Case No. VFA-0432, 27 DOE ¶ 80,158

August 27, 1998

DECISION AND ORDER

OF THE DEPARTMENT OF ENERGY

Appeal

Name of Appellant: Neutron Technology Corporation

Date of Filing: July 28, 1998

Case Number: VFA-0432

Neutron Technology Corporation (NTC) files this Appeal under the Freedom of Information Act (FOIA), 5 U.S.C. § 552, as implemented by the Department of Energy (DOE) at 10 C.F.R. § 1004. As explained below, we will deny the Appeal.

NTC requested, pursuant to the FOIA, materials concerning the trial treatment of brain cancer patients using Boron Neutron Capture Therapy (BNCT).(1) The trials were conducted by Associated Universities, Incorporated (AUI) at DOE’s Brookhaven National Laboratory (Brookhaven). The specific materials sought by NTC were the following.

1. Patient charts generated during the period September 14, 1994 to April 20, 1998.
2. Records showing the reactor power during patient treatment, the duration of neutron irradiation, and the protocol associated with each patient treated.
3. Documentation of post-irradiation calculations for each patient treated identifying actual treatment parameters for specified dose-delivery mechanisms.
4. Records showing dates of tumor diagnosis, treatment, recurrence, and patient death.
5. Documentation regarding the production, sale, and use of BPA-fructose during the clinical trials.(2)

Brookhaven responded to NTC’s request for records by stating that the requested information was contained in clinical research center records that belonged to AUI, and was thus not government property. Brookhaven's response included part of a contract for the clinical trials. Brookhaven concluded that the requested records were not subject to release under the FOIA.

In its Appeal, NTC raises three issues: (a) that there were two contracts for clinical trials, but the response letter cited only one contract; (b) the information requested by NTC cannot be construed as patient records; and (c) public policy favors disclosure of the requested documents.

Before considering the issues raised by NTC, we will examine a question not explicit in the Appeal -- whether the material is subject to the FOIA in the first place. Brookhaven stated in its letter to NTC that, according to the terms of the contract, the requested material is "considered the property of the contractor. Thus, the information is not government property and not subject to the FOIA."

The FOIA generally provides that any person has a right of access to federal agency records, except to the extent that such records, or portions thereof, are protected from disclosure by one of the specified exemptions or exclusions. The term "agency records," however, is not defined in the FOIA. In interpreting this term, we apply a two-step analysis developed by the courts for determining whether documents created by non-federal organizations, such as AUI, are subject to the FOIA. See, e.g., BMF Enterprises, 21 DOE ¶ 80,127 (1991); William Albert Hewgley, 19 DOE ¶ 80,120 (1989); Judith M. Gibbs, 16 DOE ¶ 80,133 (1987) (Gibbs). The analysis involves a determination (i) whether the organization is an "agency" for purposes of the FOIA; and, if not, (ii) whether the requested material is nonetheless an "agency record." Gibbs, 16 DOE at 80,595.

The FOIA defines the term "agency" to include any "executive department, military department, Government corporation, Government controlled corporation, or other establishment in the executive branch ... or any independent regulatory agency." 5 U.S.C. § 552(f). In addition, the courts have identified certain factors to consider in determining whether we should regard a private entity as an agency for purposes of federal law. In United States v. Orleans, 425 U.S. 807 (1976) (Orleans), a case that did not involve the FOIA, the Supreme Court defined the conditions under which a private organization must be considered a federal agency as follows: "The question here is not whether the ... agency receives federal money and must comply with federal standards and regulations, but whether its day-to-day operations are supervised by the Federal Government." Orleans at 815. In other words, an organization will be considered a federal agency only where its structure and daily operations are subject to substantial federal control. Ciba-Geigy Corp. v. Matthews, 428 F. Supp. 523, 528 (S.D.N.Y. 1977). Subsequently, the Supreme Court ruled that the Orleans standard provides the basis for ascertaining whether an organization is an "agency" in the context of a FOIA request for "agency records." Forsham v. Harris, 445 U.S. 169, 180 (1980) (Forsham). See also Washington Research Project, Inc. v. HEW, 504 F.2d 238, 248 (D.C. Cir. 1974), cert. denied, 421 U.S. 963 (1975) (degree of independent governmental decision- making authority considered); Rocap v. Indiek, 539 F.2d 174 (D.C. Cir. 1976).

Although DOE contracted for AUI’s services and exercised general control over the contract work, it did not supervise AUI’s day-to-day operations. See Contract No. DE-AC02- 76CH00016. We therefore conclude that AUI is not an "agency" subject to the FOIA.

Although AUI is not an agency for the purposes of the FOIA, its records could become "agency records" if DOE obtained them and they were within DOE’s control at the time of NTC’s FOIA request. Department of Justice v. Tax Analysts, 492 U.S. 136, 144-46 (1989); Kissinger v. Reporters Comm. for Freedom of the Press, 445 U.S. 136 (1980); Forsham, 445 U.S. at 182. In this case, Brookhaven personnel informed us that the materials requested by NTC were not in DOE's control at the time of the request. Based on these facts, these documents clearly do not qualify as "agency records" under the test set forth by the federal courts. Tax Analysts, 492 U.S. at 145-46; Forsham, 445 U.S. at 185-86.

Even if contractor-acquired or contractor-generated records fail to qualify as "agency records," they may still be subject to release if the contract between DOE and the contractor provides that the document in question is the property of the agency. DOE’s regulations state that "when a contract with DOE provides that any records acquired or generated by the contractor in its performance of the contract shall be the property of the Government, DOE will make available to the public such records that are in the possession of the Government or the contractor, unless the records are exempt from public disclosure under 5 U.S.C. § 552(b)." 10 C.F.R. 1004.3(e)(1).

Article 94 of the contract between DOE and AUI that concerns the materials requested by NTC states that:

(b) The following records are considered the property of the Contractor and are not within the scope of paragraph (a) [defining the government’s records] above....

(2) .... Clinical Research Patient Records.

Modification No. M327 Supplemental Agreement to Contract No. DE-AC02-76CH00016.

Since the materials requested by NTC are Contractor records, we find that they are neither "agency records" within the meaning of the FOIA nor subject to release under the DOE regulations.

The number of contracts in question

NTC states in its Appeal that:

there were two government contractors during the period in question, but only one contractual provision was provided as the basis of denial. Did the other contract contain the same provision?

According to Brookhaven, NTC is correct in stating that two contracts have been awarded for BNCT research. Brookhaven personnel added, however, that work has not started on the second contract. All records that would be responsive to NTC's request, therefore, would have been generated under the contract referenced in Brookhaven's response.

The status of the requested material as "patient records"

NTC's next argument claims that:

the denial was a blanket denial for all the requests even though most of the other information requested would not fall under any reasonable definition of "patient records."

When we contacted Brookhaven about the claim that certain of the requested documents might not fall under the contract provision regarding patient records, personnel there assured us that all the materials requested by NTC fall under the category of "clinical research center patient records." Moreover, since the descriptions of the documents requested by NTC all plausibly refer to records generated in clinical treatment of patients, we see no reason to doubt Brookhaven’s characterization of the material.

Public policy as a basis for the release of the requested material

NTC's last claim is that:

there should be an overriding public policy to disclose this information to the general public because terminally diagnosed brain cancer patients and their doctors cannot assess all the treatment options without access to this information. There is no other source, public or private. Patient confidentiality can be protected... It just doesn't seem right to me that a government funded researcher should be able to sequester clinical research results for almost two years to the detriment of cancer patients and their doctors.

As discussed above, the material requested by NTC is neither the property of the government nor subject to release under the FOIA. Thus, the issue of whether Brookhaven should release it on public policy grounds is moot.

In summary, we find no basis in NTC’s Appeal to remand this matter to Brookhaven or to order the release of the requested material. Accordingly, we will deny NTC’s Appeal.

It Is Therefore Ordered That:

(1) The Appeal filed by Neutron Technology Corporation, Case No. VFA-0432, is hereby denied.

(2) This is a final Order of the Department of Energy of which any aggrieved party may seek judicial review pursuant to the provisions of 5 U.S.C. § 552(a)(4)(B). Judicial review may be sought either in the district where the requester resides or has a principal place of business or in which the agency records are situated or in the District of Columbia.

George B. Breznay

Director

Office of Hearings and Appeals

Date: August 27, 1998

(1)Boron Neutron Capture Therapy is an experimental procedure for treating cancer of the brain. For further information on Boron Neutron Capture Therapy, see "A Prescription for Hope" in the Berkeley Lab Research Review, Fall 1997.

(2)FOI Requests from Ron J. Twilegar of NTC dated April 20, 1998 and April 23, 1998. The two request letters have been consolidated for the purpose of this Decision and Order.