In 2001, a group of private citizens, public health groups, and medical organizations petitioned the Food and Drug Administration (FDA) to approve nonprescription status for the emergency contraceptive Plan B and its generic cousins. Under the Food, Drug, and Cosmetic Act, the FDA’s decision was supposed to turn on whether these drugs could be taken safely and efficaciously without the assistance of a licensed health professional. Instead, an investigation by the Government Accountability Office (GAO) and fact-finding by the district court handling litigation over the controversy made clear that the FDA bowed to political pressure, first by delaying any decision as long it could and then by being as stingy as possible in granting nonprescription access to emergency contraceptives.
Over a twelve-year period, the agency resorted to extreme measures to avoid answering the statutorily dictated question: whether women and girls could safely and efficaciously take emergency contraceptives without permission from a licensed health professional. With every new stratagem, the agency dug itself deeper into an administrative law hole: inventing policies on the fly, grasping at tangents, shrouding the truth, and cowering before illegitimate political demands.
No wonder that a district judge hearing a challenge to the FDA’s decision making finally had had it with the FDA’s shenanigans and ordered the agency to make emergency contraception available without restriction to all women and girls of child-bearing age. No wonder that the FDA was left with paltry legal arguments in its (now-abandoned) appeal of the trial court’s decision. No wonder that the whole episode left observers inside and outside the agency shaking their heads over the sad retreat of a proud institution.Full text
Earlier this week, the Supreme Court heard oral argument in EME Homer City Generation v. EPA. At issue in the case was the ability of EPA to regulate cross-state pollution, or pollution generated in some states that is carried over to others downwind. Eight “downwind” states, primarily in the Northeast, filed a brief in support of the Court’s review of a previous decision by the D.C. Circuit Court of Appeals, which struck down the rule EPA implemented to regulate cross-state pollution.
The rule stems from the “Good Neighbor” provisions of the Clean Air Act, which calls on EPA’s good judgment to address the issue of one state unfairly polluting another. More than 90% of ozone levels in Connecticut stem from out of state pollution sources, contributing to the soaring levels of asthma and respiratory illness in the area. In order to mitigate this kind of pollution from other states, the EPA devised a cost-based system to determine what kind of plan an upwind state must implement in order to reduce pollution when the state has inadequately created its own plan to limit its pollution in other states, also known as the transport rule. Upwind states, industry and labor groups argue that the federal government is inappropriately inserting itself into a decidedly state issue when the federal government does not have adequate information to assign pollution-reduction plans.
Most reports of the oral arguments interpret a favorable stance from the Justices towards the EPA’s cost and science-based approach to regulate what it describes itself as a “dense spaghetti-like matrix.” However, and as I’ve discussed in this space before, the procedural questions about whether the D.C. Circuit should have reviewed the transport rule in the first place, largely escaped the attention of the Justices even though the issue was briefed.Full text
Former (de)regulatory czar Cass Sunstein is back, full of advice on how to run the government from his perch as a Harvard law professor. In a “View” column for Bloomberg News entitled “Left and Right Are Both Wrong About Regulation,” Sunstein urges his former allies and enemies to redouble their efforts to “look back” at old rules. He claims that forcing agencies to rummage through their closets in search of bad rules has already saved “billions of dollars,” although the only tangible example he offers is the recent Federal Aviation Administration (FAA) decision to allow people to use electronics on airplanes—popular, to be sure, but probably not such a plus for the economy. Sunstein is deaf to any perspective on the regulatory state other than his deeply held prejudice that it is over-regulating and must be choke-chained through the zealous application of cost-benefit analysis. As he did when he held the tight-collared short leashes of the regulatory agencies from his corner office at the White House, he ignores the many recent public health crises that tougher rules would have prevented.
Consider, for example, the 2012 meningitis outbreak that sickened 741 and killed 64 people in 20 states. In the early fall of that year, people began to die from virulent infections after receiving spinal injections of methylprednisolone, a steroid drug used to relieve back and shoulder pain. Suspicious doctors discovered that the injections originated at the New England Compounding Center (NECC) in Framingham, Massachusetts. The company, which had been in trouble with federal and state regulators repeatedly for more than a decade, is sadly representative of serious problems within this industry.
When federal and state inspectors inspected 31 “high-risk” compounders in 18 states last April, 28 got Form 483’s—FDA-speak for bad conduct reports. All were engaged in abuses from mixing drugs in “clean rooms” contaminated by mold to getting the composition of medications wrong. Yet compounders are regulated by state pharmacy boards that are ineffective. Companies are not required to register with the federal government, and the Food and Drug Administration’s (FDA) authority to prevent them from selling adulterated drugs is hamstrung by recent court decisions. As she withstood blistering condemnation of House Republicans, FDA Commissioner Margaret Hamburg begged her congressional overseers to give her agency the tools needed to police the industry.
Compounders provide 40 percent of intravenous medications used in hospitals, up from 16 percent just a decade ago. If NECC is not a rogue company but rather a typical example of how fast and loose practices allowed this industry to grow by leaps and bounds, we’re in big trouble. Yet, when Congress reared up on its tiny hind legs to address this crisis, it passed a shamefully weak law that would let compounders choose whether they wanted to register with the FDA and be regulated, or whether they preferred to do business as usual. The magical thinking behind this approach is that market forces will compel reputable companies to register.
Sunstein never says a word about such episodes. Instead, he urges the President and Congress to assign agencies like the FDA to double-down on elaborate calculations that purportedly measure whether the benefits of protecting public health might be outweighed by the costs of imposing such requirements on industry.Full text
Today, Center for Progressive Reform Member Scholar and University of Texas law professor Thomas O. McGarity published an op-ed in theNew York Times entitled,"What Obama Left Out of His Inequality Speech: Reguation."
In a speech last week, the President highlighted the problems associated with extreme socio-economic disparity.
But, as McGarity notes in his piece:
[T]here’s a crucial dimension the president left out: the revival, since the mid-1970s, of the laissez-faire ideology that prevailed in the Gilded Age, roughly the 1870s through the 1910s. It’s no coincidence that this laissez-faire revival — an all-out assault on government regulation — has unfolded over the very period in which inequality has soared to levels not seen since the Gilded Age.
History tells us that in periods when protective governmental institutions are weak, irresponsible companies tend to abuse their economic freedom in ways that harm ordinary workers and consumers. The victims are often less affluent citizens who lack the power either to protect themselves from harm or to hold companies accountable in the courts. We are in such a period today.
The laissez-faire revival of the past 35 years was no accident. The protective statutes and liberal common-law doctrines of the late 1960s and early 1970s — what can be called the Public Interest Era — had a profound impact in such areas as occupational safety and health, environmental protection, consumer finance and the safety of food, drugs and consumer products. This legislative and judicial activism placed far more constraints on the economic freedom of corporate America than had any legal regime preceding it.
But Mr. Obama’s failure to examine (or even mention) the laissez-faire revival was a missed opportunity. Deregulation may not be the central cause of the soaring inequality of recent decades, but it has certainly magnified its consequences, making it ever more difficult for workers and consumers to resist the rapacious predations of abusive employers and companies. The weakening of what used to be the great American middle class cannot be understood without also considering the embrace free-market theology. By omitting this critical factor in the rise of inequality, Mr. Obama left unchallenged the argument, recited by business like a mantra, that regulation and economic expansion are inherently in tension.
Sadly, the crises resulting from deregulation will almost certainly continue until political forces realign themselves and a new social bargain is struck under which the business community’s economic freedoms are once again constrained by a government that is more willing to impose greater responsibilities on powerful economic actors and a legal system that is capable of holding them accountable for the harm that they cause. Until then, a crucial check on the seemingly inexorable advance of economic inequality will be missing.Full text
Late last month, the Center for Progressive Reform revealed that the Maryland Department of the Environment (MDE) waives pollution permit application fees for concentrated animal feeding operations (CAFOs) in the state, and that the agency is far behind in processing such applications. Now we're able to put a number on MDE's decision: MDE is waiving $400,000 in application fees this year alone. And what might it do with that money it's choosing to leave on the table for some reason? It could speed up its delayed permitting process, for one thing.
The CAFO program was designed to be self-supporting. The idea was that the agency would collect modest fees from polluters (ranging from $120 to $1,200, depending on their size) and use that money to pay for the necessary permit writers and inspectors. By waiving the fees, MDE has shifted the responsibility of funding its program away from the polluter and instead relies on taxpayer funds. So in addition to paying a fee for their driver's licenses, car registrations, and fishing permits in the Bay, Free State taxpayers also get to pick up the tab for pollution permits for large industrial chicken operations.
This morning, CPR President Rena Steinzor and I sent Robert Summers, Secretary of MDE, a letter urging MDE to stop waiving fees. (Read the full text of the letter here).Full text
Efforts to hold private companies responsible for their contribution to climate change just took a big step forward, thanks to researcher Rick Heede. For the past eight years, Heede has painstakingly compiled the historical contribution of fossil fuel companies to today’s concentrations of greenhouse gases. According to Heede’s study ”Tracing anthropogenic carbon dioxide and methane emissions to fossil fuel and cement producers, 1854–2010,” which was published in Climatic Change, just 90 enterprises have accounted for over sixty percent of total industrial carbon dioxide and methane emissions. And just five private oil companies-- ChevronTexaco, ExxonMobil, BP, Shell and ConocoPhillips—have accounted for more than 12 percent of such emissions.
This data is a potential game-changer in how we think of responsibility for climate change. The fossil fuel industry would like us to believe that we are all equally culpable every time we turn on an ignition or a light bulb. But we are not all equally responsible for decisions that have led to climate change—and we certainly have not all benefited from climate change the same way that the five oil companies have. In addition, several of the top emissions contributors actively promoted climate change denial campaigns.
This data is legally significant as well because it gives courts a fair and defensible way for allocating responsibility for damages caused by climate change. Courts need no longer fear that it would be impossible to untangle the private sector’s historical contributions to climate change or unfair to make oil companies, for example, pay for all climate-related damages. A clear formula now exists for allocating at least a significant percentage of the costs of climate change to those companies that benefited most from the public nuisance created by their emissions. Take, for example, the costs of moving the Inuit village of Kivalina, which attempted to sue several of the top polluters for the anticipated costs of relocating their village as a result of climate change. Those costs could now be allocated to the major fossil fuel companies based on their historical contributions to the problem.Full text
A video called, “,” featured on OSHA’s website, introduces Bill Ellis, a retired painter and sandblaster. After years of exposure to fine particles of blasted rock, he developed a respiratory disease called silicosis and died, leaving behind his wife, children, and grandchildren. Ellis’s final months were painful. For a silicosis patient, just drawing breath is an ordeal—like sucking air through a straw.
Thousands of laborers are exposed to the tiny stone particles, called silica, that killed Ellis. Any time workers blast sandstone, saw concrete, or cut brick, that dust is in the air. Because of the broad danger and the availability of relatively inexpensive protective gear, OSHA has proposed rules updating worker safety standards for silica. The current rules have not been revised in over forty years.
The would lower the permissible exposure limit (PEL) of silica dust from 100-250 micrograms per cubic meter of air to 50 micrograms. The rule could nearly 700 lives and prevent 1,600 new cases of silicosis each year. After including costs of implementation, average net benefits are estimated at $1.8 to $7.5 billion per year.
The potential benefits of the rule are truly remarkable. The result seems like a dream situation, where a government agency can protect people and save money. Isn’t that what regulatory agencies are supposed to do?Full text
I’ve spent a lot of time and energy talking about the need to adapt to climate change, but I’ve also become increasingly uneasy about “adaptation” as a way to think about the situation. One of the things I don’t like about the term “adaptation” is that it suggests that we actually can, at some expense, restore ourselves to the same position we would have been in without climate change. For any given amount of climate change, we can do things that decrease the resulting harms (at a cost), but we can’t eliminate those harms. Adapting to climate change is like “adapting” to a serious chronic disease — you can get by, with luck, but it’s still not like being healthy.
But there’s also an important conceptual issue. The idea of adaptation assumes that the world will go along more or less as it always has, except that we’ll take some specific actions due to climate change to neutralize its effects. This makes sense if we think global warming is just a marginal change. But given our current trajectory, climate change, adaptation, and mitigation may go beyond marginal impacts. Climate change may well have wide societal effects, and mitigation efforts themselves could be major enough to shift the economy. Moreover, both mitigation efforts and actions to address climate-based risks will have environmental impacts of their own. ”Adaptation” suggests a marginal quality to climate change that may be quite misleading.
When it comes to OIRA’s antiregulatory meddling, the Federal Aviation Administration’s (FAA) pilot fatigue rule provides as textbook an example as you could ask for. Following Congress’s instruction that the rule be based on the best available science regarding human sleep patterns, the agency drafted a rule that set minimum rest standards for all commercial pilots. But, the rule couldn’t take effect without the White House’s Office of Information and Regulatory Affairs’ (OIRA) review and final approval. After more than four months, the rule that emerged from the OIRA review gauntlet had been significantly weakened. The minimum rest standards now applied only to commercial passengerpilots, while commercial cargo pilots were completely exempted. The change was based not on sleep science, as Congress mandated. What’s the justification? Fatigue generally affects all pilots the same, no matter what they happen to be hauling behind them. Against logic, OIRA justified the changes on the basis of an irrelevant, and arguably illegal, cost-benefit analysis: According to OIRA, the benefits of protecting cargo from fatigue-induced plane crashes, unlike the benefits of protecting passengers, simply did not justify the costs of abiding by the minimum rest standards. Not coincidentally, during the months-long review, a parade of cargo airline industry representatives marched through OIRA’s doors arguing for the change, relying on this very same cost-benefit analysis argument.
The story above is a familiar one, and most accounts of OIRA interference typically stop with the weakened and delayed final rule’s issuance. In reality, though, OIRA interference usually sets off a chain reaction of negative consequences—in the form of real harms to real people and to the effective functioning of our system of governance—that are worth taking a close look at. Indeed, the FAA’s pilot fatigue rule provides a glaring example of these negative consequences, as several recent developments have demonstrated.
Most dramatically, this past August a UPS cargo plane crashed while attempting an early morning landing at Birmingham–Shuttlesworth International Airport in Alabama, killing both crewmembers on board. In addition to the two fatalities, all of the cargo on the plane was destroyed in the crash, and some homes located near the airport were also allegedly damaged. The National Transportation Safety Board (NTSB) expects that its investigation into this incident will take several months to complete. At this point, however, the NTSB has found no evidence of mechanical failure and is now looking into whether the crash was a result of pilot error—including whether pilot fatigue was a contributing factor. The incident does provide a vivid illustration of what OIRA has put at stake with its meddling. It also provides a cautionary warning of the kinds of needless tragedies we can potentially expect if commercial cargo pilots remain exempted from the FAA’s minimum rest standards.Full text
Lately, press releases from the Maryland Department of Agriculture read like a broken record:
MDA Withdraws Phosphorus Management Tool Regulations; Department to Meet with Stakeholders and Resubmit Regulations
-- August 26, 2013
MDA Withdraws Phosphorus Management Tool Regulations; Department to Consider Comments and Resubmit Regulations
--November 15, 2013
The second headline is from this past Friday when MDA withdrew a proposed regulation aimed at cleaning up the Chesapeake Bay by restricting the use of manure to fertilize crops.
Manure is full of phosphorus, one of the nutrients choking the Bay. Indeed, manure runoff accounts for 26 percent of the phosphorus in the estuary. The proposed “phosphorus management tool,” developed at the University of Maryland, would have helped determine which fields were over-saturated with the nutrient. If the soil contained too much phosphorus, the farmer could not apply manure to fertilize that field.
As the agency’s press releases show, this is the second time MDA has pulled back its attempt to limit manure usage. An emergency regulation that was supposed to have gone into effect this fall was withdrawn in late August after the farm lobby complained that it could cripple the state’s poultry industry. MDA withdrew the rule this time after agricultural groups once again complained of its economic impact.
The abandonment of the manure-management tool comes at the same time that a new CPR report warns that the state’s regulation of industrial animal farms is lagging. According to CPR President Rena Steinzor, the two are closely connected.Full text