Wolfe v. Department of Health and Human Services, Civ. A. No. 85-1033.

• Decision Date: 26 November 1985
• Docket Number: Civ. A. No. 85-1033.
• Citation: 630 F. Supp. 546
• Parties: Sidney M. WOLFE and Public Citizen Health Research Group, Plaintiffs, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant.
• Court: U.S. District Court — District of Columbia

630 F. Supp. 546

Sidney M. WOLFE and Public Citizen Health Research Group, Plaintiffs, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Defendant.

Civ. A. No. 85-1033.

United States District Court, District of Columbia.

November 26, 1985.

William B. Schultz, Alan B. Morrison, Washington, D.C., for plaintiffs.

Harold N. Iselin, Dept. of Justice, Civil Div., Washington, D.C., for defendant.

MEMORANDUM OPINION

JOHN H. PRATT, District Judge.

INTRODUCTION

Plaintiffs, Public Citizen Health Research Group and its director, Sidney Wolfe, M.D., seek disclosure under the Freedom of Information Act (FOIA) of records which indicate the subject matter and interagency transmittal dates of proposed food and drug regulations pending either at the Department of Health and Human Services (HHS) or the Office of Management and Budget (OMB). The parties have stipulated to the material facts about which there is no genuine dispute, and therefore, solely at issue is the novel question of law whether records which reveal the "status" of proposed regulations are exempt from disclosure under Exemption 5 of the FOIA, 5 U.S.C. § 552(b)(5). So far as we can determine, this is a case of first impression. For the reasons discussed below, we conclude that the requested information is not exempt.

FACTUAL BACKGROUND

On July 18, 1984, plaintiffs submitted by letter to the defendant HHS a FOIA request for "access to records which indicate what actions have been completed by the Food and Drug Administration, but which are awaiting a final decision or approval by the Secretary of HHS and/or OMB." That letter explicitly stated that plaintiffs were not seeking access to records which disclose the substantive contents of the actions in question, but only to portions of those records which identify the subject matter of those Food and Drug Administration (FDA) decisions which were pending before HHS or OMB for decision or review. By letter dated August 23, 1984, defendant denied plaintiffs access to the requested information on the grounds that it is exempt from disclosure under Exemption 5 of the FOIA. Plaintiffs renewed their request by letter dated March 7, 1985. Plaintiffs did not receive a response within ten working days, nor have they received any response to date. Plaintiffs initiated this law suit on April 1, 1985.

On April 16, 1985, plaintiffs submitted to HHS a second FOIA request which reiterated their first request and in addition sought access to "records which indicate the date on which the record was transmitted from FDA to HHS, and where applicable, the date on which the matter was transmitted from HHS to OMB, and the date on which the matter was transmitted sic back from OMB to HHS." On April 19, 1985, defendant denied plaintiffs access to the information on the same grounds their first request was denied. On April 25, 1985, plaintiffs appealed the denial of their second request, which appeal was denied on May 31, 1985, by the Assistant Secretary for Management and Budget of HHS. On June 14, 1985, plaintiffs amended their complaint in this action to include their second request.

HHS maintains a Regulations Log that the parties agree generally contains all the information plaintiffs seek. The log is used by HHS as an internal tracking device that facilitates the Office of the Secretary's ability to follow actions moving through the clearance process. The log contains lists of actions by title and by the departmental component from which they originated and indicates the offices and persons to which the actions are routed and the actual and due dates of relevant steps in the clearance process, including dates on which actions are sent to OMB.

Pivotal to both parties' positions in the instant case is the rulemaking procedure in the area of food and drugs. Virtually all such regulations are initiated by the FDA. Once FDA determines that regulatory action should be taken, such recommendation is forwarded to the Secretary of HHS, and in turn, is usually sent for review and comments to other HHS offices. These offices then communicate their views, in writing or orally, to the Secretary, and often to FDA and other persons involved in the decisionmaking process. Only in the event that HHS concurs in FDA's recommendation to issue a notice of proposed rulemaking, will HHS submit the proposed rule to OMB for further review pursuant to Executive Order No. 12291, 46 Fed.Reg. 13,193 (1981).

Accordingly, disclosure of the fact that an HHS proposed regulation has been transmitted to OMB will also disclose the fact that HHS has recommended issuance of that proposed regulation. Likewise, disclosure of the fact that a FDA proposal has been transmitted to HHS will also likely disclose the fact that FDA has recommended issuance of that proposed regulation. Nonetheless, FDA may modify, or even rescind, its decision right up until the time when a notice of a proposed rule is sent to the Federal Register for publication. Moreover, HHS may from time-to-time communicate, orally or in writing, with OMB on a wide range of subjects, which may include tentative determinations not to take regulatory actions. Finally, the departmental clearing process is a fluid one and much of the actual process, as carried on through telephone calls and informal questions and comments, is not recorded in the log.

DISCUSSION

Exemption 5 of the FOIA exempts disclosure of "inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency." 5 U.S.C. § 552(b)(5). Congress intended this exemption to incorporate the government's common law privileges protecting it from discovery in litigation. National Labor Relations Board v. Sears, Roebuck & Co., 421 U.S. 132, 149, 95 S.Ct. 1504, 1515-16, 44 L.Ed.2d 29 (1975). The discovery privilege at issue in the instant case is the "executive" or "deliberative process" privilege, the ultimate purpose of which is to "prevent injury to the quality of agency decisions." Id. at 151, 95 S.Ct. at 1516. In construing this privilege, the Supreme Court has afforded its protections only to documents which are pre-decisional, and has further distinguished between "materials reflecting deliberative or policy-making processes on the one hand, and purely factual, investigative matters on the other." Environmental Protection Agency v. Mink, 410 U.S. 73, 89, 93 S.Ct. 827, 837, 35 L.Ed.2d 119 (1973). Thus, even if a document is pre-decisional, "the privilege applies only to the `opinion' or `recommendatory' portion of a document, not to factual information which is contained in the document." Coastal States Gas Corp. v. Department of Energy, 617 F.2d 854, 867 (D.C.Cir.1980).

The burden of showing that the plaintiff's request conforms to the requirements of Exemption 5 falls on the defendant. 5 U.S.C. § 552(a)(4)(B). The parties have stipulated that the plaintiffs are not seeking access to records which disclose the specific contents of the actions in questions and are agreed that such contents, until such time that they are published in the Federal Register, clearly are exempt under Exemption 5. Rather, plaintiffs distinguish their request as seeking information that is factual, not deliberative, and therefore, is not exempt from disclosure under the deliberative process privilege. Defendant responds with two arguments. First, defendant denies that the requested material is entirely factual and submits that disclosure of the requested information would in fact reveal significant substantive aspects of the decisionmaking process. Second, defendant contends that even if the requested material is factual, the details of particular decisionmaking processes are as protected by the privilege as are the recommendations themselves or the advice and rationale underlying the same. We conclude that each of the defendant's arguments is without merit.

The Nature of the Requested Material

To assess whether the requested material is factual or deliberative, it is significant to note what information is already available to the plaintiffs. First, the basic scheme of interagency review, whereby regulatory recommendations are transmitted from FDA to HHS, and where applicable, to OMB and back to HHS, is already a matter of public record. Second, pursuant to Executive Order No. 12291, the FDA publishes a semi-annual agenda of proposed regulations that the agency expects to issue. The plaintiffs presently seek material which would allow them to consolidate this information; that is, they seek information which would enable them to ascertain the exact location where proposed regulations are pending and precisely the date when such proposals were transmitted for interagency review. Plaintiffs thus describe their...