Yesterday, the House Science and Technology Committee subcommittee on Investigations and Oversight held a long-awaited second hearing on President Bush's recent changes to the regulatory process. Much of the hearing focused on the role of the Regulatory Policy Officer (RPO) — a position with newly enhanced responsibilities.

The changes state "no rulemaking shall commence" without the approval of the RPO. Steve Aitken, former acting administrator of the White House's Office of Information and Regulatory Affairs, told the panel that the Clinton administration had issued a dictate forbidding agencies to "issue" rulemakings without similar approval. Rep. Dana Rohrabacher (R-CA) latched on to this as reason to drop the whole case against the Bush administration.

Reg•Watch has checked its dictionary, and apparently "issue" and "commence" are two different verbs with two different meanings. Exactly when a rulemaking commences is unclear.

This kind of confusion begs the question: What transparency measures will be included in this process? Committee Chairman Brad Miller (D-NC) expressed legitimate concern that RPOs "can smother regulatory efforts in the crib before an agency can even begin considering a regulatory action."

In the hearing, OMB Watch Executive Director Gary Bass recommended several improvements in transparency. Though OMB Watch fully opposes the changes embodied in the new E.O. and Good Guidance Practices Bulletin, if they are to exist the American people should be allowed to see into the process. At the very most, Congress should act to nullify these changes. At the very least, it should shine more sunlight on the regulatory process.

Last night, the White House Office of Information and Regulatory Affairs (OIRA) issued a memo instructing agencies on how to implement President Bush's recent changes to the regulatory process. The memo was the first missive by newly minted OIRA administrator Susan Dudley.

On Jan. 18, the White House issued two documents changing aspects of the federal regulatory process and mandating agency guidance documents (memos, policy statements, etc) fall under OIRA review. If those documents were forms of guidance on guidance, yesterday's memo is guidance on the guidance on guidance.

Unfortunately, despite the plethora of guidance, many questions remain unanswered. For example, the E.O. states "no rulemaking shall commence" without the approval of agency Regulatory Policy Officers. OMB Watch has expressed concern this will allow RPOs to stifle regulations in their infancy because it is unclear when a rulemaking commences. Does a rulemaking commence when scientific testing on an issue begins, when a draft rule is published, or somewhere in between?

The memo fails to clarify this concern. It states: "As a general matter, a rulemaking commences when the agency has decided as an institutional matter that it will engage in a rulemaking."

Translation: A rulemaking commences when we say it commences.

As Reg•Watch blogged yesterday, the House Science and Technology Committee subcommittee on Investigations and Oversight will hold a hearing on President Bush's changes to the regulatory process. OMB Watch Executive Director Gary Bass will be testifying. Watch the hearing live starting at 10:00 a.m.

Not to be outdone by Alberto Gonzales, Stephen Johnson appeared before the Senate yesterday and achieved new levels of obstinacy.

The Senate Environment and Public Works Committee questioned Johnson, the administrator of EPA, about the Supreme Court's recent ruling affirming the agency can regulate carbon emissions under the Clean Air Act. The legislation instructs EPA to regulate harmful air pollutants.

The hearing started as a back and forth about the speed with which EPA would pursue regulation. Democrats want swift action and urged Johnson not to wait for potential greenhouse gas legislation. Johnson refused to commit to a timetable preferring to move with the Bush administration's usual sloth.

Things could have stymied there, but Johnson chose to antagonize the committee further by abandoning reasonable thought. Since the Clean Air Act only requires the regulation of emissions harmful to the public, EPA would not have to regulate if it determined carbon not to be harmful. But that would be a ludicrous notion, wouldn't it? The LA Times reports:

As to whether the EPA will regulate carbon emissions nationwide, Johnson said the agency must first determine whether greenhouse gas emissions endanger public health or welfare.

That remark drew criticism.

"Surely, you acknowledge that global warming does endanger public health," Sen. Joe Lieberman (I-Conn.) said.

Johnson refused to say whether he considered global warming the No. 1 environmental problem. That rankled Sen. Sheldon Whitehouse (D-R.I.).

"You astonish me," Whitehouse said.

Amen to that, Mr. Whitehouse.

Democrats want swifter EPA action on emissions standards [LA Times]

The EPA's Clean Air Scientific Advisory Committee (CASAC) is supposed to be a group of scientists who independently analyze standards for the implementation of the Clean Air Act. Those standards are integral in ensuring progressive air pollution limitations that embody the latest scientific and technological breakthroughs.

As Reg•Watch has reported, CASAC recently recommended tighter standards for smog, much to the chagrin of industry and EPA brass.

As though determined not to let that happen again, EPA has appointed to CASAC two members with industry ties. The new members will serve on the panel for nitrogen and sulfur oxides (NOx and SOx). The Center for Science in the Public Interest sums it up:

Ignoring protests from consumer watchdog groups, the EPA has appointed two conflicted scientists to the Clean Air Scientific Advisory Committee primary advisory panel that will evaluate NOx and SOx pollution. In January, CSPI wrote to the EPA opposing the nomination of Richard B. Schlesinger, who has received financial support from the American Petroleum Institute, and Christian Seigneur, who works for Air Quality Division at Atmospheric & Environmental Research (AER) Inc., which is funded by three organizations (API, the Electric Power Research Institute and the Health Effects Institute) that receive money from industries that have a direct financial interest in the committee's decisions. The final roster did exclude Roger McClellan, the New Mexico-based industry consultant whom clean air advocates also protested.

Advisors with ties to the power industry are grossly inappropriate for a panel charged with scientific recommendations on two greenhouse gases. It is not EPA's duty to include the views of industry in enforcing the Clean Air Act.

The Clean Air Act is one of our country's greatest environmental achievements in part because it was designed to stay one step ahead of pollutants and polluters. Standards are to be improved every five years and, according to the U.S. Supreme Court in Whitman v. American Trucking Association, cost and achievability are not to be considered. CASAC should be a place for unpolluted scientific thought.

Yesterday, the Senate Health, Education, Labor and Pensions Committee voted favorably to reauthorize the Prescription Drug User Fee Act (PDUFA). PDUFA allows FDA to collect money from the drug industry in order to pay for safety tests of new drugs. While this may sound like a good way for the government to raise funds, the money comes with strings attached. The drug industry, to some extent, dictates the timetable for drug approval.

PDUFA reauthorization is one part of the Food and Drug Administration Revitalization Act (S. 1082). Four Republicans and one independent joined all committee Democrats in voting to report the bill to the full Senate. If enacted in its current form, the legislation would:

• Reauthorize PDUFA for another five years. FDA will be able to collect more user fees from the drug industry, per the agency's recommendation.
• Allow FDA to review TV ads for new drugs (you know, the commercials that list a variety of unpleasant side effects). Some Republicans have raised First Amendment concerns in regard to this provision.
• Strengthen FDA's ability to monitor drug safety after the drugs reach the market.
• Reauthorize MDUFMA, a law similar to PDUFA but for medical devices instead of drugs.
• Create special provisions for the study of pediatric drugs and medical devices.
• Place medical marijuana under the regulatory purview of FDA. Sen. Tom Coburn (R-OK) added this provision as an amendment.

The bill will now move to the Senate floor. Bill cosponsor Ted Kennedy has also vowed the final bill will include language to allow FDA to approve generic drugs, a provision the drug industry adamantly opposes. The House is still developing its PDUFA reauthorization bill.

Author Rick Perlstein has an excellent opinion piece on TomPaine.com. He argues conservative values, specifically the idea of limited government, are responsible for the dwindling ability of the FDA to ensure the safety of the nation's food supply.

Perlstein argues that budget cuts are responsible for the FDA's inability to preempt contaminated food crises. When the FDA does act it is often too late, as it was with the recent peanut butter incident:

This was the system working as it is presently designed. Barn door: closed. Cow: already long gone. That, basically, is as good as it gets in the modern FDA.

The arguments in the column aren't all that surprising to me. (Conservative values have been making me sick for years.) But I do hope the idea of sticking up for big government flourishes.

America's character has long been one of progress and inclusion. Government ought to go to extraordinary lengths to ensure health, happiness, and opportunity for each and every one of its citizens. Conservatives have done a remarkable job tarnishing the reputation of government. It's time for the rest of us to get up off the mat. Big ideas need Big government, and Big government needs Big ideas. America deserves no less.

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

Recess Appointment Makes Dudley Head of White House Regulatory Policy Office

Courts Rebuke Bush Administration's Forest Actions

EPA Issues another Delay in Contaminant Regulation

Last week, the National Institutes of Health officially ended its relationship with Sciences International, a private consulting firm. As OMB Watch has reported, SI had essentially been managing an NIH group studying reproductive health. The consultant's research and summaries of a particular chemical, bisphenol A, exhibited industry bias. Subsequently, SI became the focal point of a controversy over scientific contractors and conflicts of interest.

Now, NIH will review all the work SI performed related to bisphenol A (The Washington Post reports ). This is a welcome step by NIH. Without such oversight, SI would have been able to affect scientific decisions through previously prepared documents despite having been fired.

EPA has once again delayed developing a standard for perchlorate in drinking water. Perchlorate, an ingredient in rocket fuel, can detrimentally effect the human hormonal system even in low doses.

Sen. Barbara Boxer, whose support for perchlorate regulation is unimpeachable, is perturbed with EPA's decision, or lack thereof. In a statement, Boxer said, "I am outraged that EPA has yet again refused to do its duty to protect the health of our families and communities from perchlorate pollution." For more info on the EPA decision, read NRDC's press release.

OMB Watch often criticizes the regulatory process for being too slow in responding to the public's needs. The process is muddied and subject to political interference. Perchlorate testing is a prime example of what we mean.

• 1998: EPA assesses perchlorate. Verdict: perchlorate bad.
• 1999 — 2002 : EPA assessment is peer reviewed. Verdict: perchlorate bad.
• 1999: EPA issues toothless interim guidance on perchlorate exposure.
• 2002: EPA's peer-reviewed assessment is reviewed by the Pentagon and EPA, allowing the agency to reach new heights in redundancy.
• 2003: EPA issues interim guidance about the 1999 interim guidance. (Again with the redundancy.)
• 2004: White House and Pentagon spend their time interfering in an upcoming NAS study on perchlorate.
• 2005: NAS releases study on perchlorate. Verdict: perchlorate bad.
• Yesterday: EPA decides not to regulate perchlorate citing the need for "additional investigation."

Once every five years, EPA is required by law to revise the national standards for ground-level ozone, a.k.a. smog. As the agency prepares its revisions, another scientific body has urged EPA to tighten the standard.

In a letter to EPA administrator Stephen Johnson, a group of 111 medical scientists called for tighter rules on smog, according to BNA news service (subscription). The scientists point out the current standard allows exposures which can cause serious adverse health effects.

This group of scientists joins two EPA science panels — the Children's Health Protection Advisory Committee and the Clean Air Scientific Advisory Committee — in recommending tighter standards. Considering the obvious consensus, EPA should revise the national smog standards to reflect the scientific recommendations. EPA's final decision is due in early 2008.

FDA's ability to monitor and ensure the safety of drugs and medical devices after they appear on the market has been the subject of great scrutiny lately. As OMB Watch has reported, Congress and others have been critical of the agency for failing to conduct post-market safety studies.

There are plenty of ideas for how the agency can improve their practices. Legislation is floating on Capitol Hill to beef up FDA funding and authority.

Today, with the realization that those solutions are months off, FDA took a good step to improve the process in the near term. FDA has launched a webpage where the public can monitor the progress of post-market studies on medical devices. This is certain to hold the FDA more accountable to the American people. It also improves the transparency of the agency's actions which are often criticized for being too subject to industry influence. Reg•Watch hopes FDA expands this transparency to post-market studies on drugs as well.

Susan Dudley's recess appointment is the subject of editorials in this morning's Washington Post, New York Times and Wall Street Journal. Let's compare and contrast.

Read the rest of this entry

Posted by Matt Madia, 10:54:30 AM

Thursday, April 05, 2007

Wednesday, April 04, 2007

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

OMB Manipulated Climate Science, Report Says

Miners Detail MSHA's Failings in Emotional Testimony

FDA Issues New Conflict of Interest Guidelines

Monday, April 02, 2007