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News & Analysis | REG•WATCH Blog | Press Room
Tuesday, August 26, 2008
The National Oceanic and Atmospheric Administration may be making long-overdue progress on a rule to protect the critically endangered North Atlantic right whale. A draft of the final rule has been stuck at the Office of Information and Regulatory Affairs — the White House office that must approve major agency actions — since February 2007.
However, the proposal NOAA is now floating is weaker than the proposed rule first unveiled in June 2006. NOAA now says it wants to enforce the would-be regulation in waters 20 nautical miles off the east coast. The original proposal called for a 30 nautical mile protection zone. Ships traveling in these waters would have to slow down in order to reduce the risk of striking a whale. Collisions with ships are a significant cause of right whale deaths.
In surprising yet unfortunate candor, NOAA officials acknowledged they are weakening the proposal at the shipping industry's behest. An agency spokesman told The Washington Post: "Time is money in shipping. There was a concern about the increased cost to carriers … We accommodated that by reducing the speed zones."
But the World Shipping Council, the trade group that has been lobbying NOAA and the White House, is still unhappy. Their biggest beef with the proposal is not the area in which NOAA will enforce the speed limit, it's the speed limit itself. The Council says, "We continue to see no scientific or statistical support on the record of the rulemaking to show that a 10-knot speed limit for large ships around East Coast ports will help protect right whales," according to the Post.
That argument is totally bogus. NOAA marine science experts have examined the latest science and conducted statistical analyses that show fast-moving ships increase the chances of right whale deaths.
The Council's statement attacking the science behind the rulemaking is eerily similar to the arguments being made by political forces inside the White House. Several White House offices, including the office of Vice President Dick Cheney, have been questioning NOAA's scientific findings and have gone so far as to meddle with NOAA data sets and rerun analyses.
NOAA yesterday revealed its decision to reduce the protection area to 20 nautical miles when it released a draft environmental impact statement that will accompany the final rule. The draft regulation is still stuck at the White House, but the release of the impact statement and the policy change signals that NOAA may be moving forward with the rulemaking.
Of course, the White House can continue to hold up this rule for as long as it wishes. Political forces including those in Cheney's office may pressure NOAA experts to abandon the speed limit, or they may be content to let the draft rule gather dust while the shipping industry continues to move ships through the Atlantic unfettered by new requirements.
Wednesday, August 06, 2008
The Food and Drug Administration has finalized guidelines it contends will improve the independence of the expert panels it uses to receive advice on pending decisions for both food and drug policy. But the final guidelines are weaker than the proposed version first unveiled in March 2007.
The guidelines define new FDA policies for financial conflicts of interest. If a potential member of an advisory committee has a financial interest in the issue the panel is considering — for example, ties to a pharmaceutical industry which has a new drug under review — that person's objectivity is compromised.
Under the March 2007 proposal, potential members with a financial conflict totaling more than $50,000 would be prohibited from serving on panels except in the rarest of cases. That part of the guidance has gone unchanged.
But potential members with a conflict of less than $50,000 will potentially have more influence under the final guidance than they would have under the proposed version. Originally, persons with a financial interest less than $50,000 would have been allowed to serve but prohibited from voting. FDA decided to strip the voting prohibition in the final version.
Allowing members with a financial conflict to cast deciding votes could have real consequences, especially in the area of drug approval. A 2006 study published in the Journal of the American Medical Association finds "the overall amount of conflict in a meeting could have an influence on overall voting behavior." The study finds, in hearings held on specific drugs where the advisory committee contains members with a financial interest in the approval of the drug, the committee is likely to recommend approval.
Moreover, even the strict $50,000 cutoff won't have much impact on the number of conflicted panel members providing the agency with advice. An investigation by the Center for Science in the Public Interest found the $50,000 threshold "would eliminate just one of every ten panelists who currently gets a waiver" to serve despite a financial conflict.
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