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
When we all sit down for Thanksgiving dinner next week, we hope that the food we are feeding our families is wholesome and that the workers who produce it are safe. Thanks to the U.S. Department of Agriculture (USDA), ever the mindless booster of corporate profits, that turkey at the center of the table already disappoints both expectations, and if USDA has its way, matters are about to get much worse. Hiding behind disingenuous promises to “modernize” the food safety system, USDA has decided to pull federal food inspectors off the line at poultry processing plants across the nation. No new preventative measures to ensure that poultry is free of salmonella would happen. And already crowded, bloody, stinking lines would speed up dramatically—to as many as 175 birds per minute, or three birds/second. Workers who suffer grave ergonomic injuries from the repetitive motions of hanging, cutting, and packing the birds would endure conditions that are two or three times worse than the status quo.
The consequences of USDA’s de-regulatory scheme are well documented. Back in 2001, the Government Accountability Office (GAO) found significant food safety concerns in pilot plants authorized to test the new system and just this past summer slammed the USDA’s data in justifying the program. The Agency is using data cherry-picked from two-year snapshots over a 15-year period of the piloted system to justify the program and relying on old and inaccurate economic analysis.
Congratulations to our friends at Earthjustice and their clients for a tremendous victory in federal district court today. Judge Reggie Walton (a George W. Bush appointee) ordered the Obama Administration to provide a schedule for regulating coal ash within the next 60 days. This epic battle now shifts back to the White House and Congress where nearly hysterical electric utilities that depend on coal-fired power plants will sweep in, aided by some very twisted economics from strong regulation’s staunch nemesis, the Office of Information and Regulatory Affairs (OIRA).
The coal ash crisis burst onto the national scene shortly before Christmas day, 2008, when the contents of an enormous impoundment containing coal-ash slurry from the Tennessee Valley Authority’s (TVA) Kingston Fossil Fuel Plant poured into the Emory River. The proximate cause of the spill was the bursting of a poorly reinforced dike holding back a pit of sludge that towered 80 feet above the river and 40 feet above an adjacent road. The volume and force of the spill were so large that 1.1 billion gallons of the inky mess flowed across the river, inundating 300 acres of land in a layer four to five feet deep, uprooting trees, destroying three homes, and damaging dozens of others. Miraculously, no one was killed.
The Kingston spill was the worst of its kind in U.S. history, but it was not the first, nor would it be the last. For a brief period of time, the catastrophe focused the nation’s attention on the health and environmental risks posed by dumping coal ash in unlined pits in the ground euphemistically dubbed “surface impoundments.”
The slurry contained both fly and bottom ash from scrubbers that are mandatory on coal-fired plants. Because scrubbers trap fumes before they are emitted into ambient air, the fly-ash portion of the spill contained significantly more than the quota of toxic heavy metals that typically result from burning coal. Or, in other words, in an inevitable but ironic twist, the benefits to breathers were obtained at the expense of walkers and drinkers. The Kingston Spill had released around 2.6 million pounds of toxic pollutants into the Emory River. By way of comparison, all of the other power plants in the United States released just over 2 million pounds of toxic pollutants during all of 2007.
Prominent national environmental groups demanded greater protection from Congress and the Environmental Protection Agency (EPA), both of which had long skittered away from confronting the problem in the face of unyielding resistance by electrical utilities. Any hint of regulatory intervention that would compel the safer disposal of coal ash and the reinforcement of old, poorly designed dumps was pounced on by industry and carelessly maintained coal-ash dumps remain the status quo.
Enter OIRA. Its review of EPA’s proposal to regulate coal ash involved 33 meetings with industry representatives who argued that the most effective regulatory option proposed by EPA—requiring coal ash that is not recycled to go to lined pits with leak detection systems--would impose a ruinous “stigma” on the beneficial recycling of coal ash. EPA insisted that in decades of implementing the Resource Conservation and Recovery Act, the agency had never observed such an effect. Nevertheless, the revised cost-benefit analysis that emerged from OIRA review predicted that a stigma effect would result in $233.5 billion in “negative benefits” (i.e., costs) to society. Far weaker regulatory alternatives that would treat coal ash as if it was no more dangerous than ordinary household garbage were thus presented as the only cost-effective options.
We can only hope that Judge Walton’s deadline and a Congress preoccupied with preventing each other from ruining the nation’s economy will leave this issue to be resolved by the experts at EPA. Wishful thinking, to be sure. Stay tuned.Full text
Salmonella outbreak reveals we need more, not fewer, cops on the food safety beat.
Some 317 victims of salmonella poisoning from Foster Farms chicken sold in 20 states have learned firsthand why we need government. Who knows how much faster the threat would have been contained if Centers for Disease Control (CDC) experts had been walking their usual beat, coordinating state investigators and working frantically to discover the origins of the virulent strain of salmonella that has already hospitalized 42 percent of the 317 victims?
Instead, the investigators were sent home on furlough, and only recalled to work after the scandal hit the media.
CDC investigators are a vital link in the chain of public protection because they are the people who “trace back” illness to its source. Obviously, knowing someone has salmonella poisoning is not enough: we also need to know which food, from what company, gave them the disease.
When so many people got sick, investigators were called back, but they had to do their work tracking the outbreak without the benefit of the agency's rapid response online-tracking system, Pulse Net, which was shut down as a result of the furloughs. Eventually, the culprit was isolated: a poultry processor called Foster Farms, based in California that had already amassed a pitiful track record of dirty practices, including “poor sanitary dressing practices. Insanitary food contact surfaces and direct product contamination,” as documented by USDA. Eventually, USDA discovered that one-quarter of Foster Farm chicken was contaminated by salmonella, more than three times the acceptable standard set by USDA for this bacteria, which causes diarrhea, fever, and abdominal cramps 12 to 72 hours after infection.
The USDA sent nasty letters to Foster Farms as far back as July, but did not move on the company in any serious way until October when CDC and other government officials figured out the source of the bad chicken. Even then, no recall was required. Why? According to Food Safety Inspection Service chief Daniel Englejohn, the ability of the USDA to recall meat is hampered by a court decision from 2001, which concluded that as long as a contaminant, like salmonella, can be dealt with through the cooking process, it is considered “safe” to eat. Or, in other words, companies are protected even when people, doing their best to get dinner on the table, get sick. Even proper cooking is no panacea, given the high likelihood of cross-contamination in a kitchen: Costco ordered its recall after someone was sickened with salmonella from eating the store’s rotisserie chicken, which is cooked to at least 180 degrees—15 degrees above the USDA’s recommendation. This odd catch-22 and USDA’s lackadaisical enforcement has resulted in eight outbreaks in 2012 alone.Full text
A series of catastrophic regulatory failures have focused attention on the weakened condition of regulatory agencies assigned to protect public health, worker and consumer safety, and the environment. The destructive convergence of funding shortfalls, political attacks, and outmoded legal authority have set the stage for ineffective enforcement, unsupervised industry self-regulation, and a slew of devastating and preventable catastrophes. From the Deepwater Horizon spill in the Gulf of Mexico to the worst mining disaster in 40 years at the Upper Big Branch mine in West Virginia, the signs of regulatory dysfunction abound. Many stakeholders expected that President Obama would move to reinvigorate the regulatory system, but he has not. In fact, he's gone so far as to adopt some anti-regulatory rhetoric, and suggesting that that alleged over-regulation contributes to the nation's economic woes.
One central reason for the systemic failure of effective health and safety regulation is that many regulatory matters enter and exit the White House through the Office of Management and Budget’s (OMB) little-known but extraordinarily powerful Office of Information and Regulatory Affairs (OIRA). Centralized White House regulatory review began during the Nixon administration and OIRA was created in 1980. Over four decades, the process has evolved into a gauntlet for public health, worker safety, and environmental protection initiatives,. Agencies doing their best to implement statutory mandates in a reasonable timeframe are subjected to withering rule-by-rule reviews. The process is analogous to examining the branches of individual trees without realizing that they are part of a dying forest; this myopia has obscured the causes and effects of regulatory failure for five presidents from both parties.
Late last month, the Department of Energy proposed long overdue energy efficiency standards for commercial refrigeration units. The rules, which had been held up at OMB’s Office of Information and Regulatory Affairs (OIRA) for almost two years will result in savings of over $28 billion for businesses over the next 30 years and reductions in carbon emissions of 350 million tons over the same period. As we’ve discussed numerous times, rules are required by executive order to be reviewed by OIRA for no longer than 120 days. And OIRA routinely hangs onto them for months and frequently years. Recently, a rule to green federal office building just hit the two-year mark at OIRA.
So what’s happened in the past two years to slow down the progress of these two rules along with the other energy efficiency standards stuck at OIRA? After all, back in 2009, former Energy Secretary Steven Chu described energy efficiency standards as not just low hanging fruit, but “fruit lying on the ground.”
Savings for industry and consumers as well as reducing the burden of greenhouse gases on the environment seems like a no-brainer to anyone with common sense. But then, there are always House Republicans. Just this past summer, Rep. Marsha Blackburn (R-TN) waged a war against ceiling fans. That’s right, she tacked on an amendment to the Energy and Water spending bill to stop a DOE rulemaking process to review ceiling fan standards mandated by Congress itself. Feverish and kneejerk anti-regulatory efforts like these have unfortunately taken off in recent years in spite of past bipartisan support for energy efficiency and in many cases, industry enthusiasm for moving forward.Full text
We’ve often written in this space about the Obama Administration’s very bad idea to take federal inspectors of the line at poultry processing plants, leaving the discovery of blood, guts, and feathers on the carcasses to overworked and underpaid line workers forced to process as many as 70 birds per minute at the average plant. The U.S. Department of Agriculture (USDA) is the architect of this proposal to “modernize” the food safety system without requiring a single additional test to make sure the birds are not infested with salmonella, campylobacter, and other bad bugs. Confirming the rule’s primary role as a windfall for the poultry industry, USDA’s initial cost-benefit analysis indicated that it would save companies like Holly Farm, Tyson’s, and Perdue $250 million annually. That windfall is attributable to the fact that under the proposal, the line speed will at least double, to as many as 175 birds per minute.
Today, GAO released a report that further discredits this bad idea, confirming the dire warnings of food safety experts: USDA is relying on junk data from a pilot program, raising the strong possibility that any final rule won’t survive judicial review. This rule is so controversial that it will almost certainly be challenged in court. When it is, it will be reviewed under the Administrative Procedure Act’s arbitrary and capricious standard, and USDA is running the risk that a judge will find the agency’s shoddy analysis fails to meet the standards of quality demanded by the Administrative Procedure Act (APA).
Like no other mammoth corporation that did very bad things—not Enron, not WorldCom, not Exxon, and not even HSBC (which, after all, laundered money for the Mexican drug cartel and was allowed to pay a fine without pleading guilty!)—BP has not lost its arrogant swagger. In a fit of high dudgeon it filed a lawsuit last week challenging the one step the federal government has taken that could actually hurt the company over the long run: the long-overdue debarment of this chronic scofflaw from receiving contracts to supply fuel to the U.S. military.
Despite the semi-hysterical, every-argument-known-to-humans tone of its 127-page legal filing, Bob Dudley, BP’s chief executive officer, has been blithe about the effect of the debarment on its bottom line: “We have largest acreage position in Gulf of Mexico, more than 700 blocks…that’s plenty, we have a lot (sic),” he told the Telegraph, a British newspaper, a few weeks ago. “We have been debarred from supplying fuel to the U.S. military going forward but quite frankly we have a very big business in the U.S. and this is not distracting us from what we do.”
The Clean Water Act authorizes the Environmental Protection Agency (EPA) to debar companies that are not “responsible” from doing business with the government. Other provisions of federal law give the Pentagon the same authority but it could not be bothered to find a different fuel supplier even after the Deepwater Horizon explosion killed 11 and devastated the Gulf of Mexico. Showing itself once again to be one of the last feisty entities left in government, and after contemplating just such an action since 2005, EPA debarred BP in November 2012, just a few short months before the company pled guilty to manslaughter, a slew of environmental crimes, and—just for good measure--lying to Congress. It paid a $4 billion fine—the largest in history but Dudley is apparently still smiling.
The term “scofflaw” should not, of course, be used lightly. For those who need a little boning up on BP’s recidivist history, consider the following and let’s ask ourselves whether we might have avoided the entire Deepwater Horizon horror had EPA been allowed to debar the company back in 2005.Full text
The Senate’s grudging confirmation of Tom Perez as Secretary of Labor was the first piece of good news working people have had out of the federal government for quite some time. I know Perez--as a neighbor, a law school colleague, Maryland’s labor secretary, and a civil rights prosecutor. He’s a fearless, smart, and hard-driving public servant—exactly the qualities that Sen. Mitch McConnell (R-KY) and his caucus deplore in Obama appointees. With luck, Perez will be successful in direct proportion to the unprecedented vitriol Republicans hurled in his path. Their efforts to define a “new normal” for appointees—no one need apply who has ever done or said anything the most rabid member of the Tea Party might dislike—should not distract us from the real challenges confronting Perez within the Administration.
The success or failure of Perez's tenure will be decided not by Mitch McConnell, but by a White House whose political operatives have squashed every significant regulatory initiative suggested by the Occupational Safety and Health Administration’s (OSHA) star-crossed leader, David Michaels. In fact, so relentless has this punishing counter-campaign been that there now exists the very real possibility that President Barack Obama, who probably owes at least his first-term victory to the hard work of organized labor, will finish eight years in office having promulgated only two rules to address grave threats to worker safety and health. One is the revised Hazard Communication Standard, requiring employers to change the way they notify workers about toxic chemicals in the workplace. The other changed the rules covering use of cranes and derricks in the construction industry, focusing mostly on training, certification, and inspection requirements. The “HazCom” revisions were largely driven by changes to international standards and the cranes and derricks rule was developed through a negotiated rulemaking process during the George W. Bush Administration. So, other than whatever gains the agency may have achieved through enforcement, its rulemaking agenda has almost run off the tracks, and it will take a herculean effort to get it back on.Full text
Later in this space, we plan to discuss the many and varied failings of a proposal in the Senate to reform the Toxic Substances Control Act. Unfortunately, the proposal is the joint work product of conservative Sen. David Vitter (R-LA) and liberal Sen. Frank Lautenberg (D-NJ), who died two weeks ago and therefore won’t have the chance to fix the legislation that is so unworthy of his name.
But before we take on that misguided proposal, we wanted to pay tribute to the Senator’s larger legacy. Frank Lautenberg was a tireless advocate for progressive causes, who played a key role in many of the environmental and health battles of the last three decades. He was a relentless and effective advocate for the people of the “Garden” state, which in addition to its reputation for farming on lush land, also holds the tragic distinction of hosting more Superfund toxic waste sites than almost any other state.
New Jersey, once the third largest petrochemical producing state in the union, has a very large population in a small space. All of the elected and appointed officials who have risen to prominence there are highly sensitive to these issues and have frequently offered their leadership for the good of the nation as a whole. Indeed, it’s no accident that two former administrators of the EPA—Christie Todd Whitman, a Republican (and former governor), and Lisa Jackson, a Democrat, came from the ranks of the state’s government. Both worked closely with Sen. Lautenberg, who could always be depended upon to fight for more resources and better laws to address grievous public health hazards.
Over the course of roughly 28 years in the Senate (not counting a two-year gap when he temporarily retired), Lautenberg reshaped the nation’s approach to smoking, drunk driving, domestic violence, toxic waste cleanup, and community right-to-know. Legislation he introduced in the 1980s helped trigger the smoke-free revolution by prohibiting smoking on commercial airplane flights. The law marked a significant early defeat for the tobacco lobby, making tougher legislation at the federal, state and local level, possible. Lautenberg was also instrumental in toughening the country’s drunk-driving laws, establishing a nationwide .08 blood alcohol standard and a 21-year drinking age. He wrote and got passed legislation that prohibited perpetrators of domestic violence from owning guns.
On the environmental front, Lautenberg worked tirelessly with Sen. Bill Bradley and Reps. Jim Florio, Bob Roe, and Jim Howard to win reauthorization of the multi-billion Superfund program that harnessed the federal government’s power and resources to eliminate the worst threats posed by the thousands of dumpsites filled with toxic chemicals throughout New Jersey and the country. He was instrumental in winning passage of the Emergency Planning and Community Right-to-Know Act that was designed to prevent industrial accidents like the explosion at a Union Carbide pesticide plant in Bhopal, India that ultimately claimed 3,787 lives.Full text