The Government Accountability Office (GAO) has released a new report describing how the Food and Drug Administration handles conflicts of interest on its advisory panels. Financial conflicts plague a significant number of FDA advisors and FDA panels, according to the report.

FDA advisory committees can provide valuable advice to decisionmakers inside the agency "particularly concerning controversial issues or new products," according to GAO. Committees can weigh in on the safety and efficacy of a pharmaceutical awaiting approval or the safety of chemicals found in every day products — as FDA's science board did in September when it considered the safety of bisphenol-A. "The advisory committees' recommendations are not binding on the agency, but the agency usually follows the advisory committees' advice," GAO says.

But committee members, or potential members, sometimes have financial conflicts (such as owning stock in a company with a product before the committee) that call into question their ability to provide unbiased input. In those cases, FDA can provide a waiver if it believes a person's service is critical to the operation of an advisory panel.

FDA is not doing a good job of filling panels with impartial experts and issuing too may waivers. GAO examined a sample of advisory committee meetings and made these key discoveries:

• At least one member on 49 of the 83 meetings examined had a conflict;
• Two hundred of the 1,218 participants had a conflict — about 16 percent;

FDA officials acknowledge that their source for expertise is the same as industry's:

FDA contended that it sought the same leading experts to serve on its advisory committees as industry sought to conduct its research and product trials. As a result, the experts FDA deemed most qualified to serve on its advisory committees often had industry ties, according to the agency.

GAO says that FDA needs to improve its efforts to recruit committee members. FDA's primary vehicle for recruitment is word-of-mouth which means committee members tend to be those experts known to agency officials or to an industry with a product under review. "[I]t may lead to self-perpetuating committee membership, in which a limited group of peers continually comprise an advisory committee."

The report is available here: FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest

The National Oceanic and Atmospheric Administration (NOAA) has finalized a long-awaited rule that will protect the North Atlantic right whale, one of the planet's most critically endangered marine species. Fewer than 400 right whales are left, according to NOAA.

The rule sets a speed limit on shipping vessels traveling in the Atlantic during seasons when the right whale is most active. NOAA maintained the speed limit in its initial proposal: 10 knots. That is good news, since collisions with ships are a major threat to right whales. According to The Washington Post, "Since NOAA first proposed the regulation in 2006, at least three right whales have died from ship strikes, and two have been wounded by propellers."

However, as expected, another aspect of NOAA's final rule is weaker than originally proposed. NOAA initially proposed extending the protection area in which the speed limit would be enforced 30 nautical miles off shore. In the final rule, NOAA shrank the protection zone to only 20 nautical miles.

The smaller protection zone encompasses a smaller portion of right whale activity. From the Post:

Researchers at NOAA's Fisheries Service estimate that about 83 percent of right whale sightings in the mid-Atlantic region are within 20 nautical miles of shore, while the 30-mile limit would encompass 90 percent of all sightings.

The White House could have played a role in weakening the rule. The Office of Information and Regulatory Affairs — the arm of the White House responsible for reviewing and editing agency regulations — kept the rule under its watch for 573 days. By its own rules, OIRA is to review rules for no longer than 120 days.

During that time, several other White House offices attacked the scientific basis for NOAA's plan to protect the right whale. The office of Vice President Dick Cheney said, "[W]e have no evidence (i.e., hard data) that lowering the speeds of 'large ships' will actually make a difference." The White House Council of Economic Advisors even went so far as to rerun statistical models the agency used to come to its determination.

The White House may have been working on behalf of industry. The World Shipping Council opposed the rule, and lobbied the White House to stop it.

Indeed, a NOAA official told The Washington Post in August, ""Time is money in shipping. There was a concern about the increased cost to carriers … We accommodated that by reducing the speed zones."

At least now all this mishegas is finally over. The rule will go into effect in December. (The Ocean Conservancy has more on the areas and times of year of enforcement.) If the rule is properly enforced, it will significantly increase the right whale's chances of survival.

EPA is finalizing a potentially major revision to the national air quality standard for lead, and industry has come a knockin'. On Oct. 2, several officials from the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) — the arm of the White House in charge of reviewing and editing new rules — met with several lobbyists from the battery recycling industry. That industry would eventually face new compliance requirements if EPA adopts a strict new standard.

One official from the White House Council of Economic Advisors, one from the White House Council on Environmental Quality, one official from EPA, and another from the Department of Energy also attended.

In May, EPA proposed tightening the standard for lead exposure to between 0.10 μg/m³ (micrograms per cubic meter) and 0.30 μg/m³. The current standard, which EPA has not revised since 1978, is 1.5 μg/m³.

At the meeting, the Gradient Corporation — a product defense firm whose clientele has included the tobacco industry — circulated a 15-page slide show reviewing the scientific uncertainty surrounding EPA's proposal. Injecting uncertainty into regulatory science is a common tactic of product defense firms and industry lobbyists. (Public health expert David Michaels profiled this extensively in his book Doubt is Their Product.)

The slide show is a veritable how-to manual for White House officials who like to challenge the conclusions of agency scientists in order to undermine environmental and public health regulations. (See the right whale rule for a recent example.)

Lobbyists at the meeting also complained of the potential compliance costs the rule would impose. In comments on the proposal, the Association of Battery Recyclers said a tighter standard "will threaten the continuing viability of the industry."

Fortunately for the public, the Clean Air Act prohibits EPA from considering economic factors when it sets major air quality standards. EPA must base its determination on health issues.

Lead exposure poses a number of health risks for humans, especially kids. According to EPA, lead exposure can affect brain development and "can lead to IQ loss, poor academic achievement, permanent learning disabilities, and delinquent behavior." Lead exposure can also damage red blood cells and weaken a child's immune system.

But that won't stop industry lobbyists from pressuring federal officials to finalize a rule weaker than what was proposed in May. And White House officials, never shy to circumvent the law, may help those industry lobbyists pressure EPA. The mere presence of an official from the White House Council of Economic Advisors is cause for concern. If EPA cannot consider economics, what value can economic advisors possibly add to the discussion?

The whole scenario is similar to the events leading up to EPA's revision to the national air quality standard for ozone, or smog. During that rulemaking, EPA proposed a range from which it would choose a final standard. When making its decision, EPA faced pressure from industry lobbyists and interference from White House officials.

If the pattern follows, EPA will ultimately take a step in the right direction but fall short of fully protecting public health. EPA tightened the standard for ozone but chose the upper end of its proposed range. EPA's staff scientists and independent advisors, as well as environmentalists and public health advocates, all agree the upper end of the proposed range for the lead standard, 0.30 μg/m³, is inadequate to fully protect human health.

EPA is under court order to finalize the rule by October 15. Stay tuned to Reg•Watch for updates.

As expected, the Environmental Protection Agency will not limit perchlorate in public drinking water supplies. Perchlorate is a chemical used in rocket and jet fuel and is a known inhibitor of human thyroid function. Because of its widespread use, perchlorate has made its way into drinking water systems across the nation.

EPA says that perchlorate is not present at high enough levels to cause adverse health effects in more than 99 percent of drinking water systems. Therefore, a limit on perchlorate is unnecessary.

EPA made the announcement on Friday afternoon when the federal government usually dumps information it doesn't want people to pay attention to. Juliet Eilperin at The Washington Post told the tale on Saturday:

Last month, The Washington Post reported that White House officials had extensively edited the EPA's perchlorate rule-making documentation to remove scientific data highlighting some of the risks associated with the chemical, which has been found in water in 35 states. The Defense Department and Pentagon contractors who face legal liability stemming from rocket fuel contamination have lobbied for six years to avoid a federal drinking-water standard for perchlorate.

In the document released yesterday, the EPA assumes that the maximum safe perchlorate contamination level is 15 times higher than what the agency suggested in 2002.

By that standard, the EPA estimates that more than 16 million Americans are exposed to the chemical at a level that is unsafe.

EPA will accept public comment on the rule once it is published in the Federal Register.

The Bush administration needs more time to complete work on a new standard that would require stronger roofs in cars in order to improve passenger safety during rollover crashes. From The Detroit News:

[Transportation Secretary Mary] Peters told the Senate Commerce Committee she would not be able to complete the rewrite by today -- as she had said she would in a June 30 letter -- citing the need to do additional "regulatory analysis." The department will need until Dec. 15 to finish the revision, she said.

The DOT agency responsible for the rule — the National Highway Traffic Safety Administration (NHTSA) — faced a statutory deadline of July 1 to complete the rule, but was permitted to request from Congress an extension. The agency did so, and Congress gave it until October 1. Now, NHTSA needs another extension.

Let's hope this rule is worth the wait. In 2005, DOT proposed a rule that would tighten the existing standard for roof strength which has not been updated since it was first written in 1971. But the proposal is weaker than auto safety advocates and Congress had hoped.

One of the major points of contention is preemption of state common law, which NHTSA has been pushing for. In the original notice, NHTSA claimed its final rule would prohibit states from enacting positive law — that is, laws passed by state legislatures and regulations developed by state agencies — different from the federal standard. NHTSA also claimed the rule would "preempt all conflicting State common law requirements, including rules of tort law," thereby eliminating a consumer's right to sue an automaker if the consumer is injured in a rollover crash.

NHTSA's decision to preempt state positive law and tort law through its regulation is in plain violation of the major federal law the agency enforces, the Motor Vehicle Safety Act. (Click here for details.)

The crux of the roof crush standard is the strength-to-weight ratio. Currently, a vehicle's roof must be able to withstand pressure of at least 1.5 times the vehicle's weight. The proposed standard would strengthen the ratio to 2.5. DOT estimates the rule change would result in 13 to 44 fewer rollover fatalities every year, but critics say it should make significantly more progress than that. In 2007, more than 10,000 people died in rollover crashes.

Considering the delays, NHTSA should make sure it gets the final rule right. During a June Senate hearing, Sen. Tom Coburn (R-OK) said NHTSA should give higher priority to eliminating the rule's flaws than to meeting the deadline" "If we have a little increase in roof strength that doesn't result in a major decrease in fatalities and injuries, we've done nothing."

The long-awaited rule to protect the North Atlantic right whale is coming soon, according to President Bush himself. Speaking at the Smithsonian Museum of Natural History on Friday, Bush briefly discussed the rule: "There are fewer than 400 North Atlantic Right Whales left in the world… And there are going to be new regulations that will be coming to be shortly that require ships to slow down as they approach seaports where these whales are likely to be."

Bush's pronouncement comes after the rule was stuck inside his White House for 573 days. In that time, the White House Council of Economic Advisors and the Vice President's office attacked the science behind the rule in attempt to derail it. Although the rule has not yet been unveiled, early signs indicate it may be somewhat weaker than what the National Oceanic and Atmospheric Administration originally proposed.

Had Bush been in the mood to be frank, his comment would have sounded more like this:

Scientists say if even one more right whale female dies, the entire species could be set on a path toward extinction. The National Oceanic and Atmospheric Administration has spent years developing a new policy to reduce the risk that ships will crash into and kill right whales.

The White House, under my leadership, fought hard to undermine that policy. I think the free market can save the whales. Whales don't deserve a bailout — they're not Wall Street execs. (Chuckle.) So we delayed, we interfered, we threw the kitchen sink at this rule to see if we couldn't turn it back. After a year-and-a-half, we've decided to let it through. See, I wanted to make sure this rule got finished under my watch, with a concession or two to industry, before some new guy comes in.

The New York Times published a terrific op-ed today putting into historical context China's contaminated milk scandal. Some Chinese dairies are cutting milk with a toxic chemical called melamine. The bad milk has killed at least four infants and sickened thousands.

1850's New York saw a similar crisis, author Bee Wilson writes in the Times. Milk producers saw an opportunity to boost sales in a fast-growing city. They created swill milk, "a filthy, bluish substance milked from cows tied up in crowded stables adjoining city distilleries and fed the hot alcoholic mash left from making whiskey," Wilson writes.

Like China's melamine milk, producers added foreign substances to the swill milk with dire consequences:

This too was doctored — with plaster of Paris to take away the blueness, starch and eggs to thicken it and molasses to give it the buttercup hue of honest Orange County milk. This newspaper attributed the deaths of up to 8,000 children a year to this vile fluid.

The situations leading up to the two crises carry common traits: When food producers face great demand for their products, temptation rises; and the public is placed at risk when avarice bests responsibility.

Unfortunately, regulation does not move as swiftly as the market. To straighten out the situation in New York, Wilson writes, "It took stronger food laws, better policing, the advent of pasteurization and the passage of the Food and Drug Act in 1906, 50 years after the worst of swill milk." She adds, "Above all, it took decades, not months or years."

(Inertia still plagues the U.S. government, especially Congress. The Center for Science in the Public Interest, a nonprofit group that works on food safety and other important causes, has a list of food safety bills currently pending in Congress. CSPI lists 12 different bills, not one of which has cleared the committee stage.)

So what does that mean for China? Is China decades away from meaningful regulation? It may just be. The Chinese government silences voices representing the public. Government watchdogs and independent advocates are suppressed, and journalists are never out of Beijing's crushing reach. "In China, journalists have known of the poison milk for months, but weren't allowed to spread the news because of the Olympics," Wilson writes.

That is why the U.S. government cannot afford to wait to keep American consumers safe. Congress should explore ways to improve the safety of imported foods, just like it did with imported toys this summer.

A new law reforming the Consumer Product Safety Commission, the agency in charge of toys, household products, and other non-food items, requires third-party testing and certification of imported children's products. The law allows regulators to keep dangerous toys out of American stores and, by extension, allows the U.S. to use its leverage as a major importer to force exporters like China to clean up their act.

Clearly, the federal government needs to cast a wider safety net to protect Americans from the dangers of contaminated food imports. The melamine contamination scandal has already spread into the U.K., where Cadbury has been forced to recall Chinese-made candies.

The 110th Congress sputtered in passing new laws to ensure a safer food supply. The 111th Congress will have to do better.

The White House Office of Management and Budget opposed EPA's efforts to clean up a Montana town contaminated by asbestos, according to a new report. EPA wanted to declare a public health emergency in the town of Libby in order to compel the removal of attic insulation threatening thousands of residents and to extend medical care to residents at risk.

The report, prepared by a team of congressional staff led by the office of Montana Sen. Max Baucus (D), says, "EPA's decision not to declare a public health emergency in 2002 has had a profound and lasting impact on the people of Libby as they continue to struggle with disease and death from asbestos contamination." Although EPA maintains it made the decision, OMB may have pressured it to do so.

Why would OMB oppose the declaration of a public health emergency in Libby? Because it could mean other parts of the country would benefit too. In 2002, EPA convened a meeting with OMB to discuss the situation. "At that meeting, OMB expressed concern about EPA's imminent declaration of a public health emergency because of the precedent it would set for other sets with Libby asbestos and the public concern it could cause."

In other words, the asbestos products sickening Libby residents made it outside of Libby, and other Americans could be at risk. If the government helps Libby residents, it may have to help everyone else…perish the thought.

An OMB official also urged EPA to add language to a memo outlining the cleanup strategy saying, "…activities at this site set no precedent for possible future removals from other locations," according to the report.

EPA used a legal loophole to remove the insulation from Libby homes anyway. But there were other consequences to the agency's refusal to declare an emergency:

The residents of Libby were deprived of medical care from the federal government to which they were legally entitled. A public health emergency existed in Libby in 2002. In cases of a public health emergency caused by exposure to toxic substances, exposed individuals are entitled to medical care from the federal government and other medical assistance as appropriate under the circumstances. Consequently, had a public health emergency been declared, medical care would have been provided by the federal government to the resident of Libby exposed to asbestos.

The report lists other consequences Libby residents faced as a result of OMB's meddling and EPA's refusal to stand up to it. The report is available here.

The White House has finally given approval to a rule that would protect the North Atlantic right whale, one of the planet's most critically endangered marine species.

Last Monday, September 15, OMB's Office of Information and Regulatory Affairs — the White House office in charge of reviewing and editing new regulations — approved the rule "consistent with change" (its most common designation for rules it has reviewed). OIRA had been reviewing the rule since Feb. 20, 2007. Since agencies cannot go forward without OIRA's blessing, the National Oceanic and Atmospheric Administration has been unable to make substantive progress on the rule for more than one-and-a-half years.

According to the executive order that governs the OIRA review process, OIRA has 90 days to review agency proposals. OIRA, in consultation with the agency, may extend the period once by 30 days. So, under the White House's own rules, OIRA is not supposed to hold up rules for more than 120 days.

OIRA reviewed the right whale rule for 573 days.

During that time, OIRA and other White House offices tried hard to derail NOAA's efforts to protect the species by imposing speed limits on large ships sailing in the Atlantic during certain seasons. The office of Vice President Dick Cheney attacked NOAA's scientific basis for the rule saying, "[W]e have no evidence (i.e., hard data) that lowering the speeds of 'large ships' will actually make a difference."

The White House Council of Economic Advisors even went so far as to rerun statistical models the agency used to come to its determination.

For now, we don't know what the version of the rule OIRA approved looks like. The proposed rule, published way back in June 2006, called for a speed limit of 10 knots up to 30 nautical miles off the coast.

In August, NOAA released an environmental impact statement that may be a precursor to the final regulation. Fortunately, in that document, NOAA maintained the 10 knot limit. Unfortunately, it shrank the protection zone to only 20 nautical miles. A NOAA official acknowledged the agency was considering the change under pressure from the White House and the shipping industry.

Why now? Perhaps the White House is finally standing aside because it wants to move a weaker version of the rule while President Bush is still in office. A future administration may want a more stringent standard that keeps the speed limit and extends the protection area to 30 nautical miles, as under the original proposal.

Who knows what NOAA's plans are now that it controls the rule's destiny once again? Hopefully, it will publish the rule soon in a form most protective of the right whale. After all, fewer than 300 remain, and experts warn that even one more dead female could set the species on an irrevocable path toward extinction. Reg•Watch hopes this drama will soon be over.

Last week, the Government Accountability Office (GAO) released a report on the Environmental Protection Agency's policies for considering children's health. GAO's title sums it up well: "EPA Efforts to Address Children's Health Issues Need Greater Focus, Direction, and Top-Level Commitment."

A Clinton-era executive order on children's health created an advisory committee that was to provide expert opinion to government decision makers. But at EPA, the committee's advice has gone unheeded, GAO found. A new article from OMB Watch's The Watcher reports:

EPA requested advice from the committee on regulations only three times, on guidance three times, and only once on developing a policy. Fourteen other times, EPA asked for advice on other issues such as developing plans and evaluating pilot programs. Yet over the period GAO reviewed, the committee sent to over 600 recommendations for action EPA should take on a wide variety of issues, ranging from mercury regulation and farm worker protections to pesticides and air pollution. GAO concluded, "EPA has largely disregarded the advisory committee's recommendations."

One example where EPA has ignored the children's health advisory committee came earlier this year when it finalized a standard for ozone, or smog, weaker than what the entire scientific community — including those experts on the committee — was recommending.

In March 2007, the committee wrote to EPA administrator Stephen Johnson and was quite clear with its scientific opinion: "[I]n order to more protective of the respiratory health of susceptible children, the committee recommends that the EPA choose a standard of 0.060 [parts per million]."

But when Johnson announced the standard in March 2008, he chose 0.075 ppm as the standard. According to the estimates of EPA's staff, choosing a standard of 0.065 ppm — not even as strict as the committee had recommended — could have prevented an additional 8,100 asthma-related emergency room visits for people 18 and younger every year.

Read more about EPA's record of protecting children from environmental hazards.

The Bush administration will continue to allow perchlorate, a chemical found primarily in rocket fuel, to pollute America's drinking water supply. Perchlorate has been found to disrupt thyroid functions in humans, and can be particularly dangerous for infants and children. Yet, the U.S. Environmental Protection Agency (EPA) will pass on an upcoming opportunity to set a new limit for drinking water, according to The Washington Post.

The Post obtained an early copy of EPA's "preliminary regulatory determination" on perchlorate. The White House Office of Management and Budget (OMB) has been making significant edits to the document in order to downplay the negative health effects of the chemical, according to the Post. OMB has been reviewing the document since September 4.

From the Post:

The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe -- 700 nanograms per kilogram of body weight per day -- if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

OMB officials said during the drafting process that there was "no need" for detailed data to flesh out a table suggesting that infants would be exposed to perchlorate levels above the academy's recommendation.

To determine safe levels of exposure, the administration opted not to use the academy's "reference dose," a formula that includes a tenfold safety factor to protect children and vulnerable populations, and instead used a computer model developed by the Chemical Industry Institute of Toxicology. EPA officials initially inserted language in the document calling this a "novel approach," but the OMB deleted that language.

This is not the first time OMB has meddled with EPA's efforts to regulate, or not regulate, perchlorate. The Bush White House and the Department of Defense — a major rocket fuel user and, subsequently, perchlorate polluter — have spent years working hard to make sure the Pentagon and defense contractors won't have to clean up their acts. More on that here.

When it comes to the environment, the Department of Defense is the nation's biggest polluter and, apparently, the government's biggest bully.

The Pentagon continues to ignore the instructions from another arm of government, the U.S. Environmental Protection Agency, to clean up toxic sites at military bases. DOD officials are also intimidating state environmental agencies to back off clean-up efforts and are threatening to withhold federal funding Congress intended to go to those states, according to The Washington Post.

Yesterday, Wayne Arny, a deputy undersecretary for defense, told a Senate panel that he was unaware of any threats to withhold funding, and that he would put a stop to it.

But at the same hearing, "He said that the military is committed to protecting public health and the environment and merely differs with the EPA over cleanup procedures," according to the Post. "He said the Pentagon was proceeding with its own cleanup."

To that, Sen. Barbara Boxer (D-CA) shot back, "I don't want the EPA making decisions on war strategy, and I don't want you making decisions on environmental cleanup, because you have an interest in the easiest way out."

Boxer is correct: DOD's impartiality and commitment to the environment cannot, and should not, be counted on. DOD is the nation's biggest polluter. EPA says the three most controversial clean-up sites (Maguire Air Force Base in New Jersey, Fort Meade in Maryland, and Tyndall Air Force Base in Florida) may present "an imminent and substantial threat" to public health and the environment.

Moreover, the Pentagon is in violation of federal law. Again, the Post reports:

Although the law gives final say to EPA Administrator Stephen L. Johnson in cleanup disputes with other federal agencies, the Pentagon refuses to recognize that provision. Military officials have asked the Justice Department and the White House to intervene in the dispute.

In May, Arney wrote to OMB asking it to resolve the dispute between DOD and EPA. No public word yet on the views of the White House.

Yesterday, a House panel held an oversight hearing concerning Labor Secretary Elaine Chao's proposal to change the way the Occupational Safety and Health Administration and the Mine Safety and Health Administration calculate on-the-job risks. Occupational health advocates and good government groups, such as OMB Watch, oppose the controversial rule. However, Bush officials are aggressively pushing the new policy through the rulemaking pipeline.

Rep. Lynn Woolsey (D-CA), chair of the House Education and Labor Committee subcommittee on Workforce Protections, opened the hearing by airing her concerns with the speed of the rulemaking and the Labor Department's priorities:

I am troubled by the Agency's attempt to rush through this rule without a full consideration of its effect on the health and safety of the American worker. This proposed rule has without explanation leapfrogged ahead of many other worker protection standards that OSHA should have been working on for the last 8 years, including a standard for diacetyl, the long delayed silica standard, the long delayed beryllium standard, and the long delayed crane standard…[The rule] is being propelled forward at lightning speed.

Celeste Monforton, a health and safety advocate and a researcher from George Washington University, testified before the panel. She reminded committee members that OMB had tried to impose on regulatory agencies a politically-driven set of risk assessment mandates, but the National Academies of Science trashed the proposal forcing OMB to abandon it. Monforton pointed out that DOL's proposed rule ignores many of the important recommendations NAS articulated in its critique of the earlier OMB proposal.

Peg Seminario, director of safety and health for AFL-CIO, discussed the delay the proposed rule would cause. OMB Watch has complained that future administrations will have to grapple with these new requirements anytime they want to address new workplace hazards. But Seminario wisely noted that current rulemakings would also be affected:

The proposal doesn't apply only to future rules, it applies to those in process as well. We have three important health rules moving along at OSHA: one on silicia, one on beryllium, another on diacetyl…This rule requires that OSHA go back to square-one and start all over…This will result in dozens and dozens of unnecessary deaths.

DOL is only accepting public comment on the proposed rule for 30 days. (The standard comment period lasts 60 days.) Occupational health advocates want this rule abandoned altogether, but at the very least, they hope the comment period will be extended to allow for full examination.

A group of advocates, led by the Center for Progressive Reform, wrote to DOL requesting an extension. A DOL spokesperson said, "[W]e will evaluate their letter, along with the hundreds of other letters the department receives," according to BNA news service.

But another request for an extension may not be brushed off so easily. Sen. Barack Obama (D-IL) shined a spotlight on the controversy yesterday when he wrote to Chao requesting an extension:

In the interest of transparent governance, an informed process, and an informed public, I strongly urge you both to release the results of the review the Department commissioned and extend the comment period for another 30 days.

Today, the Food and Drug Administration debated the safety and potential need for regulation of bisphenol-A (BPA), a common chemical used in hard plastics and the lining of food cans. There has already been one surprise at the long-awaited meeting: today, a group of scientists revealed the results of a study linking BPA exposure to heart disease and diabetes.

The new study will throw more fuel on the debate over whether FDA should set strict limits on the use of BPA. Two other recent studies also indicate a potential risk. One of those was conducted by the National Toxicology Program which, like FDA, is housed within the U.S. Department of Health and Human Services.

A few other studies have drawn a link between BPA exposure and adverse health effects. Lyndsey Layton at The Washington Post reports:

Scientists flagged possible health risks of BPA more than a decade ago. From 1997 to 2005, 116 studies of the compound were published. Of those funded by government, 90 percent showed evidence of a health effect linked to BPA.

The study released today is significant because it ties BPA exposure to human health effects, whereas most other studies look at effects on lab rats. This may prove to be a landmark study. The Post has more on the findings:

The research, published today in the Journal of the American Medical Association by a team of British and American scientists, compared the health status of 1,455 men and women with the level of the chemical, also known as BPA, in their urine.

The researchers divided the subjects into four groups according to their BPA levels and found that those in the quartile with the highest concentrations were nearly three times more likely to have cardiovascular disease than those with the lowest levels, and 2.4 times more likely to have diabetes. Higher BPA levels were also associated with abnormal concentrations of three liver enzymes.

Although the scientists acknowledge certain limitations to their study and call for more research, shouldn't this evidence be enough to prod the federal government into action? Shouldn't regulators extend at least some protection to the public in the interim instead of waiting for more conclusive, but potentially more frightening, science to develop? Considering the grave consequences, uncertainty should not be used as an excuse to delay regulation.

And yet, for now, it will be. From the Associated Press:

"A margin of safety exists that is adequate to protect consumers, including infants and children, at the current levels of exposure," Laura Tarantino, a senior Food and Drug Administration scientist, told an expert panel…

Of course, the plastics industry will do everything in its power to make the debate even more contentious. Early reports on today's news are peppered with quotes from industry lobbyists attacking the scientific conclusions of the human health study.

According to the Post, "The North American Metal Packaging Alliance, which represents can manufacturers, dismissed the JAMA study article as an "unsubstantiated scientific leap" and called for additional research." According to AP, "The American Chemistry Council, an industry trade group, said the study is flawed, has substantial limitations and proves nothing."

Yesterday, a federal court delivered a win for conservationists when it overturned a Bush administration policy that would have opened Yellowstone National Park to unacceptable numbers of snowmobiles. Juliet Eilperin reports for The Washington Post:

U.S. District Judge Emmet G. Sullivan threw out the National Park Service's 2007 plan, calling it "arbitrary and capricious, unsupported by the record, and contrary to law." The administration rule would have allowed 540 recreational snowmobiles and 83 snow coaches a day to enter Yellowstone and Grand Teton national parks and the John D. Rockefeller Jr. Memorial Parkway. Sullivan said the plan violated the agency's mission statement.

Luckily for environmental advocates and park wildlife, the National Park Service did a good job making the case against its own policy. Had the Park Service chosen to ban snowmobiles and allow only snowcoaches (like public buses on the snow), it reports the adverse effects on air quality would be "negligible." Instead, under the 540-snowmobiles-per-day plan, the effects would be "moderate."

Another environmental consideration, "natural soundscapes," would also suffer under the plan to allow 540 snowmobiles per day, according to the Park Service itself. Furthermore, according to the Post, "Studies by the agency have found that snowmobiles in Yellowstone have frequently exceeded noise thresholds."

Choosing a policy option that is obviously not the most environmentally protective doesn't jibe with federal law. According to the Post, the act which created the Park Service "states that the agency's overriding mandate is to 'conserve park resources and values,' but it permits federal managers to 'allow impacts' as long as they do not impair the park's resources."

In his opinion, Judge Sullivan wrote, the act "clearly states, and Defendants concede, that the fundamental purpose of the national park system is to conserve park resources and values."

Sullivan's decision is the latest chapter in an ongoing saga. For at least a decade, the limit on snowmobiles in Yellowstone has been the subject of a pitched battle between conservationists and snowmobile advocates. Just before leaving office in Jan. 2001, the Clinton administration banned all snowmobile use in Yellowstone. The Bush administration was able to delay implementation until a federal court invalidated the ban in 2004 in a case brought by the snowmobile industry. The Park Service then instituted a temporary cap, which it then replaced with the 540 per day cap.

The International Snowmobile Manufacturers Association has already pledged to appeal Sullivan's decision, according to The New York Times.