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June 11, 2009 by Matt Shudtz

IRIS Update: New CPR Report and a House Science Committee Hearing

This afternoon, Congressman Brad Miller (D-NC), Chairman of the House Science Committee’s Subcommittee on Investigations and Oversight, will hold a hearing on recent revisions to the IRIS assessment process. IRIS (the Integrated Risk Information System) is EPA’s premier database of toxicological profiles for dangerous chemicals. The profiles are used for everything from setting cleanup standards at Superfund sites to determining liability in toxic tort suits. The problem is, IRIS only contains profiles for 548 chemicals. On average, 700 new chemicals enter commerce each year. Because IRIS numbers can serve as a cornerstone in the risk assessment/risk management process, an extensive database would greatly benefit policymakers in their daily work to protect public health.

We wanted to see whether some well-known toxins are adequately covered in the IRIS database, so we looked at the number of hazardous air pollutants that are listed in the Clean Air Act but missing from IRIS. We found that 17 percent of the chemicals have no profile at all. More remarkably, for a full two-thirds of the chemicals listed in the Clean Air Act, there is no data point in the IRIS database for the most relevant toxicological value needed to devise controls …

June 10, 2009 by Matt Shudtz
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This afternoon, Congressman Brad Miller (D-NC), Chairman of the House Science Committee’s Subcommittee on Investigations and Oversight, will hold a

hearing

on recent revisions to the IRIS assessment process.

IRIS

(the Integrated Risk Information System) is EPA’s premier database of toxicological profiles for dangerous chemicals. The profiles are used for everything from setting cleanup standards at Superfund sites to determining liability in toxic tort suits. The problem is, IRIS only contains profiles for 548 chemicals. On average, 700 new chemicals enter commerce each year. Because IRIS numbers can serve as a cornerstone in the risk assessment/risk management process, an extensive database would greatly benefit policymakers in their daily work to protect public health.

 

We wanted to see whether some well-known toxins are adequately covered in the IRIS database, so we looked at the number of hazardous air pollutants that are listed in the Clean …

May 22, 2009 by Matt Shudtz
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The Milwaukee Journal-Sentinel continued its impressive BPA reporting Sunday with disturbing revelations about former FDA political appointees’ utter disregard for the agency’s career scientists. Using the Freedom of Information Act, the Journal-Sentinel uncovered e-mails showing that high-level officials went to industry lobbyists for advice about new research on bisphenol A (BPA) before asking FDA career staff.

In one instance, the U.S. Food and Drug Administration's deputy director sought information from the BPA industry's chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.

"I'd like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study," Mitchell Cheeseman, deputy director of the FDA's center …

May 18, 2009 by Matt Shudtz
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On May 9, at the conclusion of the Fourth Conference of the Parties (COP-4) to the Stockholm Convention, negotiators from around the world agreed to add nine chemicals to the list of persistent organic pollutants (POPs) that are too dangerous for international trade. It was an important step toward protecting the world community from toxic exposures, but it unfortunately highlights our country's inability to take a leading role in international environmental law.

How it works

In 2001, representatives of nations from across the globe met in Stockholm to negotiate a treaty that would eliminate the production, distribution, and use of the most dangerous chemicals in the world marketplace. They originally agreed to phase out DDT, PCBs, and ten other substances known as the “dirty dozen” because of their high toxicity, ability travel great distances in air or water, and tendency to bioaccumulate in the food chain …

May 5, 2009 by Matt Shudtz
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At long last, the Consumer Product Safety Commission (CPSC) is getting the injection of new blood that it has needed for years. President Obama announced today that he will nominate a new Chairwoman and a new Commissioner for the agency.

This is great news. CPSC has been operating with just two commissioners for several years. As originally designed, CPSC is supposed to have five commissioners and needs a quorum of three to undertake any meaningful regulatory action, such as create new safety standards or issue mandatory recalls. When President Bush was unable to nominate a suitable third commissioner, Congress let CPSC operate temporarily with two commissioners, but only on a limited budget.

That leads to the second reason President Obama’s announcement is such great news. His budget request of $107 million for the agency – a substantial increase over last year’s $80 million – will likely be …

April 15, 2009 by Matt Shudtz
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Avery DeGroh, a three-year old from Illinois, had a defibrillator implanted in her heart to deal with a congenital condition called “long QT syndrome.” It was a brand-new model with a specially designed wire (or “lead”) that is thinner and easier for doctors to install. Unfortunately, due to a problem with the new lead, one day the defibrillator shocked Avery unnecessarily nine times, sending jolts of electricity through her young heart. She was rushed to the hospital and had the device removed. She’s doing well with a portable defibrillator now, but the episode was just the beginning of a new battle for her parents.

Removing the device, of course, was incredibly expensive. But even though the company that manufactured the defective defibrillator, Medtronic, recalled the device, it refused to reimburse Avery’s parents for any of the costs associated with getting a replacement since they didn …

March 20, 2009 by Matt Shudtz
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In his appearance on Jay Leno's show last night, President Obama argued (video, transcript) for financial regulations by making a comparison between credit cards, mortgages, and toasters:

"When you buy a toaster, if it explodes in your face there's a law that says your toasters need to be safe. But when you get a credit card, or you get a mortgage, there's no law on the books that says if that explodes in your face financially, somehow you're going to be protected."

But is there really a law that says your toasters must be safe? Well, not exactly. You are protected by the protection of last resort -- the right to sue in a civil court for damages if you are injured. But it shouldn't have to come to that; there should be some sort of protection enforced by government. Yet for thousands …

March 13, 2009 by Matt Shudtz
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Last week's Supreme Court decision in Wyeth v. Levine protected consumers’ longstanding right to take pharmaceutical companies to court for failing to properly warn patients and their doctors about the risks posed by the drugs they market.  Unfortunately, people injured by faulty medical devices don't have the same right following last year’s Riegel v. Medtronic decision.

Without the protection of the courts, patients with medical devices rely solely on the protections afforded by the FDA approval process.  But last week, the Wall Street Journal's Alicia Mundy gave a glimpse at just how broken that process can be.  

Mundy tracked the FDA approval of Menaflex, a small pad made of cow collagen that can be implanted in a torn meniscus to both patch the tear and promote tissue regrowth.  The manufacturer, ReGen, originally submitted the device for FDA approval under normal procedures for new …

March 11, 2009 by Matt Shudtz
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Monday was a good day for our nation’s science policy.  At the same time he announced that the federal government will abandon misguided restrictions on stem cell research, President Obama unveiled an effort to promote a sea change in the way political appointees will treat the science that informs so many federal policies.

 

In a memorandum to department heads across the government, President Obama announced that John Holdren, the soon-to-be-confirmed Director of the White House Office of Science and Technology Policy (OSTP), will develop a plan to achieve a goal of “ensuring the highest level of integrity in all aspects of the executive branch's involvement with scientific and technological processes.”

 

The memorandum hints at some very encouraging ideas that reflect a significant change in attitude from the Bush Administration.  For starters, President Obama writes that “science and the scientific process must inform and guide decisions …

March 3, 2009 by Matt Shudtz
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Last Wednesday, Secretary of the Interior Ken Salazar announced that the Bureau of Land Management is going to "review and reconsider" the oil shale leases proposed in the waning days of the Bush Administration.  The Bush proposal would have potentially opened 1.9 million acres of land in Utah, Colorado, and Wyoming for oil shale development and would have locked in a paltry royalty rate.  The Obama Administration is going to take 90 days of public comment on the shortcomings of the old plan and then come up with a new one, potentially in a very short time frame.

 

Salazar’s and BLM’s comments on the oil shale research, development, and demonstration (RD&D) program do not paint a clear picture about the Obama Administration’s agenda. Last week, Salazar spoke to the National Governors’ Association and told them that oil shale has “great potential” and “that …

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