Thursday, January 11, 2007

The Office of Management and Budget is one of the less-well-known tools the Bush administration has been using to advance its agenda of freeing corporations from pesky health and safety regulations. Last January, OMB’s Office of Internal and Regulatory Affairs (OIRA) released a proposed risk assessment bulletin that would have made it much more difficult for EPA, OSHA, and other agencies to carry out their function of protecting our health and safety. Today, this boon to corporate interests received a smackdown from none other than the National Academies.

Public Citizen’s Robert Shull, one of the leaders in the fight against this proposal, posted the good news earlier today at the public health blog The Pump Handle. For those who aren’t as familiar with the proposal and the criticisms against it, here’s a bit more background.

Industry Wants to Make the Regulatory Process More Cumbersome
As we’ve seen from the tobacco and fossil-fuel industries, a popular tactic for defeating or delaying regulation is to insist that we need to do more research and learn more about a threat before we let the government take any action to stop it. Industry-funded think tanks like the Center for Regulatory Effectiveness constantly push for regulations like the Data Quality Act that require federal agencies to go through more complicated and time-consuming processes to issue any new regulations. As Chris Mooney wrote in Washington Monthly:

If these efforts succeed, industry groups will have a new set of tools to stop regulations before they even get started--often by using questionable scientific critiques paid for by industry to challenge legitimate science sponsored by taxpayers. "Anyone who is involved in the regulatory process knows it begins ten years or so before you ever see a rule," says William Kovacs, a Chamber of Commerce vice president who's met with [CRE president Jim] Tozzi "a hundred times" to plot strategy. The Data Quality Act "allows you to begin inputting, and access the process [from] the very beginning."


Already, Tozzi's Data Quality Act has led to suits challenging a government report on climate change and a National Institutes of Health study on diet, both of which represent state-of-the-art scientific work in their fields. The latter suit was recently filed by the Chamber of Commerce and the Salt Institute, an industry group, as a strategic test case to establish judicial review under the Data Quality Act. Slowly, Tozzi and allies are laying the groundwork for a broader assault on the regulatory state. Data quality, says Kovacs, is going to have "a revolutionary impact on the regulatory process."

It’s useful for these industry interests to have an in with OIRA, because that office has to approve all final rules issued by federal agencies. The OMB bulletin on risk assessment was issued under OIRA director John Graham, who is, like so many Bush appointees, closely connected to several problematic industries. When Bush nominated Graham for his position, Public Citizen issued a report on Graham (68-page PDF here)

Graham’s research has been used to lend a “scientific” veneer to corporate efforts to roll back safety and environmental standards, and to push for a top-down reorganization of the government’s basic regulatory scheme. Graham’s [Harvard Center for Risk Analysis] is funded by more than 100 large corporations and trade associations, including such known environmental offenders as Dow, 3M, DuPont, Monsanto and Exxon, in addition to the Chlorine Chemistry Council, the American Automobile Manufacturers Association, the American Petroleum Institute, and the Chemical Manufacturers Association, now called the American Chemistry Council. High-ranking corporate officers from Oxford Oil, the National Association of Manufacturers, Eastman Chemical, Tenneco Inc., CK Witco Corp., and Novartis Corp. sit on the Center’s Executive Board. The HCRA Advisory Council includes executives from DuPont and the Grocery Manufacturers Association, and the chief attorney for environmental affairs at Exxon Chemical Americas.

Second, Graham’s methodology appears to be informed more by the wishes of his corporate backers than by anything recognizable as “science.” Although he often calls himself a “scientist,” Graham’s field of risk analysis is a discipline within the field of public policy, and he does not in fact hold any degrees in the hard science disciplines that often form the basis for regulatory policy. As this report demonstrates, Graham’s research conclusions are frequently marred by his inflation of industry costs and underestimations of the public benefits of safeguards. The practice of cost-benefit analysis also omits or downplays ethical and moral factors such as justice, consent and equity, and inappropriately discounts the value of human life and the environment.

So, when Graham was appointed OIRA director, it wasn’t surprising to find the office issuing a bulletin that would place more hurdles in the path of regulation. The bulletin elicited lots of comments, with federal agencies and advocates for health and the environment opposing it and industry groups favoring it.

Agencies, Advocates, and Scientists Protest
OMB Watch reported that EPA submitted comments stating that the proposal would burden the agency with new analytical requirements and would require the use of assumptions that fail to adequately protect vulnerable populations, and the Department of Labor noted that it "could add significant time" to risk assessments by the Occupational Safety and Health Administration (OSHA) without improving the usefulness of the assessments.

The Center for Progressive Reform also criticized the bulletin's one-size-fits-all approach (PDF here) for “imposing the detailed analysis that dominates cancer risk assessment on risk analysis of all kinds, including the Department of Transportation, the Federal Emergency Management Association, and the Army Corps of Engineers.”

It’s not surprising to find advocacy groups vehemently opposing a proposal from the Bush administration. The reaction from the National Research Council, issued today, was much more surprising.

It’s not unusual for OIRA to ask the National Research Council (part of the National Academies) to review its proposals, and since the NRC is hardly a bastion of raging liberals, they probably didn’t expect the review to be negative. Apparently, this proposal over the line even by Bush administration standards, though, because the NRC didn’t even recommend changes – instead, they concluded that the bulletin was “fundamentally flawed” and should be withdrawn altogether. They state in their report (emphasis added):

Risk assessment is not a monolithic process or a single method. Different technical issues arise in assessing the probability of exposure to a given dose of a chemical, of a malfunction of a nuclear power plant or air-traffic control system, or of the collapse of an ecosystem or a dam. Thus, one size does not fit all, nor can one set of technical guidance make sense for the heterogeneous risk assessments undertaken by federal agencies. Although the bulletin generally acknowledges that diversity and attempts to meet it with frequent references to “where appropriate” or “where feasible,” the bulletin does not reflect an adequate understanding of the many risk assessment disciplines, particularly those devoted to analyzing the risks of engineered structures and natural systems. … The details should be left to the agencies or expert committees appointed by the agencies, wherein lies the depth of expertise to address the issues relevant to their specific types of risk assessments.

The Bush administration doesn’t seem to like to leave things up to the experts, but the experts have finally decided they’re not going to take it anymore.



As the president of the Salt Institute, which you mention as the plaintiff for the DQA test case, I feel I must correct an error incorporated into your blog. You repeat Chris Mooney's erroneous statement that the lawsuit challenges "a National Institutes of Health study on diet" that is "state-of-the-art scientific work."

Actually, we agree that the study is "state of the art" -- and vitally important. But our lawsuit did not challenge the study at all. The lawsuit challenged the fact that the government had not made the data available for independent experts to validate its "insider" interpretation of the data as required by the DQA. We asked, specifically, that the beginning blood pressure and the standard deviations of the subgroup analyses be disclosed; they have not been published and it is impossible to determine the accuracy of the conclusions being drawn without these statistics that could be provided in a millisecond from the data of the study's authors. The data are fine, but incompletely divulged and we asked only a tiny bit of information. As it is, published data by the authors have already confirmed that the agency has mischaracterized the findings. The government says the health of "all Americans" would be helped by cutting back on salt. Not only does this study not address that question at all (it is confined to blood pressure, not the net health effects of salt reduction, but in six of the eight reported subgroups -- representing the vast majority of Americans -- even blood pressure lowering is not statistically significant. This says nothing of the adverse impacts on glucose metabolism and the heart attack-stimulating production of the kidney hormone renin.

So, to set the record straight: we challenged the agency's application of its own DQA guidelines, not the study which seems to be first-rate (if not fully understood).

Dick Hanneman
Salt Institute

Posted by Dick Hanneman at Thursday, January 11, 2007 17:46:26

Yes, this is the kind of legislation we've got: Scientists who received federal money are supposed to provide their data to anyone who requests it. Privately funded researchers face no such requirement. So, it's not really a level playing field.

Tobacco industry documents reveal that Philip Morris wanted to get legislation passed that would allow them to access data from studies about the effects of smoking. It appears that they were particularly interested in research data from Elizabeth Fontham, who published studies demonstrating that exposure to secondhand smoke increased the risk of lung cancer in nonsmokers. At the time, the tobacco industry was concerned about legislation on environmental tobacco smoke (ETS).

An industry document described some possible best case scenarios for its legislative efforst, including this one:

"Federal legislation passes on data sharing only. We get the data from the Fontham study and prove it does not show any association between ETS and disease. These results prevent Occupational Safety and Health Administration from acting and stops/repeals smoking bans."

In other words, Philip Morris wanted the data so they could re-analyze it and make it show what they wanted it to show.

Posted by DCvote at Thursday, January 11, 2007 19:46:47

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