The Data Access Law: Promoting Accountability and Privacy
With the passage of the Freedom of Information Act (FOIA) in 1966, our society decided to promote government transparency: what is done in government’s name should be open to public oversight, with specific limited exemptions. Now more than 30 years later, agencies have long-established practices for applying FOIA and its various privacy protections, and we have an extensive case history applying the law. This history shows that courts and agencies have used the law to provide public access and accountability in government, while ensuring that both medical privacy and trade secrets are protected. Indeed, given their decades of experience, federal agencies have shown their sensitivity to medical and personal privacy issues, which has made FOIA access remarkably free of errors that would jeopardize private data.
Federal courts have ruled that FOIA applies to all data in the possession of federal officials, but until recently, it did not apply to research data conducted under federal grants or contracts for research.2 But federal agencies now outsource the gathering of much of the data that underlies critically important public policy decisions. In doing so, this data remains hidden from public view – even when it serves as the basis for regulations. Agencies often require that researchers provide them with the data (which makes it available under FOIA) when agencies contract research. But when outside researchers produce data using federal grant funds, agencies base regulations on such data even when the agency does not take possession of the data.3
To rectify this problem and promote accountability, Senator Richard Shelby (R-AL) and others included a provision in the FY1999 Omnibus Appropriations bill that applies to FOIA to data produced under federal grants.4 The law – often called the Shelby Amendment or the data access law – did not change FOIA, the law simply adds grant-funded data to the pool of data to which FOIA applies.
Nevertheless, some in the scientific establishment have raised several questions about the application of FOIA to research data. Because of such questions, Rep. George Brown (D-CA) has introduced legislation (H.R. 88) to repeal the data access law, and the House Appropriations Committee voted on an amendment offered by Rep. David Price (D- NC) and James Walsh (R-NY) on whether to delay the standard. The amendment failed 33 to 25, but the issue may emerge as an amendment on the House floor.
Will FOIA adequately protect researchers’ commercial trade secrets? Long-established agency practices and case law provide strong protections for such competitive data before patents are issued. These protections will apply to grant-generated data in the same way that they apply to other data collected or produced by the federal government. Specifically, exemption 4 of FOIA reads that the law does not apply to: "trade secrets and commercial or financial information obtained from a person and privileged or confidential."5
When applying this section, courts follow the National Parks test, which holds that information may be protected under exemption 4 if release of the data would "(1) impair the Government’s ability to obtain necessary information in the future; or (2) to cause substantial harm to the competitive position of the person from whom the information was obtained."6 The first ensures that parties will continue to provide information voluntarily to the government and the second protects the privacy rights of those who provide information under government mandates.
Accordingly, agencies withhold the portions of the data that researchers mark as proprietary commercial data, if researchers can show that (prior to patent issuance) such protection is necessary to prevent competing firms from preempting the patent status. FOIA legitimately exempts public access to this data, so long as there’s a confidential commercial situation in which the product or design is "competing" for competitive advantage. Courts have held that voluntary submissions of valuable data that are "customarily" withheld from the public shall remain confidential.7 And the courts have held that FOIA officers can protect mandatory submissions if there is a showing of actual competition, and the potential exists for substantial harm, e.g. premature dissemination while a patent is pending.8 Moreover, proprietary rights gain protection because agencies closely follow Executive Order 12,600. The Order established the process for marking and notification prior to any disclosure of commercially sensitive records and gives submitters the opportunity to object to release, including time to seek court review of the disclosure decision.9
Is grant-funded research of non-profits and public-private partnerships protected under FOIA? Courts have ruled that the same proprietary protections apply to this research data. While the law does require the information to be "trade secret" or "financial" information to gain protection, the source need not be a for profit company, but simply a "person."10 Accordingly, in Critical Mass Energy Project v. NRC, the court held that a nuclear industry association’s reports were confidential under FOIA because the information warranted protection under the National Parks test.11 Accordingly, under this precedent, a nonprofit group that generates such data can ask that agency’s FOIA officers to protect their ability to gain future private commercial advantages – under the old law as well as the new data access law.
Historically, FOIA processing staff have done a reasonably good job of withholding commercial records for which such exemptions are justified. Therefore, if a university hopes to license a product it developed with federal funds, it can expect that its claim to justify withholding will be just as well received as are the same claims by the regulated companies for commercial confidentiality protection. Agencies will use the same criteria for evaluating exemption claims.12
Will FOIA adequately protect the privacy of the subjects of a research study? Disclosure of Medical data requested under the data access law will have to meet the same high privacy standards that are applied to other personal privacy data collected under FOIA. Medical privacy is well understood and protected under both FOIA exemption (6) and the Privacy Act.13 If an agency gets a request for disclosure of data that contains medical information, it will deny access to the patients’ medical records and identifiable personal information. Case law overwhelmingly supports this practice.14
Furthermore, agency FOIA officers have shown their sensitivity to medical and personal privacy issues, which has made FOIA access remarkably free of errors that would otherwise jeopardize private medical data. Agencies exclude patient names, delete identifying codes, and excise details so that what agencies disclose amply protects personally embarrassing or medically sensitive topics such the AIDS or cancer status of individuals. Agencies like the Center for Disease Prevention and Control (CDC) routinely employ exemption 6 of FOIA to withhold such details, backed by the case law.15 When promulgating the Advisory to agencies on how to apply the data access law, the Office of Management and Budget (OMB) acknowledged this consistent pattern of privacy protection.16 The Shelby Amendment links into this system, so that personal privacy interests will receive the same sensitive handling, regardless of source.
Won’t the Shelby Amendment add cost on to researchers who will have to fill numerous FOIA requests? Grantees will only have to provide their data once upon request of the agency. Most grantees will probably never have to provide data. But if they do, they will simply copy it once for the agency, marking the areas they want to keep confidential. Moreover, that law explicitly states that "the agency may authorize a reasonable user fee [on requestors] equaling the incremental cost of obtaining the data,"17 so agencies can properly shift the costs of the FOIA process on to the requester. Hence, the agency bears the processing costs and then charges the costs of searching and screening to the requester.
Will making the data available to the public chill academic freedom? Given that FOIA clearly protects both individual privacy and property rights, applying FOIA to grant research won’t adversely impact the scientific process. If anything, access to this information will encourage healthy peer review, enabling the scientific establishment to weed out unsound research and uphold good research. The existence of flaws in social science data has led at least one court to repudiate a federal rule based on the erroneous study.18 The ability to detect errors is critical when these studies have such profound impacts on public policy. Scientists aspire to do accurate work, and when they receive federal funding, their accuracy has a public dimension, which is served by allowing public access to the data.
Can FOIA requests be used to deliberately disrupt ongoing research? No. The research will be completed at the time of the publication results. The OMB rule implementing the data access law clearly states that the law applies only to published studies. Moreover, the OMB proposed rule also states that it follows the intent of the law, which "According to Congressional floor statements ... is to ‘provide the public with access to federally funded research data’ that is ‘used by the Federal Government in developing policy and rules.’"19 Given that agencies need complete studies on which to base their rules, the law provides access to data from complete studies related to public policy.
Conclusion. Researchers can overcome their fear of the unknown by coming to a better understanding the FOIA process. Unfortunately, FOIA is not well understood by those unfamiliar with its daily operation. In fact, the agencies already effectively screen out medical and other private records as well as shield proprietary documents. The data access law will work when fully implemented because the FOIA process, to which it will simply become a part, already works very well. It properly balances private interests in the data with the public’s interest in seeing the results of studies that the government funds.
For further information on the data access law, please read On Point No. 40 entitled "The Data Access Law: Decreasing Secret Science While Increasing Accountability" (June 7, 1999) By Jennifer Zambone. This On Point can be found on the Competitive Enterprise Institute website at www.cei.org
1 James T. O’Reilly is visiting Professor of Law at the University of Cincinnati and is the author of the standard reference treatise, Federal Information Disclosure (West 1977, 2d. Ed. 1992, Supp. 1999). He is also the author of numerous scholarly articles disclosure policy and FOIA’s evolution. Under University of Cincinnati policy, the views expressed in this paper reflect those of the author and do not necessarily reflect that of the University.
2 Forsham v. Harris, 445 U.S. 169 (1980).
3 Supreme Court justices dissenting from the majority opinion in Forsham v. Harris warned that if government-funded information related to the regulatory process is immune from FOIA access, "then government by secrecy must surely return."
4 Congressional Record, October 7, 1998, p. H9875, Vol. 144, No. 139; Pub. L. 105-277 Div. A §101(h).
5 5 U.S.C. §552(b)(4).
6 National Parks and Conservation Assn. v. Morton, 498 F. 2d 765, 790 (D.C. Cir. 1974).
7 Critical Mass Energy Project v. NRC, 975 F.2d 871, 879 (D.C. Cir. 1992), cert denied 113 S.Ct. 1579 (1993).
8 National Parks, 498 F.2d at 770.
9 3 C.F.R. 235; also published in the Department of Justice’s FOIA Update (Summer 1997) available at http://wwwusdoj.gov/oip/foia_updates/Vol_VIII_2/viii2page2.htm.
10 Critical Mass, 975 F.2d at 880.
12 See e.g., 21 CFR 20.61, outlining procedures under FOIA section 4 to keep confidential all information that private entities submit to FDA.
13 5 USC. §552(b)(6); 5 USC §552a et seq.
14 See e.g. Arieff v. Dept. of Navy, 712 F.2nd 1462 (D.C. Cir., 1983), shielding Senators’ prescription records; Epps v. Dept. of Justice, 801 F.Supp. 787 (D.D.C. 1992), summarily aff’d in part, No. 92-5360 (D.C. Cir. Apr. 29 1993), withholding autopsy photos; Katz v. Natl. Archives & Records Service, 862 F.Supp. 476 (D.D.C1994), preventing the release of x-ray films.
15 See e.g., Farnsworth v. Proctor and Gamble Co., 758 F.2d. 1545 (11th Cir. 1985), denying an industry request to access names and addresses of women involved in a CDC study.
16 64 Fed. Reg. 5684 (1999).
17 Congressional Record, October 7, 1998, p. H9875, Vol. 144, No. 139; Pub. L. 105-277 Div. A §101(h).
18 See e.g., Almay v. Califano, 569 F.2d 764 (D.C. Cir. 1977), vacating a hypoallergenic cosmetics rule.
19 64 Fed. Reg. 5684 (1999); Congressional Record, October 9, 1998, p. S12134.