regulation

By David Michaels The federal regulatory system is in shambles. Regulated industries call the shots and career scientists are prohibited from pushing back. With the agencies in retreat, fear of litigation has become an increasingly important mechanism for discouraging bad corporate behavior. Now, âregulation by litigationâ is under attack. Following a Bush Administration edict, a Texas judge is about to dismiss 1,000 Vioxx cases because the FDA asserts that any warning label the agency has approved -- no matter how faulty or inadequate -- must be considered adequate warning of danger. Over…
By David Michaels The Bush Administration has gone all out to make sure states play no role in setting health and safety standards. This is not surprising, of course, since many states are far more committed to health and safety protection than the folks who currently run the federal government. Yesterday I talked about California's efforts to protect workers from diacetyl. Todayâs example: chemical plant safety. Some weeks ago, I wrote about how Vice President Cheneyâs son-in-law Philip Perry orchestrated a backroom maneuver that cut EPA out of chemical plant safety. Perry made sure…
Our colleagues at our sister site, The Pump Handle, are doing a good job of keeping the public health community aware and apprised of things that often go unnoticed but are of real importance. If TPH isn't one of your daily reads, I'd suggest you make room for it. Yesterday we learned that the Bush administration has just made another of its famed "recess appointments" (remember that supreme nutcase, John Bolton at the UN?). This one goes to Susan Dudley to head OIRA, the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). Celeste Monforton covered her…
The Supreme Courtâs decision in Massachusetts v. EPA was big news this week; Justin Pidot at Gristmill takes an in-depth look at the rulingâs implications, while Kevin Grandia at DeSmogBlog scrutinizes the stances of the parties opposing it. Then, of course, there was Bushâs recess appointment of Susan Dudley to head the Office of Information and Regulatory Affairs, which Ian Hart at Integrity of Science describes as part of larger White House assault on science in policymaking. At the state level, Lisa Stiffler at Dateline Earth notes that Washington State is the first in the nation to ban…
When President Bush nominated Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA) last year, her nomination didn't make it out of the Senate committee. (See Celeste Monforton's post on Dudley's underwhelming performance before the committee.) Yesterday, Bush avoided Senate opposition by giving Dudley a recess appointment. As head of OIRA, Dudley will be able to block regulations proposed by government agencies -- and since she thinks that markets do a better job of regulating than the government does, she'll probably do a lot of blocking. "Dudley's record is one of…
By David Michaels The Wall Street Journal (sub required) is reporting that the White House will bypass the Senate confirmation process and announce later today that President Bush has given a recess appointment to Susan Dudley to head the Office of Information and Regulatory Affairs (OIRA). The office, part of the Office of Management and Budget (OMB), oversees all of the Administrationâs regulatory and especially anti-regulatory activities. (Some background on President Bushâs efforts to get her confirmed are here and here). Public Citizen and OMB Watch have compiled an extensive collection…
By David Michaels The Center for Public Integrity has launched an exciting project examining the work of the federal advisory committees. It's been named âThe Shadow Government,â and it is directed by veteran journalist Jim Morris. The project's first report focuses on the Advisory Board on Radiation and Worker Health, a panel that provides advice related to the program that compensates civilian nuclear weapons workers who developed occupational illnesses following exposure to radiation, beryllium and other toxic materials encountered in the production and clean up of nuclear weapons. (I'll…
For those whoâve been following the investigations into how the Bush Administration interfered with government climate science, the news about political interference into Interior Department science had a familiar ring. Chris Mooney sums it up well: âSubstitute for Philip Cooney an Interior Department official named Julie MacDonald, and it's basically the same story as it was with climate change: A political appointee, friendly with industry, overruling the determinations of agency scientists.â (Cooney was chief of staff on the White Houseâs Council on Environmental Quality â previously with…
U.S. environmental regulations were on several bloggersâ minds this week. Frank OâDonnell at Blog for Clean Air explains that EPAâs new rule on particle soot is terrible, while Mike Dunford at The Questionable Authority warns that Bush administration is about to release a set of administrative rules changes that would completely eviscerate the Endangered Species Act. At least The Olive Ridley Crawl has some good news: the National Marine Fisheries Service is proposing stronger regulations to reduce sea turtle bycatch. Infectious diseases were a hot topic, too. Tara C. Smith at Aetiology…
OMB Watch is reporting that the Senate Committee on Homeland Security and Governmental Affairs, Chaired by Joseph Lieberman (I-CT) will soon hold a confirmation hearing on Susan E. Dudley. nominated to be Administrator of the White Houseâs Office of Information and Regulatory Affairs (OIRA). The office, part of the Office of Management and Budget (OMB), oversees all of the Administrationâs regulatory (or anti-regulatory) activities. There's lot's more information on Ms. Dudley, and on OMB's latest shenanigans, at OMB Watch's website Dudley Watch. Genevieve Smith, at the American Prospect…
By David Michaels It is starting to feel like a groundswell. Last week, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking Congress not to reauthorize the Prescription Drug User Fee Act (PDUFA), the system that funds the Food and Drug Administrationâs drug review process. In that letter, we wrote âuser fees may appear to save the taxpayers money, but at an unacceptable cost to public health.â Yesterday, at a House Energy and Commerce Oversight and Investigations Subcommittee hearing, chaired by Rep. Bart Stupak (D-MI) , several members suggested…
By David Michaels OMB Watch has just released its newest report on the recent changes President Bush has made to the federal regulatory process. The report A Failure to Govern: Bush's Attack on the Regulatory Process explains in clear, compelling language how two arcane but pernicious documents, one amended the other new, threaten to significantly reduce the ability of government agencies to protect our health and environment. The two documents are: Executive Order 13422 (amending the way the White Houseâs Office of Information and Regulatory Affairs (OIRA) reviews the rules issued by EPA…
By David Michaels In the wake of the debacles involving Vioxx, Ketek, and other dangerous drugs that should never have been approved in the first place, Congress is about to take up reauthorization of the user fee system that funds the Food and Drug Administrationâs drug review process. The system is governed by the Prescription Drug User Fee Act (PDUFA), which will expire this year. The FDA has asked Congress to reauthorize the program for five more years. Yesterday, a group of 22 experts on drug safety and regulation issued an open letter to lawmakers asking them not to reauthorize the…
An article in yesterday's Financial Times reveals that prior to the deadly explosion at its Texas City refinery, BP successfully lobbied against environmental regulations that could have mitigated-- if not prevented-- the catastrophe from having taken place in the first place. BP's own report regarding the March 2005 explosion noted that an exhaust system upgrade to a flare system could have "reduced the severity" of the event by containing and burning off emissions before they could catch a spark. That's funny, because in December 2004, BP was celebrating having gotten out of spending 150…
At today's Senate hearing on Senator Patty Murray's (D-WA) proposal to ban asbestos in the U.S., Senator Johnny Isakson (R-GA) said some very interesting things.  (Audio here) His opening statement began predictably: There is no debate that certain forms of asbestos are toxic and deadly.  (Oh yeah, I know where this is going.  It's the same old debate about amphibole v. serpentine fibers.)    We will hear today that there are several types of asbestos.  Different forms of asbestos pose different health risks.  (I knew it.  I know where he's going now.  Another defender of…
By David Michaels This is how it always works. A leading medical journal publishes a study saying a commercial product may be dangerous, perhaps even killing people. The trade association representing the manufacturers quickly attacks the study (preferably in the same news cycle), accusing the scientists of incompetence or worse. The latest issue of the Journal of The American Medical Association (JAMA) includes a study that links that use of antioxidants (beta carotene, vitamin A, and vitamin E) with increased mortality. The issue was published today. Yesterday, the Council for Responsible…
By Liz Borkowski Last week, the Project on Scientific Knowledge and Public Policy (SKAPP) held a panel discussion on the FDA featuring four former FDA Commissioners. While all of the panelists made a point of saying that there are a lot of wonderful people working at the FDA, they also acknowledged that the agency has some serious issues that must be addressed. David Kessler, MD (FDA Commissioner from 1990 â 1997) remarked that being at the event was âin some ways very bittersweet.â He reflected: I left the agency now a decade ago and I thought had done a pretty good job. Frank had approved…
Mike Hendricks from the Kansas City Star notes in a recent article that all-too-often, trench collapses happen when "work crews take shortcuts because they're in a hurry or think a trench box interferes with the job they're doing." While it may be true that workers are "cutting corners" to finish the job they are assigned to do, blaming the workers ignores the 800 pound gorilla in the room. Instead of blaming the worker for the tragedy that has befallen him, let's blame those responsible for making him cut corners in the first place. Workers hurry because their priority is getting their work…
By David Michaels The handcuffs President Bush recently imposed on regulatory agencies continue to be the focus of public attention. (Weâve compiled a listing of posts on the Executive Order and its nefarious implications). Members of Congress, along with public health and environmental advocates, are now considering legislative approaches to overturning these new requirements. Media attention is criticial for building political will to address this issue. Robert Pear's New York Times piece (subscription-only access) drew attention to the Executive Order's implications, and a now we're…
By David Michaels In the issue of Science Magazine on your virtual newsstand today, Don Kennedy has written a powerful editorial entitled âScience, Information, and Power.â (sub required) Dr. Kennedy observes that the confrontation between Congress and the White House over the production and control of science used in regulation is about an issue fundamental to both science and democracy â the presidentâs claims to exclusive power over knowledge. Drawing as examples the House Oversight Committeeâs hearings on politicization of federal science, along with the recent changes President Bush…