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Wednesday, January 30, 2008

FDA a "Hollow Government" Agency

Resource shortfalls at the Food and Drug Administration were the focus of a House panel hearing yesterday. The House Energy and Commmerce subcommittee on Investigations and Oversight heard from members of FDA's Science Advisory Board who recently completed a report titled, "FDA Science and Mission at Risk." Among other things, the report highlighted how funding and staffing have not kept pace with FDA's ever-growing responsibilities to ensure the safety of the nation's food and drug supply.

One member of the board, Gail Cassell, spoke of the glaring problems the board saw when preparing the report:

It became rapidly apparent that the FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities…Since every regulatory decision must be based upon the best available scientific evidence in order to protect the public's health, we concluded that American lives are at risk and that there is an urgent need to address the deficiencies.

But both members and witnesses recurrently brought the conversation back to resources. Another member of the board, Peter Barton Hutt, argued scientific problems at the agency cannot be fixed without an infusion of cash and an increase in staff:

The accumulating unfunded statutory responsibilities imposed on FDA, the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for premarket review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates — coupled with chronic underfunding by Congress — have conspired to place demands upon the scientific base of the agency that far exceed its capacity to respond. FDA has become a paradigmatic example of the "hollow government" syndrome — an agency with expanded responsibilities, stagnant resources, and the consequent inability to implement or enforce its statutory mandates.

Hutt called on Congress to double appropriations to FDA over the next two years and called on FDA to use that money to increase employment by 50 percent.

FDA Commissioner Andrew von Eschenbach also testified. Subcommittee chairman Bart Stupak (D-MI) pressed the commissioner on whether the president would be asking for an increase in funds for the agency when he releases his FY 2009 budget request next week. Von Eschenbach said he had asked for an increase in funding for his agency but could not comment on the president's budget before its release.



Posted by Matt Madia, 11:05:49 AM



Tuesday, January 29, 2008

Minnesota Pesticide Rule Weakened after Industry Meetings

A recent article from the Minneapolis Star Tribune reminds us industry meddling in the regulatory process is not solely a federal problem, it is occurring at the state level as well:

After three years of research, [Minnesota] was ready to impose the nation's first water-quality limit for acetochlor, a potent farm chemical that was washing into rivers and lakes.

But after hearing from scientists from agribusiness giants Monsanto and Dow AgroSciences, the Minnesota Pollution Control Agency (MPCA) decided to allow more than twice the concentration of the chemical in rivers than it had originally proposed.

As a result, three of five rivers that the state had previously classified as "impaired" by acetochlor, including a popular trout stream in southeastern Minnesota, will no longer be considered polluted.

The whole thing sounds pretty fishy. MPCA was prepared to set a standard of 1.7 parts per billion for the chemical, but, after the agriculture industry representatives presented published studies the agency had not reviewed during the decision making process, MPCA weakened the standard to 3.6 parts per billion.

A former MPCA staffer "said he is baffled that the state would spend years of research preparing to establish an official standard of 1.7 parts per billion, and then change its mind in the space of a few weeks," according to the article.

Controversies like this one may become more common as more states push for progressive environmental policy to make up for the federal government's failures. Hopefully, industry influence will not succeed in derailing state efforts as it has federal regulation.

(Thanks to Center for Science in the Public Interest for pointing this story out.)



Posted by Matt Madia, 02:35:16 PM



Friday, January 25, 2008

House Members Begin Investigation of Plastics Chemical

Last week, the House Energy and Commerce Committee began an investigation into the use and federal regulation of bisphenol-A (BPA), a chemical commonly found in a host of consumer products including CDs and baby bottles.

Reps. John Dingell (D-MI) and Bart Stupak (D-MI) wrote to seven manufacturers of infant products inquiring as to the chemical's use:

We have learned that BPA may be contained in the material used to line cans that contain infant formula and that BPA from this lining may leach into the formula itself, thereby exposing babies to BPA. We are interested to know how often BPA is used in such lining, whether the companies that produce the infant formula are aware that BPA is being used in this manner, and if they have tested their product for the presence of BPA.

The committee members also wrote to FDA Commissioner Andrew von Eschenbach asking about FDA's recent determination that BPA is not currently a safety concern and, therefore, not worth regulating:

On what studies is FDA basing the claim that there is no "safety concern at the current exposure level"? If FDA is relying on published studies, please provide us with the scientific citations from any studies used by FDA in making this determination.

The committee's oversight is welcome in light of recent evidence that another BPA study — this one conducted by the National Toxicology Program — gave improper weight to scientific studies sponsored by chemical makers. The study called the chemical's risks "negligible" — a conclusion which could undermine the argument in favor of BPA regulation. The National Toxicology Program has since announced it will conduct a thorough review of the study.



Posted by Matt Madia, 10:57:50 AM



Thursday, January 24, 2008

EPA Staff Advised Johnson Against Denying California

Yesterday, Reg•Watch blogged about EPA's refusal to release background documents on its decision to deny California's attempt to regulate greenhouse gas emissions from vehicles. EPA rattled off several lame excuses for withholding the information from the public.

Details of those documents are beginning to surface. As expected, they show that EPA staff advised Administrator Stephen Johnson to grant California's request and instructed him that, if EPA blocked California from enacting its own regulations, the agency would likely lose in litigation.

Yesterday, the Senate Environment and Public Works Committee, headed by Sen. Barbara Boxer (D-CA), released the information, though not the actual documents. According to BNA news service (subscription), "EPA allowed committee staff to look at three different versions of the October PowerPoint presentation during a meeting Jan. 22. Three staff members were given five hours to review the three versions, according to the committee. They were not allowed to make copies."

We're not talking about nuclear launch codes or classified intelligence here. This information should not be shared solely with Congress. The American people have a right to know exactly why their government is preventing states from curbing greenhouse gas emissions from vehicles.

Johnson is scheduled to appear before Boxer's committee today at 10:00 am. The hearing is scheduled to be broadcast on C-SPAN.

Posted by Matt Madia, 10:03:56 AM



Wednesday, January 23, 2008

Americans Is Too Dumb to Understand Enviromint

On Jan. 10, overcome by optimism and naiveté, Reg•Watch declared that Americans may get answers about who was responsible for EPA's decision to deny California's efforts to regulate greenhouse gas emissions from vehicles. Reg•Watch has now been properly grounded, as EPA has refused to turn over any pertinent information, citing a host of bogus excuses.

A statement by EPA's general counsel instructing agency staff to turn over all communications related to the decision engendered the false optimism. Instead, EPA will provide little to the public, for fear of violating "Executive Branch confidentiality" or creating a "chilling effect" among agency staff if their opinions "were to be disclosed in a broad setting."

(Apparently, the only chilling effect EPA is interested in creating is the one that may occur if greenhouse gases wind up causing a disruption in the Gulf Stream and turn the northeast into an arctic mess.)

But that's nothing compared to EPA's most ridiculous excuse for not fully turning over information: "Further disclosure could result in needless public confusion about the Administrator's decision that EPA will be denying California's request."

This excuse isn't surprising from an administration that has consistently adopted a Bush-and-Cheney-know-best attitude to government decision making — but that doesn't make it any less insulting.



Posted by Matt Madia, 10:50:49 AM



Friday, January 18, 2008

The Price of Regulatory Delay

The nonprofit group Environmental Defense has released a new analysis showing that a one-year delay in the implementation of a diesel emissions reduction rule could result in 1,400 premature deaths, 3,000 heart attacks, and 24,000 asthma attacks.

The regulatory process is often slowed to a halt under the weight of analytical burdens and political pressure from top agency officials or the White House. Environmental Defense's analysis proves regulatory delay is not just a government management issue — it's a public health issue.

According to Environmental Defense, the rule has been in development since at least 2004:

In 2004, EPA announced plans to put in place new standards for the nation's fleet of diesel locomotives and ships by mid-2006, but missed the deadline. In March 2007, EPA Administrator Stephen Johnson issued draft federal standards that would reduce particulate pollution and smog-forming nitrogen oxides from each engine by 80 percent or greater when fully phased in.

The analysis uses EPA's own data to prove that implementing the rule in 2008 would yield substantially greater public health benefits than implementing the rule in 2009. (See Environmental Defense's PowerPoint slides for side-by-side comparisons.)

EPA plans to issue the final rule in March. However, the rule is currently being reviewed by the White House Office of Information and Regulatory Affairs which could water down the regulation or impose further delay if it so chooses.



Posted by Matt Madia, 10:55:16 AM



Thursday, January 17, 2008

The Bush Administration's Attacks on State Law

In a new article written for the American Constitution Society, Georgetown law professor David Vladeck examines a toubling yet underreported tactic the Bush administration has been using to undermine public health and safety protections: federal preemption of state tort claims.

Federal agencies are responsible for enforcing the positive law enacted by Congress. However, even when positive laws and regulations work, citizens must have an opportunity to seek legal redress if they are harmed by a product. Tort law provides that opportunity by allowing citizens to seek damages from the makers of those products.

The Bush administration is consistently conflating these two types of laws. In the article, "The Emerging Threat of Regulatory Preemption," Vladeck goes over several case examples in which federal agencies have written regulations that they claim "preempts" state tort law, thereby making it impossible for citizens to seek damages on products regulated by the federal government.

Preemption language has been included in all sorts of product safety regulations that cover everything from cars to mattresses. One FDA regulation preempts damage claims if a drug maker fails to warn consumers of a certain risk, so long as the drug has received FDA approval. In addition to robbing consumers of their right to sue, drug makers would have no motivation for monitoring the safety of their drugs after FDA approval.

Why would the Bush administration engage in such a broad attack on state law? One reason, Vladeck argues, is to help industry allies:

[T]here have been repeated charges that the regulators implementing this pro-preemption campaign have deep ties to the industries that will benefit. For example, the architect of the Food and Drug Administration's new preemption position is a partner at a major law firm where he specializes in representing drug companies regulated by the FDA — the very companies that benefit from the agency's new pro-preemption position.

As if the public health and safety ramifications of the campaign to render state law impotent was not enough, the administration is implementing these policies surreptitiously and undemocratically:

[A]gency decisions to extinguish common law remedies are not made in a transparent way. Agencies simply announce their conclusions in preambles, which are lengthy and jargon-filled explanations of agency regulatory action. Agencies do not go through notice and comment rulemaking to formulate their positions…Nor do agencies…provide states and local governments with notice and an opportunity to participate in any proceeding that may affect state and local law.

Read Vladeck's article here.



Posted by Matt Madia, 04:16:56 PM



Tuesday, January 15, 2008

FDA Backs Meat and Milk from Clones; Where's USDA?

The Washington Post has obtained a copy of an FDA risk assessment that endorses the safety of food from cloned cattle, pigs, and goats. The assessment, long expected, comes on the heels of a European Union draft scientific opinion which came to similar conclusions. The Post has a summary of and excerpts from the risk assessment and background on the issue in an article published today.

Usually a risk assessment is an early stage of the regulatory process that informs officials responsible for making the ultimate decision. But in this case, the federal government does not need to regulate to allow food production from clones because there is currently a "voluntary moratorium," according to the Post. With FDA's endorsement, the agricultural industry may move more quickly with food production stemming from cloned animals.

According to the Post, FDA will be monitoring cloned animals should production increase:

Looking ahead, the report says FDA is collaborating with veterinary and scientific organizations, notably the International Embryo Transfer Society, to create a database on the health of new clones, which will help the agency track the field as the industry grows.

As the debate on cloned animals will surely continue, FDA should make this information publicly available.

Interestingly, neither the article nor the selected excerpts from the risk assessment mention USDA, the federal body in charge of monitoring and inspecting livestock and regulating meat products. Maybe it is more appropriate for FDA to conduct the risk assessment, but the continued safety of the nation's supply will depend on the work of inspectors in the field. Hopefully, FDA consulted USDA.



Posted by Matt Madia, 10:08:11 AM



Friday, January 11, 2008

Hong Kong's Equitable Approach to Pollution Control

Yesterday, The New York Times published an article on new electricity producer regulations in Hong Kong which would tie electricity prices to a producer's emission levels:

The 10-year agreement reached this week between the Hong Kong government and the territory's two companies — Hong Kong Electric and CLP — authorizes the companies to charge electricity rates that will give them a 9.99 percent return on assets.

If either company exceeds regulatory limits for any pollutant, however, it would be required to charge customers less, reducing its allowed rate of return by 0.2 to 0.4 percentage point.

If the companies manage to cut their pollution more than required, then they are allowed to raise prices to the point where they effectively earn bonuses of 0.05 to 0.1 percentage point on their rate of return.

Like most pollution regulations in the U.S., this one creates an economic incentive for industry to comply. But the U.S. usually uses government-imposed financial penalties or, in the case of sulfur dioxide (and possibly greenhouse gases in the future), a cap-and-trade system.

In those regulatory schemes, polluters wind up paying the federal government. In Hong Kong, polluters would be penalized by having their revenue reduced when prices are lowered. This puts money directly back into the pockets of consumers. When electricity producers meet or exceed compliance requirements, consumers pay a little more.

Here's the interesting part: In the U.S., when the federal government collects fines Americans benefit in the form of improved government services, lower taxes, or both; but those benefits may not be realized for years and the average person likely would not even notice them.

Moreover, if a government-imposed fine leads to lower taxes, that disproportionately benefits the top 50 percent of income earners (who contribute 97 percent of tax revenue). In Hong Kong's scheme, the money goes back to all consumers based on consumption levels, which would disproportionately improve the marginal utility of low-income earners.

Oh yeah, and those low-income earners, they're the ones disproportionately affected by pollution in the first place.

When producers are in compliance with the regulations, consumers — regardless of wealth status — pay a little more for the benefits of cleaner air and water.

Reg•Watch isn't sure this would ever work in the U.S., but it could be a more equitable alternative to the kinds of regulations we usually turn to.



Posted by Matt Madia, 04:40:45 PM



Questions for the Year Ahead: Regulatory Policy Outlook for 2008

As Reg•Watch mentioned last week, in 2007, new regulatory policies and the inability of federal agencies to protect the public made headlines more so than at any time in recent memory. Newspapers continually ran stories on White House interference, unsafe imports, and new hazards being ignored by government despite scientific evidence imploring regulation.

In 2007, Americans became trenchantly aware of the positive role government can play and the consequences that can be wrought when regulatory protections break down. But 2007 may have only been the beginning of a new chapter in American domestic policy. Many problems have been identified, but few have been solved. Dangerous imports, workplace hazards and environmental degradation may dominate headlines to an even greater extent in 2008.

But will mounting evidence be enough to tip the scales in favor of regulation in the face of the Bush administration's obstructionist policies? Federal agencies like EPA and OSHA may continue to drag their feet on issues such as diacetyl exposure (which threatens workers and consumers exposed to the artificial butter flavoring in microwave popcorn) and greenhouse gas emissions, and the White House will likely continue to meddle with agency regulations and may find new ways to enact even more damaging systemic changes.

Will a Democratically controlled Congress be able to move with the force necessary to pass new laws that respond to public needs? Despite the increased attention given to resource shortfalls at agencies like the Consumer Product Safety Commission and FDA, Congress has been unable to approve appropriations bills that would make funding and staffing at those agencies commensurate with regulatory responsibility. Legislative measures, like those to improve import safety or reform our nation's energy policy, are constructive but have gained little traction in a Congress seemingly without a sense of national priorities — a Congress which prefers partisan bickering to positive governing.

Most importantly, will the public continue to look to government to play a positive role in society? If regulatory failures do indeed continue through 2008 and beyond, will the public succeed in imploring government intervention where circumstance has not? If our leaders continue to disregard science, govern on the cheap, and make politics a higher priority than policy, the public must hold those leaders accountable and demand change.



Posted by Matt Madia, 04:09:19 PM



Thursday, January 10, 2008

AG Wants Answers: Was the White House Involved in the California Waiver Denial?

Today, Sen. Barbara Boxer (D-CA), in her role as chairwoman of the Senate Environment and Public Works Committee, held a field hearing in Los Angeles on EPA's recent decision to block state action on greenhouse gas emissions. At least 17 states are seeking to adopt vehicle emission regulations to reduce emissions.

California's attorney general, Gerry Brown, spoke at the hearing. Brown exhaustively rebuts the arguments EPA Administrator Stephen Johnson gave in denying the state's request. In one part of his written testimony, Brown counters the ridiculous notion (like Reg•Watch does here) that allowing states to regulate greenhouse gases would create multiple regulatory schemes with which automakers would have to comply:

Echoing the automobile industry's Washington, D.C. lobbyists, Administrator Johnson's letter claims that allowing California's regulation would lead to a "confusing patchwork of state rules." In fact, there is no "patchwork." Congress long ago gave other states only two choices: to stick with federal standards or adopt California's standards "identically."

Brown also questions whether Johnson is solely responsible for the decision:

Aside from requiring Mr. Johnson and EPA to provide sworn testimony and to produce all relevant documents, I urge you to question him about his contacts with the White House staff and his meetings with automobile industry executives and the White House. We have probably all seen the press accounts describing the auto executives direct appeal to Vice President Cheney. EPA staffers told the LA Times that Johnson "made his decision" only after Cheney met with the executives. On multiple occasions in October and November, Cheney and White House staff members are said to have met with industry executives, including the CEOs of Ford Motor Co. and Chrysler. We have a right to know what happened at those meetings, who was there, and what was said. Was Administrator Johnson acting on the Administration's directives when he denied California's waiver request?

Brown may just get answers to his closing quiestion. EPA's general counsel has instructed agency staff to turn over all documents surrounding Johnson's decision, including communications with the White House.



Posted by Matt Madia, 05:33:40 PM



Plastics Chemical Report to Go under the Microscope

The National Toxicology Program (NTP) will conduct a thorough review of a controversial assessment of the health effects of bisphenol-A, a chemical commonly found in a host of consumer products including CDs and baby bottles. NTP will give the report "unprecedented scrutiny," according to The Milwaukee Journal-Sentinel.

NTP's reproductive health panel released the report, which was roundly criticized by scientists and environmental advocates, last August . The report came on the heels of a National Institutes of Health study which found health problems in newborn animals exposed to bisphenol-A.

Critics complained NTP had relied on industry-funded science which downplayed the negative effects of bisphenol-A. The panel called the chemical's risks "negligible" — a conclusion which could undermine the argument in favor of bisphenol-A regulation. In December, a Journal-Sentinel investigation confirmed those complaints.

The Journal-Sentinel found the panel "gave more weight to industry-funded studies and more leeway to industry-funded researchers." In one case, "The panel accepted a Korean study translated by the chemical industry's trade group that found bisphenol A to be safe."

The report's authors conveniently omitted other studies which concluded bisphenol-A does pose a health risk: "The newspaper found that the panel missed dozens of studies publicly available that the newspaper found online using a medical research Internet search engine."

The panel's report has been the object of controversy for some time. Last March, OMB Watch reported on Sciences International, a contractor with ties to the plastics industry which had been hired by NTP to prepare the report. After it was alleged Sciences International's conflict of interest had led to suspect scientific research, their contract was terminated.

Stay tuned to Reg•Watch for more.



Posted by Matt Madia, 01:48:27 PM



Thursday, January 03, 2008

States Turn to Courts to Allow GHG Regulation

Yesterday, 16 states sued the U.S. Environmental Protection Agency (EPA) over its refusal to allow California to implement a program for reducing greenhouse gas emissions from vehicles. Had EPA granted California permission, the other 15 states in the suit would have adopted the California program.

EPA administrator Stephen Johnson denied California's request on Dec. 19. Johnson claimed California's proposed program is unnecessary in light of a recent federal law which would tighten the national fuel economy standard and that a federal regulation is preferable to a "confusing patchwork of state rules."

Johnson's argument is bogus. Had EPA approved California's request, other states could have adopted California's program (not created their own willy-nilly). The presence of two policies is neither confusing nor a patchwork. Furthermore, the Clean Air Act (not to mention the Constitution) contains provisions affording states the opportunity to enact their own regulatory schemes even if they are stricter than federal standards.

EPA insiders have acknowledged Johnson's decision does not hold water and will likely be overturned in court. But, since federal lawsuits take months or years, the Bush administration will still achieve its goal: delaying any meaningful action on climate change for eight long years.

Some progress may occur in the short term if Congress moves swiftly with focused oversight hearings. Rep. Henry Waxman (D-CA), chairman of the House Oversight and Government Reform Committee, and Sen. Barbara Boxer (D-CA), chairwoman of the Senate Environment and Public Works Committee, have both requested EPA documents and communications related to Johnson's decision. EPA's general counsel has instructed agency personnel to provide said material, including any evidence of communications with the White House, according to the Associated Press.

Although congressional attention will alter policy, identifying who is responsible for the denial of the California's request will allow the public to hold the culprits accountable.



Posted by Matt Madia, 10:57:20 AM



Wednesday, January 02, 2008

A Year for Failure: Regulatory Policy News in 2007

In 2007, new regulatory policies and the inability of federal agencies to protect the public made headlines more so than at any time in recent memory. Four themes dominated regulatory policy in 2007: White House influence over agency rulemaking activity and discretion; the inability of the federal government to ensure the safety of imported goods; the influence of industry groups; and the Bush administration's refusal to regulate in the face of overwhelming scientific evidence.

Click on these links for a recap of 2007's highlights and lowlights:



Posted by Matt Madia, 01:45:47 PM




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