The system of checks and balances devised by the Framers of the Constitution 220 years ago was all about the sharing of power. In practice, it makes for a messy flow chart, and lends itself to lots of inside-the-Beltway conversation about who’s in, who’s out, who’s winning and who’s losing. But as messy as the how-a-bill-really-becomes-a-law flow chart is, the structure within the White House itself usually features one constant: When the President says jump, staffers ask how high.
Every now and again, however, things get turned on their head, and the forces of bureaucracy manage to thwart Presidential will. That dynamic appears to be at work right now in the White House Office of Management and Budget, where Obama appointees Peter Orszag and Cass Sunstein, the director of OMB and Administrator of the Office of Information and Regulatory Affairs, respectively, seem to be operating in defiance of an Executive Order by President Obama. On March 17, 2010, several of my fellow CPR Board Members and I wrote to White House counsel Robert Bauer asking him to investigate Orszag and Sunstein’s clear violation of decisions made by this President with respect to regulatory review.
The most troubling practice is OIRA’s assertion of authority to review guidance documents from regulatory agencies, which include speeches, advice letters, electronic mail exchanges and other efforts to advise regulated parties about how to comply with regulations. OIRA typically reviews major regulations, and has an Executive Order authorizing it to do so, but guidance documents are another matter. This huge extension of OIRA’s field of operation was first established in the waning days of the George W. Bush Administration with the issuance of Executive Order 13,422. The Bush EO’s extension of this authority was criticized by progressives as an example of brazen overreaching that could paralyze the federal government’s efforts to regulate everything from financial services to pollution.
Full textIn response to a question at a National Press Club appearance on Monday, Lisa Jackson said that the EPA would be finalizing an action plan on BPA in the "very near future."
As I noted here in January, the EPA had announced in September that it would be releasing action plans on a number of chemicals, including BPA, but when the first group of plans was released in late December, BPA was not among them. I raised a red flag because EPA had sent six draft chemical action plans to White House's Office of Information and Regulatory Affairs (OIRA) on December 14, OIRA hosted a meeting with BPA industry lobbyists a week later, then the BPA action plan was absent from the list of plans released on December 30. OIRA had no business reviewing the chemical action plans in the first place since they are not regulatory actions covered by EO 12,866.
Last week, Sen. Chuck Schumer put some pressure on EPA and OIRA, asking Administrator Jackson for a written explanation regarding the “confounding decision” to hold back the BPA action plan. Now that the BPA action plan has been released from OIRA’s grip (Inside Story, 3/4/10) and delivered to EPA for publication, what can we expect it to say?
Full textThis post, by Sarah Vogel, is cross-posted from The Pump Handle.
If you thought the scientific debate about bisphenol A was over or even quieting down, you haven’t been reading the latest issues of Toxicological Sciences. (What are you doing with your spare time?) Last month in an editorial piece published in the journal, Richard Sharpe queried: “Is It Time to End Concerns over the Estrogenic Effects of Bisphenol A?” His answer was an unequivocal ‘yes’, based on the latest study from Ryan et al. (published in the same issue) that found no reproductive effects from bisphenol A exposure in rats. The study, according to Sharpe, “throws cold water on this controversy.”
Not so fast. On Wednesday, February 17, 2010, the journal published a second letter to the editors, “Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research,” by Fred vom Saal and 23 other researchers. In a position quite contrary to Sharpe’s, the letter pointed to an important design flaw in the study.
This latest iteration of the controversy is about a fundamental and persistent challenge in the research on bisphenol A and other endocrine disrupting chemicals—what is the appropriate study design. Issues of animal selection, route of exposure, animal feed and housing, and appropriate use of positive controls all point to the complexity of studying extremely low levels of endocrine disruptors.
Full textThe Milwaukee Journal-Sentinel had its latest article on BPA this weekend, this time looking at the role of the December 22 meeting between the industry and OIRA. Writer Meg Kissinger contrasts the forceful EPA statements on BPA from last year with the lack of an EPA action plan on the chemical now. As for the documents presented to OIRA at the meeting,
The Journal Sentinel reviewed the list and found 13 of the 19 papers and presentations cited were paid for by the BPA industry. The funding source for the authors of two other papers could not be determined. Only one was written by a scientist without ties to the industry.
Perhaps it's not surprising. But it bears noting that this is what's going on over there.
Full textFDA scientists have had a chance to develop an assessment of the risks of BPA in food contact applications using a fuller body of low-dose studies and concluded last week that there’s some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children (for a helpful analysis of the context of FDA’s decision, see Sarah Vogel’s post at The Pump Handle). Now, it’s time to look at what EPA is doing with respect to the ubiquitous endocrine-disrupting chemical.
In late September, Lisa Jackson announced that EPA’s Office of Pollution Prevention and Toxics would develop “action plans” for four chemicals or groups of chemicals, outlining potential future regulatory actions aimed at protecting the public and the environment from unreasonable risk. BPA was one of the candidates for an action plan, but when EPA released its four plans on December 30, BPA’s was not among them. EPA’s reason for delaying the BPA action plan was that it was waiting on FDA’s newest analysis and the results of $30 million worth of new studies being conducted under various grants from NIEHS.
Full textOver the weekend, the Associated Press ran a story on the results of its enterprising investigation into the toxic content of children’s jewelry imported from China. Pressed to abandon the use of toxic lead in toys and jewelry, manufacturers have apparently begun using an even more dangerous metal, cadmium, which can cause neurological damage – brain damage – to children and give them cancer. AP tested 103 pieces of jewelry bought in American stores within the last few months, and found that 12 percent contained at least 10 percent cadmium. One item, a cute little Rudolph the red-nosed reindeer trinket, was 91 percent cadmium.
Addressing the question that leaps to mind – How did these extraordinarily dangerous trinkets get onto store shelves in the first place? – reporter Justin Pritchard writes these utterly terrifying and completely truthful words:
A patchwork of federal consumer protection regulations does nothing to keep these nuggets of cadmium from U.S. store shelves. If the products were painted toys, they would face a recall. If they were industrial garbage, they could qualify as hazardous waste. But since there are no cadmium restrictions on jewelry, such items are sold legally.
Of course, this is just the latest in a series of startling tales of dangerous products making it to market in the United States – poisoned peanut butter, toxic drywall, lead-painted toys, and more. Not to put too fine a point on it, but such products often kill people – sometimes immediately, from acute exposure to toxins, and sometimes over a longer period of time by way of cancer. If folks are lucky, their lives simply become miserable, with headaches, nausea, respiratory and heart problems a daily occurrence.
Full textYesterday came and went with no announcement from the FDA on the safety of BPA in food packaging. The agency had created a self-imposed November 30 deadline for releasing a new finding, and in the intervening months, a number of new studies on the health effects of BPA have been released and FDA has brought in an outside expert to head up the review. These developments have understandably slowed the review process.
The question before FDA is whether BPA is safe for its intended use in food contact applications -- the lining inside cans, for example. So Kaiser Permanente’s recent headline-grabbing study that showed an increased likelihood of erectile dysfunction and problems ejaculating among workers who were highly exposed to BPA in a Chinese plant might not be very useful in making that determination. But the many studies showing correlations between various exposures to BPA and other adverse health effects might be more important.
As Meg Kissinger reports in the Milwaukee Journal-Sentinel, FDA’s review panel – now headed by Lynn Goldman of the Johns Hopkins School of Public Health, a renowned expert on endocrine-disrupting chemicals – must make its safety determination amidst a whirlwind of other developments, including voluntary restrictions on certain uses of BPA by the chemical’s manufacturers, local laws banning BPA use in baby bottles, and petitions from public health NGOs for new product labels, warnings, and temporary bans on specific uses of BPA.
The intertwined policy developments and evolving science on BPA’s toxicology have created a difficult environment for FDA to communicate a clear statement to the public about the health concerns connected to BPA. But slow reactions to experts’ warnings on public health threats have plagued FDA in recent years (e.g., suicides linked to antidepressants, dangers posed by children’s use of over-the-counter cough and cold medicines). The BPA review presents an opportunity for FDA to show it can be on the leading edge for a change.
Full textOn Monday, the big news out of FDA was the announcement that they’re going to publish a new assessment of the risks posed by BPA in food packaging, due out by the end of November. Jesse Goodman, FDA’s Chief Scientist, made the announcement at a meeting of the agency’s Science Board, which also heard two presentations by scientists from different offices within FDA working on the new assessment.
Last year, FDA formed a task force to assess the risks of BPA and the task force quickly concluded that “there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.” Given the rapid development of new studies on BPA in the diet, it’s a good thing that FDA is taking another comprehensive look at the available science. In the development of their new assessment, FDA ought to use a “weight-of-the-evidence” approach to their work and give due consideration to each study’s funding source and the researchers’ freedom to design and publish their work without sponsor interference.
Full textWhen President Obama launched his open government initiative on his first full day on the job, few assumed that the ambitious endeavor it contemplated would be easy. After all, lack of transparency and even active efforts to conceal information had become almost an inextricable feature of the federal government’s internal operations and decision-making—especially during the George W. Bush Administration. A recent series of developments confirms just how challenging the effort to achieve a more open government will be; fortunately, some of these developments also suggest that the Administration has learned some lessons from the initiatives’ early difficulties and perhaps is now moving in the right direction.
Obama launched the good ship “open government,” via a memorandum issued on January 21, laying out a vision of open government that was predicated on three pillars: transparency; public participation; and collaboration. The memo directed the Chief Technology Officer to work with the Director of the Office and Management Budget and the Administrator of General Services to develop a series of recommendations for an “Open Government Directive” that would direct executive agencies (including independent agencies) to take specific actions that are calculated to integrate the three pillars of open government into the agencies’ daily operations and decision-making procedures. The memo gave the Chief Technology Officer 120 days—that is, until May 21st—to achieve this task.
Full textIn 2007, the FDA came under criticism for failing to inform the public about studies it had had for two years which indicated that users of the diabetes drug Avandia faced up to a 42% greater chance of suffering a heart attack. More recently, it was revealed that Bush-era political appointees at the agency surreptitiously worked with chemical industry representatives to downplay evidence of the adverse health effects caused by bisphenol A (BPA), a chemical frequently used in making plastic toys and baby bottles. Thanks to scandals like these, the FDA has long been dogged by criticisms for the lack of transparency with which it conducts regulation.
The Obama Administration says it will be taking on the issue. The FDA announced Tuesday that it would be beginning a process to enhance “the transparency of the agency’s operations and decision-making process.”
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