FDA higher-ups pushed forward with a controversial rule that makes it harder for patients to learn of drugs' side effects despite objections from its own experts, a new report shows. The rule also removes patients' ability to sue pharmaceutical manufacturers when harmed by a drug.

In 2006, FDA changed its policy for updating drug labels. Drug makers must now seek FDA approval before adding new information to labels, even if that information is critically important to public health. Critics say the mandatory FDA approval is inefficient and that FDA does not have the resources to act quickly on all label-change requests.

The rule also reversed the agency's longstanding position on preemption of common law, according to the new report, released by House Oversight and Government Reform Committee Chairman Henry Waxman (D-CA). If FDA approves a drug and its label, drug makers are shielded from liability, removing the right of citizens harmed by a drug to seek legal redress. From the report:

FDA has historically viewed state lawsuits as providing a valuable complement to the agency's regulation of these products.3 The agency has asserted that these cases help to uncover risks that are unknown to the agency at the time of approval and that they provide an important additional layer of consumer protection against unsafe products.

The two issues (label-change approval and preemption) are interrelated. By mandating FDA approve changes to drug labels, the agency provides drug makers even more protection from citizen suits. Since the rule preempts common law, FDA approval shields drug makers from so-called "failure-to-warn" claims.

The Waxman report shows that experts inside the FDA opposed both controversial aspects of the rule. Dr. John Jenkins, who works in FDA's drug review office, said, "We know that many current approved drug labels are out of date and in many cases contain incorrect information (e.g., the overdose section) … [I]t is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information."

Like many others at FDA, officials from research centers inside the FDA objected to preemption of common law:

[T]he centers believe that an extensive discussion of preemption should not be included in this rule. The question of preemption is tangential to the purpose of this rule and any controversy that results from including it in the final rule may detract from the public health benefits that will be realized from revising prescription drug labeling.

The White House could have been responsible for including preemption in the rule, known as the Physician's Labeling Rule. Waxman's report says Bush administration officials have not turned over all documents related to FDA's communications with the White House. "The documents that have been provided, however, suggest that officials in the White House and the Department threatened to block the Physician Labeling Rule, a major public health initiative on which FDA career officials had worked for many years, until the preemption changes were included," the report says.

FDA's rule is bad for consumers and is a prime example of the Bush administration's penchant for making sure regulated industries are subject to as little government and legal oversight as possible. In Waxman's report, Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, sums it up best: "The rule is not, as it purports to be, consistent with the agency's role in protecting the public health."

FDA's panel of independent science advisors charged with reviewing the agency's work on bisphenol-A, a chemical commonly found in hard plastics and the lining of food cans, criticized FDA's current policy on the substance. The panel has "significant concerns" with the draft scientific assessment FDA released in August.

In FDA's draft assessment, the agency identified "margins of safety" for both infants and adults and contended, at levels most humans are exposed to, the margins are adequate. But the science panel's report says the available evidence "provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as 'adequate' are, in fact, inadequate."

The panel criticized the agency's selection of studies on which it based its assessment, saying FDA excluded many studies suitable for determining the health effects of exposure to bisphenol-A. The report says FDA's list of the studies it used "creates a false sense of security about the information that is used in the assessment, however, as it overlooks a wide range of potentially-serious findings."

Last week, a Milwaukee Journal Sentinel investigation turned up evidence showing FDA used studies funded by the plastics industry lobby and some studies that are decades old.

The panel's stinging rebuke of FDA's risk assessment will quiet charges that the panel chair, Martin Philbert, has unacceptable ties to an anti-regulatory activist, Charles Gelman, who believes bisphenol-A is perfectly safe. The tone of the report and the panel's recommendation that FDA look at more studies finding bisphenol-A poses a risk vindicate Philbert who claims he was aware of Gelman's views but would not be swayed by them.

FDA continues to bury its head in the sand. In a press release responding to the panel's report, FDA says, "Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies."

Nearly every study on bisphenol-A raises concerns. A recent study published in the Journal of the American Medical Association concludes human adults with high levels of bisphenol-A in their urine are at greater risk of heart disease and diabetes. The National Toxicology Program — which, like FDA, is an arm of the U.S. Department of Health and Human Services — "has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures."

Under a deadline imposed by White House Chief of Staff Josh Bolten, federal agencies were to propose any regulation they wished to finalize under President Bush's watch by June 1 or wait for a new president to take the reigns of government. But several controversial rules that missed the June 1 deadline appeared destined for completion nonetheless.

Reg•Watch has been keeping track of the controversial rules which include rules which would allow local law enforcement to engage in domestic spying without good cause; change the way government agencies comply with the Endangered Species Act; educe women's access to federally funded reproductive health services; change the way occupational health agencies calculate estimates for on-the-job risks; and require mandatory drug testing for miners.

Evidence indicates the Bush administration intends to finalize these rules even though they missed the June 1 deadline ordered by Bolten in a May 2008 memo. Most went through an expedited review at OMB's Office of Information and Regulatory Affairs (OIRA) — the White House office in charge of reviewing agency rules — and were open to public comment for only a short time.

The Institute for the Study of Regulation — a project of the NYU School of Law — wrote to OMB expressing concern about some of the rules and questioning their status under the Bolten deadline. (h/t The Pump Handle.) Susan Dudley, head of OIRA, responded: "[T]he Memorandum was not intended to be a moratorium on proposed regulations, and thus excludes from its terms regulations proposed after June 1, 2008 that are not finalized during this Administration."

Dudley's statement implies because the batch of rules mentioned above missed the June 1 deadline, they won't be finalized under Bush's term. That would certainly be good news. Unfortunately, she follows with this statement: "It further contemplates some circumstances in which it would be appropriate for individual regulations to proceed without regard to deadlines if approved by OIRA."

Indeed, at least the rule that would change the way government agencies treat endangered species is proceeding apace. The Department of Interior instructed its employees to review the 300,000 comments it received on the proposal — most of which opposed the plan — in just one week. An environmental assessment of the regulation is open for public comment …for just 10 days.

Whether proposed rules made or missed the June 1 deadline, agencies are now in a rush to comply with the second deadline in the memo which requires agencies finalize rules by November 1. But with that deadline fast approaching, and some Bush administration whims not yet satisfied, even more rules may violate the Bolten memo.

The administration is pushing other rules which would ease restrictions on mountaintop mining; allow truck drivers to work longer hours without taking breaks; restrict access to family and medical leave for workers; and exempt factory farms from reporting air pollution.

Dudley's office is in the process or reviewing a these controversial rules, among others, and agencies may be sending more rules over to OIRA in the coming days. After OIRA's review, agencies may still need to dot i's and cross t's making the November 1 deadline increasingly impractical.

The only conclusion one can draw from these circumstances is that the Bush administration will do what it wants, when it wants. Is anyone surprised?

OMB Watch Executive Director Gary Bass appeared on the Diane Rehm show today to discuss the issue of midnight regulations and President Bush's attempt to secure an administrative legacy. Listen to it here.

By now, most are aware that the Food and Drug Administration continues to assert that bisphenol-A, a chemical commonly found in plastics and food containers, is safe for humans despite the mountain of independent studies that say otherwise.

The Milwaukee Journal Sentinel continues to shed light on how and why FDA is able to maintain claims of safety. The FDA staff report on bisphenol-A safety is based on research sponsored by the plastics industry:

The newspaper reviewed the body of evidence that the task force considered. It found memos with entire sections blacked out, reviews commissioned by the American Plastics Council, an arm of the American Chemistry Council, and reviews completed by consulting firms with clients who have financial interests in the sale of bisphenol A. …

Much of the science that the task force considered was 20 years old or older, including a study commissioned in 1976.

A panel of independent experts is reviewing the FDA staff report and is expected to give its opinion later this month.

The panel will have the opportunity to expose the incredible flaws in FDA's research. However, as Reg•Watch blogged last week, the FDA-appointed chair of the panel has ties to an anti-regulatory zealot who is also convinced of bisphenol-A's safety.

Scientists cannot say with 100 percent certainty how bisphenol-A affects the body or what doses of the chemical are dangerous. However, nearly every study on bisphenol-A raises concerns. A recent study published in the Journal of the American Medical Association concludes human adults with high levels of bisphenol-A in their urine are at greater risk of heart disease and diabetes. The National Toxicology Program — which, like FDA, is an arm of the U.S. Department of Health and Human Services — "has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures."

Considering studies like those, FDA should provide at least some protection from bisphenol-A while gaps in the scientific literature are closed. Setting an exposure standard is essential to both human health and peace of mind.

The Bush administration is moving at warp speed to finalize a rule that will allow government-approved projects to intrude on the habitats of endangered species.

The Department of the Interior received about 300,000 public comments, mostly negative, on its proposal after it was unveiled in August. According to an internal email obtained by the Associated Press, Interior wants to review all the public comments in just four days:

In an e-mail last week to Fish and Wildlife managers across the country, Bryan Arroyo, the head of the agency's endangered species program, said the team would work eight hours a day starting Tuesday to the close of business on Friday to sort through the comments. …

At that rate, according to a [House Natural Resources Committee] aide's calculation, 6,250 comments would have to be reviewed every hour. That means that each member of the team would be reviewing at least seven comments each minute.

That gives each comment just enough time to slide across someone's desk, directly into the trash. Welcome to the federal rulemaking process, thanks for participating.

Interior Secretary Dirk Kempthorne instructed the agency to review all the comments this week, according to AP.

Kempthorne is obviously trying to hurry the rule out the door before President Bush himself is hurried out the door. A new president may not cotton to the idea of government-approved projects threatening endangered species.

Interior's proposal would allow federal land-use managers to approve projects like infrastructure creation, minerals extraction, or logging without consulting habitat managers and biological health experts responsible for species protection.

Allowing agencies to bypass expert scientific review for development projects runs counter to long-standing practices required by the Endangered Species Act. The act requires project managers to request from Interior "information whether any species which is listed or proposed to be listed may be present in the area" where construction will occur.

Kempthorne may be trying to comply with a deadline set by White House Chief of Staff Josh Bolten. In a May memo, Bolten instructed Bush administration agencies to finalize regulations by November 1.

But the endangered species rule has already violated other provisions in the memo. Bolten also instructed agencies to propose rules by June 1. (Probably so agency officials wouldn't be stuck reviewing hundreds of thousands of comments in just a few days.) The endangered species rule was not published until Aug. 15.

Other peculiarities have signaled Kempthorne's intent to ramrod this rule through the regulatory pipeline. Interior initially announced only a 30-day comment period. (Comment periods usually last 60 days; Interior extended the period to 60 days after public outcry.) Also, OMB's Office of Information and Regulatory Affairs — the White House office in charge of reviewing agency rules — spent only three days looking at the endangered species changes. OIRA's average review time for Interior Department rules in 2008 is 58 days.

So despite the overwhelming public opposition and the time constraints on the agency's ability to give this major policy shift careful consideration, Kempthorne will plow ahead. The rule would be a feather in Bush administration's cap; Bush's record on protecting endangered species is abysmal. Stay tuned to Reg•Watch for updates.

The Environmental Protection Agency exaggerates its penalties on polluters according to a new GAO report to be released later today, AP reports. GAO charges that EPA overstates its total penalty amounts by including fines that are never actually collected. From AP:

The levied fines in 2004, 2005 and 2006 included a total of $227.2 million in so-called default judgments. The agency admitted these hard-to-collect fines were larger in those years; GAO said they are unlikely to be collected.

It took a GAO report to uncover this problem because information on EPA penalties is not readily available to the public; and Bush administration officials would like to keep it that way. EPA's head of enforcement activities, Granta Nakayama, told GAO, "We do not believe that penalties collected should be publicly reported."

Instead, EPA reports when fines are levied. (It makes for better press releases when the agency announces it is cracking down on polluters.) So not only is EPA being disingenuous with the information it presents, it would prefer to withhold the really important information from the public.

The follow through is the key to meaningful deterrence. Industry needs to know it will be held, at the very least, financially accountable for violations of environmental laws. The public needs to know EPA is aggressively policing environmental scofflaws and that fines are finding their way into public coffers.

The picture GAO paints is part of a much larger body of work illustrating the Bush administration's poor record on environmental enforcement. Voluntary compliance and chummy cooperation have severed the long arm of the law. According to AP, "Fines levied against polluters by the EPA decreased from $240.6 million in 1998 to $137.7 million in 2007."

Update: Download the GAO report here

This morning Reg•Watch blogged about EPA's revision to the national air quality standard for lead. The new regulation is significantly better than the current standard which had not been revised since 1978.

But another part of the new regulation raised Reg•Watch's suspicion. Currently, the network EPA uses to monitor concentrations of airborne lead has some serious problems. According to Felicity Barringer at The New York Times, "Currently, 133 monitors are in operation nationwide, down from about 800 in 1980, an E.P.A. spokeswoman, Cathy Milbourn, said."

That's a problem because, after all, you can't enforce an air quality regulation if you don't know how much pollution is in the air. Recognizing this, EPA proposed some new requirements for monitoring lead particles suspended in the air.

In its proposed rule, released in May, EPA announced that it would set emissions thresholds as one criterion to determine whether monitoring is needed. The air around any facility emitting amounts of lead above the threshold would have to be monitored. EPA proposed a range for the threshold: 200 kg - 600 kg per year.

A draft of the final rule circulating among officials at EPA and OMB just days ago showed that EPA had settled on ½ ton per year as the final threshold. But the final rule, published yesterday, set the emissions threshold at 1 ton per year. What gives?

Well, the White House Office of Management and Budget may be responsible for the decision to water down the emissions threshold requirement. On Oct. 14, just one day before EPA administrator Stephen Johnson signed the final version of the rule, an EPA employee sent an email to an OMB employee saying, "[I]f OMB wants a 1 ton threshold, it would have to provide a rationale for that point of view."

The officials named in the email are the same who squared off during EPA's recent revision to the national standard for ozone, or smog: EPA deputy administrator Marcus Peacock and Susan Dudley, head of OMB's Office of Information and Regulatory Affairs.

Apparently, OMB was able to provide some kind of rationale that satisfied EPA. According to EPA estimates, the ½ ton threshold would have swept in about 259 lead polluting facilities while the 1 ton threshold will apply to 135 facilities. Reg•Watch is not well versed in air quality monitoring, but something sure smells fishy. Feel free to email with thoughts or insight.

Yesterday, the Environmental Protection Agency announced a new national air quality standard for lead which will lead to cleaner air and healthier children. EPA tightened the standard to 0.15 μg/m³ from the current level of 1.5 μg/m³. The standard has not been revised since it was first set in 1978.

The new standard is consistent with the advice of EPA staff and its scientific advisors who had called for a standard between 0.10 μg/m³ and 0.20 μg/m³.

Removing lead from gasoline went a long way in improving public health, but lead still poses a threat. It persists in the environment like the dickens. Lead can be especially dangerous for 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." Many environmentalists and children's health advocates are hailing EPA's decision.

For now, it looks as though EPA set the standard absent from any undue political influence. (The White House, perhaps acting on behalf of industry lobbyists, meddled with EPA's recently revised ozone standard.) Industry lobbyists were asking EPA to leave the lead standard alone or choose a much weaker option, but EPA resisted.

However, we cannot totally discount the prospects of White House or industry interference. One shortcoming of the rule concerns how compliance is determined. Currently, EPA looks at the concentration of lead in air everyday and averages those figures over a three-month period. If an area's average is more than the standard, the area is out of compliance. If the average is under the standard, everything is hunky dory.

EPA's science advisors want the agency to change this formula to calculate the average over a one-month period. This would better account for big spikes in emissions. In the current compliance system, two months of low emissions could attenuate emissions spikes in the third month. Subsequently, polluters may have an incentive to release lead emissions in bursts.

EPA's advisors say switching to a one-month averaging time would be more protective of those most sensitive to lead's effects (like children) who can be hurt by higher, albeit shorter, exposures. Irrespective of the level of the standard, shortening the averaging time effectively makes for a stricter regulation.

But EPA chose to continue averaging airborne lead concentrations over a three-month period. In a meeting with the battery recycling lobby, whose clients will face compliance with the stricter standards, a product defense firm gave White House officials a slide-show attacking the science EPA used as the basis for the new lead regulation. In the document, the firm attempts to undermine the scientific evidence that short-term exposures can be harmful. The firm even goes so far as to say, "A 1 month exposure will increase blood lead, but blood lead will decrease after the exposure ceases."

Was the product defense firm specifically lobbying the White House against a one-month averaging time? Did White House officials pressure EPA to adopt that view? We may never know. But we do know that continuing the three-month averaging time is not consistent with the advice of EPA's science advisors and is not as protective of public health as it could be.

Reg•Watch Update: "Did OMB Weaken EPA Efforts to Monitor Airborne Lead?"

On Tuesday, President Bush issued one of his infamous signing statements for a bill that will improve the independence of inspector general (IG) offices within the federal government. Since IG offices monitor efficiency, waste, and fraud in the government, but are also housed within the federal government, Congress saw fit to enact new measures to insulate IG offices from political pressures. (More on the bill here.)

Bush objects to a part of the bill that attempts to stem political interference in the work of IG offices. If administration officials find an IG particularly vexing, they can slash the IG's budget in order to reduce their capacity to uncover government fraud and waste. Since the budget process is not transparent, the administration can claim its request is all the IG needs — without revealing the intra-administration conflict.

The bill requires the president to include in his annual budget request to Congress a separate line item for each agency's IG. More importantly, it requires the president to submit the IG's original request for funds, that is, what each IG believes he or she needs to carry out the functions of the office.

In the signing statement, Bush basically makes the claim that the president can ignore this provision. He complains, "[T]he bill includes provisions that purport to direct or regulate the content of the President's budget submissions, including provisions that purport to direct the President to include the comments of Inspectors General with respect to those submissions."

Actually, upon Bush's signature, the bill does not "purport" anything. Bills passed by Congress and signed a president become law. They set rules and conditions of behavior for the government and society. Mr. Bush would do well to consult a dictionary for the meaning of both words.

Bush goes on to state, "The executive branch shall construe section 8 of the bill in a manner consistent with the President's constitutional authority to recommend for congressional consideration such measures as the President shall judge necessary and expedient."

Of note, the bill does not require the president or Congress to actually abide by the IG's request; it merely requires greater transparency so that Congress and the public have access an important bit of government information. As it is, nothing in the bill impedes a president's ability to carry out any function.

Luckily for inspectors general, and for the prospects of good governance, Bush won't be submitting any more budget requests to Congress.

Over the weekend, the Milwaukee Journal-Sentinel broke the news that the head of an FDA advisory panel studying the safety of the chemical bisphenol-A (BPA) has ties to an "anti-regulation activist" who happens to think BPA is perfectly safe.

The activist and retiree from the manufacturing industry, Charles Gelman, was "once labeled the second worst polluter in Michigan by the state's Department of Natural Resources," according to the Journal-Sentinel. Gelman donated $5 million to the University of Michigan Risk Science Center which is headed by Martin Philbert. Philbert is also the chair of the FDA Science Board's subcommittee on BPA.

That committee is preparing to release its opinion on the safety of BPA, a chemical used in hard plastics and in the lining of food cans. The committee's recommendation could affect FDA's decision to limit BPA in consumer products or its decision not to regulate at all.

Currently, FDA says BPA is safe at levels to which humans are exposed. But that opinion has been marred by its own controversy. FDA is relying on two flawed studies, according to the House Energy and Commerce Committee: [I]t appears that the Food and Drug Administration's position on BPA's safety is entirely dependent on two studies, both of which are funded by the American Plastics Council, and one of which has not been published or peer-reviewed."

The lion's share of scientific literature would move FDA toward a finding that BPA is not safe, according to The Washington Post: "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."

But even after JAMA published a new study finding evidence of harm in humans exposed to BPA (which was first presented in front of Philbert's committee), FDA officials continue to tell the public BPA is perfectly safe.

Philbert says Gelman has not, and will not, affect his decisionmaking. Gelman says he has told Philbert on multiple occasions that he believes BPA is safe. Philbert denies he and Gelman spoke on the matter.

He-said-he-saids are tough to settle, but the circumstantial evidence doesn't look good: Gelman made the contribution either shortly before or shortly after Philbert was named committee chair, according to the Journal-Sentinel.

Public health advocates had hoped the advisory panel's recommendation would provide clear cut advice that FDA would be pressured to follow. Three recent studies have raised additional flags about BPA's safety. Unfortunately, regardless of whether Philbert's judgment is colored, the panel's credibility is suffering.

FDA should have done a better job of weeding out this potential conflict. Philbert did not declare the donation when filing the requisite conflict-of-interest disclosure information, but FDA's response to the new scandal is just as pitiful as its vetting of him. From the Journal-Sentinel:

Norris Alderson, the FDA's associate commissioner of science, learned of the link from the Journal Sentinel. He looked into the matter and said he was satisfied there was no conflict of interest because Philbert's salary is not paid by the donation.

Considering Philbert is a founder and co-director of the now-flush-with-cash Risk Science Center, Alderson's claim is ridiculous.

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.