas’ realization as to what had happened came only with the publication of the revised list.

The Wisconsin Oneidas wasted no time thereafter by petitioning the Trademark Trial and Appeal Board of the United States Patent and Trademark Office (“TTAB”) to cancel the New York Oneidas’ registration of the marks “Oneida” and “Oneida Indian Nation.”  The Wisconsin Oneidas touted their new federally recognized name “Oneida Nation” – in arguing that the New York Oneidas should not be allowed to limit the Wisconsin Oneidas use of that name.

The New York Oneidas then brought an action against DOI in federal district court in Albany, New York, asserting claims under the Administrative Procedure Act.  The New York Oneidas asserted a lack of due process, and injury due to the confusion caused by DOI’s approval of the Wisconsin Oneidas’ name change.  In addition, the New York Oneidas alleged a conflict of interest considering that a member of the Wisconsin Oneida served as the DOI official that approved the name change.

The federal district court granted the government’s motion to dismiss the case against DOI for lack of subject matter jurisdiction because it determined that the New York Oneida lacked standing. On appeal, the Second Circuit Court of Appeals affirmed the district court ruling on October 21, 2019. Oneida Indian Nation v. United States Department of the Interior, Case No. 18-2607.

The key issue in the New York Oneidas not having standing centered on the redressability of the alleged wrongs.  Because the DOI’s present policy is to allow tribes to call themselves what they want pursuant to a duly called election, remanding the case back to DOI made no sense in the courts’ view.  Both the district and appellate courts noted the lack of notice to the New York Oneidas and the possibility of future confusion by outside entities as to which of the tribes is the “real” Oneida Indian Nation.  Efforts between the tribes to resolve the dispute have proven unsuccessful.

Given the DOI’s policy of allowing tribes to self-name and BIA’s lack of intervention in the Wisconsin Oneidas administrative name change, the New York Oneidas have since decided to change their name to the “Oneida Indian Nation,” leaving out any geographical reference.  It is expected that the 2020 Federal Register will list both tribes preferred monikers. 

In the meantime, the TTAB trademark litigation rages on, and unless and until DOI changes its tribal names policy, any outside entity doing business with one of the Oneida tribes had best determine which tribal nation is which!

WHEN DOES “RESPONSIBLE” MEAN NEVER HAVING TO SAY YOU’RE SORRY TO CERCLA?

Posted on January 15, 2020 by Jeff Thaler

Given the billions of dollars that have been spent at federal Superfund sites, and the billions still to come, it is fascinating how relatively little attention has been devoted to the case of Atlantic Richfield Company (ARCO) v Christian recently argued in the U.S. Supreme Court. Is it because there might not yet be a final judgment in the Montana court case? Or because preemption is an insufficiently dramatic attention-grabbing legal issue? Or because relatively few amicus briefs were filed? Or are people just plain tired of CERCLA?

To the last question, certainly environmental lawyers and engineers are not so fatigued! Indeed, the Christian case raises some interesting issues.  If the Court reaches the merits rather than remands the case for lack of a final judgment, resolution of the issues could impact clean-up cases and the scope of remediation efforts all over the U.S., as well as who is a “potentially responsible party” under CERCLA, and potentially also impact federal-state relations and conflicts in other areas of law.

In 1980—the year that CERCLA was enacted—the Anaconda Smelter ceased its copper refining operations. However, because Anaconda’s smokestacks had emitted arsenic and lead across five nearby towns, 20,000 acres and thousands of homes, in 1983 EPA placed the area on its list of Superfund sites. While ARCO (the then-owner of the smelter) was identified as the lead Potentially Responsible Party (PRP), and has since spent $450 million in carrying out the EPA’s remediation plan, downwind landowners wanted more cleanup work done on their lands than what EPA had ordered. They thus sued ARCO in state court 11 years ago.

In its December 29, 2017 decision, the Montana Supreme Court allowed plaintiffs to bring state law claims for more clean-up at federally designated sites of ongoing remediation. The U.S. Supreme Court granted certiorari in June 2019. Two of the granted issues are particularly interesting and potentially far-reaching: 1) Is a private (downwind) landowner at a Superfund site a PRP who must first get EPA’s approval for remedial action, even if that landowner has not been ordered to pay for a cleanup—in other words, who really is “responsible” under CERCLA? And 2) Does CERCLA explicitly or implicitly preempt or otherwise bar state common law claims for restoration, if such claims seek cleanup remedies at odds with (i.e. exceeding) EPA-ordered remedies?

Public Citizen and a group of 15 states (led by Virginia) filed amicus briefs in support of the Montana landowners and the Montana court decision; the Solicitor General and the Chamber of Commerce (with a group of other trade groups) supported ARCO. Arguments of statutory interpretation and federal-state sovereignty were front and center in the briefs.

The case was orally argued on December 3, 2019. Some of the Justices seemed concerned with precluding the claim in light of CERCLA’s text which allows for states to have a meaningful role in the remediation of hazardous sites. Other Justices seemed sympathetic to EPA and ARCO’s concerns that plaintiffs’ desired remediation might worsen groundwater quality by releasing toxins in the soil. And the Solicitor General’s representative spent much of his time defending the assertion that the plaintiff landowners should be treated as PRPs.

Ultimately, should the Court reach the merits, the Justices appeared to be trying to devise a way for the states to maintain an active role in CERCLA remediations without allowing landowners to “interfere” with EPA’s cleanup plan. Coincidentally, in an ACOEL small world moment, because Vermont and Maine were part of the 15-state amicus team, ACOEL members Pat Parenteau (VT) and Jeff Thaler (Maine) were each interviewed after the oral argument by the same news reporter.

Fortunately, they did not contradict each other, or have to say “sorry” when the article came out.

Superfund: 20+20 = 40

Posted on January 14, 2020 by John Barkett

It seems hard to believe that the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)—affectionately known as the Superfund law—will be forty-years old in December 2020.

I first became involved with CERCLA in 1981, a few months after the law’s adoption. The State of Florida’s environmental regulatory agency was concerned about a transformer salvaging operation. It feared that mineral oil containing polychlorinated biphenyls that had been spilled on the ground would be carried throughout the surrounding area if a hurricane hit Miami and caused severe flooding. So it called on the Environmental Protection Agency to conduct a removal action – an emergency response – under CERCLA. That led to a lawsuit to gain access.  I represented a utility that had sold transformers to the salvager. A federal district court judge set a hearing on EPA’s motion for a preliminary injunction to gain access and allowed two weeks for discovery.  The judge also ordered the utility to intervene in the action.  We were taking depositions around the clock until the judge called us into chambers just before the hearing was scheduled to begin. We left chambers and headed not to the courtroom but to a hotel where we were ordered to engage in settlement discussions and not to return until a settlement had been reached.  The settlement was reached.  No hurricane hit.  The site was eventually remediated.  And acronyms like RI/FS, RD/RA, PRP, and NPL became a part of my daily vocabulary.

This case, however, was not the norm.  Once Chem-Dyne came down establishing the principle that in a government cost recovery action, the Superfund law created joint and several liability, and other cases affirmed EPA’s position that liability was also strict and retroactive, the litigation floodgates opened.  To conserve enforcement resources, EPA (the United States) sued “deep pocket” parties. Those parties then sued other PRPs who sued other PRPs—waves of multi-party actions.  The calls to members of Congress became louder as pizza parlors were spending more money on lawyers for the hazardous substances in the ink on their pizza boxes than they could make on a calzone.

Reforms eventually followed in the next two decades of Superfund.  The Superfund Amendments and Reauthorization Act (SARA) in 1986 plugged some holes in the statute and expressly provided for contribution actions.  The “innocent landowner” defense was added and literally created an industry – environmental assessment firms sprung up over night offering their services to anyone buying land or lending money for a real estate acquisition. 

Other amendments followed.  Section 107 of CERCLA initially ended in subparagraph (m).  Now there is a subparagraph (n) to protect fiduciaries, (o) to protect “de micromis” parties, (p) to create a municipal solid waste exception, (q) to address contiguous properties, and (r) to address prospective purchasers.   The Superfund Recycling Equity Act was passed in 1999 to reverse decisions of courts which found that a person recycling certain products was an arranger for disposal liable under Section 107(a)(3) of CERCLA.

Landfills, used oil recyclers, and solvent recyclers received most of the attention in the first three decades of Superfund—and in many cases are still receiving attention.    In the fourth decade of Superfund, river sediment sites have been the most prominent sites on the National Priorities List.  Their remedial investigation/feasibility study and remedial design/remedial action costs dwarf those of landfills on the NPL.

The Supreme Court has weighed in on the Superfund law on a few occasions. Key Tronic wounded the private Superfund enforcement business when the Court in 1994 determined that a private Superfund plaintiff could not recover litigation attorneys’ fees under CERCLA. Aviall (2004), Atlantic Research (2007), and Burlington Northern (2009) followed in a string of decisions that shook up the Superfund jurisprudence in the arena of contribution actions, cost recovery actions, and the evidence required to establish when someone has arranged for disposal or treatment of a hazardous substance. Burlington Northern also weighed in on how to prove a reasonable basis for apportionment in a cost recovery action.

A lot of money has been spent on Superfund sites these past 39 years.  Whether the risk reduction bought with those dollars was the best use of these funds can be debated.  But there is no debate that toxicology has risen in prominence because of Superfund and lawyers have had to become familiar with notations or phrases like 1 x 106, slope factor, and reference dose, to make sense of the difference between carcinogenic and non-carcinogenic risks in human health risk assessments.

All Superfund lawyers know Section 113(f)(1) of CERCLA, the statutory standard applicable in a contribution action: the court is to allocate response costs according to “such equitable factors as the court determines are appropriate.”  That text has resulted in the “Gore factors,” the “Torres factors,” and a host of arguments – sometimes supported by facts and oftentimes supported by inferences or even educated guesswork – as judges and allocators attempt to satisfy the statutory standard.

As we embark on a fifth decade of Superfund, we have another Superfund Task Force and a new set of recommendations focused on trying to speed up cleanups, accelerate remedial design, encourage private investment resulting in reuse of Superfund sites, promote redevelopment of sites to revitalize communities, and promote transparency and engagement with Superfund stakeholders. Actions always speak louder than words, so we can all just watch and hope that the noble goals of this latest Superfund Task Force can be met.

So, here’s to a “Happy 40th” to the Superfund law in 2020.  I was there for your birth and am glad to still be around to declare: you have definitely aged, but you still seem to be going strong!

It’s Not Going to Be Easy to Be Green

Posted on January 8, 2020 by Seth Jaffe

The New York Citizens Budget Commission has released a report regarding the state’s ability to meet its ambitious GHG reduction targets.  It’s sobering reading.  The CBC states that it is “uncertain” whether New York can meet those goals.  It identifies four reasons:

Immense scaling up of renewable generation capacity is necessary and is likely infeasible by 2030.

The focus on building renewable resources, particularly offshore wind, and entering into long-term power contracts limits flexibility and diminishes consideration of other cost-effective approaches.

State policies on nuclear, natural gas, and hydropower are counterproductive.

The focus on other sectors—particularly transportation—is insufficient.

I understand that some people think that natural gas’s time has passed.  I understand that some people don’t like nuclear power.  I understand that some people don’t like hydropower.

However, I also understand, as the report points out, that some people also don’t like the transmission lines necessary to bring large-scale wind to consumers.  And, indeed, some people don’t even like wind power.  At the same time, people do like their iPhones and their cars, and fresh fruit from foreign places.  In short, even if you don’t like some of the conclusions of this report, it’s a valuable reminder of just how difficult this is going to be.

It’s not easy being green.

When is risk reduction not a benefit?

Posted on January 7, 2020 by Adam Babich

EPA filed a status report on October 15 in the slow-moving mercury and air toxics (MATS) litigation, which is now Murray Energy Corp. v. EPA, No. 16-1127 (D.C. Cir., filed April 26, 2016). The case is a challenge to EPA standards for coal-fired power plants that have been on the books since April 16, 2012, despite a U.S. Supreme Court remand in Michigan v. EPA, 135 S. Ct. 2699 (2015), followed by a D.C. Circuit decision not to vacate, White Stallion Energy Center v. EPA, 2015 WL 11051103 (D.C. Cir. 2015), cert. denied, 136 S. Ct. 2463 (2016), and the pending 2016 challenge to an EPA supplemental finding. EPA’s October 15 status report says that the agency has sent OMB a draft final rule regarding its proposal—published in February 2019—to withdraw its finding that a MATS rule is “appropriate and necessary” while leaving the applicable emission standards in place. 84 Fed. Reg. 2670 (Feb. 7, 2019). These proceedings retain a relevance apart from their utility in illustrating the occasionally bizarre nature of the world in which we live and litigate.

EPA’s proposal would, among other things, implement a new approach to analyzing the benefits of a regulation. Specifically—when calculating benefits for purposes of determining whether regulation of hazardous air pollutants is appropriate—EPA would eschew consideration of “co-benefits” flowing from accompanying reductions in emissions of other pollutants, such as nitrogen oxides, sulfur dioxide, and fine particulate matter. Thus, “if the HAP [Hazardous Air Pollutant]-related benefits are not at least moderately commensurate with the cost of HAP controls, then no amount of co-benefits can offset this imbalance for purposes of a determination that it is appropriate to regulate under CAA section 112(n)(1)(A).” 84 Fed. Reg. at 2676. The idea is that non-HAP benefits should not receive “equal consideration” because criteria pollutants “are already addressed” by another regulatory program. Id. at 2677.

The analysis is reminiscent of EPA’s infamous Select Steel opinion, which dismissed an environmental-justice complaint. EPA File No. 5R-98-R5. In that 1998 opinion, the agency found that because the NAAQS for ozone “has been set at a level that is presumptively sufficient to protect public health and allows for an adequate margin of safety … there is no affected population which suffers ‘adverse’ impacts within the meaning of Title VI resulting from the incremental VOC emissions [that do not cause NAAQS violations].” There could be no disproportionate impact on a minority community that met NAAQS because there was no “adverse” impact at all!

The conclusion that achievement of NAAQS eliminates risk ignores a reality that Congress perceived when it amended the Clean Air Act in 1977. Congress recognized the need to protect people from harmful exposures “notwithstanding attainment and maintenance of all national ambient air quality standards.” 42 U.S.C. § 7470(1). The legislative history acknowledges, “The idea that the national primary standards are adequate to protect the health of the public has been belied.” H.R. Rep. No. 95-294 at 112 (May 12, 1977) (accompanying H.R. 6161). Senator Muskie—the father of the Clean Air Act—explained, “[T]here is no such thing as a threshold for health effects,” S. Deb. on S. 252, 123 Cong. Rec. 18,460 (June 10, 1977). “Even at the national primary standard level, which is the health standard, there are health effects that are not protected against.” Id.

“Appropriate” is an “all-encompassing term that naturally and traditionally includes consideration of all the relevant factors.” 135 S. Ct. at 2707 (quotation marks and citation omitted). Just as it was not “appropriate” for EPA to ignore costs when deciding to promulgate MATS, id., it would be inappropriate to ignore the benefit of lives saved because of ancillary reductions of criteria pollutants.

Risky Business: Ethylene Oxide Business Closures Prompt FDA Alert; EPA Regulations to Follow

Posted on January 6, 2020 by David Tripp

Plant closures of medical equipment sterilization facilities in Chicago and Atlanta prompted the Federal Drug Administration to issue a statement on potential shortages of surgical and medical devices across the country. On October 25,  FDA Commissioner Sharpless noted the closure of two large sterilization facilities resulting in a shortage of pediatric breathing tubes and said, "The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care."

The FDA underscores an important dilemma in environmental matters: when risk assessment information based on emerging science predicts cancer-causing effects at extremely low concentrations, how can citizen concerns be addressed while EPA is developing regulations to minimize impacts on health and protect availability of necessary goods and services?

What is EPA's role in these plant closures?  In the Chicago suburb of Willowbrook, EPA participated in public meetings and confirmed the Sterigenics facility was permitted under the Clean Air Act and operating within permit limits. Sterigenics used Ethylene Oxide (EO or EtO) to sterilize medical devices. EO is uniquely suited for use on medical devices and is the most common sterilizing agent  in the U.S., safeguarding an estimated 50 billion medical devices annually including surgical kits for C-sections, cardiac and knee surgeries, and feeding tubes for neonatal care units. At Willowbrook, based on community health concerns, EPA asked ATSDR for input. ATSDR issued a Letter Health Consultation on August 21, 2018, stating that if measured and modeled data represent typical EtO concentrations in ambient air, an elevated cancer risk exists, and the Illinois Department of Public Health should investigate any elevated cancers in the surrounding population.

IDPH followed with its Cancer Incidence Assessment report, covering 1995 through 2015, finding increases in certain cancers, but concluding that limitations in methodology and data existed. IDPH strongly recommended future studies with larger populations, preferably involving multiple EtO emissions sites to confirm the assessment's findings.

The recommended longer term emission reductions and studies did not happen. Public opposition resulted in lawsuits seeking injunctive relief, and a Seal Order was filed by the State of Illinois. Sterigenics reached settlement with the State to allow reopening with additional emission controls, then closed both Willowbrook and a similar facility in Atlanta. Sterilization facilities which have closed, or are facing public pressure, are caught in a predicament of compliance with existing Clean Air permit requirements being overtaken by local and public pressure. EPA has begun the development of a numeric standard for EO, but in the interim a calculated risk screening level for EO at the 0.10 part per trillion threshold became the de facto control number. However, that threshold number is being hotly debated and one state has indicated it will promulgate a limit 40,000 times higher.  

The concerned citizens and municipalities believe the right result was reached when the facilities closed. FDA and the medical community believe a crisis in availability of sterilization for medical devices and instruments is foreseeable. For the companies, operation in compliance with federal and state permits did not offset sudden forces leading to closure. EPA has announced its "Suite of Actions to Address Ethylene Oxide," including proposed rulemakings for two sets of EO emission standards. The fair notice of these EPA regulatory actions  contrasts with the abrupt pressure for closure forced on the shuttered companies by a risk assessment more commonly used as the beginning step in a screening process that leads to a balanced decision on remedial actions.

Whether EPA and FDA can cooperate effectively to prevent critical shortages of sterilized medical devices remains to be seen. Until a viable option to EO sterilization of medical devices is found and implemented, medical sterilization remains a risky business.