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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

Friday, August 26, 2005

Paralysis by Analysis: Snowmobiles in Yellowstone
A New York Times op-ed examines the Bush administration's decision to authorize a fourth study of the environmental impact of snowmobiles in Yellowstone National Park, despite the wealth of scientific information already available:

Since 1996, there have been three major official assessments of snowmobiles' impact on the park in winter. Two of those were done during the Bush administration. Now a fourth major study has been authorized; it is to be completed by 2007, when the current three-year plan for winter use comes to an end. This new study will cost $2 million to $3 million - for a park that is annually underfinanced by nearly $23 million. There is only one conceivable reason for this study. It's part of the tried and true methodology of the Bush administration: if you don't like the results the first time, do it again and change the definitions so you do get the results you like.

Read more about the snowmobile controversy: Court Rejects Ban on Snowmobiles in Yellowstone

Posted by Genevieve Smith, 11:42:38 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

Nine States Commit to Reducing Global Warming
Facing a standstill in the Bush administration, nine states have decided to take matters into their own hands and cut greenhouse gas emissions from power plants, according to the New York Times. Read more about state efforts to raise the bar on public protections in the latest Watcher: States Present Opportunities and Pitfalls for Progressive Regulation.

Posted by Genevieve Smith, 02:28:37 PM

Tuesday, August 23, 2005

OIRA Meetings with Industry, Senate

On Tuesday August 9, Microsoft lobbyists met with OIRA, Department of Labor and Department of Homeland Security administrators to discuss labor certification for permanent employment of aliens in the U.S.

Also on August 9, pesticide manufacturers Bayer CropScience and Crop Life America met with EPA and OIRA to discuss protections for test subjects in human research.

On Tuesday August 16, representatives from the Cement Kiln Recycling Coalition (CKRC) met with OIRA and EPA representatives over the "maximum achievable control technology" (MACT) standards for hazardous waste combustion.

On Thursday Aug. 18, representatives from OIRA and EPA met with Michele Nellenbach of the Senate Environment and Public Works Committee over EPA's Spill Prevention, Control and Countermeasure (SPCC) proposed rule.

Posted by Genevieve Smith, 03:06:28 PM

Overtime: Hazardous to Your Health
BNA's subscription-only Daily Report for Executives got a sneak peek at the September issue of the Journal of Occupational and Environmental Medicine, which will publish a report addressing the health and safety consequences of working overtime. According to BNA, the study "found that working in jobs with schedules that routinely involved overtime work or extended hours increased the risk of a job-related injury or illness." Moreover, "[w]orking overtime was associated with a 61 percent higher injury hazard rate when compared with jobs that did not involve overtime."

More from the BNA snapshot of the study:

"The results of this study suggest that jobs with long working hours are not more risky merely because they are concentrated in inherently hazardous industries or occupations, or because of the demographic characteristics of employees working those schedules," the report said. "Our findings are consistent with the hypothesis that long working hours indirectly precipitate workplace accidents through a causal process, for instance by increasing fatigue or stress in affected workers."
The study on long work hours also found:

Overtime schedules had the greatest relative risk of occupational injury or illness, followed by schedules of 12 or more hours per day and those of 60 or more hours per week. Working at least 12 hours a day was associated with a 37 percent increased hazard rate; working at least 60 hours per week was associated with a 23 percent increased hazard rate.
The risk of injury was found to increase with the increasing length of the work schedule.
Multivariate analyses indicated that the increased risks are not merely the result of the demanding work schedules being concentrated in riskier occupations or industries.

Posted by Robert Shull, 01:40:58 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

Friday, August 12, 2005

OIRA meets over MSHA Diesel Rule
OIRA and the Department of Labor met with representatives from the National Mining Association, FMC Corporation (a major chemical producer), as well as a lobbyist from Patton Boggs over the Mine Safety and Health Administration's diesel rule.

On June 6, MSHA published the Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners Rule. The rule changes the way MSHA calculates diesel particulate matter emission limits in underground mines. According to the agency, the new calculations, based on permissible exposure limits measured by elemental carbon, are comparable to the former measurements, which measured limits based on total carbon emissions. In comments filed on behalf of the United Mine Workers of America, however, Advanced Technologies and Laboratories International senior scientist James Weeks points out that the new emissions standards are actually weaker than the older standards. By basing emission standards on elemental carbon rather than total carbon emissions, the new emissions standard will no longer capture the hundred of organic compounds combined with diesel particulate matter, many of which are carcinogenic.

The new regulation also contains other provisions that weaken the protection and could ultimately render the regulation impotent. Mines will be able to receive an unlimited number of one-year special extensions, administered by an MSHA district manager. Moreover, the new regulation now requires the agency to consider economic feasibility rather than just technical feasibility when considering special extensions for compliance with the rule. This new provision could open a floodgate of special extensions that will allow mines to avoid implementing the emissions standards altogether.

MSHA originally established the health standard using total carbon emissions on Jan. 19, 2001. Industry challenged the rule and organized labor intervened. The settlement agreement that followed required MSHA to promulgate a further series of rules addressing specific issues, including several that are addressed in this rulemaking. The new standard is an interim final rule. MSHA is required to create a more stringent standard in 2006, revising the concentration limit to 160 micrograms per cubic meter of air.

Read comments on the regulation by the United Mine Workers of America and the Center for Progressive Reform.

Posted by Genevieve Smith, 03:14:53 PM

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