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Interactive Public Docket

COMMENT BY: U.S. Chamber of Commerce
SUBJECT: In favor of proposed revision to OMB Circular A-110
DATE: April 1, 1999

Dear Mr. Charney

These comments are being filed on behalf of the Chamber of Commerce of the United States ("The Chamber"), which is the world's largest business federation, representing more than three million businesses of every size, sector, and region. Many of the Chamber's members are subject to government rules that were written with the support of underlying technical data developed as a result of taxpayer-funded research by institutions of higher learning, hospitals, or other non-profit organizations. Each year, businesses must absorb the spiraling cost of trying to comply with the growing tangle of regulations. At a minimum, these businesses should be entitled to understand the basis of these rules and their purported benefits. Accordingly, the Chamber strongly supports the proposed revision to Circular A-110, which would allow the public to obtain and review federally-sponsored research data through the Freedom of Information Act ("FOIA") process.

The proposed revision to Circular A-110 will provide welcome and overdue public access to publicly-funded research data. Fundamentally, the Chamber believes that research funded by the public should be accessible to the public, to the extent that the data is not proprietary and does not present a security threat. Efforts to make such information inaccessible to the public and to the Congress are an affront to the democratic principles of our nation.

I. The Public Should Have Access to Publicly-Funded Data Used to Impose New Regulatory Burdens

At the outset, we must emphasize that the Chamber regards the public's access to publicly-funded data as an extremely serious issue. At the heart of this issue is the critical role that such information plays in the development of regulations. Data derived from government-sponsored research often provides the impetus and justification for promulgating new or tighter regulations in the first place, and always shapes the scope and reach of a rule's requirements. Publicly-funded research data significantly affects a broad range of rules that have a tremendous impact on U.S. businesses, including health regulations, environmental requirements, agricultural rules, food and drug safety, product safety, and occupational safety.

Each year, the U.S. government issues approximately 65,000 pages of text representing some 4,000 new rules. Every one of these rules comes with a cost: the overall cost for U.S. business to comply with the regulatory process exceeds $700 billion each year. The annual cost of regulation in America is roughly three times greater than the total amount of all corporate income taxes and is equal to the total amount of all personal income taxes paid. Additionally, the regulatory burden is growing annually. Regulatory agencies, such as the Environmental Protection Agency, are diverting more and more resources toward developing information - ranging from health effects data to visibility impairment studies to research on climate change - that is used to support expanded regulation. A significant portion of the data ultimately developed through this type of publicly-funded research is controversial, and the public rightfully questions whether the data truly supports expanded regulation

II. The Public Deserves Better Assurance That Data Used To Support Regulations Is Reliable And Is Not Manipulated To Support A Particular View

The adoption of Public Law 105-277 with Senator Richard Shelby's (R-AL) amendment requiring public access to publicly-funded data reflects Congress's concern that, at present, there are insufficient checks and balances on the process of developing data to support agency rulemaking efforts. The Chamber agrees with Senator Shelby that the public deserves better assurance that this critical data is accurate and has not been distorted to promote a particular regulatory outcome. Regrettably, there have been too many recent controversies that have centered on the validity of thc data cited by an agency as demonstrating the need for a proposed rule.

A. An Example Of Inaccessible Data That Does Not Support A Proposed Regulation To The Degree An Agency Claims

Concerns about the validity of research data have been particularly acute in the case of epidemiological data, as evidenced by the 1997 debate over mortality estimates from exposure to fine particulate matter (soot) in the air after EPA's proposal to tighten the National Ambient Air Quality Standards ("NAAQS"). The agency originally estimated that the revised rule would cost $5 billion per year to comply with. The private sector disagreed, asserting that the annual cost of compliance would range between $50-150 billion. EPA justified the tightened air standard on epidemiological data which the agency said showed that as many as 40,000 persons would die prematurely each year from inhaling soot. EPA was asked by the public and by Congress to release the data supporting that claim, and the agency refused on the ground that it did not have to release the data because it was under the control of outside researchers. Ultimately, EPA revised its estimate of the annual cost o compliance with the revised NAAQS standard from $5 billion per year to more than $50 billion, and revised the mortality estimate (because of a "data glitch") from 40,000 persons per year to 10,000 persons per year. To date, the NAAQS data has not been released to the public for review and analysis. As a result of this secrecy by EPA, there is a general suspicion that the agency does not have a basis for imposing at least $50 billion in annual costs on American business.

III. The Proposed Revision Will Benefit the Nation

The Chamber believes that the proposed revision to Circular A-110 clearly provides several significant benefits to all Americans:

o Regulated entities will have a better opportunity to evaluate the data supporting proposed regulations and to participate in open, democratic discussion of the merits of such regulations.

o The revision will promote honest, robust scientific discussion by bringing a rule's supporting data out into the open.

o The revision will improve the reliability of the final data, and give greater assurance to the public that a rule is justified and that the scope of the rule is appropriate.

o The revision will help to avoid situations in which data that cannot withstand vigorous scrutiny is used to support new regulation.

o The revision provides a means of evaluating research that is separate from the current "peer review" process; it is useful to not have to rely solely on the peer review process, since that process can often be secretive and highly politicized.

o The revision will help regulatory agencies achieve an important goal - actually providing the public with access to publicly-funded data. Virtually every agency that sponsors research activities has some sort of policy to make the ultimate data available to the public. It is the general practice of these agencies, however, not to request or compel researchers to release their data. Moreover, federal agencies rely upon a Supreme Court case, Forshman v. Harris, 445 U.S. 169 (1980), which holds that data controlled by an organization that has received a federal grant to develop the data is not part of the agency's records, and therefore, is not subject to disclosure under FOIA. The revision will prevent a repeat of situations such as the one described above where EPA and researchers refused to release supporting data which had been requested by the public and Congress, even though that information was critical in the ongoing debate over the public benefit of a new rule that would cost Americans more than $50 billion each year.

The Chamber believes that the proposed revision to Circular A-110 will provide greater assurance that critical research data is accurate and reliable, and that the data truly lends support to proposed regulations.

IV. The Arguments Offered Against the Proposed Revision Are Greatly Exaggerated

By contrast, the Chamber believes that the reported concerns of some members of the research community (particularly epidemiological researchers) are exaggerated and groundless. These commenters have objected to the proposed revision on the basis that (1) researchers would be inundated and distracted by data requests from the public, (2) that the revision will have a chilling effect on research and unfairly force researchers to turn their data over to rivals, and (3) that the data will be distorted by interest groups and presented to the public in a grossly misleading fashion.

These concerns are exaggerated. The Freedom of Information Act process provides important protections against inappropriate or frivolous requests for information.

First of all, a private party requestor must be prepared to pay substantial copying costs for requested materials, which prevents many frivolous requests. Second, and more importantly, materials are exempted from release under FOIA if they are proprietary or involve trade secrets, implicate national security or foreign policy, relate to law enforcement records, relate to internal personnel rules, or involve medical or other records of a private nature. Also, the overall experience of government agencies under FOJA strongly suggests that far fewer data requests will actually be made than researchers fear.

Third, it is important to keep in mind that the revision of Circular A- 110 will be followed by additional rulemaking and guidance, allowing a reasonable balance to be struck between public access to data and the protection of data that should not be released. In striking that ultimate balance, decisions can be made as to the best ways to preserve incentives for researchers to perform research (i.e., publication of results, exclusive use of data during initial time period, etc.).

Finally, with respect to the fear that research data will be distorted to mislead the public, the Chamber believes that controversial research data needs to be fairly scrutinized and subjected to open public debate. There is no reasonable basis to take the position that this data must be kept from the public or that the public should only be given information that the agencies deem to be fit for public consumption. With the enormous issues at stake when agencies propose an expansion to the comprehensive regulatory framework, it is reasonable and appropriate that the public be allowed to determine whether the underlying research data ultimately supports the proposal. This critical decision should not be left solely to a small cabal of government officials and researchers.

The Chamber appreciates the opportunity to submit these comments and thanks the Agency for soliciting the opinion of the U.S. business community concerning this important proposal.


William L. Kovacs