James Goodwin on CPRBlog {Bio}
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Better Late Than Never: OIRA’s Meeting Logs Just Got a Lot More Transparent

This week the Office of Information and Regulatory Affairs (OIRA)—the obscure White House Office charged with reviewing and approving agencies’ regulations—took an important and much-appreciated step in the direction of greater transparency by updating and improving its electronic database of lobbying meetings records that the agency holds with outside groups concerning the rules undergoing review.  As detailed in a 2011 CPR report, corporate interests have long used OIRA as a court of last resort for seeking relief from regulatory requirements they find inconvenient; these lobbying meetings provide them with a powerful and secretive forum in which to push for substantive changes to critical agency safeguards that would ensure the public continues to bear the cost of their polluting activities.  With the improved database, the public, policymakers, and the media will be better able to track the efforts of corporate interests to exploit the OIRA review process to weaken or block regulatory protections.

Before the upgrade, OIRA docketed all its meetings in a barebones and often careless fashion on a separate section of its website.  As the 2011 CPR report explained, the meetings dockets suffered several serious flaws.  The meetings were not linked to the rule undergoing review that was the subject of the meeting, nor was there any standardized format for documenting what rule was the subject of the meeting.  Often, interested members of the public would have to consult a number of different sources to verify what rule was at issue in a given meeting.  To make matters worse, key meetings log data—including the attendees of the meeting and their affiliations—were often rife with typos and inaccurate or incomplete information.  These log data were also supposed to provide links to all documents presented at the meeting, but in some cases the links do not work.  Even when accurate, the meetings data were of limited utility because they were not presented in a searchable database.  If, for example, a member of the public wanted to see how many meetings took place with regard to a particular rule, he or she would have to assemble these data manually.  CPR sought to overcome this problem by creating its own searchable meeting database, which available here.

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CPR Member Scholars Send Letter to Senate Criticizing “Attempted Misuse” of the Congressional Review Act

Yesterday, 13 Member Scholars of the Center for Progressive Reform (CPR) sent a letter to the U.S. Senate expressing their concern about S.J. Res. 30, a Congressional Review Act (CRA) “resolution of disapproval” introduced by Senate Minority Leader Mitch McConnell (R-KY) that seeks to block the Environmental Protection Agency’s (EPA) proposed Clean Air Act New Source Performance Standard (NSPS) to limit greenhouse gas emissions from future fossil-fueled power plants.  Drawing on their many years experience in administrative law, the Member Scholars make the case that McConnell’s proposal is at odds with the CRA, because it seeks disapproval not of a final regulation, but of a regulation that has merely been proposed.  “By attempting to subject a proposed rule—as opposed to a final rule—to this process,” they write, “S.J. Res. 30 is contrary to the statutory language and could raise questions as to the legitimacy of any resolution of disapproval.”

Some history is in order.  Senator McConnell introduced S.J. Res. 30 in January, and in a slap in the face to, well, everyone, he fired off a letter to the Government Accountability Office (GAO) raising the very issue that the CPR Member Scholars are now flagging:  He asks them to “review” Congress’s ability to use the CRA to force an up-or-down vote to stop the EPA’s proposed NSPS. As explained below, what McConnell hopes to use the CRA for is to prevent any kind of rule that resembles the proposal to go forward.  The GAO has not yet responded to Senator McConnell’s inquiry, but he seems determined to move ahead with the resolution anyway.  Incidentally, the GAO FAQs page on the CRA seems to suggest that the GAO presumes that the CRA does not apply to proposed rules.  One question asks: “Should agencies submit proposed rules to GAO? [i.e., to initiate the CRA process].”  The answer provided states: “No. Agencies should only submit major, nonmajor, and interim final rules to GAO.

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The “Best” Regulatory System Money Can Buy: Lessons from North Carolina’s “Regulatory Reform” Movement

For years, Duke Energy has enjoyed virtual free rein to contaminate North Carolina’s surface and ground waters with arsenic, lead, selenium, and all of the other toxic ingredients in its coal ash waste in clear violation of the Clean Water Act and other federal environmental laws.  And it seems that both North Carolina’s regulators and state legislators are determined to keep it that way.

Last year, the state’s environmental agency actively thwarted citizens’ efforts to sue Duke for violating the Clean Water Act by intervening in the lawsuit at the last minute and then settling with the company for just over $99,000—chump change for a company worth more than $50 billion—and no obligations to clean up their coal ash waste sites or prevent future pollution.  As detailed previously on CPRBlog, the head of the state’s environmental department—appointed by Gov. Pat McCrory, a former executive at Duke who had worked for the company for nearly three decades—promised that he would work as a “partner” to regulated industries in the state.  Federal prosecutors are now looking into whether North Carolina’s environmental regulators engaged in any criminal activity in their efforts to shield Duke.

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CPR Submits Comments on FDA's Proposed Generics Labeling Rule

If you’re harmed by an improperly labeled prescription drug you’ve taken, should your ability to hold the manufacturer accountable in court depend on whether that drug was “name brand” or “generic”? Strangely, it does matter, thanks to the 2011 U.S. Supreme Court decision in Pilva v. Mensing. There, the Court held that because of a quirk in the Food and Drug Administration’s (FDA) regulations, generic drug manufacturers were shielded against plaintiffs’ state tort law failure-to-warn claims that alleged that a generic drug’s labeling failed to provide adequate warning of particular health risks.  The Court reasoned that since the FDA’s regulations didn’t readily allow generic drug manufacturers to update their labels quickly to warn consumers against any newly discovered risks, it would be impossible for those same generic drug manufacturers to fulfill a separate state tort law duty to provide such warnings through adequate labeling.  The impossibility of complying with both legal duties simultaneously compelled the Court to find that the FDA’s regulations preempted the plaintiffs’ state tort law claims.

In the wake of that decision, the FDA has proposed to amend its regulations to eliminate this disparity.  Specifically, the proposal seeks to extend to generic drug manufacturers the ability to use the “changes being effected” supplement process (often called “CBE changes”) to make changes to their product labels.  It’s a little complicated, but the basic gist is that CBE changes enable drug manufacturers to update product labels relatively quickly whenever they become aware of certain kinds of information regarding the potential risks of their drugs.  The goal of the CBE changes process is to empower drug manufacturers to provide consumers and their doctors with relevant risk information as quickly as possible, so that they can make the best-informed decisions possible about whether and how to take a particular drug.   The public comment period for the proposal ends this Thursday, and CPR Member Scholars Tom McGarity and Sid Shapiro and I have submitted comments that aim to highlight for the FDA an important, but easily overlooked benefit of this rulemaking—namely, the invaluable role that a vibrant state civil justice system can play in complementing and reinforcing the FDA’s regulatory programs so that they are better able to protect the public against unreasonably dangerous drugs. 

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The Regulatory Accountability Act: Or How to Defeat the Public Interest in Just 65 Easy Steps

Cue the majestic fanfare, for this week marks House Republicans’ so-called “Stop Government Abuse Week”—you know they mean business, because they have a clever Twitter hashtag and everything.   So how does one celebrate such an auspicious occasion?  Apparently, by wasting precious House floor time with a series of votes on several extreme anti-regulatory bills that, if enacted, would make it all but impossible for agencies to carry out their congressionally mandated missions of safeguarding the public against corporate abuses.  The jewel in this potentially catastrophic crown is the Regulatory Accountability Act, which has been repackaged as Title II of the overstuffed “Regnibus” bill, officially known as the All Economic Regulations are Transparent (ALERT) Act (H.R. 2804).

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Has OIRA really improved the timeliness of its reviews? Nope, it just has a new scheme for delaying safeguards and defeating transparency

It’s time to put to bed an unfortunate myth that’s been floating around the last few weeks.  The myth goes something like this:  The Office of Information and Regulatory Affairs (OIRA)—the opaque bureau within the White House charged with approving agencies’ draft regulations before they can be released to the public—has succeeded in improving the timeliness of its reviews during the last few months.  OIRA has long been a roadblock to the successful implementation of critical safeguards, so if true, this claim would be welcome news.  But, when OIRA’s recent record is viewed with a more critical eye, this claim simply does not hold up.

While it’s true that OIRA has recently cleared its docket of several high profile draft rules that have been stuck there for several months or even years, in many cases OIRA has done so by relying on what almost amounts to an accounting trick—one that seems calculated to skirt any meaningful transparency requirements.

A few months ago, CPR noticed a disturbing trend in which OIRA was increasingly using an obscure and relatively uncommon process known as a “withdrawal” to end some long-overdue reviews of high profile draft rules.  Among the first rules to be disposed of through this scheme included the Environmental Protection Agency’s (EPA) draft proposed Chemicals of Concern list (withdrawn from OIRA review on September 6, 2013, after 1,214 days) and the National Highway Traffic Safety Administration’s (NHTSA) draft final rule for rearview cameras in automobiles (withdrawn from OIRA on June 20, 2013, after 583 days).

So, what is a withdrawal and why does it matter?  A withdrawal occurs when the rulemaking agency (for example, the EPA or NHTSA) voluntarily withdraws a draft rule from OIRA review before it has been completed.  The withdrawal process is distinct from a “return,” which occurs when OIRA ends the review by sending the draft rule back to the rulemaking agency for more work instead of approving it.  From a transparency perspective, there is a crucial difference between withdrawals and returns.  When OIRA uses a return to end a review, Executive Order 12866 (a legal document that governs OIRA review) requires that it issue a public “return letter” that explains the problems with the draft rule and why OIRA was otherwise unable to approve it.  In contrast, with a withdrawal, the rulemaking agency is under no obligation to offer a public explanation for why it decided to withdraw the draft rule from OIRA review.

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Anti-science and anti-democratic: House Republicans’ farm bill rider seeks to tie up critical safeguards indefinitely

It’s like a Russian nesting doll of bad policy:  House Republicans have contrived to take one of the most anti-science bills in memory and then place it inside one of the most anti-democratic legislative vehicles available.  It’s part of an attempt to ram through into law new rulemaking requirements that would benefit the already-healthy bottom lines of their corporate benefactors at the devastating expense of the health, safety, pocketbooks, and perhaps even lives of the American public.  That’s what is at stake with an obscure three-page rider—Section 12307, euphemistically entitled “Ensuring High Standards for Agency Use of Scientific Information”—in the 700-page House version of the Farm Bill (H.R. 2642, the Federal Agriculture Reform and Risk Management Act of 2013) that is currently undergoing conference committee consideration to resolve differences between it and the Senate version of the Farm Bill.  (See page 654 of the bill for the rider—seriously, page 654!—which is available here; warning, this is a huge PDF.)

This anti-science rider began life as a stand-alone anti-science bill (also) euphemistically entitled the “Sound Science Act” (H.R. 1287), originally introduced by Rep. Stephen Fincher, a Tennessee Republican.  If enacted, it would require all agencies (including independent agencies) to develop a conspicuously complex set of guidelines, which would purportedly improve agencies’ use of “science” in “policy decisions,” a term the rider defines very broadly to include virtually any type of agency activity, including non-legally binding guidance documents.  The rider states that these policy decisions may not take effect unless they are in strict compliance with those guidelines.  The rider appears to make this requirement judicially enforceable by declaring that policy decisions that fail to comply with an agency’s guidelines are “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.”  (Because this section of the rider is so amateurishly drafted, it’s not entirely clear how this mechanism will work in practice.  What is clear, though, is that if the rider becomes law, this section is sure to invite lots of costly, time-consuming, and wasteful litigation.)

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Should Congress have to pass a bill twice? OIRA’s interference endangers pilots

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.

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Transparency Withdrawn: A New Tactic for Shielding OIRA’s Regulatory Review Activities?

Yesterday, the Environmental Protection Agency (EPA) announced that it was “withdrawing” from White House review its draft final guidance that sought to clarify the scope of the Clean Water Act.  The guidance had been languishing at the Office of Information and Regulatory Affairs (OIRA), which oversees the White House regulatory review process, for 575 days, even though Executive Order 12866, the document that governs OIRA review of regulations, caps the length of reviews at 90 days plus a limited, one-time extension of 30 days.  This is just the latest episode in what now appears to be a new disturbing trend:  The Obama Administration seems to be increasingly relying on a relatively uncommon practice known as a “withdrawal” to unceremoniously dispose of long-overdue OIRA reviews involving important safeguards that are vigorously opposed by industry. 

Over the last few months, several other industry-opposed rules have met a similar fate of being withdrawn after sitting at OIRA for well beyond the time limit permitted by Executive Order 12866:

·The National Highway Traffic Safety Administration’s (NHTSA) draft final rule mandating rearview cameras to prevent back-over accidents involving children:  “Withdrawn” from regulatory review on June 20, 2013, after collecting dust at the OIRA for 583 days.

·The EPA’s draft proposed Chemicals of Concern list—an absurdly modest regulatory “action” that would have merely identified a handful of potentially harmful chemicals as worthy of additional agency scrutiny:  “Withdrawn” from OIRA review on September 6, 2013, after an astonishing delay of 1214 days.

· The EPA’s draft proposal to limit the chemical industry’s specious “confidential business information” claims to shield crucial health and safety data on their new chemicals from public disclosure:  “Withdrawn” from OIRA review on September 6, 2013 after 620 days.

Before delving into why this apparent uptick in withdrawals is cause for concern, some background may be in order.   A “withdrawal” occurs when an agency voluntarily chooses to “withdraw” a draft proposed or final rule from the regulatory review process before OIRA, as the regulatory gatekeeper, has either formally approved the draft—clearing it for publication in the Federal Register—or denied it, through a “return letter,” sending the draft back to the agency for more work.  At least, that’s the theory of how withdrawals work.  In some cases, the circumstances suggest that OIRA or other White House officials have pressured the agency into withdrawing a rule.

The Executive Order does impose on OIRA important disclosure requirements that if followed, would help to bring needed transparency to the withdrawal process.  Under the Order, these obligations are very broad, requiring OIRA to “make available to the public all documents exchanged between OIRA and the agency during the review by OIRA.”  (Emphasis mine.)  See for yourself at section 6(b)(4)(D).  Presumably, included in “all” these “documents” would be evidence of flaws or policy disagreements that led the agency to withdraw the rule.  It would also shed some light on whether this withdrawal was in fact voluntary or under pressure from the White House—and thus just a return letter by another name.

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The Regulatory Czar’s Recent Blog on Truck Driver Paperwork and the West, Texas, Tragedy

 Last week, Regulatory Czar Howard Shelanski embarked on his maiden voyage into the glamorous world of White House blogging, penning a post that touts the latest burden-reducing accomplishment of President Obama’s dubious regulatory “look-back” initiative.   On this auspicious occasion, he trumpets the Department of Transportation’s (DOT) proposed rulemaking to reduce the number of inspection reports that commercial truck drivers have to file, resulting in reduced paperwork burden costs to the tune of $1.7 billion annually.

Shelanski makes clear in the post that this DOT rulemaking is not an isolated incident, but is in fact part of the regulatory look-back initiative’s broader antiregulatory project.  He explains that the initiative is necessary because “some regulations that were well crafted when first issued can become unnecessary over time as conditions change—and regulations that aren’t providing real benefits to society need to be streamlined, modified, or repealed.”  (Emphasis mine)  In case the look-back’s antiregulatory objective wasn’t clear enough the first time around, Shelanski states emphatically at the end of the post:  “This Administration will expand and further institutionalize our regulatory look-back efforts to ensure that we continue to identify rules that need to be modified, streamlined, or repealed.”  (Emphasis mine again)

I’ve got a serious bone to pick with Shelansk’s three-part formulation of the look-back initiative’s goals (“streamline,” “modify,” “repeal”), and it’s this:  The clear language of Executive Order 13563—which lays the initiative’s groundwork—reveals that Shelanski is deliberately overlooking a fourth stated goal—to “expand” existing rules where appropriate—which, not incidentally, is all that provides the look-back process with any semblance of balance.  It’s right there in Section 6 of the order:  “. . . agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.”  (Emphasis mine yet again)  See for yourself.  I’ll wait.

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