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September 10, 1999

Public Access to Research Data

By

Public Comment to: F. James Charney Policy Analyst Office of Management and Budget

Dear Mr. Charney:

Thank you for the opportunity to comment on the Clarifying Changes to Proposed Revision on Public Access to Research Data (the "Shelby amendment" pursuant to Public Law 105-277 "to require awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act"). The following comments reflect my own opinion and do not necessarily reflect those of The Heritage Foundation.

This statutory requirement and its implementing language are very important to bringing much needed openness and accountability into the policymaking process. One of the main objectives of this provision is to make available to the public information that is used by the federal government to justify new policies or rules and to do so in a timely manner so that the public has an opportunity to express its opinions and debate the policies as they as being considered.

The Reproposal Undermines Congressional Intent and Government Accountability to the Public. Unfortunately, OMB's reproposal only continues to undermine congressional intent and make it even more unlikely that the government's response to a request from the public ultimately will be useful or timely. For too long, hard working taxpayers have provided billions of dollars annually to the scientific community in the form of research grants and contracts and, too often, little or nothing is required in return for that money. The intent of the Shelby amendment is to bring some balance into the policymaking process by requiring the scientific community to understand that it will be held to account for its work and how it impacts our nation's policies and allocation of resources. Indeed, such research should be held to an even higher standard because of its consumption of taxpayer money. The recent case of a federally funded reseacher at the Lawrence Berkeley National Lab who was forced to leave when it was learned that he had faked data to produce results is one example of the problems from a lack of accountability and transparency. The impact of this fraudlent research was significant.

There are several elements of the reproposal that ultimately thwart the intent of the Shelby language and, in too many cases, actually make this proposal worse than the status quo:

Loopholes ensure that researchers will be less, not more accountable, than they are today. Section (d)(2)(i) defines so broadly research data that can be excluded by the recipient that it is highly unlikely little or any data would be turned over to an agency in response to a FOIA request. Particularly troublesome is the fact that "…Research data also do not include…materials necessary to be held confidential by a researcher until publication of their results in a peer-reviewed journal, or information which may [emphasis added] be copyrighted or patented." This represents a gigantic loophole which allows researchers to all but essentially refuse to turn over any data to an agency. Copyrighting material is a simple process and this language creates a huge incentive to use (or just to suggest the use of) that process to avoid the requirements of the Shelby language. Indeed, the inclusion of this language probably represents a setback relative to existing FOIA protections, making the status quo preferable to what OMB is now suggesting should be the standard -- a standard that allows researchers to be more evasive and even less accountable than they are today.

The length of time a recipient and agency can take to respond is not at all related to the public's interest in participating in the policy development process. Unfortunately, the OMB reproposal also appears to take an already long, frequently frustrating Freedom of Information Act process and make it worse. Most notably, the OMB reproposal makes sure that those parties with the most incentives to keep the public in the dark have all the decisionmaking authority for when and what data to release. Indeed, Section (d)(1) now outlines a vague "reasonable time" period that a researcher can take to provide the agency with data. After the data is provided, the agency then is tasked under FOIA and its legal requirements to make the information available to the public. Previously, an agency would respond, however slowly and incompletely, based on the legal requirements of FOIA. And the agency would make the determination of what could be released under FOIA. Now, agencies and researchers have an additional opportunity to further delay a response because of the undefined time period in which to provide the information to the agencies and screen information before the agency sees it. Again, this language renders the FOIA policy even worse than the status quo.

By creating these new uncertainties and lengthening the FOIA response time, OMB's reproposal undermines the basic intent of the Shelby language - to empower the public with information it can use to participate in the policymaking process. This participation includes telling Congress what it wants our nation's laws and policies to be. Ironically, while the public is frequently asked to comment on proposed rules, for example, within 30 to 60 days (even for some of the most complex and expensive rules), an agency has no obligation to the public to respond within a similar tight time period to a request for scientific information already extensively considered and used by the agency to shape that rulemaking. Indeed, those familiar with filing FOIA requests know all too well that agencies can take years, and often do, to respond to simple FOIA requests. OMB's reproposal further diminishes the likelihood that an agency will produce information pursuant to a FOIA in any useful timeframe. Thus, OMB's actions only serve to weaken the public's ability to participate, for example, more effectively in notice and comment rulemaking or to demand that Congress act to change a policy or rule using a tool such as the Congressional Review Act.

The phrase "policies or rules" has been too narrowly defined to mean notice and comment rulemaking. Congressional intent was to provide the public with an opportunity to review and validate scientific data that is proposed as justification for a federal policy or rule. The intent was to do this in a timely manner, ideally before a policy or rule is finalized and enforceable. Instead of focusing on narrowly interpreting "policy or rules" to mean notice and comment rulemaking, OMB should focus on the full phrase "used by the federal government in developing policies or rules." OMB should interpret this language in a manner more consistent with congressional intent -- the public should have timely access to research data used in developing policies or rules in order to be able to participate in a more informed way in the policymaking process.

Certainly any policy or rule that will be in effect and enforceable is covered by the Shelby language and the intent is that the public have access to the research data as a policy or rule is being finalized. This suggests timeliness and relevance in an agency's action. In the context of notice and comment rulemaking, that time period is certainly clearer. Nevertheless, an agency should be expected to notify the public when it is poised to finalize policies or rules that may take other forms. OMB gives agencies far too little credit for being able to make reasonable assessments of where they are in a policy decisionmaking process and their need and responsibility to notify the public.

If implemented as intended, the effect of the Shelby language also would force agencies that are inclined to circumvent public notice and comment rulemaking and finalize policies using other means, such as guidance documents or other documents, to be more open about the scientific basis for such policies if a FOIA request is made. OMB's reproposal would have the opposite effect by adding yet another reason for agencies to try to avoid notice and comment rulemaking and seek stealth means of implementing new policies.

The policies or rules covered should not be limited only to "major regulations." In addition to not limiting "policies or rules" to regulations only, OMB should not further restrict the applicability of the Shelby language to only "major" rules of $100 million or more. According to data maintained under the Congressional Review Act and provided to The Heritage Foundation by the U.S. General Accounting Office (GAO), between April 1, 1996 and March 31, 1999, agencies produced 12,925 final rules of which less than 1 percent, 188 rules, were considered "major."

OMB asks for examples of rules that would not meet this threshold but would benefit the public by having access to the underlying research data. As a former OMB employee in the Office of Information of Regulatory Affairs, I would suggest that there are numerous rules that would fall into this category. For example, these include permissible exposure limit (PEL) rules issued by the Occupational Safety and Health Administration, Food and Drug Administration rules related to nutrition labeling, food additives, etc., as well as medical device classifications and labeling (just think of how breast implants were classified several years ago based on data that has now been repudiated). The vast majority of the more than 500 EPA rules issued annually are not considered major, and it would be absurd to suggest that non-major rules never have an underlying basis in science.

Agencies too often provide very little detail in their Federal Register notices about the studies (sometime just one or two) they used to justify a regulatory action that will have a significant impact on workers, individuals or businesses. As part of OIRA's review of rules, it was not uncommon to ask an agency for more information about the studies used to justify a rule. It also was not uncommon for OMB to encounter agency resistance to providing more information. And, on occasion, OMB raised concerns about the number and quality of the studies. If OMB's review job is not easy, certainly the task for the public is even harder.

There is no justification for OMB to continue to further render ineffective the Shelby language by narrowing its applicability to only "major rules." The public should have the freedom to inquire about any federally funded research used to justify any federal policy or rule.

Assessing a separate fee on top of the current FOIA fee federal agencies already have authority to levy is an unnecessary burden, another layer of tax that further discourages public access to information. Today, an agency is allowed to charge a fee for responding to a FOIA request. The fee is based on the time and burden of replying to the request. There is no evidence to suggest that an additional fee is needed. The intent of the Shelby language was only to acknowledge and reinforce an understanding that any added burden of a request for data would fall within the existing authority of an agency to charge a FOIA fee. In addition, federal grants and contracts have administrative cost components that are built into the awards. The possibility of providing the types of information covered by the Shelby amendment is already taken into consideration in the administrative component. The fact that agencies and the public have been discouraged from requesting such information in the past only means that one of the administrative cost factors has not been tapped and those resources likely have been put to other uses. There is no reason why the Shelby language should trigger any additional demands on agency funds (paid for by taxpayers) by recipients of federal grants or contracts. In the absence of any specific evidence that there are real incremental additional costs in complying with the provision that are not already accounted for in the administrative component of an award -- which is designed to allow flexibility to address precisely these kinds of needs -- OMB should not establish any separate fee.

Sadly, OMB's interpretation of the Shelby amendment seriously undermines the intent of Congress. Even more troubling, OMB has managed to develop a regulation that actually weakens the public's ability to hold agencies accountable for policy decisions that will have an impact on American families, consumers, and businesses. Amazingly, OMB has chosen to interpret the Shelby language to take away the freedom of the public to participate in the policymaking process. This reproposal can be considered worse than the status quo.

OMB must reconsider its proposal. Absent such reconsideration, Congress should act to specify more clearly exactly how the policy is to be implemented.

Sincerely,

Angela Antonelli
Director, Thomas A. Roe Institute
For Economic Policy Studies
The Heritage Foundation

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