Earlier this month, EPA released for public comment a new white paper on probabilistic risk assessment, marking the Obama Administration’s first major foray into the contentious debate about EPA's evolving risk assessment methods. Back in May, EPA Administrator Lisa Jackson announced changes to the way the Office of Research and Development (ORD) will update risk assessments for the IRIS database, but that announcement was made without any real public input and it only implicated the inner workings of one program office (albeit an important one). The public comment period on the new white paper presents the first opportunity for the various stakeholders who usually weigh in on EPA’s risk assessment policies to have some say in the new administration’s policies.
The new white paper, Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision Making, focuses on one of the fundamental problems in regulatory risk assessment – how should risk assessors and risk managers address the uncertainty and variability intrinsic to the risk assessment process?
The most straightforward way to answer that question, and EPA’s approach in many situations, is to use default assumptions. When the pesticides program staff is working on setting a limit for pesticide residue on apples, they can use a standard assumption about the number of apples a person eats. Or when ORD staff updates IRIS profiles, they can assume a linear dose-response relationship for a suspected carcinogen’s toxicity. But as scientific knowledge about certain parameters and models used in risk assessments grows, default assumptions might legitimately be replaced by data collected in the real world. Recognizing that every parameter and model used in a risk assessment has some inherent level of uncertainty, and that variability in the population can have a significant impact on risk determinations, risk assessors can use probabilistic data to replace point estimates of specific parameters or generic model assumptions.
Full textThis item cross-posted by permission from Legal Planet.
In April, Interior Secretary Ken Salazar asked a federal court to vacate a last-minute Bush administration rule relaxing stream buffer zone requirements for dumping waste from mountaintop removal mining. Salazar said that the rule didn’t pass the smell test, and that it had been improperly issued without ESA consultation. Environmental groups which had challenged the rule welcomed Salazar’s announcement, but the National Mining Association, which had intervened in support of the rule, vigorously opposed it. Wednesday, Judge Henry Kennedy of the federal district court in Washington, D.C., denied Salazar’s motion. Where no court has ruled on the merits, he said, an agency cannot unilaterally repeal a rule without going through the normal notice and comment procedure required by the Administrative Procedure Act.
The ruling is frustrating for opponents of mountaintop removal mining, who are convinced that the Bush rule was unlawful. But the dangers of allowing a new administration to duck the public rulemaking process by simply declaring that its predecessor had made a legal error are obvious. If the administration is really serious about stopping mountaintop removal (which is not entirely clear, given its equivocal behavior over the past several months), it has plenty of other tools at its disposal in the short run, while it goes through the notice and comment procedure to restore the old buffer rule. And of course Salazar’s public proclamation that the Bush rule was improperly adopted ought to help plaintiffs persuade Judge Kennedy to enjoin implementation of the Bush rule pending judicial review. (Hat tip: Charleston Gazette.)
By now, followers of the controversy over the appointment of Cass Sunstein to serve as Obama Administration “regulatory czar” can do little but shake their heads in astonishment. The controversy over the Harvard professor’s nomination to OMB’s Office of Information and Regulatory Affairs has taken on a picaresque quality, as one bizarre delay follows another. The latest development in the Sunstein saga is reportedly the placement of another, as-yet unidentified senatorial hold on the nomination, perhaps at the behest of cattle rancher and National Rifle Association interests, with Majority Leader Harry Reid promising to take steps in September to release the nominee from limbo.
Meanwhile, as I have noted before in this space, like other nominees with delayed confirmations, Sunstein appears to be in firm control of his 50-odd person staff at the Office of Information and Regulatory Affairs (OIRA) where he has worked in a consultant capacity for several months. The nominee has left no discernible paper trail demonstrating his influence and, until recently, was also refusing to meet with outsiders or talk to the press. (He did meet with the ranchers in an effort to reassure them regarding his stance on animal rights, ultimately persuading Sens. Saxby Chambliss (R-GA) and John Cornyn (R-TX) to lift their holds.) Given Sunstein’s seeming ubiquity in the Old Executive Office Building, his high energy level and broad interests, the relatively small size of the office, and his stalwart commitment to doing this job, it is hard to imagine that much happens at OIRA without his knowledge and, most likely, his direct supervision.
If OIRA under Sunstein – if and when he’s finally confirmed – is going to be something other than what it was during the Bush Administration, one might already expect to see green shoots of real change emerging from the place. Unfortunately, it looks a lot like business as usual during this early period of the Sunstein era. The most recent indication of that is the approach OIRA has followed on one crucial toxics controversy, and the experience suggests that Sunstein has no intention of reversing some of the most destructive traditions established by his Bush Administration predecessors.
Full textThis is one of two posts today by CPR member scholars evaluating NY Gov. David Paterson's recent executive order on regulations; see also Sid Shapiro's post, "New York Governor Channels Ronald Reagan: Governor Paterson’s Flawed Plan to Review Regulations."
It is open season on environmental, health, and safety regulations in New York. Last Friday, August 7, Governor Paterson issued an Executive Order directing his public safety agencies to review all of their regulations with an eye toward eliminating any that are “unnecessary, unbalanced, unwise, duplicative or unduly burdensome.”
This language could have been lifted directly from anti-regulation lobbying groups. The Governor's press release actually touts: "Streamlined Regulations Will Better Protect the Health, Safety and Welfare of all New Yorkers." Nothing could be further from the truth.
The Order requires each agency to conduct a 60 day comment period and then select at least two regulations to designate for further review, the selection to be based on which regulations have generated the most widespread or substantive criticism and opposition.
Think about what this means.
Paterson’s Executive Order gives well-financed, well-organized business groups a second bite at the apple on a host of regulatory battles that they have already lost. Regulations that protect the people and the state of New York already go through extensive public comment and review. Now regulations that that have been duly enacted, sometimes after much struggle, will be on the chopping block. This process ensures that the most controversial regulations, often those dedicating resources to protecting the most vulnerable among us, will be cherry-picked for review.
Full textThis is one of two posts today by CPR member scholars evaluating NY Gov. David Paterson's recent executive order on regulations; see also Rebecca Bratspies' post, "Paterson's Executive Order: Win for Industry, Loss for Public Health and Safety."
Who knew? With his newly announced plan to require New York departments and agencies to look back at proposed and existing regulations, Governor Paterson placed himself squarely in the anti-regulatory tradition of Ronald Reagan, George H.W. Bush, and George W. Bush. Like Governor Paterson, these presidents created a look-back process to identify regulations that they said needed to be reformed. The history of White House look-backs suggest the New York is at a minimum misguided and could well be harmful to New York residents.
Shortly after being elected, President Reagan created the Task Force for Regulatory Relief, headed by then Vice-President George Bush, to create a list of regulations that were the most burdensome on business. As the name implies, the goal was not to strengthen regulatory protections. Facing reelection, the first President Bush announced a 90-day moratorium on new regulations and required regulatory agencies to undertake a look back. Given the timing, the plan appeared to be an effort to curry favor with conservatives and the business community, which is Governor Paterson’s motive, according to his critics. The second President Bush invited the public to send requests to the White House for regulatory revisions, which it passed on to the agencies, a process that was heavily dominated by requests from business interests.
Governor Paterson defended his plan as a way to reduce “red tape,” a typical ploy of regulation opponents. Because government needs information to adopt regulations and then to enforce them, it requires regulated entities to fill out forms. To those filling out the paperwork, this can appear to be government run amok, and sometimes it is. But most of the time it is not. Regulated entities have ample opportunity to point out to departments and agencies that reporting requirements are unnecessary before they are put in place, and there is no proof that government usually adopts them anyway. Still, if the Governor’s plan had been limited to reducing paperwork requirements, it would not be so alarming. But the plan isn't just about reducing paperwork, it's about changing -- weakening -- regulations.
Full textCPR's Sid Shapiro is interviewed in this week's edition of Living On Earth, the environment-focused public radio show heard in 300 markets around the nation. The subject is David Michaels's nomination to head the Occupational Safety and Health Administration.
Says Shapiro: "David Michaels has his job cut out for him. I think it's fair to say that OSHA is one of the most dysfunctional agencies in Washington. For example, Congress had a plan how to regulate toxic chemicals in the workplace. And OSHA has been almost unable in the last ten years or so to fulfill that plan. In fact, it's only issued three health regulations in roughly the last 10 to 15 years."
Text of the interview is here. It's downloadable, here. And streamed, here.
Full textLike Alice's adventure, the development of regulatory oversight in the Obama administration is becoming "curiouser and curiouser." President Obama selected Cass Sunstein to be the head of the Office of Information and Regulatory Affairs (OIRA), a curious choice since Sunstein, although one of the country’s most distinguished academics, is in favor of extending the use of cost-benefit analysis, a position so popular with the business community that the Wall Street Journal endorsed his nomination. Sunstein's confirmation hearing was uneventful, probably because he avoided answering any difficult questions, but Sunstein's nomination is now being held by Senator John Cornyn, who objects to Sunstein's previous statements on animal rights -- an issue that the head of OIRA is highly unlikely to encounter.
In the meantime, the development of a new Executive Order on regulatory impact analysis has had its own curious journey. The new administration invited public comment on shaping the executive order, an unprecedented and welcome development. The administration also sought the input of agencies, although it has not made their comments public. That's defensible -- Presidents defend such secrecy as necessary to ensure that subordinates will be candid in giving advice -- but the administration missed an opportunity to fulfill its pledge to be more transparent since it is unlikely that agencies would have been affected had the comments been disclosed.
To fulfill its transparency commitment, the administration also should have put out a draft Executive Order for public comment. In Republican administrations, OIRA review has been used to scuttle regulation, while OMB in the Clinton administration adopted a more benign attitude towards executive oversight. The ideal outcome would be to replace the current cost-benefit centered review process with a more pragmatic approach, a result CPR board members called for in March. But given Sunstein’s appointment, this outcome would be unexpected (but welcome). If a cost-benefit approach is to be retained, the devil will be in the details, all the more reason to invite public comment on a draft executive order.
Michael Livermore is right to suggest that environmentalists should be focused on Cass Sunstein’s first official day as regulatory czar for the Obama Administration. After months of delay over the Harvard professor’s eclectic and provocative writings, he will eventually take office if he can placate cattle ranchers concerned about his views on animal rights. Whatever their level of paranoia about Sunstein’s ability to grant animals standing to bring lawsuits, the likely character of his reign was more accurately predicted by the editorial page of The Wall Street Journal, which applauded Sunstein’s devotion to cost-benefit analysis, the major weapon of Presidents Reagan, Bush I, and Bush II to smother health, safety, and environmental protections.
Livermore, an advocate of kinder, gentler cost-benefit analysis that he hopes will lead to regulatory controls more palatable to conservatives, offers a depressing list of priorities for Sunstein on his first day. They boil down to continuing the mission of George W. Bush’s regulatory czars: using number-crunching of “costs” and “benefits” (e.g., a life saved by regulation is worth anywhere from $1-10 million) as the transcendent tool in making decisions on climate change, public health protections, worker safety, and sustainability. I cannot help but remember many economists’ awesome failure to predict and avoid the global economic meltdown and wonder why their predictions in the health and safety arena should be even more essential these days.
Many progressives fear that, despite Lawrence Summers and Timothy Geithner’s claims that they are interested in “true” reform of a fatally corrupt banking system, the two men have essentially missed the opportunity of this generation to overhaul it—and the recent comebacks of the largest firms seem to underscore these fears. In a similar vein, we should be very disappointed if Sunstein does not deliver on the president’s promise of “change we can believe in.” To do that, he should:
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Bowing to right-wing political pressure, Cass Sunstein, nominee for “regulatory czar” in the Obama Administration, broke months of official silence to plead his case with the cattle ranchers and agribusiness lobby who have engineered a hold on the nomination by Senator Saxby Chambliss (R-GA). Sunstein’s move was all the more troubling because his absence from the public eye has included an across-the-board refusal to meet with or respond to any inquiries from a wide range of progressive groups and mainstream news reporters. Everyone who has tried to approach Sunstein has been shunned—from reporters at several top news outlets to representatives of labor unions and advocacy groups. The strict wall of “no comment until I am confirmed” has persisted despite the fact that Sunstein has been working at OMB for months, actively participating in a series of decisions by the Obama Administration on regulatory matters.
Don’t get me wrong, on some level I feel some sympathy for Sunstein. Once again foiled by his own eclectic, even lush, scholarship, Sunstein is in trouble because he has written that animals are widely mistreated in our society and even suggested that, like children, they may deserve to have their “rights” protected in court (see, for example, his 2002 article entitled “The Rights of Animals: A Very Short Primer”). In the energetic and unrestrained tone that accompanies all his academic writing, Sunstein opined: “Do animals have rights? Almost everyone believes in animal rights, at least in some minimal sense; the real question is what that phrase actually means. [My argument] puts the spotlight squarely on the issues of suffering and well-being. … It strongly suggests, for example, that there should be extensive regulation of the use of animals in entertainment, scientific experiments, and agriculture.” He continues: “My argument—that we should consider refraining from certain practices if this is the only feasible way to avoid widespread suffering—raises a host of questions….Why couldn’t farms generally give their animals decent lives, as many farms now do? … If vegetarianism were widespread, would human health be undermined (as many contend) or improved (as many also contend)? … My suggestion is that on a reasonable reading of the facts, many practices will have to yield.” So, if Professor Sunstein is to be taken at his scholarly word, the cattle growers would be rightly as agitated as progressive groups have been about, for example, Sunstein’s equally provocative suggestion in a 2008 article that the Occupational Safety and Health Administration is unconstitutional.
Full textAs expected, Cass Sunstein's nomination for Administrator of the Office of Information and Regulatory Affairs (OIRA) was approved Wednesday by the Senate Committee on Homeland Security and Government Affairs. Senator Tom Coburn (R-Okla.) alone voted against confirmation (we're guessing his vote was not motivated by concerns over Sunstein's past support for cost-benefit analysis and strengthening the institution of centralized regulatory review.) Sunstein is expected to be approved by the full Senate soon.
What now? In his confirmation hearing, Sunstein pledged he'd use underlying statutory standards to guide regulatory decision-making, and illustrated the point by acknowledging that some statutes do not allow agencies to take costs into account at all, such as the provisions of the Clean Air Act that direct EPA to set National Ambient Air Quality Standards. He said the agencies, not OIRA, must play the primary role in making regulatory decisions.
Sunstein also promised that he would not allow the exercise of regulatory review to put regulation in an "arithmetic straightjacket." He said that he believed that cost-benefit analysis should be "inclusive" and "humanized" -- that it should include the consideration of "soft variables" like moral values and distributional concerns.
These weren't the most ground-breaking promises, but they're important -- a starting point. Soon we'll see how Administrator Sunstein is able to live up to them.
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