Conflict Disclosures for Regulatory Science: Slow but Steady Progress at Last
Basic disclosures of conflicts of interest have been required by the top science journals for decades. Yet most regulatory agencies – despite strong urging from a variety of bipartisan sources – have failed to require these disclosures for private research submitted to inform regulatory decisions. This omission is particularly alarming since, unlike journals, agencies used this research to determine the appropriate standards for protection of public health and welfare. If anything, one would expect the agencies to apply higher scientific standards and insist on greater transparency for privately submitted research as compared to journal editors.
The failure of agencies to meet these bare minimum standards of science has not gone unnoticed. Recently, the Administrative Conference of the U.S. recommended that agencies should, where possible, require these basic disclosures of conflicts, including “whether the experimenteror author had the legal right without approval of the sponsor of the research to: design the research; collect the data; interpret the data; and author, publish or otherwise disseminate the resulting report or fulldataset.” See Recommendation #11. Both the Bipartisan Policy Center (p.42) and the Keystone Center (p.20,24) preceded the ACUS recommendation with similar calls for basic conflict disclosures for private research that …
Maryland faces an important deadline in its long-running effort to clean up the Chesapeake Bay. By 2017, the state will be legally required to have put in place a number of specific measures to reduce the massive quantities of pollution that now flow into the Bay from a range of pollution sources in the state. Unfortunately, if the terms of a draft Chesapeake Bay Watershed Agreement are any indication, we’re going to miss the deadline.
Today, CPR President Rena Steinzor and I submitted comments to the Chesapeake Executive Council, a collaborative partnership of Bay state governors currently chaired by Gov. Martin O’Malley, arguing that the Agreement falls well short. As the first interstate agreement since EPA issued the Total Maximum Daily Load (TMDL) for the Chesapeake Bay, the Agreement is an opportunity to build off the TMDL and tackle the issues that plan does not …
A scant five days before the Department of Interior opens a new round of bids for oil leases in the Gulf of Mexico, the EPA has blinked, pronouncing BP, the incorrigible corporate scofflaw of the new millennium, once again fit to do business with the government.
To get right to the point, the federal government’s decision that BP has somehow paid its debt and should once again be eligible for federal contracts is a disgrace. Not only does it let BP off the hook, it sends an unmistakable signal to the rest of the energy industry: That no matter how much harm you do, no matter how horrid your safety record, the feds will cut you some slack.
Back in 2012, the agency’s intrepid staff had finally gotten permission to pull the trigger on the company, de-barring it from holding any new U.S. contracts …
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 …
EPA’s budget is in free-fall. Members of Congress brag that they have slashed it 20 percent since 2010. President Obama’s proposed budget for 2015, released on Tuesday, continues the downward trend. The budget proposal would provide $7.9 billion for EPA, about $300 million, or 3.7 percent, less than the $8.2 billion enacted in fiscal year 2014.
To cope with these cuts, the agency plans to fundamentally change the way it enforces environmental laws. A draft five-year plan released in November signals that the agency is retreating from traditional enforcement measures, such as inspections, in favor of self-monitoring by regulated industries. Specifically, the agency aims to conduct 30 percent fewer inspections and file 40 percent fewer civil cases over the next five years as compared to the last five.
Even before releasing the draft plan, the agency had already begun cutting down on …
The media has reported, erroneously, that the Obama Administration’s environmental impact statement concluded that the Keystone Pipeline would have no impact on global climate disruption. The facts are a bit more complicated, and much more interesting. Basically, the final EIS concedes that Keystone would increase greenhouse gas emissions, but it uses a silent political judgment masquerading as scientific analysis to minimize its estimate of the increase’s magnitude. Accordingly, President Obama has ample grounds to reject the Keystone Pipeline application.
Let me explain. The EIS concedes that the construction project creating the Keystone Pipeline would produce .24 metric tons of carbon dioxide equivalents (MMTCO2E) per year until TransCanada completes the pipeline. It also admits that operation of the pipeline after construction would produce 1.44 MMTCO2E per year, about the emissions of 300,000 passenger vehicles.
Although this is a lot of …
The regulatory process has become more opaque and less accountable. We need to fix that.
Every year, thousands of law students take a course in administrative law. It’s a great course, and we wish even more students took it. But there’s a risk that students may come away with a vision of the regulatory process that is increasingly disconnected with reality. Worse, the leading judicial opinions on the subject suggest that judges may suffer from a similar disconnect.
The Administrative Procedure Act is based on the premise that Congress delegates the power to address a problem to an agency, which then applies the statute to formulate a regulation. Policy is driven by the statute along with the views of the agency head, who is appointed by the President and confirmed by the Senate. But the realities are often different. Policy is often driven, not so …
In recent weeks, celebrations throughout the Pacific Northwest marked the 40th anniversary of the “Boldt decision” – the landmark decision in the tribal treaty rights case, U.S. v. Washington. This decision upheld tribes’ right to take fish and prohibited the state of Washington from thwarting tribal harvest. Judge Boldt’s 1974 decision was intended to close a chapter in our history during which tribal fishers were harassed, beaten, and imprisoned for the act of fishing. In recognition of this anniversary, the Washington state legislature voted to clear the criminal records of all the tribal people who had been arrested for fishing – that is, for exercising the rights they had been guaranteed under the treaties. Yet the legacy of this shameful era may be revived if Washington’s Department of Ecology calculates water quality standards so as to reflect and perpetuate the time when tribes could not harvest …
It sounds like a rare piece of good news about climate change: emissions of carbon dioxide, the principal cause of global warming, grew at a slower rate after 2000 in the United States, and have actually dropped since 2007. In Europe the story sounds even better, as overall emissions dropped from 1990 to 2008, often roughly matching, or in some cases exceeding, the reductions promised under the Kyoto Protocol.
Yet the apparent progress on emission reductions in rich countries has occurred at a time of widespread outsourcing of manufacturing to China and other developing countries. In the process, we have effectively outsourced our carbon emissions as well. If consumers are responsible for the emissions from making the consumer goods they buy, then we have not solved the problem. We have just made it harder to see - and much harder to measure.
Here's the problem: if a …
Today, Center for Progressive Reform analyst Michael Patoka testified at a Maryland Senate Finance Committee Hearing in support of SB 774, which would require construction companies contracting with the state to be prequalified based on their worker health and safety performance measures.
The widely supported legislation would ensure unscrupulous employers do not receive contracts funded by taxpayer dollars.
In his testimony Patoka notes:
Currently, construction firms are screened on a number of factors prior to bidding, but worker-safety considerations are not included. As a result, agencies can easily end up financing companies that operate hazardous worksites and endanger Maryland workers. Indeed, the current system encourages firms to cut corners on worker safety, since by doing so they may be able to offer lower bids than their more responsible competitors and thus have a better chance at winning lucrative contracts.
The construction industry is responsible for a disproportionately …
