June 11, 2013 by Lisa Heinzerling

EPA's Formaldehyde Rule: The Mystery of the Shrinking Benefits

Why does the White House take so long to review rules from the regulatory agencies?  As I have documented elsewhere, many rules have been stuck at the White House’s Office of Information and Regulatory Affairs (OIRA) for years.  Some of these remain there to this day.  What is the White House doing for the months and years that rules are stuck there?

One rule that just escaped from the clutches of regulatory review might provide a clue.  Just yesterday, EPA posted documents generated as a result of White House review of its rule on formaldehyde emissions from wood products.  These documents show at least one possible answer to the question of why review takes so long: perhaps it takes a very long time to make the benefits of regulation disappear!  This, at least, appears to be a primary consequence of the more-than-year-long tenure of the formaldehyde rule at the White House’s OIRA.

EPA’s rule on formaldehyde emissions went to OIRA with an estimate of annual benefits that ranged from $91 million at the low end to $278 million at the high end.  The rule left OIRA, however, with an estimate of annual benefits that ranged from $9 …

June 11, 2013 by Lisa Heinzerling

The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court …

May 29, 2013 by Lisa Heinzerling

Cross-posted on ACSBlog.

A panel of the Second Circuit Court of Appeals in New York has just taken under consideration the Food and Drug Administration’s motion for a stay of a district court order directing the agency to make levonorgestrel-based emergency contraceptives available to women and girls of any age without a prescription and without other point-of-sale restrictions. In deliberating on this motion, the panel of judges should not, I am sorry to say, take anything the FDA has said in its briefs at face value. The government’s opening and reply briefs on the motion to stay are so full of misstatements and omissions that the court could badly err if it did not take everything the government says with a shaker full of salt.

One of the factors in deciding whether to grant a stay pending appeal is the likelihood that the moving party …

May 10, 2013 by Lisa Heinzerling

Cross-posted at ACSBlog.

“The easiest way to save money,” President Obama declared in his 2012 State of the Union address, “is to waste less energy.”  In his 2013 State of the Union address, President Obama took another step and issued “a new goal for America”: “let’s cut in half the energy wasted by our homes and businesses over the next twenty years.” The President also vowed that if Congress did not “act soon” to address climate change, he would “direct his Cabinet to come up with executive actions we can take, now and in the future, to reduce pollution, prepare our communities for the consequences of climate change, and speed the transition to more sustainable sources of energy.”

Such welcome sentiments! So sensible and right and good! But here is a puzzling fact: at the same moment President Obama was uttering these wise and welcome remarks …

April 30, 2013 by Lisa Heinzerling

Reposted from RegBlog.

In his revealing new book about his nearly four years as President Barack Obama’s “regulatory czar,” Harvard Law School professor Cass Sunstein describes a striking moment:  “After I had been in the job for a few years, a Cabinet member showed up at my office and told my chief of staff, ‘I work for Cass Sunstein.’  Of course that wasn’t true – but still.” 

But still, indeed.  Sunstein’s book, Simpler: The Future of Government, makes clear just how much power the Administrator of the Office of Information and Regulatory Affairs (OIRA) wields in this administration.  As I have written elsewhere, Sunstein informs us that, as OIRA Administrator, he had the power to “say no to members of the president’s Cabinet;” to deposit “highly touted rules, beloved by regulators, onto the shit list;” to make sure that some rules “never saw the …

Feb. 6, 2013 by Lisa Heinzerling

Eighty percent of the antibiotics used in this country are given not to humans, but to animals destined for the human food supply.  Most of these antibiotics are given to the animals not for the purpose of treating active infections, but for the purposes of promoting growth and preventing infection in the microbe-rich environment of the modern factory farm.  For over 40 years, the Food and Drug Administration (FDA) has been collecting evidence that this agricultural practice contributes to the development of antibiotic-resistant infections in the human population. Based on such evidence, in fact, the agency proposed to withdraw its prior approvals for two antibiotics used in animal feed due to the risks they posed to human health. The agency promised to hold hearings on the matter. That was over 35 years ago. On Friday, the future of this issue will be debated in oral arguments in …

June 14, 2012 by Lisa Heinzerling

Cross-posted from Georgetown Law Faculty Blog.

Despite initial signs suggesting a different path, the Obama Administration has promoted the role of cost-benefit analysis in regulatory policy as fiercely as any administration before it. Nothing demonstrates this more clearly, I think, than the Administration’s bizarre and unfortunate decision to apply cost-benefit analysis to measures to limit rape and sexual abuse. 

Last month, the Department of Justice issued a final rule on rape and sexual abuse in confinement facilities.  The rule was required by the Prison Rape Elimination Act ("PREA"), a law passed by a unanimous Congress and signed by President George W. Bush.  In PREA, Congress directed DOJ to set national standards to prevent, detect, and respond to rape and other forms of sexual abuse in federal, state, and local confinement facilities.  PREA did not say that DOJ should do a cost-benefit analysis to decide whether actions …

June 8, 2012 by Lisa Heinzerling

Cross-posted from Georgetown Law Faculty Blog.

When an agency defends over three decades of inaction on an important problem by saying that acting would take too long, one hopes a judge reviewing the agency's inaction will see through the pretense.  This is exactly what happened this week, when a federal magistrate judge in New York ruled that the U.S. Food and Drug Administration had acted arbitrarily in citing time and resource constraints in declining to limit the use of antibiotics in animal feed. 

Some 80 percent of the antibiotics used in the United States are given to animals destined to become part of our food supply.  Most of these drugs are given not to sick but to healthy animals; they are used not to treat disease but to promote animal growth or to prevent bacterial infections from occurring.  Both of these purposes are tied to …

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