Today, President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. The law reauthorizes the Prescription Drug User Fee Act, an important source of funding for FDA, just in time to avoid agency layoffs. The law should also improve the ability of the agency to assure the safety of prescription drugs after they have been approved for the market.

For a description of the bill and a recap of the debate in Congress, see OMB Watch's analysis, "Congress Expands FDA User Fee Program, Reforms Drug Safety Process."

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Congress Hears Pleas for Expanded Authority and Resources at CPSC

New White House Guidelines Fit into Broad Attack on Federal Protections

Senate Reviews Agencies' Attempts to Preempt Congress and the States

Congress Expands FDA User Fee Program, Reforms Drug Safety Process

Earlier, Reg•Watch blogged about the concerted lobbying efforts of senior administration officials intent on killing an effort by the state of California to enact its own greenhouse gas reduction program. There are so many issues at stake here it's mind-boggling:

• Environmental Simply put, Waxman's investigation shows how the Department of Transportation, EPA, and White House Council on Environmental Quality (CEQ) tried to kill a program which would effect a major reduction in greenhouse gas emissions from vehicles. That's probably not in their respective mission statements.
• Industry influence As Reg•Watch mentioned earlier, the Department of Transportation was aided and abetted by the Auto Alliance in targeting certain congressmen. The Auto Alliance — comprised of Ford, GM, Toyota and others — has a big interest in making sure California and other states can't require tougher vehicle emissions standards.
• Federalism California's appeal for a waiver has always been a federalism issue. The Clean Air Act reserves the federal government's rights to regulate vehicle emissions, but also permits EPA to grant waivers for state programs. By delaying California's plan and rendering state regulators impotent, the administration is unfairly and unilaterally shifting power away from the states and to the federal government. The Bush administration ought to be more faithful to the principles of federalism upon which our nation was founded.
• Legal The Anti-Lobbying Act prohibits government personnel from lobbying Congress on proposed legislation. While administration officials may not have said "vote no" so explicitly, they did convey their opposition to the California waiver, and Congress is considering legislation that would force EPA to make a decision on the waiver. Moreover, Congress has the ultimate authority in initiating and overseeing agency regulatory activity through statute, so any opinion on a regulatory decision could be construed as lobbying. The Department of Justice does not apply the Anti-Lobbying Act to direct communications between agency personnel and legislators (only to "grassroots" lobbying) so don't hold your breath on legal action unless someone takes this to the courts.
• Resources and priorities Regardless of the legal question, this controversy raises significant concern over agency priorities and the use of resources. Couldn't Secretary Peters' and Chairman Connaughton's time be of better use elsewhere? More importantly, as Rep. Waxman says in his letter, "It is not an appropriate use of taxpayer dollars to organize a lobbying campaign to politicize this vital regulatory decision."

The Bush administration engaged in a broad, multi-agency effort to lobby congressmen and governors to urge them to oppose a California plan to reduce greenhouse gas emissions, according to a recent investigation.

In December 2005, California petitioned EPA to let the state develop its own program and standards for regulating greenhouse gas emissions from vehicles. Under the Clean Air Act, the federal government holds the express right to regulate emissions but may grant waivers to states, which it often does. If EPA grants California's waiver request, 11 other states could follow suit.

In June, EPA Administrator Stephen Johnson wrote California Governor Arnold Schwarzenegger stating EPA would make its decision by the end of 2007. That's two full years after the initial request.

Why so long? Since the Supreme Court decided in April greenhouse gases may be subject to regulation under the Clean Air Act, there is no basis for denying California's petition. Therefore, for an administration which holds environmental regulation in contempt, the only remaining choice is endless delay.

But apparently Johnson's obstinacy was not enough for the Bush administration. An investigation by the House Oversight and Government Reform Committee has revealed a coordinated effort to prevent California from pursuing its state regulations. The effort includes Johnson, Secretary of Transportation Mary Peters, and James Connaughton, the Chairman of the White House Council on Environmental Quality.

Committee Chairman Henry Waxman (D-CA) has written to Connaughton. The letter explains the full details of the campaign. Here are some highlights:

Mr. Gros, who was the Deputy Chief of Staff in the Transportation Department, provided details about how the lobbying campaign was conducted. He explained that five Department staffers contacted between 20 and 25 members of Congress. He also said that Secretary Peters personally called between two and four governors.

And this gem:

The lobbying campaign was coordinated with the auto industry. On June 5, the Auto Alliance provided a list of automotive facilities organized by congressional district to the Department. According to Mr. Gros, the Department then used this document to create a target list of members of Congress to lobby.

Waxman's committee should be commended for its investigation. It couldn't have been easy because, as always, senior administration officials suffer from selective memory loss:

[Council on Environmental Quality] Chief of Staff, Mr. Hall, was asked about the White House role when the Committee staff interviewed him. He did not confirm or deny White House involvement. He said he could not remember specifics. At least twenty times during the interview, he responded to questions about his knowledge of the lobbying campaign with variations of "I don't recall."

Reg•Watch Update: "More on the California Waiver Controversy"

Today, the White House issued a memo to the heads of federal agencies regarding risk assessments — a process by which agencies identify and evaluate risks such as toxic exposure or structural failure. Susan Dudley, head of OMB's Office of Information and Regulatory Affairs, and Sharon Hays, a senior official in the Office of Science and Technology Policy, issued the memo. The memo takes existing principles from a 1995 White House memo and includes additional text in order to place the Bush White House spin on each item.

In January, the National Research Council (NRC), a National Academy of Science, urged the White House to abandon its previous effort to manage federal risk assessments — the much-maligned "Proposed Risk Assessment Bulletin." The bulletin proposed scientifically questionable standards which would have governed the risk assessment process of all federal agencies.

Although the memo is an improvement on the proposed bulletin, and although — because it is not mandatory — it will not necessarily have a big impact on agency practices, the memo still marks an attempt by the White House to micromanage agency actions. One way the memo does this is by reaffirming existing OMB policies which diminish agency discretion.

• The memo reminds us that there are new requirements for agency "guidance documents" set out by the Good Guidance Practices Bulletin and amendments to Executive Order 12866. Apparently, the White House believes risk assessments (which are not just documents but entire processes) to be a form of guidance.
• For risk management, the memo consistently urges agencies to consult OMB Circular A-4, a document spelling out the process by which agencies prepare cost-benefit analyses for regulatory activities. Even in a memo on risk assessment, the White House reminds us of its penchant for making economics the primary consideration in rulemaking.
• The memo states, "The agency also should identify the sources of the underlying information … and the supporting data and models, so that the public can evaluate whether there may be some reason to question objectivity." While Reg•Watch is all for transparency and objectivity, this statement appears to be a thinly veiled attempt to promote Data Quality Act challenges (background on that here). DQA challenges are a favorite way of the White House and industry to delay regulation.

Like the proposed bulletin before it, the memo fails to identify a problem it seeks to correct. Federal agencies are full of individuals with vast expertise and experience. If there is some major problem with the conduct of risk assessments, Reg•Watch hasn't heard about it. The White House would be better off leaving expert discretion where it belongs — with the experts.

The White House Office of Information and Regulatory Affairs and the Office of Science and Technology Policy have issued a new memo on federal agency risk assessment practices. In 2006, the offices proposed a more detailed "bulletin" which public interest groups, lawmakers, and scientists roundly criticized. Today's memo acknowledges that bulletin has been withdrawn, and instead sets out broad principles.

Stay tuned to Reg•Watch for a fuller account of the memo later today.

Reg•Watch update: "White House Expands Micromanagement of Agency Activity"

The Sunday New York Times featured an article on the efforts of U.S. industry groups to push for federal regulation. As the article points out, this represents a marked shift in the traditional conception of industry's views on regulation. Historically, industry representatives often see regulation as costly and vexing.

A graphic in the article briefly summarizes 14 examples of new federal regulations supported by manufacturers or industry lobbyists.

In some cases, such as the toy industry, representatives appear to have good intentions. A recent hearing proves that industry representatives recognize the benefits associated with a strong federal regulatory regime.

Unfortunately, as with lead paint in toys and diacetyl in popcorn, even the combination of strong public and industry support (not to mention overwhelming health-based evidence) is not enough to prompt the Bush administration into action. As the article shows, agencies often don't act to regulate substances like lead and diacetyl despite support for doing so from industry lobbyists. Is this a sign senior administration officials' anti-government ideology trumps their industry loyalties?

In other cases, representatives may be employing a calculated strategy. Industry lobbyists may rather have product regulations written by the Bush administration (and edited by Bush's OMB) than by a future administration that may be less friendly. With the clock running down on Bush's second term, this may be the last opportunity for a middle-of-the-road regulatory approach.

The Sunday Times also featured two editorials (here and here) titled, "The Need for Regulation."

Be sure to check out the latest issue of our biweekly newsletter, The Watcher. Regulatory policy articles this time:

Federal Agencies Knew of Diacetyl Dangers and Kept Silent

Bush's Anti-Regulatory Ideology under Increasing Scrutiny

It's Industry vs. Consumers and Health Specialists in National Ozone Hearings

New Small Business Program Will Influence Agency Regulatory Reviews

An article in yesterday's New York Times describes how President Bush has started a flurry of 11th hour regulatory activity. Every president since John Adams has used the waning days of his presidency to issue executive edicts and final regulations in order to ensure his policy beliefs outlast his days in the White House.

The article mentions the environmentally damaging mountaintop mining rule the administration proposed last month (click here for details) as a precursor of things to come.

Reg•Watch is concerned Bush may be more effective at this than many of his predecessors. While presidents have spent the end of their terms pursuing individual policy goals, Bush appears to place just as high a priority on altering the policymaking system.

In January, Bush amended Executive Order 12866, Regulatory Planning and Review. The changes will further politicize the rulemaking process by giving senior officials unlimited reach into agency scientific and technical decisionmaking (as if they needed it). The changes also force agency guidance documents — i.e. policy statements and interpretive memos — through a White House review process.

The next year may bring more meddling in the cross-cutting policy by which agencies develop rules. Susan Dudley, the White House's regulatory czar, has indicated she will pursue finalization of OMB's Risk Assessment Bulletin. The Bulletin would create uniform and inflexible requirements for the preparation of agency risk assessments — the process by which agencies determine the severity of an environmental risk. Dudley would pursue the Bulletin despite the pleadings of Congress and the National Academies of Science.

And that's just what we know they're planning. The next 16 months could prove to be tumultuous.

The Senate is debating the nomination of Jim Nussle to be the director of the White House Office of Management and Budget. (Watch the debate on C-SPAN here.)

OMB Watch has issued a statement on Jim Nussle. Among other things, OMB Watch urges Nussle to "work toward ensuring greater transparency within the agencies and the White House and to stimulate public participation in the rulemaking process" and to "lead an OMB respectful of agencies' scientific and technical expertise and to focus on providing adequate resources rather than additional analytical burdens."

Read the OMB Watch statement here.

Reg•Watch Update: The Senate confirmed Nussle 69-24. (Roll call)