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Wednesday, November 30, 2005

EPA to Reduce Testing of Ground Zero
In a slap in the face to resident of New York City, EPA released yesterday a reduced testing plan for contaminants released in the collapse of the World Trade Center. EPA backed away from initial broader testing plan that included parts of Brooklyn and areas north of Canal Street in Manhattan. From the Washington Post:

The fires at Ground Zero burned for three months, and western Brooklyn sat directly within the smoke-and-dust plume from the World Trade Center. But EPA officials said that their tests have not been able to distinguish between World Trade Center contamination and the dust and detritus of normal urban life.
"We would prefer to go further, but the science won't let us," said E. Timothy Oppelt, an EPA official who has chaired an expert technical review panel intended to guide the testing. "We can't be whimsical."
The EPA also announced Tuesday that it is shutting down Oppelt's review panel -- which includes toxicologists, doctors, environmentalists and residents. The committee was supposed to meet monthly but has not convened since July.
The panel will hold a final meeting in December, and that meeting will be shorter than usual.
"It's crucial for this panel to continue," said Suzanne Mattei, New York City executive of the Sierra Club, which has issued several studies on Ground Zero-related contamination. "If we can't get a proper response after a disaster of this magnitude, what's the point of having a federal government?"

In a statement on the testing, Sen. Hilary Clinton lamented that "[t]he panel has not even begun to meet its mandate to identify unmet public health needs," she said. More on EPA's testing plans and the panel.

Posted by Genevieve Smith, 11:44:00 AM

Friday, November 18, 2005

Maybe This Time the Wrap Will Stick
This might make you think twice the next time you order pizza or unwrap a piece of candy. An ex-DuPont official recently leaked documents detailing how DuPont covered up 20-years of studies showing that the chemical Zonyl, produced by DuPont and used in the making of candy wrappers, microwave popcorn bags, pizza boxes and other food packaging, was degrading into the dangerous chemical perfluorooctanoic acid (PFOA) and seeping into the food products at levels three-times the FDA-recommended limit from 1967. Studies in rats, which DuPont conveniently withheld from federal agencies and the public, showed kidney and liver damage as a result of exposure. Zonyl is related to another DuPont chemical, Teflon, which has also been found to leak PFOA into food when the Teflon coating degrades.

In January, EPA issued a draft risk assessment of the PFOA, which though acknowledging the potential health risks, fell far short of condemning the chemical or its makers. EPA will have a change to redeem itself, however, when an advisory panel meets next month to decide whether PFOA should be listed as a likely human carcinogen. EPA is also currently in settlement with DuPont over the withheld studies.

More Information:

AP: Papers: DuPont Hid Chemical Risk Studies"

EPA Risk Assessment Finds Potential Risk to Humans in Teflon(1/24/2005)

Making Sure that Nothing Sticks: EPA and DuPont (1/18/2005)

Posted by Genevieve Smith, 06:39:49 PM

Tuesday, November 15, 2005

Plan B Decision "Not Typical," GAO Finds
A new GAO report has confirmed what most of us have been suspecting for months: that an FDA rejection of over-the-counter status for Plan B, commonly known as the "morning-after pill," was "highly unusual," involving atypical involvement from high-level officials and levels of scrutiny that are not applied to other over-the-counter drug applications. In fact, the report details how the decision was made months before the scientific review of the application was even complete and that the decision countered not only the advice of the scientific advisory committee but also the opinions of many of FDA's staff members involved in the decision. From the report:

While FDA followed its general procedures for considering the application, four aspects of FDA’s review process were unusual. First, the directors of the offices that reviewed the application, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter. Second, FDA’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications. Third, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed. Fourth, the rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices. The Acting Director stated that he was concerned about the potential behavioral implications for younger adolescents of marketing Plan B OTC because of their level of cognitive development and that it was invalid to extrapolate data from older to younger adolescents. FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency previously has considered it scientifically appropriate to extrapolate data from older to younger adolescents.

Among their findings, GAO found that the Commissioner and Acting Director of CDER, Steven Galson, disputed the scientific findings of the drugmaker even after the company conducted additional studies at the request of the agency:

According to interviews with officials from the Office of New Drugs and review staff within the Offices of Drug Evaluation III and V, and as documented in their respective reviews of the Plan B application, they said these data provided sufficient evidence that there was neither an increase in risky behaviors nor any difference in appropriate use between younger adolescents and older populations. According to FDA’s minutes of this meeting, the Commissioner expressed multiple points, including the potential for changes in future contraceptive behaviors after adolescents took Plan B and that counseling by a learned intermediary might be beneficial, particularly for adolescents. He also noted that he was not convinced that the additional studies used as evidence had "enough power" to determine if behavioral differences existed between adults and adolescents.

GAO also found that though the Galson claimed the decision to not approve Plan B for over-the-counter use was made right before he signed the level of non-approval, Office of New Drug staff claim they were told the application would not be approved months before they had even completed their review of the application:

FDA officials gave conflicting accounts of when the not-approvable decision for the Plan B OTC switch application was made. FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner. The Acting Deputy Commissioner for Operations and the Acting Director of CDER denied that they had said that the application would not be approved. In addition, although minutes of the January 15, 2004, meeting stated that the Acting Director told review staff that a not-approvable decision was "recommended," review staff documented that they were told at this meeting that the decision would be not-approvable. Both office reviews were not completed until April 2004.

Galson's rationale for rejecting the application was also highly unusual:

The rationale for the Acting Director of CDER’s decision was novel and did not follow FDA’s traditional practices. The Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity. The Acting Director further concluded that because these differences in cognitive development made it inappropriate to extrapolate data from older to younger adolescents in this case, there was insufficient data on the use of Plan B among younger adolescents. FDA review officials disagreed with the Acting Director’s rationale and noted that the agency had not considered behavioral implications resulting from differences in cognitive development in prior OTC switch decisions

GAO report seems to prove incontrovertibly that the Plan B was not based on sound science and was likely politically motivated. The decision has been under scrutiny ever since it was made in May 2004. It remains to be seen whether this new evidence will force the agency to re-review the OTC application. For more on Plan B see FDA Ignores Experts, Reject Plan B for Over-the-Counter Use (5/17/2004), Details Emerge in Data Rejected in Morning-After Pill Decision (6/28/2004), Plan B Decision Delayed by FDA (8/29/2005).

Posted by Genevieve Smith, 12:10:01 PM

Monday, November 14, 2005

FDA Mad Cow Testing Not Good Enough
You may have noticed the administration in the news touting its decision to keep up the level of testing for mad cow disease. Good news, on one hand...

...but there's bad news on the other hand. GAO released last week a report dated October 11 faulting FDA for weaknesses in its program for testing what gets feed to the cattle. From the abstract:

Specifically, under the program guidance, FDA did not require districts to document their follow-up reviews or the basis for their final determinations on samples that the laboratories identified as potentially containing banned protein products. Although the districts may have conducted rigorous follow-up and exercised sound judgment, the basis for their decisions cannot be reviewed and confirmed.
For nearly half the 989 samples, FDA took longer than 30 days from the date the sample was collected until the date the laboratory completed its analysis -- including 21 samples that took longer than 100 days. This extended period does not include the time FDA's districts would have spent following up on samples that indicated potential violations. FDA and industry agree that cattle feed is consumed very quickly. By the time FDA conducted its follow up to determine whether a violation had occurred, the feed may have been consumed.
FDA managers in headquarters did not adequately oversee the feed testing program. Specifically, FDA managers did not receive periodic reports or have other oversight controls in place to assure that the program was implemented correctly.

Get the report here.

Posted by Robert Shull, 12:02:49 PM

Friday, November 04, 2005

We Can't Trace Back Mad Cow Cases
When cases of mad cow are found, we currently don't have any way to go back, find all the related cows that could also be at risk, and remove their meat from the food supply until we know for sure:

Researchers hunting the herd linked to the first U.S. case of mad cow disease found that most of the animals were slaughtered, and possibly in the human food supply, even before the government inquiry began.
The federal and state governments closed an investigation into the infected cow, which was raised at an unidentified Texas ranch, in August.
But The Dallas Morning News on Tuesday obtained details about the search for the 413 cows and calves under a Texas open records request. About 350 of the cows, or roughly 85 percent, were sent to slaughter.
The reports, compiled for the Texas Animal Health Commission by a government employee, demonstrate how problematic it was to track the herd mates and progeny of the diseased cow.
The investigators' searches for feed records as well as "animals of interest" went back years, but many records were no longer available.
The state wound up relying on its own data in the county between 1990 and 1994 to get a snapshot of the herd.

Oh, and if we can't do this for mad cow disease, we can't do it for bioterror, either.

Read on for more: Katie Fairbank, "Too late to track mad cow," Dallas Morning News, Nov. 2, 2005

Posted by Robert Shull, 07:17:05 PM

Thursday, November 03, 2005

How Safe Will the Feds Keep Us from Bird Flu?
Not very, at least according to the latest public opinion polls. The CNN/USA Today/Gallup poll reports 47% responding that they are "not too confident" or "not confident at all" that the federal government can handle an outbreak of avian flu, and the Fox News/Opinion Dynamic poll reports 55% responding that the federal government is "not very prepared" or "not prepared at all" to deal with an outbreak.

Meanwhile, some in Congress are asking the same questions about our preparedness. The Bush administration avian flu plan is being criticized for forcing the states to cough up 75% of the cost of antivirals and would offer the states $100 million for their own avian flu planning -- while still taking away $130 million from state and local government first responders.

Money aside, there's still a significant management problem. As Larry Wilkerson recently observed in a speech he delivered at the New America Foundation,

Generally with regard to domestic crises like Katrina, Rita -- and I could go on back -- we haven't done very well on anything like that in a long time. And if something comes along that is truly serious, truly serious, something like a nuclear weapon going off in a major American city, or something like a major pandemic, you are going to see the ineptitude of this government in a way that will take you back to the Declaration of Independence. . . . Read in there what they say about the necessity of the people to throw off tyranny or to throw off ineptitude or to throw off that which is not doing what the people want it to do. And you're talking about the potential for, I think, real dangerous times if we don't get our act together.

The people have a right to expect that their government will act in their interests. The fundamental problem is that this administration is far more interested in serving corporate special interests than in protecting the public. You just can't deliver good government service when you start from an anti-government mindset.

Posted by Robert Shull, 04:06:32 PM

Wednesday, November 02, 2005

More Yuckiness on Genetically Modified Crops
Perhaps you've already read our article in the latest issue of The OMB Watcher about developments in nanotech and genetically modified crops that spotlight gaps in our regulatory protections. Hungry for more on GMOs?

Well, it turns out a Russian scientist tested Monsanto's RoundUp Ready genetically engineered soy by feeding it to a batch of female rats to compare the offspring of the GM-soy-fed rats with those of a control group:

Ermakova's first surprise came when her pregnant rats started giving birth. Some pups from GM-fed mothers were quite a bit smaller. After 2 weeks, 36% of them weighed less than 20 grams compared to about 6% from the other groups.
But the real shock came when the rats started dying. Within three weeks, 25 of the 45 (55.6%) rats from the GM soy group died compared to only 3 of 33 (9%) from the non-GM soy group and 3 of 44 (6.8%) from the non-soy controls.

The researcher ran out of funds to extend the study. For more information, click through: Jeffrey M. Smith, "Most offspring died when mother rats ate GM soy diet," Foodconsumer.org, Nov. 1, 2005.

Both that article and this scholarly take consider the very big stakes for Monsanto and the GM crop industry -- as well as the stakes for the public health.

Posted by Robert Shull, 07:54:53 PM

Tuesday, November 01, 2005

Clear Skies No Better than Existing Regs
EPA recently released cost-benefit analysis of competing legislation to curb power plant emissions, including the President's Clear Skies legislation as well as legislation introduced by Sen. James Jeffords (I-VT) and separate legislation introduce by Sen. Thomas Carper (D-DE).

The cost-benefit analysis showed that the President's Clear Skies bills perform no better than regulations already on the book. Furthermore, though the analysis predicts lower costs for the Clear Skies Act compared to competing legislation, it also predicts far fewer benefits.

While Clear Skies would cost less than $3 billion and produce $66 billion to $78 billion in benefits, Carper's bill (S.843, introduced in the 108th), which goes further in reducing emissions and setting strict deadlines, would cost $10 billion and produce $109 billion to $128 billion in benefits. Jeffords bill (S.150), which seeks the greatest level of emissions reductions, could produce up to $162 billion worth of benefit and cost $41 billion.

You would think that these numbers would clearly indicate that the Clear Skies initiative does not go far enough in protecting the public. Stricter regulations could produce tens of billions of dollars more in added benefit. Unfortunately, cost-benefit analysis—especially as wielded by this administration--consistently sides against more stringent protections, seeking to minimize costs rather than maximize benefits. EPA Administrator Stephen Johnson actually pointed to the cost-benefit analysis as a clear indication that Bush's proposal was the best option, even though the facts clearly state otherwise.

Even if cost-benefit analysis is used to maximize benefit, it still works as a one-way ratchet, consistently overestimating cost and underestimating benefit. While costs can be easily monetized, many benefits are more difficult to quantify. Cost-benefit analysis tends to focus only on risks for which there is a standard monetization, such as the risk of cancer or death. Other risks, such as asthma, neurological disorders or the impact of climate change, that can be associated with power plant pollution are often not folded into the cost-benefit equation.

For more information on how cost-benefit analysis gets it wrong, read "Is Cost-Benefit Analysis Needed?"

Posted by Genevieve Smith, 02:29:52 PM

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