regulation
cmonforton | December 1, 2010Nearly a month ago, I made predictions about what we might read in OSHA's and MSHA's regulatory agendas. The Administration's regulatory plan is supposed to be published in October; it's been an annual requirement since 1993 (see Executive Order 12866.) When I wrote my post last month, the Obama Administration was already a few days late releasing their plan. Today is December 1 and the President's regulatory czar Cass Sunstein, the director of the White House's Office of Information and Regulatory Affairs (OIRA), has still not issued it.
The regulatory plan gives the public a sense of…
cmonforton | November 30, 2010The US Senate passed today the Food Safety Modernization Act on a by a 73 to 25 vote. More than a dozen Republican Senators broke ranks with their leadership and voted in favor of the bill: Alexander (TN), Brown (MA), Burr (NC), Collins (ME), Enzi (WY), Grassley (IA), Gregg (NH), Johanns (NE), Kirk (IL), LeMieux (FL), Lugar (IN), Murkowski (AK), Snowe (ME), Vitter (LA), and Voinovich (OH). Supporters of the bill are calling it a milestone that will provide better protection for consumers from foodborne illness (here, here, here.)
Section 103 of the food safety bill (S.510), will require…
lborkowski | November 17, 2010by Eileen Senn
After decades of dysfunction, OSHA is poised to do something about their badly outdated rules for occupational exposures to chemical hazards. Millions of U.S. workers are exposed to chemicals every day at work, such as asbestos fibers in insulation, asphalt fumes in roofing and road work, carbon monoxide gas from burning fuels, chlorine in disinfectants, formaldehyde in bonded wood, isocyanates in foam, lead in bullets and solder, liquid mercury in instruments and light bulbs, solvents in cleaning products and paints, and silica in concrete. Yet most standards for chemicals on…
cmonforton | November 16, 2010On January 29, OSHA proposed a simple revision to a paper form---called the OSHA 300 log---on which some U.S. employers are required to record work-related injuries. The Bureau of Labor Statistics (BLS) collects a sample of these forms annually to estimate national rates of work-related injuries. The change proposed by OSHA involves adding a column to the form so that work-related musculoskeletal disorders (MSD) would be distinguished from other conditions like amputations, burns, fractures, etc. MSDs account for 30-60% of all work-related injuries and illnesses. They take a large toll on…
cmonforton | November 3, 2010It's that time of year, when the Secretary of Labor is supposed to outline her rulemaking priorities for next 12 months. This would include new proposal to protect mine workers, like the 64 killed already this year, and the tens of thousands made ill by inadequate OSHA standards on exposure to chemicals. The Presidential Executive Order governing this process dictates that agencies' regulatory plans be published in October. Last year the Obama Administration didn't release its plan until December, but I chalked that delay to the stalled Senate confirmation of the President's reg czar,…
cmonforton | October 21, 2010Updated (below) 10/22/2010
Industry trade association are masters of using scare tactics and misinformation about environment, health and safety regulations to recruit and retain members. The latest evidence is the Chamber of Commerce's "This Way to Jobs" propaganda campaign, with the worn out message: regulations on workers' safety and environmental protection hurt the economy and businesses. A video cartoon promoting the campaign says: "
Washington isn't good at everything but recently it's been great at issuing regulations."
The sites features a photo of a small businessman, Ronald…
cmonforton | October 14, 2010Labor Secretary Hilda Solis and MSHA asst. secretary Joe Main are proposing new rules to protect U.S. coal mine workers from developing illnesses related to exposure to respirable coal mine dust. The most commonly known adverse health effect is black lung disease, but exposure is also associated with excess risk of chronic obstructive pulmonary disease, progressive massive fibrosis, chronic bronchitis, and emphysema. The proposal, scheduled to be published in the Federal Register on Oct 19,* takes a comprehensive approach to the problem. I've not had a chance to read carefully the entire…
cmonforton | October 4, 2010Ever since the Reagan Administration, the White House's Office of Information and Regulatory Affairs (OIRA), which is part of the Office of Management and Budget (OMB), has been reviewing rules proposed by federal agencies. These regulations might come from the Dept of Energy (DOE) on efficiency standards for home refrigerators, HHS rule on premarket safety report for drugs or devices, or the Dept of Transportation (DOT) on limiting the use of wireless devices by commercial drivers. Presidential Executive Order (EO) 12866, issued in 1993 by President Clinton, is the instrument that grants…
cmonforton | September 25, 2010Updated below (9/28/2010)
Is anybody else getting tired of hearing Obama Administration officials say "sunlight is the best disinfectant?" It was uttered again on Thursday (9/23) when the President's regulatory czar, Cass Sunstein, was speaking at an event hosted by the Small Business Administration. His speech was loaded with all the transparency catch terms: "disclosure," "openness," "sunshine," "open government," "accountability," blah, blah, blah. The rhetoric was annoying to read because I'd been wrestling this week with OIRA's lack of transparency. I've been in the midst of trying…
lborkowski | September 17, 2010Earlier this week, FDA Commissioner Margaret Hamburg presented Frances Kelsey with the first in what will be a series of awards bearing Kelsey's name. Fifty years ago, as a new medical officer with the FDA, Kelsey refused to approve US sale of Kevadon, a drug widely recognized by its generic name, thalidomide. The drug was widely used as a sleep aid and anti-morning-sickness drug in Europe, but Kelsey questioned its safety.
While thousands of children were being born in Europe with missing limbs and other thalidomide-induced birth defects, the US avoided such widespread tragedy. In 1962,…
dgmacarthur | August 20, 2010The recent Government Accountability Office report into the direct-to-consumer genetic testing industry certainly made a splash: it took centre stage at a Congressional hearing on the industry, and garnered media headlines about "bogus" results being generated by testing companies.
As I noted at the time of its release, the report is an obscenely one-sided affair: it's transparently framed as an attack piece rather than a balanced analysis of the state of the industry. That's a real shame, because the information collected by the GAO could so easily have been used to provide valuable insight…
dgmacarthur | August 9, 2010In my previous post I quoted from Mary Carmichael's excellent interview with two officials from the FDA, Alberto Gutierrez and Elizabeth Mansfield (part of her fantastic week-long DNA dilemma series, which you should read in full if you haven't already). There are numerous nuggets of gold tucked away in this interview that warrant further analysis, and I wanted to highlight a few in more detail. For a more complete dissection I'd recommend Keith Grimaldi's post commenting on the whole interview.
I wanted to focus on two crucial tidbits unearthed by Carmichael: the attitude of the FDA towards…
dgmacarthur | August 5, 2010Two days ago I reported a rumour that the FDA might have convinced genotyping chip provider Illumina to stop providing its products to direct-to-consumer genetic testing companies - a move that would effectively prevent these companies from being able to operate.
The rumour seemed plausible at the time, based on two pieces of evidence. Firstly, a letter sent to Illumina by the FDA in June warned the company that the use of its chips by personal genomics companies appeared to violate FDA regulations:
Although Illumina, Inc. has received FDA clearance or approval for several of its devices,…
dgmacarthur | July 29, 2010(This is an edited excerpt from an op-ed piece I just wrote for Xconomy, posted here as I think it provides some nuance on my views on regulation of genetic testing that was lacking from my post last week.
Some context for new readers: a Congressional investigation into the direct-to-consumer (DTC) genetic testing industry last week left a sour taste in the mouths of many observers of the embryonic industry; it was a vicious, one-sided affair, starring a biased report on a "sting" operation performed by the US Government Accountability Office. Along with other recent moves by the FDA, it…
dgmacarthur | July 21, 2010
I mentioned last week on Genetic Future that a reporter with the Washington Post, Rob Stein, had emailed the National Society of Genetic Counsellors to search specifically for people with negative experiences of personal genomics for an upcoming article on the industry. At the time I called for personal genomics customers with positive experiences to email Stein, to ensure that he had a balanced view of the industry's impact.
Stein's article came out a couple of days ago, presumably timed for maximum impact in advance of the FDA's meeting on lab-developed tests over the last two days.…
cmonforton | July 16, 2010In an amazing and comprehensive report entitled "Picked Apart," the Centro de los Derechos del Migrante and the International Human Rights Law Clinic of American University College of Law reveal the ugly, dark side of the Maryland crab industry. Some employers are skirting the law and exploiting workers hired under the H2-B guestworker program. Many of these workers are women from Mexico who've traveled thousands of miles in a bus to remote villages on Maryland's eastern shore. They'll work during the Blue crab harvesting season, to pick the meat by hand. The H2-B program allows employers…
sb admin | July 6, 2010Liz Borkowski writes: I wrote last week about how federal agencies can solve the problems that create conditions for disease outbreaks - or fail to solve them, as is too often the case. This week, I wanted to focus on the role Congress plays in public health agencies' effectiveness, because that's another angle that crops up repeatedly in Inside the Outbreaks.
Congress's creation of federal agencies is clearly a huge achievement, and they've also periodically given new powers to already existing agencies. For instance, Mark Pendergrast tells the story of the Dalkon Shield, an IUD that turned…
lborkowski | July 6, 2010Liz Borkowski writes: I wrote last week about how federal agencies can solve the problems that create conditions for disease outbreaks - or fail to solve them, as is too often the case. This week, I wanted to focus on the role Congress plays in public health agencies' effectiveness, because that's another angle that crops up repeatedly in Inside the Outbreaks.
Congress's creation of federal agencies is clearly a huge achievement, and they've also periodically given new powers to already existing agencies. For instance, Mark Pendergrast tells the story of the Dalkon Shield, an IUD that turned…
sb admin | July 2, 2010Steve Schoenbaum writes: In his blog this week, Mark Pendergrast challenges someone/anyone to take on explaining the differences between case-control studies vs. cohort studies. As an EIS officer, back in late May/early June 1968, I did a case-control study as part of the investigation of a common source outbreak of hepatitis in Ogemaw County, Michigan, so I will try to pick up the challenge. I believe it was only the second time case-control methods were used in a CDC epidemic investigation. In using this method I learned about the power of comparison, not just that numerators need…
sb admin | June 30, 2010Karen Starko writes: When the "financial crisis" started and the news media started throwing around numbers in the trillions and projected fixes in the billions, I realized I just didn't get it. So I got a little yellow post-it, labeled it "understanding trillions," and started a list of examples. And when I learned that the US GDP in 2006 was 13T and the derivative market, estimated in June 2007, was valued at 500T, I quickly got a sense of the potential drain of the derivative market (in which money is spent on items without real value...my definition, please correct me if I am wrong). I…