U.S. Environmental Protection Agency
Dear Mr. Chamey
EPA has reviewed the Notice of Proposed Rule Making (64 Fed. Reg. 5684 (1999)) (proposed Feb. 4, 1999) to amend OMB Circular A-110 as required by Public Law No. 105-277. We offer the following comments.
Recommendations for Clarification of Terms
The proposal does not define the term "data." Data may vary by their nature, quality, or intended use. EPA suggests that "data" be defined, and that OMB consider different treatment for different types of data..
For example, environmental monitoring or health surveillance data that are gathered for assessing status end trends to inform decision-making and that meet quality assurance standards should be made available to the public as early as possible. Retaining these data sets to be "mined’ for publication purposes (e.g., National Health and Nutrition Evaluation Survey) deprives the public of the timely use of such data. Conversely, data gathered for the purpose of "hypothesis testing" (e.g., laboratory, clinical, or field research) should generally be made available to the public only after peer review and quality assurance to ensure the scientific credibility of the data and validity to the user.
EPA also suggests that the definition of data address mixed public/private funding of research and spell out what data must be released under those circumstances.
The proposal applies only to "published" data, but "published" is not defined. To avoid inconsistent meanings by agencies, EPA recommends that OMB clarify whether the term applies to both informal and formal presentations of research results. For example, federally-funded researchers at a scientific conference may report preliminary results, which can adversely affect third parties. Even though the results have not been formally "published" in a peer-reviewed journal, outside parties may be extremely interested in obtaining and testing the results. The proposal also does not cover situations where agencies use data, but the data or research findings are not published or publication is delayed. This could be addressed by establishing a presumption of publication after the passage of a reasonable period of time.
The proposed addition to Section 30.36 refers to requests under the Freedom of Information Act (FOIA) for "data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules...." EPA recommends that OMB clarify this language to address whether it is the "data" or the "research findings" that must be "produced under an award" and/or "used by the Federal Government." In some cases, the raw data itself might not be produced under a grant, but the production of the subsequent research report is supported with grant funds.
The proposed revision does not define "use" by an agency. Absent a definition, it is unclear whether the proposal would cover a FOIA request submitted when an agency is in the process of considering a research report but does not have the underlying data in its possession. The ability of an outside party to affect agency policymaking will be substantially increased if access to such data is allowed during the decision-making process.
The proposal contains several timing and fee provisions that raise questions as to the interplay between Circular A-110 and the FOIA.. The proposal states that a Federal agency has "a reasonable time" to obtain the data from the awardee. Currently, there is a 20-day statutory response limit for FOIA requests, and it is unclear how the "reasonable time" provision would affect that limit. If the grantee does not respond to the agency’s request for the data in a timely manner, there is no provision extending the time to respond to the FOIA request.
In addition, the proposal allows an agency to charge a fee equal to the "full" incremental cost of obtaining the data. Currently, fees collected under FOIA are not kept by the agency, but are deposited in the Treasury as miscellaneous receipts. The costs incurred by a grant rccipient are to be reimbursed as allowable costs under the grant, the fees collected should be kept by the agency or paid directly to the grantee by the requestor.
The proposal provides that fees may be charged if the data is requested by a "private party," but fails to define the term. The term could mean only an individual or any non-governmental entity. We recommend that OMB clarify the application of the FOIA fee categories (commercial, media, etc.) and fee waivers to the Circular A-110 fees.
Confidentiality of Research Subjects
EPA believes that the proposal should specifically address issues related to the protection of data from human subjects. While there appears to be a broad consensus on the need to adequately protect confidential data secured from human subjects, it is unclear how far this consensus extends beyond the obvious personal identifiers. The issue is complicated by emerging technologies, such as Geographic Information Systems, which provide geographic data, including spatial and temporal coordinates, that can compromise confidentiality. Further, under Public Law No. 105-277, human subjects can no longer be promised by the investigator that data taken on them would be used anonymously and for research purposes only, since such decisions would likely be made by others. Clinical trials could also be unblinded prematurely, thereby vitiating the trials.
Protection of Proprietary Information
If not properly implemented, the law could have a chilling effect on private/public research collaboration out of fears that proprietary information would be released. EPA therefore suggests the proposal discuss how intellectual property will be protected.
We appreciate the opportunity to comment on the proposed revision. If you have any questions about these comments, please call me or Pat Hirsch.
Howard F. Corcoran