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

The House has passed the Popcorn Workers Lung Disease Prevention Act (H.R. 2693) in a 260-154 vote (roll call). The legislation would force the Occupational Safety and Health Administration to issue an interim standard on diacetyl exposure within 90 days of the law's enactment. Then, within two years of the law's enactment, OSHA would have to issue a final standard.

A standard is necessary because exposure to diacetyl — a common ingredient in the butter flavoring found in popcorn — can cause bronchiolitis obliterans, a debilitating and sometimes fatal lung disease. The standard would protect factory workers who are exposed to the chemical because they are particularly susceptible to the adverse effects.

The legislation is necessary because OSHA doesn't set standards on its own. Despite a $17 million budget and a staff of 83, OSHA's standard-setting program set only four standards in 2006 and expects to set only three in 2007. OSHA under the Bush administration has set only one significant standard (for hexavalent chromium), and that was as a result of a court order.

The legislation is supported by unions, scientists, doctors and occupational health experts. It also has broad support from industry groups who recognize the need to protect their employees.

President Bush and OSHA both oppose the bill. They claim OSHA has already initiated a rulemaking on diacetyl exposure (they did it yesterday) and that the agency needs more time to study diacetyl's effects in order to develop a fully protective standard.

Simply put, that argument is garbage. The legislation mandates an immediate interim standard (if President Bush needs a definition of "interim," he can find it here) and then gives the agency plenty of time to develop a final rule which will follow the regular notice-and-comment rulemaking process. This two-step plan gives workers at least a modicum of protection in the short term while long-term strategies can be developed.

Bush has issued a statement voicing "strong opposition" to the bill but has not threatened a veto. No word yet on a senate version. Stay tuned to Reg•Watch for updates.

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 House and Senate have both passed the final version of the PDUFA reauthorization/FDA reform bill. The bill now goes to the White House where the president is sure to sign it. The Pump Handle blog has all the details on the final version: "Congress's FDA Bill Includes Reforms"

In June, OMB Watch reported on EPA's new risk assessment program for endocrine disruptors. An endocrine disruptor is any substance which alters the function of the endocrine system. The endocrine system regulates certain mood, growth and development functions including hormonal and thyroid functions.

Scientists are still uncertain as to the types of substances which may be endocrine disruptors and the levels of exposure that may jeopardize public health. Scientists suspect endocrine disruptors to be commonly found in a number of consumer products including pesticides, cosmetics and finished plastics.

In 1996, Congress passed the Food Quality Protection Act (FQPA), which requires EPA to screen the effects of pesticides on the human endocrine system. Since then, EPA has done…well…nothing.

Congress is pressing EPA on the issue. Today, seven representatives wrote to EPA Administrator Stephen Johnson expressing their displeasure with the inexplicable delay:

Over the past ten years, EPA has not completed a single step of this multi-stage process. This summer, the agency finally published its first draft list of chemicals to be screened by pesticide manufacturers for endocrine disrupting properties. This initial list of 73 chemicals is only a small fraction of the universe of 1,700 chemicals that the agency has identified for screening under the FQPA mandate, and a minute percentage of the 75,000 chemicals currently listed on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. EPA apparently has no internal deadline for identifying subsequent sets of chemicals for testing, and no plan whatsoever for ensuring that all chemicals of potential concern will be tested.

Yesterday, a subcommittee of the House Judiciary Committee unanimously approved a bill (H.R. 3564) which would reauthorize the Administrative Conference of the United States (ACUS) through FY 2011. Congress initially formed ACUS in the 1960's, but vanquished it in the mid 1990's as part of the Newt Gingrich-led effort to reduce government. Reps. Chris Cannon (R-UT) and Linda Sanchez (D-CA) are pushing the bill.

ACUS was a panel of administrative law experts. (Supreme Court Justices Antonin Scalia and Stephen Breyer have both served at ACUS.) ACUS studied the federal rulemaking process and other operations of federal agencies. The panel took long-term views and made recommendations on improved performance.

Improvements identified by ACUS can allow agencies to be more responsive to public need and can save taxpayers money through increased efficiency. According to the National Journal (subscription), "Sanchez said the bill was 'an extremely nominal investment [that] will unquestionably rebound in billions [of dollars] in savings in taxpayer dollars.' "

Technically, ACUS already exists. 2004 legislation reauthorized the panel. Unfortunately, since then, Congress has not funded it, making it impossible for ACUS to have employees, office space, pens, binder clips, etc...

Sanchez and Cannon hope to get ACUS up and running in a hurry. They will attempt to add a $1 million start-up appropriation to the FY 2008 (which begins Oct. 1) Financial Services and General Government Appropriations bill. That bill has already passed the House, but not the Senate. Sanchez says she hopes to add the minor provision when the two chambers form a conference to reconcile the two bills, according to BNA news service (subscription).

The full Judiciary Committee will consider the bill in the near future. No word yet on a Senate version.

In today's Washington Post, columnist Dana Milbank reports on yesterday's Senate hearing on toy safety and the Consumer Product Safety Commission's role in assuring it. The hearing, held by an appropriations subcommittee responsible for approving CPSC's budget, featured testimony from Nancy Nord, acting chairman of the commission.

CPSC has been under increasing scrutiny for failing to protect American children from the dangers of lead paint in toys — by no means a newly discovered threat. While most of the tainted products have come from China, the string of recalls has left many Americans wondering why our strong regulatory system is being circumvented by shoddy foreign manufacturing.

Milbank characterizes Nord as evasive and smug and the panel's senators as confounded by the idea our federal regulatory protectors could operate with such complete and utter ineffectiveness.

Of course, as Durbin recognized in the hearing, the agency is not wholly to blame for its troubles. Congress and the White House have slowly let the agency fall into a state of disrepair. Milbank includes a summary of some startling statistics:

Among the nuggets served up at yesterday's hearing: The CPSC's staff, once 978, is down to 401; its budget is half of what it was three decades ago, in inflation-adjusted terms; its toy-testing department consists of one man, Bob, who drops toys on the floor in his office; and its toy-testing lab is an overloaded workbench in its outmoded headquarters.

Another panel of witnesses included Mattel chairman Robert Eckert. Some of Eckert's recent comments in the wake of massive recalls of Mattel products indicate he does not believe federal consumer product laws apply to his company. (See the Sept. 5 post, "Is Barbie above the Law?")

Refreshingly, Eckert was contrite for the dangers posed by Mattel's now-recalled products and expressed full-throated support for a strong and well-resourced CPSC. Unfortunately, none of the Senators pressed Eckert on his comments. It is still unclear if Mattel violated federal law by failing to report potential product defects in a timely manner.

Yesterday, Reg•Watch blogged about Congress's FDA reform bill which has passed the House and the Senate but is now stuck in a conference committee charged with reconciling the two versions.

One important provision contained in the House bill, but not in the Senate version, would reduce conflicts of interest on FDA advisory panels. Those panels make important recommendations about the safety of prescription drugs, among other things. However, FDA is often criticized for letting individuals with ties to the pharmaceutical industry serve on the panels. The provision in the House bill would allow only one conflicted member serve on each panel.

Sen. Dick Durbin (D-IL) offered a similar provision as an amendment to the Senate version. Unfortunately, it was not added to the bill because the vote on the amendment was a 47-47 tie.

Two of the senators who voted against Durbin's amendment, Ted Kennedy (D-MA) and Chris Dodd (D-CT), are now serving on the conference committee and will soon work with House members to decide whether the bill Congress sends to the president will contain the conflict-of-interest provision or not.

Now, the heat is on Kennedy and Dodd to make the right call and support the provision. According to the Center for Science and the Public Interest (CSPI):

nine prominent physicians, including two former editors of the New England Journal of Medicine, are calling on Senators Edward M. Kennedy and Christopher J. Dodd to limit the number of industry-connected scientists who may serve on Food and Drug Administration advisory panels.

The letter is available on CSPI's website. Stay tuned to Reg•Watch for updates on this provision and the overall FDA reform bill.

Sens. Ted Kennedy (D-MA) and Patty Murray (D-WA) have written to the FDA and the Centers for Disease Control and Prevention (CDC) expressing their concern over diacetyl exposure and asking the agencies to take action. (More from the Pump Handle blog here.)

The federal government, the popcorn industry and public and occupational health advocates have known for some time that exposure to diacetyl — a chemical used to give microwave popcorn its buttery flavor — can cause severe lung problems for workers in the popcorn manufacturing industry.

Recent evidence shows the presence of diacetyl in microwave popcorn may also pose a danger to consumers. The news has thrust the issue back into the national spotlight. No word yet on how FDA and CDC might respond to the Senators' letters.

Congress might also consider prodding the Environmental Protection Agency on its response to the potential danger to consumers. As OMB Watch has reported, in 2003, EPA began studying the risks and completed a report last year. EPA has released the report to the popcorn industry but has refused to give access to the public.

The popcorn industry has begun to take voluntary steps to eliminate the use of diacetyl and should be commended. However, that is no reason for EPA to withhold crucial public health information from concerned Americans. Federal officials should be in the business of fostering knowledge, not hiding the facts.

Yesterday, The Chicago Tribune published a story about a new medical study that has found a dramatic increase in adverse effects associated with prescription drugs. According to the article, "The annual number of 'serious adverse event' reports jumped to 89,842 in 2005 from 34,966 in 1998. Meanwhile, the number of 'fatal adverse drug events' increased nearly threefold to 15,107 in 2005 from 5,519 in 1998."

The article also mentions the Congressional reauthorization of the Prescription Drug User Fee Act (PDUFA) and the FDA reform measures lumped in with it. The legislation renews PDUFA (a program which allows FDA to collect money from drug makers in order to conduct drug safety reviews) and expands FDA's authority to conduct post-market safety reviews and pull drugs from the market if necessary.

The Senate passed its version in May, and the House approved its version in June. Because of disparities in the FDA reform provisions, a House/Senate conference committee will need to reconcile the bills before sending a final version to the president. The bill is considered must-pass legislation, because the PDUFA program expires at the end of September.

While the bill must pass, findings in the medical study underscore the fundamental problems with the legislation. The PDUFA program is a double-edged sword. While it is an important source of funding for the agency, it comes with strings attached and allows drug companies to call the shots during the approval process.

Moreover, by focusing only to expand FDA's powers in regard to post-market drug safety, Congress is only trying to close the gate after the horse has left the corral. When it comes to drug approval, both parts of the bill presume speed to be more important than safety.

In the Chicago Tribune article, FDA spokeswoman Julie Zawisza tries to put a positive spin on the news by saying, "More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market. Now that we get more reporting, people are saying that there is something wrong. We know that under-reporting is a problem so one would think that when we get more reports it could suggest that the system is actually working better but we don't for sure."

Tortured logic aside, Zawisza's quote and Congress's pending legislation beg the question: Do our government leaders ever consider assuring a drug's safety before it hits the market?

Reg•Watch Update: "For Congress, an Opportunity to Limit Conflicts of Interest at FDA"

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)