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Monday, August 29, 2005

Plan-B Decision Delayed by FDA
FDA officials announced that the agency will again delay its decision on the over-the-counter status of Plan B, or the "morning-after pill." The agency claims that it needs more time to evaluate how it will enforce an over-the-counter regulation. The agency also decided to arbitrarily raise the age limit for receiving Plan B without a prescription from 16 to 17. The agency was initially required to decide the Plan B OTC status in January, but the agency has delayed a decision ever since. In fact, Senators Hillary Rodham Clinton and Pat Murray approved the confirmation of FDA Administrator Lester Crawford contingent upon an agency decision on Plan B.

More on Plan B: FDA Ignores Experts, Rejects Plan B for Over-the-Counter Use (5/17/2004) and Details Emerge on Data Rejected in Morning-after Pill Decision (6/28/2004).

Posted by Genevieve Smith, 02:32:40 PM

OIRA meets on animal feed rule
OIRA met with animal feed associations and cattle associations from both the U.S. and Canada to discuss substances prohibited in animal feed. Loopholes in the mad cow disease regulations allow cow parts to be fed back to cows in animal feed products, thereby potentially spreading the disease among cows. This meeting is one of several recently held by OIRA on mad cow-related topics. The agency also recently met with industry over substances prohibited in human food products as well as on the prohibition of specified-risk materials.

Posted by Genevieve Smith, 11:17:47 AM

Thursday, August 25, 2005

OIRA meeting with Rendering, Feed Industry
OIRA met on Aug. 23 to discuss substances prohibited in human food with rendering industry representatives including the National Renderers Association, Valley Proteins, Kaluzny Bros. and Griffin Industries, Inc. Rendering is "the process of transforming waste from the meat industry into useable products for animal feeds and technical use," according to the NRA website. OIRA met over the same rule on Aug. 24 with the American Feed Industry Association.

Posted by Genevieve Smith, 10:26:09 AM

Wednesday, August 24, 2005

OIRA Meeting on Mad Cow Disease
OIRA met with the North American National Casing Association on July 12 over the prohibition of specified-risk material for human food and the requirements for disposition of non-ambulatory cattle. Specified-risk material is the part of the cow most likely to transmit the mad cow disease prion. Currently regulation prohibits the use of specified-risk material in meat products. However, several loopholes to the regulation exist. Non-ambulatory cattle are essentially cattle that appear to be ill (i.e. they can't walk). Most of the cows that test positive for mad cow disease have been non-ambulatory. Read more on mad cow disease.

Posted by Genevieve Smith, 02:29:54 PM

Failure on Fuel Economy
The Bush administration unveiled a plan to modestly increase fuel economy for some but not all vehicles. Get some public interest perspectives on the weakness of the proposal and the missed opportunity to do something to protect the environment and save us all money at the pump:

Posted by Robert Shull, 10:08:09 AM

Monday, August 22, 2005

Missed Opportunities in Auto Safety
Two new regulatory developments fail to do enough to make our roadways safe:

The Federal Motor Carrier Safety Administration issued revised rules governing the maximum number of hours that companies can force their truck drivers to work without rest. As Public Citizen notes, these new rules are virtually unchanged from the inadequate rules recently rejected by a federal court:

Like the 2003 rule, today’s proposed rule makes permanent a dramatic increase in the allowable weekly driving time and on-duty hours for truckers. It reduces weekly off-duty time for the most exhausted drivers (truckers who drive the maximum number of allowable hours) and significantly weakens safety requirements for short-haul drivers.
While we support the portion of the rule that no longer allows drivers to split the time they spend in sleeper berths, the overall increased driving and working time is not supported by the vast body of scientific literature that exists about fatigue and driver safety. Nor does this proposal help drivers get on a 24-hour circadian schedule.
Read more.
Meanwhile, the National Highway Traffic Safety Administration finally moved to update its 30-year-old standard to prevent vehicle roofs from crushing in on top of occupants during rollover crashes, but that proposed rule "falls tragically short of what is needed to fix the problem of roof collapse in rollovers," explains Public Citizen:
The long-delayed roof crush rule proposed today by NHTSA fails to comply with new safety mandates issued by Congress just last month. The highway funding bill requires roof strength be tested both on the driver and passenger sides of a vehicle. However, the proposed rule tests roof strength only on one side.
Most auto manufacturers already produce vehicles that can pass this very weak test, which requires a roof to withstand 2.5 times its weight. It’s not enough because forces in a rollover crash exceed that amount. Rollover crashes are responsible for about a fourth of all traffic fatalities and about one-third of all occupant fatalities each year. In 2004, 10,553 people died in rollover crashes; roofs crush in during roughly a quarter of all rollover crashes, NHTSA has estimated. And SUV rollover deaths are up nearly 7 percent. It is feasible to make much stronger roofs; in fact, the Volvo XC 90 has a roof that can withstand at least 3.5 times its weight.
The agency still has no plans to require real world crash tests to gauge roof strength, known as a dynamic test. This test is the only way to learn what happens in a rollover crash to the roof, its supporting structures, the windows and the belt system, and of course, to the occupants.
Read more.

Posted by Robert Shull, 07:45:21 PM

Sunday, August 21, 2005

Easing Burdens on Scientific Evidence
Be sure to catch the latest article from CPR member scholar Lisa Heinzerling, "Doubting Daubert, forthcoming in the Brooklyn Journal of Law & Policy. In Daubert v. Merrell Dow Pharmaceuticals, Inc., the Supreme Court announced that it was liberalizing the rules on admissibility of expert scientific evidence by rejecting a requirement that such evidence be generally accepted in the scientific community. Daubert has had, Heinzerling notes, just the opposite effect from the one the Court said it intended. Among other reasons:

it has narrowed rather than enlarged the range of expert evidence admitted by courts, as courts have taken dicta from the case and applied them as a rigid test;
it has encouraged more junk science in legal cases rather than less, as courts have scrutinized studies paper by paper rather than looking, as scientists do, at the larger universe of studies to identify the weight of the evidence;
it has encouraged the industry assault on science by reiterating the industry talking points about "junk science" -- talking points that have been circulating precisely because science so often reveals that corporate special interests are harming us all;
and it has legalized science, as legal precedents codify scientific (or anti-scientific) conclusions and then are applied in subsequent cases as the law.

Proposals to extend Daubert to the administrative setting should be rejected, Heinzerling concludes, and the courts should pull back from Daubert itself.

Download the article.

Posted by Robert Shull, 06:25:46 PM

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