The U.S. Environmental Protection Agency recently made changes to its program for studying the toxic effects of industrial chemicals — the Integrated Risk Information System (IRIS). Under the revised process, the White House Office of Management and Budget (OMB) is given unprecedented control over the content and conduct of these studies.

Today, OMB Watch released a factsheet "OMB Interferes in IRIS Assessments of Toxic Chemicals," which details the problems with the revised process. The factsheet answers the following questions:

• What is IRIS?
• How does OMB interfere in IRIS assessments?
• How does the new IRIS assessment process make matters worse?
• Why is the IRIS assessment process important?

Also today, the House Science Committee's subcommittee on Investigation and Oversight held a hearing on the changes to the IRIS process. Committee members and witnesses focused their discussion on the transparency, or lack thereof, in OMB's review of IRIS assessments and on the slow pace of completion of IRIS assessments. (EPA has completed only four assessments in the past two years.)

The committee heard from John Stephenson, the Director of Natural Resources and Environment for the Government Accountability Office (GAO). Stephenson's testimony was based on a recent GAO report critical of OMB's involvement in the IRIS assessment process.

Stephenson's primary complaint about the IRIS process is that any comments from OMB or other federal agencies will not be disclosed to the public. Stephenson also warned additional steps included in the revised process could further slow EPA's efforts to complete assessments.

Rep. Brad Miller (D-NC), chair of the panel, released a document that reveals the opinions of EPA staff scientists on OMB's role in the IRIS assessment process. In responding to GAO's report, staff involved in the IRIS program said OMB's comments are often "troubling to address" and the OMB review process "has added tremendously to the time it takes to release" draft and final assessments.

An investigation by the House Oversight and Government Reform Committee shows that the White House pressured the Environmental Protection Agency to refuse a request by the state of California to regulate greenhouse gas emissions.

In December, EPA denied a California petition, or waiver, that would have allowed the state to set standards for greenhouse gas emissions from vehicles. Under the Clean Air Act, only the federal government may regulate vehicle emissions; but California — and only California — may request permission to set up its own regulatory scheme. If EPA grants California permission (as it had with every request prior to this one), other states may choose between California's program and the federal program. At least 15 other states were prepared to follow California's plan, if permitted.

When EPA announced the denial, Administrator Stephen Johnson claimed the decision was his alone. But the denial of the California petition had the White House's fingerprints all over it. Last fall, Vice President Dick Cheney met with executives from Ford and Chrysler who urged him to deny the request, according to the investigation. The White House Council on Environmental Quality (along with the Transportation Department) lobbied U.S. representatives and governors urging them to oppose California's efforts.

At the time of the announcement, no hard evidence existed to refute Johnson's claim that he, and not the White House, was responsible for the denial. The deposition of an EPA assistant administrator, taken by the House investigators, begins to shed some light on who was actually responsible for the decision.

Committee investigators heard from EPA Associate Deputy Administrator Jason Burnett, whose carefully chosen words nonetheless cast doubts on Johnson's claim that the Dec. 19 decision to deny the waiver was his alone:

According to Mr. Burnett, Administrator Johnson's preference for a full or partial grant of the waiver did not change until after he communicated with the White House about the matter. When asked by Committee staff "whether the Administrator communicated with the White House in between his preference to do a partial grant and the ultimate decision" to deny the waiver, Mr. Burnett responded: "I believe the answer is yes." When asked "after his communications with the White House, did he still support granting the waiver in part," Mr. Burnett answered: "He ultimately decided to deny the waiver." Mr. Burnett also affirmed that there was "White House input into the rationale in the December 19th letter."

Unfortunately, we still don't know which White House offices or officials pressured EPA. Burnett repeatedly refused to answer the committee's questions on who communicated with EPA or what exactly was discussed. Burnett informed the committee he was under instruction from senior EPA officials to keep that information under wraps.

Check out the Committee's investigation and supporting documents here.

Friday, White House Chief of Staff Joshua Bolten sent a memo to the heads of federal agencies outlining the administration's policy on rules those agencies want to finalize by the end of the Bush administration. The memo states, "Except in extraordinary circumstances, regulations to be finalized in this Administration should be proposed no later than June 1, 2008, and final regulations should be issued no later than November 1, 2008."

So, agencies will have just three weeks to announce proposed rules they want to finalize by year's end.

More importantly, it means agencies will have to announce final rules by November 1. The November 1 deadline ensures the i's will be dotted and the t's will be crossed on all Bush regulations, before a new presidential administration takes over.

Most significant rules are published in the Federal Register shortly after the agency makes its final decision; but the Administrative Procedure Act requires agencies usually wait at least 30 days before making the rules effective. (Agencies sometimes choose to wait 45, 60, 90 days, or longer.)

So what will the next five-and-a-half months bring? Here's a sampling of rules the Bush administration may push to finalize in its waning days of power, in the event a new administration disagrees with its policy positions:

• A rule revoking the 25-year-old ban on carrying loaded weapons in national parks (proposed by the National Park Service in April 2008);
• Changes to the enforcement of the Family and Medical Leave Act that would make it more difficult for employees to claim leave time in certain situations (proposed by the Department of Labor in February 2008);
• A rule to exempt farms from reporting air pollution caused by animal waste (proposed by EPA in December 2007);
• A rule to ease air pollution control requirements on industrial facilities operating near national parks (proposed by EPA in June 2007).

Yesterday, the House Judiciary Committee's subcommittee on administrative law held a hearing to investigate how the Bush administration has used rulemaking practices to advance the Unitary Executive Theory .

President Bush and his minions use the Unitary Executive Theory to claim the president has complete control over the conduct of the executive branch, and that he is accountable to no one in exerting said control. Bush's penchant for issuing signing statements and his refusal to accept congressional input in his conduct of the war in Iraq are two examples of this theory.

Federal agency rulemakings also provide an opportunity for Bush to apply the Unitary Executive Theory. Time and time again, the Bush White House has foisted upon agencies decisions that ignore the plain language of federal statutes (for example, EPA's recent revision to the national air quality standard for ozone). After such decisions are made, the White House routinely invokes executive privilege in order to escape the oversight powers of Congress and extend itself beyond the grasp of public accountability.

What's really galling is that, instead of being frank about opposing public protections on their face, the Bush White House frequently attempts to alter the substantive considerations that inform regulatory decisions. In other words, officials inside White House offices, such as OMB, meddle with science in an attempt to legitimize their political opinions.

Rick Melberth, OMB Watch's director of regulatory policy, testified at the hearing, and summed up the problem:

The application of the unitary theory as it is practiced in this administration and framed in executive branch directives gives the president, and a cadre of employees that represent the president, control over the substantive decision making of agencies. As a result, politics is injected and elevated into decisions where science and rational judgment should prevail. Political appointees have greater control over the substance of regulations; politics supersedes scientific and technical information that is critical to protecting our environment and health and safety at home and in the workplace. ...

When the president has the ability to override this statutory delegation of authority, the balance of power between Congress and the Presidency is altered. There is the perception, if not the reality, that special interests are favored heavily over the needs of the public. This process does not lead to better rules and public protections. When the president makes a substantive regulatory decision based on political considerations, scientifically-based protective standards are vitiated.

New evidence shows that the White House is meddling with a National Oceanic and Atmospheric Administration (NOAA) rule to protect the North Atlantic right whale — one of the most critically endangered whale species in the world. The rule has been awaiting clearance — or, more accurately, gathering dust — at the White House Office of Information and Regulatory Affairs (OIRA) since February 2007.

NOAA's National Marine Fisheries Service (NMFS) has been working on the rule since 1999, and in 2006 proposed limiting the speeds of large ships in the Atlantic during seasons when the right whale is most active. Ship strikes are a major cause of death for right whales. "Ship strikes are responsible for 37% of whale deaths in just the last twenty two years," according to the office of Sen. John Kerry (D-MA).

An investigation by the House Oversight and Government Reform Committee shows the White House is not merely stalling, but also actively working to thwart the efforts of NMFS's staff and undermine the marine science serving as the basis for the rule. "According to documents obtained by the Committee, the rule's delay appears to be due to baseless objections raised by White House officials, including officials in the Office of the Vice President."

Today, Committee Chairman Henry Waxman (D-CA) wrote to Susan Dudley, the administrator of OIRA who President Bush installed by recess appointment last year. Documents show that as many as three separate White House offices — the Council of Economic Advisors, the Office of the Vice President, and one unnamed White House source (probably OIRA) — are pressuring NOAA to change the rule, or simply drop its efforts to protect the right whale altogether. From Waxman's letter:

[T]he Vice President's staff "contends that we have no evidence (i.e., hard data) that lowering the speeds of 'large ships' will actually make a difference." NOAA rejected these objections, writing that both a statistical analysis of ship strike records and the peer-reviewed literature justified the final rule. In its response to the objections from the Vice President's staff, NOAA reported that there is "no basis to overturn our previous conclusion that imposing a speed limit on large vessels would be beneficial to whales."

A third document reveals that the White House requested that NOAA consider unpublished information relating to the birth rate of right whales. NOAA responded that it "used the latest, peer-reviewed, scientific data when developing" the rule.

Stalling regulations and putting politics ahead of science is always bad, but they are especially troubling in this instance, as time is of the essence for the right whale. Fewer than 350 of the mammals remain. Since the summer of 2004, seven have died as a result of ship strikes, according to Waxman. Two right whales have been struck by ships, and one has likely died, in the time the rule has been stuck at OIRA. NMFS officials warn that even one more dead female could set the species on an irrevocable path toward extinction.

NMFS experts have been working diligently to extend protections for the right whale but have been stonewalled by political apparatchiks like OIRA Administrator Susan Dudley and Vice President Dick Cheney. The White House's delay and scientific interference is truly an example of executive power run amok.

OMB Watch recently reported on an EPA decision to revise its process for assessing human exposure and associated health risks of industrial chemicals. Under the revised process, EPA will give the White House, specifically the Office of Management and Budget (OMB), an opportunity to alter or delay scientific results at nearly every stage of the chemical assessment process. By attacking the scientific basis for future regulatory decisions, OMB will be able to erode the foundations upon which public protection standards are built.

In reality, OMB has already been tinkering with EPA's chemical assessments, according to a new Government Accountability Office report. The report hasn't been officially released, but the Associated Press has obtained a copy, and report H. Josef Hebert wrote an article published last night discussing some of the results:

The GAO said many of the deliberations over risks posed by specific chemicals "occur in what amounts to a black box" of secrecy because the White House claims they are private executive branch deliberations.

Such secrecy "reduces the credibility of the ... assessments and hinders the EPA's ability to manage them," the GAO report said. …

"Unless there is concurrence by other agencies, ... things don't go forward. It means we stop what we are doing," said the scientist, speaking on condition of anonymity because of fear of endangering his career.

"The (EPA) scientists feel as if they have lost complete control of the process, that it's been taken over by the White House and that they're calling the shots," the scientist said.

In addition to outright interference, OMB is also able to achieve its anti-regulatory goals by delaying chemical assessments indefinitely. The report mentions at least four chemicals for which EPA has yet to determine carcinogenicity, despite widespread use and evidence of risk. They are naphthalene, trichloroethylene, perchloroethylene, and formaldehyde, according to the AP article.

Now, under the revised process EPA recently announced, OMB will have even more opportunities to meddle in EPA science, and even more incidences of interference, suppression, and delay are likely to occur. Unfortunately, because EPA has mandated this process occur behind closed doors, these incidences may never come into the light of day.

Check back here later today, Reg•Watch will post the GAO report when it becomes available electronically. Update: Here is the link to the GAO report.

In a story that has garnered little media attention, the U.S. Food and Drug Administration has announced it will ban certain forms of cattle feed in order to reduce the risk of mad cow disease. The announcement came after the White House Office of Management and Budget (OMB) had stalled the rule for months. (Click here for more on the delay of the rule.)

FDA's new rule adds to the list of substances that cannot be fed to cattle. Allowing cattle to feed on the rendered meat, bones, or blood of other cattle raises the risk of mad cow, also known as Bovine Spongiform Encephalopathy (BSE). According to the agency, "FDA believes that the final rule would effectively remove about 90 percent of any remaining BSE infectivity from possible spread through the animal feed system."

FDA's announcement came as a bit of a surprise since OMB seemed content to allow the rule to languish under its review while the cattle industry continued to avoid further regulation. The turning point came at a meeting between U.S. and South Korean officials on trade. According to The Wall Street Journal, "South Korea last week agreed to lift restrictions on U.S. beef and, according to one U.S. government official, the country did so on the condition that the U.S. strengthen its livestock feed rules."

Since late 2003, when a U.S. cow was diagnosed with mad cow disease, some foreign nations have been reluctant to import U.S. beef. In fact, when identifying potential benefits of the rule, FDA argued, "The U.S. economy may also benefit from increased exports to the extent that the rule persuades foreign governments to import U.S. beef products."

Nonetheless, it's a sad commentary that the Bush White House is more responsive to the concerns of the South Korean government (and the domestic producers who will benefit from increased exports) than to its own food safety agency or considerations of public health. The rule is fairly typical of Bush's cronyism approach to regulation: "Fight tooth-and-nail against government intervention, unless it would help out my buddies."

But bottom line, new policies are now in place that could prevent an outbreak of mad cow disease. The rule takes effect in April 2009.

Today, the Senate Commerce Committee approved a bill that would force the White House Office of Management and Budget to stop sitting on a regulation to protect the North Atlantic right whale. The rule has been held up at OMB's Office of Information and Regulatory Affairs (OIRA) since Feb. 2007.

The North Atlantic right whale is one of the most critically endangered marine species in the world. Although the species has benefited from federal protections for years, it is still having difficulty recovering. Collisions between whales and shipping vessels are a particularly serious problem.

In response, the National Oceanic and Atmospheric Administration (NOAA) began working in 1999 on a federal rule to limit the speed of large shipping vessels traveling along the eastern seaboard. The speed limits would vary based on geographic location and season.

NOAA published a proposed rule (which OIRA also reviewed) in June 2006. Since receiving and reviewing public comments into early 2007, NOAA has been waiting for OIRA to give its approval.

The bill, passed by voice vote, states, "Not later than 30 days after the earlier of the date of the enactment of this Act or June 1, 2008, the Secretary of Commerce, acting through the Under Secretary for Oceans and Atmosphere, shall prescribe regulations to reduce the incidence of vessels colliding with North Atlantic right whales (Eubalaena glacialis) by limiting the speed of vessels."

The Ocean Conservancy has a timeline on the rulemaking and reported ship strikes of the right whale. According to the Ocean Conservancy, since NOAA published the proposed rule, there have been five reported ship strikes and three confirmed deaths.

While that may not sound like much, Sen. John Kerry (D-MA), who cosponsored the legislation along with Sen. Olympia Snowe (R-ME), points out that the species' ranks are small and growing smaller and that federal action is critical:

We've only got less than 350 whales left alive today and passage of this legislation comes at the eleventh hour. Ship strikes are responsible for 37% of whale deaths in just the last twenty two years. Without this legislation, the United States would have continued to risk extinction of the right whale.

The bill (S. 2657) will now move to the full Senate for a vote. A similar bill (H.R. 5536) is awaiting consideration by the House Transportation and Infrastructure Committee.

Yesterday, the National Academy of Sciences' National Research Council (NRC) released a report citing "strong evidence" that exposure to ozone, or smog, contributes to premature mortality. According to BNA news service (subscription), "John Bailar, who led the National Research Council team, told BNA the agency is 'quite sure there is an effect, but not knowing how big it is, that's the challenge for the EPA. They have to find out the size of the problem.' "

The report says that, if there is any threshold at which exposure to ozone is safe, it is likely below the level EPA recently announced as the new national air quality standard (0.075 parts per million).

The NRC report should close the book once and for all on any uncertainty surrounding the link between ozone exposure and premature death. During the recent debate over the ozone standard, independent scientists, public health advocates, and EPA all recognized the potentially deadly effects of ozone and endorsed tight standards.

The last remaining deniers reside mostly in the White House Office of Management and Budget (OMB). In fact, when EPA was preparing to propose its new standard for ozone, OMB edited a supporting document in order to downplay the relationship between ozone and premature mortality.

The original document read, "There is considerable variability in the magnitude of the ozone-related mortality association reported in the scientific literature." OMB altered the language to, "There is considerable uncertainty in the magnitude of the association between ozone and premature mortality." [Emphasis added.]

The nonprofit group Environmental Defense came up with another example of OMB interference. In a rulemaking that would limit emissions from small engines, OMB objected to EPA's assertion that ozone is related to premature death:

The EPA response to OMB's objection states: "We have removed all references to quantified ozone benefits (including mortality) in the most recent version of the [economic impact statement]." The EPA document in question was, in fact, finalized with the monetized benefits of reducing ozone removed. Meanwhile, EPA has yet to finalize the clean air standards for these high-polluting engines.

The NRC report says that policy makers "should give little or no weight" to arguments like the one advanced by OMB.